Exemptions and Limited Institutional Review Board Review: A Practical Look at the 2018 Common Rule Requirements for Exempt Research.

Amelia Walch-Patterson

doi:10.31486/toj.19.0095

Abstract

Background: The revised Common Rule sought to modernize an outdated regulatory framework, provide clarity to the research community about the application of regulations, and reduce regulatory burden. From the advance notice of proposed rulemaking in 2011 to the implementation of the Final Rule, a significant amount of commentary and opinion was generated about the rules that govern most federally funded human subjects research.Methods: This article provides insight into the changes to the regulatory framework for low-risk research, clarifies when exemptions can be applied, and explains the use of limited institutional review board (IRB) review.Results: In attempting to fulfill the objectives of reducing regulatory burden, freeing IRB administrative resources, and protecting human subjects, the new regulations acknowledge low-risk research and privacy concerns, as well as the increased use of biospecimens. In the Final Rule, the Office for Human Research Protections updated the definition of human subject and expanded the exemption framework. The definition of human subject in the Final Rule includes biospecimens, and the new exemption framework includes expanded definitions, modifications to existing exemption categories, the creation of new categories, and the creation of a new concept called limited IRB review. The expanded exemption framework was designed to help alleviate the regulatory burdens of low-risk research.Conclusion: Whether the revised regulations will meet the needs of the research community and human subject participants is unknown. While the revised Common Rule includes some welcome modifications and additions, the changes have also introduced new concepts that are not fully elucidated and have therefore introduced new ambiguities.

Highlights

BackgroundThe revised Common Rule sought to modernize an outdated regulatory framework, provide clarity to the research community about the application of regulations, and reduce regulatory burden
In January 2017, the first major revisions to the FederalPolicy for the Protection of Human Subjects—found at 45 CFR §46 and known as the Common Rule—were signed into law
Two new exemption categories envisioned in the notice of proposed rulemaking (NPRM) were introduced in the Final Rule (Table 8)

Summary

Background

The revised Common Rule sought to modernize an outdated regulatory framework, provide clarity to the research community about the application of regulations, and reduce regulatory burden. Methods: This article provides insight into the changes to the regulatory framework for low-risk research, clarifies when exemptions can be applied, and explains the use of limited institutional review board (IRB) review. Results: In attempting to fulfill the objectives of reducing regulatory burden, freeing IRB administrative resources, and protecting human subjects, the new regulations acknowledge low-risk research and privacy concerns, as well as the increased use of biospecimens. The definition of human subject in the Final Rule includes biospecimens, and the new exemption framework includes expanded definitions, modifications to existing exemption categories, the creation of new categories, and the creation of a new concept called limited IRB review.

INTRODUCTION

CONCLUSION