On September 2, 2015, sixteen federal departments and agencies, including the US Department of Health and Human Services (HHS) released a proposed rule to modernize regulations governing human research subjects under the Common Rule (45 C.F.R. Part 46). Under the current regulations, 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 exemptions, 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: Stricter requirements on study information given to prospective subjects; and informed consent for the use of stored biospecimens in secondary research (e.g., using part of a blood sample that is leftover from prior clinical use – even if those specimens have been stripped of identifying information)
  • Single IRB Review: Single institutional review board (IRB) review of multi-site studies; and elimination of the continuing review requirement for studies that undergo expedited review and studies with completed intervention
  • Exclusions & Exemptions: Exclusion of activities that are not deemed to be research, are inherently low-risk, or where protections are separately mandated

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 and can be submitted here. Please note that a Reed Smith Client Alert on the proposed rule and its impact on FDA-regulated entities is forthcoming. ** 11/25/2015 update:  The comment period has been extended until January 6, 2016.