Charlotte Paul: Keep the ethical safeguards in medical research

If the Government's plan goes ahead, the protection of participants in trials will be diminished. Photo / File

Government is proposing to downgrade the protection of participants in health research, in response to a Health Select Committee report that argues for fast-tracking clinical research trials but gives scant consideration to the protection of research participants.

If the government's proposal goes ahead, careful safeguards that were created in the
aftermath of the Cartwright Inquiry will be lost. Instead of a system of rigorous review by ethics committees, the proposal allows "expedited review'' (delegating the chair to approve summarised applications) for some clinical trials. It also almost halves the number of ethics committees and downgrades their role. Not only is this bad ethics - it's also uninformed. Minister of Health Tony Ryall did not seek advice from his own National Ethics Advisory Committee), before formulating the government response to the Health Select Committee report, which runs counter to NEAC's previous advice.

In 2004, the Government agreed to new processes for the ethical review of health research in New Zealand, based on a thorough review by the committee. Problems of duplication and delay were resolved. One national committee was created so that multi- centre studies would be subject to only one review.

Fifteen committees were reduced to seven, because of the reduced workload. The national advisory committee subsequently developed detailed ethical guidance on the conduct of observational research and audit (2006) and on clinical trials (2009). The observational studies guidelines removed the requirement for audit - an essential part of a high quality health system - to undergo formal ethical review, except in certain situations, where expedited review was allowed. The result of these changes has been an efficient system for ethical review of health research, balanced by rigorous protection for participants.

The main flaws in the Government proposal are in the plans to restructure ethics committees and to downgrade the type of review. The number of regional committees will be cut to four.

To do this, some clinical trials will receive only expedited review. This was not recommended by the national advisory committee in 2009 because clinical trials, compared to observational studies, entail an intervention and hence more potential for harm. Indeed the committee recommended "close ethical scrutiny'' for trials.

The oddest Government decision is to insist that ethics review does not require particular scientific or clinical expertise. The committees members, we are told, "will not be expected to be experts in the technical detail of the research they review'' because the focus of the committee will be on ethical standards.

This is wrong. Determining whether ethical standards are met entails getting to grips with the scientific and clinical issues. For example, to assess whether a clinical trial has sufficient risks to require independent monitoring, the ethics committee members have to be able to judge the clinical risks described by the applicants.

To judge whether the risks are reasonable in relation to the anticipated benefits of a trial comparing different antipsychotic medicines for schizophrenia, some knowledge of the condition is required. And think of it the other way: if someone on the ethics committee wants a change made (on ethical grounds) which would undermine the scientific validity of the proposed research, then the committee needs other people with a background in science to debate the issues - to try to find away to protect both the participants and the scientific integrity of the research.

The strength of ethics committee decision - making lies in the ability of people of different backgrounds to deliberate issues in an informed way. The current ethics committee structure, at its best, allows this to happen.

Ethics committee members have worked tirelessly in the public interest. Sometimes they have been over-zealous. But to remove their role as informed deliberative bodies is a grave mistake.

If the Government's plan goes ahead, the protection of participants in trials (and in observational research) will be diminished. Of course investigators should take primary responsibility for the ethics of their research, but let us not kid ourselves that that is always enough. There are investigators who are morally blind, as the unfortunate experiment at National Women's attests.

There are also substantial conflicts of interest at stake, especially in pharmaceutical industry sponsored clinical trials.

The Minister should pause and ask the advice of his Ministerial Advisory Committee about all the substantive issues.

They in turn need to consult, particularly with the District Health Boards. If DHBs consider ethics review insufficient in a national system, they may all (and indeed some already have) set up their own local DHB review. Then the whole rationale for having ethics review away from the institution will collapse.

Judge Silvia Cartwright showed there were good reasons to have a national system of ethics committee review, away from the bias of institutional committees. But this national system needs to protect participants and protect the integrity of the research.

* Charlotte Paul is Professor of Preventive and Social Medicine, Otago University, was a member of NEAC from 2002 to 2008 and was a medical advisor to the Cartwright Inquiry.