Hostname: page-component-78c5997874-t5tsf Total loading time: 0 Render date: 2024-11-02T20:39:56.519Z Has data issue: false hasContentIssue false
  • English
  • Français

Differences between research ethics committees

Published online by Cambridge University Press:  18 January 2007

Sarah J. L. Edwards ,
Tracey Stone  and
Teresa Swift
Sarah J. L. Edwards
Affiliation:
University College London/University of College London Hospitals
Tracey Stone
Affiliation:
University of Bristol
Teresa Swift
Affiliation:
University of Bristol
Get access Rights & Permissions [Opens in a new window]

Abstract

Objectives: To examine differences in the ethical judgments made by Research Ethics Committees (RECs) or Institutional Review Boards (IRBs).

Methods: We did a review of the literature and included any study that attempted to compare the ethical judgments made by different RECs or IRBs when reviewing one or more protocol.

Results: There were twenty-six articles reporting such discrepancies across Europe, within the United Kingdom, Spain, and United States. Of these studies, there were only five reports of some RECs approving while others rejecting the same protocol. All studies, however, reported differences in the clarifications and revisions asked of researchers regarding consent, recruitment, risks and benefits, compensation arrangements, and scientific issues.

Conclusions: The studies were generally anecdotal reports of researchers trying to do research. New rules requiring a single ethical opinion for multi-site research at least in European Member States may simply conceal problematic issues in REC decision making. In the last analysis, we should expect a certain degree of variation and differences if we are to keep a committee system of review, although there is a pressing need to investigate the way in which RECs make these judgments. In particular, we need to identify the source of any aberrations, distortions, or confusions that could arbitrarily affect these judgments. Furthermore, local conditions remain important ethical considerations and should not be sidelined in pursuit of greater “consistency.”

Keywords

Research ethics committeeEthics committeeEthics reviewInstitutional review boardResearch ethics
Type
GENERAL ESSAYS
Information
International Journal of Technology Assessment in Health Care , Volume 23 , Issue 1 , January 2007 , pp. 17 - 23
Copyright
© 2007 Cambridge University Press

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Ah-See KW, MacKenzie J, Thakker NS, Maran AG. 1998 Local research ethics committee approval for a national study in Scotland. J R Coll Surg Edinb. 43: 303– 305.Google Scholar
Ahmed AH, Nicholson KG. 1996 Delays and diversity in the practice of local research ethics committees. J Med Ethics. 22: 263– 266.Google Scholar
al-Shahi R, Warlow CP. 1999 Ethical review of a multicentre study in Scotland: A weighty problem. J R Coll Physicians Lond. 33: 549– 552.Google Scholar
Black M, Leese B, Gosden T. 1995 Local research ethics committees. Differences in application process cause problems. BMJ. 311: 1572.Google Scholar
Burman W, Breese P, Weis S, etal. The effects of local review on informed consent documents from a multicenter clinical trial consortium Soc Sci Med. 2003; 24: 245– 255.Google Scholar
Busby A, Dolk H. 1998 Local research ethics committees' approval in a national population study. J R Coll Physicians Lond. 32: 142– 145.Google Scholar
Clark S, Pelletier AJ, Brenner BE, et al. 2006 Feasibility of a national fatal asthma registry: More evidence of IRB variation in evaluation of a standard protocol. J Asthma. 43: 19– 23.Google Scholar
Cohen A, Dolan B, Eastman N. 1996 Research on the supervision registers: Inconsistencies in local research ethics committee responses. J Forensic Psychiatry. 7: 413– 419.Google Scholar
Dal-Re R, Espada J, Ortega R. 1999 Performance of research ethics committees in Spain. A prospective study of 100 applications for clinical trial protocols on medicines. J Med Ethics. 25: 268– 273.Google Scholar
Department of Health, 2002. Report of the ad hoc advisory group on the operation of NHS research ethics committees. Available at: www.corec.org.uk/public/index.htm.
Department of Health, UK. 2001. Governance arrangements for NHS research ethics committees. Research governance framework for health and social care. Available at: http://www.doh.gov.uk/research.
Department of Health, UK. 2001. Governance arrangements for NHS research ethics committees. Section 7.3 states that standard operating procedures shall be compatible with European and UK law. Available at: www.dh.gov.uk/assetRoot/04/05/86/09/04058609.pdf.
Department of Health and Human Services National Institutes of Health. Part 46 Protection of Human Subjects. Code of Federal regulations, Title 45 Public Welfare. Department of Health and Human Services National Institutes of Health. Office for Protection from Research Risks, 2001. Available at: www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm.
Edwards SJL, Ashcrodt R, Kirchin S. 2004 Research ethics committees: Differences and moral judgement. Bioethics. 18: 408– 427.Google Scholar
European Forum for Good Clinical Practice. Guidelines and recommendations for European ethics committees, 1997. Available at: http://www.efgcp.org/.
European Parliament and of the Council of Europe. Directive 2001/20/EC on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. Available at: http://europa.eu.int/ This piece of legislation was influenced by international guidelines adopted by some US, European and Japanese Pharmaceutical Industries and regulatory authorities. International Conference on Harmonisation of Good Clinical Practice. General Considerations for Clinical Trials. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Tripartite Guideline. 1997. Available at: http://www.ifpma.org/ich1.html.
Garfield P. 1995 Cross district comparison of applications to research ethics committees. BMJ. 311: 660– 661.Google Scholar
Green LA, Lowery JC, Kowalski CP, Wyszewianski L. 2006 Impact of institutional review board practice variation on observational health services research. Health Serv Res. 41: 214– 230.Google Scholar
Goldman J, Katz MD. 1982 Inconsistency and institutional review boards. JAMA. 248: 197– 202.Google Scholar
Harding T, Ummel M. 1989 Evaluating the work of ethical review committees: An observation and a suggestion. J Med Ethics. 15: 191– 194.Google Scholar
Harries UJ, Fentem PH, Tuxworth W, Hoinville GW. 1994 Local research ethics committees. Widely differing responses to a national survey protocol. J R Coll Physicians Lond. 28: 150– 154.Google Scholar
Hearnshaw H. 2004 Comparison of requirements of research ethics committees in 11 European countries for a non-invasive interventional study. BMJ. 328: 140– 141.Google Scholar
Hirshon JM, Krugman SD, Witting MD, et al. 2002 Variability in institutional review board assessment of minimal risk research. Acad Emerg Med. 9: 1417– 1420.Google Scholar
Kent G. 1999 Responses by four local research ethics committees to submitted proposals. J Med Ethics. 25: 274– 277.Google Scholar
Lewis JC, Tomkins S, Sampson JR. 2001 Ethical approval for research involving geographically dispersed subjects: Unsuitability of the UK MREC/LREC system and relevance to uncommon genetic disorders. J Med Ethics. 27: 347– 351.Google Scholar
Lux AL, Edwards SW, Osborne JP. Responses of local research ethics committees to a study with approval from a multicentre research ethics committee. BMJ. 2000 29; 320: 1182– 1183.Google Scholar
Middle C, Johnson A, Petty T, Sims L, Macfarlane A. 1995 Ethics approval for a national postal survey: Recent experience. BMJ. 311: 659– 660.Google Scholar
Penn ZJ, Steer PJ. 1995 Local research ethics committees: Hindrance or help? Br J Obstet Gynaecol. 102: 1– 2.Google Scholar
Redshaw ME, Harris A, Baum JD. 1996 Research ethics committee audit: Differences between committees. J Med Ethics. 22: 78– 82.Google Scholar
Rogers AS, Schwartz DF, Weissman G, English A. 1999 Adolescent Medicine HIV/AIDS Research Network. A case study in adolescent participation in clinical research: Eleven clinical sites, one common protocol, and eleven IRBs. IRB. 21: 6– 10.Google Scholar
Stair TO, Reed CR, Radeos MS, Koski G, Camargo CA. 2001 Variation in Institutional Review Board Response to a Standard Protocol for a Multicenter Clinical Trial. Acad Emerg Med. 8: 636– 641.Google Scholar
Tully J, Ninis N, Booy R, Viner R. 2000 The new system of review by multicentre research ethics committees: Prospective study. BMJ. 320: 1179– 1182.Google Scholar
Vick CC, Finan KR, Kiefe C, Neumayer L, Hawn MT. 2005 Variation in institutional review processes for a multisite observational study. Am J Surg. 190: 805– 809.Google Scholar
While AE. 1996 Research ethics committees at work: The experience of one multi-location study. J Med Ethics. 22: 352– 355.Google Scholar
World Health Organization. Operational guidelines for ethics committees that review biomedical research, 2000. Available at: http://www.who.int/tdr/publications/publications/ethics.htm.
World Medical Association. 2000. Declaration of Helsinki. 52nd General Assembly, Edinburgh,