Home Page Search Final Report Interim Report Evidence - Transcripts - Witness Statements - Submissions - CCNR Report and associated documents - Statistical Reports and associated documents - Background Papers - Expert Papers Inquiry Seminars About the Inquiry Help		Daily transcripts Hearing summary 21 July 1999   Today the Inquiry heard evidence from retired Medical Director and Cardiothoracic Consultant Surgeon at United Bristol Healthcare NHS Trust (UBHT), Mr James Wisheart. Mr Wisheart answered questions from the Inquiry Panel relating to his workload as Medical Director, resources and the role of the Medical Royal Colleges in maintaining standards. He was then re-examined by his own legal representative in order to clarify several issues covered heard during previous evidence. Mr Wisheart’s legal representative then made a brief statement outlining the history of the Cardiac Surgery Department at UBHT from 1975 onwards and Mr Wisheart’s involvement in audit.   Professor Michael Green, Royal College of Pathologists, gave oral evidence to the Inquiry. He described the importance of the autopsy in medical practice, focussing on its use in the recognition of new diseases and in the assessment of new surgical techniques, the dissemination of information, the teaching of medical students, identifying trends in the community and providing tissue for transplantation. He went on to discuss the issue of retention of tissue and the information which should be given to relatives prior to a post-mortem taking place and consent for retention being given. He explained that tissue often needed to be retained for some time in order for a full pathological examination to take place. He concluded by commenting on the disposal of tissue.   Mr Robert Clifford, of the Home Office, Coroners Unit, concluded the day’s evidence. He told the Inquiry about the Home Office’s powers and duties in relation to coroners. These responsibilities include their appointment, regulation and training. He went on to discuss the Home Office’s advocacy of consistency in the approach of coroners. He commented on whether it was the role of the coroner to identify trends amongst the deaths reported to them and concluded by describing the complexity of the disposal of tissue at a later date than the original burial or cremation.

FULL TRANSCRIPT

   1                      Day 42, 21st July 1999
   2   (9.30 am)
   3            MR JAMES WISHEART (RECALLED):
   4   THE CHAIRMAN: Good morning, everyone. Good morning,
   5     Mr Wisheart. Mr Langstaff?
   6   MR LANGSTAFF: Good morning, sir. Mr Wisheart, this morning
   7     there are some questions from the Panel, and then
   8     Mr Moon wishes to ask you some questions in
   9     re-examination.
  10   A. Thank you.
  11             EXAMINED BY THE PANEL:
  12   MRS HOWARD: Good morning Mr Wisheart. Just one question.
  13     You have made mention of the advantage of having
  14     a doctor as a Chief Executive. I wonder whether we
  15     could just talk for a few minutes about that: do you
  16     feel that the fact that Dr Roylance was a doctor, he may
  17     have taken on much of the clinical and management types
  18     of issues that may have come your way as a Medical
  19     Director if he had not been a doctor? That would be the
  20     first part of the question I would like to ask you.
  21   A. Thank you. I think that that undoubtedly happened.
  22     I think not as much as part of any deliberate policy,
  23     but because of his knowledge and relationships within
  24     the hospital group. It just happened automatically.
  25     I think we both recognised that and it was not

   1     a problem. But of course its significance for me was
   2     when he retired, then of course I had to expect that
   3     rather more work of that sort might land up with myself.
   4   Q. Would it be a reasonable comment, therefore, to say that
   5     you may have moved from a rather ambassadorial role to
   6     a more direct management role with your fellow doctors?
   7   A. That is interesting. I had never thought of it quite
   8     that way. I think that, in the conversations we have
   9     had about my role as Medical Director, I hope it has
  10     been clear that the role expanded really quite
  11     dramatically over a few years. I think that was not
  12     chiefly due to the fact that Dr Roylance retired;
  13     I think it was due to all the new issues that came on to
  14     the agenda, the junior doctors' hours, Calman and so
  15     forth, that we went over on Monday, I think. Looking
  16     back, I would say that it was the work I had to do in
  17     relation to those and other similar issues that
  18     developed my role as a manager in relation to my
  19     colleagues, whereas before I would have exhorted them on
  20     this and that, but there was so much to do that was
  21     really management, but it grew and it grew very
  22     definitely in that way.
  23   MRS HOWARD: Thank you very much.
  24   THE CHAIRMAN: Professor Jarman?
  25   PROFESSOR JARMAN: I do not want to discuss any of the

   1     details of concerns but more general points. Two or
   2     three questions. In your evidence on page 57, you have
   3     previously talked about financial problems all the way
   4     through, and you mentioned, I am quoting to you,
   5     a shortage of equipment, nurses, et cetera, which you
   6     described as "potentially dangerous".
   7        I do not know if you would like to see that, on
   8     page 57? I can read it out to you. You said:
   9        "... problems that might relate to shortage of
  10     equipment, shortage of nurses, blocked beds and other
  11     potentially dangerous circumstances."
  12        We have heard earlier in the Inquiry about
  13     problems with equipment and so on. Were there any
  14     particular problems that you met, for instance with
  15     shortages due to financial problems and so on?
  16   A. Please correct me if I am wrong, but I think the context
  17     of the extract that you have referred to is in relation
  18     to whether or not an operation was carried out, and
  19     I think it goes on to say that where there was such
  20     a potentially dangerous situation, then in fact an
  21     operation might from time to time have to be cancelled.
  22     Please correct me if I am wrong.
  23   MR LANGSTAFF: Sir, I wonder if perhaps both Mr Wisheart
  24     and those who watch would be assisted by having
  25     WIT 120/57 on the screen?

   1   PROFESSOR JARMAN: It is talking about avoidance of --
   2     unsafe or dangerous circumstances.
   3   A. Yes.
   4   Q. You had earlier in your evidence talked about continuing
   5     financial problems, and then in particular, you say:
   6        "Under this heading one has to consider the
   7     possibility of short-term problems that might relate to
   8     shortage of equipment, shortage of nurses, blocked beds
   9     and other potentially dangerous circumstances."
  10        Did you have any instances or examples of, for
  11     instance, problems with equipment?
  12   A. I think what I am referring to here is not so much the
  13     larger overriding question of resources but the fact
  14     that at any given time we had a finite resource: beds,
  15     ventilators, equipment, numbers of nurses, numbers of
  16     doctors and so forth. Within that finite resource,
  17     there is always the possibility that nurses might be
  18     sick, that a ventilator might be out of order,
  19     circumstantial things of that nature. If something like
  20     that did happen -- and if of course we were aware of
  21     it -- then it might be necessary to postpone an
  22     operation because otherwise the safety of the patient
  23     would be at risk.
  24        That is what I am referring to in this section.
  25   Q. But you did not have any particular examples that

   1     you can think of that would cause problems?
   2   A. Do you mean an example of malfunctioning of equipment
   3     that would cause a problem with a patient?
   4   Q. That type of thing, because it has been referred to
   5     previously in this Inquiry.
   6   A. The incident that comes to mind is indeed the one
   7     that has been referred to, and maybe that is why it has
   8     come to mind. There was the question of the infusion
   9     pumps which were found to malfunction, and I think Fiona
  10     Thomas has discussed that. I can certainly recall that
  11     because there was a lot of discussion and thought about
  12     that at the time.
  13        I honestly feel I need notice to give you a proper
  14     answer to that one, because I cannot say that there were
  15     no incidents. I think I would need to think about it to
  16     give you a precise answer.
  17   Q. It is more the general impression that I want to get
  18     from you.
  19   A. I do not believe the situation was generally one in
  20     which there were recurring problems. I believe the
  21     situation was one in which the equipment was well
  22     maintained, functioned satisfactorily, but inevitably
  23     occasionally there is the possibility of something
  24     having happened.
  25   Q. Just to go on to the next question, on page 34 you

   1     say that the Colleges had statutory responsibility for
   2     the maintenance of standards. Did you feel that that
   3     was the case?
   4   A. I think throughout my time as a consultant, I was
   5     always conscious that those responsibilities were
   6     exercised in at least two ways, maybe three ways: first
   7     of all, their role in any consultant appointment, be it
   8     a new or replacement appointment; secondly, their role
   9     in the supervision of training of people for hospital
  10     specialties, which of course grew in its detail and its
  11     sort of interventionist interest over the period of my
  12     consultant life. And I think that the third role which,
  13     again, I think became more important in the latter part
  14     of the period, was their role in making recommendations
  15     about practice. The one that comes to mind is the issue
  16     of the book about guidelines on day case surgery. They
  17     also issued 1989 guidelines about clinical audit. So
  18     they were adopting a more active role in relation to
  19     various aspects of clinical practice in the latter part
  20     of the period.
  21        Those would be the headings under which I would
  22     respond to that.
  23   Q. You do say that their advice would always be taken
  24     with the utmost seriousness?
  25   A. Yes.

   1   Q. There was a visit which has been reported to us by the
   2     Royal College of Physicians in 1992, when I think you
   3     were Medical Director. I think it was November 1992.
   4   A. Is that the visit in relation to the potential creation
   5     of a Senior Registrar in paediatric cardiology?
   6   Q. It was an inspection by the Royal College of
   7     Physicians. They said:
   8        "There are major problems due to great increase
   9     in workload. It seems probable that at times the
  10     quality of patient care may fall below safe levels."
  11        Would you tell me what sort of action in general
  12     might be taken in relation to something like that? It
  13     is quite a serious concern.
  14   A. That was a problem which was present then and which
  15     in fact grew as I think it grew in many hospitals
  16     through those years of the 1990s. I am sorry, I should
  17     say by way of preamble that I believe that this report
  18     concerned the training of Senior Registrars in general
  19     medicine.
  20   Q. But it was a general report actually about the
  21     situation in the hospital?
  22   A. I believe it was a report about the situation in general
  23     medicine.
  24   Q. Yes, it was about general medicine.
  25   A. I think the only information that they were receiving,

   1     reporting on and commenting on, was in the context of
   2     general medicine.
   3   Q. General medicine, that is correct.
   4   A. It is in general medicine where the increase in
   5     emergency admissions has posed such a big problem
   6     nation-wide. We certainly experienced that also. So it
   7     was a problem that we were conscious of and which was
   8     repeatedly being addressed at that time and over
   9     subsequent years, and in fact -- I am not sure of the
  10     exact year, but there were a number of quite major steps
  11     to reorganise the way we dealt with emergency medical
  12     admissions. The most dramatic of those was to create
  13     a ward -- I forget the number of beds, it might have
  14     been 16 or 20 -- which was specifically to receive
  15     emergency medical admissions. Previously they had gone
  16     to all the regular medical wards, so this was a specific
  17     admission ward with consultancy provision and staff
  18     allocated to it, medical nursing and so forth.
  19        So a series of steps were taken to try to meet
  20     with this growing problem.
  21   Q. So you were sympathetic to their view that there were
  22     possibilities, for the reasons that they stated, that
  23     there might be a problem and patient care could fall
  24     below a safe level?
  25   A. I think we were very concerned, not only because of

   1     their report but because of the situation that we
   2     recognised to be the case. We did seek to address it.
   3     But of course it continued to grow year by year, so in
   4     a sense the goalposts were constantly changing, but
   5     I think the step that I have mentioned was a most
   6     effective one.
   7   Q. The last question is that you mention on page 43 that
   8     you had these guidelines and then later on, page 61,
   9     that the guidelines were not used so much after the
  10     mid-1980s -- the guidelines you drew up with regard to
  11     patient care in cardiac surgery.
  12   A. Not so much after the late '80s.
  13   Q. The late 1980s, yes. Do you think there is any
  14     possibility that the non-use or less use of these
  15     guidelines could have affected patient care in any way?
  16   A. Maybe I should clarify just a little bit what happened,
  17     and that may answer your question. Beginning in 1975,
  18     when I began, there was of course just Mr Keen and
  19     myself, and then later on there was Mr Dhasmana who
  20     joined us, and then there was Mr Hutter. In the earlier
  21     days we were quite a small, cohesive group, and the
  22     guidelines that I drew up and revised from time to time
  23     were fairly consistently used at that time. But by the
  24     time the early and mid-90s had come, we were a larger
  25     group. There were at least five of us as surgeons, and

   1     there were of course diverse views and there were
   2     changing practices. So different people did have
   3     somewhat differing approaches to problems.
   4        So my remark about it not being used so
   5     consistently means that not all the surgeons used it in
   6     the way that pretty well all the surgeons had used it
   7     earlier. I myself continued to practice -- well, not in
   8     a rigid way according to the guidelines as practice
   9     evolved, but broadly according to those guidelines.
  10   PROFESSOR JARMAN: Thank you.
  11   THE CHAIRMAN: Mr Wisheart, I have no questions, but
  12     Mr Moon, re-examination?
  13           RE-EXAMINED BY MR MOON:
  14   Q. Mr Wisheart, the day before yesterday it was put to
  15     you that unlike Dr Thomas, you did not welcome outside
  16     input.
  17        In that context, can I ask you: did you have any
  18     part to play in the establishment of the chair in
  19     cardiac surgery?
  20   A. Yes. I had a considerable part to play.
  21   Q. Can you briefly summarise what part you had to play in
  22     that?
  23   A. In the first instance, it was my idea and it became
  24     a view and a conviction that it was right that an
  25     academic department of cardiac surgery, a University

   1     department, should be developed. I then discussed that
   2     with my immediate colleagues and following discussion
   3     over some period of time, we all agreed that that was
   4     correct.
   5        The next step was to prepare an outline proposal,
   6     and armed with that, if you like, we were able to gain
   7     the support of the hospitals on the one hand and the
   8     University on the other.
   9        We then proceeded to approach the British Heart
  10     Foundation, and again, after a long period of discussion
  11     and debate and negotiation, they agreed in principle to
  12     fund a personal chair in cardiac surgery.
  13   Q. What, if anything, do you say that says about your
  14     reactions to outside influences and outside input?
  15   A. There was not going to be an inside appointment to the
  16     chair, so clearly, whatever sort of a person it was who
  17     occupied the chair, he was going to be someone from
  18     outside and as a Professor, he would always have
  19     considerable influence, both within the department and
  20     within the hospital.
  21   Q. I would like now to turn to the question of workload.
  22     Yesterday and the day before you gave us some indication
  23     about certain reductions in workload which had occurred
  24     during the course of your career in Bristol.
  25        Can I ask you whether or not there was any

   1     reduction in about 1990 or 1991, in your workload at the
   2     Children's Hospital?
   3   A. Yes. I think I referred to that. This was a time
   4     following Mr Dhasmana's appointment -- it was a few
   5     years later -- and I had operated for two sessions there
   6     and he was operating for one session, so around 1990 or
   7     1991 we swapped that, so I gave him one session of mine
   8     and reduced my operating, therefore, from two sessions
   9     to one session.
  10   Q. So summarising, the effect of that is that you reduced
  11     your work at the Children's Hospital by one session in
  12     alternate weeks?
  13   A. Yes, thank you, it was alternate weeks. Thank you.
  14   Q. Was there a reduction in 1992 when you became Chairman
  15     of the Hospital Medical Committee?
  16   A. Yes. When I became Chairman of the Hospital Medical
  17     Committee I reduced my open-heart operating in the
  18     Infirmary from three whole days, that is six sessions,
  19     to four sessions each week.
  20   Q. And that was in what year?
  21   A. That was in 1992.
  22   Q. Can we turn now to 1995? In 1995 was there an occasion
  23     when you reduced your workload at the Children's
  24     Hospital yet further?
  25   A. When Mr Pawade came to Bristol in May 1995, I withdrew

   1     from paediatric work so that one session on alternate
   2     weeks that we mentioned just now I no longer carried
   3     out. So I stopped doing that.
   4   Q. Lastly, was there a yet further reduction when you
   5     became Medical Director?
   6   A. There was a further reduction when I acquired a new
   7     job description and contract for being Medical Director
   8     in early 1996. At that point, I reduced my open-heart
   9     operating further from four sessions to two sessions
  10     each week, that is to say, one whole day.
  11   Q. You were asked on the first day whether anyone had ever
  12     suggested to you that your managerial commitments might
  13     be having a negative impact on your clinical work. You
  14     told the Panel that you were asked that by a Professor
  15     Stirrat.
  16        What you were not asked was what your answer to
  17     that question was. I wonder if I could ask you, what
  18     was your answer to Professor Stirrat's question?
  19   A. It was a serious question and it had a serious answer
  20     and my answer was that I believed it did not have
  21     a negative impact upon my clinical work.
  22   Q. You were also asked generally about workload. Can I ask
  23     you this: were there others who you felt had a similar
  24     workload to you, or were you unique in that respect?
  25   A. I always felt that there were a large number of my

   1     colleagues who carried a very similar load of
   2     professional work. There are a number of possible
   3     areas: it could be academic work; it could be work with
   4     the Royal Colleges, specialist societies; it could be
   5     work in private practice. All legitimate and proper
   6     activity, but I know many colleagues who worked
   7     certainly as hard and in some instances harder, that is
   8     to say, longer hours than myself.
   9   Q. Can I ask you this: would you find it invidious to
  10     name names on this topic?
  11   A. I would hesitate to, but if anyone felt that it would
  12     make what I am saying more acceptable, then I could
  13     certainly do so. But there is not a shortage of names.
  14   Q. I do not think I will pursue that. Did you or did you
  15     not take your full holiday entitlement?
  16   A. I did take my full holiday entitlement.
  17   Q. Can we now turn to the question of audit. You were
  18     asked a number of questions yesterday about regular
  19     audit and the effect of your answers was that regular
  20     audit began from about late 1989.
  21        Can I ask you whether it was your practice to
  22     carry out audit, in the broadest sense of the word,
  23     before 1989?
  24   A. Yes, we did. Whether the correct adjective is "broad"
  25     or "primitive" or what, but we carried out an activity

   1     which we will describe as "audit" in the sense that it
   2     was a monitoring of the results of our work.
   3   Q. I wonder if we could have turned up document JDW 7 at
   4     page 4?(JDW 7/4) This is a document dated 6th June 1986. It is
   5     a memorandum from you to a number of doctors,
   6     cardiologists, surgeons and -- are there any
   7     anaesthetists there?
   8   A. Yes, Dr Masey is an anaesthetist and at that time
   9     Mr Hutter and Mr Chatterjee were our junior surgical
  10     colleagues. Dr Wilde is a cardiac radiologist.
  11   Q. Dr Joffe and Dr Jordan are both cardiologists?
  12   A. Correct -- paediatric.
  13   Q. The heading is the "Fontan operation" and there is
  14     a reference in the first paragraph to the sad death of
  15     a patient. At the bottom of the page, having identified
  16     a number of other difficulties in relation to the Fontan
  17     operation, the last paragraph says:
  18        "When faced with a problem of this type, there
  19     seem to be two attitudes which can arise in response.
  20     The first one can say is that if the correct things are
  21     being done then one should persevere and things will
  22     come right in due course. Secondly, one can say because
  23     of the disappointing results things are not being done
  24     right and therefore must be altered."
  25        You go on to say, over the page to page 5(JDW 7/5) of this

   1     document, that you believe that probably a combination
   2     of views is appropriate and as a basis for further
   3     discussion you say you would like to concentrate on the
   4     selection criteria and make the following suggestions.
   5        You make a number of suggestions including the
   6     setting up of a formal written protocol to be checked
   7     out in every case.
   8        You are suggesting in this memorandum some
   9     discussion with the recipients of this document. Did
  10     that discussion take place?
  11   A. Yes, it did.
  12   Q. And put shortly, what was the result of that
  13     discussion?
  14   A. The result of the discussion was that we should be
  15     much more rigorous in the application of the selection
  16     criteria for this particular operation.
  17   Q. In general, how does this document reflect your attitude
  18     to "primitive" audit, if I can put it in that way?
  19   A. This document essentially is something I wrote because
  20     I considered that the results of this operation, at that
  21     particular time, were disappointing. So I wanted to
  22     draw the attention of my colleagues to that so that we
  23     could discuss it together. I then go on to suggest, as
  24     I have pointed out, some possible reasons for the
  25     disappointment, that we should consider, and some

   1     possible changes or adjustments in our approach that we
   2     perhaps should consider implementing.
   3        But because the work is teamwork, it was important
   4     that we should look at it together. That was what
   5     happened.
   6   Q. Could I ask the document UBHT 61/218 to be turned up?
   7        This is a letter to you, we can see, dated
   8     16th March 1990. If we scroll to the bottom of the
   9     page, we can see that it is from Mr Sethia, a consultant
  10     cardiac surgeon at the Children's Hospital in
  11     Birmingham.
  12        Going back up to the top of the page, the heading
  13     of the letter is "Second annual meeting of the UK
  14     paediatric cardiac surgical group."
  15        Mr Sethia refers to a letter from you in the first
  16     paragraph, and then in the second paragraph he says:
  17        "I write to you because I took the opportunity to
  18     publicise the comments enclosed in your letter to me of
  19     4th January 1990 and you will be pleased to know that
  20     your comments received general support and in
  21     particular, this seems to be a measure of agreement that
  22     we should move towards some more generalised system of
  23     audit."
  24        Do you recall the gist of your letter to
  25     Mr Sethia of 4th January 1990? We do not have that in

   1     the documents that I am aware of, but do you remember
   2     what the gist of that letter was?
   3   A. Unfortunately, I do not have the letter either but the
   4     gist of the letter was to suggest that all the
   5     paediatric cardiac surgeons in the UK should work
   6     together to develop a common database, a common source
   7     of information, that would be similar to the UK cardiac
   8     surgical register, but much more detailed, so that we
   9     would be helped by that in auditing our work and in
  10     sharing information, because as we said yesterday, there
  11     is a terrific problem in paediatric cardiac surgery
  12     stemming from the small number of operations in each
  13     individual category.
  14   Q. Could I ask now for you to look at document DOH 4 at
  15     page 45? We looked at this document yesterday; it is
  16     a document dated either 6th or 8th February 1992. If we
  17     identify those present, it relates to a meeting with
  18     people at the Department of Health, including Mr Owen.
  19     You are the third person mentioned under "Bristol",
  20     although your name, I think, is misspelt.
  21        If we scroll down the page, you were referred to
  22     the second substantial paragraph beginning with
  23     "Mr Wisheart presented the surgical results to date."
  24        You gave certain statistics comparing the Bristol
  25     results with the UK average results.

   1        What, if anything, do you feel this document has
   2     to say about your attitude in relation to sharing
   3     information with the Department of Health?
   4   A. Mr Owen was a civil servant and my understanding is
   5     that his interest was limited to knowledge of the number
   6     of operations we carried out, but at the meeting, he was
   7     provided with information by category with the results
   8     and with the UK comparator in terms of what was
   9     available at the time.
  10        Indeed, there is some evidence that he also had
  11     a paper record of these results which he took away,
  12     because one of the documents is in the file from the
  13     DOH .
  14        So I was anxious that our results should be on
  15     the table, should be openly known and that hopefully one
  16     would benefit from feedback and so forth.
  17   Q. Can I now ask you to turn to the document UBHT 308/170?
  18     This is a letter from you to Professor Berry, which you
  19     were taken to and cross-examined on in some detail
  20     yesterday, a letter dated 9th September 1992.
  21        Parts of the letter were quoted to you by
  22     Mr Langstaff in the course of that cross-examination.
  23   THE CHAIRMAN: Mr Moon, I prefer "examination".
  24   MR MOON: I beg your pardon, sir. I am sure that is not
  25     a Freudian slip, but I apologise.

   1   Q. One sentence which Mr Langstaff did not identify to you
   2     is the penultimate sentence. I wonder if we could read
   3     that together:
   4        "I would be grateful therefore if you would simply
   5     confirm your advice and of course we can discuss it the
   6     next time we meet. Thanks for your letter."
   7        So there you are asking for confirmation of the
   8     advice that Professor Berry had apparently given you,
   9     given your confusion about the apparent easing in
  10     relation to the new Coroner.
  11        Do you recall receiving such confirmation at any
  12     time from Professor Berry?
  13   A. I do not recall any further conversation or letters on
  14     this subject following this.
  15   Q. Can we turn, please, to UBHT 60 at page 1: the
  16     application for Trust status.
  17        If we turn to page 41(UBHT 60/41), please, and scroll down
  18     the page, under the heading "Quality of service" you
  19     were referred in examination by Mr Langstaff to the
  20     sentences:
  21        "Within the Trust, each contract will be the
  22     personal responsibility of a Clinical Director supported
  23     by a manager" and the next sentence and that following
  24     were referred by Mr Langstaff to you.
  25        Did you write this document?

   1   A. No. I had no part in the writing of this document.
   2   Q. Lastly, Mr Wisheart, we have discussed this morning the
   3     guidelines which you wrote for the care of cardiac
   4     surgical unit patients. I think the guidelines appear
   5     at UBHT 152/8. That is the font page of the guidelines
   6     which you wrote.
   7        In fact this document is a 69-page document with
   8     five appendices. I think we looked at one or two
   9     sentences in the introduction yesterday.
  10        Can you just summarise for me: what was this
  11     document and what was its purpose?
  12   A. The document is basically a handbook setting out how
  13     I, after consultation with many of my colleagues, felt
  14     the patients should be treated. So it contained
  15     a framework for the treatment of the patients both
  16     pre-operatively and post-operatively.
  17        It sought to provide for the needs of a patient
  18     who went through in a fairly uncomplicated way, and it
  19     also sought to give advice for the various problems that
  20     might arise and how they should be approached.
  21        It was important to do this because the care of
  22     cardiac surgical patient involves doctors and nurses and
  23     other people from many disciplines who have to work
  24     together, so it was intended as a document which would
  25     help to co-ordinate the contributions of the different

   1     team members.
   2        Of course, in intensive care, which is a 24-hour
   3     enterprise, people obviously work for a time and then
   4     hand over their responsibility to others, and so forth,
   5     so it is quite important to achieve consistency of care
   6     with those changes taking place.
   7        Of course, finally, working with members of the
   8     team of varying experience and competence, it is
   9     important that they should each have some understanding
  10     of what are the limits to which they should go.
  11        So there is very positive advice here as to when
  12     people should be seeking advice.
  13   Q. Did I understand your evidence yesterday correctly:
  14     you effectively wrote this document?
  15   A. Well, I wrote it in collaboration with colleagues
  16     because, in as much as it was intended to integrate the
  17     work of a team, then I had to have the views and
  18     contributions of the team members, which made it much
  19     more difficult to write, but that was done.
  20   MR MOON: I am grateful. Sir, I have no further questions.
  21   THE CHAIRMAN: Thank you, Mr Moon, I am very grateful.
  22     That was most helpful.
  23   MR MOON: Sir, I have a brief application -- it is a brief
  24     application -- to make a short speech on behalf of
  25     Mr Wisheart. I wonder if it would be appropriate for me

   1     to do that now, or whether it might perhaps be more
   2     appropriate for Mr Wisheart to leave the witness-box?
   3     I am entirely in your hands, sir.
   4   THE CHAIRMAN: Why do we not ask Mr Wisheart to step
   5     down, but before we do so, merely say, you gave evidence
   6     for two long days, and we are grateful. We have been
   7     helped by what you have had to say. We will hear from
   8     you again in due course, but for the moment, thank you.
   9            (The witness withdrew)
  10   THE CHAIRMAN: Mr Moon?
  11   MR MOON: Sir, I shall not take longer than 15 minutes.
  12     I think I took exactly 20 minutes to re-examine, and
  13     I do not intend to take more than 15 minutes in making
  14     this short speech.
  15        MR MOON: SPEECH ON BEHALF OF MR WISHEART
  16   MR MOON: The speech deals with two main subjects. The
  17     first is an overview of the history of the cardiac
  18     surgical unit at Bristol, which I thought might be
  19     helpful to the Panel, and secondly, a focus on
  20     Mr Wisheart's part in the development of audit
  21     generally.
  22        Dealing first of all with the question of the
  23     history, in 1975 Mr Wisheart arrived at Bristol and at
  24     that time the cardiac surgical unit was undertaking
  25     about 110 open-heart adult and paediatric operations per

   1     year. There was one full-time and one half-time surgeon
   2     and the future was clearly quite uncertain.
   3        By 1995 the number of open-heart operations in
   4     Bristol had increased to approaching 1,000. There were
   5     five surgeons. The paediatric work was established in
   6     the Children's Hospital and the adult work in the
   7     Infirmary. It is fair to say, and you have heard
   8     a great deal of evidence about this already, that that
   9     development was incremental and each step came after
  10     what might be described as quite a hard struggle. The
  11     unit was always under immense pressure and the number of
  12     patients needing operations really exceeded the
  13     resources available to cater for those patients.
  14        Through nearly all of this time, the closed
  15     operations, the closed-heart surgery was performed at
  16     the Children's Hospital and the open-heart surgery in
  17     the Infirmary and this undoubtedly increased the
  18     pressure and demands placed on the surgeons because they
  19     had to see acutely ill patients in two different
  20     hospitals.
  21        The need to change this state of affairs was
  22     recognised in the early and mid-1980s, accepted as
  23     a practical proposition towards the end of the 1980s,
  24     and eventually achieved in 1995.
  25        It was suggested on the first day of his evidence

   1     to Mr Wisheart that whilst others welcomed outside
   2     input, Mr Wisheart did not. In my submission, that
   3     view, that suggestion, patently does not accord with the
   4     facts. It was Mr Wisheart who was the driving force
   5     behind the creation of the Chair in cardiac surgery and,
   6     sir, you will be well aware that academic approaches
   7     bring fresh and outside views to the practice of
   8     medicine in a practising department.
   9        That is just an example of Mr Wisheart's openness
  10     to outside influences. We saw this morning that
  11     Mr Wisheart was very careful to share information with
  12     the Department of Health in February 1992, at the
  13     meeting with Mr Owen.
  14        That is the history, a short overview of the
  15     history in Bristol.
  16        Turning now to the question of audit, Mr Wisheart
  17     was deeply involved in audit in the hospital and the
  18     Trust generally, as well as within paediatric cardiac
  19     surgery generally. He was a member of the Audit
  20     Committee from the beginning when the leadership was
  21     provided by Dr Thomas and Dr Stansbie, and when
  22     Dr Thomas resigned, you will recall, no-one could be
  23     found to step into his shoes so Mr Wisheart became
  24     Chairman of the Audit Committee thereafter.
  25        Mr Wisheart assisted the process of change from

   1     unidisciplinary to multidisciplinary clinical audit and
   2     strengthened audit at directorate level. He was
   3     involved with discussions with the purchasers about the
   4     role of audit within the service agreements, and he was
   5     involved in the evolution of audit to enable the
   6     purchaser and the provider to work together. There are
   7     numerous examples of his advocacy in relation to audit
   8     of outcomes in the minutes of the meetings, through the
   9     latter part of 1994 and in 1995 and indeed, Mr Wisheart
  10     organised a national conference about outcomes in
  11     January 1995.
  12        It is also clear from the documents and from his
  13     evidence that Mr Wisheart advocated openness about
  14     outcomes. Even before formal audit was introduced,
  15     Mr Wisheart maintained his personal log of all the
  16     open-heart operations he carried out, and from 1977
  17     until 1992 he completed a return to the United Kingdom
  18     Cardiac Surgical Register on behalf of the unit.
  19        From the early 1980s until 1992, Mr Wisheart
  20     produced an annual statistical summary of the cardiac
  21     surgical work, including the paediatric cardiac surgical
  22     work of the unit. The 30-day mortality was given,
  23     together with the mortality for all the relevant
  24     categories from the most recently published UK Cardiac
  25     Surgical Register. These facts may be seen simply by

   1     looking at the statistics, the successive annual
   2     statistical summaries.
   3        These facts do not appear to be consistent with
   4     the assertions by some that the figures were not
   5     available. These facts do not appear to be consistent
   6     with the assertions by some that the figures were not
   7     available in a form that could be compared with the
   8     United Kingdom Cardiac Surgical Register and these facts
   9     are not consistent with the assertions by some that
  10     mortality figures were just not available.
  11        From the mid-1980s the multidisciplinary meetings
  12     and the clinico-pathological conferences, together with
  13     the statistical summaries I have just mentioned, were
  14     effective, although primitive, forms of audit. The
  15     ethos of the audit meetings was an ethos of openness,
  16     self criticism and a desire to achieve constant
  17     improvement with an ethos of dialogue leading to
  18     improvement.
  19        Once audit became established and generally
  20     practised, paediatric cardiac surgery undertook audit in
  21     the following formats: firstly, paediatric cardiological
  22     audit completed by Dr Martin; secondly, cardiac surgical
  23     audit; thirdly, the clinico-pathological conferences
  24     following the death of a patient; and fourthly, the
  25     continued preparation of annual statistical summaries

   1     and the return of data to the United Kingdom Cardiac
   2     Surgical Registrar and to the Department of Health Supra
   3     Regional Services Advisory Group, or its ad hoc working
   4     parties.
   5        So, really summarising Mr Wisheart's part in
   6     relation to audit, there was openness in the use of the
   7     figures. They were generally circulated to members of
   8     the team. The figures including mortality and
   9     comparators were used at meetings with representatives
  10     of the Supra Regional Services Advisory Group and when
  11     they visited Bristol and by way of an example,
  12     Mr Wisheart made presentations to the Public Health
  13     doctors of the South West Region in March 1993.
  14        If I could just conclude by reference to one of
  15     the documents which has come up twice this morning, that
  16     is to say, the guidelines for the care of patients in
  17     the cardiac surgical unit, in my submission that
  18     document really reflects three aspects of Mr Wisheart's
  19     approach. The first is, his energy. Mr Wisheart, you
  20     can see, was an energetic person. The second aspect
  21     that that document reflects is his commitment to his
  22     patients. The third, which is connected in a sense with
  23     the second, is his attitude towards his patients.
  24        The prime object of those guidelines was to
  25     improve the standards of patient care in a situation

   1     where many different disciplines are working together
   2     and where, because of the 24-hour nature of the
   3     commitment, inevitably the care of the patient is handed
   4     over from one person to another from time to time, such
   5     a document was of immeasurable value. Within such
   6     a framework, it was particularly important to maintain
   7     co-ordination and continuity of the management of
   8     a patient, and that is what the book is directed towards
   9     and that is why it was revised three times and continued
  10     to be used. It was an important instrument in forging
  11     teamwork within the cardiac surgical unit.
  12        Of course, if one takes the time simply to
  13     skim-read this document, one can see immediately what
  14     the focus of the document is and what it was that was
  15     always at the forefront of Mr Wisheart's mind, and that
  16     is the well-being of his patients.
  17        Sir, thank you very much for giving me this
  18     opportunity to make a short speech on behalf of
  19     Mr Wisheart.
  20   THE CHAIRMAN: Thank you, Mr Moon. Mr Langstaff?
  21   MR LANGSTAFF: Sir, before I deal with the rest of
  22     today's programme, which I will in a moment, I wonder if
  23     I may just make two comments.
  24        It may have seemed to those who listened to
  25     Mr Moon that his application and the accession to it by

   1     the Panel may have come as a surprise, and I want to
   2     take this opportunity to remind both the general public
   3     and indeed the representatives of participants in the
   4     Inquiry that before this Inquiry ever started last
   5     October, it was said by you that those witnesses who
   6     chose to do so, by themselves or through their legal
   7     representatives, might make a short final presentation
   8     in writing or, at the panel's discretion, orally. That
   9     is, you will remember, an opportunity which Mr Lissack
  10     availed himself of I think at the end of the first day
  11     or the second day of the Inquiry, on behalf of parents,
  12     and Mr Moon has only, I think, been the second person to
  13     take advantage of it, which is why I simply remind
  14     people of it in the spirit that we engendered this week
  15     of reminding those of some of the ground rules that you,
  16     sir, have adopted for this Inquiry.
  17        May I also take this opportunity to reiterate one
  18     of those guiding principles that whatever the views of
  19     others may be and however expressed, it is the
  20     determination, I know, of this panel to make its own
  21     decision on the facts as seems right on the evidence
  22     that you hear.
  23        Reference was made quite rightly by Mr Moon to
  24     the fact that there were published records of statistics
  25     and audit during the time that Mr Wisheart had

   1     responsibility as, amongst other things, Associate
   2     Director of Cardiac Surgery. We, at the moment, in the
   3     Secretariat, have difficulty in tracing any such record
   4     beyond his tenure of office and during the tenure of
   5     office of Mr Dhasmana. I mention it at this stage so if
   6     anyone who is listening to this knows of the existence
   7     of those documents, would they please get in touch with
   8     the Secretariat so we can get to the bottom of things
   9     and know whether in fact those documents were actually
  10     produced, even if they were never circulated and if they
  11     were produced, whether they were circulated.
  12        I say this not to suggest that Mr Wisheart had
  13     responsibility for them, but simply to comment that, at
  14     the moment, it appears that they are absent, beyond the
  15     beginning of 1993.
  16        Sir, the rest of the morning, we have Professor
  17     Green. Miss Grey will be asking him questions. He, as
  18     I indicated yesterday, must finish his evidence by 12.30
  19     or thereabouts so that he may catch a train at a quarter
  20     past 1. We will then hear from Mr Clifford of the Home
  21     Office Coroners' Unit. Both witnesses will be directing
  22     their evidence towards the question of tissue retention
  23     and the exercise of the coronial jurisdiction.
  24        Sir, it may be appropriate, perhaps given the time
  25     at this stage, to take a short break before Professor

   1     Green begins. I suggest perhaps no more than 10
   2     minutes.
   3   THE CHAIRMAN: That is helpful, Mr Langstaff. If we
   4     take 10 minutes, then you are contemplating that we go
   5     through Mr Green's evidence throughout; is that right?
   6   MR LANGSTAFF: Yes.
   7   THE CHAIRMAN: Very well. Let us do that. Shall we break
   8     for 10 minutes until about half past.
   9   (10.25 am)
  10               (A short break)
  11   (10.40 am)
  12   MISS GREY: Sir, we have today now the evidence of Professor
  13     Michael Alan Green, who is speaking on behalf of the
  14     Royal College of Pathologists. If I could ask firstly
  15     for witness 210/1 to be put up on the screen.
  16        Before we come to the detail of the evidence, we
  17     have, of course, been taking evidence on oath or
  18     affirmation in the Inquiry, so could I invite you to
  19     stand first, please?
  20         PROFESSOR MICHAEL ALAN GREEN (SWORN):
  21             Examined by MISS GREY:
  22   Q. Would you like to sit, Professor Green?
  23        Professor Green, we have here the first page of
  24     your witness statement to the Inquiry. If we could
  25     simply turn to the second page, is that your signature

   1     that we see at the bottom?
   2   A. It is, yes.
   3   Q. Are the contents of this statement true to the best of
   4     your knowledge and belief?
   5   A. They are.
   6   Q. If we could also turn to WIT 54/2, this is the statement
   7     of Professor MacSween on behalf of the Royal College of
   8     Pathology --
   9   A. May I interrupt for one moment, Miss Grey? It is, for
  10     the record, the Royal College of Pathologists. It is
  11     the Association of Clinical Pathology, but the College
  12     is the Royal College of Pathologists. I think we had
  13     better have it correct for the purposes of the record.
  14   Q. If we could scroll down the page, please, we see there
  15     that Professor MacSween speaks of consulting you in
  16     relation to part of his statement; is that correct?
  17   A. That is correct, yes.
  18   Q. Can you tell me what your involvement was with Professor
  19     MacSween's statement?
  20   A. My involvement was to prepare a briefing document which
  21     I can produce should the Inquiry so require. It is
  22     dated 3rd March of this year and in fact Professor
  23     MacSween has used it almost word for word with only
  24     minor modifications in preparing pages 25 to 35 of the
  25     report which he has submitted.

   1   Q. If we turn to page 25 of his statement, which you have
   2     just referred to, it should be coming up on the screen
   3     in front of you. We see there that that is the section
   4     headed "Postmortems and inquests."
   5   A. Yes.
   6   Q. So are you happy to adopt that part of his evidence as
   7     your own, and can you speak to it?
   8   A. I can speak to it. As I say, it is largely as I wrote
   9     the briefing document, some modifications were made by
  10     Professor MacSween, but he did consult me about them
  11     when he made them and I was happy to accept them.
  12   Q. Thank you. If we go back to your statement, that is
  13     210/1, we see there your qualifications at the first
  14     paragraph?
  15   A. Yes.
  16   Q. In particular, you mention that you were, until
  17     recently, the Professor of Forensic Pathology in the
  18     University of Sheffield and that you are still
  19     a consultant pathologist to the Home Office. You are
  20     now, of course, the Emeritus Professor of Forensic
  21     Pathology in the University of Sheffield.
  22        Can you tell us just briefly what your general
  23     role has been in both of those functions?
  24   A. Yes. In the eyes of the general public and I think in
  25     the eyes of a lot of the medical profession, forensic

   1     pathology and forensic medicine is associated entirely
   2     with the investigation of murder and suspicious deaths
   3     and the teaching of medical students and young doctors
   4     on those particular aspects.
   5        In fact, forensic pathology and forensic medicine
   6     incorporate a far wider brief than that. I prefer the
   7     old-fashioned name "medical toxicology and
   8     jurisprudence" because in fact at least a third of the
   9     curriculum and a third of my teaching time in the days
  10     when forensic medicine was an examinable subject was
  11     devoted to teaching medical students about the interface
  12     between medicine and the law, particularly the law
  13     relating to consent, confidentiality, the disposal of
  14     the dead and, of course, the law relating to injury.
  15     But that was a relatively small part of it. Obviously
  16     a lot of my teaching time, which has progressively
  17     diminished over the years as the medical undergraduate
  18     curriculum has changed, was devoted to teaching medical
  19     students about what to do when someone dies and how to
  20     comply with the law in those matters.
  21   Q. It may well have been, at least in part, because of your
  22     experience in these areas that you then served on the
  23     Specialist Working Party which has recently produced the
  24     document "Guidelines for the retention of tissues at
  25     postmortem examination", to which I think again you can

   1     speak today?
   2   A. I can speak to that document. The reasons I became
   3     involved in its production are three-fold. First, for
   4     a few years before I became a member of the College
   5     Council, I had been Chairman of the Forensic Pathology
   6     Sub-committee of the College.
   7        Secondly, it was known that I had wide experience
   8     in teaching and had served on various working parties,
   9     established by the government, by OPCS as it then was,
  10     now the Office of National Statistics, on death
  11     certification, cremation and so on.
  12        My Home Office involvement, of course, came into
  13     it, and also over the late 1980s, my wife and I wrote
  14     a series of articles in the first instance for the
  15     Nursing Times on death in ethnic communities and this
  16     was then brought together in a book which I have
  17     produced as an exhibit to the Inquiry called "Dealing
  18     with Death". This was published in 1991, and is divided
  19     basically into three parts: the law; the social problems
  20     of dealing with death; and then thirdly, it examines
  21     death by ethnicity and religious group and gives advice
  22     on as much what not to do as what to do if you do not
  23     wish to cause hurt and offence.
  24        This book is intended not just for doctors but for
  25     nurses, bereavement counselling officers, Coroner's

   1     officers and everybody else who might be involved in
   2     a death in a family in the broadest sense.
   3   Q. We are grateful to you, Professor Green, for supplying
   4     a copy of your book. We will be scanning into the
   5     record those parts of it which are most relevant to the
   6     Inquiry, after which it will be returned to you.
   7   A. Thank you.
   8   Q. I think perhaps the general point that emerges from
   9     the work is that you have a particular interest in what
  10     might be called the "social" aspects of death as well as
  11     the medico-legal aspects of it?
  12   A. Yes.
  13   Q. However, can I ask you this: the Inquiry has been
  14     concerned with this issue partly at least out of the
  15     events at the Bristol Royal Infirmary's pathology
  16     department, the hospital pathology department. Do you
  17     yourself have any experience as a consultant clinical
  18     pathologist who would provide a routine hospital
  19     pathology service?
  20   A. I have only worked for a relatively short time as
  21     a part-time hospital consultant and this was at
  22     St James' Hospital, Leeds in the mid-1980s. For most of
  23     my career in pathology I have been in the University
  24     Department of Forensic Pathology so my dealing with the
  25     public and dealing with families of the recently dead

   1     has been limited. But I must emphasise at the outset
   2     that most pathologists have little contact with the
   3     relatives of the dead in the hours and days immediately
   4     after death. The first contact, and most of the seeking
   5     consent and so on, is the role of the clinicians who
   6     have been treating the patients in life.
   7   Q. To the extent that I ask you questions this morning on
   8     the content of hospital consent forms or the practice of
   9     clinicians or pathologists in seeking and obtaining
  10     consent from relatives for postmortems, on what
  11     experience and knowledge would your answers be based?
  12   A. My experience and knowledge would be based first of all
  13     on personal experience as a junior and middle-rank
  14     doctor. As all doctors do, I started my career with
  15     pre-registration house jobs. At that time it was my
  16     intention to follow a career in clinical paediatrics, so
  17     I spent a total of three and a half years in clinical
  18     paediatrics, mainly in a teaching hospital, where I was
  19     dealing with the parents of dead babies on a fairly
  20     regular basis.
  21        After that, I was in general practice in the
  22     United Kingdom as a principal for six months. I was
  23     also in the Flying Doctor service in South Australia for
  24     two years and although this sounds romantic, it was
  25     basically a general practitioner with an aeroplane, so

   1     I was dealing with patients and relatives under those
   2     circumstances as well.
   3        So I have a fairly sound knowledge base, although
   4     it was established in the past. Indeed, it was
   5     established at about the time that the Human Tissue Act
   6     was passed, which I think is relevant, because I have
   7     therefore been able to follow the changes in
   8     professional and public attitudes that have evolved over
   9     those 30-odd years, even though for the last few years
  10     I have been teaching people how to do it rather than
  11     doing it myself.
  12        Incidentally, I must apologise for the voice, like
  13     you, Chairman, I am in the club, I had my sinuses washed
  14     out yesterday and I am not at my happiest and talking as
  15     though I have a clothes peg on. If I am inaudible,
  16     please tell me.
  17   Q. I think you are very clear so far, Professor Green,
  18     thank you.
  19        You have talked about the firsthand knowledge you
  20     gained about the time when the Human Tissue Act was
  21     passed.
  22   A. Yes.
  23   Q. I think thereafter what you are saying is that your
  24     knowledge would not have necessarily have been, as it
  25     were, front-line, but you have been directly concerned

   1     in teaching and therefore in examining these sorts of
   2     aspects, these sorts of issues, during the remainder of
   3     your career and to date?
   4   A. Yes. I was involved in teaching at both undergraduate
   5     and junior doctor level, and quite frequently throughout
   6     my career, I have been consulted by clinicians of all
   7     grades, particularly as to whether a death should be
   8     referred to the Coroner, how a particular issue should
   9     be dealt with in talking to relatives and so on. There
  10     was one period in my career when there was an acute
  11     shortage of paediatric pathologists in part of the North
  12     East of England which I serve, where my department was
  13     responsible for investigating the majority of cases of
  14     cot death, sudden death in infancy. At that time, when
  15     everybody seemed to be less busy than they are now, it
  16     was standard practice at the Coroner's request for me or
  17     the member of staff who carried out the autopsy to meet
  18     the relatives afterwards and explain what had been found
  19     and what its significance was.
  20        So I have had second-line involvement throughout
  21     my career with occasional forays into the front-line,
  22     although they have become less frequent.
  23   Q. If we could look, please, at the document RCP 1/73,
  24     this should be the first page of the Working Party's
  25     document which we have just referred to, the guidelines

   1     for the retention of tissues at postmortem examination.
   2        There is an introduction there speaking about the
   3     role of the autopsy and its importance.
   4        I wonder if you could outline to us, Professor
   5     Green, what you would see as the continued importance of
   6     an autopsy in medical practice?
   7   A. I think that it says in the last line of paragraph 1.1:
   8        "The autopsy will always remain the gold standard
   9     against which new techniques are assessed."
  10        It has been important in the recognition of new
  11     diseases, Creutzfeldt-Jakob disease is mentioned, and it
  12     has certainly been important in the assessment in the
  13     success or the modification of various surgical
  14     techniques, particularly laparoscopic surgery as opposed
  15     to minimally invasive surgery for things like
  16     gallbladder operations and so on.
  17        It also remains of importance because the
  18     information gained at autopsy can be passed on to the
  19     relatives either directly by the pathologist, more
  20     commonly by the clinician after he has received the
  21     pathologist's report and in cases of deaths within the
  22     community which make up approximately a third of the
  23     autopsies which are carried out in the average city the
  24     size of Leeds or Sheffield, deaths on the district, as
  25     they are known. What tends to happen there, certainly

   1     in the area in which I practised, was the postmortem
   2     report was passed by modem to the family practitioner --
   3     he is now called the FHSA -- who in turn distributed to
   4     the deceased's general practitioner, so it is important
   5     for the dissemination of information.
   6        It is important for the teaching of medical
   7     students because, although one can use videos, one can
   8     use colour photographs et cetera, and we use these
   9     increasingly, I think it is important for doctors,
  10     whatever their specialism, to know what normal and
  11     abnormal tissue looks like, and feels like -- this is
  12     particularly important if a candidate intends to follow
  13     a career in surgery and again, particularly in the
  14     training grades whatever the specialism, the importance
  15     of the clinico-pathological conference cannot be
  16     over-emphasised when all the doctors in the team and the
  17     pathologist who carried out the autopsy are together.
  18        The human body -- this is mentioned at one of the
  19     bullet points which is at the bottom of the screen -- is
  20     an invaluable source of spare parts. I do not use this
  21     term facetiously. In the replacement of cardiac valves,
  22     for example, particularly 15 years ago, when we were
  23     treating, or the profession was treating a spate of
  24     elderly and middle-aged people who had had rheumatic
  25     fever in childhood, the best type of aortic valve to use

   1     as replacement which had the longer success rate was
   2     a human aortic valve rather than a metal prosthesis.
   3     The fasciolata, the broad tendon found along the outside
   4     of the thigh, is a useful building block for many
   5     medical and orthopaedic procedures: there is no
   6     artificial substitute which works as well and it is
   7     infrequently rejected. The value of corneas has been
   8     appreciated since the early 1950s. So again,
   9     a sensitively conducted autopsy with appropriate
  10     permission beforehand provides material not only for
  11     research and teaching purposes, but provides an ongoing
  12     source of treatment for the living.
  13        The other point I would make is that particularly
  14     during the tenure of office of Sir Kenneth Calman as
  15     Chief Medical Officer, the importance of audit became
  16     increasingly appreciated. It had been appreciated by
  17     the anaesthetists a few years earlier, Lennon and
  18     Mushin published their first report on mortality
  19     relating to anaesthesia in the late 1970s, but the
  20     autopsy forms an invaluable part of audit. I have
  21     already referred to the clinico-pathological conference
  22     which takes place in hospitals, but an aspect of the
  23     autopsy which is often overlooked is the community
  24     autopsy. It identifies trends in deaths in the
  25     community, changes in mortality, for example, from acute

   1     unexpected cardiac death in young to middle-aged males;
   2     the community autopsy led to the recognition of the
   3     association between the first high dosage contraceptive
   4     pills, deep vein thrombosis and pulmonary embolism in
   5     young women, and the community autopsy likewise was the
   6     way in which the potential dangers of monoamine oxidase
   7     inhibitors associated with consumption of red wine,
   8     Marmite sandwiches, tyramin-containing foods in general,
   9     was identified. Because, as I say, a third of the
  10     population at least die outside hospital and it is those
  11     deaths which are reported to the Coroner and autopsied
  12     under the coronial system which provide audit of death
  13     in the community as well as the contribution that we
  14     make to audit in hospital.
  15        Of course, there are now three main areas: NCEPOD,
  16     which looks at peri-operative deaths in general; CESDI,
  17     which looks at deaths in infancy and the perinatal
  18     period, and CEMD, the Confidential Enquiry into Maternal
  19     Deaths. In all these statutorily established enquiries,
  20     the autopsy plays an invaluable and major role. In
  21     fact, if no autopsy is performed or an inadequate
  22     autopsy is performed, that particular case has to be
  23     excluded from the study.
  24   Q. If I could ask you to turn to WIT 54/938, this is the
  25     first page of a document called the Autopsy and Audit of

   1     1991. If we turn to page 941, we see there, in the
   2     introduction, a discussion of the continued use of the
   3     autopsy to examine discrepancies between clinical and
   4     autopsy diagnosis, because one argument that might be
   5     used against the use of permission autopsies in
   6     particular is that with the increasing sophistication of
   7     diagnostic techniques, an autopsy might not be regarded
   8     as being so important these days. The thrust of the
   9     argument in this paper, however, is that it remains of
  10     central importance as a means of checking,
  11     cross-checking and gaining further information upon the
  12     accuracy of the clinical diagnosis.
  13        Is that something you would care to comment on?
  14   A. Yes, I would support entirely the statistics which are
  15     given and are shown on the screen at the moment.
  16     Although the clinical diagnosis is confirmed in the
  17     majority of cases, in a significant number of cases
  18     other conditions emerge or the clinical diagnosis is
  19     modified. You will notice that particularly in the
  20     investigation of cancers arising within the abdomen,
  21     particularly liver, pancreas, biliary tract, the areas
  22     that are not easy to approach through an endoscope,
  23     there was this situation described in paragraph 2 where
  24     in only 56 per cent of cases was the primary site
  25     identified correctly. That, of course, was 1991; this

   1     is 1999. What is called ERCP, where you are able to now
   2     look up the biliary tract as well as into the intestine,
   3     has reduced that gap, but there is still a significant
   4     divergence, even in the permission autopsy, where the
   5     case has been fully worked up in hospital, the
   6     pathologist will still find diseases of other organs or
   7     modify slightly the disease of the principal organ as
   8     a consequence of the autopsy.
   9        Again, this is even more important, I think, in
  10     community autopsy, because not infrequently one examines
  11     a patient who has died of a heart attack and one finds,
  12     for example, a cancer in the upper lobe of the left
  13     lung, industrial disease such as asbestosis, or
  14     pneumoconiosis in my part of the world, which was
  15     unsuspected during life. This is important for correct
  16     mortality statistics for the community as a whole and it
  17     also means that widows and other dependents are not
  18     denied benefit which they might have been denied if this
  19     associated industrial disease had not been identified.
  20        So I am a great believer in the continued value of
  21     the autopsy, and like Sir Kenneth Calman, I would like
  22     to see more sampling autopsies carried out both in
  23     deaths in hospital and deaths in the community, if we
  24     are to improve accuracy of medical statistics and
  25     therefore adequacy of medical treatment.

   1   Q. Whilst we are on that page, if we just scroll down
   2     a little bit, I would just ask you to note that in the
   3     middle paragraph that we are looking at there, the
   4     reference is given there to an audit in a paediatric
   5     cardiologist unit, showing unsuspected abnormalities in
   6     80 per cent, with undiagnosed abnormalities or surgical
   7     problems contributing to death in 38 per cent. I think,
   8     if we looked at reference 16, we would find that that is
   9     a reference to the paper written by Professor Berry?
  10   A. Rushman and Berry, 1988/89.
  11   Q. Yes. That is there cited as being consistent with the
  12     general trend of autopsies revealing abnormalities or
  13     other diagnoses that were not previously identified in
  14     the previous clinical diagnoses?
  15   A. Yes.
  16   Q. We will come back to that later, if we may, but if we
  17     turn back to RCP 1/74, back to the Working Party's
  18     report, this starts to describe the need to retain
  19     either tissues or organs following autopsy, and its
  20     purposes or medical justification.
  21        Can you help us by telling us in general terms how
  22     likely it is that either tissues or whole organs would
  23     need to be retained either for a short period of time or
  24     for longer following an autopsy?
  25   A. Yes. I will start with tissues, if I may, and then move

   1     on to organs.
   2        The view of the College is that no autopsy is
   3     complete with (sic) microscopical examination of
   4     a representative small piece of tissue, and I stress
   5     "small". We are looking at something as big as the top
   6     of my little finger.
   7   Q. Could I interrupt, you say no autopsy is complete
   8     "with", or "without"?
   9   A. "Without". An autopsy from the days of Virchow in the
  10     late 1970s, the old Virchow description of a complete
  11     autopsy was an autopsy with microscopy. It is for this
  12     reason in fact that recently the College has got rid of
  13     the old term "morbid anatomist" and now calls people
  14     like me histopathologists, emphasising the fact that
  15     good pathology should look at cells as well as the whole
  16     body. So a small piece of tissue should be taken from
  17     every major organ. This is important (a) because it
  18     teaches and trains young pathologists; but (b) because
  19     again we come back to this recognition of unsuspected
  20     disease which is important for accurate mortality
  21     statistics.
  22        If I can now move on to the retention of whole
  23     organs --
  24   Q. Can I just ask you, if those samples are taken, what
  25     would be the practice regarding their retention?

   1   A. I can speak mainly only for Coroner's cases because by
   2     the very nature of a department such as mine, all the
   3     cases that I examined, except in very unusual
   4     circumstances, were Coroner's autopsies. Tissue
   5     retained under those circumstances tended to be retained
   6     usually until the Coroner had completed his Inquiry,
   7     either with inquest or without it. Then the
   8     paraffin-fixed material from which the slides had been
   9     taken is permanently archived, and this is referred to
  10     in a report published by the College recently on the
  11     archiving and storage of pathological specimens and
  12     records. The so-called wet tissue, i.e. the tissue
  13     which had been fixed in formalin but not used for
  14     processing, is disposed of in hospitals either by
  15     incineration or by using what is called a macerator.
  16     Its disposal is controlled not just by aesthetics and
  17     standards of decency, but also, particularly in these
  18     days of awareness of hepatitis C, et cetera, we are
  19     subject to Health and Safety Executive regulations and
  20     so on.
  21   Q. You were going to go on and talk about organ retention?
  22   A. Yes. There are many circumstances in which it is either
  23     difficult, impossible or unsatisfactory to examine an
  24     organ immediately it has been removed from the body.
  25        The brain in particular, particularly if the brain

   1     is swollen because of the way the patient has died or
   2     because the patient has been nursed on an intensive care
   3     unit where brain swelling is often a complication, it is
   4     literally like trying to dissect a jelly or
   5     a blancmange. You do not get much of value out of it
   6     with the naked eye and you are liable to create more
   7     artifacts as you cut the unfixed specimen which then
   8     misleads you when you look at the microscopic specimens.
   9        So to examine a brain properly requires fixation
  10     for a minimum of weeks and preferably 12. Examination
  11     before that time is unsatisfactory because the brain is
  12     fixed on the outside but the structures at the centre of
  13     the brain, which are often the ones of most interest,
  14     are not properly fixed so you get all sorts of artifacts
  15     during the processing that leads to the preparation of
  16     the slide. Examination of the heart may require
  17     retention in two sets of circumstances: to examine an
  18     adult heart properly in some of the rarer diseases like
  19     hypertrophic obstructive cardiomyopathy, the young
  20     schoolboy who collapses at the end of a PE session, the
  21     soldier who collapses at the end of a training
  22     programme. It is important to get it because it is
  23     a genetically structured disease and it is important to
  24     counsel the other members of the family.
  25        A baby's heart, the heart of a neonate is about

   1     the top of my index finger. One cannot examine that
   2     properly, even using a pair of loop-lenses on your
   3     spectacles and a video-camera. It is often necessary --
   4     although I am neither a cardiac nor paediatric
   5     pathologist -- to inject the blood vessels of the
   6     heart. Also it is often necessary to cut serial
   7     sections, as many as 300, through the so-called
   8     "conducting bundle", and this can only be done on fixed
   9     tissues. To fix a heart in formalin takes 10 days.
  10     There is experiment now with microwave fixation
  11     techniques but this can only be used on relatively small
  12     organs and it is not, in my view, anywhere near as
  13     satisfactory as conventional formalin fixation, which
  14     has withstood the test of time --
  15   Q. If I just stop you there for a moment and ask you to
  16     look at WIT 204/8, this is a part of Professor Berry's
  17     statement which I think you have had an opportunity to
  18     look at. If we scroll down the page a little, we will
  19     see, paragraph 26, please, down a little, there
  20     a discussion of the necessities, the requirements, for
  21     examination of hearts after surgery. Professor Berry
  22     makes the point that this is a difficult dissection,
  23     even for paediatric pathologists and that it was his
  24     practice to perfuse the heart with preservative under
  25     pressure for several hours, to restore its contours in

   1     life?
   2   A. Yes.
   3   Q. And then to carry out most of this dissection after the
   4     postmortem examination of the body itself?
   5   A. Yes.
   6   Q. Then he talks about the retention of lung tissue, if we
   7     just go over the page, please, to make that complete,
   8     page 9?
   9   A. I think this is important, because, you see, a goodly
  10     percentage of congenital heart disease is in fact not
  11     confined to the heart. There are associated
  12     abnormalities of the vessels which run between the heart
  13     and the lungs and also the aorta, the main blood
  14     vessel. So really, to do it properly -- and this
  15     applies in coronial practice as well, such as mine, for
  16     example, every so often I would do a sudden infant death
  17     case which turned out to be unsuspected congenital heart
  18     disease, so it was desperately important to take the
  19     thoracic organs en bloc, fix them, recolour them and
  20     then look at them with the aid of magnifying spectacles,
  21     television camera, dissected against a clean and
  22     bloodless background, and as I say, it takes 10 days to
  23     do it properly and you would delay the funeral for
  24     10 days if you returned the organs to the body.
  25        The point I was going to make, when you quite

   1     rightly interjected, is that increasingly we live in
   2     litigious times. I think Professor Berry has adverted
   3     to this in his statement, but it has certainly been my
   4     experience now, as far as post-operative death is
   5     concerned. For example, if you are passing an
   6     endoscope, a flexible fibre-optic examining rod, tube,
   7     call it what you will, down the intestinal tract or up
   8     the intestinal tract, there is a risk of perforation of
   9     the gut, particularly if the gut is diseased.
  10     Increasingly, I find, in the biased sample that I see,
  11     that relatives want an independent opinion. They retain
  12     a firm of solicitors. The solicitors in turn will
  13     retain another pathologist, who wants to see the actual
  14     organ. You will then find that the hospital Trust
  15     retains their lawyers, their pathologist, and so on, so
  16     there is a new reason for keeping whole organs which
  17     might have been damaged as a result of surgery, which
  18     has emerged in the last ten years of my working life,
  19     which we never even considered when I was younger.
  20        Finally, and I must mention this en passant,
  21     although it is rare, there are after all only 850
  22     homicides a year in England and Wales, it is usually
  23     said that the organ should be retained until the Coroner
  24     has completed his inquiry. Of course in a criminal
  25     case, the best advice we can get from the Crown

   1     Prosecution Service at the moment is that the organ in
   2     question, for example, a brain in a head injury, or
   3     a lung with a stab wound through it, should be retained
   4     until the conclusion of the criminal proceedings, and
   5     this has recently been extended to include due time for
   6     appeal. So we find ourselves in forensic departments
   7     particularly under duress to keep whole organs for
   8     a very long time indeed. Indeed, it was the view of the
   9     recently retired Director of Public Prosecutions that
  10     organs should be kept until the whole sentence had been
  11     served. This has not been confirmed by the new split
  12     directorate, but you can see it leaves forensic
  13     pathologists in a very difficult situation as far as
  14     retention of organs is concerned. And again, a third of
  15     homicides in England and Wales are head injury related.
  16     The brain is an organ which is sensitive as far as
  17     relatives are concerned, but by the very nature of our
  18     work, we have to retain an awful lot of them.
  19   Q. If I could take you back to the example of prospective
  20     or possible civil litigation as being a reason to retain
  21     tissue or organs, would it be your practice in the
  22     biased sample of cases you see to retain habitually
  23     because that might be in prospect, or would you only
  24     retain if there was some knowledge or indication that
  25     the relatives or other concerned individuals might be

   1     wishing to pursue that further?
   2   A. Even in a Coroner's case, where the case has been done
   3     more or less the morning after death, or the Monday
   4     after death if it has occurred at the weekend, the
   5     Coroner's officer has already interviewed the relatives
   6     and the fact that they are thinking of consulting
   7     solicitors usually emerges early rather late.
   8        In the small minority of cases where the relatives
   9     have not expressed concerns but my findings or my
  10     staff's findings at autopsy have suggested that there is
  11     something which might cause concern later, it has been
  12     policy to retain the organ in question, but only after
  13     telephoning the Coroner in question and making sure that
  14     he or she was in agreement and this fact is recorded in
  15     the autopsy note, both the rough note made at the time
  16     and the typed report which is subsequently made
  17     available.
  18   Q. That, I think, leads on to the question of how much
  19     information was habitually given to relatives of
  20     a deceased person about the need or the practice of
  21     retaining tissues or organs. If we could look, please,
  22     at RCP 1/75, again from the Working Party's report, if
  23     we can go down a little.
  24        Could you scroll back up to the top of the page?
  25     The paragraph there, perhaps to give you the full

   1     context I should take you back first to page 74(RCP 1/74), where
   2     the Working Party sets out legal and ethical principles
   3     relating to the retention of tissues, firstly that it
   4     must be legal, secondly that it must be professionally
   5     regulated to high ethical standards?
   6   A. Yes.
   7   Q. And over the page, then, the reasons must be defensible,
   8     open and justifiable in law and in clinical practice?
   9   A. Yes.
  10   Q. Can I ask you, please, about the word "open" in those
  11     guidelines. To what extent has past practice in this
  12     area been open?
  13   A. I am sorry to go into history and I will try to be as
  14     brief as possible. I qualified in 1960. The Human
  15     Tissue Act was passed in 1961. My generation were,
  16     therefore, taught by those who had always themselves
  17     been taught that there was no property in a dead body
  18     and the general lesson that was drilled into me as
  19     a medical student was, be courteous, be polite, explain
  20     that you are asking for permission for this autopsy
  21     because it will help others, both in learning and in the
  22     treatment of disease, but do not go into any more
  23     detail; it will upset the relatives and they will be
  24     distressed and they might refuse consent.
  25        This was the attitude on which my generation was

   1     brought up.
   2        The Human Tissue Act was passed the year
   3     I qualified. At first it made little difference.
   4     I think everybody, both hospital management and
   5     clinicians, said "But we are doing all this anyway. We
   6     have a consent form which we always have witnessed", and
   7     in those days there were no such things as bereavement
   8     counselling officers, it was usually the SHO or the
   9     Registrar who saw the relatives and got permission, and
  10     you simply had a bald consent form which said "I, being
  11     [the wife, husband, et cetera] of ... hereby agree to an
  12     autopsy being carried out. I understand this will help
  13     advance medical knowledge", or words to that effect.
  14     There was nothing organ specific and equally, there was
  15     no option of a limited or restricted postmortem.
  16        As I say, immediately after the passing of the
  17     HTA, it did not make very much difference. Then
  18     I suppose in the 1970s, people started talking about
  19     "informed consent", which is in my view an Americanism
  20     which has crept into English law; I was always taught to
  21     talk about "valid consent", but the realisation dawned
  22     on the profession that fully informed consent involved
  23     rather more than just using the old-fashioned bald
  24     one-paragraph consent form, and my understanding in the
  25     various hospitals that I went to, because as a forensic

   1     pathologist I am, by the nature of my job, peripatetic,
   2     although I was based then in Leeds and Sheffield, I used
   3     to carry out autopsies in every NHS hospital in the
   4     whole of the Yorkshire region, and two-thirds of the
   5     Trent region. So I had a pretty shrewd idea of what
   6     common practice was amongst the pathologists, but of
   7     course I did not meet the clinicians at firsthand, but
   8     I got the feeling that there was a gradual swing to them
   9     either verbally or in writing incorporating,
  10     "I understand that it might be necessary to retain
  11     certain tissues for further examination", but as far as
  12     I know, it is only in the last few years in this present
  13     decade that people have then carried it forward and
  14     started making what I call the organ-specific consent
  15     form, which is the thing that is now recognised.
  16        Even so, I think from the early 1980s onwards,
  17     I certainly in my teaching, was emphasising to medical
  18     students and to young doctors, "Look, distasteful though
  19     you might find it, you must get used to the idea of
  20     asking relatives specifically for retention of an organ
  21     or tissues" and by the time the book which you have
  22     before you was published in 1991, I had said and I quote
  23     from memory, "under no circumstances should this issue
  24     be fudged", and emphasised the point that to comply with
  25     the HTA, we really had to get our act together and start

   1     being more specific.
   2   Q. You should not have to do it from memory. If we look
   3     first at HOME 6/26, we should see there the first
   4     page of your book, is that right?
   5   A. That is it, yes.
   6   Q. Together with Jennifer Green?
   7   A. Yes.
   8   Q. Over the page, page 27(HOME 6/27), we are told there that this
   9     edition, the first edition, was 1992. Was it actually
  10     written in 1991 but formally published in 1992?
  11   A. It was written over the period late 1989 to the middle
  12     of 1991, but of course publication is a slow business,
  13     or certainly was then. Things are speeding up now. The
  14     book came on the market in January 1992, as I recall.
  15   Q. If we then turn to page 28(HOME 6/28) of this database, we see
  16     there -- if you could look at the last --
  17   A. It is the bottom of page 57.
  18   Q. Could we have that, please, "When may an autopsy be
  19     performed?" This is a discussion of hospital autopsies
  20     specifically, but we see that at the very bottom of the
  21     guidance that you and Miss Jennifer Green give, you see
  22     there:
  23        "If it is desirable that tissues or organs should
  24     be retained, specific consent coupled with further
  25     explanation should be sought. Under no circumstances

   1     should this issue be fudged or material illicitly
   2     retained. Such actions invite at best serious complaint
   3     or censure, and at worse litigation."
   4   A. Yes.
   5   Q. To what extent do you think that your advice reflected
   6     current practices in hospitals for hospital autopsies at
   7     that time?
   8   A. It represented best practice and certainly in the two
   9     teaching hospitals in Leeds with which I was associated
  10     when I started writing the book, this was being done,
  11     although, before when the old style form was still being
  12     used which did not specifically have a printed "I agree
  13     to the retention of ...", house officers, SHOs et al
  14     were hand-writing in the appropriate permission.
  15        When I moved to Sheffield, it was my understanding
  16     that that was the practice at the Royal Hallamshire
  17     Hospital and the Northern General. I did get the
  18     feeling that it might not be the practice in many
  19     district general hospitals, but I would make a broader
  20     point here about the permission autopsy, the academic
  21     autopsy: when I first qualified over 50 per cent of
  22     deaths in a teaching hospital would be subjected to
  23     a permission autopsy and round about 15 to 20 per cent
  24     in district general hospitals. By the time this book
  25     was written, in the teaching hospitals with which I am

   1     associated, the permission autopsy rate was less than
   2     10 per cent and I can think of some district general
   3     hospitals where a permission autopsy has not been
   4     carried out for several years. So it was a relatively
   5     rare event. So nobody, not medical staff senior nor
   6     junior, nor bereavement counselling officers, really had
   7     the opportunity to hone this particular skill. As
   8     Professor Berry says in his paper which you have already
   9     referred to, over the period from 1961 to the mid-1980s,
  10     there was what he called a lamentable decline in the
  11     incidence of permission autopsies.
  12   Q. If we go back to WIT 54/25, this is Professor MacSween's
  13     statement, the part in which you were heavily involved
  14     in writing. If we scroll down a little, you say there
  15     is a discussion there of the general issue. Then down
  16     a little further, please, the beginning of a discussion:
  17     before the Human Tissue Act there was no statute law
  18     relating to autopsies by consent.
  19        Then over the page, please: "Medical students were
  20     taught there was no property in a dead body."
  21        Then it was felt that if organs were to be
  22     retained, "relatives should not be further distressed by
  23     being presented with a list of organs that might be
  24     retained."
  25        Can I just ask you to clarify, does it follow from

   1     the early evidence that you were given that this
   2     paragraph in Professor MacSween's statement relates to
   3     practice before the passage of the Human Tissue Act
   4     only? Or does it also relate to a more general attitude
   5     that persisted after its passage?
   6   A. My own experience in my own part of the world, and
   7     I admit responsibility for this paragraph, by the way,
   8     although it is over Professor MacSween's signature, was
   9     that it would be right, under the Human Tissue Act, to
  10     use this broad expression which I used earlier, of
  11     course it might be necessary to retain some tissue for
  12     further examination, but it was not more specific than
  13     that; it was, I think, into the 1970s before the
  14     thinking -- well, all doctors think, but the ethically
  15     concerned members of the profession started saying,
  16     "Just a minute, everybody is talking about informed
  17     consent, specific consent", and I suppose this really
  18     came to a head in a paper written by Bernard Knight in
  19     about 1984/85 --
  20   Q. 1985.
  21   A. -- which pointed up the fact that a lot of doctors might
  22     not be complying with the letter of the Human Tissue
  23     Act, and that more specific consent should be
  24     incorporated into dealings with relatives, be they
  25     verbal or written, particularly if whole organs as

   1     opposed to small pieces of tissue were being retained.
   2        So there was, as I said when I first started
   3     giving my evidence on this subject, the general feeling
   4     when the Act was first passed that it did not make all
   5     that much more difference, you only needed one extra
   6     sentence in the consent form. The realisation that
   7     specific agreement to the retention of organs and
   8     tissues I think crept on the profession more generally
   9     and I think the profession in general, over those early
  10     years of my involvement with it -- and I admit it freely
  11     and I think most doctors of my age do -- is that we were
  12     generally rather paternalistic. We knew what was best
  13     for the patients and the relatives and did not want to
  14     upset them and this was the attitude which was
  15     inculcated and has only gradually been replaced I hope
  16     by a more enlightened one.
  17   Q. When the College announced the publication of the
  18     consultation paper that we have looked at several times
  19     on its website, it wrote on the website, under the hand
  20     again of Professor MacSween, these words:
  21        "Stemming in part from the Bristol Royal Infirmary
  22     Inquiry, there has been heightened public interest in
  23     the issue of retention of organs or tissue following
  24     postmortem examination. Such retention of organs or
  25     tissue was previously implicit in the granting of

   1     permission for postmortem examinations by the relatives
   2     of the deceased. The College appreciates that it is now
   3     essential to be more explicit on these matters."
   4        Would you agree with the statement or its
   5     implication that in the past, or up to date,
   6     pathologists have considered that consent to postmortem
   7     to a hospital autopsy implied consent to the retention
   8     of tissues or organs without further information on that
   9     subject being passed to them?
  10   A. I must confess that I had not seen that particular
  11     website announcement. I have to, with reluctance,
  12     disagree with my President on this, in that, as I have
  13     said, I think there was a gradual groundswell change and
  14     by the 1970s, we were starting to incorporate, or many
  15     hospitals were starting to incorporate a sentence to the
  16     effect that it might be necessary to retain tissues, and
  17     certainly, by the time that I wrote the book -- and I am
  18     not getting plugs in here -- but for several years
  19     beforehand, my teaching to medical students, to junior
  20     doctors, lectures on ethics I gave for continuing
  21     education purposes, I had been saying "The way the wind
  22     is blowing it would be wise to be more specific than you
  23     have been before".
  24        So I think perhaps to make his website
  25     announcement punchy and short, perhaps Professor

   1     MacSween has contracted a bit, because again it does not
   2     make it clear in that website that we had already
   3     started preparing this, partly as a result of response
   4     to the 1991 document, the autopsy and audit, but also
   5     partly in response to correspondence generated with the
   6     College by the publication of the Green & Green book.
   7     The Council had been debating the establishment of the
   8     Working Party for some time. It had been our intention
   9     to publish it as a definitive document, as this one was,
  10     but once this Inquiry was announced it was felt that the
  11     issues were so important that it would be better,
  12     although it delayed formal publication, to put it out as
  13     a consultation paper, because we are hoping for advice
  14     and input from this Inquiry.
  15        I understand that the Inquiry will not finally
  16     report until well into next year, but if there is
  17     a mechanism by which you, sir, can give interim advice
  18     or any comment on the content of this document so that
  19     we can bring forward its publication in final form, we
  20     as a College would be grateful.
  21   Q. Going back then to the question I was asking you, would
  22     it be fair to say that if it was ever thought that
  23     consent to a postmortem implied consent to the retention
  24     of organs or tissues, that was an attitude which was
  25     dying in the 1970s and began to die in the 1970s, and

   1     perhaps died finally some time throughout the 1980s.
   2     You mention as a milestone the article by
   3     Professor Knight, but that it was a gradual change in
   4     evolution and attitudes throughout that period?
   5   A. It was a gradual change in evolution and attitude, and
   6     of course, as I explained right at the beginning, I and
   7     my fellow pathologists are in some difficulty here, in
   8     that it was not our place, usually, to act as the person
   9     seeking consent; it was the clinical team who had been
  10     giving treatment in life. So one could only get
  11     a groundswell view of what was happening by talking to
  12     mortuary attendants, by talking to young doctors who
  13     happened to come into the PM room to sign a cremation
  14     form while you happened to be there, and so on. But the
  15     water-testing which I carried out throughout my working
  16     life as first a senior lecturer and then a Professor
  17     gave me the idea that things were gradually improving
  18     along the sort of time-scale which I have indicated, but
  19     there was no day when everybody said, "Oh, it is all
  20     right, consent to one thing means consent to everything"
  21     and the next morning everybody woke up and said,
  22     "Express consent is necessary rather than implied
  23     consent".
  24   Q. If we go on to page 27 of this statement, we see
  25     a discussion of the movement and change because you

   1     discussed there the passage of the Human Tissue Act.
   2        Can I ask you about that paragraph, if we scroll
   3     down a little? It talks there of the fact, firstly, of
   4     being of the opinion that the most senior doctor who
   5     treated a patient in life should be the person who
   6     interviews the relatives and explains the need for and
   7     the implications of autopsy.
   8        Why do you make that recommendation at that
   9     point?
  10   A. Because I think that relatives are entitled to the best
  11     information and the most senior doctor, senior
  12     registrar, consultant, particularly in surgical cases,
  13     the person who carried out the procedure related or
  14     which might be related to the patient's death or the
  15     condition for which the patient had been treated.
  16     I think it is only a matter of courtesy that whenever
  17     possible, the consultant or a person at the end of his
  18     higher specialist training should be the person who does
  19     the talking, especially on a matter as serious as
  20     a death in the family. But, although it does not say so
  21     in the report in this particular paragraph, the point
  22     that I have always made in my teaching -- and I think
  23     colleagues like Bernard Knight have done the same
  24     thing -- said that right from the day somebody qualifies
  25     and becomes a pre-registration house officer, they

   1     should sit in when the boss is seeing the relatives, so
   2     they learn how it should be done, and by the time they
   3     are Registrars, Calman higher specialist trainees, they
   4     should be capable of obtaining such consent sensitively
   5     and giving a full explanation.
   6   Q. We will come back to that if we may, but could I ask you
   7     also about this paragraph? There is a sentence in the
   8     middle:
   9        "Consent had to be obtained in writing from the
  10     relatives and it was advised that if an organ was to be
  11     retained for teaching or research that specific consent
  12     should be obtained."
  13        Can you tell us, when "advised" is written there
  14     and underlined, who was advising that, and when?
  15   A. I know of no formal data publication from the College or
  16     from the Association of Clinical Pathologists that said
  17     this, but of course these were the days when every
  18     medical school in the whole of the United Kingdom still
  19     had a course in forensic medicine which was examinable,
  20     and as I say, approximately one third of that course was
  21     related to law and issues of death and dying, and
  22     certainly, my own specialist organisation, the British
  23     Association in Forensic Medicine, from the early 1970s
  24     onwards, when this was discussed at meetings of our
  25     Council and at open meetings of our membership, were

   1     suggesting that this advice should be disseminated to
   2     hospitals, but as I say, I know of no formal publication
   3     at that time, and this really is one of the first
   4     documents bearing the College authority which sets out
   5     what must be done as opposed to what is merely best
   6     practice.
   7   Q. If we look at WIT 204/41, this again is Professor
   8     Berry's statement and he attaches as an Appendix the
   9     form which he suggested should be put into use at the
  10     Children's Hospital and Maternity Hospital in 1985.
  11        If we look through that, we see the general
  12     consent to the performance of the postmortem is set out,
  13     and then it goes on to deal with the removal of tissues
  14     for diagnosis, medical education and medical research.
  15        If we scroll through to the bottom of the page,
  16     one can see that medical education and research may be
  17     deleted if thought appropriate by the relative.
  18        Would that be a form that would be consistent with
  19     those in use in other hospitals at around that time, to
  20     the best of your knowledge?
  21   A. Yes, it would. This would be what we might call
  22     Mark II. Mark I was the simple form in use when I was
  23     a medical student and for several years into the 1960s,
  24     "I hereby consent to a postmortem on the body of my
  25     relative..." so-and-so. This is now "...including the

   1     removal of such tissues as is considered necessary for
   2     the purposes of...", but there is still this groundswell
   3     underneath of, "Well, if we start talking about brains,
   4     hearts, livers, specifically, we will put people off",
   5     but this is the form which I should think was used in
   6     pretty well every teaching hospital and district general
   7     hospital at that time. I cannot recall seeing
   8     organ-specific consent forms until into the early 1990s.
   9   Q. It is the organ-specific retention form that you have
  10     attached as annex A to the consultation document, and
  11     now recommend for use?
  12   A. Yes.
  13   Q. If we go back to doing this from memory, so it may be
  14     wrong, page 39 of WIT 204 --
  15   A. That is Berry again, is it?
  16   Q. Yes -- we may see there what might be regarded as being
  17     a fairly extreme version of Mark I, is that right?
  18   A. This is bald even by the standards of the consent form
  19     that was in use in the 1950s when I was a medical
  20     student.
  21   Q. This is the form Professor Berry will say he was
  22     endeavouring to have changed into the one we have just
  23     seen at page 41.
  24   A. I do not wish to be too critical, but I would express
  25     surprise that this was still being used in a teaching

   1     hospital at that time. I would have thought that it
   2     would have been a little more sensitively worded. The
   3     form that was in use at Leeds General Infirmary, for
   4     example, at the time I was a Paediatric Registrar,
   5     contained a little paragraph of, "I understand that this
   6     will further medical knowledge and may help others", or
   7     words to that effect, to soften the blow a little bit;
   8     it was not just one sentence, it was padded out
   9     without -- it was vague, but it was not just a one-liner
  10     as this one is.
  11   Q. I think it is fair to add that Professor Berry refers to
  12     that particular form as being out of line with the usual
  13     UK form at that time?
  14   A. I would certainly confirm this from my own experience,
  15     yes.
  16   Q. He also, at points in his evidence, refers to a standard
  17     DHSS form. Are you aware of any guidance having been
  18     given by the DHSS in the format of consent forms?
  19   A. I cannot recall them. In fact it was a complaint which
  20     was made frequently in my early years as a senior
  21     lecturer in forensic pathology which was, what, 1972
  22     onwards, that every hospital -- they were not called
  23     Trusts in those days, they were either boards of
  24     governors or manager's committees -- were left to devise
  25     their own consent form, rather than there being any

   1     useful advice from the centre. So if Professor Berry
   2     says there was such a form, I accept that but I do not
   3     know when it was circulated.
   4   Q. If we could go to WIT 43/42 that will give us the start
   5     page of the Coroners' Rules. I would like to ask you
   6     some questions about rule 9 specifically. The text is
   7     to be found at page 48.
   8        If we see there the text of rule 9, I will not
   9     read it out, it is there on the screen. I think that we
  10     could agree that it would require, indeed, the
  11     pathologist to make provision, as far as possible, to
  12     preserve material that bore upon or was needed to
  13     establish the cause of death, but it would not, on its
  14     face, authorise the retention of tissue for the purposes
  15     of medical education and teaching.
  16   A. That is correct.
  17   Q. Can I ask you, what was the general attitude prevalent
  18     among the profession of pathologists towards the
  19     retention of tissue for medical education, teaching,
  20     research, during the period of the early 1970s and
  21     1980s?
  22   A. The view that was generally taken was that in hospital
  23     permission cases, the consent which the relative had
  24     given for the retention of tissues or organs allowed one
  25     to take whatever one felt may be useful for medical

   1     research. You might have, for example, a rheumatology
   2     unit in your hospital who said "We would like a drop of
   3     synovial fluid and a bit of cartilage from every knee
   4     joint of everybody". We would for example, particularly
   5     in orthopaedics and some aspects of surgery, allow
   6     surgical trainees into the autopsy room to practice
   7     a technique upon a cadaver in the course of the routine
   8     autopsy which was being carried out anyway.
   9        Coroners' autopsies have always been much more
  10     difficult. In my very early years as a forensic
  11     pathologist in the 1960s, again one tended to have this
  12     view that there is "no property in a dead body" and an
  13     awful lot of research material was taken. But even by
  14     the mid-1960s to the late 1960s, it was becoming
  15     increasingly understood by pathologists who carry out
  16     Coroners' autopsies and by Coroners that the Coroners'
  17     Rules were prescriptive and restrictive and that one
  18     could only take such tissues or organs as might have
  19     a bearing upon the cause of death.
  20        The problem then -- and the problem still is
  21     now -- that the onus is left entirely on the pathologist
  22     who is carrying out the autopsy. Where does one stop as
  23     far as this sort of thing is concerned?
  24        To give you a very simple example, the General
  25     Medical Council's advice is that it is not right to test

   1     postmortem for HIV and hepatitis C, but a common defence
   2     which is used in murder and manslaughter on the gay
   3     scene, and I quote, is, "It was when he told me that he
   4     was HIV positive that I lost my rag and hit him on the
   5     head", so the pathologist in some circumstances is
   6     damned if he does and damned if he does not.
   7        The policy adopted in my own department, or what
   8     was my department until a few weeks ago, is that we take
   9     tissue -- tissue, I hasten to add, not organ -- which in
  10     my view might have a bearing on the cause of death,
  11     particularly in cases where civil or criminal litigation
  12     may result. If we feel that it is necessary to retain
  13     a whole organ, a brain in a head injury, a heart in
  14     a stabbing case, a stomach specimen where there has been
  15     perforation by an endoscope, we retain that organ but
  16     tell the Coroner or his officer by telephone immediately
  17     after the conclusion of the autopsy, and a statement to
  18     the effect that that organ has been retained is
  19     incorporated into our report.
  20        Three of the full-time Coroners in the area which
  21     I now serve over the last two years or so -- and
  22     I suspect that this Inquiry might have something to do
  23     with it -- now automatically write to the relatives of
  24     that deceased person explaining that a particular organ
  25     has been retained and the reasons for it. Certainly,

   1     two of the Coroners whom my department serves go further
   2     and explain what the possible means of disposal of that
   3     organ available to the relatives are.
   4        One Coroner incorporates a tear-off slip at the
   5     bottom of the letter which says, "If you do not wish to
   6     have any further involvement with this organ, return
   7     this slip in the prepaid envelope and I will pass it to
   8     the pathologist so it can be dealt with according to
   9     routine practice at the lab". In the few months that
  10     that practice has been in use, the vast majority of
  11     people have returned the slip and said, "Dispose of the
  12     organ as you would; we do not wish to be involved in its
  13     ultimate disposal".
  14   Q. I think that practice of informing relatives is the one
  15     that is recommended by the College in its consultative
  16     document as being good practice to be adopted across the
  17     country in the future.
  18   A. Yes, but I think when Mr Burgess gives evidence
  19     tomorrow, and possibly when Mr Clifford gives evidence
  20     this afternoon, you will find that the Coroners' Society
  21     were having parallel discussions about the time we were
  22     drawing up our Working Party document and they have sent
  23     out codes of best practice to their members.
  24   Q. You say that it is a matter for the pathologist to
  25     decide what the scope of retention may be -- what

   1     retention may be necessary to establish the cause of
   2     death -- and that there may be a wide margin of
   3     discretion involved in that judgment.
   4        What about the role of the Coroner in this
   5     matter? Is there also a variation in the attitudes
   6     taken by Coroners towards the scope of the investigation
   7     by the pathologist that is necessary for the Coroner's
   8     purposes?
   9   A. Yes, and again, Mr Burgess, I hope, will be able to deal
  10     with this. I can only speak from the experiences which
  11     I have in my own area. There was one Coroner, recently
  12     retired, who would under no circumstances permit the
  13     retention of any organ, no matter how strongly one
  14     argued that it might be wanted -- the defence might want
  15     a view of it and it might need to be fixed for three
  16     months before examination. He, I hasten to act, was an
  17     exception, but increasingly, I have advised my junior
  18     staff over the years (and it is the practice of my
  19     successors in my department) to inform the Coroner if
  20     a whole organ is being retained and the reasons for it.
  21   Q. But can there be difficulties caused to the pathologist
  22     by different attitudes on the part of different Coroners
  23     as to the scope of their jurisdiction?
  24   A. I think that there can be, certainly in the medico-legal
  25     field. I am particularly concerned -- again, I can only

   1     speak from my own personal interests here -- but most of
   2     my research and most of my specialisation over the last
   3     ten years of my working life was in physical child
   4     abuses in the first six months of life, and a lot of
   5     this involved some shaking, or shaking plus impact. One
   6     of the best ways, it is emerging from research, both in
   7     this country and in other countries, of proving that
   8     shaking has taken place is to examine the inside of the
   9     baby's eye. There is one Coroner for whom I used to
  10     work who under no circumstances would permit the removal
  11     of the eyes, no matter how strong the arguments which
  12     I put forward. This certainly, in one case I can think
  13     of, resulted in an acquittal.
  14        So whilst most of the time most pathologists and
  15     most Coroners will discuss and come to an appropriate
  16     modus operandi, the current vagueness of the Coroners'
  17     Rules and the fact that, although they are rules, they
  18     are open to wide individual interpretation, can produce
  19     difficulties.
  20        There are other difficulties within the Coroners'
  21     Rules which are of only indirect interest to this
  22     Inquiry but which should be mentioned, for example, the
  23     circumstances in which microscopical examination can be
  24     paid for and cannot be paid for. This sometimes, in
  25     a Trust which is short of money, restricts the value and

   1     the scope of an examination of, say, a peri-operative
   2     death carried out on behalf of the Coroner. As I say,
   3     this is not directly within the remit of the Inquiry,
   4     but it is something which should be considered if
   5     recommendations are going to be made about a radical
   6     revision of the Coroners' Act 1988 and the Coroners'
   7     Rules of 1984.
   8   Q. If we return to the issue of the understanding of the
   9     scope of rule 9, you were saying, I think, that there
  10     was an appreciation, gradually, that the scope of rule 9
  11     was not wide enough to permit retention for medical
  12     research and education.
  13        If we look at WIT 43/153, this is an extract from
  14     a Home Office newsletter. We get the date from the
  15     statement of Mr Clifford who speaks to it: it is from
  16     1989. The circular there is advising that Coroners
  17     should remind their pathologists that ministers are
  18     concerned that tissue and organs should not be taken for
  19     teaching or research purposes from Coroner's postmortem
  20     examination cases.
  21   A. Yes, and I think this is standard practice, certainly in
  22     the teaching hospitals in the areas that I serve.
  23     Certainly in the department -- my own department until
  24     recently -- I imposed an absolute ban on the retention
  25     of any organ tissue or body fluid for research purposes,

   1     and it was made very clear to any clinician who came to
   2     me with a request for material that if they wanted
   3     material from a Coroner's case, somebody from their unit
   4     would have to see the relatives and obtain permission,
   5     just as they would if it was a hospital permission case.
   6   Q. But there are two categories of retention, are there
   7     not, or continued retention, I should say: the first is
   8     taking a sample, taking an organ, specifically for the
   9     purposes of medical education or research. I think it
  10     is quite clear from that circular, from what you have
  11     been saying, that the realisation came by the late 1980s
  12     at least, if not earlier, that that was not permissible
  13     under the Coroners' Rules. Is that a fair summary?
  14   A. It is a fair summary, and I would certainly take it back
  15     to the "even earlier". Throughout all of my senior
  16     professional life it has been clearly understood by
  17     Coroners' pathologists that if somebody comes to them
  18     with a request for tissue, urine, blood or anything else
  19     from a routine Coroner's case, you have to say: no, not
  20     without permission.
  21   Q. The Inquiry's terms of reference start in 1984. That
  22     would have been the understanding from 1984, if not
  23     earlier, then?
  24   A. I think so, yes.
  25   Q. The more difficult case, perhaps, is the case in which

   1     organs are properly retained for examination and study
   2     of the cause of death, and so are properly taken under
   3     rule 9, but there is then an issue as to their
   4     subsequent disposal or retention after that purpose has
   5     been exhausted.
   6        Can you tell us what the understanding would have
   7     been of the legality of that practice?
   8   A. The understanding throughout my career, not just advice
   9     I have taken from Coroners but also advice I have taken
  10     on behalf of my department, and the College has taken
  11     similar advice, from counsel as opposed to Coroners, is
  12     that the material which is left over, for example, the
  13     heel of a paraffin fixed block of tissue which has been
  14     used to determine the cause of death, pneumonia in the
  15     case of a lung, or meningitis or whatever, once the
  16     Coroner has discharged his function and he is
  17     functus officio, that piece of tissue is in effect the
  18     property of the pathologist and the department which has
  19     processed it. It has had something done to it and
  20     therefore it is perfectly licit to use the heel of that
  21     block for research purposes; it is perfectly licit to
  22     use that organ for teaching purposes, museum purposes,
  23     but it has always been the tradition, in the profession,
  24     right back to the days of the Anatomy Act, back into the
  25     nineteenth century -- and I can speak from experience

   1     here because at one stage in my life I looked after
   2     a museum which went back to the 19th century -- care was
   3     always taken to anonymise such material. It was
   4     identified only by reference number and register.
   5   Q. Just on the [draft] transcript here, you were talking
   6     about a piece of tissue, the heel of a block, and saying
   7     that it has had something done to it and therefore it
   8     was perfectly "licit", I think was your word -- it has
   9     come out as something else on the [draft] transcript,
  10     but you were saying that it is perfectly licit to use
  11     that organ for teaching purposes?
  12   A. Yes. My understanding -- and I am sure the Chairman
  13     will correct me -- from Kennedy and Grubb is that once
  14     tissue or an organ has been treated, property passes
  15     into the hands of the person or department who did the
  16     treating, and I think this is mentioned in Dobson and
  17     others quite recently, but I think it goes back much
  18     further than that.
  19   Q. Professor Green, we are not looking so much for
  20     a definitive analysis of the law from you --
  21   A. Thank goodness.
  22   Q. -- we are in fact commissioning an opinion on the
  23     subject, but what I am concerned to ask for your
  24     assistance on is what the understanding of the law was
  25     amongst practitioners, pathologists, clinicians, during

   1     the period in particular of our terms of reference?
   2   A. Our understanding was, and I think still is -- and this,
   3     as I say, has been confirmed repeatedly by the different
   4     Coroners I have spoken to -- the Sheffield Department
   5     serves a total of 15 Coroners, full and part-time, and
   6     in the course of my career I consulted with all of
   7     them -- was that you can only take material to establish
   8     the cause of death under rule 9, but once the cause of
   9     death has been established and the coronial process has
  10     been completed, fixed tissue in particular can be used
  11     for research purposes. For example, a lot of DNA work
  12     has been done on archived coronial material and things
  13     like congenital heart, good specimens of a slice of
  14     cirrhosis of the liver or whatever, provided they are
  15     suitably anonymised, can be retained for museum
  16     purposes, plastination purposes.
  17        Again, I should add that there has been a radical
  18     change as technology has advanced. The need for the old
  19     classical "organ in the pot" has been largely replaced
  20     by video techniques, computer-generated images, and so
  21     on, so there is not the need to do that as there was 30
  22     or 40 years ago. But as I say, throughout my career,
  23     putting it shortly, we always understood -- and the
  24     Coroners for whom I worked always understood -- that
  25     although you could only retain tissue to confirm the

   1     cause of death, once that had been done, you could use
   2     that tissue for research and teaching purposes.
   3   Q. And that attitude would apply similarly, would it, to an
   4     organ that had been retained but re-perfused, examined,
   5     and then preserved in some shape or form by the
   6     pathologist?
   7   A. Yes. That would be right. It would be reasonable to
   8     keep it either because it was a particularly good
   9     teaching specimen, for example, I have mentioned a slice
  10     of cirrhosis of the liver, or the lobe of a lung
  11     affected by lobar pneumonia which can be shown to
  12     students either as a jarred specimen or a plastinated
  13     specimen, but I think also, particularly in something
  14     like congenital malformations, particularly of the heart
  15     where there is such a broad spectrum of them, it is
  16     reasonable to keep a reference collection of whole
  17     organs so that you can go back after five or ten years
  18     and say, "This particular combination of defects is more
  19     common than that one and here is the material", and we
  20     can photograph them side by side even though they have
  21     been photographed in isolation. It is often very useful
  22     to be able to produce a compound image of, say, two
  23     organs, four organs, laid out side-by-side and say,
  24     "Look, this is a recurring pattern".
  25   Q. There are two questions arising out of that. The first

   1     is this: would it be fair to say that the sources for
   2     this understanding of the law are really two-fold:
   3     firstly, the old tag that there is no property in
   4     a body; and secondly, added to that, the understanding
   5     that if a pathologist has performed some activity, has
   6     in some way transformed or shaped the section of tissue
   7     or organ that he or she has been examining, he or she
   8     then has a claim to the specimen that has been created
   9     by that process?
  10   A. Yes. Dealing with the second point first, this question
  11     of processing equalling property, I think only came to
  12     the forefront in the last few years. Before that, the
  13     understanding, as I said right at the beginning, before
  14     1961, was that there was no property in a dead body, or
  15     the pieces of a dead body. It passed from person to
  16     person as that body went on its journey from hospital to
  17     disposal.
  18        I think, simply, tradition grew up that although
  19     it was clearly understood in a Coroner's case that you
  20     must not retain tissue or organ without good reason, it
  21     was perfectly right, if it would benefit research or
  22     teaching, to retain that tissue or organ once it had
  23     served its function of determining the cause of death.
  24   Q. I will come back to my second point later. We might
  25     perhaps look at a paper from the Royal College of

   1     Physicians which went, perhaps, to underline that view.
   2     It is to be found at WIT 54/975.
   3        It is the second paragraph which just gives us the
   4     context. This is from the President of the Royal
   5     College of Physicians, I think. If we just scroll down
   6     the page to see the end of the letter, please, it is
   7     from Professor Alberti. If we just go back up to the
   8     second paragraph, we can see there that Professor
   9     Alberti is referring to guidance from the Royal College
  10     of Physicians. He talks firstly about the guidance of
  11     1984 being updated in 1990, where the College gave
  12     specific guidance concerning the use of discarded
  13     tissue.
  14        We can find that, please, at page 978.
  15        If we go down a little to "Use of Discarded
  16     Tissues", if you could enlarge that, please:
  17        "The anonymous use for research of tissues
  18     genuinely discarded in the course of medical treatment,
  19     and of tissues removed at surgery or at autopsy, is
  20     a traditional and ethically acceptable practice that
  21     does not need consent from patients or relatives ..."
  22        Was that the understanding that was common amongst
  23     pathologists?
  24   A. It was the understanding that was common amongst
  25     pathologists and it was the understanding that was

   1     common amongst clinicians as well, particularly
   2     surgeons, of course.
   3   Q. If we could just complete the quotation by going over
   4     the page, 979, they add there that there may be legal
   5     constraints; it does not raise ethical issues, although
   6     there may be legal constraints, but they do not,
   7     however, give us any guidance as to what those legal
   8     constraints might have been.
   9   A. I think the problem is, Miss Grey, that nobody has ever
  10     addressed the issue properly. It has been skated around
  11     repeatedly. This is one of the difficulties, or the
  12     greatest difficulties which practising pathologists and
  13     clinicians wanting to use material for research --
  14     again, you see, we are looking at a much broader area
  15     than histopathology here; we are looking at blood
  16     specimens taken by the Haematology Department, urine
  17     specimens in clinical pathology, and so on.
  18   Q. Professor Alberti has also supplied us with the 1996
  19     guidelines and they are to be found at page 980. There,
  20     I might suggest, it appears that the College is becoming
  21     more uncertain in the guidance that it is offering, in
  22     that it says now that the use of research in anonymous
  23     tissues, and as I have quoted before, is a "traditional
  24     and ethically acceptable practice that we suggest does
  25     not need consent from patients or relatives and may not

   1     need to be submitted to a Regional Ethical Committee."
   2        Then it goes on to say that there may be legal
   3     constraints and it remains unclear to whom such samples
   4     belong in terms of beneficial ownership.
   5        Is the period from 1990 to 1996 one in which this
   6     issue became more problematic or more vexed?
   7   A. I think it became more problematic from a clinical point
   8     of view. It concerned physicians, clinical researchers
   9     and it concerned people working in the field of DNA far
  10     more than it concerned pathologists, particularly people
  11     like me who are Coroners' pathologists.
  12        You see, 40 years ago, when virology relied very
  13     extensively on using what are called "HeLa cells", which
  14     derived from the cancer of a woman called Helen Lane,
  15     nobody batted an eyelid about this, but then, of course,
  16     particularly when DNA came into prominence with all the
  17     profits which may be generated by genetic modification,
  18     use of bacteria, and so on, this claim in America caused
  19     problems about who owned what and, for example, do you
  20     still own your leg after you have given consent to its
  21     amputation?
  22   Q. This is the case of Mr Moore that you are referring to;
  23     is that correct?
  24   A. This is the American one, yes.
  25   THE CHAIRMAN: Miss Grey, just for the sake of the record,

   1     you referred to "REC" there; it is Research Ethics
   2     Committee, rather than "Regional", I think.
   3   MISS GREY: Yes, thank you.
   4   A. I think the other change in general is that whereas,
   5     once upon a time, a department such as mine or
   6     a department of general histopathology would have taken
   7     the attitude of, "Yes, this seems a reasonable research
   8     project, let us go ahead and do it", now, no matter what
   9     the work -- for example, I am now involved, in my
  10     retirement, in a major study on baby's eyes funded by
  11     the MRC -- whereas, even at the beginning of this decade
  12     we would not have taken it to an ethical committee, it
  13     has been fully scrutinised by both the Leeds and
  14     Sheffield RECs, just as any study involving living
  15     patients would have been, so on the whole, the
  16     profession is anticipating that outside scrutiny by
  17     a neutral body like an ethical committee is now
  18     essential, whereas at one time everybody said, oh, the
  19     pathologist must go to -- the clinicians must go to the
  20     REC, pathologists do not need to. I think we are
  21     anticipating public concern and responding to it before
  22     that concern is generally raised.
  23   Q. If I could complete this picture of this guidance by
  24     going to RCP 1/69, these are the notes of the Royal
  25     College of Pathologists on the consensus statement that

   1     was produced --
   2   A. This is an earlier report.
   3   Q. For the record I will read out the title: Consensus
   4     Statement of Recommended Policies for Uses of Human
   5     Tissue in Research, Education and Quality Control.
   6   A. This is the most recent edition.
   7   Q. Indeed.
   8   A. This is a Working Party on which I served. It was
   9     chaired by Dame Rosalinde Hurley.
  10   Q. And the College has published the consensus statement
  11     together with notes reflecting UK law and practice, and
  12     what we have on the screen there is one of those notes,
  13     note (H), where we start again by discussing the advice
  14     of the Royal College of Physicians that the use of
  15     anonymised left-over tissue from research is
  16     a traditional and ethically acceptable practice that
  17     does not need consent from patients or relatives and
  18     need not be submitted to a Research Ethics Committee.
  19        There is then a suggestion that that is a view
  20     endorsed by the Nuffield Council on Bioethics. I will
  21     not, I think, take you to that report this morning, but
  22     it may be that the report in full is rather more complex
  23     than that brief summary would suggest.
  24        Then if we could scroll down the page, please,
  25     there is then a further comment that the authors of the

   1     Nuffield report have suggested that general consent
   2     forms might usefully refer to the possibility that
   3     removed tissue may be used for the purpose of research,
   4     teaching or study, "but there remains a substantial body
   5     of opinion that express consent for usage for research
   6     is not vital."
   7        Does that remain the view of the Royal College?
   8   A. I think that this is the view which is taken in
   9     general. You see, remember that this is a much broader
  10     document than merely postmortem specimens; it applies to
  11     every discipline of pathology. There were people from
  12     all the major branches of pathology represented on this
  13     Working Party.
  14        The problem is that one has always archived
  15     paraffin-fixed tissue from surgical specimens mainly for
  16     medico-legal purposes, but now, for example, they are
  17     suddenly coming into their own for other reasons
  18     instead. One of the tests for Creutzfeldt-Jakob disease
  19     was developed by looking at tonsil tissue from people
  20     who had had their tonsils out many years previously. So
  21     I think the view of the College, even since this report
  22     was published, is going to come round to the idea of
  23     a universal consent form for operation, but again, this
  24     would involve consultation with the Royal Colleges of
  25     Surgeons, and remember that there were three, so that

   1     the consent to surgery form will have to be modified,
   2     saying it may be that the removed gallbladder, the
   3     removed appendix, may be used for research purposes in
   4     the future "unless you express an objection". But as
   5     I say, this moves out of the field of postmortem
   6     pathology which is my particular concern.
   7   Q. If we remain in the field of postmortem pathology, it
   8     is right now, is it not, that the attitude or views
   9     expressed in the consultative document are in favour of
  10     the need for specific consent having to be obtained for
  11     the retention of organs following a Coroner's
  12     postmortem?
  13   A. This is right, yes. Tissues, I think the situation
  14     remains as it was, which was if whole organs are going
  15     to be used, I think consent is now advised.
  16   Q. I may be guilty of over-simplifying a little if we look
  17     at the document itself. If we turn to, firstly,
  18     page RCP 1, page 80, and scroll down to the bottom
  19     there, please, we see there that firstly there should be
  20     information given to relatives on retention of organs,
  21     so that they are kept fully in the picture and advised
  22     when tissues can be disposed of, or would no longer be
  23     required, and then, over the page, page 82(RCP 1/82), we see there
  24     under the heading of "Disposal of tissue retained at
  25     postmortem examination", you see paragraph 6.3, once the

   1     inquest is closed or once the Coroner's jurisdiction is
   2     finished or comes to an end, responsibility reverts in
   3     practice to the pathologist. Obviously this
   4     paragraph is written against the background of relatives
   5     having already been informed of retention. If we scroll
   6     down to paragraph 6.4, the suggestion there is in effect
   7     that the pathologist may retain tissue provided that
   8     relatives have not expressed wishes to the contrary. Is
   9     that a fair summary?
  10   A. I think so, yes.
  11   Q. Why the difference in this case, then, between relatives
  12     giving express consent and relatives not expressing
  13     wishes to the contrary?
  14   A. I find that one hard to answer.
  15   Q. Perhaps I could suggest a reason. It may be that unlike
  16     in a case of a hospital autopsy, where one would see the
  17     relatives and discuss matters with them, and so can
  18     obtain a valid consent, in the case of a Coroner's
  19     autopsy the relatives may be informed of a practice
  20     which the Coroner first authorises, but may not,
  21     thereafter, respond to requests to give permission for
  22     disposal or otherwise?
  23   A. Yes. That is right. I recall now the discussion that
  24     took place about this. Basically, an awful lot of
  25     coronial work, again as I explained at the beginning of

   1     this autopsy, is death on the district, either sudden
   2     natural death, road accident, suicide, industrial
   3     accident and so on. Relatives are distressed, there is
   4     the knock on the door from the policeman in the middle
   5     of the night or whatever, they are told their relative
   6     has died and an autopsy is going to be done.
   7        Experiments were tried in the past, certainly
   8     Leeds was one of them, where, during the next working
   9     day, a representative of the hospital transplant team
  10     went round and said, "We are terribly sorry about the
  11     bad news but we would like to retain the aortic valve
  12     for the treatment of others". This was met with such
  13     hostility from recently bereaved and distressed members
  14     of the public that it rapidly went.
  15   Q. When you say "it rapidly went", what do you mean by
  16     that?
  17   A. It was rapidly discontinued. It was realised this was
  18     counter-productive. So as you have said, in hospitals,
  19     a lot of the deaths that are reported to the Coroner,
  20     even so the relatives have had time to prepare
  21     themselves for the fact that their relative is seriously
  22     ill, and some form of direct contact with clinical staff
  23     is taking place, but in at least a third of Coroners'
  24     cases, as I say, there is no contact with relatives,
  25     except through either a police or civilian Coroner's

   1     officer, and it was for this reason that we made this
   2     distinction about it is perfectly licit to retain issues
   3     unless relatives have expressed wishes to the contrary.
   4   Q. If we go back to the question of practices at the time
   5     of the period of the Inquiry and look at WIT 54/29, this
   6     is again Professor MacSween's statement.
   7        The statement refers to the fact that there is no
   8     clarity in the issue of for how long tissue should be
   9     kept and what their ultimate disposal should be, and the
  10     statement says there that coronial practice varies
  11     widely.
  12        Can you give us more detail as to the width of
  13     the variation in Coroner's practices on these issues?
  14   A. Yes. I can only speak for the area which I used to
  15     serve, and as I say, that was a total of 15 Coroners,
  16     5 full-time and the remainder part-time. The majority
  17     of Coroners took the view that tissue should be disposed
  18     of as soon as the inquest was completed. Some Coroners,
  19     particularly in the industrial cities like Rotherham,
  20     Sheffield and Leeds, said, "No, the tissue must be
  21     retained for three months, six months, one year",
  22     depending on whether the relatives have expressed an
  23     interest in taking legal action, whether what used to be
  24     called the Pneumoconiosis Panel was informed, and so
  25     on.

   1        The practice in our department was to consult with
   2     the Coroner wherever possible and say, "In these
   3     circumstances, how long do you wish us to retain the
   4     specimen for?" In cases where the Coroner said, "I have
   5     no opinion", or in cases where the Coroner had suspended
   6     his jurisdiction under -- I think it is rule 16, where
   7     there is a possibility of a murder or manslaughter
   8     trial -- the tendency we had in the Department was to
   9     mark the request form that goes from the autopsy room to
  10     the laboratory, "retain 3 months", "retain 6 months",
  11     and so on.
  12        As I say, the advice which Coroners tended to give
  13     related to the circumstances of the case and whether
  14     there was industrial illness, possibility of litigation,
  15     but some Coroners tended to say, "Well, it is up to you
  16     to make your mind up" and leave it very firmly in the
  17     hands of the Department.
  18   Q. When you say that the majority of Coroners took the view
  19     that disposal should follow the closing of their
  20     inquest, do you mean that they gave instructions to
  21     pathologists that tissues should be disposed of, or do
  22     you mean that they took the view that they had nothing
  23     further to do with it and it was a matter for the
  24     pathologist to decide what to do therefore?
  25   A. Well, yes, basically the Coroner does not order

   1     a pathologist or a pathology department to dispose of
   2     tissue. The Coroner's view is, "I no longer have any
   3     interest in this case; it is now up to you what to do
   4     with it". It was the other way round. The Coroner can
   5     say "You must hang on to this tissue for a minimum of
   6     three months after the conclusion of the inquest". They
   7     can tell you for how long you can keep it, but they tend
   8     not to tell you that you must dispose of it, or there is
   9     no disposal order. You are ordered to keep it, but
  10     disposal is left to the discretion of the pathologist,
  11     and the problem that one has in a busy department with
  12     a lot of homicide and suspicious death cases is one of
  13     space. You have fixed organs in freezers, and
  14     particularly since this CPS advice that stuff must be
  15     kept until the completion of the legal process,
  16     departments such as the one in Sheffield and the one in
  17     Guys, which has the heaviest workload in the country,
  18     have very real problems of physical storage.
  19   Q. In general the consultative document will require, if
  20     implemented, a great deal to be done in terms of seeking
  21     or informing relatives of the practice of autopsies and
  22     what happens to bodies and parts of bodies during those
  23     practices and obtaining explicit consent for those
  24     practices.
  25        How well equipped do you think that the medical

   1     profession is, whether we are talking of clinicians or
   2     pathologists, to carry out that task successfully in the
   3     future?
   4   A. In a well organised teaching hospital where there are
   5     regular clinico-pathological conferences and good and
   6     close relationships between the clinicians and the
   7     pathologists, and particularly if there is a bereavement
   8     counselling service as well which brings everything
   9     together, all death certificates signed in an office
  10     down at the front door, and so on, it should be
  11     relatively easy to implement.
  12        In the smaller hospital which does not have the
  13     benefit of these services, where there tend to be books
  14     of death certificates kept on every ward and matters are
  15     dealt with on what you might call a "firm by firm"
  16     basis, it will be rather more difficult. I think the
  17     biggest problem is going to come in the area of coronial
  18     pathology in which I am most concerned, and this applies
  19     to only a few cities in the country, where there are
  20     public mortuaries and medico-legal centres which are
  21     separate both geographically and under the control of
  22     the local council rather than under the control of
  23     a health authority. In Sheffield, for example, where
  24     the medico-legal centre is two miles from the Royal
  25     Hallamshire Hospital, four miles from the Northern

   1     General Hospital, close liaison between pathologist,
   2     clinician and relatives under those circumstances is
   3     going to be difficult, but with increased efficiency of
   4     communication, and we have a model for this in Sheffield
   5     with our immediate communication with GPs through the
   6     SHSA by computer network, the difficulties will be there
   7     but they should be "overcomable".
   8   Q. Is this issue, the question of death and handling of
   9     bodies and parts of bodies after death, one that has
  10     been given any or any sufficient attention in the
  11     medical curriculum in the training of junior doctors?
  12   A. The problem here is one of what you might call the
  13     "exponential expansion of knowledge", in other words,
  14     the curve has gone up straight instead of increasing
  15     gradually. When I was a medical student, we had 40
  16     lectures in forensic pathology, in forensic medicine, in
  17     Leeds, and there was a requirement in the then Medical
  18     Act -- I think it was 1956, the most recent one -- that
  19     forensic pathology and legal medicine should (a) be
  20     taught at undergraduate level and it should form part of
  21     either the fourth MB or the final examination.
  22        Once that requirement was withdrawn and there was
  23     more and more competition from other specialties and
  24     subspecialties, particularly things like molecular
  25     biology, for space in the curriculum, forensic medicine

   1     in its broadest sense rapidly disappeared. Examinations
   2     in most medical schools were abolished by the
   3     mid-1970s. Leeds continued to examine until the late
   4     1980s, but I think it was the last medical school in
   5     England and Wales to do so, and to give you a simple
   6     example, until I left Leeds in 1990, I gave a total of
   7     four lectures to clinical medical students on the legal
   8     and social aspects of death.
   9        When I moved to Sheffield, I was allowed two hours
  10     to teach on the legal and social aspects of death. Now
  11     I think the total amount of forensic teaching in
  12     Sheffield amounts to one working day and there is just
  13     one hour devoted to death certification and cremation
  14     certification, which does not give you much time to talk
  15     about dealing with families. In Leeds, and I think
  16     Leeds does better than some other medical schools, there
  17     is one half day devoted to the teaching of forensic
  18     medicine which includes the interpretation of injuries,
  19     death certification, cremation, abuse of alcohol and
  20     everything else.
  21        So the amount of time that has been given to
  22     teaching undergraduates, and that is where it has to
  23     start, has been reduced.
  24        The other problem is one of increasing sizes of
  25     medical schools, in that, when I started, there were 45

   1     in my year. There were never more than 6 of us on
   2     a firm. We literally lived on the job. When the SHO
   3     was talking to relatives about the death of a member
   4     their family, we were expected to be there sitting in
   5     the corner and taking notice.
   6        So right from passing second MB, I had seen how
   7     doctors ought to deal with families of the recently
   8     bereaved. Now, of course, they get 220 medical students
   9     in a year. Your firms are enormous. When they are on
  10     acute, they do not get the opportunity of the
  11     time-consuming social aspects of medicine that were
  12     available to my generation, and, now, of course, whilst
  13     I do not wish to criticise in any way the new training
  14     schemes post-Calman, I think they are going to produce
  15     technically better doctors more quickly, finding time in
  16     the pre-registration year to teach doctors. Again in my
  17     last four years in Leeds and my first three years in
  18     Sheffield, I took part in every house officer's
  19     induction course, not just on death certification and
  20     cremation, but on how to deal with the questions that
  21     the relatives might raise. As far as I know, there is
  22     no time in any PRHO induction course for that sort of
  23     thing to happen now.
  24   Q. At the risk of giving inadequate time to the various
  25     issues, I am also conscious of the time at the moment

   1     and I would like to invite your comments briefly on two
   2     further matters.
   3        One appears from WIT 54/33, please, where
   4     Professor MacSween's statement deals with the usefulness
   5     of the Coroner's Court as an unofficial forum for audit
   6     and comments that if certain patterns of death emerge in
   7     a particular hospital or at the hands of a particular
   8     clinician, the Coroner can quite rightly comment on
   9     those.
  10        I am sure that no one would venture to disagree
  11     with the good sense of that observation as it stands,
  12     but the question that I have is, is that realistic,
  13     because does it ever occur that a Coroner is able to see
  14     sufficient numbers of deaths to enable him to draw those
  15     sorts of conclusions, see those sorts of patterns?
  16   A. It happens rarely, but it happens. I can recall two
  17     episodes in the last ten years where it was a result of
  18     the Coroner's autopsy system and the enquiries
  19     surrounding deaths in preparation for inquest that it
  20     became obvious that one particular surgeon in
  21     a particular specialty within surgery had a high
  22     mortality rate and that there was a similarity in the
  23     accidents or incidents which had led to those patients'
  24     deaths.
  25        I hasten to add, though, that in both cases after

   1     the first and in one case the second inquest, the
   2     Coroner and the pathologist involved were so already
   3     alerted that most of the preparatory work, the informing
   4     of the hospital Trust, the making arrangements which
   5     resulted in the suspension of the surgeon in one case
   6     and his voluntary early retirement in another, took
   7     place before the inquest in the third case took place.
   8        I think what this leads on to is that a good
   9     coronial service, staffed by conscientious pathologists,
  10     or served by conscientious pathologists, will be alert
  11     to problems arising in a particular hospital or at the
  12     hands of a particular clinician, will consult the
  13     Coroner early and will give advice to the Coroner about
  14     the best way forward.
  15        You see, there are many causes of death or
  16     contributory causes of death which you cannot see at
  17     postmortem or microscopically: errors in management of
  18     fluid balance on an intensive care unit; anaesthetic
  19     problems of one sort or another; a pathologist, these
  20     days, cannot keep up with all the advances in
  21     pharmacology. But if one gets the feeling that the
  22     death rate in a particular unit of a particular hospital
  23     due to a particular set of circumstances is turning up
  24     more often than usual, it is the Coroner who instigates
  25     that investigation. It might be through civil and

   1     management channels, but I can think of two series of
   2     cases in my area where equipment on an intensive care
   3     unit was tampered with. I can think of three series of
   4     cases in my area where syringe drivers were tampered
   5     with in the administration of pain-killing drugs on the
   6     ward, and it was the coronial system and the spotting of
   7     the similarities that the Coroner's enquiries plus the
   8     autopsy revealed that brought about the further
   9     investigation, the police involvement and so on.
  10        So the Coroner system is not just the first line
  11     of defence against secret homicide or malpractice, you
  12     know, criminal malpractice; it also, in a few
  13     circumstances, albeit rare, is the gatekeeper for
  14     certain types of incident of a repetitive nature on
  15     a particular unit in a particular hospital, but
  16     I emphasise its uncommonness.
  17   Q. Is it the Coroner who is more likely to pick that up,
  18     or is it more likely the pathologist who might do so?
  19   A. It is usually a team thing. The Coroner's pathologist
  20     looks at the case notes. He has his attention drawn to
  21     comments which the relatives might have made to the
  22     Coroner's officer, and he goes along to the Coroner and
  23     he says, "Look, I am not happy about this one; there is
  24     something going on here".
  25        I can recall a case 18 months ago, 6 months ago,

   1     and I have brought the postmortem report with me;
   2     I think perhaps more detailed enquiries should be made
   3     and the relatives should be warned that the inquest can
   4     be opened tomorrow, but it is going to be longer than
   5     usual before the inquest is completed.
   6   Q. You are describing there a system which really depends
   7     on the happy chance of someone spotting a similarity or
   8     a coincidence. If one focuses now on the role of the
   9     pathologist, what role does a pathologist have in
  10     a hospital setting -- I am talking of a hospital
  11     pathologist now -- in, as it were, supervising, auditing
  12     or examining standards of clinical practice?
  13   A. I think the pathologist has an important role. The
  14     pathologist, it used to be said, knows everything, but
  15     24 hours too late. This of course is untrue. As
  16     I said, we cannot keep up with advances in pharmacology,
  17     surgical technique and everything else, but careful
  18     study of the case notes, consultation with the
  19     clinicians before the autopsy rather than after, is as
  20     essential a part of the autopsy as is the gross
  21     dissection and the microscopy. And I would certainly,
  22     if I was asked to do a hospital death, and in the last
  23     three or four years of my career I would say 40 per cent
  24     of my major cases were civil rather than criminal,
  25     because I was not an NHS employee, I was called in as

   1     the "honest broker" because relatives were complaining,
   2     or the conduct of the hospital was being called into
   3     question. I would never dream of starting the autopsy
   4     without having waded through the case notes, preferably
   5     with a member of the clinical team with me. Sometimes,
   6     if necessary, I would put off the autopsy for 24 or
   7     36 hours to give me time to familiarise myself with the
   8     case, and the background, and I think the modern
   9     pathologist, trained to the standards which the College
  10     requires, is aware of his or her role within audit and
  11     is aware that he or she cannot audit properly if they do
  12     not apprise themselves of all the facts surrounding the
  13     patient's illness and death before starting the PM.
  14   Q. We have in our papers the College's 1991 document on
  15     autopsy and audit which of course gives us further
  16     guidance on that subject. However, I think for the
  17     moment, mindful of the time, I will need to stop there,
  18     Professor Green. We have a taxi ordered for you in five
  19     minutes time. With that reminder in mind, I think we
  20     have, really, some 5 to 10 minutes in truth if Professor
  21     Green is to catch his train.
  22        Could I ask firstly whether there is anything
  23     that, Professor Green, you would like to add at this
  24     stage? You can of course at any time contact us further
  25     in writing if there is anything that this morning we

   1     have had to skate over rather rapidly, but is there
   2     anything which for the moment you would like to add?
   3   A. I can think of nothing else that I need to add. To
   4     summarise, the autopsy is still the gold standard. The
   5     autopsy is still the best way for assessing new methods
   6     of treatment and investigation. It is a useful research
   7     tool. It identifies occasionally, but occasionally,
   8     errors of surgical technique or competence, or medical
   9     technique or competence, and it also is an essential
  10     statistic public health tool because it often identifies
  11     associated diseases as well as the disease that led to
  12     the death of the patient.
  13        I am consulting with my President on Friday of
  14     this week. He no doubt will have read my evidence on
  15     the website. He will no doubt clip me round the ear at
  16     the point where I deserve clipping round the ear, and if
  17     there is any further guidance that he wishes me to
  18     communicate on behalf of the College, either I will
  19     write or Professor MacSween will write and do so.
  20   MISS GREY: Thank you. Sir, I have left a little time, but
  21     I hope I have left you enough time not to feel in any
  22     way constrained.
  23   THE CHAIRMAN: Miss Grey, as ever you put things so
  24     eloquently.
  25        Professor Green, if I may detain you very shortly,

   1     there are two questions from the Panel. Perhaps you
   2     could bear with us.
   3             EXAMINED BY THE PANEL:
   4   MRS MACLEAN: Very briefly, Professor Green, can I ask you
   5     to think back to 1992, when your book was published. At
   6     that time, would you expect the Medical Director of
   7     a large teaching trust to be taking organ specific
   8     consents -- to be seeking consents specifically with
   9     regard to particular organs?
  10   A. I would have thought by then there was so much general
  11     knowledge of the importance of informed consent that the
  12     director of the average medium sized or teaching
  13     hospital Trust would be sitting looking closely at the
  14     consent form used by that Trust and making sure that it
  15     reminded the doctors, the VCOs or whoever, that they
  16     must obtain specific consent for the retention of organs
  17     or tissues.
  18   THE CHAIRMAN: Professor Jarman?
  19   PROFESSOR JARMAN: You have emphasised the importance of the
  20     postmortem in terms of improving clinical care for
  21     doctors, and I think about half of deaths occur outside
  22     hospital, so the doctor involved there is the GP. You
  23     said in your area the FHSA was sent a postmortem
  24     report. Is that general and should it be general?
  25   A. It is not general, because not every FHSA has an

   1     inter-web site linking all its GPs. We in Sheffield are
   2     fortunate in that we have a dedicated medico-legal
   3     centre with the Coroner's office and pathology
   4     department on the same site. We have close links with
   5     the FHSA. As each batch of reports is typed, up goes
   6     the modem and everything is transmitted very quickly.
   7     In a perfect world, every large city would do this. But
   8     remember that in this country, in England and Wales we
   9     have, I think it is 140 coronial jurisdictions of
  10     different sizes, some of them run on a half day a week
  11     district by a local solicitor, with only 200 deaths
  12     a year. My own view is that the days of the part-time
  13     Coroner are dead; we need big regional coronial areas
  14     and this would improve communications. But I am sure
  15     Michael Burgess would not agree with me at all on that
  16     one!
  17   PROFESSOR JARMAN: Thank you.
  18   THE CHAIRMAN: Professor Green, we very grateful indeed for
  19     your coming and helping us this morning. It has been of
  20     great assistance to us. As Miss Grey said, if there are
  21     other matters, whether they are consequent upon your
  22     conversation on Friday or otherwise, that you want to
  23     bring to our attention, we would be grateful to have
  24     them. For today, thank you very much and if I may say,
  25     bon voyage as well.

   1   PROFESSOR GREEN: Thank you very much indeed, sir. May I be
   2     released?
   3   MISS GREY: Sir, it may be that this will be an appropriate
   4     moment to break for lunch, or whatever. I do not know
   5     what you would like to do by way of the length of the
   6     break, however?
   7   THE CHAIRMAN: I would have thought until half past 1. That
   8     is around 45 minutes. So shall we say until half 1, and
   9     then we will reconvene, thank you.
  10   (12.50 pm)
  11            (Adjourned until 1.30 pm)
  12   (1.35 pm)
  13   MISS GREY: Sir, we are to hear evidence now from Mr Robert
  14     Clifford, head of the Coroner's Section of the Animals,
  15     Byelaws and Coroner's Unit of the Home Office.
  16        If you could stand, please, Mr Clifford, for the
  17     oath or affirmation.
  18           MR ROBERT CLIFFORD (SWORN):
  19             Examined by MISS GREY:
  20   Q. Could we have on the screen, please, WIT 43/1? This is
  21     a document entitled:
  22        "Home Office statement to the Bristol Royal
  23     Infirmary Inquiry."
  24        You are mentioned and your title and position is
  25     set out in paragraph 1 of that statement.

   1        If we turn, please, to page 11, is that your
   2     signature that we see there?
   3   A. It is, yes.
   4   Q. Are the contents of the statement true to the best
   5     of your knowledge and belief?
   6   A. They are.
   7   Q. Mr Clifford, your title and your position are set out in
   8     paragraph 1 of the statement, if we turn back, please,
   9     to page 1, can I ask you first, how long have you held
  10     that post?
  11   A. I have been in the post since August 1995.
  12   Q. So, to the extent that this statement deals with past
  13     practice and events or policy during 1984 onwards, is
  14     that something that you have consulted with colleagues
  15     or looked in the archives to gain more direct knowledge?
  16   A. That is right. I will have consulted colleagues
  17     earlier, or relevant Home Office papers.
  18   Q. Can you tell us more about the responsibilities of the
  19     Coroner's section for this area of the law on autopsy
  20     and postmortems?
  21   A. My section has a general responsibility for Coroner law
  22     and practice, part of which is inevitably concerned with
  23     the fact that autopsies are necessarily part of the
  24     Coroner system and Coroner process. We have a wider
  25     responsibility for various aspects under the Coroner's

   1     Act for matters relating to Coroners such as their
   2     organisation and management, and we are generally
   3     responsible for administrative matters arising from
   4     that.
   5        In relation to postmortems and autopsies, then
   6     our interest derives from the provisions in the
   7     legislation, for example, provision for autopsies to be
   8     held and provisions for payments to be made to various
   9     parties in connection with this, and there is also the
  10     Coroners' Rules which govern aspects of the autopsies.
  11   Q. Aspects of the law relating to autopsies are governed
  12     by Acts such as the Human Tissue Act. What would be the
  13     breakdown of responsibilities between your unit and that
  14     of the Department of Health in relation to the law or
  15     policy on this area?
  16   A. We would certainly consult the Department of Health on
  17     any aspects relating to the Human Tissue Act, for
  18     example, and I think you will have seen, in my evidence,
  19     that one of the practices of the Home Office was to
  20     ensure that guidance issued by the Department of Health
  21     in relation to that Act, the Human Tissue Act, was
  22     brought to the attention of Coroners.
  23   Q. But if one were to be dealing, for instance, with the
  24     subject of hospital or permission autopsies and the
  25     obtaining of consent for those, would that fall

   1     underneath your remit at all, or not?
   2   A. It would depend on exactly what we were talking about.
   3     To what extent it was necessary or appropriate to
   4     involve the Coroner or his officers in the process of
   5     obtaining consent where it was necessary, I think this
   6     is an area where the Home Office and the Department of
   7     Health responsibilities would abut and we would approach
   8     them on a joint basis.
   9   Q. The Inquiry has been hearing evidence in relation to
  10     the subject of the retention of tissue or organs
  11     following autopsies carried out after paediatric cardiac
  12     surgery was carried out at the Bristol Royal Infirmary.
  13     Evidence has been given of what might be described as
  14     fairly widespread retention of organs following such
  15     autopsies. We have obviously been hearing from many who
  16     will say, or have said to the Inquiry, that they had no
  17     knowledge that this was a consequence or a possible
  18     consequence of either a hospital or a Coroner's
  19     postmortem.
  20        Can I ask you, what knowledge did the Home Office
  21     Coroners' Unit have of this particular issue or area of
  22     practice following a Coroner's postmortem?
  23   A. I can say that virtually nothing came to our attention
  24     of matters of concern regarding the retention or
  25     disposal of body parts or tissue from Coroners'

   1     postmortems until, I think, 1996, which certainly was
   2     the first I had heard of this as a potential problem.
   3        I have researched the matter and I am aware that
   4     the Home Office drew or reminded Coroners of the
   5     limitations on what might be done with material retained
   6     from a postmortem some years before as a result,
   7     obviously at that time of some complaints or information
   8     coming to our attention that the material was being
   9     retained for purposes which did not seem to be
  10     authorised under the legislation. But only since 1996
  11     has the possibility of a problem in this area,
  12     a potential problem in the area, really come to our
  13     attention.
  14   Q. Just to pick up on one reference there, you say that the
  15     Home Office issued guidance on this subject in the
  16     past. Is that a reference to the extract we find at
  17     page 153 of your statement?
  18   A. That is correct.
  19   Q. I think you date that document to 1989 --
  20   A. That is right.
  21   Q. -- in your statement. So are you able to help us any
  22     further as to the reasons why that particular piece of
  23     guidance was issued at that time?
  24   A. Unfortunately not. I have looked for the papers that
  25     might shed light on the background to that advice and

   1     I have not been able to trace them. I do not know
   2     whether that is because they might have been devoid
   3     after this lapse of time or for whatever other reason.
   4     My interpretation of it, for what it is worth, is that
   5     there might have been one or more instances which came
   6     to our attention, and it seemed appropriate to issue
   7     that advice. Whether that was in consultation with
   8     others, for example the Department of Health, I cannot
   9     say.
  10   Q. Would that be a formal method of proceeding: that if,
  11     for instance, a few complaints had been made to you or
  12     had reached you concerning specific practices, that you
  13     might respond by issuing guidance to Coroners about the
  14     correct practice or the correct view of the law?
  15   A. One has to be a little careful about the correct view of
  16     the law, but certainly we would consider, in the light
  17     of the information that came to our attention, whether
  18     it was a one-off issue, an isolated incident, whether it
  19     was more widespread, whether it was the sort of thing it
  20     was proper for the Home Office to give advice on, and in
  21     doing so we would consult certainly with the Coroner's
  22     representatives and probably with the Department of
  23     Health or whatever department or organisation might be
  24     responsible for the area of concern.
  25   Q. You say that one might have to be a little careful about

   1     issuing advice on a correct interpretation of the law,
   2     but what are the sensitivities in that regard, because
   3     this document, for instance, is in effect setting out
   4     a view of the legal scope of rule 9 of the Coroners'
   5     Rules?
   6   A. Yes. Clearly, though, it would be my practice to be
   7     cautious in appearing -- or in the Home Office appearing
   8     to interpret the legislation in practice. At
   9     a practical level, one may feel that it would be helpful
  10     to offer a view as to the practical handling of
  11     a situation that might arise, and I think this is
  12     probably aimed in that area.
  13   Q. If we look, please, at UBHT 308/44, this is a copy of
  14     an article, if we scroll down to the second column,
  15     please, written by Professor Bernard Knight on Legal
  16     Considerations in the Retention of Postmortem Material.
  17     I think you have had a opportunity to look at that
  18     recently; is that right?
  19   A. Yes, I have.
  20   Q. If we turn over the page(UBHT 308/45), please, we can see there
  21     that there is the view expressed by Professor Knight
  22     that the retention of tissues for teaching and research
  23     is not covered by the Coroner's permission and the
  24     Coroner, indeed, cannot grant such permission as it is
  25     not within his remit to do so, and positive permission

   1     is therefore required under the terms of the Human
   2     Tissue Act.
   3        Then the view is set out that in spite of frequent
   4     claims to the contrary, the Coroner has no authority to
   5     give permission for such removal.
   6        That article, which was written in 1985, might
   7     suggest that the scope of the powers under rule 9 was
   8     a matter of concern or potential interest to some
   9     clinicians at least, at least a few years, four years,
  10     before the Home Office circular on this subject we have
  11     just looked at was released.
  12        Is that something that, to your knowledge, was
  13     within the knowledge or part of discussion within the
  14     Home Office at that time?
  15   A. I do not know.
  16   Q. I think it is right, then, that this article was only
  17     brought to your attention recently; it is not something
  18     that features, as it were, in Home Office files at the
  19     time?
  20   A. Not to my knowledge.
  21   Q. Not to the extent that you have been able to discern in
  22     the records that are now available; is that right?
  23   A. That is right.
  24   Q. If we could turn, then, to the Royal College of
  25     Pathologists statement, WIT 54/29, there is there set

   1     out a review of the retention of tissues in Coroners'
   2     cases, and it says that what is unclear is for how long
   3     those tissues should be kept and what their ultimate
   4     disposal should be, and the College then goes on to say
   5     that coronial practice varies widely.
   6        If I could just invite to you read through the
   7     rest of that paragraph, if we scroll up it a little, the
   8     view, as I say, is set out there, that differing
   9     practices are adopted by different Coroners on the
  10     retention and disposal of tissue.
  11        Can I ask you first, what knowledge do you have of
  12     the practices adopted by different Coroners in this
  13     regard?
  14   A. We have no definite knowledge. A lot of these things
  15     are mentioned in an anecdotal way. Our perception is
  16     that the Coroners generally do leave the arrangements
  17     for disposal to the pathologist. Again, we understand
  18     that how long or whether they lay down specific lengths
  19     of time for the material to be retained does vary, but
  20     we have no information as to whether there is a majority
  21     view of any particular length of time, for example, or
  22     any other detailed aspects.
  23   Q. Do you have any knowledge of the practices that are
  24     adopted or had been adopted by Coroners in relation to
  25     informing the next of kin upon the retention and

   1     disposal of tissues?
   2   A. Not in general. I have come across one case fairly
   3     recently, where a Coroner has made it clear to me that
   4     he does take steps to ensure that there is clarity for
   5     the relatives in this regard. But we have not, for
   6     example, conducted any kind of survey.
   7   Q. In general, the impression gained from your evidence on
   8     this point, both today and in your statement, is that
   9     this was not something that the Coroners' Unit was aware
  10     of as being an issue or a subject of potential concern
  11     until 1996; is that right?
  12   A. That is correct.
  13   Q. What was it that altered in 1996 that raised this as
  14     a possible problem?
  15   A. A particular case came to our attention where an organ
  16     had been retained and enquiries were made about that, or
  17     rather, in effect, a sort of complaint about that
  18     established that the organ had been retained and raised
  19     questions about why it had been retained, and what
  20     authority, and whether there were proper arrangements
  21     for disposal.
  22   Q. Was this a case concerned with the Bristol Royal
  23     Infirmary?
  24   A. No, it was another case.
  25   Q. Was it the case of a child or an adult?

   1   A. An adult.
   2   Q. So another case involving an adult raised as a potential
   3     area of concern. What steps did the Coroners' Unit take
   4     to investigate this area?
   5   A. We contacted the Department of Health to clarify whether
   6     there was any guidance issued by that department or
   7     whether there was any professional practice guidance
   8     issued by a relevant organisation, for example, the
   9     Royal College, to find out what the practice was, what
  10     procedures there might be, levels of compliance, if
  11     known, and so on and so forth, to seek to identify
  12     whether this was an isolated incident or whatever.
  13   Q. And the response?
  14   A. My attention was drawn to the work that Professor Berry
  15     was at that time undertaking to look into this as an
  16     issue. In due course, I contacted Professor Berry,
  17     indicated our interest in the work and maintained
  18     contact since that time.
  19   Q. Is that a reference to the fact that Professor Berry
  20     was initially involved in the consultation paper now
  21     published by the Royal College of Pathologists on the
  22     guidelines for the retention of tissues at postmortem
  23     examination?
  24   A. Whether it was -- exactly that. At the time he had
  25     a Working Party looking at the range of issues, one of

   1     which would address or consider these points of points.
   2   Q. If he was looking at a range of issues, what did you
   3     understand him to be examining?
   4   A. I cannot remember offhand what other issues. There must
   5     have been related ethical, for example, issues of
   6     a similar nature to do with postmortems, but my interest
   7     was simply on the fact that he appeared to be looking at
   8     this area which was of interest to us.
   9   Q. And a Working Party set up by what organisation?
  10   A. I believe, under the auspices of the Royal College of
  11     Pathologists.
  12   Q. Was the conclusion then, having heard of this Working
  13     Party looking into this subject, that the Home Office
  14     would, as it were, wait for that party to report before
  15     itself taking any action?
  16   A. Yes, essentially. I mean, we were not clear on
  17     time-scales at the time as to when they were likely to
  18     come to any conclusion, but it seemed sensible, before
  19     attempting to take any other action, which might well be
  20     misdirected, to find out what professional practice view
  21     was of a situation and possible ways forward.
  22   Q. And there has now, of course, been published this
  23     consultation paper by the Royal College of
  24     Pathologists. Is it right that you had some input into
  25     that in terms of commenting or being consulted upon

   1     guidelines?
   2   A. That is correct. We were involved over the last few
   3     months in looking at a number of versions of that
   4     document and commenting where we thought appropriate to
   5     do so.
   6   Q. Does it follow from that, when the statement from
   7     Professor MacSween says that coronial practice varies
   8     widely, that the Home Office itself has not undertaken
   9     any independent investigation of this area, but has so
  10     far been waiting for the consultation document before
  11     deciding further what steps are needed to be taken?
  12   A. That is right.
  13   Q. And now that the consultation document has been
  14     published?
  15   A. Well, it is still a consultation document, and while
  16     I am not sure what sort of timescales the College is
  17     looking at in terms of completing its consultation
  18     process, presumably one is getting close to the final
  19     version. I think when one has a final version on which
  20     there has been quite wide consultation, one can sensibly
  21     look to using that document to decide the best way
  22     forward for any advice or guidance to Coroners on how
  23     they might approach these issues, as indeed the document
  24     anticipates.
  25   Q. Presumably the Home Office will be making any further

   1     comments that it wishes to make upon the consultation
   2     document as and when it is ready to do so, but are there
   3     any comments that you would like to offer today upon
   4     that document?
   5        If we turn to RCP 1/84, there is a summary of
   6     recommendations, if that will assist. But as I say, are
   7     there any comments you would wish to make today, or are
   8     these things that must needs wait until the appropriate
   9     time within the Home Office?
  10   A. I think perhaps it is worth saying that generally we
  11     think this document is very much heading in the right
  12     direction. It seems to be approaching the matter in
  13     a way which we think is appropriate. Obviously there
  14     are some practical aspects that need to be considered
  15     and there are points of detail which we can address.
  16     One or two points which I would need to make further
  17     enquiries about, for example. But in our view, this is
  18     broadly an acceptable form of document which is a basis
  19     for further work, which I think is recognised in the
  20     recommendation, for example, for an information leaflet
  21     and guidance and so on and so forth, coming at the
  22     problem from the Coroner's point of view.
  23   Q. Perhaps one of the practical issues that might arise out
  24     of it is that if one looks at the recommendations in
  25     general, and perhaps in particular at paragraph 8.5,

   1     which is over the page at 85(RCP 1/85), one sees there the need
   2     for an information leaflet which sums up a general
   3     thrust about the need for more liaison with relatives
   4     and more information being given to them about the
   5     practices that are consequent upon a coronial postmortem
   6     and the possible need for retention of tissue, and the
   7     issues that may arise on the disposal of tissue
   8     thereafter.
   9        Can I ask you, what do you think will be the
  10     implications in terms of staffing and the demands placed
  11     upon Coroners' staff to implement these sorts of
  12     guidelines about informing relatives better about what
  13     goes on in inquest, or autopsy?
  14   A. It is probably worth saying -- to put some sort of
  15     framework around this -- that in general the Home Office
  16     has been working recently with Coroners to improve
  17     generally the information available to the public about
  18     the inquest system, to provide more advice to families
  19     about what to expect in the actual hearing, and so on
  20     and so forth. There is a broad movement towards
  21     providing more information to the public.
  22        In this area there are a couple of points to bear
  23     in mind. One is that there is a provision under the
  24     Coroners' Rules for certain issues relating to
  25     postmortems to be drawn to the attention of the

   1     relatives, where practical, at the outset in terms of
   2     relatives having rights to be represented at the
   3     postmortem itself, so we are not talking about something
   4     which is breaking wholly new ground in terms of Coroners
   5     or more particularly their officers having a contact
   6     with relatives where practical before the postmortem,
   7     although it has to be said, our understanding is that it
   8     is not often practical to be able to contact families in
   9     advance, but nevertheless, it is usually contact at that
  10     point. So the staff will have contact with families;
  11     they will often have to explain perhaps that the
  12     postmortem has taken place, and they will have that
  13     degree of contact and experience in explaining to
  14     families the nature of what has been happening.
  15        What I think is needed in the light of this sort
  16     of recommendation is further guidance on the sort of
  17     additional information that might be needed or probably
  18     will be needed to be given to families and at what time
  19     and in what circumstances, maybe, to help them
  20     understand what the position is and what steps might be
  21     open to them to take.
  22   Q. The document speaks, in many places, of the role of
  23     clinicians in informing families of the nature of
  24     autopsies and the sorts of tests that might be carried
  25     out at autopsies in the case of hospital deaths, but

   1     many deaths which result in Coroners' autopsies are not
   2     hospital deaths and they are therefore ones in which
   3     a clinician will not have had contact with a family
   4     prior to death, as might often be the case in the case
   5     of a hospital death.
   6        How do you think the emphasis of this document on
   7     informing relatives of the nature of inquests,
   8     autopsies, can be handled in the context of non-hospital
   9     deaths where the Coroner's officer will be the only
  10     person who the family would habitually see when there
  11     has been no clinician involved?
  12   A. This is an issue that arises in any event, or has
  13     a potential to arise in any event, in that families may
  14     ask for a copy of the postmortem report in such cases,
  15     and it is the practice, as I understand it, that
  16     Coroners would tend to recommend that such postmortem
  17     reports are provided to the deceased's general
  18     practitioner or other appropriate clinician and that
  19     that person may well be the best person to talk through
  20     the implications of the postmortem report with the
  21     family of the deceased.
  22        So I think a process already exists where clinical
  23     expertise, if you like, is brought to bear and acts as
  24     a conduit for information to the family.
  25        One also has to remember -- it depends what one is

   1     talking about at this juncture, because there are two
   2     potential issues here: one about whether or not there
   3     are questions of material being retained for a long
   4     period, and there is the question of the disposal
   5     arrangements as well.
   6        If there is a question of tissue being retained,
   7     somebody is going to have to take that decision, or at
   8     least express that wish for the material to be
   9     retained. I am not quite sure whom that would be in
  10     a non-hospital death, but it could conceivably be
  11     a pathologist attached to the hospital, whatever it
  12     might be, in which case that would draw in the expertise
  13     that was necessary.
  14        One would have -- it is one of the practical
  15     aspects of this -- to look at the channels of
  16     communication which we can discuss with the various
  17     practitioners involved to make sure there is a workable
  18     procedure. I think there is a potential for the right
  19     channel to be in place. One has to make sure that they
  20     can in fact operate in that intended way.
  21   Q. We have looked at that part of Professor MacSween's
  22     statement which talks about practice amongst Coroners
  23     with the disposal of tissues being variable. You deal
  24     briefly in your statement, at page 2, I think, with the
  25     subject of the training of Coroners.

   1        I am looking here at paragraph 13, where you make
   2     the point that there is no statutory responsibility for
   3     training standards or for Coroners to undergo training,
   4     but the Home Office, since 1984, has provided regular
   5     study opportunities for Coroners to attend on
   6     a voluntary basis.
   7        Firstly, can I ask you, what importance would the
   8     Home Office attach to consistency of practice amongst
   9     Coroners?
  10   A. Clearly, the Coroner service is a local service and in
  11     the nature of such services, there will be variation
  12     between various Coroners. Those variations may arise
  13     for all kinds of reasons, and the real issue is probably
  14     consistency of approach. We think it is an important
  15     aspect that there should be a degree of consistency of
  16     approach in matters. It is the sort of point we will
  17     discuss and do discuss with Coroners, to encourage as
  18     far as possible that they approach whatever matter it
  19     might be in a broadly consistent way, having regard to
  20     their independent position.
  21   Q. If you provide regular study opportunities for Coroners
  22     to attend on a voluntary basis, can I ask you firstly,
  23     what does "regular" mean, how often do these take place?
  24   A. Normally there are at least two training weekends
  25     a year. These are occasionally supplemented by

   1     additional day courses.
   2   Q. If Coroners attend on a voluntary basis, what sort of
   3     attendance do you achieve amongst Coroners?
   4   A. I do not have the figures to hand, but we did conduct
   5     a survey of Coroners, a wide range of issues, a couple
   6     of years or so ago, and I think the percentage Coroners
   7     who had attended -- I cannot remember if it was one or
   8     more courses, three or four courses -- whatever it was,
   9     it was quite high. I do not think everybody had been on
  10     a course, but the vast majority of Coroners have been on
  11     a course and have been on a number of courses over the
  12     period of their appointment.
  13   Q. If one looks at -- as a parallel -- other judicial
  14     officers, that is, judges who are governed as it were in
  15     this area by the Lord Chancellor's Department, there is
  16     quite a coherent and a mandatory scheme run by the
  17     Judicial Studies Board which requires attendance,
  18     I think, for senior judicial officers on a number of
  19     training courses.
  20        How does that compare with the practice in
  21     relation to Coroners?
  22   A. It compares favourably. The Home Office has, as it
  23     says in my statement, only taken on this responsibility
  24     since 1984; it is not itself a statutory responsibility
  25     of the Home Office to offer such training, but it seemed

   1     the Home Office was satisfied at the time that it was
   2     a necessary and appropriate step to take. The training
   3     is provided within the constraints of the budget
   4     available for these activities.
   5        We, and Coroners, regard training as important and
   6     would encourage -- in fact, Coroners are anxious to
   7     increase the training that they can obtain. We do not
   8     think that the Home Office is the only source of
   9     training for Coroners; there are other potential
  10     sources, but the training that the Home Office is able
  11     to provide is relatively limited.
  12   Q. If we look at WIT 43/7, this is your statement, of
  13     course, you discuss there the scope of the inquest being
  14     limited -- I am looking at paragraph 31 at the top. In
  15     particular, the fact that no questions of criminal
  16     liability or civil liability should be determined by the
  17     verdict of the inquest.
  18        If that is the general purpose or the limitation
  19     on the purpose of an inquest, what role do you think an
  20     inquest legitimately play, or what role can the
  21     Coroner's office more broadly play, in detecting or
  22     becoming alert to problems of hospital practice or
  23     performance?
  24   A. I think one has to remember that the inquest system
  25     is very much designed to look at individual deaths and

   1     establish the facts surrounding particular deaths.
   2     There is no requirement -- and I think it would be
   3     difficult to alter the current arrangements; there is no
   4     requirement to look across a range of deaths in
   5     a structured, analytical sort of way that would
   6     necessarily enable trends or wider issues to be
   7     discerned.
   8        It is true that others have said that the Coroner
   9     system can act in a way which can identify potential
  10     difficulties which go beyond the issues arising from
  11     individual death, and I think that is true, but I think
  12     that is, if you like, the by-product in a way.
  13     "Haphazard" is too strong a word, but the system is not
  14     designed to persistently detect that sort of
  15     information.
  16   Q. Perhaps we could look there at WIT 54/33, because it
  17     may be that that you have in mind. It is the passage
  18     from the evidence of Professor MacSween again that we
  19     were looking at this morning, where he speaks of the
  20     Coroner's court as a "useful unofficial forum for audit"
  21     and says that if certain patterns of death emerge in
  22     a particular hospital or at the hands of a particular
  23     clinician, the Coroner, quite rightly, can comment upon
  24     these and draw the attention of the appropriate
  25     authorities to them.

   1        It is really that, the sort of thing you have just
   2     characterised as being a happy by-product of the system,
   3     if it occurs, but not something which the system is
   4     specifically designed to achieve?
   5   A. That is right. I mean, it may well be that there are
   6     a number of instances that the witness can refer to, and
   7     I have no reason to doubt that it has not happened.
   8     I can think of instances myself that have come to our
   9     attention, not on medical issues but other issues,
  10     concerns about road traffic accidents, for example,
  11     where Coroners have been concerned and identified
  12     perhaps an accident occurring in a similar place or the
  13     same place, and have drawn matters to the attention of
  14     the authorities. It does happen, but it is not designed
  15     in a way that it would happen consistently, for all
  16     kinds of reasons, not least of which is that although
  17     there is a Coroner for a given area and you might assume
  18     therefore that all cases pass through his hands, but he
  19     is not asked or required to retain information from
  20     preceding cases and also he has a deputy and assistant
  21     deputy who may equally see cases and therefore not
  22     associate one case with another, so it is not designed
  23     for that sort of purpose.
  24   Q. So there is not necessarily any institutional memory, as
  25     it were, that might be capable of picking up patterns of

   1     death and therefore drawing conclusions from them?
   2   A. That is right.
   3   Q. What sort of steps would be needed to create a Coroner's
   4     service that would be capable of doing that, if it were
   5     thought to be desirable?
   6   A. The first thing to come to mind would be an appropriate
   7     database of all the information that came out of
   8     individual inquests, so that they can be
   9     cross-referenced. It would require someone with
  10     responsibility to analyse that information to see what
  11     issues might arise from that. There would need to be
  12     some assurance that what we were looking at were
  13     questions of issues arising on the basis of a fixed
  14     geography, Coroner's district, the Coroner's
  15     responsibility for cases arises from the fact that the
  16     body is in his jurisdiction. The death may not have
  17     occurred there, so you have potential issues that go
  18     outside his jurisdiction that one would need to be
  19     looking at if one is to do the job, if I may put it this
  20     way, in a proper fashion.
  21        All of this would be quite demanding in resources,
  22     and in terms of trying to work out the benefits or the
  23     likely product of that activity, I would doubt that this
  24     would justify the necessary change in procedures,
  25     functions, staffing of the system. It would suggest to

   1     me that it might well need to change from a local system
   2     to some sort of national system, and you would need to
   3     be linked, or I would need to be linked into other
   4     sources of information, for example, non-Coroner deaths
   5     in cases which have not been picked up and reported to
   6     the Coroner.
   7   Q. So the return, you think, would be fairly low for
   8     a fairly expensive and time-consuming undertaking of
   9     information gathering?
  10   A. Bearing in mind that the Coroner system is looking at
  11     deaths in a wide range of circumstances and not, for
  12     example, in relation to deaths arising in hospitals,
  13     then you have a wide range of issues that people would
  14     be looking for, and I think this would be a very
  15     resource-absorbing activity. It is not one we have
  16     considered in detail, but I do not think that the system
  17     could necessarily be the right gatekeeper or auditing
  18     process. I think that sort of auditing process could be
  19     done elsewhere in another system.
  20   Q. At the moment are there any institutional links to
  21     shared information between Coroners and, say, the Health
  22     & Safety Executive or other organisations that would
  23     have an interest in patterns of deaths arising from
  24     Coroners' inquests or autopsies?
  25   A. I am not aware of any in relation to the example you

   1     have given. There is information in relation to certain
   2     drug-related deaths which are reported centrally.
   3     Obviously the information that Coroners obtain in the
   4     course of their enquiries feed into the office for
   5     national statistics, information about mortality
   6     statistics, so in a sense, this information is captured,
   7     but it may not be the sort of information that would be
   8     needed for the purposes that we might be looking at
   9     here, in terms of errors, problems, wider issues,
  10     looking more at incidence of disease or whatever.
  11   Q. If we look at paragraph 32 of your statement, which
  12     I think is at page 7, WIT 43/7, you speak there of the
  13     fact that Coroners should not direct or request
  14     a pathologist, if the conduct of any member of the
  15     hospital staff or associated with the hospital might
  16     potentially be called into question, to make
  17     a postmortem examination if the pathologist does not
  18     wish to do so.
  19        Can I just ask you to compare that view there,
  20     that is, the requirement of the rules there set out,
  21     with the view of the Royal College of Pathologists at
  22     WIT 54/949. Perhaps we should go back to page 938
  23     first, just to give you the reference. This is from the
  24     1991 document, the autopsy and audit", issued by not
  25     merely the Royal College of Pathologists but also the

   1     Royal College of Physicians and the Royal College of
   2     Surgeons.
   3        If we go back, then, please, to page 949, there
   4     is a general view set out there that the practice of
   5     removing bodies from the hospital or public mortuary for
   6     medico-legal purposes in patients dying in hospital has
   7     little to commend it; and generally the view is that
   8     permission should be obtained from the Coroner for
   9     autopsies to be performed in the hospital.
  10        Presumably that is subject to the requirements of
  11     rule 6, but in general, do you have any knowledge or
  12     information of the subject of what proportion of
  13     hospital deaths would have an autopsy performed in
  14     hospital?
  15   A. No.
  16   Q. And is that something that would not be monitored
  17     centrally?
  18   A. It is not monitored centrally.
  19   Q. Is there any way, therefore, of finding out on
  20     a national basis how Coroners would generally apply
  21     rule 6 and the extent to which hospital autopsies would
  22     be carried out by pathologists in hospitals other than
  23     the hospital concerned?
  24   A. One would have to go to Coroners' offices and ask for
  25     the information, if it could be discerned from their

   1     orders.
   2   Q. I am sorry, I said "hospital autopsies" a moment ago.
   3     I think you understood that as meaning Coroners'
   4     autopsies, which is what I meant?
   5   A. Yes.
   6   Q. Could I turn to one further subject, please, and that
   7     is the subject of the cremation or disposal of body
   8     parts after they have been retained for autopsies. If
   9     we look at WIT 54/30, again, this is the statement of
  10     Professor MacSween, he sets out there in the first
  11     paragraph difficulties relating to the disposal of
  12     organs that may be experienced after they have been
  13     retained for a postmortem, and some recently adopted
  14     forms contain a tear-off slip to be completed by the
  15     relative indicating whether or not they wish to take
  16     possession of the organs. What deters the majority of
  17     relatives is the expense of arranging appropriate
  18     disposal. He then goes on to say:
  19        "The vast majority of tissues and organs therefore
  20     are disposed of either by incineration or maceration
  21     within the hospital or department concerned."
  22        He then sets out the view that "Due to the anomaly
  23     in the various Cremation Acts from 1903 onwards,
  24     crematoria are not allowed to cremate anything other
  25     than a complete body."

   1        I think you comment in your statement that the
   2     source of that problem was not the Cremation Act but the
   3     various statutory instruments issued under it which
   4     provide for the certification of bodies through
   5     disposal. Can you tell us a little about that anomaly
   6     and whether it is apparent or real?
   7   A. Firstly, I am not sure that "anomaly" is the right
   8     expression. I think the position is this: that
   9     originally the Home Office was under the impression or
  10     took the view that there was a problem, or potential
  11     problem, because of the nature of the certification
  12     requirements of the Cremation Regulations under the
  13     Act. And certainly the view of the cremation industry,
  14     was that the prospects of cremating body parts was at
  15     the very least problematic.
  16        We have considered this point again --
  17   Q. Could I just ask, when you say "problematic", was that
  18     for practical reasons or for legal reasons?
  19   A. Both, I think, and certainly, I can expand on some
  20     points on the practical side of it, if that would be
  21     helpful?
  22   Q. Please, do.
  23   A. To get back to the legal position, we have had a think
  24     about the Cremation Regulations and obviously while the
  25     Home Office is not in a position to ultimately interpret

   1     the legislation, we think that the legislation may well
   2     allow for the cremation of body parts if the original
   3     body itself has been cremated, for example, as I said
   4     earlier, the Cremation Regulations provide for
   5     certification to have taken place and it seems that it
   6     is arguable that certification for the body initially
   7     can reasonably cover the requirements for any subsequent
   8     cremation of body parts that have been removed from that
   9     body. It is based on the fact that the body itself has
  10     been cremated, initially, and that, therefore, it would
  11     not seem to be permissible for a body part to be
  12     cremated itself if the body itself has been buried.
  13   Q. Perhaps we can just briefly look at the regulations.
  14     They are to be found at HOME 6, and the start of the
  15     relevant passage is page 4(HOME 6/4). It is a little difficult to
  16     read, but that is the start of a series of chronological
  17     lists of instruments in this field, and in particular,
  18     if we go over the page(HOME 6/5), there are set out -- we see the
  19     title at the bottom of that page -- regulations as to
  20     cremation, SR & O 1930/1016. In particular, over the
  21     page, regulation 8, page 6(HOME 6/6):
  22        "Except as hereafter provided no cremation shall
  23     be allowed to take place unless ...", then there are
  24     various certification requirements set out. Would I be
  25     right in thinking that those are the relevant ones, and

   1     the point is that if a certificate has been issued under
   2     that, it might reasonably be thought that it is now
   3     believed to cover subsequent disposal of parts as well
   4     as the, as it were, first ceremony?
   5   A. In a nutshell, yes.
   6   Q. Is it likely, therefore, that that view of the law is
   7     what lies behind the slightly different flavour of the
   8     Royal College of Pathologists' recent statement on the
   9     subject in the consultation document we have looked at
  10     already? If we turn it up, it is RCP 1/83. If we
  11     scroll down the page, we see at paragraph 6.7 that they
  12     there set out in the last two sentences their
  13     understanding:
  14        "We understand that the cremation of such tissue
  15     may not be unlawful if the body itself has been
  16     cremated."
  17   A. That is right. Obviously, in commenting on their
  18     document, we have passed our view of what the
  19     regulations may in fact allow.
  20   Q. Obviously, as you have said very clearly, you are the
  21     ultimate arbiters of the law, but is it the Home
  22     Office's view now that there is any need for legal
  23     change in this area, or is it now the view that, if
  24     properly interpreted, these regulations, so far as you
  25     are aware, should not cause any problems in this

   1     difficult and obviously very distressing field for
   2     relatives who are concerned with these practical
   3     issues?
   4   A. Our concern initially was to try to determine, or
   5     ascertain, what the law as it currently stands will or
   6     will not allow. I think to say whether we think there
   7     may or may not be further changes needed is a different
   8     question. It raises questions about, for example,
   9     whether it is desirable for parts to be cremated
  10     separately, whether there are any practical issues that
  11     might influence any views on that; whether there might
  12     arguably be a need for clarification of the law,
  13     because, as you say, the Home Office cannot interpret
  14     the law so it is perfectly permissible for cremation
  15     authorities and medical referees to take a different
  16     view. Therefore one is getting into realms of potential
  17     inconsistency in approach. So I think it is some way of
  18     saying that the question of whether a change in the law
  19     may or may not be needed is something one needs to
  20     consider in a slightly wider context.
  21   Q. Can you help us on that wider context?
  22   A. These are the sort of things we need to consider with
  23     the cremation industry, and by the "cremation industry"
  24     I mean the representative bodies such as the Federation
  25     of British Cremation Authorities, who have concerns

   1     about cremation of body parts, the implications, the
   2     practicalities, the technical aspects, which is not
   3     something we have had, yet, the opportunity to discuss
   4     with them. It seems to me that until we have those sort
   5     of discussions, until we have perhaps considered
   6     potential implications, if there are any, that need to
   7     be addressed, then really we are not in a position to
   8     say whether any changes may or may not be needed.
   9   MISS GREY: Thank you very much, Mr Clifford. Can I ask
  10     you, first, is there anything that you, on behalf of the
  11     Coroners' Unit, would like to add to your evidence
  12     today, if it is not been covered or has not been covered
  13     adequately in the questions that I have been asking?
  14   MR CLIFFORD: No, I think everything has been covered.
  15   MISS GREY: Thank you. Are there any questions from the
  16     Panel?
  17             EXAMINED BY THE PANEL:
  18   THE CHAIRMAN: Yes. Good afternoon, Mr Clifford. I have
  19     just one question. We were just talking about the law
  20     relating to cremation and you drew a distinction between
  21     changing the law and clarifying it. Assuming changing
  22     the law would require some kind of legislative action,
  23     what did you have in mind by way of clarifying the law?
  24   A. At the moment there may be different views about how the
  25     law is to be interpreted and although one is embarking

   1     on dangerous ground in talking about "clarifying" the
   2     law because it implies that maybe the law is not clear
   3     at the moment which, when it is untested, it is rather
   4     hard to make that argument, that would be a possibility,
   5     but one is also talking about whether there are wider
   6     changes. One of the things perhaps we should mention is
   7     the question of burial of body parts, which itself
   8     raises a different set of issues. I think we are less
   9     clear about what scope there might be for burial of
  10     separate body parts, for example. So there is
  11     a potential range of legislation in the burial and
  12     cremation area which could be considered for change, on
  13     the assumption, and this is perhaps a big assumption,
  14     that it would be desirable to expressly provide for the
  15     separate disposal of body parts either by burial or by
  16     cremation.
  17   Q. If I could ask a further question, it is that if
  18     conversations are going on or you intend to have
  19     conversations, i.e. the Home Office, with others, what
  20     sort of time-scale do you have in mind, and would we be
  21     kept informed of what the thinking is of the Home Office
  22     and others on this matter?
  23   A. I do not think we have addressed the sort of
  24     timescales. We are conscious that the cremation
  25     industry, as I say, has some concerns, and I suspect

   1     they would like to discuss these issues with us earlier
   2     rather than later. I would imagine we might well want
   3     to have some sort of discussions with them over the next
   4     couple of months or so.
   5   THE CHAIRMAN: Thank you.
   6          FURTHER EXAMINATION BY MISS GREY:
   7   MISS GREY: I am sorry, could I interrupt to stand up once
   8     again, because I have been reminded that I invited you
   9     to tell us a little bit more about the practical
  10     concerns that the cremation industry might have. You
  11     mentioned those briefly, but I did not actually give you
  12     an opportunity to explain what you meant by that.
  13   A. Thank you. I think, again I am in a sense speaking on
  14     their behalf without being fully conversant with the
  15     issues, but the points that have been raised with me is
  16     a concern that cremation of body parts, the process
  17     could well result in no residue, which would be
  18     a concern to them and would be a point that would need
  19     to be brought to the attention of the people who may
  20     wish to have that process applied.
  21        There are, I think, technical issues about using
  22     cremators for small amounts of tissue, whether it is
  23     uneconomic or whether it actually may have a damaging
  24     effect, or whether there are some environmental issues
  25     about passing material through the cremator, I have not

   1     yet explored that point, but this is a concern. Also
   2     they are concerned about potential abuse if the process
   3     is insufficiently, in their view, documented, and there
   4     is a potential that it cuts across these industries'
   5     Code of Practice, or has potential to cut across their
   6     Code of Practice.
   7        So these are initial concerns which I think are
   8     not fully clarified to us yet, but they are the sort of
   9     immediate responses that we have had about our view of
  10     what the legislation may allow.
  11   Q. And these are the sorts of things, amongst others, you
  12     will be discussing further?
  13   A. Exactly.
  14   MISS GREY: I am sorry, sir, I do not know if there are any
  15     further questions arising out of that?
  16   THE CHAIRMAN: No, Miss Grey, that was very helpful. Thank
  17     you, Mr Clifford. We are most grateful to you for
  18     coming and helping us this afternoon. Thank you very
  19     much indeed.
  20            (The witness withdrew)
  21   MISS GREY: Sir, that then completes the hearings for
  22     today. Tomorrow we will be hearing from Michael Burgess
  23     of the Coroners' Society, who will be giving evidence at
  24     9.30, and thereafter Diane Kennington, the Patient
  25     Affairs Officer of the UBHT, who will be giving evidence

   1     to you, sir.
   2   THE CHAIRMAN: Thank you, Miss Grey. We will adjourn then.
   3     Good afternoon to everyone:
   4   (2.40 pm)
   5     (Adjourned until 9.30 am on Thursday, 22nd July 1999)
   6
   7
   8                I N D E X
   9
  10     MR JAMES WISHEART (recalled):
  11        Examined by the Panel...................... 1
  12        Re-examined by Mr Moon..................... 10
  13
  14     MR MOON: Speech on behalf of Mr Wisheart ........ 23
  15
  16     PROFESSOR MICHAEL ALAN GREEN (sworn):
  17        Examined by Miss Grey ..................... 32
  18        Examined by the Panel...................... 107
  19
  20     MR ROBERT CLIFFORD (sworn):
  21        Examined by Miss Grey ..................... 109
  22        Examined by the Panel...................... 141
  23        Further examined by Miss Grey ............. 143
  24
  25

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Published by the Bristol Royal Infirmary Inquiry, July 2001
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