September 2015

In early September, the federal government issued proposed revisions to the "common rule"  – the body of regulations covering the protection of human subjects in research.  The common rule impacts federally funded research supported by 18 different federal agencies and has a significant impact on research conducted at universities and other public institutions.

Below are some of the key features of the proposed changes to the common rule:

• 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.

The ATS will closely review the proposed changes to the common rule and submit comments on behalf of our members.  Public comments on the proposed changes to the common rule must be received by close of business, December 7, 2015.