Citation:

Nelson, D., C. Jeans, M. Khote, P. Marshall, AND E. White. Chapter 11-8: Overview of Select Common Rule Agency Requirements, in Institutional Review Board (IRB): Management and Function. Edition 3rd, Chapter 11, EA Bankert, BG Gordon, EA Hurley, SP Shriver (ed.), Institutional Review Board (IRB) Mangement and Function. Jones & Bartlett Learning, Burlington​, MA, 13(1):847-857, (2018).

Impact/Purpose:

This is an invited Chapter to be published in "Institutional Review Board (IRB) Management and Function" which is the primary textbook for the field of human subjects research. This chapter provides an overview of agency-specific regulations and policies that go beyond the "Common Rule" shared by 20 Federal Agencies. The chapter will include sections about EPA, VA, DOD, DOE, DOJ and DOD research regulations, each section authored by a representative from that agency. The textbook is used by Institutional Review Boards (IRBs), researchers, university administrators and others working with human subjects research.

Description:

Abstract/Summary: The Federal government annually funds and conducts tens of thousands of human subjects studies within the United States and internationally. In total, 20 federal agencies have agreed to follow the revised Common Rule (published January 2017, amended January 2018, effective July 2018). All are official signatories to the revised Common Rule. Each federal agency codifies it with an exact duplicate of the wording in 45 CFR 46 subpart A. Each federal agency may write additional agency specific regulations or policies to define how the Agency implements the revised Common Rule, the 45 CFR 46 subparts B, C, D, and E, and the FDA regulations. In addition, all federal agencies are part of the executive branch and therefore are subject to the Privacy Act. There are additional federal laws applicable to the support or conduct of human subjects research studies by federal agencies unless the federal law excludes a specific federal agency.

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