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Is 'inconsistency' in research ethics committee decision-making really a problem? An empirical investigation and reflection

By Emma L. Angell, C. J. Jackson, R. E. Ashcroft, A. Bryman, K. Windridge and Mary Dixon-Woods

Abstract

Research Ethics Committees (RECs) are frequently a focus of complaints from researchers, but evidence about the operation and decisions of RECs tends to be anecdotal. We conducted a systematic study to identify and compare the ethical issues raised in 54 letters to researchers about the same 18 applications submitted to three RECs over one year. The most common type of ethical trouble identified in REC letters related to informed consent, followed by scientific design and conduct, care and protection of research participants, confidentiality, recruitment and documentation. Community considerations were least frequently raised. There was evidence of variability in the ethical troubles identified and the remedies recommended. This analysis suggests that some principles may be more institutionalized than others, and offers some evidence of inconsistency between RECs. Inconsistency is often treated as evidence of incompetence and caprice, but a more sophisticated understanding of the role of RECs and their functioning is required

Publisher: Royal Society of Medicine Press
Year: 2007
DOI identifier: 10.1258/147775007781029500
OAI identifier: oai:lra.le.ac.uk:2381/9495
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  1. A plea for consistency in ethical review. doi
  2. (1995). Are ethical committees reliable?.
  3. Centrality in sociocognitive networks and social influence: an illustration in a group decision-making context. J Pers Soc Psychol 1997;73:296- doi
  4. Comparison of requirements of research ethics committees in 11 European countries for a non-invasive interventional study. doi
  5. (2006). Consistency in research ethics committee decision-making: a controlled comparison. doi
  6. (1969). Content Analysis for the Social Sciences and Humanities. doi
  7. Diffusion of innovations in service organizations: systematic review and recommendations. doi
  8. Ethics review roulette: what can we learn?. doi
  9. (2004). Ethnographic content analysis. In: Lewis doi
  10. (2006). Governance Arrangements for Research Ethics Committees (GAfREC). Available at: http://www.dh.gov.uk/assetRoot/04/05/86/09/04058609.pdf.
  11. (2005). Health. Report of the ad hoc advisory group on the operation of NHS research ethics committees. London: Department of Health; doi
  12. International variation in ethics committee requirements: comparisons across five Westernised nations.
  13. (2006). Operating Procedures for Research Ethics Committees. Available at: http://www.corec.org.uk/applicants/help/docs/SOPs.doc.
  14. (1996). Qualitative Media Analysis. Thousand Oaks, doi
  15. Research ethics committees: differences and moral judgement. doi
  16. (1968). Social theory and social structure. doi
  17. (2003). The ethics and governance of medical research: what does regulation have to do with morality?. New Rev Bioeth doi
  18. (2001). The European Parliament and the Council of the European Union. Directive 2001/20/EC of the European Parliament and of the council of 4 doi
  19. (1959). The Presentation of Self in Everyday Life. doi
  20. (1991). The Reflective Practitioner : How Professionals Think in Action. doi
  21. (2005). Why do women consent to surgery, even when they do not want to? An interactionist and Bourdieusian analysis. Soc Sci Med doi

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