Common Rule Proposed Changes

The DHHS issued a News Release in July regarding proposed changes to the “Common Rule”, and is welcoming all comments regarding changes that would affect biomedical and social/behavioral research.    Highlights of the proposed changes include:

  • Revising risk assessment rules
  • Multi-site trials must have a single IRB of record
  • Updating the informed consent process
  • Establishing mandatory data security standards
  • Improved and standardized adverse event reporting and collection techniques
  • Extending Federal regulatory protections to all institutions that receive funding from Common Rule agencies
  • Providing uniform guidance on federal regulations

Specific changes can be found here.  One major change is listed as Issue 2, which describes the new regulation that would necessitate written authorization to use patient specimens even if there were no identifiers.  Identifiers such as names and social security numbers are not provided to researchers who examine specimens after collection, to protect patient confidentiality.  DHHS commented that patients wanted more control of whether or not their samples could be used in research.

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