The U.S. Department of Health and Human Services today announced proposed revisions to the regulations that govern research on individuals who participate in research.
The current regulations that protect individuals who participate in research, which have been in place since 1991, are followed by 18 federal agencies and are often referred to as the Common Rule. They were developed at a time when research was predominantly conducted at universities, colleges and medical institutions, and each study generally took place at a single site.
The expansion of research into new scientific disciplines, such as genomics, along with an increase in multisite studies and significant advances in technology, has highlighted the need to update the regulatory framework. Notably, a more participatory model of research has also emerged, with individuals looking for more active engagement with the research enterprise.
Changes proposed include:
- Strengthened informed consent provisions to ensure that individuals have a clearer understanding of the study’s scope, including its risks and benefits, as well as alternatives to participating in the study.
- 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 example, blood or urine, for research with the option to consent to their future use for unspecified studies.
- Requirement, in most cases, to use a single institutional review board for multisite research studies.
The proposed rules would apply to all clinical trials, regardless of funding source, if they are conducted in a U.S. institution that receives funding for research involving human participants from a Common Rule agency.
Read more at the Federal Register: Federal Policy for the Protection of Human Subjects.
