Those questions that Research Ethics Committees need to know the answers to.
Today an exciting new booklet "Research and Rare Genetic Differences" has been published for members of Research Ethics Committees and medical researchers, by the Genetic Interest Group (GIG) the UK alliance for all people affected by genetic conditions, the Oxford Genetics Knowledge Park and the Ethox Centre at the University of Oxford. This booklet helps to highlight and answer some of the common questions and concerns that Research Ethics Committees (RECs) ask when looking at research proposals relating to genetic disorders. The booklet is available online at http://www.gig.org.uk/gig/docs/GIG-OGKP.pdf or in printed from the addresses below.
Research Ethics Committee (REC) approval is a valuable safeguard for researchers and patients alike. Satisfying a research ethics committee helps to ensure that researchers have thought about the implications and the impact of what they are proposing to do, and so reduces the risk that potentially vulnerable patients will be disadvantaged by their participation in a research study. REC approval provides reassurance to patients and other volunteer participants that the proposed study is ethically sound, thereby maintaining confidence in the integrity of the researcher, and of the study, but also in the process of research itself. In addition to, and as part of, protecting patients, research ethics review facilitates good quality research.
In research into rare inherited disorders, the process of securing Ethics Committee approval for a proposed study can however sometimes prove disproportionately burdensome and this can, in some cases, undermine the viability of good-quality research.
This is particularly the case where such research is funded by patient groups. In the eyes of many such patient groups, who have had to work hard to raise funds to support research into "their" disorder, the bureaucracy of the REC process and, the questions asked by some RECs, can seem inappropriate, appearing to demonstrate either misperception by the REC about why what is proposed is proposed, or the application of an ethics framework more appropriate to a very different kind of research e.g. a large clinical trial, but inappropriate to smaller studies..
To help clarify this situation the Genetic Interest Group (GIG), the UK alliance of charities and support groups for all those with genetic disorders, convened a number of workshops to explore this issue. Resulting from these, a list of "frequently asked questions - FAQ's" emerged that were indicative of the issues which RECs have seemed to find challenging when evaluating proposals.
This booklet has been written to help highlight some of these common questions and concerns that RECs ask when looking at research proposals relating to genetic disorders. The questions that follow reflect ways in which RECs can sometimes misunderstand this area of research and consequently turn down proposals. We hope that this document will help RECs to answer some of these questions.
Professor Mike Parker of ETHOX commented "It is important for the review of medical research to take seriously the full range of ethical implications of such research: these will include not only the protection of the interests of research participants but also the facilitation of high quality, ethical research. This means that the regulatory regime should be as light as possible concomitant with the requirement to ensure quality, appropriate methodology and the protection of research participants. For a variety of reasons research on very rare conditions currently faces disproportionate difficulties when submitted for review by ethics committees. The leaflet we have produced is intended to help to address that problem by informing members of ethics committees about the nature and benefits of such research."
Alastair Kent, Director of the Genetic Interest Group added "When patient support groups have worked hard to raise funds into valuable research into their condition, the current process can be extremely frustrating, and we hope that this new guidance for ethics committees which is long over due will help give RECs insight into the real issues when dealing with rare genetic disorders."
For more information on the Genetics Interest Group, visit their web site at www.gig.org.uk | 
