Abstract

This article provides an overview of recent changes to 45 C.F.R. § 46, the policy that undergirds human-subjects protections in research and that is manifested in institutional review board (IRB) review of research. Originally published in 1991, this policy was updated on January 19, 2017, with the changes set to be implemented in early 2018. This article discusses the unique process of engaging with local IRBs and addresses how updates to federal policy regarding international research may impact service-learning and community-engaged scholarship. Specifically, researchers should be familiar with regulations outside of the United States and engage thoughtfully with the study design process such that IRB submission and review are most effective and expedient. These goals are fortified by considering the updated regulatory framework as justice-oriented.

Highlights

  • This article discusses the unique process of engaging with local institutional review board (IRB) and addresses how updates to federal policy regarding international research may impact service-learning and community-engaged scholarship

  • While institutional review board (IRB) across the United States work toward the compliance date in early 2018, researchers can minimize the impact of this policy change on their research and their partners

  • A U.S.-based researcher working with a co-investigator from another nation—sharing experiences and policies early and often regarding human-subjects protections—will ensure that as the U.S.-based counterpart engages with the IRB review process all needs are accounted for, especially if the co-investigator’s nation has particular concerns

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Summary

Introduction

This article discusses the unique process of engaging with local IRBs and addresses how updates to federal policy regarding international research may impact service-learning and community-engaged scholarship. It outlines some implications these updates may have on individual researchers’ experiences with their local IRBs. Publications like those discussed earlier suggest that service-learning and community engagement researchers are aware of their respective local institutional review board’s oversight.

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