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Ethics committees

Ethics committees come under the Official Information Act

In late January the National Advisory Committee on Health and Disability Services Ethics informed all ethics committees that they must operate within the Official Information Act. This follows years of lobbying from Women's Health Action and complaints to the Ombudsman about the withholding of information.

Now new guidelines issued by NACHDSE remind ethics committees within CHEs, RHAs or universities that they can only withhold information if they have a reason under the OIA. These are set out in sections 6,7,9,10 and 18 of the Act.

If section 9 is used, there is an extra requirement that the interests of withholding it are not outweighed by the public interest in releasing it.

Researchers should be informed, says the committee, but their views are not binding or decisive.

Ethics committees are reminded of the general provisions of the OIA, that information must be made available unless there is a good reason to withhold it and that the person handling the request has a duty to help the requester.

Reasons always have to be given for refusing to release any information and these must fall within the Act.

Write to NACHDSE at Ministry of Health, PO Box 5013, Wellington


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Access to information held by ethics committees

Ever since the Cartwright Report, Women's Health Action has been keeping a watch on the conduct of ethics committees, which were reformed with new national terms of reference. One vexed issue has been access to research protocols before ethics committees. We began writing letters on this back in 1991, at which time the Auckland ethics committees would not even divulge the names of research protocols, let alone the protocols themselves.

In recent years in the Auckland region, the North Health Ethics Committees have taken the position that requests for protocols should be made to the researcher concerned.

The committees justified their stance on the grounds of concern for protecting the researcher's 'intellectual property'. We have responded that this is a matter outside the proper business of ethics committees. If someone stole researcher's proposal, the researcher would have a remedy in law.

When we have approached researchers directly for proposals, as required by the committee, we have sometimes been refused.

So in 1995 we approached the National Advisory Committee on Health and Disability Services Ethics and asked for an opinion on this matter. The committee consulted ethicist Grant Gillett who prepared a short paper on this matter and also the matter of whether meetings of ethics committees should be open to the public. (Auckland holds open meetings, but this is not the practice in all parts of New Zealand).

Openness is best
On the second matter, Dr Gillett said that the guiding principle should be that meetings are open. He said it was very rare that any proposal would contain information

It would violate patient confidentiality (the privacy issue), and he said that there was 'widespread misunderstanding about the degree to which the intentions [of a researcher] are likely to be of great interest to other researchers.' He said one would have to 'strain the imagination to concoct a plausible scenario' whereby a researcher would steal another's research having become aware of it through an ethics committee.

Dr Gillett recommended that with regard to access to research protocols, as long as the inquirer acted in good faith, it should be made available. This was the stance adopted by NACHDSE after a meeting with the chairs of all the regional ethics committees.

We reported this in our newsletter of October 1995. We also had discussions with Dr Rae West, the chair of North Health's Conjoint Ethics Committee, a sort of higher level of ethics committee which oversees the two Auckland committees and looks at common matters. Through these discussions with Dr West, the matter seemed to be resolved.

An unexpected turnaround
However, in the course of some correspondence with the committee in May this year, Deirdre Milne, chair of one of the two ethics committees, made the unexpected statement that the NACHDSE decision 'cannot be considered a ruling but is a report of a discussion at a meeting I attended. The standard for the operation of Ethics Committees is the National Standard for Ethics Committees which, while it suggests that meetings should be open to the public, does not make a definite ruling on the availability of research protocols.'

She raised issues of intellectual property, commercial sensitivity, and privacy.

'...though Russell Kerse's [chair of NACHDSE] letter sets out one guideline for the Committee to use, the Auckland Committees have decided that the simplest, quickest, most time-effective way of deciding the intellectual property question is to leave it to the owner of the intellectual property, ie the researcher. Russell Kerse's scheme would involve the inquirer and the Committee Secretary or Chair in quite a degree of paperwork and it is a rather and, with respect, bureaucratic approach.'

Given the amount of paperwork WHA had already been involved in on this matter, this last statement indeed rubbed salt in the wound!

The committee's stance was all the more extraordinary as a lawyer on the staff of North Health had drafted an internal memo for the Conjoint Committee stating simply that the committees were subject to the Official Information Act and that they must operate within it. That meant that any refusal to provide information which the committee had must meet the criteria of the act.

In frustration we took the matter to the Ombudsman and the text of his response is below. This firmly establishes that ethics committees must conduct themselves according to the statues laid out in the Official Information Act, and that an deviations and refusals must be able to be justified within the Act.

Response of the Ombudsman
Dear Ms Coney

Thank you for your letter of 16 July 1996, in which you raised concerns about the manner in which the North Health Ethics Committee has dealt with requests for copies of research protocols. If my understanding is correct, your main concern is an apparent practice of asking the requester to seek the information from the researcher involved. In this respect you refer to occasions when your requests have been answered in such a manner and to Deirdre Milne's letter dated 14 June 1996. In that letter Ms Milne advised that the preferred approach of the Ethics Committee was to refer requesters of research protocols to the researcher. On the other hand, your view is that protocols put before ethics committees should be accessible to the public under the Official Information Act.

The Official Information Act provides that, with some limited exceptions, any person may request any official information held by an organisation subject to the Act. A request does not have to be in writing and neither does the requester need to cite the Act, although both actions may be preferable. Upon receipt of a request the holder of the information must, as soon as practicable and within 20 working days, decide whether the request is to be granted and give notice of the decision to the requester. In making a decision on a request regard must be had to section 5 of the Act, which provides that requested information must be made available unless there is 'good reason for withholding it'. (The 'good reasons' for withholding are set out in the Act.) Should a request be refused, the requester may ask an Ombudsman to investigate and review the refusal. My function upon undertaking an investigation and review of a decision to refuse a request is to fomm an independent opinion as to whether or not the decision was correctly made in accordance with the Official Information Act. In reaching such a view I must consider the information at issue and the particular circumstances of the case. In other words, I proceed on a case by case by case basis and it is not possible for me to form a view that a certain category of information should always be disclosed upon request.

Tuming to the matter you have raised, I have no doubt that the research protocols put to the North Health Ethics Committee constitutes official information for the purpose of the Act. Furthermore, as the Ethics Committee is a committee of the Regional Health Authority, the official information is deemed to be held by North Health. Accordingly, if you have made a request for a protocol and this request has been refused, you may ask me to investigate and review the refusal. This would also include the situation where you had been advised that the question of disclosure was solely at the discretion of the researcher. While the views of a researcher may be pertinent to the question of disclosure, the decision to refuse or grant a request must be made by the organisation to which the request is made. This would not, of course, prevent the Regional Health Authority from consulting with a researcher before making a decision in accordance with the Act.

As mentioned above, I am not able to say that a particular type of information should always be disclosed, or for that matter withheld. This, of course, also applies to research protocols. In previous cases concerning similar issues I have reached differing views on such matters, depending on the nature of the information and the circumstances. There have also been cases where I have favoured release of some general information in a protocol, while finding that good reason existed to withhold the remaining information. For example, if a protocol reveals a proprietary process for the preparation of a particular type of medication, there may be strong grounds for saying that section 9(2)(b)(ii) of the Official Information Act applies to that particular information. The question to be asked in such circumstances is not whether the information is 'intellectual property', but rather whether disclosure of the information would be likely unreasonably to prejudice the commercial position of the researcher. At times issues of privacy (section 9(2)(a)) and obligations of confidence (section 9(2)(ba)) may also arise, depending again on the nature of the information.

In summary, should you wish to complain about any response North Health has made to a specific request for information, I would be happy to consider that matter further. Please feel free to telephone Richard Fisher at this Office should you have any queries about what I have said or if you otherwise wish to discuss this letter. Finally, as the issues you have raised are of some. importance I have forwarded a copy of this letter to the Chief Executive of North Health.

Sir Brian Elwood
Chief Ombudsman


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Public to have access to research protocols

Women's Health Action has spent a considerable amount of time this year trying to access a particular research protocol from one of the Auckland Ethics Committees. We have taken the view that as the fundamental role of ethics committees is to protect the public and research subjects, protocols coming before the committee should be publicly accessible.

Some researchers have been unhappy about this, arguing that their protocols are their intellectual property and they might be stolen if others can access them. We have responded that the issue of intellectual property is outside the jurisdiction of an ethics committee whose prime duty is to the public. If researchers intellectual property rights are breached this is a separate matter and researchers have a civil remedy.

The ethics committees in the Auckland area have been in the habit of telling people who request protocols to go directly to the researcher. We have been turned down when we have done this and this occurred again this year. So we decided to take this matter to the newly established National Advisory Committee on Health and Disability Services Ethics for a ruling.

Recently, we received a reply which opened the way to public access to treatment protocols.

The Committee said that the matter had been discussed at the National Ethics Committee meeting on 11/12 May 1995, and at the meeting of National Chairs of ethics committees on 19/20 May l995.


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New national ethics committee

The membership of the new National Advisory Committee on Health and Disability Service Ethics has now been announced. Members are: medical ethicist Grant Gillett; Andrew Gregory, public affairs manager of the NZ Employers' Federation who has an interest in disability support services; Moera Douthett, a New Zealand Samoan who is involved with Pacific Islands groups and women's health; Anne Bray, who is involved in research on intellectual disabilities; Rea Wikara, Manager of Maori Health in Health Waikato Ltd; Janine Abernethy, Manager of Health Advocate Services Ltd in Auckland; Mereana Ratana, a voluntary community worker in Taranaki; Elizabeth Cunningham, a Maori cultural adviser to the Southern RHA; Catherine Ryan a solicitor in the Faculty of Management at Waikato University.

There is no specifically women's health representation on the committee. Neither of the nominations of Federation of Women's Health Councils was appointed to the committee.


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New national ethics structure disappoints consumer groups

Women's health groups were disappointed at the government's announcement in late May, that it would establish a national ethical review committee to advise the Minister of Health. The powers of the proposed committee fall far short of what was hoped for. The Federation of Women's Health Councils of New Zealand had hoped that the committee would be placed within the Office of the Health Commissioner but the Associate Minister of Health Katherine O'Regan. said that this would be 'impractical' as the Health Commissioner legislation has not yet been passed. She did not rule out the possibility that the committee could be shifted to the commissioner's office in the future. The location will be reviewed in two years.

The government's decision ignored the advice given by the Ethics Taskgroup in late February. This group was asked to recommend what structures should be established for ethical committees. It decided that a national advisory committee should be set up and take responsibility for ethical review until such time as the Health Commissioner's office was established.

The Federation was disappointed that the proposed National Advisory Committee on Health and Disability Services Ethics will not have a role in evaluating and monitoring existing regional ethics committees. The committee's role is limited to

  • advising the Minister of Health
  • looking into emerging ethical issues .
  • developing national standards with guidelines accrediting ethics committees where they meet the national standard
  • providing information to ethics committees.

Possibly the worst aspect of the announcement. says Judi Strid. the Federation's spokesperson, is the proposal that Regional Health Authorities would purchase ethical review services'.

Formerly ethics committees were the responsibility of area health boards. They were cut adrift by the health reforms. RHAs may end up needing ethical approval from the very services they have purchased.

Such a situation has already occurred in Auckland. North Health recently reacted adversely when a local GP, Dr Nellum Soysa, took a trial the RHA hoped to run through her group practice to the ethics committee for ethical approval. North Health executives attended the meeting, and persuaded the committee that what they wanted to do was not research. The committee agreed to this, even though Professor Brian McAvoy, of the university's Department of General Practice, and Dr David Seedhouse, senior lecturer in medical ethics, said that the trial was indeed research.


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Ethical Committees in Disarray

Before the implementation of the Health and Disabilities Services Act on 1 July 1993, ethical committees were under the control of area health boards (AHBs). Now AHBs no longer exist, it is not at all clear who controls ethical committees. Regional health authorities (RHAs) were mean to roll over arrangements to ensure ethical committees continued. Some RHAs have continued to fund existing ethical committees, others have not allocated any funds such a purpose, and in some areas crown health enterprises (CHEs) have taken over existing ethical committees.

CHE-based ethical committees would be not unlike the old institutional (hospital-based) ethical committees which the Cartwright Report recommended should cease, saying they lacked independence. Since CHEs are charged to run in a business-like matter, their autonomy must be even more under question. Community health groups have fought long battles with AHB-based committees round issues of access, accountability and openness. These issues could become even more problematic when considerations of profit are brought into the equation.

The other development is moves to form ethical committees in other (health and non-health) areas, including the private sector. Polytechs and drug companies are just some of the bodies considering establishing their own ethical committees.

Currently, there are national standards for ethic committees, set down by the Ministry of Health, and an Interim Taskgroup is reviewing this standard as well reviewing existing committees and making recommendation about the functions and composition of ethical committees the future.

The Taskgroup is to report to the Ministry in Februay. Members are Maria Brucker of Peat Marwick, Grant Gillen an ethicist with the Bioethics Research Centre at Otago University, Gaye Payze of the Ministry, Hohua Tutengaehe and Regina Peretini, members of the Health Research Council's Maori Committee, Jan Crosthwaite, a lecturer in philosophy from Auckland University with a special interest in ethics, and Sharon Kletchko of the Ministry of Health.

There are complex issues to be resolved. Ethical issues arise in research, treatment, and over broader issues, such as the allocation of health resources, what health services are provided free to the public and waiting lists.

The increasing commercialisation of health adds another dimension, especially in a community in which people are still prevented from suing. This places an even greater burden on public agencies to protect the public and hold people and institutions to account.

The Health Research Council has an ethics committee which accredits ethical committees. This is some argument in favour of this committee having national oversight on health research ethics but not other ethical areas, but there are concerns that this would lead to fragmentation of ethical oversight, and the fear that some ethical issues might fall between two stools and never receive scrutiny. Another concern is how complaints about projects or decisions about ethical committees' decisions would find their way to a national ethical committee.


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