Friday, August 03, 2007

Research Ethics in the UK: The present "system"

This post is inspired in part because of the discussion I am having with James on this post: Distinguishing Audit from Research But it is also inspired by a discussion that I am having over at the Institutional Review Blog an excellent blog by Zachary M. Schrag, Assistant Professor of History, George Mason University focused on the American research ethics system. The particular discussion is whether more general ethics review ought to be preferred to departmental review. As part of this, I have said I would give a general description of the research ethics
"system" (insofar as that is a fair description) here in the UK. I'm also doing this because I want to suggest and discuss a few problems the present system in the UK has, and to do this, first we have to know what the system is. As such this will be a series of posts, like the series on the Human Tissue Act.

Currently much of the research carried out in the UK is unregulated, barring either common law or regulations on specific types of research. Most professional bodies have codes which usually indicate how their members ought to conduct research, but it is up to individual members to follow these.

There are a variety of systems for ethics review in place, ranging from the highly regulated, and well constituted NHS research ethics committees to the unregulated university research ethics sector to private research which often avoids any independent scrutiny. I will now briefly describe each system, then move on to detailing what research requires what review in the next post in this series.

The most rigorous system for review is that in the NHS, which has a national framework detailing operating procedures, REC membership and a common form: Standard Operating Procedures for Research Ethics Committees in the United Kingdom General details can be found here: National Research Ethics Service Presently all applications are reviewed by a full committee, although a system of proportional review is presently being trialled for "low risk" research. Reaching this point of a common system and form has been long and (particularly for researchers) somewhat painful, but it is hard to argue that what we have now isn't considerably better than the mishmash that the UK had 16 years ago.

In contrast what is present in UK universities is a multiplicity of different systems of ethical review, a real mishmash.

Many universities have set up research ethics systems, both due to internal reasons and because of outside drivers such as journals requiring evidence of ethics review and in particular the Economic and Social Research Council requiring that universities funded conform to their Research Ethics Framework

The most comprehensive review of the different systems is University Research Ethics Committees: Their role, remit and conduct a report published in 2004 by Anthea Tinkler and Vera Coomber.

There are basically three broad systems in operation in UK universities.

The first system is a system of review by a central research ethics committee for the university. In principle these will look at all research, but in practice this seems unlikely. According to the report half of the universities with just central committees, reported reviewing between 1-50 pieces of research a year. It would be surprising if this was all that was carried out at these research institutions.

The main alternative is a decentralised model by some School or Faculty based committee. This will often involve particularly ethically complex or worrisome research being reviewed by a higher or central committee.

The third model of ethical scrutiny is some other form of ethical scrutiny which takes a more hands off approach and either includes ethical review as a part of peer review or perhaps by providing ethical training for individual researchers and then trusting the researchers to abide by the principles which they have learned.

In the next post in this series I will indicate when there is regulatory requirements for ethical review and what these entail.


James Wilson said...

Hi david. I think things have moved on a lot since the Tinkler and Coomber report. I suspect that nearly all universities now adopt your second model. (This is in part because it is strongly suggested by the ESRC REF that this is a good model to adopt). My evidence for this is mostly anecdotal: I've trained committees at a dozen or more universities over the past two years, and all of them were (now) operating with this model.

David Hunter said...

Hi James
I am sure you are right, things have moved on, I think for the better since that report. I've still heard of a few universities using the third model quite recently, through a couple of research ethics/research governance mailing lists I am on.

I'm not sure the ESRC REF does push for the 2nd model, at least as many universities seem (again this is anecdotal) to have adopted it.

"Where peer review has confirmed that a research proposal requires full ethical review and approval,this should be carried out by a REC.This needs to be constituted and operate in accordance with the following standards and guidelines.In particular, a REC must have at least one academic member from outside the Department conducting
the research and at least one appropriately trained lay member.If the chair of the REC is also a member of the Department making the proposal, the institution should ensure that this function is performed by another member of the REC for this particular proposal."

It seems hard for delegated RECs to meet that last requirement.

"The need to be independent also has a bearing on where RECs might be located within an institutional structure. Departmental RECs that comprise members from only one discipline or a small number of closely related disciplines may
be regarded as too closely aligned with the interests of researchers. Faculty or school RECs are likely to be multidisciplinary and,apart from the requirement for at least one lay member, could include individuals from outside the
institution as well as those with the requisite skills and experience to evaluate more complex and ambitious research applications. RECs at University level are also likely to be more broadly based,leaving the work of reviewing applications to RECs in schools or departments and to concentrate on policy matters and oversight of the lower-level RECs."

So it depends on where they are located institutionally.

"RECs should be multidisciplinary and comprised of both men and women.They must include at least one lay member from the local community with no affiliation to the university or research institution in question.There must be members who have broad experience of and expertise in the areas of research regularly reviewed by the REC and who
have the confidence and esteem of the research community.At least one member must be knowledgeable in ethics. There must be a chair. RECs would also benefit from including individuals who reflect the ethnic diversity of the local community, users of specialist health, education or social services where these are the focus of research activities, individuals with experience of professional care or counselling and individuals with specific methodological expertise (for example,statistics or qualitative methods) relevant to the research they review."

So they need both a lay person and an ethicist on each committee, fairly hard to have many committees.

I'd love to do some follow up research to see what is presently done, and whether it meets up to the standards in the ESRC REF, my feeling is it is better than it was, but, still not there yet.