FDA Refreshes 16-Year Old Informed Consent Guidance, Addresses Considerations for Vulnerable Populations

July 17, 2014

By James E. Valentine* —

On July 15, 2014, FDA announced the availability of a draft guidance, titled “Informed Consent Information Sheet: Guidance for IRBs, Clinical Investigators, and Sponsors” (“FDA Draft Information Sheet”).  When final, it will replace the Agency’s informed consent  1998 Information Sheet, “A Guide to Informed Consent,” and the related informed consent sections of “Frequently Asked Questions”. 

The proposed FDA Draft Information Sheet, builds upon its previous guidance, assisting parties involved in clinical investigations of FDA-regulated products in carrying out their responsibilities related to informed consent under 21 CFR part 50.  FDA’s recommendations cover the informed consent process, the elements of informed consent, and the documentation of informed consent.  

The basics remain unchanged, but FDA explained that it is issuing these proposed recommendations as a draft guidance because of revisions to the previous Information Sheets that respond to changes in regulation and regulatory policy, as well as to questions from external stakeholders. 

The FDA Draft Information Sheet emphasizes unique considerations for informed consent of certain vulnerable populations, including:

  • Careful consideration of ethical ramifications of enrolling or excluding potential subjects when there is a language barrier between investigator and potential subjects, and ensuring the information presented is understandable to subjects who do not understand English;
  • Modifications to the consent form and process when enrolling subjects with impaired consent capacity, and additional considerations to address challenges and provide safeguards for subjects who lack consent capacity;
  • Safeguards for inclusion of children as subjects, explaining the framework that is based upon receiving parental permission and child assent; and
  • Approaches to modification of informed consent for subjects with low literacy or numeracy.

The FDA Draft Information Sheet also provides new recommendations in other areas, including:

  • Addressing the new element of informed consent for “applicable clinical trials,” the requirement to include a statement that clinical trial information and results have been or will be submitted for inclusion on www.ClinincalTrials.gov (see our previous posts on this requirement here and here);
  • Determining whether review of patient records is considered part of the clinical investigations and requires informed consent;
  • Discouraging subject participation in more than one clinical trial; and
  • Notifying and providing study information to subjects in the events of study suspension or termination.

The FDA Draft Information Sheet comes at a time when HHS and the Office of Human Subjects Research are reviewing various ways to enhance regulations overseeing research on human subjects (see our previous post on the Advanced Notice for Proposed Rulemaking for revision to the Common Rule here).  FDA assured stakeholders that it is actively working with HHS to harmonize the Agencies’ regulatory requirements, and that the FDA Draft Information Sheet was developed as part of these efforts.

Comments on the FDA Draft Information Sheet can be submitted to FDA until September 15, 2014 here

* Not admitted in the District of Columbia