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

doi:10.1136/bmj.329.7460.286

BMJ 2004;329:286-287 (31 July), doi:10.1136/bmj.329.7460.286

Education and debate

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

Konrad Jamrozik, professor¹

¹ Department of Primary Care and Social Medicine, Imperial College, London W6 8RP jamrozik@imperial.ac.uk

The standardisation of applications to local research ethicscommittees seems likely to make ethical approval less efficientand more time consuming for everyone

The first 150 words of the full text of this article appear below.

Introduction

Researchers in the United Kingdom now have to submit their studyproposals to local research ethics committees using a nationallystandardised form. The form overcomes the problem of inconsistenciesin the paperwork required by different committees.^1
2 It isincredibly long, however, and threatens to overwhelm both committeesand investigators with paperwork.^2-4 The administrative burdenis likely to be increased by the advent of a research managementand governance framework for health and social care⁵ and therequirement for ethical clearance for all research by studentson humans, including their tissues or data.⁶ Current trendsare not sustainable in terms of time, money, or their impacton the environment, and it seems we have lost the plot. In thisarticle, I examine how we can streamline the process.

Basics of ethical review

The first step is to determine the essential information requiredfor ethical approval. Based on my experience as a member ofthree ethics . . . [Full text of this article]

What are the hazards?

Reducing the hazards

Strategies to minimise the realisation of risks

-->

Proportionality between risks and potential gains

Improving applications

CiteULike

Complore

Connotea

Del.icio.us Add to Digg

Digg

StumbleUpon Add to Technorati

Technorati What's this?

Relevant Articles

Regulation—the real threat to clinical research: Paul M Stewart, Anna Stears, Jeremy W Tomlinson, and Morris J Brown
BMJ 2008 337: a1732. [Extract] [Full Text]

NHS research ethics committees: Louise Robinson, Deborah Murdoch-Eaton, and Yvonne Carter
BMJ 2007 335: 6. [Extract] [Full Text] [PDF]

Ethics and research governance in a multicentre study: add 150 days to your study protocol: Glyn Elwyn, Anne Seagrove, Kym Thorne, and Wai Yee Cheung
BMJ 2005 330: 847. [Extract] [Full Text]

Advisory group to review NHS research ethics committees: Susan Mayor
BMJ 2004 329: 1258. [Extract] [Full Text]

Research bureaucracy in the United Kingdom: Seeking a balance: response from the Department of Health and COREC: John Pattison and Terry Stacey
BMJ 2004 329: 622. [Extract] [Full Text] [PDF]

Research bureaucracy in the United Kingdom: Ethics committees have important roles in research: David A Walsh and Michael Hewitt
BMJ 2004 329: 623. [Extract] [Full Text]

Research bureaucracy in the United Kingdom: Practical example illustrates problems of ethical review of genetics: Patrick Morrison
BMJ 2004 329: 624. [Extract] [Full Text]

New ethics committee regulations hinder research
BMJ 2004 329: 0. [Full Text] [PDF]

My last choice: Richard Smith
BMJ 2004 329: 0. [Extract] [Full Text] [PDF]

Campaign to revitalise academic medicine: Don't believe us: David L Sackett
BMJ 2004 329: 294. [Extract] [Full Text]

Campaign to revitalise academic medicine: Is the bubble due to burst for medical research funding?: Bruce G Charlton and Peter Andras
BMJ 2004 329: 294. [Extract] [Full Text]

This article has been cited by other articles:

Davies, H, Wells, F, Czarkowski, M (2009). Standards for research ethics committees: purpose, problems and the possibilities of other approaches. J. Med. Ethics 35: 382-383 [Abstract] [Full text]
Angell, E, Dixon-Woods, M (2009). Do research ethics committees identify process errors in applications for ethical approval?. J. Med. Ethics 35: 130-132 [Abstract] [Full text]
Stewart, P. M, Stears, A., Tomlinson, J. W, Brown, M. J (2008). Regulation--the real threat to clinical research. BMJ 337: a1732-a1732 [Full text]
Hallowell, N., Cooke, S., Crawford, G., Parker, M., Lucassen, A. (2008). Ethics and research governance: the views of researchers, health-care professionals and other stakeholders. Clin Ethics 3: 85-90 [Abstract] [Full text]
Hackshaw, A., Farrant, H., Bulley, S., Seckl, M. J, Ledermann, J. A (2008). Setting up non-commercial clinical trials takes too long in the UK: findings from a prospective study. JRSM 101: 299-304 [Abstract] [Full text]
Arshad, A, Arkwright, P D (2008). Status of healthcare studies submitted to UK research ethics committees for approval in 2004-5. J. Med. Ethics 34: 393-395 [Abstract] [Full text]
Richardson, S., McMullan, M. (2007). Research Ethics in the UK: What Can Sociology Learn from Health?. Sociology 41: 1115-1132 [Abstract]
Robinson, L., Murdoch-Eaton, D., Carter, Y. (2007). NHS research ethics committees. BMJ 335: 6-6 [Full text]
Wade, D. (2007). Ethics of collecting and using healthcare data. BMJ 334: 1330-1331 [Full text]
Califf, R. M (2006). Clinical trials bureaucracy: unintended consequences of well-intentioned policy. Clin Trials 3: 496-502 [Abstract]
Sheard, L, Tompkins, C N E, Wright, N M J, Adams, C E (2006). Non-commercial clinical trials of a medicinal product: can they survive the current process of research approvals in the UK?. J. Med. Ethics 32: 430-434 [Abstract] [Full text]
Al-Shahi, R. (2005). Research ethics committees in the UK--the pressure is now on research and development departments. JRSM 98: 444-447 [Full text]
Elwyn, G., Seagrove, A., Thorne, K., Cheung, W. Y. (2005). Ethics and research governance in a multicentre study: add 150 days to your study protocol. BMJ 330: 847-847 [Full text]
Abbasi, K., Heath, I. (2005). Ethics review of research and audit. BMJ 330: 431-432 [Full text]
Wade, D. T (2005). Ethics, audit, and research: all shades of grey. BMJ 330: 468-471 [Full text]
Pattison, J., Stacey, T. (2004). Research bureaucracy in the United Kingdom: Seeking a balance: response from the Department of Health and COREC. BMJ 329: 622-622 [Full text]
Walsh, D. A, Hewitt, M. (2004). Research bureaucracy in the United Kingdom: Ethics committees have important roles in research. BMJ 329: 623-623 [Full text]
Morrison, P. (2004). Research bureaucracy in the United Kingdom: Practical example illustrates problems of ethical review of genetics. BMJ 329: 624-624 [Full text]
Warlow, C. (2004). Clinical research under the cosh again. BMJ 329: 241-242 [Full text]

Rapid Responses:

Read all Rapid Responses

Researchers concerns must be taken seriously: Sarah E Lamb
bmj.com, 30 Jul 2004 [Full text]
Drowning in bureaucracy: Adrian A Boyle
bmj.com, 3 Aug 2004 [Full text]
Ethics Committees - the Investigator's View: John Ham
bmj.com, 3 Aug 2004 [Full text]
Ethics committees play important roles in research: David A Walsh, et al.
bmj.com, 4 Aug 2004 [Full text]
Please don't shoot the messenger!: The Revd Dr B Clark
bmj.com, 5 Aug 2004 [Full text]
Gender perspective as an ethical issue: �va R�sky, et al.
bmj.com, 25 Aug 2004 [Full text]