Ethics review for international data-intensive research

Type Journal Article Author Edward S. Dove Author David Townend Author Eric M. Meslin Author Martin Bobrow Author Katherine Littler Author Dianne Nicol Author Jantina de Vries Author Anne Junker Author Chiara Garattini Author Jasper Bovenberg Author Mahsa Shabani Author Emmanuelle Lévesque Author Bartha M. Knoppers URL http://science.sciencemag.org/content/351/6280/1399 Rights Copyright © 2016, American Association for the Advancement of Science Volume 351 Issue 6280 Pages 1399-1400 Publication Science ISSN 0036-8075, 1095-9203 Date 2016/03/25 Extra 00000 PMID: 27013718 DOI 10.1126/science.aad5269 Accessed 2016-04-14 20:04:18 Library Catalog science.sciencemag.org Language en Abstract Historically, research ethics committees (RECs) have been guided by ethical principles regarding human experimentation intended to protect participants from physical harms and to provide assurance as to their interests and welfare. But research that analyzes large aggregate data sets, possibly including detailed clinical and genomic information of individuals, may require different assessment. At the same time, growth in international data-sharing collaborations adds stress to a system already under fire for subjecting multisite research to replicate ethics reviews, which can inhibit research without improving the quality of human subjects' protections (1, 2). “Top-down” national regulatory approaches exist for ethics review across multiple sites in domestic research projects [e.g., United States (3, 4), Canada (5), United Kingdom, (6), Australia (7)], but their applicability for data-intensive international research has not been considered. Stakeholders around the world have thus been developing “bottom-up” solutions. We scrutinize five such ef orts involving multiple countries around the world, including resource-poor settings (table S1), to identify models that could inform a framework for mutual recognition of international ethics review (i.e., the acceptance by RECs of the outcome of each other's review). Ad hoc approaches mix and match existing components Ad hoc approaches mix and match existing components