Implications of the Revised Common Rule for Human Participant Research

Chest: The Journal of Circulation, Respiration and Related Systems

Evan G. DeRenzo^1¹  Joel Moss^2²  Eric A. Singer^3³ 

[1] John J. Lynch Center for Bioethics, MedStar Washington Hospital Center, Washington, DC^1;Pulmonary Branch, National Heart, Lung, and Blood Institute, NIH, Bethesda, MD^2;Rutgers Cancer Institute of New Jersey and Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ^3

关键词: biospecimen;    capacity;    clinical research;    common rule;    human participant research;    human subject research;    informed consent;    institutional review board;    research ethics;    revised common rule;    IRB;    institutional review board;    OHRP;    Office for Human Research Protections;    RCR;    Revised Common Rule;    sIRB;    single institutional review board;   

DOI  :  10.1016/j.chest.2018.09.022

学科分类：呼吸医学

来源: American College of Chest Physicians

【 摘 要 】

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.

【 授权许可】

CC BY