Photo by Richard Lord for Fogarty/NIH
The U.S. Department of Health and Human Services (HHS) has announced proposed revisions to the regulations that protect individuals who participate in research, known as the Common Rule. They are followed by 18 federal agencies, including NIH, and have been in place since 1991. The expansion of research into new scientific disciplines, such as genomics, along with an increase in multisite studies and significant advances in technology, have highlighted the need to update the regulatory framework.
Proposed changes include:
- Strengthened informed consent provisions to ensure that individuals have a clearer understanding of the study’s scope, including its risks and benefits.
- Requirement, in most cases, to use a single institutional review board (IRB) for multisite research studies.
- Requirements for administrative or IRB review that would align better with the risks of the proposed research, thus increasing efficiency.
- New data security and information protection standards that would reduce the potential for violations of privacy and confidentiality.
- Requirements for written consent for use of an individual’s biological samples for research, with the option to consent to their future use for unspecified studies.
- The proposed rule would apply to all clinical trials, regardless of funding source, if they are conducted by a U.S. institution that receives funding for research involving human participants from a Common Rule agency. This includes research at foreign sites.
HHS will take public comment on this proposal for 90 days, beginning September 8, 2015.