Modernization Updates to the Common Rule: Recommendations for Researchers Working With Human Participants

Abstract

Introduction: This tutorial article explicates some of the 2017 updates to the 1991 Common Rule. Implemented in January 2019, these changes impact the evolving landscape of research with human participants in the US. The introduction provides context for the article as well as framing research questions. Key concepts: These include a brief definition of research for the purposes of the article; a discussion of the foundational ethical principles of autonomy (respect for persons), beneficence, and justice; and a brief overview of the recent policy revision process and its impact on scholarship in the field. After establishing this context, readers are provided five key lessons from the policy revisions. Key lessons: The lessons for researchers working with human participants include discussion of the impact of policy changes in the Common Rule associated with broad consent, single Institutional Review Board (IRB) mandate/cooperative review, updated exemptions, modified definitions of vulnerability, and international research. These are all contextualized within a specific example for professional communication researchers. Implications for practice: Although educative efforts are underway at both the federal and institutional levels, it is important for disciplines and researchers to understand how policy changes will impact the IRB review process. Attendance to the infrastructures that guide our research design and development warrants attention.