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University of Otago Law Festschrifts |
Last Updated: 31 May 2019
HEALTH AND DISABILITY RESEARCH ETHICS COMMITTEES IN NEW ZEALAND: WILL THE CURRENT SYSTEM PREVENT ANOTHER ‘UNFORTUNATE EXPERIMENT’?
Nicola Peart*
INTRODUCTION
When the University of Otago appointed Peter Skegg to a chair in Law in 1984, it could not have known that the doctor-patient relationship in New Zealand was about to be turned on its head. An article by Sandra Coney and Phillida Bunkle published in June 1987 in Metro magazine, entitled “An unfortunate experiment at National Women’s”, revealed shocking abuse of the doctor-patient relationship that would have far-reaching consequences for the future of healthcare and health research in New Zealand.1 Peter Skegg had by then established an international reputation in medical law, having devoted his academic career to the development of this new field of law. His return to New Zealand from New College, Oxford, could not have been better timed.
Within two weeks of the Metro article appearing, the Minister of Health appointed Judge Sylvia Cartwright, then a Judge of the New Zealand Family Court, to be a Committee of Inquiry into the allegations made in the article.2 On 29 July 1988 Judge Cartwright submitted her Report into Allegations Concerning the Treatment of Cervical Cancer at National Women’s Hospital and into Other
Professor of Law, University of Otago. I have received a wealth of assistance in writing this paper. I am particularly indebted to Philippa Bascand, Manager of Ethics Committees at the Ministry of Health, and Gary Witte, Manager Academic Committees at the University of Otago, for responding to many questions and locating archived materials. I am grateful to Emeritus Professor Linda Holloway for assisting me to work out how the current ethical review process would have dealt with Dr Herbert Green’s study; to Andrew Snoddy JD, Research Assistant, Faculty of the Law, University of Otago for his research assistance, and to Dr Dayle Matthews and Ruth Sharpe from Health Research South, Dunedin School of Medicine for their assistance. Thank you also to Dr Neil Pickering and Associate Professor Lynley Anderson from the Otago Bioethics Centre and Associate Professor Andrew Moore, from the Department of Philosophy at the University of Otago, and to Barry Smith, Chair of the Health Research Council Ethics Committee and Victoria Hinson, Chair of the National Ethics Advisory Committee, for their assistance. The usual caveats apply.
Sandra Coney and Phillida Bunkle “An unfortunate experiment at National Women’s” Metro (New Zealand, June 1987) at 47.
The Committee of Inquiry was appointed on 10 June 1987 pursuant to s 13(3) of the Hospitals Act 1957.
Related Matters, commonly referred to as “The Cartwright Report”.3 It made many recommendations in regard to the provision of healthcare and the conduct of health research, including the need for independent ethics committees with specialist members to judge the scientific validity of research proposals and an equal number of lay members to advocate on behalf of research participants.4
Shortly before the Cartwright Inquiry, Peter Skegg had been appointed as the first legal member of the Otago Hospital Board Ethics Committee. He and Mrs Gwennyth Taylor, a retired philosopher, were the only laypersons on the committee at the time. The other members and the chairperson were all medical doctors. When Peter Skegg went on sabbatical leave in 1989, he asked me to take his place on the Ethics Committee. I had recently immigrated to New Zealand and taken up a lectureship at the Law Faculty at the University of Otago. I had no knowledge about medical law or medical ethics, but with guidance and support from Professor Skegg and Gwen Taylor I developed a keen interest in the area. On his return from sabbatical in 1990, Skegg resumed his position on the Ethics Committee until his appointment to the National Advisory Committee on Core Health and Disability Support Services in March 1992.
The Cartwright Report recommendations in regard to ethics committees had been implemented by then. Appointment of members was no longer a matter of shoulder tapping. It was a formal process and members were selected for their professional expertise or their ability to contribute a community perspective. I applied for the vacant legal member’s position and was appointed in 1992. Much of my research in medical law was sparked by legal issues that arose in the context of my work on the Ethics Committee.5 Although Peter Skegg was heavily involved in work at the national level, he remained a tremendous resource and support as I endeavoured to develop my knowledge and understanding of medical law. He was a great teacher and an excellent listener. I am greatly indebted to him for his generous guidance over nearly thirty years and the confidence he had in me that I could contribute to the field of medical law, albeit in a small way.6 In this collection
3 The Report of the Committee of Inquiry into Allegations Concerning the Treatment of Cervical
Cancer at National Women’s Hospital and into Other Related Matters
(Auckland, 1988), hereafter “The Cartwright Report”. Time
for reporting was extended three times.
4 The Cartwright Report, above
n 3, at 146 and 176.
5 For example, Nicola Peart and Andrew Moore
“Injury compensation for participants in
clinical trials” (1997) 5(1) Med L Rev 1; Nicola Peart and Grant Gillett “Re G: A life worth living?” (1998) 5(3) JLM 239.
of essays in honour of Peter Skegg, it seems fitting to return to the beginning of my engagement with medical law by writing about ethics committees.
I chose this topic not merely because it was through ethics committees that Peter Skegg introduced me to the field of medical law, but because much has changed in recent years. In 2012 the scope of review by Health and Disability Ethics Committees (HDECs) was significantly reduced and the focus narrowed.7 These changes make it worth asking whether the current ethical review system is adequate to prevent another ‘unfortunate experiment’. Jan Crosthwaite, from the Department of Philosophy at the University of Auckland, asked that question in 2008, 20 years after the Cartwright Report was released.8 Her conclusion then was that it could happen again, but it was very unlikely. My conclusion is that the radical reforms to the ethical review system in 2012 make the chance of another ‘unfortunate experiment’ more likely, but only slightly so.
Before dealing with the current ethical review system, it is necessary to recall the findings and recommendations of the Cartwright Report. It is also an opportunity to record briefly what the ethical review system was like in Otago at the time of the Cartwright Inquiry. Auckland was by no means unique in its lack of robust regulation of health research. I then set out how the Cartwright recommendations in relation to ethics committees were implemented, followed by a brief overview of the first reforms to the system in the first decade of 2000, before going on to discuss the adequacy of the current ethical review system in the wake of the radical reforms in 2012.
THE CARTWRIGHT INQUIRY
The Cartwright Inquiry concerned Dr Herbert Green’s research between 1962 and 1982 on patients whose cervical smears revealed the presence of carcinoma in situ (CIS). Dr Green did not accept the prevailing international view that CIS was a precursor to invasive cervical cancer and that early detection through cervical screening could save lives.9 His theory was that invasive cervical cancer was a separate disease and that CIS was not harmful in most cases.10 Concerned that standard treatment for CIS could render women infertile, Green opted
and Ron Paterson (eds) Health Law in New Zealand (Thomson Reuters, Wellington, 2015).
9 The Cartwright Report, above n 3, at 38.
10 Metro,
above n 1, at 48.
for surveillance and limited treatment, even when the pathology reports were “conclusive for malignancy”.11 He also did not inform the patients that they had CIS, or that he was studying the progress of their disease rather than giving them conventional treatment, or that his theory was not shared by the international medical community.12 He believed that doctors, not patients, should decide about appropriate treatment when the natural history of the disease was uncertain.13 Many patients lived with the disease in total ignorance that there was anything wrong. Some developed invasive cancer and a few died.14
In 1966 Dr Green presented his study15 to the Hospital Medical Committee for approval and to encourage his colleagues to refer their patients to him for inclusion in the study. The Committee was chaired by Professor Dennis Bonham, then Professor of Obstetrics and Gynaecology and head of the Postgraduate School. The other committee members were drawn from the senior medical staff at the hospital and included Dr Green. Dr Bill McIndoe, who performed all the colposcopies on Dr Green’s patients, had by then developed concerns about Dr Green’s study. He expressed his concerns at a meeting of the Senior Medical Staff immediately preceding the Hospital Medical Committee meeting, but they fell on deaf ears.16 The study was thought to have sufficient safeguards and Dr Green was the acknowledged expert.17 After the Committee had approved Dr Green’s study, his colleagues referred their patients with CIS to him. Nobody seemed concerned that the women did not know they were part of a research study despite the Nuremberg Code 1947 and the Declaration of Helsinki 1964 clearly stipulating that human experimentation without informed consent was unethical.18
11 Standard treatment was either a full cone biopsy, which carried considerable risk of morbidity, or a hysterectomy. The Cartwright Report, above n 3, at 24-26 and 149.
12 From the early 1960s the prevailing view was that if CIS was left
untreated it would progress to invasive cancer in a substantial
proportion of
cases: The Cartwright Report, above n 3, at 106.
13 Metro,
above n 1, at 50.
14 The Cartwright Report, above n 3, at 210.
15 There was debate as to whether Dr Green’s 1966 proposal was research
or merely a move to treat patients more conservatively.
The Cartwright Inquiry
concluded that it was a clinical research proposal combined with patient care.
It was an experimental study,
not an observational study, aimed at advancing
medical knowledge: The Cartwright Report, above n 3, at ch 3. The
proposal had a research hypothesis (that CIS was not a pre-malignant disease),
but lacked a study design and
a termination date, which even in 1966 would have
been expected.
16 The Cartwright Report, above n 3, at 70.
17
The Cartwright Report, above n 3, at ch 1.
18 The Cartwright
Report, above n 3, at 67-69.
By 1973 evidence disproving Dr Green’s theory was mounting and Dr McIndoe was no longer alone in voicing concern about Dr Green’s management of his patients.19 A Working Party, set up in 1975 to investigate the concerns, vindicated Dr Green’s conservative treatment. Its report was seen as a whitewash and did nothing to halt the spread of unease.20 As time passed and more patients developed invasive cancer, treating clinicians stopped referring their patients to Dr Green, but the study was never formally halted.21 After Dr Green’s retirement in 1982 Dr McIndoe and others sought to publish a review of the study, showing clearly that CIS did have a significant invasive potential, but they encountered major resistance from senior staff at National Women’s Hospital. The review was eventually published in 1984 in the journal of the American College of Obstetricians and Gynecologists.22 This publication was the impetus for the Metro article in 1987. It was only then that the full scale of this unethical study became widely known in New Zealand and action was taken.
1.1 The Inquiry’s Findings23
The Cartwright Inquiry was tasked with investigating matters relating to Dr Green’s treatment of CIS as well as issues relating to the conduct of health research in general.24 It found that Dr Green had been conducting an experimental study, not a change of treatment, as he initially claimed;25 that the study lacked scientific validity; that ethical considerations had received very little attention; that the safeguards had been ignored; that patients had been adversely affected by the lack of treatment; that there was no independent monitoring of the study; and that the patients did not know or consent to being part of the study.26 The
19 The Cartwright Report, above n 3, at ch 4.
20 The Cartwright
Report, above n 3, at 84-86.
21 The Cartwright Report, above n 3,
at 102.
22 William McIndoe and others “The invasive potential of carcinoma in situ of the cervix” (1984) 64(4) Obstet and Gynecol 451.
23 Since The Cartwright Report some people have argued that the Inquiry’s findings were incorrect, for example Jan Corbett “Second thoughts on the unfortunate experiment” (July 1990) Metro 54 and Linda Bryder A History of the ‘Unfortunate Experiment’ at National Women’s Hospital (Auckland University Press, Auckland, 2009). Their views are discussed and countered by Barbara Brookes “The making of a controversy” in Joanna Manning (ed), above n 8, at 100 and Charlotte Paul ”Medicine in context” in the same volume at 118.
24 See the terms of reference for the Committee of Inquiry, The Cartwright Report, above n 3, at 4.
25 The Cartwright Report, above n 3, at ch 3. Dr Green eventually conceded that the proposal he put before the Hospital Medical Committee was a research proposal into the natural history of CIS.
26 The Cartwright Report, above n 3, at ch 3. See also Charlotte Paul “The New Zealand cervical cancer study: Could it happen again?” (1988) 297 BMJ 533 at 535-6 where the author argues
lack of adequate response to sustained, detailed, and well documented concerns about the treatment of these patients called into question the future of peer review within the medical profession.27 Clinical freedom and loyalty to colleagues had overridden the doctors’ primary duty to their patients.28
The Inquiry found that by the early 1970s the need to establish ethics committees in hospitals was recognised. While National Women’s Hospital had established an Ethical Committee in 1977,29 the Cartwright Inquiry found that it lacked independence and impartiality to adequately review in house research proposals. Its members were clinicians at National Women’s Hospital and the chair was Professor Bonham from whose Postgraduate School most of the proposals emanated.30 The Committee’s only “lay member” was a pharmacist. The Committee lacked proper procedures for ensuring that research proposals to which it was granting ethical approval had received independent scientific assessment.31 This was a major deficiency, because a research proposal that was not scientifically valid was unethical. The Committee also had a poor record for ensuring that informed consent to participation in research was properly sought. Consent was treated as protection of doctors against liability rather than as a means of protecting patients’ rights.32 The Ethical Committee was found to have a limited understanding of ethical principles and their application to research projects. Furthermore, once a study had received approval, there was no process in place for monitoring the project or ensuring that results were accurately reported and published.33 New
that results were not accurately reported. Dr Paul was one of the medical
advisers to Judge Cartwright.
27 The Cartwright Report, above n 3, at
101.
28 The Cartwright Report, above n 3, at 127.
29 The Medical Superintendent-in Chief of the Auckland Hospital Board had
issued guidelines for the introduction of ethics committees
in 1974, setting out
their purpose, remit and composition. Committee members were to be experienced
clinicians with knowledge of
clinical research and one layperson: The
Cartwright Report, above n 3, at 142-145.
30 The Cartwright Report,
above n 3, at 145.
31 The Cartwright Report, above n 3, at
139-140.
32 The Cartwright Report, above n 3, at 176.
33 The Cartwright Inquiry found that several of the safeguards were either ignored or overlooked, in particular the eligibility requirements that the women be under the age of 35 and free of clinical signs of invasive carcinoma and that treatment would be provided if invasive disease was suspected or detected. Laboratory and clinical evidence from women in the study suggesting the possibility of invasive cancer or of progressive disease were downplayed, ignored, or dismissed. Data emerging during the study demonstrated that Dr Green’s theory was wrong and that he was wrongly interpreting the data in his publications: The Cartwright Report, above n 3, at 49-55.
treatment procedures were not systematically reviewed by the Ethical Committee, and formal peer review of treatments was almost non-existent.34
1.2 The Otago Hospital Board Ethics Committee
National Women’s Hospital was not alone in lacking robust procedures for approving and monitoring health research. The late Gwennyth Taylor, a philosopher and the first layperson appointed to the Ethics Committee of the Otago Hospital Board in early 1981, paints a very similar picture. In an undated note she sent me in 2003 (appended to this chapter),35 she describes how she came to be appointed to that Committee and the role she carved out for herself. She had retired in 1980 from the University of Otago’s Philosophy Department, where she had been teaching ethical dilemmas in medicine in her first year paper Introduction to Moral Philosophy. She was known to the Otago Medical School for her interest in medical ethics, having contributed to several seminars on a range of moral questions in medicine at the request of Professor Geoff Brinkman, then Dean of the Otago Medical School.36 Five of the other members of the Hospital Board’s Ethics Committee were medical professors, and Dr Berendsen, the medical superintendent at the time, chaired the Committee. Her role on the Committee was not clarified. She realised she would have to rely on the medical members to evaluate the science, but she had no idea what her own role should be.
She describes going along to the first meeting very tentatively, feeling her way. The medical members, all male, must have wondered what they had landed by way of a layperson – a woman and, even more hazardous, a philosopher! She said little at her first meeting, asking only for some clarification and left the meeting as puzzled by her role as she had been at the beginning. On her way out, one of the medical members, Professor Graham Mortimer, made a comment that prompted her to review the protocols and compare them to the information provided to the participants. She then discovered her role: the participants were volunteers who were being asked to consent. Aristotle’s conditions for an action to be voluntary were central to these cases. For the participants’ consent to be valid, they had to know what they were consenting to. They had to know about the objectives of the research, the procedures, the risks and benefits, and the likely outcome of the project. Their decision to participate must not be made under any sort of threat,
34 The Cartwright Report, above n 3, at 212.
35 With permission
from her daughter Meg Taylor.
36 Professor Brinkman had a particular interest in medical ethics and believed passionately that the public should be better informed and involved in debates about the moral and legal implications of new birth technologies, life prolonging treatment and other ethical issues in medicine. Taylor attributes to him the early initiatives on teaching medical ethics at Otago.
such as fear that refusal to participate might jeopardise their future healthcare. The information given to participants should also be known to the members of the Ethics Committee. It should be in written form so that the participant could take it away and the Committee could scrutinise it. It should also be readily intelligible to a layperson, such as Gwen Taylor herself. It took a little time for researchers to produce information sheets that contained the necessary information, free from professional lingo and expressed in plain English.
The following year, at Taylor’s suggestion, a nurse was appointed to the Ethics Committee, doubling the number of women on the Committee. In 1987 a lawyer was added: Professor Peter Skegg. With his expertise in medical law, he was an obvious choice for appointment to the Otago Hospital Board Ethics Committee. Although Taylor and Skegg were far outnumbered by health practitioners, they were not in any sense token lay members. Not only did they both have highly relevant expertise to contribute to the Committee’s deliberations, their personal and professional standing ensured that their views were taken seriously. They enjoyed the respect of their medical colleagues.
1.3 Cartwright Inquiry Recommendations
The Cartwright Inquiry recommended significant changes to ethics committees and the process for ethical review of research proposals and innovative treatments. Citing a publication of Professor Alastair Campbell, then a visiting professor of Biomedical Ethics at Otago University and a witness at the Inquiry, Judge Cartwright agreed that an ethics committee had to be both competent and impartial.37 That required a diverse and balanced membership with specialist members competent to assess the scientific aspects of research proposals, members from other professions, and lay members capable of mediating the research participants’ point of view. Approximately half the committee should be non-health professionals drawn from a cross section of the community. All research projects should receive scientific and ethical assessment prior to their commencement. The Cartwright Inquiry also recommended the adoption of a statement of patient rights, the appointment of independent patient advocates to ensure patients were able to give fully informed consent, and the appointment of a Health Commissioner to deal with complaints from patients.38 These recommendations were to apply to research participants as well.
37 The Cartwright Report, above n 3, at 146. In 1990 Professor
Alastair Campbell was appointed as Professor of Biomedical Ethics and Director
of the Bioethics
Research Centre, established at Otago University in 1988 at the
initiative of Professor D Gareth Jones.
38 The Cartwright Report,
above n 3, at 213-214.
2. IMPLEMENTING THE CARTWRIGHT REPORT RECOMMENDATIONS
This first decade following the Cartwright Inquiry can be characterised as embracing the regulatory reforms recommended in the Report. While the recommendations in the Cartwright Report were directed at National Women’s Hospital and the University of Auckland, they were seen as relevant to the whole country and implemented nationally over the next few years. Rather than amending existing legislation and procedures, new legislation was adopted to protect patients and research participants and clarify their rights. The Health and Disability Commissioner Act 1994 provided for the appointment of a Health and Disability Commissioner, the establishment of a Health and Disability Services Consumer Advocacy Service, and the promulgation of a Code of Health and Disability Services Consumers’ Rights (Code of Patients’ Rights) in 1996 with its associated complaints procedure.39 The Heath Information Privacy Code, issued in 1994 by the Privacy Commissioner under the Privacy Act 1993, regulated the collection, use, access and disclosure of identifiable health information and also provided for a complaints procedure. Central to both of these codes is the duty of healthcare providers to respect patients’ rights and choices in relation to treatment, research and confidentiality of their information. The New Zealand Medical Association also played its part, issuing a Code of Ethics in 1989 that placed greater emphasis on the doctor-patient relationship as a partnership and the rights of patients to full information.40
In regard to ethical review of health research and new treatments, the Department of Health (as it then was) wasted no time. In October 1988, a mere three months after the Cartwright Report was released, the Department of Health issued a National Standard for Hospital and Area Health Board Ethics Committees Established to Review Research and Treatment Protocols (National Standard 1988). It was a direct response to the findings and recommendations of the
39 The Code of Health and Disability Services Consumers’ Rights was promulgated as a regulation under the Health and Disability Commissioner Act in 1996. The rights expressed in that Code apply not only to treatment, but also to teaching and research: Right 9. For an explanation of the development, status, scope and effects of this Code see PDG Skegg “A fortunate experiment? New Zealand’s experience with a legislated code of patients’ rights” (2011) 19 Med L Rev 235.
40 Jing-Bao Nie and Lynley Anderson “Bioethics in New Zealand: A historical and sociological review” in John Peppin and Mark Cherry (eds) The Annals of Bioethics: Regional Perspectives in Bioethics (Swets & Zeitlinger, Lisse, 2003) 341 at 349.
Cartwright Inquiry and, by virtue of Right 4(2) of the Code of Patients’ Rights, the National Standard became a legal standard.41 Its objectives were:
(1) To ensure the ethical aspects of health related research are adequately considered.
(1) To ensure the ethical aspects of treatment protocols are adequately considered.
(1) To assure the rights of the subjects of research and protect them from harm.
(1) To assure the public that this is being done.
(1) To foster the awareness of ethical principles within the service delivery units of the Hospital or Area Health Board and within the community served by the Board.
(1) To consider any matter of ethics relevant to the Board’s role under the Hospital and Area Health Boards Acts.42
These objectives implicitly acknowledged the serious breach of trust by the medical profession in approving Dr Green’s study and failing to respond adequately to concerns about patient safety. The inclusion of these objectives in a national standard also shows that the lack of trust went well beyond the individual researchers or the particular hospital. Indeed, as Charlotte Paul commented not long after the Cartwright Report was released, public distrust in the medical profession as a whole was an unavoidable consequence of the Inquiry.43 The profession’s internal morality, as displayed by Dr McIndoe and others who raised concerns and sought to halt the study, was denigrated or disregarded.44
The National Standard required each Hospital and Area Health Board to appoint an ethics committee with a minimum of five members drawn from the health profession and the lay community in approximately equal numbers.45 The Committee had to be chaired by a lay member.46 Ethics committees in the major research centres often had as many as 12 members to provide the medical and
41 Right 4(2) states that “[e]very consumer has the right to have services provided that comply with legal, professional, ethical, and other relevant standards”.
42 Department of Health Standard for Hospital and Area Health Board Ethics
Committees Established to Review Research and Treatment Protocols (1988) at
1.1, hereafter “National Standard 1988”.
43 Paul, above n 26, at
538.
44 Charlotte Paul “Internal and external morality of medicine: Lessons from New Zealand” (2000) 320 BMJ 499.
45 A total of 14 committees were established, with two in the Auckland region. Some years later a second committee was appointed for the Canterbury region: National Advisory Committee on Health and Disability Support Services Ethics (NEAC) Report of the Current Processes for Ethical Review of Health and Disability Research in New Zealand (Wellington, 2003) at 15.
46 National Standard 1988 at 3.5. Gwennyth Taylor was the first layperson to chair the Otago Hospital Board’s Ethics Committee from 1989 until March 1990. Professor Alastair Campbell
scientific expertise necessary to assess the range of research protocols for which ethical approval was sought. Professional members were drawn from women and children’s health, surgery, pharmacology, psychological medicine, biostatistics, public health, general practice, and nursing. If a committee lacked the necessary scientific expertise to assess an application, it was expected to seek advice from independent experts.47 To ensure impartial consideration of a proposal, members whose own research was to be reviewed had to withdraw from the committee’s assessment.48
The remit of the ethics committees was broad and non-exhaustive.49 Ethical approval was required for all forms of health research, including research involving patients, healthy volunteers and members of the community at large, as well as research requiring access to confidential health records.50 Boards were expected to encourage external organisations and individuals to submit community research protocols to the Boards’ Ethics Committees.51 New treatment protocols and significant changes to existing protocols also required ethical approval, as did any treatment proposal over which a responsible member of the public or a health professional raised some doubt.52
The ethics committees’ primary responsibility was to focus on the outcome for patients and their protection.53 To that end committees had to ensure that the basic elements of informed consent were present, that research proposals were scientifically valid, that an appropriate monitoring system was in place, and that the investigators were competent to carry out the research procedures.54
Although each Area Health Board was responsible for the performance of the ethics committees in its area, the Health Research Council Ethics Committee (HRCEC), established under the Health Research Council Act 1990, had a statutory mandate
took over as chair in mid-1990 when he took up his appointment as Director of
the Bioethics Research Centre at Otago University.
47 National Standard 1988
at 5.4.
48 National Standard 1988 at 5.3.
49 National Standard 1988 at
5.1.5.
50 National Standard 1988 at 5.1.1.
51 National Standard 1988 at
7.1.
52 National Standard 1988 at 5.1.2-5.1.5. For example, proposals to withdraw
or withhold life sustaining treatment have been referred
to the ethics
committees for an opinion: Auckland Area Health Board v A-G [1993] 1 NZLR
235 (HC); Re G [1997] 2 NZLR 201 (HC). So too new assisted reproductive
procedures prior to the establishment of the Interim National Ethics Committee
on Assisted Reproductive
Technology in 1993.
53 National Standard 1988 at
G.G. This clause was written in capital letters.
54 National Standard 1988 at
G.
to monitor all ethical aspects of health research in New Zealand.55 It approved Area Health Board and institutional ethics committees that satisfied the National Standard’s composition and jurisdictional requirements.56 It received the annual reports from approved committees and gave advice and second opinions on request.
2.1 Problems Emerge
Not long after the ethical review system had been set up, investigators started complaining that the process was a barrier to research.57 It was criticised for being cumbersome, time-consuming and, in some cases, unnecessary. Obtaining ethical approval was seen as a compliance issue, rather than adding value to the research proposal. The competence of the committees to assess the scientific validity and evaluate risks and benefits of research proposals was questioned.58 The National Standard did not draw a distinction between intervention and observational studies, even though they raised different ethical issues. The assessment of cultural appropriateness also received mixed reviews.59 These criticisms suggested that ethics committees were not fulfilling their primary objective of protecting research participants from harm.
Multi-centre studies posed particular problems for investigators. The regional jurisdiction of each committee meant that applicants wishing to conduct a study in more than one centre had to apply to each centre and respond to different, sometimes inconsistent, responses from each ethics committee. This fragmented approach was obviously unsatisfactory.60 The development of a national application
55 Health Research Council Act 1990, ss 24 and 25. The Health Research Council (HRC) has its own Guidelines on Ethics in Health Research, directed at researchers.
56 Only an “approved” ethics committee can certify that a clinical trial is not conducted principally for the benefit of the manufacturer or distributor of the drug or device being trialled, so that any personal injuries sustained by research participants are covered by the no fault accident compensation scheme: Accident Rehabilitation and Compensation Insurance Act 1992, s 5(8), replaced by Accident Compensation Act 2001, s 32(6). The HRC’s current approval criteria are set out in its Guidelines for Approval of Ethics Committees (2012).
57 See for example the evidence of Professor David Skegg to the Gisborne
Inquiry: Report of the Ministerial Inquiry into the Under-reporting of
Cervical Smear Abnormalities in the Gisborne Region (2001), hereafter
“The Gisborne Inquiry Report”, at 239; Charlotte Paul
“Health researchers’ views of ethics committee functioning in New
Zealand” (2000) 9 NZ
Med J 210.
58 Paul, above n 57, at 211-212.
59
At 212.
60 See David Skegg’s comments: The Gisborne Inquiry Report, above n 57, at 237-238. See also John Dockerty and Mark Elwood “The difficulties and costs of ethical assessment of a national research project” (1992) 105 NZ Med J 311; Martin Tolich and Barry Smith The Politicisation of Ethics Review in New Zealand (Dunmore Publishing, Auckland, 2015) at 42-46.
form and the appointment of a lead ethics committee to handle all the regional responses and present a single consensus view relieved only some of the burden on investigators.61
Aside from the regional ethics committees funded by the Ministry, there were institutional ethics committees within universities and other tertiary institutions, private industry and other research organisations.62 This cross-sectorial system created boundary issues, jurisdictional overlap and duplication, not to mention confusion and frustration for investigators who sometimes needed approval from more than one ethics committee.63
Another, more subtle, concern was that the regulatory framework left researchers in some uncertainty as to their own role in the ethics of their research proposals.64 The public distrust generated by the Cartwright Inquiry led some investigators to think that ethics was no longer their responsibility, while others saw ethics as integral to good medical practice, including health research, and wanted a meaningful role in discussing ethical issues. Pressure for change was mounting.
The Report of the Ministerial Inquiry into the Under-reporting of Cervical Smear Abnormalities in the Gisborne Region in 2001 was the final blow.65 This Inquiry was told about ethical and legal obstacles to an independent evaluation into the effectiveness of the National Cervical Screening Programme.66 The Committee of Inquiry was very critical of the fragmentation inherent in the multi-centre process and the need for ethics committee approval of audits and quality assurance
61 The review process for multi-centre research proposals was set out in the
Operational Standard for Ethics Committees 2002 at 7.15.
62 NEAC Analysis
– Clinical Trials (September 2010), at [12] and [32]-[37].
63 In the Otago region the chairs of the Area Health Board Ethics Committee
and the University of Otago Ethics Committee agreed that
all health research
would be reviewed by the Area Health Board committee, rather than the University
committee. But that was apparently
not the case in Auckland.
64 Paul, above n
57, at 212-213.
65 The Committee of Inquiry was appointed in October 1999 under the Health and Disabilities Act 1993, s 47. Its members were Ailsa Duffy QC, Druiscilla Barrett and Gordon Wright (later replaced by Máire Duggan). The Committee of Inquiry found systemic deficiencies in the National Cervical Screening Programme, including the absence of a system to monitor and evaluate the Programme: The Gisborne Inquiry Report, above n 57, at 1.5-1.6.
66 In 1999 the Ministry of Health had appointed an independent team of investigators from Otago University to evaluate the effectiveness of the National Cervical Screening Programme. Because it was an external national audit, it needed approval from all the ethics committees, which they would not grant unless the investigators obtained consent from the women before retrieving their information from the National Cancer Register and the National Cervical Cancer Register. The investigators refused to comply with this condition as it would jeopardise the statistical reliability of the evaluation.
programmes.67 While ethical oversight of research was appropriate, such oversight was superfluous for audits and quality assurance activities.
3. THE FIRST REFORMS
Shortly after the release of the Gisborne Inquiry Report, the Minister of Health set up the National Advisory Committee on Health and Disability Support Services Ethics, subsequently renamed the National Ethics Advisory Committee (NEAC), to provide independent advice to the Minister on ethical issues of national significance in respect of any health and disability matters, to determine nationally consistent ethical standards across the health sector, and to provide scrutiny for national health research and health services.68 NEAC’s first priority was to address the ethical review issues raised by the Gisborne Inquiry.69
On NEAC’s recommendations, all audits were removed from the scope of ethical review70 and a single Multi-region Ethics Committee (MREC) was set up to review all multi-centre and national research proposals.71 To ensure locality issues were addressed, multi-centre research proposals required approval from the host institutions that their facilities, resources and the local researchers were suitable and that any special features of the local population had been appropriately addressed.72
By transferring national and multi-centre applications to MREC, the workload of the regional committees was substantially reduced, particularly in the smaller centres where on average 62 per cent of the workload comprised national or multi-centre research proposals.73 The number of regional ethics committees was
67 The Gisborne Inquiry Report, above n 57, at 239-243.
68 New Zealand Public Health and Disability Act 2000, s 16. NEAC replaced the
earlier National Advisory Committee on Health and Disability
Services Ethics,
established in 1994.
69 NEAC Report on Current Processes, above n 45,
at 5.
70 Ministry of Health, Operational Standard for Ethics Committees (Wellington, 2006) at 4.0-4.2.
71 NEAC Report on Current Processes, above n 45, at 21. The Operational Standard 2002 defined “multi-centre research” at 134 as “Research conducted simultaneously by several investigators at different centres with identical methods and following the same protocol”, quoted in the NEAC Report on Current Processes, above n 45, at 12. NEAC defined “national research” as “Research conducted by the investigator(s) at one centre, potentially or actually involving participants nationwide”: NEAC Report on Current Processes, above n 45, at 12.
72 NEAC Report on Current Processes, above n 45, at 21-23. As national
studies were conducted by researchers at one centre, locality approval from that
centre only was
required. The Operational Standard 2006, ch 7, set out the
ethics committees’ responsibilities in regard to locality
assessment.
73 NEAC Report on Current Processes, above n 45, at 14-15.
Only in Auckland, Wellington,
consequently reduced from 15 to six Health and Disability Ethics Committees (HDECs), each covering a larger geographical area with jurisdiction for research and innovative practices conducted only in their region.74
The membership of each committee was increased from 10 to 12 to strengthen the health professional membership whilst retaining the equal representation of lay members. Each committee had to have two health researchers, a pharmacist or pharmacologist, a biostatistician and two health practitioners.75 The committees were established by the Minister of Health under s 11 of the New Zealand Public Health and Disability Act 2000, which gave them the statutory authority and public accountability they had previously lacked.76 But members and the chair were appointed by the Minister, which gave them less independence and was a less transparent process than before.77
NEAC developed study specific guidelines. The Ethical Guidelines for Observational Studies 2006 and the Ethical Guidelines for Intervention Studies 2009 are directed primarily at investigators, rather than ethics committees, to assist them to conduct high quality studies.78 An “intervention study” or experimental study is defined as “a study in which the investigator controls and studies the intervention(s) provided to participants for the purpose of adding to knowledge of the health effects of the intervention(s)”.79 All health and disability research that is not an intervention study is an “observational study”.80
Soon after the new ethics committee structure was put in place, it became apparent that NEAC’s estimate of the MREC’s workload had been grossly underestimated.81
Canterbury and Otago did multi-centre studies constitute about one third of the ethics committee’s workload.
74 The six committees were Northern X (Auckland), Northern Y (Hamilton), Central, Upper South A, Upper South B, and Lower South.
75 See the composition and membership requirements in the Terms of Reference of each ethics committee, Appendix 2 to the Annual Reports of each committee.
76 This was another NEAC recommendation: NEAC Report on Current Processes, above n 45, at 24-25.
77 Tolich and Smith discuss the control that the appointment process gave to the Ministry and the many complaints from the HDEC chairs about lengthy delays in appointing replacement members: above n 60, ch 3.
78 NEAC Ethical Guidelines for Observational Studies: Revised edition
(Wellington, 2012) and Ethical Guidelines for Intervention Studies:
Revised edition (Wellington, 2012) at 2.1.
79 NEAC, Intervention
Guidelines, above n 78, at 2.4.
80 SOPs, above n 7, at [26].
81 Based on its review of the workloads of the regional ethics committees, NEAC estimated that the workload for a national committee would be 121 studies per annum or about 11 studies at each meeting, which was not out of line with the average workload of the regional ethics
Additional meetings were needed, but health professional members were often unable to commit to more than one monthly meeting, with consequential loss of expertise to conduct effective ethics review.82 Additional health professionals were appointed, but the workload continued to be a source of concern.83 A second MREC was contemplated but never implemented.84
4. THE MAJOR REFORMS OF 2012
In 2008 the National Party defeated the Labour Party in the general election. Having been elected at a time of global recession, its economic policies drove a range of reforms. One of its economic initiatives was to encourage innovation through clinical trials, because they had been shown to have health benefits as well as economic and educational benefits.85 But New Zealand had lost its competitive advantage in the clinical trial industry, in part because of its ethical review system. The pharmaceutical industry criticised the system for being an unwieldy and complicated bureaucracy that made New Zealand an unattractive country in which to run clinical trials.86
In an attempt to make New Zealand a more supportive environment for clinical trials, the Ministry of Health put in place a new system of ethical review. Its Standard Operating Procedures for Health and Disability Ethics Committees (SOPs), adopted in 2012 and revised in 2014, regulate the jurisdiction, scope and procedures of HDECs, while NEAC’s Ethical Guidelines for Observational Studies and Ethical Guidelines for Intervention Studies provide ethical guidance.87 Approved institutional ethics committees reviewing health research also use NEAC’s Guidelines, but their procedures are guided by the Health Research Council (HRC) Guidelines for Approval of Ethics Committees 2012.88
committees in the major centres: NEAC Report on Current Processes,
above n 45, at 18. The Annual Reports of the MREC indicate that it was often
dealing with double the number of applications.
82 Annual Report of the
Multi-region Ethics Committee 2007, at 1.
83 MREC could have up to 16
members.
84 Tolich and Smith, above n 60, ch 3 provides a critical review of the ethical review system in New Zealand and of the Ministry’s unwillingness to approve Tolich’s proposal for a private ethics committee to alleviate pressure on the MREC.
85 Health Committee Inquiry into Improving New Zealand’s Environment
to Support Innovation to Clinical Trials (Report 1.6F, June 2011) at 11 and
19.
86 At 12.
87 SOPS, above n 7, at [3]. The SOPs replace all other process guidance for HDECs. NEAC’s Guidelines were revised to remove the procedural sections.
88 The effect of these changes appears to be that the Operational Standard for Ethics Committees 2006 is now effectively redundant, though it has not been formally repealed.
The SOPs have radically changed the jurisdiction, composition, scope, focus and procedures of the HDECs. There are now only four committees, with joint responsibility for the review of health and disability research conducted anywhere in New Zealand.89 They review a narrower range of research proposals and their focus is on ethical review, not scientific validity. Given the more limited focus, a broad range of professional expertise was deemed unnecessary and, hence, the membership of each committee was reduced from 12 to a maximum of eight members, whilst retaining the balance between lay and non-lay members. Many research proposals now go through an expedited review process, where they are assessed more quickly by a sub-committee, rather than going through the longer process of a full committee review.
4.1 Reduced Scope of HDEC Review
The SOPs have significantly reduced the scope of HDEC review in three ways. First, HDECs will now only review “health and disability research”, which is defined as “research that aims to generate knowledge for the purpose of improving health and independence outcomes”.90 HDECs therefore do not review research that involves healthcare interventions that are not intended to improve health care, such as studies to improve the performance of athletes that involve healthcare interventions which may put them at risk of significant harm.
Second, the range of studies requiring HDEC approval has been significantly reduced to allow HDECs to focus on research with a higher than minimal risk of harm. HDECs will review health and disability research that involves human participants who are consumers of health and disability services, or relatives or caregivers of consumers, or healthy volunteers in clinical trials.91 However, studies that involve a “low risk” medical device, as classified by Australia’s Therapeutic Goods Administration,92 or observational studies carrying “minimal risk” are excluded from HDEC review. A study involves more than “minimal risk” if potential participants could reasonably be expected to regard the probability
89 Terms of reference of each HDEC.
90 SOPs, above n 7, at [21]. Research covered by the Human Assisted
Reproductive Technology Act 2004 was already excluded from HDEC
review and must
be approved by the Ethics Committee on Assisted Reproductive Technology on the
basis of guidelines or advice issued
by the Advisory Committee on Assisted
Reproductive Technology. See further Nicola Peart “Alternative means of
reproduction”
in PDG Skegg and Ron Paterson (eds) Health Law in New
Zealand (Thomson Reuters, Wellington, 2015), ch 17.
91 SOPs, above n 7,
at [29.1].
92 The risk must be classified as low (class 1) by Australia’s Therapeutic Goods Administration: SOPs, above n 7, at [30].
and magnitude of possible harms resulting from their participation in the study to be greater than those encountered in those aspects of their everyday life that relate to the study. A study always involves more than minimal risk if any of the participants will not be giving informed consent, or if they are vulnerable because of restricted capability to make independent decisions about participation,93 or if standard treatment will be withheld, or if human tissue will be stored or used without consent, or health information disclosed without authorisation.94
HDECs will also review the use, collection or storage of human tissue,95 unless informed consent to its use in research has been obtained and the tissue will not be made available to the researchers in a form that could identify the individual from whom the tissue was taken,96 or a statutory exception to the need to gain informed consent applies.97 Studies involving the use or disclosure of health information are also within scope, unless the use or disclosure has been authorised by the individual(s) concerned, or the information will not be disclosed to the researchers in a form that could reasonably be expected to identify the individuals concerned, or allow the information to be matched with other data sets, such as National Health Index numbers of the individuals.98
A further surprising exclusion from HDEC review is all observational research conducted wholly or principally for the purpose of a student’s educational qualification at or below Masters level. The Ministry of Health takes no responsibility for the ethical review of such research studies, even if the participants are patients and the risk of harm is “more than minimal” so that it would require
93 NEAC Intervention Guidelines, above n 78, at 5.28 where the
category of “vulnerable people” is described as broad and includes
children and young
people, people with mental illness, people with serious
intellectual disability, people with English as a second language and/or
a
different cultural background to the investigators, people whose freedom to make
independent choices is restricted (e.g. prisoners,
students or employees of a
sponsoring company), people with serious illness for which the study treatment
offers potential benefits
that substantially exceed those of any other available
treatment.
94 SOPs, above n 7, at [31] and [32].
95 SOPs, above n 7, at [29.2]. “Human tissue” is defined in Human
Tissue Act 2008, s 7. The HEDCs will also review studies
that involve the use of
human tissue taken as part of New Zealand’s Newborn Metabolic Screening
Programme (Guthrie cards),
the establishment or maintenance of a tissue
bank.
96 SOPs, above n 7, at [29.2.1].
97 SOPs, above n 7, at [29.2.2]: informed consent is not required for the use of tissue in external audits or evaluations of services or quality assurance programmes intended to assure or improve the quality of services: Human Tissue Act, s 20(f), and Code of Patients’ Rights, Right 7(10)(c).
98 SOPs, above n 7, at [29.3]. The HEDCs will also review studies that are funded by the HRC but are not able to be reviewed by an ethics committee accredited by the HRCEC.
HDEC review if it was to be conducted by a PhD student or healthcare provider. Presumably, the expectation is that such research proposals will be reviewed by the institutional ethics committee where the student is enrolled. But not all institutions have approved ethics committees.99
The third change to the scope of HDEC review is that only substantial amendments to approved studies require ethical approval. Applicants can make minor amendments without approval from or notification to the HDEC.100 A ‘substantial amendment’ is one that is likely to affect to a significant degree the safety or physical or mental integrity of participants, or the scientific value of the study, or the conduct or management of the study or the quality or safety of any medicine or item used in the study.101 There are two weaknesses in this change. The first is that the responsibility for deciding whether an amendment is significant lies with the investigators. While they are assisted by a list of examples of what would be a substantial amendment and what would be regarded as minor and may submit the amendment for review if in doubt, relying on the investigators’ subjective assessment ignores the conflict they invariably have.102 The second weakness is that where there are multiple amendments, sometimes over a period of time, each amendment may in itself be minor, but cumulatively they may be substantial, yet never submitted for approval. Nor would the HDECs be aware of these amendments.
4.2 Reduced Focus of HDEC Review
Another significant and highly controversial change is that HDECs now focus on ethical issues, rather than scientific, legal, or locality-specific issues.103 HDECs are merely required to be satisfied that these matters have been or will be attended to and that appropriate Māori consultation has taken place, as required by the HRC Guidelines for Researchers on Health Research involving Māori.104 To ensure that the research proposal is scientifically valid, HDECs must check that “appropriate peer
99 The HRCEC has approved 11 institutional ethics committees: three at Massey
University; two at Otago University; and one at the
Universities of Auckland,
Waikato and Lincoln, Auckland University of Technology, Wintec and Unitec.
Neither Canterbury University,
nor Victoria University of Wellington have
approved ethics committees. Nor do several polytechnics that offer nursing
degrees.
100 SOPs, above n 7, at [186].
101 SOPs, above n 7, at
[188].
102 SOPs, above n 7, at [189] and [190].
103 SOPs, above n 7, at
[10]-[18].
104 Health Research Council of New Zealand Guidelines for Researchers on Health Research Involving Māori (Auckland, 2010).
review has been carried out”.105 If they have doubts about the peer review process or the scientific validity of the proposed study, they may insist on additional peer review.106 As explained below, the separation of scientific review from ethical review is widely seen as a major weakness of the current review process and has been severely criticised.107
4.3 Reduced Membership of HDECs
The reduced scope and restricted focus of HDEC review is reflected not only in the smaller number of the committees, but also in the membership and composition of the committees.108 The Terms of Reference of the HDECs state that an HDEC should usually comprise of eight members. From time to time some HDECs have had fewer than eight members.
At least three members must be laypersons. A “layperson” is defined negatively, as a person who is not and has not been a registered health practitioner in the five years preceding appointment, is not involved in conducting health or disability research or employed by an organisation whose primary purpose relates to health and disability research, and would not otherwise be construed by virtue of employment, profession, relationship or otherwise to have a potential conflict or bias.109 One of the lay members must be a lawyer,110 preferably with medico-legal expertise, while the other laypersons should have expertise or experience in ethical and moral reasoning, consumer perspectives and the community perspective.111
105 SOPs, above n 7, at [10]. If the study involves the application of a
medicine for which approval under s 30 of the Medicines Act
1981 is required,
the HDEC can expect issues relating to scientific validity to have been
satisfactorily addressed by the HRC’s
Scientific Committee on Therapeutic
Trials (SCOTT): SOPs, above n 7, at [12].
106 SOPs, above n 7, at [11].
107 Grant Gillett and Alison Douglass “Ethics committees in New
Zealand” (2012) 20(2) JLM 266; Charlotte Paul “Research
participants
need protection” Otago Daily Times (New Zealand, 12 October 2011)
at 9; Tolich and Smith, above n 60, at ch 4. See also the unpublished report of
Professor Joan Pettit,
2015 Fulbright Specialist Visitor, sponsored by the
University of Otago to evaluate the human subjects research protection program
in New Zealand. Her report is held by the University of Otago and was
disseminated to the University of Otago Human Ethics Committee
(Health) in
February 2016.
108 Terms of Reference of each HDEC. The members are appointed
by the Minister of Health.
109 Terms of Reference of each HDEC.
110 The requirement that one member be a lawyer is a recent change to each HDEC’s Terms of Reference. It follows concerns about HDEC members’ understanding of the legal limits on the right of others to consent on behalf of incompetent adults.
111 Terms of reference of each HDEC. Southern HDEC the minimum of three lay members and five non-lay persons, while Northern B five lay members and only three non-lay members. The other two HDECs four lay and four non-lay members.
The non-lay membership must include at least two persons with expertise and experience in the design and conduct of intervention studies. Other non-lay members should have expertise and experience in the design and conduct of observational studies and the provision of health and disability services. At least one member should have awareness of te reo Māori and an understanding of tikanga Māori. HDECs must be chaired by a layperson, and, as before, the chairs and members are appointed by the Minister.112
In keeping with the reduced size of the committees, the quorum for an HDEC meeting is now five members, which must include at least two lay and two non-lay members.113 The chair is able to co-opt members from one of the other three committees if the HDEC would otherwise be inquorate.114 Co-option is common.
4.4 Procedural Changes to HDEC Review
One of the aims of the SOPs is to ensure the system is efficient. To that end, the HDEC meetings are staggered so that there is an HDEC meeting almost every week of the year. These meetings are open to the public unless the investigator requests consideration of their study in a closed meeting to protect confidentiality or commercial sensitivity. Several commercially sponsored research proposals were reviewed with the public excluded. Applications are submitted online to a central secretariat by means of an electronic algorithm that directs investigators only to questions that are relevant to their study. The secretariat screens the applications and distributes only those that are in scope to the next available HDEC meeting, unless the applicant requests review by their closest HDEC.115
Studies may be reviewed by the full committee or through the expedited pathway. Expedited reviews are conducted by a sub-committee of between two and four members of which at least one must be a non-lay person if the application concerns an intervention study.116 The time limit for these reviews is 15 days from submission of the application, whereas the time limit for full reviews is 35 days from the cut off date for submission of applications for the next HDEC meeting, unless the applicant asks for review by the geographically closest HDEC.117 By
112 Terms of Reference of each HDEC.
113 SOPs, above n 7, at [69].
114
SOPs, above n 7, at [71].
115 SOPs, above n 7, at [40].
116 The minimum
number of members is two: SOPs, above n 7, at [112].
117 SOPs, above n 7, at [57]-[62] and [102]-[105]. Additional meetings can be scheduled to meet the time limit. An HDEC meeting should normally consider no more than 12 new applications and allocate no less than 30 minutes for discussion of each new application and 15 minutes for each substantial amendment: SOPs, above n 7, at [64] and [65].
the end of 2013 approximately one third of the applications had been reviewed through the expedited pathway, but the average time exceeded 15 days for all of the committees.118
Full review is required for studies that involve
All other applications are reviewed through the expedited pathway.
As might be expected, the vast majority of applications reviewed by the full committee are intervention studies, whereas most of the expedited reviews deal with observational studies.120 Expedited review may also be used for substantial amendments to studies that were approved through the expedited pathway and, at the discretion of the chair, substantial amendments to studies that were approved by the full committee. All progress reports and final reports, all protocol deviations or violations, and all notifications of the conclusion or early termination of a study can also be dealt with by a sub-committee.121
The distinction between studies requiring full review and those for which expedited review is available, is intended to reflect the degree of risk to which participants are likely to be exposed. The lesser the perceived risk, the lower the level of review. Decisions in both a full review and an expedited review should be reached by consensus. If that is not possible, the decision can be made by simple majority
118 The Annual Reports of the HDECs for 2012 and 2013 reveal that of the 801
applications reviewed, 270 went through the expedited
pathway and 531 went to a
full committee.
119 SOPs, above n 7, at [52].
120 For example, in 2013 Northern A HDEC, which has seen slightly more
applications than the other HDECs, did a full review of 102
applications of
which only 15 were observational studies. Of its 55 expedited reviews that year
40 were observational studies and
15 intervention studies.
121 SOPs, above n
7, at [101].
with the chair having a casting vote.122 Full reviews can therefore be decided by a majority of 3:2 and expedited reviews by a majority of 2:1. In practice, majority decisions are very rare.
Attendance of applicants at the HDEC meetings, either in person or by teleconference, aids efficiency.123 That was an initiative introduced many years earlier. Applicants are able to provide immediate answers to questions, address concerns and assure the HDEC about the scientific and ethical validity of the study. Their attendance not only increases the chance of approval being granted at the first HDEC meeting, but also clarifies for both the HDEC and the investigators what matters still need to be addressed.124 If provisional approval is granted, final approval is often delegated to a sub-committee of the HDEC or even to the HDEC secretariat when the outstanding issues relate only to minor technical matters or the provision of information. Provisionally-approved studies seldom come back to the full committee for final approval.125
The HDEC’s monitoring of approved studies has also changed.126 Studies are now approved for the duration of the study, rather than for a year at a time. Investigators do still have to submit progress reports at least annually and, if the report concerns an intervention study of a new medicine, an annual safety report must be attached.127 These reports are reviewed through the expedited pathway, rather than the full committee. If a report reveals grounds for concern, ethical approval must be reconsidered by the full committee, which may then suspend or cancel
122 SOPs, above n 7, at [92] and [116].
123 SOPs, above n 7, at
[82]-[86].
124 In 2014 and 2015 researchers were present for 1182 of the 1289 applications considered by full meetings of the four HDECs. Of the 300 applications approved at the first meeting, the applicant was absent in 30 cases, 21 of which were approved by the Southern HDEC. Of the 428 applications that were provisionally approved at the first meeting, 77 did not have an investigator present.
125 The workload of committee members between monthly meetings is
considerable and may initially have been underestimated. Members
were to be paid
for a maximum of three days work per month and the chairperson for five days
work per month. The HDECs’ terms
of reference have since been amended to
increase the maximum to four days for members and nine days for the chairperson,
indicating
that the workload of the chairperson, in particular, is significantly
greater than first thought.
126 SOPs, above n 7, at section 12.
127 Line listings of serious adverse events that are commonly sent to investigators of commercially sponsored international clinical trials should not be sent to HDECs. They are meaningless without explanation and the HDECs do not have the expertise or resources to review them. If any of the serious adverse events impacts on the safety of the participants, the investigator should include them in the annual safety report or alert the HDEC sooner of the need to halt or change the study.
the study.128 Urgent safety concerns or temporary halts to a study must be notified to the HDEC immediately for review of the ethical approval.129 HDECs are not responsible for proactively monitoring approved studies.130 Primary responsibility for such monitoring lies with the study sponsor and the principal investigators. That accords with the usual practice that operated previously and clarifies the limits on the monitoring responsibilities of HDECs. Closer monitoring is seen as impractical and unrealistic.
5. COULD AN ‘UNFORTUNATE EXPERIMENT’ HAPPEN AGAIN?
In 2008, 20 years after the Cartwright Inquiry was completed, Jan Crosthwaite concluded that an unethical research project similar to the ‘unfortunate experiment’ could happen again, although the risk was small.131 In her paper to mark this occasion, she addressed three questions: whether an unethical research project would be approved by the ethics committees; whether an unethical research project would bypass the ethical review process; and whether the research could deviate from the protocols approved.
In response to her first question, she thought the risk of ethics committees approving unethical research was very low. The independence, diversity, expertise, and experience on the committees and the scope of their review made it very unlikely that they would approve research that was unethical at the time of review, particularly research that presented undue risks to patients or failed to secure their informed consent. One might be rather less confident about that conclusion in 2016, given the reduced professional expertise on the HDECs and their restricted focus of review. Instead of carrying out their own assessment of the scientific validity, the HDECs require others to peer review the study.
Robust peer review depends on the knowledge, expertise, and integrity of the reviewers. They have to be familiar with the literature and be able to determine that the question or hypothesis is valid, that the methodology will answer the question or prove or disprove the hypothesis, that the risks and benefits of the study have been fully identified, and that the proposed monitoring system is appropriate. It may require more than one expert to provide a full review of a study. A person with specialist knowledge of the relevant literature would be needed to determine
128 SOPs, above n 7, at [218]-[224].
129 SOPs, above n 7, at [209]-[212]. Notifications of urgent safety measures,
temporary halts and the recommencement of studies after
a temporary halt are
deemed to be amendments to the study and thus require review.
130 SOPs, above
n 7, at [218].
131 Crosthwaite, above n 8.
whether the question is worth asking; a biostatistician or an expert in qualitative studies may have to assess the methodology; someone with clinical research expertise would have to assess the proposed monitoring system and the criteria for stopping a clinical trial; a pharmacologist may need to assess the risks and benefits of a medicine and whether the appropriate exclusions had been identified; and a clinical specialist may have to determine the risks and benefits of other interventions. To ensure that this assessment is reliable, the experts have to be independent to avoid conflicts of interest and bias. That was the justification for increasing the ethics committee membership prior to 2012 and part of the reason for Crosthwaite’s confidence in the system that existed in 2008. The question now is whether the peer reviews that the HDECs receive are sufficiently robust and whether the HDEC members have sufficient expertise to assess the reliability of the peer review.
The very detailed minutes of the HDECs’ meetings provide some reassurance that members are scrutinising the science. Investigators are almost always in attendance, either in person or by teleconference, and are questioned quite rigorously about the design, the methods, and the risks and benefits of their study. In cases where the committee was not satisfied that the peer review was adequate or independent, the study was declined.132 A proposal such as Dr Green’s study is highly unlikely to be approved today. Even if the HDEC had not had the expertise to identify the flawed design and the risks to participants, they would have noted the absence of peer review and participant consent. Regrettably, there is no detailed record of reviews by the expedited pathway to enable some kind of assessment of the rigour of the process. While most of the studies reviewed by this pathway were observational, where there may be less risk of harm to participants, some intervention studies were reviewed in this way as well.
Despite the reassuring picture painted by the minutes of the HDEC meetings, the reduced range of expertise on these committees does increase the risk that a study will be approved that lacks scientific validity and could expose the participants to harm. Peer reviews are notoriously hit and miss. There may be only one review, or the review may have been done by an in house panel, or the reviewers’ expertise may be inadequate to provide a thorough objective assessment. The HDEC reviewing the applications may lack the expertise to appreciate that the peer review submitted does not provide an accurate or complete picture of the scientific validity of the study, particularly if there are only two non-lay members present, who might not be health professionals. Even if they are health professionals, it
132 Between July 2012 and December 2015, the four HDECs had declined a total of 43 applications.
places a heavy burden on them to be confident that the proposed study is valid and poses no unacceptable burden or risk on participants. The risk of approving unethical research is even greater in expedited reviews, where there is generally less scientific oversight.
The separation between science and ethics is both conceptually and practically problematic. Assessing the scientific validity of a project is “an intrinsic and inseparable component” of the ethical review process altogether. To outsource this task is to “emasculate” the reviewer’s ability to protect human subjects.133
In 2008 Crosthwaite was more concerned that unethical research or treatment could bypass the ethical review process, not necessarily intentionally, but through ignorance and not being part of an established research community.134 Research was no longer the domain of hospitals and universities.135 It was increasingly being conducted in the community: in general practice, pharmacies, and other allied and alternative healthcare settings, where there is less of a history of research and participants might find it difficult to refuse to participate. That trend has continued. But whereas in 2008 such research could still be submitted to the HDECs, that may no longer be the case. Investigators whose studies are “out of scope”, either because they do not come within the categories that HDEC will review or because they have not correctly completed the online application form, are left to look elsewhere for ethical review of their studies and may have nowhere to go. There are no approved institutional ethics committees outside of the tertiary institutions and not all tertiary institutions have approved ethics committees.136 There is no default mechanism for capturing such research, which may well proceed without ethical review and cause harm to the participants.
Crosthwaite’s third question addressed the issue of monitoring approved studies. She noted that there was nothing specifically to prevent researchers from gaining ethical approval and then not following the approved protocol. While investigators were required to report regularly to the HDECs, disclosure of concerns about the study depended heavily on the investigators. Their belief in their research and their desire for scientific success could blind them to the reality of what is going on, as in the case of Dr Green. That risk is still there today and appears to
133 Pettit, above n 107, at [4].
134 Crosthwaite, above n 8, at
175-179.
135 Dr Green was part of a research community and appreciated the need to get
approval for his project from the Hospital Medical Committee.
Had he made his
application today and responded to the questions as he would have done in 1966,
he would have found that his project
required review by the “full
review” pathway.
136 Above n 99.
be greater than before. Regular reports from the investigators are the principal means of monitoring approved research proposals, but there is no mention in the HDEC minutes of these reports being received or scrutinised by the HDECs. Furthermore, they may be unaware of changes to approved protocols because they are not informed of minor amendments and may not be aware of substantial amendments if the investigators did not submit those amendments for approval.
The risk of an ‘unfortunate experiment’ happening again is thus greater than it was in 2008. There is a good deal of research that is outside the scope of HDEC review and for research that is within scope, the HDECs are less equipped than they were before the 2012 reforms to carry out the ethical review of research proposals and prevent unethical departures from approved ethical protocols. The political desire to create a more efficient and less cumbersome process to encourage commercially sponsored trials has come at the expense of patient safety and is a major departure from the recommendations of the Cartwright Report. It must be noted, however, that the ethical review system does not exist in isolation. The impact of the Cartwright Inquiry went well beyond regulatory reform. The professional community is more aware of its ethical responsibilities and the public is more aware of its rights and has effective processes to enforce them. Dr McIndoe’s concerns would not be so easily brushed off in 2016.
CONCLUSION
The purpose of the 2012 changes was to make the ethical review system robust, efficient, transparent and consistent.137 There can be little doubt that the current process is efficient and probably more so than in the past, if only because researchers can access an HDEC every week, rather than once a month. Transparency is partial. While the minutes of HDEC meetings and the annual reports for 2012 and 2013 are available on the website, there are no minutes of the expedited reviews or of the monitoring process. Of particular concern in this regard is that members are appointed by the Minister, which calls into question the independence of the HDECs.138 There is no overarching legal framework for ethical review in New Zealand that would give HDECs the independence and transparency to perform their role without political oversight or interference. The claim to robustness is even more difficult to defend. The reduced scope of HDEC review, the separation between scientific and ethical review, and the limited scientific expertise on the committees provide less confidence that the current ethical review system can fulfill its paramount purpose of protecting patient safety.
137 SOPs, above n 7, at [1].
138 Gillett and Douglass, above n 107, at 271.
Peter Skegg’s brother, Sir David Skegg, described the Cartwright Inquiry as “a watershed in the history of medicine and health care in New Zealand”.139 It radically changed the doctor-patient relationship and the conduct of health research in New Zealand. Much of the change was for the good. Respect for patient choice and the importance of patient safety are central to the doctor-patient relationship. But the Inquiry also created public distrust in the health profession and undermined the internal morality of the profession, to the detriment of the doctor-patient relationship. Through his research, and in collaboration with others, Peter Skegg made a significant contribution to restoring some of that trust in the health profession and its internal morality. That trust is essential if patients and research participants are to be protected from harm.
Nonetheless, the lessons of the past are easily forgotten and history has an unfortunate habit of repeating itself. The changes in the ethical review system introduced by the SOPs in 2012 are disturbing because they rely on external processes for the protection of patient safety. That reliance may be misplaced, leaving scope for another ‘unfortunate experiment’ to eventuate.
APPENDIX
It recently occurred to me that certain early initiatives, those in particular taken by the Dean of Medicine in the late ‘70s and 1980s (Professor Geoff Brinkman); and the way to have a lay person on the Area Health Board’s Ethics Committee may not have been recorded, leaving unexplained why it was that Otago was ahead of other centres in its concern about what came to be known as bioethics. I do remember that while I was still on that committee a brief outline of its history was presented to it; but it gave no account of the first appointment of a lay person to it or of [the] contribution Geoff Brinkman made to the establishment of Otago as a centre for the teaching of bioethics.
It must have been very early in the 1980s that Professor Brinkmam got in touch with Alan Musgrave about a public seminar he was planning to discuss some of the moral dilemmas and legal problems thrown up by new, some radically new scientific and medical knowledge and technology. He wondered whether anyone from the Philosophy department would be interested in participating? This I think was in the year in which I retired (1980/81)
As it happened in the two years before my retirement, in the last couple of lectures to the large first year Introduction to Moral Philosophy class, I presented some
139 David Skegg “Foreword: The Cartwright Inquiry and its legacy” in Manning, above n 8, at 7.
moral dilemmas, asking students to consider what they thought proponents of the various moral philosophies we had discussed would be likely to say about them. Anxious to get away from the usual ‘make up’ examples, it seemed to me that medical practice and research would sometimes generate genuine and serious moral dilemmas. So I took myself off to the Medical Library looking for relevant articles and/or reports citing cases presenting moral puzzles; maybe involving a clash between principles. As I remember it the New England Medical Journal (I cannot remember its title) discussed some cases of interest to me.
Aware of what I had been doing for the last couple of years Alan suggested that I might be interested. The upshot was that I spoke at that first Seminar in one of the Medical school lecture theatres and participated in several subsequent ones; as did several members of the Medical Faculty and Peter Skegg. These were lunchtime affairs and well attended by nurses, medical students, social workers and members of the general public. Professor Brinkman believed quite passionately that the public should be better informed and that there should be public debate about the moral and legal implications of for example the new birth technologies, life prolonging technologies. He gathered together a small group( Professor Jones and David Green and I think Professor Stewart. We met occasionally and informally to discuss plans. We had a weekend seminar, the Master of Knox generously making the College available and the city council through Louise ---? was involved. I also remember the Dean telling us that he had managed to get finance to subscribe to a new Medical Ethics journal that was being published in the UK. He was eager too that there should be some sort of filing system specifying references to relevant articles in journals held in the Medical Library them so that anyone wanting material on these issues would be readily able to access relevant articles. How could this be done? The Library did not have the resources to undertake it. What about getting a senior student , with the background and nous to make a start on this during the long vacation? (This was in those wonderful days when university students could be paid, subsidized by government for doing vacation jobs. But how to get hold of one with the required skill? I suggested a young woman finishing her honours degree in Philosophy who had also gained a first class honours science degree and worked on a post graduate degree in Zoology. She was taken on to do this job (she has since had a couple of very prestigious jobs in London). During that long vacation she worked for us, identifying.and recording references. Then there was the occasion when Professor Brinkman announced to us that he had got funds from the Medical school (and was it also from the Presbyterians and the Mosgiel Roman Catholics – or was that for the journal?) to bring out from England for a term (or was it a month) a bioethicist from the UK (Alistair Campbell’s first visit). And in 1988 Grant Gillett arrived; and the formal teaching of bio-ethics in the Medical School began.
It would have been late 1980 or early 1981 that the Otago Area Health Board decided that it should have a lay person on its committee, they approached the university about it, and the Registrar and Robin Irvine sounded me out, and with some qualms, I agreed to be that person (I had just retired). I received a very welcoming phone call from Dr Berenson, saying that he would be readily available should I encounter any difficulties, or need information. At this point the committee was primarily concerned with vetting research protocols although there was a very occasional case, maybe in the provence of life support. As I recall there were around three to four protocols presented at each of our monthly meetings and occasionally some general item on the agenda or a special treatment case that had cropped up (eg request for life support to be terminated.) Dr Berenson chaired the committee and there were, I think, about five other members of the committee, all medical Professors. My first papers arrived a couple of days before the meeting. Each research project included a consent form for those volunteering to participate to sign. Some protocols included a a short information sheet for participants or perhaps a statement saying that procedures, side effects had been explained to those agreeing to participate. I went along to that first meeting wondering what on earth my role could be, given my non science background, ignorance of possible hazards in taking part in the research projects, let alone what side effects or what if any the hazards of participating might be. The medicos round the table either had the know-how or knew who did. I would have to rely on their know-how. So of what practical use could my membership of the committee be? I could try to make sure that the information sheet if there, contained ef information about possible side-effects referred to in the main body of the protocol. I went along to that first meeting wondering what part I could play. My bemusement seems almost unaccountable now. But in 1981 I had no role model, I knew of no one, even elsewhere, performing such a task. (The Mary Warnock report was yet to come, as were Sylvia Cartwright’s findings on the National Women’s scandal). So I went along to that first meeting very tentatively, very much feeling my way. And no doubt those medicos all male, all medical Professors sitting round the table wondered what they had landed by way of a lay person – a woman and even more hazardous, a philosopher for heavens sake! However despite any reservations they may have harboured, they welcomed me in a very friendly manner. And I limited myself asking, I think only once, for some clarification. At the end of that session I felt as puzzled about my role as I had at the beginning. I walked away from our meeting place in the Hospital with Graham Mortimer, talking about the meeting. He made some comment – I now have no idea what he said, but whatever it was it was a trigger for me. Getting back to my own desk and looking again at the protocols, I focused in particular on the consent forms and information for participant notes where they were included,
and compared them with information concerning eg possible side effects contained in the protocol . Sometimes the consent form had a brief paragraph setting out information about side effects and the object of the research; sometimes the consent simply included a paragraph saying that the procedures and objectives of the research had been explained and X consented to participate. These people were volunteers and were being asked to be responsible – providing safety, competency factors were met. Aristotle’s conditions for an action to be voluntary were central to these cases. For consent to do some act, or for the action to be done voluntarily, certain conditions had to be met. The agent – research participant – must be informed, know about the objectives of, the procedures and likely outcome of the project; it must be an ‘informed’ decision (consent). And the decision to participate must not be made under any sort of threat eg fear that refusal to participate might jeopardize future health care. So, eg, if the participant sought was a patient of a doctor involved in the research project they should be assured that a decision not to participate would in no way effect their future medical care. It seemed to me that the information given participants should be known to us, should be in written form so that the subject could take it away and so that the Committee could scrutinize it; and that it should be readily intelligible to a lay person; for example, at least, to me. And all Information Notes for participants in the study should detail side effects It took a little time for some researchers – by no means all, to produce Information Notes free of professional lingo and in simple, direct English. (I had explained my position concerning this at one of my early meetings, saying as I recall that a consent form simply saying – without evidence of an explanation- “ I consent to procedure X” (or what ever) had about the same moral weight and maybe legal weight as a bus ticket.) So I came quickly to see my role (as a good fan of the worthy Aristotle) as attempting to ensure that participants (regrettably, they tended to be called “subjects’ at that time) were indeed volunteers, they had given voluntary consent, their ‘agency’ recognized. Looking back now I find it difficult to accept that I could not see immediately what my role should be; until I recall that medical ethics, as it was spoken of then, generally referred to traditionally enshrined professional principles or codes of practice eg duty to save lives, relieve suffering, respect confidentiality and trust of patients. It was in part because the new scientific knowledge and technical know-how produced not only benefits but moral problems and new responsibilities that discussion of and training in the underlying values and principles of our moral scheme became important. By the late eighties in the wake of the Cartwright Report, membership of Ethics committees was under review. We had made a number of additions since my appointment. A year or so after I joined the committee I suggested that we should have a Nurse on it; and this was agreed – so we had two women on the Committee. Next I think we had a lawyer,
Professor Peter Skegg later succeeded by Nicola Peart; and when Dr Jessie succeeded Professor Mullen (Psychiatry) we had four women on the Committee about eight years after I had joined it. I chaired the Committee for about fifteen months before I went abroad and Alistair Campbell arrived. It was a quite strenuous time for me; secretarial help being limited to covering meetings of the committee and about half a day for writing of letters etc. Fortunately the person doing that work for me was quite exceptionally able. Nor did I have an office of my own and by this time the number of research protocols had grown and telephone calls also (these I dealt with at my home). I left for UK in March 1990 having a commitment there that prevented me being in Dunedin when Alistair arrived. Three years later I was again abroad for several months, and on my return had a phone call from Alistair asking would I be prepared to take on the Chair of the Committee for (I think it was) nine months of his leave overseas. I at first declined, citing my age – 76 – as sufficient reason. But when he told me that the exceptionally able young woman I had recommended to him was now working full time as Secretary to the Committee I changed my mind! During my first period as ‘chair’ I gave a number of talks to groups two of which I remember clearly; one in Dunedin to the Business and Professional Women and another to a large group in Timaru, the women coming from as far afield as Omarama. On my return from abroad and for a second stint as Chair I found many changes (this was 1993) in the Health structure, and an enlarged Committee – a Patient’s Advocate, and a Maori [representative].
This is a very rough and ready account of my recollections of those early years, the twelve or so years I was lucky enough to be associated with the Committee and with Professor Brinkman’s design to establish Otago as a centre for Bio-ethics
In simply relying on what is now a very elderly, maybe threadbare memory, I may well have omitted reference to others and to significant events in those early years. If so, I am sorry. And I regret too that I seem to have given undue prominence to my own minor part – maybe because I found my involvement a wonderfully interesting retirement activity. My principal reason for writing this and giving it to a couple of interested people is to ensure that Geoff Brinkman’s role in all this is not overlooked when (maybe) a formal history is written.
Gwennyth Taylor.
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