HHS Announces Proposal to Improve Rules Protecting Human Research Subjects
NOTE: The 2011 Advance Notice of Proposed Rulemaking, (ANPRM), has been followed by a Notice of Proposed Rulemaking, (NPRM), put on public display by the Federal Register on September 2, 2015. Publication in the Federal Register is expected on September 8, 2015.
Changes under consideration would ensure the highest standards of protections for human subjects involved in research, while enhancing effectiveness of oversight
In July, 2011, the U.S. Department of Health and Human Services announced that the federal government is contemplating various ways of enhancing the regulations overseeing research on human subjects. Before making changes to the regulations – which have been in place since 1991 and are often referred to as the Common Rule – the government is seeking the public’s input on an array of issues related to the ethics, safety, and oversight of human research. The changes under consideration can be found in an ANPRM, Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators, published in the July 25, 2011 Federal Register. The proposed changes are designed to strengthen protections for human research subjects.
- Read the ANPRM online. (PDF 286KB)
- Read the Federal Register Notice Extending the Public Comment Period (PDF 140KB)
- Access the July 22, 2011 Press Release describing the ANPRM.
- Frequently Asked Questions regarding the ANPRM.
- How to browse comments that have been submitted regarding the ANPRM.
- Read a table comparing existing regulation with changes in the ANPRM. (PDF KB)
NOTE: The ANPRM comment period has closed.