On January 19, 2017, federal regulators published the Final Rule to amend and update the Federal Policy for the Protection of Human Subjects (“the Common Rule”). Key provisions govern research with identifiable private information, identifiable biospecimens, broad consent, new exemption categories, and single IRB review of multi-site research.
HHS Announces Proposal to Improve Rules Protecting Human Research Subjects
Changes proposed to ensure the highest standards of protections for human subjects involved in research, while enhancing effectiveness of oversight
The U.S. Department of Health and Human Services and fifteen other Federal Departments and Agencies have announced proposed revisions to the regulations for protection of human subjects in research. A Notice of Proposed Rulemaking (NPRM) was published in the Federal Register on September 8, 2015. The NPRM seeks comment on proposals to better…
Website announcing NAS study on the benefits and risks of GE crops.
A report commissioned by NIH and other sponsors on promoting responsible access to participant level data.
An article discussing areas of agreement and difference in determining what constitutes a biobank.
Many important advances in human health depend on the effective collection, storage, use, and sharing of biological specimens and their associated data. However, recent controversies involving specimen-based research have raised important questions about ownership, data-sharing, privacy considerations, group harms, and standards for responsible specimen stewardship.
This November 2016 symposium addressed key…
AMA statement on genetically engineered crops and foods.
A proposal from the editors of major medical journals across the world to make publication in their journals contingent on sharing de-identified, individual-level participant data from clinical trials with other researchers under certain parameters.