Research Ethics Committee and when ethics goes wrong

Posted on Sep 23, 2011 by Leslie Gelling in Ethics

On Thursday it was my privilege to chair an NHS Research Ethics Committee (REC). These meetings usually involve many mixed emotions for both the researchers and the members of the committee. Researchers often find it hard to hide their joy and relief when they are informed that a provisional favourable opinion is heading their way. Delight is unbounded when a favourable opinion is offered. Although I have never been present when notification of an unfavourable opinion is delivered, I have no doubt that emotions will include disbelief, despair, frustration and no small amount of anger.

Research Ethics Committee members take great pride in the service they offer researchers, potential research participants, including research nurses, and society – but they also experience similar emotional extremes. There is considerable pleasure in issuing a favourable opinion and some frustration when issuing an unfavourable opinion, especially when there is some value in the research. This week’s Research Ethics Committee meeting included all of these emotions.

So what three simple things could researchers do to increase the positive and to reduce the negative?

Get the participant information sheet (PIS) right. It is common practice for Research Ethics Committee members to begin their review by reading the PIS. If they find it hard to read, can’t understand what the research is about or aren’t sure what participation will involve, then there is a problem. Unfortunately researchers are probably the last people in the world who should be trying to write a PIS in a language that the average lay person will understand. The best PIS are written with the involvement of patients and support groups who can highlight for researchers the incomprehensible sentences. It is also more difficult for Research Ethics Committees to question the readability of a PIS if patients have been involved its development.
Answer the questions. This might sound like an extraordinary statement but it is extremely common for long and detailed responses to fail to answer the question asked. The result is that the Research Ethics Committee often doesn’t have the information required to form a reasoned opinion about the proposed research. The outcome for researchers can be long post-review letters with multiple questions which should have been addressed in the application.
Attend the meeting. Researchers have often been planning their research and working on their ethics application for weeks or even months. On occasion the research is part of a larger programme of research lasting many years. In contrast, the Research Ethics Committee members are faced with between 6 and 8 new, and sometimes extremely complex, applications every month with about a week to read and absorb the many pages of each application. If researchers and research nurses are able to attend the meeting they can ensure that the Research Ethics Committee has the clearest possible understanding of the research and what it will involve for participants. The presence of researchers and research nurses can, in some instances change the Research Ethics Committees initial decision but researchers should try to avoid beginning their response to a question with ‘As it states on page 252 of the protocol …’.

Researchers and Research Ethics Committees have much more in common than is sometimes suggested. Researchers want to undertake high quality research that will make a real difference to people’s lives and Research Ethics Committees want to support that research. If researchers and research nurses were to address the above three points it should make the ethical review process easier and a more positive experience for all involved.