CHA News Article

HHS Issues Proposed Rule on Human Subject Research Protections

The U.S. Department of Health and Human Services (HHS), along with 15 other federal agencies that fund medical research, last week published a notice of proposed rulemaking on protections for human subjects in federally supported research studies. The proposed rule would revise the Common Rule, a set of federal regulations with which researchers must comply to receive federal research funding from any of the 16 federal agencies that fund research (this does not include the Food and Drug Administration). Important provisions in the proposed rule include:

  • Expansion of the Common Rule to all research studies at U.S. institutions receiving federal support for non-FDA human subject research, regardless of whether a particular study at the institution is specifically federally supported.
  • A requirement that researchers comply with the Common Rule – including the informed consent requirements – when conducting research using biospecimens, even if the biospecimens contain no identifiable information (with very limited exceptions). HHS has proposed to allow researchers to obtain broad consent for storage of biospecimens and subsequent secondary research use, and has developed a template that researchers may use.
  • Revisions to the elements of informed consent for human subject research and changes to the requirements for Institutional Review Board (IRB) waiver of the informed consent requirements.
  • New exemptions and exclusions from the Common Rule’s requirements.
  • New data security and privacy requirements.
  • Revisions to requirements for cooperative research and expedited review for minimum risk studies.

CHA is currently reviewing the proposed rule and its impact on hospitals. Comments are due by Dec. 7. CHA publishes the Consent Manual, A Reference for Consent and Related Health Care Law, which includes a chapter describing state and federal laws regarding consent to human subject research. CHA also publishes the California Health Information Privacy Manual, which includes a chapter on privacy and the conduct of research. To learn more about CHA’s manuals or to order, visit