Implications of the Revised Common Rule for Human Participant Research

• Published in: Chest Vol. 155; no. 2; pp. 272 - 278
• Main Authors: DeRenzo, Evan G., Moss, Joel, Singer, Eric A.
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.02.2019; American College of Chest Physicians
• Subjects: Ahead of the Curve; Biomedical Research - ethics; Biomedical Research - legislation & jurisprudence; biospecimen; capacity; clinical research; common rule; Ethics Committees, Research - legislation & jurisprudence; human participant research; human subject research; Humans; informed consent; Informed Consent - ethics; institutional review board; Needs Assessment; Policy Making; Research Design - standards; Research Design - trends; research ethics; Research Subjects - statistics & numerical data; revised common rule; United States; United States; RCR; human subject research; biospecimen; research ethics; institutional review board; revised common rule; capacity; human participant research; OHRP; sIRB; informed consent; clinical research; IRB; common rule
• ISSN: 0012-3692; 1931-3543; 1931-3543
• DOI: 10.1016/j.chest.2018.09.022

This paper looks at the implications of changes to the regulatory governance of human participant research that can be expected with implementation of the Revised Common Rule (RCR). The RCR refers to revisions of the existing federal regulations that govern the performance of research involving human subjects (ie, clinical research) in the United States and, under certain circumstances, when such research is also performed outside the United States. The term “common” is included because it refers to the fact that these regulations, often referred to as Code of Federal Regulations 46, is the common denominator regulations agreed to across a wide swath of federal agencies.