HHS Announces Proposal to Improve Rules Protecting Human Research Subjects
The U.S. Department of Health and Human Services (HHS) and fifteen other Federal Departments and Agencies have announced proposed revisions to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was promulgated as a Common Rule in 1991. A Notice of Proposed Rulemaking (NPRM) was put on public display on September 2, 2015 by the Office of the Federal Register. The NPRM, which can be accessed at the following URL: https://www.federalregister.
gov/articles/2015/09/08/2015- 21756/federal-policy-for-the- protection-of-human-subjects, seeks comment on proposals to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. It is expected that the NPRM will be published in the Federal Register on September 8, 2015, when the docket will be open for submitting public comments.
A brief summary of the proposed changes can be accessed at the following HHS website: http://www.hhs.gov/ohrp/