As discussed on our Health Industry Washington Watch blog here, on September 2, 2015, the Department of Health and Human Services (HHS), along with fifteen other federal departments and agencies, released a proposed rule to modernize regulations governing human research subjects under the Common Rule. Currently the Common Rule applies to all research involving human subjects that is conducted or supported by a federal department or agency that has adopted the policy. Subject to only specified exclusions, the proposed rule extends the Common Rule’s requirements to all clinical trials regardless of funding source if: (1) the clinical trial is not regulated by the FDA, and (2) is performed at a US institution that receives any support from a federal agency. Other major changes introduced in the proposed rule include Informed Consent, Single IRB Review and Exclusions & Exemptions.
The notice of proposed rulemaking is scheduled to be published in the Federal Register on September 8, 2015. Comments to the proposed rule are due by December 7, 2015.
Stay tuned for a Reed Smith Client Alert on the proposed rule and its impact on FDA-regulated entities.