Publication: 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.
Accepted Date
2013-09-09
Issued Date
2013-09-11
Copyright Date
2013
Resource Type
Language
eng
ISSN
1472-6939 (electronic)
Rights Holder(s)
BioMed Central
Bibliographic Citation
Adams P, Wongwit W, Pengsaa K, Khusmith S, Fungladda W, Chaiyaphan W. et al. 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. BMC Med Ethics. 2013 Sep 11;14:33.
Suggested Citation
Pornpimon Adams, พรพิมล อดัมส์, Waranya Wongwit, วรัญญา ว่องวิทย์, Krisana Pengsaa, กฤษณา เพ็งสา, Srisin Khusmith, ศรีสิน คูสมิทธิ์, Wijitr Fungladda, วิจิตร ฟุ้งลัดดา, Warissara Chaiyaphan, วริสรา ไชยพันธุ์, Chanthima Limphattharacharoen, จันทิมา ลิ่มภัทรเจริญ, Sukanya Prakobtham, สุกัญญา ประกอบธรรม, Jaranit Kaewkungwal, จรณิต แก้วกังวาน 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.. Adams P, Wongwit W, Pengsaa K, Khusmith S, Fungladda W, Chaiyaphan W. et al. 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. BMC Med Ethics. 2013 Sep 11;14:33.. doi:10.1186/1472-6939-14-33. Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/853
Research Projects
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Thesis
Title
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.
Author(s)
Pornpimon Adams
พรพิมล อดัมส์
Waranya Wongwit
วรัญญา ว่องวิทย์
Krisana Pengsaa
กฤษณา เพ็งสา
Srisin Khusmith
ศรีสิน คูสมิทธิ์
Wijitr Fungladda
วิจิตร ฟุ้งลัดดา
Warissara Chaiyaphan
วริสรา ไชยพันธุ์
Chanthima Limphattharacharoen
จันทิมา ลิ่มภัทรเจริญ
Sukanya Prakobtham
สุกัญญา ประกอบธรรม
Jaranit Kaewkungwal
จรณิต แก้วกังวาน
พรพิมล อดัมส์
Waranya Wongwit
วรัญญา ว่องวิทย์
Krisana Pengsaa
กฤษณา เพ็งสา
Srisin Khusmith
ศรีสิน คูสมิทธิ์
Wijitr Fungladda
วิจิตร ฟุ้งลัดดา
Warissara Chaiyaphan
วริสรา ไชยพันธุ์
Chanthima Limphattharacharoen
จันทิมา ลิ่มภัทรเจริญ
Sukanya Prakobtham
สุกัญญา ประกอบธรรม
Jaranit Kaewkungwal
จรณิต แก้วกังวาน
Corresponding Author(s)
Other Contributor(s)
Mahidol University. Faculty of Tropical Medicine. Office of Research Services.
Mahidol University. Faculty of Tropical Medicine. Department of Social and Environmental Medicine.
Mahidol University. Faculty of Tropical Medicine. Department of Tropical Pediatrics.
Mahidol University. Faculty of Tropical Medicine. Department of Microbiology and Immunology.
Mahidol University. Faculty of Tropical Medicine. Department of Tropical Hygiene.
Mahidol University. Faculty of Tropical Medicine. Department of Social and Environmental Medicine.
Mahidol University. Faculty of Tropical Medicine. Department of Tropical Pediatrics.
Mahidol University. Faculty of Tropical Medicine. Department of Microbiology and Immunology.
Mahidol University. Faculty of Tropical Medicine. Department of Tropical Hygiene.
Abstract
BACKGROUND: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSION: 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.