WE NEED TO TALK ABOUT...SCIENCE AND ETHICS

We need to talk about …science and ethics.  I am not persuaded that we have the relation between science and ethics clear.  Committees established to ensure that medical research is ethical should surely do that – no more and no less.  Instead, research ethics committees quite happily make judgements about the scientific integrity of proposed research. 

Back to the beginning.  When research ethics committees were established by Lovell and McCaughey in Australia under the NHMRC umbrella, they were to have lay people, lawyers, ethicists and clergy on them as well as members from the research community. Ethics are not the same as science. Society has an ethical code, give or take, and that is understood as well by lay members of these committees as it is, or better, than the research workers. 

The ethics committee were to be multiple and local.  They were to represent the view of the local community in assessing whether research should go ahead and under what conditions of informed consent, safety, ethical integrity and confidentiality.  Their job was to review the ethics – not the science, not the financials, not what is now known as ‘governance’ (by which is meant all the liability, contractual, public resource use matter pertaining to the research). 

Not only was reviewing the science not their job, the committees were not constituted to do it even if they wanted to.  They were not like NHMRC project grant review panels. And yet in the most recent documents about how eastern Australia is now moving to an arrangement whereby one ethics committee can review a multicentre trial for conduct anywhere in Australia, the documents speak of ‘mutual acceptance of ethical and scientific review’ of multi-centre clinical studies by any one accredited Human Research Ethics Committee.

The defenders of this faith assert that scientific members of an ethics committee can make the necessary scientific assessment of research proposals, or call on mates (I presume) who can help.  The clergyperson, the lawyer and the lay people on the committee are disenfranchised form this discussion.  Secret scientists business, it would seem.

Research that lacks scientific integrity, because it is poorly thought out, wastes people’s time, has sample sizes that are inadequate or is in other ways weak (and there is a lot of stuff that masquerades as research that matches these criteria) simply should not be done – it is unethical. It is unethical to invade people’s privacy because a study is fatally flawed.  That ethical call can be made by a scientific review committee, composed of scientists from all relevant disciplines.  Those projects that are scientifically sound are the only ones that should go to an ethics committee for further assessment.

There are lots of reasons why this ideal arrangement does not work in practice everywhere – staff shortages, ethics committee members suffering from delusions of grandeur, and administrative ignorance about the nature of ethics, to say nothing of pharmaceutical companies rattling the pill bottle about how, after a decade of development, their latest product cannot be held up by such trifling impediments as ethical review.

Is this arrangement good enough?  No. Could it be changed?  Yes – by insisting that scientific and ethical review be separated.  Not so hard after all.