Thursday, April 14, 2022

Calvin Ho et al on Streamlining Ethics Review for International Health Research (Science)

Published on 24 February 2022
Abstract: International biomedical research, in which projects span borders and engage participants from multiple countries, has increased substantially during the last several decades. Despite the proven value of large, geographically, and ethnically diverse studies, further advancements are being impeded by the burden of submitting separate, and often numerous, applications for research ethics approval in compliance with country-specific laws or varied policy frameworks. To address this, we see promise in applying the international concept of “adequacy,” contained in the European Union (EU) General Data Protection Regulation (GDPR) (1), to ethics review of international health research. We advocate for countries to publish their prior determinations about the adequacy of ethics review requirements in other countries to enable review by one institutional review board (IRB) or comparable body (“single-site” review) in the researcher’s country, streamlining ethics review while safeguarding the welfare of local research participants.

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