Research protocols: Lessons from ethical review

Jelsma, Jennifer; Singh, Shajila

Research protocols: Lessons from ethical review

Journal Article

2005

Journal Title

South African Medical Journal

Link to Journal

http://www.samj.org.za

Publisher

University of Cape Town

Department

Division of Physiotherapy

Faculty

Faculty of Health Sciences

Abstract

The aim of this study was to document the decisions made by the University of Cape Town (UCT) Research Ethics Committee (REC) and to identify the reasons for rejection or acceptance of protocols subject to additional requirements/conditions. Identifying ethical problems that are grounds for rejection of protocols can assist in educating researchers on these issues and facilitate the implementation of well-designed, socially valuable research. The establishment and support of human RECs is considered a major priority by the Secretary General of the Council for International Organizations of Medical Sciences (CIOMS).1 The terms of reference of RECs require the boards 'to review and recommend modification, if needed, of research protocols, to reject irresponsible protocols and to monitor ongoing projects'.2 The UCT REC currently reviews 300 - 400 research protocols per year originating from UCT or affiliated hospitals. UCT has not previously documented the number and nature of protocol acceptances and provisional and absolute rejections by its REC. Similar studies have been conducted elsewhere but there are few research overviews of REC stipulations in the literature.3 Audits of practice can provide useful information to institutions and researchers3 and result in a reduction in approval time.4 They can also assist academic institutions in monitoring their faculty research priorities.

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