Research ethics paperwork: what is the plot we seem to have lost?

The standardisation of applications to local research ethics committees seems likely to make ethical approval less efficient and more time consuming for everyone Researchers in the United Kingdom now have to submit their study proposals to local research ethics committees using a nationally standardised form. The form overcomes the problem of inconsistencies in the paperwork required by different committees.1 2 It is incredibly long, however, and threatens to overwhelm both committees and investigators with paperwork.2–4 The administrative burden is likely to be increased by the advent of a research management and governance framework for health and social care5 and the requirement for ethical clearance for all research by students on humans, including their tissues or data.6 Current trends are not sustainable in terms of time, money, or their impact on the environment, and it seems we have lost the plot. In this article, I examine how we can streamline the process. The first step is to determine the essential information required for ethical approval. Based on my experience as a member of three ethics committees in two countries, I think that members ask themselves four basic questions:

[1]  C. Warlow,et al.  Ethical Review of a Multicentre Study in Scotland: A Weighty Problem , 1999, Journal of the Royal College of Physicians of London.

[2]  N. Maskell,et al.  Variations in experience in obtaining local ethical approval for participation in a multi-centre study. , 2003, QJM : monthly journal of the Association of Physicians.

[3]  N. Dunn,et al.  Costs of seeking ethics approval before and after the introduction of multicentre research ethics committees , 2000, Journal of the Royal Society of Medicine.

[4]  K. Jamrozik The case for a new system for oversight of research on human subjects , 2000, Journal of medical ethics.

[5]  N. Thakker,et al.  Local research ethics committee approval for a national study in Scotland. , 1998, Journal of the Royal College of Surgeons of Edinburgh.

[6]  Marc Taylor,et al.  Research governance framework for health and social care. , 2002, Health & social care in the community.