An appraisal of the process of protocol review by an ethics review conmmittee in a tertiary institution in Ibadan.
ABSTRACT It is a well established norm that biomedical research involving human participants must conform to acceptable scientific principles and international codes of research ethics. The University of Ibadan/University College Hospital Health Research Ethics Committee (UI/UCH HREC) is the body that plays an oversight role and performs the function of a third party independent review of research protocols submitted by staff and students of the two institutions. A 6-year (2002-2007) retrospective audit of the protocols submitted to the HREC was performed to determine the profile of the lead investigator, sources of funding for the research and the duration for review using a 25 item questionnaire. A total of 752 protocols were submitted, 618 protocols (82%) were approved while 38 protocols were not approved. The principal investigators were mainly postgraduate students (67.1%) while academic staff constituted 21.3%. The average time from submission to approval was approximately 21 weeks (95% CI: 20-23 weeks). The period from submission to approval is significantly affected by the number of revision required and the funding agent (p < 0.05); it took a shorter time to review internationally funded research.
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ABSTRACT: Recruiting minorities into research studies requires special attention, particularly when studies involve "extra-vulnerable" participants with multiple vulnerabilities, e.g., pregnant women, the fetuses/neonates of ethnic minorities, children in refugee camps, or cross-border migrants. This study retrospectively analyzed submissions to the Ethics Committee of the Faculty of Tropical Medicine (FTM-EC) in Thailand. Issues related to the process and outcomes of proposal review, and the main issues for which clarification/revision were requested on studies, are discussed extensively. The study data were extracted from proposals and amendments submitted to the FTM-EC during the period October 2009 -- September 2012, and then analyzed qualitatively and quantitatively. The main issues for clarification/revision were analyzed by thematic content analysis. 373 proposals were submitted; 44 studies involved minority groups with 21 extra-vulnerable minorities. All clinical and 2/3 of non-clinical studies submitted for initial review underwent full-board review. For combined clinical and non-clinical study submissions, 92.1% were referred back to the investigators and approved after clarification/revision, while 2.7% were deferred due to major/critical changes, and 2.1% not approved due to substantial violations of ethical principles. The main issues needing clarification/revision differed between all studies and those involving minorities: participant information sheet (62.2% vs. 86.4%), informed consent/assent form (51.2% vs. 86.4%), and research methodology (80.7% vs. 84.1%), respectively. The main ethical issues arising during the meetings, regarding studies involving minorities, included ensuring no exploitation, coercion, or pressure on the minority to participate; methodology not affecting their legal status; considering ethnicity and cultural structure; and providing appropriate compensation. Delays in the approval or non-approval of studies involving minorities were mainly due to major or minor deviations from acceptable ethical standards and/or unclear research methodology. The FTM-EC has employed several mechanisms in its operations, including transparency in the review process, building good relationships via open communication with investigators, requesting investigators to consider closely the necessity to enroll minority groups and the risk-benefits for individuals and their communities, and the inclusion of minority-community engagement when developing the proposal. Other effective activities include annual study-site inspections, and offering refresher courses to raise awareness of minority and vulnerability issues among researchers.BMC Medical Ethics 09/2013; 14(1):33. DOI:10.1186/1472-6939-14-33 · 1.60 Impact Factor
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ABSTRACT: Examining the ethics of long-term, career involvement by physicians in global health work is vital, given growing professional interest and potential health implications for communities abroad. However, current literature remains heavily focused on ethical considerations of short-term global health training experiences. A literature review informed our development of an ethics framework centered on two perspectives: the practitioner perspective, further subdivided into extrinsic and intrinsic factors, and community perspectives, specifically that of the host community and the physician's home community. Some physician factors included cultural/linguistic differences, power imbalances, and sustainable skills/competencies. Receiving community factors included resource limitations, standard of care disparities, and community autonomy. Home community factors focused on the opportunity cost of an unavailable physician who was trained and supported by the local community. Descriptive review permitted comparison with existing short-term literature, noting similarities and differences. Our framework provides a basis for further research and critical analysis of ethical implications of career-long physician global health work.Journal of Bioethical Inquiry 02/2015; DOI:10.1007/s11673-014-9591-7 · 0.71 Impact Factor