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Conducting human challenge studies in LMICs: A survey of
researchers and ethics committee members in Thailand
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File Size: 931 KB Simultaneous Device Usage: Unlimited Publication Date: March 20, 2020 Sold
by: Amazon.com Services LLC Language: English ASIN: B0866HDHW2 Text-to-Speech: Enabled X-Ray:
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Book Description
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.

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