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CHAPTER 47

Introduction

Chapter 24 described the circumstances in Manchester through which the joint programme obtained brains from Coroners' cases without the knowledge of the relatives. Subsequent chapters have shown that the use of brains from Coroners' cases for research was commonplace in other locations.
This chapter considers how procedures have already changed to prevent the unauthorised research use of brains from Coroners' cases. The previous chapter suggested some measures that would reduce the possibility of brains being used for research or teaching without the knowledge and agreement of relatives. This chapter sets out other measures intended to prevent the recurrence of organ retention without the knowledge and consent of the relatives.
While the chapter focuses on retained brains, the measures described also apply to other organs and tissues retained from Coroners' cases for diagnosis.
The priority for the future
The restoration of confidence and trust must be the immediate and top priority. The principle is that the relatives must be fully informed, unless they decline the information offered. All discussions with the relatives about hospital and Coroners' post mortems should be characterised by 'transparency and openness'.
In all circumstances where the Human Tissue Act applies, objections expressed by the relatives must be respected. Their agreement to organ retention for research or teaching must never be assumed.
Brain retention in Coroners' cases
There were a number of reasons why brains were used for research without the relatives' knowledge and agreement.
Post mortem reports concealed brain retention
Brain retention was hidden by the omission of any reference in post mortem reports to the Coroner. This was intended to avoid distress, but that good intention has left many relatives feeling deceived and betrayed.
Ignorance of the Human Tissue Act
It is surprising that so many pathologists and morticians stated during this investigation that they were unaware of the limitations imposed by the Human Tissue Act and that relatives had the right to object to the use of brains for research or teaching.
Misunderstanding of Coroners Rules 9 and 12
The misunderstanding of these Coroners Rules was perhaps the principal reason why brain retention for research occurred so frequently. Pathologists who had discretion from Coroners to retain the organs and tissues that they considered necessary for diagnosis believed that they also had the Coroner's authority to retain brains for research.
Some, but by no means all, researchers also believed that brains could be lawfully obtained from Coroners' cases without the knowledge or agreement of the relatives.
Proper use of Rules 9 and 12
These Rules give the Coroner authority to retain 'material'. The Coroner must clearly be asked before any research is conducted under these Rules. This is what happened before the research studies at the Clinical Research Centre and at St George's Hospital began, as described in Chapter 32.
Coroners' verbal consent for brain retention for research
During the course of this investigation, several pathologists have referred to verbal consent given by Coroners to brain retention for research. It has been impossible to confirm these accounts due to the passage of time and the deaths of those involved. There is nothing in writing to confirm or refute these recollections.
However, such has been the frequency of these recollections that it seems probable that in the 1980s some Coroners did indicate to their pathologists that brains could be retained for research.
Misuse of brains after the Coroner's purposes had been completed
Research in many locations has been carried out on brains of Coroners' cases originally retained for diagnosis. The need to ask the relatives about further use of brains was not recognised. Some pathologists and researchers were ignorant of the Human Tissue Act. Others failed to appreciate that it applied to them.
Brains from Coroners' post mortems were an easy source of research material and relatives were not asked if they had objections to this use.
The current position
Hospital post mortems
Public attitudes to post mortems have changed significantly since 1985-1996, the years mainly covered in this report. The decrease in the number of hospital post mortems shows that relatives are now much less willing to agree to a hospital post mortem.
The reports of the Royal Liverpool Children's HospitalInquiry, the Bristol Royal Infirmary Inquiry and the work of the Retained Organs Commission have alerted the public to the issues of organ and tissue retention. When the relatives do consent to a hospital post mortem, permission to retain organs and tissues is more often refused.
The publicity given to retained organs has reminded pathologists, morticians, researchers and all others involved of their legal and ethical obligations and of the need for the relatives to be consulted about the use of retained organs for research.
Coroners' post mortems
Many Coroners have given instructions to pathologists that nothing must be retained without their knowledge.
Some Coroners will no longer authorise a full post mortem and/or the opening of the skull without their agreement on a case by case basis.
Special forms have been introduced to record what organs, tissues and other specimens have been retained and pathologists are required to complete these at the end of each post mortem. These forms list all organs and tissues that have been retained and why retention was needed. An example of a form in use in one district is at Annex 113.	Annex 113
Pathologists are now unlikely to omit reference to retained organs and tissues from post mortem reports.
For their part, relatives are better informed and ask well-directed questions of the Coroner's Officer before a post mortem takes place.
In many districts Coroner's Officers have been instructed routinely to make enquiries of the relatives before the post mortem examination to ascertain their views on organ and tissue retention. The relatives' instructions for disposal are included in the forms used in some districts.
There are, however, some relatives who prefer not to know the details about a Coroner's post mortem examination. If that is their wish relatives are entitled 'not to know'. It would be wrong to force details on relatives who do not wish to be informed, but the fact that they have declined information should be recorded.
Possible changes to the law
The Department of Health has issued a consultation document entitled 'Human Bodies; Human Choices'. This document asked for opinions on possible changes in the law.
Until the Human Tissue Act and/or the Coroners Rules are amended, every effort must be made to re-establish the confidence and trust of relatives within the existing legal and ethical framework. The wishes of the relatives must be respected whenever the law requires 'consent' or 'lack of objection'.
Unless this principle is followed trust will not be re-established and anxieties will remain that Coroners' post mortems are being used as a covert way of obtaining organs and tissues for research. It was the covert retention of brains from Coroners' post mortems that led to this investigation.
Ethics Committees
Ethics Committees have an important responsibility to ensure that, in future, research on post mortem brains is only undertaken when consent has been properly obtained. In the past, Ethics Committees were not fully involved or informed.
·  The retention of organs for research
In the late 1980s when research involved patients in life and further study of their brain after death, it was clear that Ethics Committee approval was required. There was less clarity about the role of Ethics Committees in research that began after the death of the patient but required access to the patient's medical records.
·  Disclosure of all relevant details to Ethics Committees
Researchers have always been expected to disclose all relevant factors to Ethics Committees. The collection of brains and other organs from Coroners' cases was widespread in the 1970s and continued in some locations into the mid 1990s. Without knowing all the relevant details it is axiomatic that Ethics Committees can be misled.
It is my opinion that some Ethics Committees were misled, and that some of the studies investigated in this report would not have been permitted to use brains from Coroners' cases without the knowledge of the relatives if the LRECs had known about this practice.
The current position
In 1991 the guidance on the responsibilities of Ethics Committees was clarified. This required that any research on the 'recently dead in NHS premises' should be submitted to an Ethics Committee.
For reasons unconnected to post mortem research studies, Ethics Committees have become more aware of the need for the consent of relatives where the mental capacity of the patient is impaired.
Ethics and organisations that host research
In the late 1980s, universities and other institutions that hosted research funded from other sources left the researchers to decide whether to obtain ethical clearance and did not enquire about the need for such clearance.
The current position
Universities and other institutions have now set up their own Ethics Committees. These committees require all researchers to notify them of applications made to Ethics Committees and of ethical approvals received from LRECs or other Ethics Committees. For example, Manchester University Ethics Committee placed this requirement on all staff of the University for research begun since 1994.
Research funding organisations
Organisations that fund post mortem research should ensure that any research they support has the appropriate consents. Under former arrangements this did not happen routinely.
·  In the 1970s and 1980s not all research funding organisations required applicants to submit evidence that an Ethics Committee had approved their projects. The decision whether to seek Ethics Committee approval was left to the applicants. In 1983 the Medical Research Council's conditions for project grants included under a heading 'Human Subjects': 'Local ethical committee approval is required for research that includes clinical trials and/or involves human subjects (whether patients or normal) and appropriate evidence of such approval must be incorporated in the application'. These requirements were later strengthened, Chapter 38.	Annex 110
·  Other research funding organisations made similar requirements for applicants.
·  Despite the guidance, two research teams examined in this study did not in the mid-1980s observe the MRC's guidelines and policies.
The current position
In 1995 the Medical Research Council's Guidelines on MRC-funded brain banks and brain research emphasised that any studies involving the recently dead should comply with the guidance and be referred to Ethics Committees.
The latest MRC requirements were published in April 2001 in 'Human Tissue and Biological Samples for Use in Research'(1). This emphasises:
'Informed consent is required from the donor (or the next of kin, if the donor has died) whenever a new sample is taken wholly or partly for use in research';
'All research using samples of human biological material must be approved by an appropriately constituted Research Ethics Committee'.
The guidance also has a section that addresses the use for research of old samples:
'Researchers should satisfy themselves that the samples were not obtained in an unethical or improper way and that there was valid consent to the taking'.
Action to ensure guidance is observed
These statements of principle are welcome, but without back-up are not enough.
To make certain that researchers observe the MRC's guidance, the Council and other organisations that provide funds for post mortem research should put in place their own procedures to ensure the guidance is followed. Otherwise, a repetition of the 1980s incidents in which researchers failed to follow the MRC's stated policies could be repeated.
Research funding bodies should not delegate this responsibility. Provided the MRC's principles are scrupulously observed, research on the brain will only be undertaken with the knowledge and agreement of the relatives.
Access to medical records
In the 1980s there was no specific NHS guidance on access to the records of dead patients, but in 1983 the General Medical Council issued guidance to doctors on 'Professional Conduct and Discipline':	Appendix 13
'the death of the patient does not absolve the doctor from the obligation to maintain secrecy' and 'information may also be disclosed if necessary for the purpose of a medical research project which has been approved by a recognised ethical committee'.
This guidance was sent to all registered medical practitioners, but it was still widely believed that access to medical records for research on the dead did not require any specific clearance.
The current position
Since the 1980s there have been major changes in the arrangements for access to patient data.
The General Medical Council has updated its guidance to doctors in 'Good practice in research. The role and responsibility of doctors'(2).
The Caldicott Report of December 1997, which was distributed under HSC(98)089, recommended the appointment of Caldicott guardians and has set out new requirements for access to personalised data on NHS patients.
The Medical Research Council in its 'Ethics Series' has issued 'Personal Information in Medical Research'.
These documents provide the basis on which Ethics Committees review the acceptability of any research protocol that involves access to medical and/or personal information about deceased persons.
For the future, the Department of Health is consulting on a code of practice for the NHS on confidentiality matters.
Guidance from the Royal College of Pathologists
In the 1980s and 1990s the difference between a Coroner's and hospital post mortem became blurred.
Chapter 40 described the policy of a full post mortem examination that was recommended by the Royal College of Pathologists in the guidance issued in 1993 in the College's 'Guidelines for Post Mortem Reports':
'that a single standard should be applicable to all post mortem examinations, whether funded by the NHS, Coroner or Procurator Fiscal'.	Appendix 29
The current position
The College published revised guidelines in March 2000. Further advice has subsequently been issued in 'Guidelines on Autopsy Practice' and further guidance is in preparation.	Appendix 46 Appendix 49
Public awareness of post mortem practice and consent forms
In the late 1980s the public were very largely unaware of what a post mortem entailed. Many relatives did not ask or wish to know the details.
The current position
In the aftermath of the publicity about organ retention, the public are much better informed about the nature of a post mortem examination. This awareness provides a further safeguard against unauthorised use of retained organs.
Consent forms
In 2002 the Department of Health circulated for consultation a paper with five different consent forms for post mortem examinations.
Before the Department's consultation document had been issued, many NHS Trusts had already amended their consent forms so that the relatives who consented to a post mortem are now separately asked for their consent to organ or tissue retention. For those relatives who prefer not to know the details of a post mortem examination, one of the Department of Health consultation consent forms was designed for that purpose.
Neuropsychiatric research
In the 1980s some studies were undertaken with the knowledge of the relatives when these investigations began before the death of the patient. Others, as this report has demonstrated, were conducted without the knowledge of the relatives.
During this investigation no current study has come to light in which the relatives are not consulted when a brain is obtained for research purposes.
In view of the events of the past two years, it would be remarkable if any research teams today are unaware of the need to obtain the agreement of relatives for post mortem studies involving the brain.
Unresolved matters
There remain a number of subjects on which action is still required. This, the last section of the report, addresses these problem areas.
1.  Who is responsible for staff in an NHS mortuary when a Coroner's post mortem is carried out?
-  Public mortuaries were and are still the responsibility of the local authority and, with the exception of the pathologist who is appointed by the Coroner on a case by case basis, all the staff of the mortuary are employees of the local authority.
- The position was and remains confused where a NHS hospital mortuary also serves as the public mortuary. The pathologist is accountable to the Coroner on a case by case basis, but it is far from clear whether the Coroner or the NHS management are responsible for any irregularities that occur in the mortuary when a post mortem is carried out on a Coroner's case.
-  Coroners, particularly those who are legally qualified, have stated to me that they do not consider they are or can be responsible for the actions of NHS employed staff in NHS premises when irregularities occur.
-  Where hospital mortuaries doubled as community mortuaries, the hospital managers did not regard the Coroner's post mortems as coming within their responsibility.
This confusion over who is responsible for staff involved in Coroners' post mortems carried out in NHS premises remains unresolved. This question has been discussed with Coroners, pathologists, hospital managers and morticians. No one was clear where the responsibility lies. Whatever the legal position may be, none of those directly involved knew who was accountable.
I recommend that this confusion be resolved quickly.
2. Training in forensic histopathology
-  The discipline of forensic pathology has fallen between the responsibilities of the Department of Health and the Home Office. While hospital histopathology is clearly an NHS discipline, forensic pathology is not regarded as a Department of Health responsibility but a matter for the police and the Home Office.
-  The large majority of Coroners' post mortems are sudden and unexplained deaths with no suspicious circumstances. Most of these post mortems are undertaken by an NHS pathologist at the request of the Coroner. The NHS does not pay for these duties and the NHS does not provide training for Coroners' post mortems.
-  Training opportunities in forensic pathology have reduced as the uncertain position of forensic pathology has continued since the 1980s.
-  The Home Office maintains a list of forensic pathologists who are usually called upon to undertake post mortems in criminal cases. Most Home Office pathologists undertake their duties as independent contractors.
While responsibility for forensic pathology and training for this discipline is beyond my Terms of Reference, I feel obliged to draw attention to the unsatisfactory position of the specialty, which has continued for far too long.
3.  Quality assurance in Coroners' post mortems
-  The NHS has developed a quality assurance programme in pathology.
-  There is no quality assurance system of any kind for Coroners' post mortems.
-  This is a subject outside my Terms of Reference on which the Coroners services review is currently consulting.
In the light of my findings, the importance of a quality assurance system for Coroners' post mortems is clearly required.
References
1  'Human tissue and biological samples for use in research: Operational and Ethical Guidelines': MRC Ethics Series, April 2001.
2  General Medical Council: 'Good practice in research: the role and responsibility of doctors', 2002.

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