The Department of Health and Human Services last week announced potential revisions to research regulations in order to modernize these rules. Current regulations are sometimes referred to as the Common Rule and have been in place since 1991. Since that time the nature of research has changed, with advances in technology, multi-site studies becoming more common place, and more active patient engagement. A call for public input was announced by HHS in July 2011. The Notice of Proposed Rulemaking (NPRM) now issued lists the input that will go into consideration for the changes to the rules. HHS will take public comment on this for 90 days from today. Changes proposed in the NPRM 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 rule 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.
