Conducting human challenge studies in LMICs: A survey of researchers and ethics committee members in Thailand

Autoři: Jaranit Kaewkungwal aff001;  Pornpimon Adams aff002;  Jetsumon Sattabongkot aff003;  Reidar K. Lie aff004;  David Wendler aff005
Působiště autorů: Department of Tropical Hygiene, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand aff001;  Office of Research Services, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand aff002;  Mahidol Vivax Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand aff003;  Department of Philosophy, University of Bergen, Bergen, Norway aff004;  Department of Bioethics, National Institutes of Health Clinical Center, National Institutes of Health, Bethesda, Maryland, United States of America aff005
Vyšlo v časopise: PLoS ONE 14(10)
Kategorie: Research Article
doi: 10.1371/journal.pone.0223619


Questions have been raised over the acceptability of conducting human challenge studies in low and middle income countries (LMICs). Most of these concerns are based on theoretical considerations and there exists little data on the attitudes of stakeholders in these countries. This study examines the view of researchers and REC members in Thailand regarding the design and conduct of challenge studies in the country. A questionnaire was developed based on ethical frameworks for human challenge studies. The target respondents included those who had experience with health-related research at universities, non-university hospitals, and research institutes. A total of 240 respondents completed the on-line survey. In general, the respondents felt that the ethical issues raised by human challenge studies in LMICS do not differ significantly from those in high income countries, including: scientific rationale, safety, appropriate risks, and robust informed consent process. In contrast, issues that have been described as important for human challenge studies in LMICs were rated as having lower importance, including: a publicly available rationale, national priority, and community engagement. Responses did not vary significantly between researchers in different fields, nor between researchers and REC members. These findings provide an important perspective for assessing existing frameworks for human challenges studies in LMICs.

Klíčová slova:

Clinical research design – Quality assurance – Quality control – Questionnaires – Social research – Survey research – Surveys – Thailand


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Článek vyšel v časopise


2019 Číslo 10