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.

Srisin Khusmith,Waranya Wongwit,Chanthima Limphattharacharoen,Jaranit Kaewkungwal,Wijitr Fungladda,Warissara Chaiyaphan,Krisana Pengsaa,Pornpimon Adams,Sukanya Prakobtham

doi:10.1186/1472-6939-14-33

Srisin Khusmith, Waranya Wongwit + Show 7 more

Open Access

https://doi.org/10.1186/1472-6939-14-33

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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.

Highlights

Recruiting minorities into research studies requires special attention, 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
Like the outcomes of proposal review in other regions, most studies reviewed at FTM-EC required one round of revision and a few were deferred or not approved
To mitigate problems and avoid unfavorable review outcomes, in studies conducted among vulnerable minority populations, it is recommended that investigators should demonstrate that they have closely considered the necessity of enrolling such populations as well as the benefits of their study to both minority participants and their communities

Summary

Introduction

Recruiting minorities into research studies requires special attention, 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. They have obligations to ensure and protect the rights of study participants, to the society that provides the resources for research, and to researchers, and the obligation to treat their proposals with just consideration and respect [6] The management of these principles, roles, and obligations can be highly complex, and conflict may arise since they are not necessarily complementary or mutually exclusive. Special attention is usually required when study populations are incompetent persons, women (pregnant or not), children, prisoners, refugees, other socio-economically disadvantaged groups, and ethnic minority groups [4,5,7] It becomes even more complex, usually requiring extensive discussion among IRB members, when studies involve participants with multiple vulnerabilities, described as “extra-vulnerable” populations, e.g., pregnant women or the fetuses/neonates of ethnic minorities, children inhabiting refugee camps, or illegal cross-border migrants

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