Practice

Practice Pointer

Applying for ethical approval for research in the United Kingdom

BMJ 2009; 339 doi: 10.1136/bmj.b4013 (Published 16 October 2009)
Cite this as: BMJ 2009;339:b4013

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  1. A Smajdor, lecturer in ethics 1, vice chair2,
  2. M R Sydes, senior medical statistician 3, statistician 4,
  3. L Gelling, senior research fellow 5, chair 4,
  4. M Wilkinson, consultant pathologist and honorary senior lecturer1, chair 6
  1. 1School of Medicine, Health Policy and Practice, University of East Anglia, Norwich NR4 7TJ
  2. 2Riverside Research Ethics Committee, Charing Cross Hospital, London W6 8RF
  3. 3Cancer Group, MRC Clinical Trials Unit, London NW1 2DA
  4. 4Cambridgeshire 4 Research Ethics Committee, Cambridge CB21 5XB
  5. 5Faculty of Health and Social Care, Anglia Ruskin University, Cambridge CB1 1PT
  6. 6Institute of Health Research Ethics Committee, University of East Anglia
  1. Correspondence to: M Wilkinson mark.wilkinson{at}nnuh.nhs.uk
  • Accepted 10 August 2009

This article offers practical advice on how to expedite the ethical review process.

Applying for ethical review in the United Kingdom can be time consuming and burdensome for researchers.1 2 3 The process can often be made easier by implementing relatively minor changes in the early stages of drawing up the application. In this article we discuss the practicalities of preparing an application for ethical review, and the process by which decisions are made. We offer advice on how to avoid common problems when applying to a research ethics committee and provide information on the integrated research application system, launched in January 2008.

Glossary of useful terms

  • Chief investigator: Person with overall responsibility for the research. All applications for ethical review should be submitted by the chief investigator

  • Clock: Period allowed for the ethical review of a new application or substantial amendment. The clock starts on receipt of a valid application

  • Employing organisation: Organisation employing the chief investigator, other investigators, or research collaborators. Employers remain liable for the work of their employees

  • Integrated research application system (IRAS): Online application system used to apply for most permissions and approvals for research in health and social care in the UK (www.myresearchproject.org.uk/)

  • Local collaborator: Person undertaking certain types of straightforward research not requiring the appointment of a principal investigator and a site specific assessment (see “site specific exemption”). Local collaborators at NHS sites should still seek approval from the research and development office

  • Principal investigator: Person responsible for the local research site in studies with multiple sites

  • Protocol: Document that describes the objectives, design, methodology, statistical considerations (or other methods of data analysis), and organisation of a research study

  • Research site: Organisation or unit responsible for conducting any of the research procedures in a study at a particular locality

  • Site specific assessment: Assessment of the …

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