Ethical issues in research involving minority populations: the process and outcomes of protocol review by the Ethics Committee of the Faculty of Tropical Medicine, Mahidol University, Thailand

Abstract

BackgroundRecruiting 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.MethodsThe 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.Results373 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.ConclusionDelays 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.

Risk Assessment of Medical Study Procedures in the Documents Submitted to a Research Ethics Committee

“…Inadequately described risks of study procedures have been reported to be one of the most common reasons why RECs request clarifications or demand amendments to research protocols and participant information sheets ( Adams et al, 2013 ; Dal-Re et al, 2004 ; Lopez-Parra et al, 2012 ; Happo et al, 2017 ), and our present findings are in line with these observations. However, there is still limited knowledge as to why researchers appear to focus on the presentation of certain potential study procedures risks more than others.…”

“…If a study protocol does not provide sufficient information to the REC about the risks inherent in the proposed study, the risk assessment may be conducted subjectively or have to be based on intuition ( Resnik, 2017 ). Moreover, incomplete risk descriptions may also lead to a delayed handling of the application because the REC may need to ask for clarifications regarding the possible risks ( Adams et al, 2013 ; Resnik, 2017 ; Happo et al, 2017 ).…”

Is Your Ethics Committee Efficient? Using “IRB Metrics” as a Self-Assessment Tool for Continuous Improvement at the Faculty of Tropical Medicine, Mahidol University, Thailand

“…Research methodology is another issue discussed and explained to researchers. A previous study conducted by FTM-EC, regarding the approval or non-approval of studies involving minorities, reported that one reason for non-approval was unclear research methodology [58] . The IRB Metrics results also indicate that the importance of research methodology is not research design per se , but rather sample size, data and specimen collection, inclusion-exclusion criteria, and confidentiality and privacy.…”

The effect of study type on research ethics committees’ queries in medical studies

“…Evaluation processes of RECs can be analysed through assessment of their decision documents. In this connection, study methods, such as selection and recruitment of subjects, along with statistics, have been reported to be the key subjects of queries made or amendments requested by RECs (Adams et al, 2013; Angell et al, 2008; Boyce et al, 2002; Bueno et al, 2009; Dal-Re et al, 1999; Kent, 1999; Lutz et al, 2012; Mansbach et al, 2007; Martín-Arribas et al, 2012; van Lent et al, 2014). Studies involving vulnerable groups, such as minors, often prompt certain queries (Adams et al, 2013; Lidz et al, 2012; Martín-Arribas et al, 2012).…”