How Do We Know that Research Ethics Committees are Really Working? The Neglected Role of Outcomes Assessment in Research Ethics Review

BMC Medical Ethics, Vol. 9, No. 6, 2008

Seton Hall Public Law Research Paper No. 1114564

23 Pages Posted: 30 Mar 2008

See all articles by Carl H. Coleman

Carl H. Coleman

Seton Hall University School of Law

Marie Charlotte Bouesseau

Department of Ethics, Equity, Trade & Human Rights

Abstract

Countries are increasingly devoting significant resources to creating or strengthening research ethics committees (RECs) to review research involving human participants, but there has been insufficient attention to assessing whether these committees actually provide significant benefits to research participants or their communities. This article examines the obstacles RECs face in achieving their goals and the strengths and limitations of existing methods to assess RECs' effectiveness. It then proposes specific mechanisms for incorporating outcomes-oriented questions into the process of REC oversight.

Keywords: research, health, medicine, ethics, developing countries, accreditation, quality assurance, outcomes assessment

Suggested Citation

Coleman, Carl H. and Bouesseau, Marie Charlotte, How Do We Know that Research Ethics Committees are Really Working? The Neglected Role of Outcomes Assessment in Research Ethics Review. BMC Medical Ethics, Vol. 9, No. 6, 2008 ; Seton Hall Public Law Research Paper No. 1114564. Available at SSRN: https://ssrn.com/abstract=1114564

Carl H. Coleman (Contact Author)

Seton Hall University School of Law ( email )

One Newark Center
Newark, NJ 07102-5210
United States
201-204-9512 (Phone)
973-642-8194 (Fax)

HOME PAGE: http://law.shu.edu/Faculty/fulltime_faculty/Carl-Coleman.cfm

Marie Charlotte Bouesseau

Department of Ethics, Equity, Trade & Human Rights ( email )

20 Avenue Appia
Geneva 27, CH-1211
Switzerland

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