FDA issues draft guidance on informed consent documents

The FDA has issued draft guidance on the informed consent process, and particularly the content and language of the informed consent sheet and related discussions. The changes under consideration can be found in in the July 26, 2011 Federal Register in an ANPRM titled “Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators.”

The draft covers all elements of informed consent, from the general required elements to the specific responsibilities of IRBs, investigators, sponsors and the FDA. It also addresses specific additional topics:

  • Review of Patient Records
  • Non-English Speaking Subjects
  • Subjects with Low Literacy and Numeracy
  • Physically Challenged Subjects
  • Impaired Consent Capacity
  • Children as Subjects
  • Subject Participation in More Than One Clinical Investigation
  • Suspension/Termination of a Study
  • Data Retention upon the Withdrawal of Subjects
  • Reporting Aggregate Results of the Clinical Investigation

However, the lobby group AllTrials has criticised the FDA for omitting any discussion of the anonymised sharing of patient data by sponsors, which it supports as part of its agenda for transparency and open research.

The FDA will welcome comments on this draft until September 15th, 2014.