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- Title
Public Engagement, Notice-and-Comment Rulemaking, and the Common Rule.
- Authors
FERNANDEZ LYNCH, HOLLY; COHEN, I. GLENN; BIERER, BARBARA E.
- Abstract
The article talks about changes proposed by the Department of Health and Human Services (HHS) to the Federal Policy for the Protection of Human Subjects, also known as the Common Rule. Topics discussed include rule-making differing from a public referendum thereby affording agencies substantial discretion to proceed as they see fit, and the development of regulations being governed by the Administrative Procedure Act (APA) at the federal level.
- Subjects
UNITED States; RESEARCH ethics; PUBLIC administration; PATIENT participation; RULES; HUMAN research subjects -- Legal status, laws, etc.; LAW
- Publication
IRB: Ethics & Human Research, 2017, Vol 39, Issue 1, p17
- ISSN
0193-7758
- Publication type
Opinion