Ethics Committees – guardians of research participants’ rights or expediters of clinical research?
If the September response of the Government to the Health Select Committee's 'Inquiry into improving New Zealand's environment to support innovation through clinical trials' is implemented, there is the real likelihood that the role of regional health and disability ethics committees (HDEC) will become one of rubberstamping and expediting research rather than one of giving considered and principled analysis to ensure that the research is ethical and that there are adequate safeguards to protects the rights and interests of research participants.
The main aim of the Select Committee's inquiry was to ascertain how clinical trials and research proposals can be streamlined and how an effective clinical trials environment can be created. It identified the current system of ethical review as one of the main obstacles to delivering efficient clinical trial outcomes and made a large number of recommendations to radically alter the system of ethical review.
A number of submitters to the Select Committee inquiry, principally pharmaceutical companies and researchers, argued that the present ethical review system is 'overly bureaucratic' and that it is a hindrance to research, with one submitter arguing that it 'has become so unwieldy it is unethical'. Interestingly, submitters with an ethical expertise and a number of consumer groups argued that while the present process can always be improved (usually simply addressed by better resourcing), there was no evidence to suggest that the present system needed a major overhaul or to substantiate the allegations that the present system of ethical review was either flawed or a major hindrance to the carrying out of effective research.
Not all the Select Committee's fifty four suggestions have been taken up by the Government but it has accepted most of the recommendations which in summary are:
- developing standardised operating procedures for ethics committees (to have effect from 1 July 2012). These standardised operating procedures will:
- introduce timelines for full review (35 days) and expedited review (15 days)
- expand the expedited review pathway to include some clinical trials, and clarify and reduce the scope of HDEC review as a whole (focus more narrowly on ethical issues)
- reduce duplication by clarifying the roles of HDECs, researchers, localities, and the Standing Committee on Therapeutic Trials
- define when amendments to approved studies themselves require HDEC review
- developing shorter, simpler application forms (by mid-Jan 2012)
- implementing an online application system, with a 'central clearing house' (by 1 July 2012)
- reducing the number of committees from seven to four
- reducing committee size from twelve to eight members, including at least three lay members
The main concern that emerges from the Government's acceptance of many of the committee's recommendations is that the present primary objective of ethical review to 'safeguard the rights and interests of participants in research and innovative practice, and consumers of health and disability services' will be diminished.
The present carefully constructed system, which has been shaped by New Zealand's unique society, protects research participants by having:
- Regionally-based ethics committees, in touch with and responsive to the needs of their local communities. The proposal to have fewer ethics committees will mean a move to a more centralised system with a loss of the unique advantages offered by the regional system.
- Regionally-based committees which allow local iwi to have input, in line with Treaty obligations. The place of the Treaty in the system of ethical review is unique to New Zealand and means the principles of the Treaty are honoured.
- Committees with twelve members, including six lay members, which give extensive scientific, medical, ethical, legal, disability, Maori and many other perspectives. It is the composition of ethics committees with people of different backgrounds each adding to the deliberation of ethical views that is one of the strengths of the present system. As C Wright Mills says, thinking in terms of a variety of viewpoints, "catching light from as many angles as possible."
- Independent scientific, research and medical expertise which means an assurance that the research has scientific integrity and strengthens the committee's understanding of the scientific and clinical issues and of risk/benefit, thus contributing to more ethical, stronger decision making. The government's proposal is to take away this expertise and for the investigator or sponsor to obtain peer review. This is of real concern as the pharmaceutical companies are significant funding sources for researchers, making it extremely difficult for investigators to obtain un-conflicted or independent review.
Since 2007, many observational studies have received expedited review as they are reviewed by only the chair or deputy chair. The Government now proposes that expedited review should be available not only for observational studies but also for some 'low risk clinical trials'. It is not clear who will determine which trials constitute 'low risk' and thus qualify for chair-only review but the spectre of exposure to unanticipated risk is certainly raised. The proposal to include clinical trials in expedited review is both puzzling and concerning as the National Ethics Advisory Committee, whose primary function is to provide advice to the Minister of Health on ethical issues of national significance, had in 2009 identified interventional clinical trials as having a greater potential to cause harm and thus requiring close ethical scrutiny.
Since 2002, I have given a number of presentations on the system of ethical review in New Zealand, noting the strengths as outlined above but also outlining my concerns:
- Lessons of past quickly forgotten e.g.
- Greenlane Hospital and collection of babies' hearts
- Physiotherapy on babies at National Women's Hospital
- Attempts to revise history – e.g. the 'Unfortunate Experiment'
- Perception of lack of real commitment to, and understanding of, the importance of ethical review
- Low priority given to ethical matters e.g. length of time to review Operational Standard, lack of resourcing, lack of advertising
- 'Generalists' and vested interests appear to ignore the input of experienced working ethicists
As the New Zealand system of ethical review arose from the recommendations of the Cartwright Report, it behoves any reviewer to keep in mind Judge Cartwright's strong criticism of the poor quality of review surrounding clinical research at the time. She was fiercely critical, among many other things, of the lack of independence and impartiality of the Hospital Ethics Committee that approved Professor Green's research. She was pessimistic about the then existing medical establishment to develop a system of ethical review that would give adequate protection to research participants.
The ever shrinking and increasingly restricted nature of ethics committees since 2004, culminating in these proposed radical changes, makes it very difficult to be at all optimistic about the robustness of ethical review in the future.