As Prescribed


After almost a decade, the Food and Drug Administration (FDA or Agency) finalized the Informed Consent guidance document (Final Guidance). The Final Guidance finalizes the 2014 draft Informed Consent Information Sheet guidance document (Draft Guidance) and supersedes the 1998 FDA guidance document, “A Guide to Informed Consent.” FDA issued the Final Guidance as part of an ongoing effort to modernize and harmonize its human subject protection policies and regulations.

In the Final Guidance, FDA highlights several changes the Agency made in finalizing the Draft Guidance that affect sponsors, study sites, institutional review boards (IRBs), and researchers. This blog post details the more substantial changes FDA made in the Final Guidance, as well as other areas where FDA made less substantial changes.

Streamlining Communication of New Information with Subjects

In the Final Guidance, FDA provides a thorough discussion regarding communicating to subjects “significant new information that could affect a subject’s willingness to continue their participation in the clinical trial.” In these situations, the IRB is responsible for determining (1) “whether currently enrolled subjects should be provided with the new information and given an opportunity to affirm their willingness to continue in the research” and (2) “whether the investigator should provide currently enrolled subjects with the new information either with the revised informed consent document or an alternative method.”

According to the Final Guidance, there are also occasions when new information concerning a clinical investigation does not need to be communicated to previously enrolled subjects, including when a subject has completed active participation in the study and when the information is unlikely to affect the subject’s willingness to continue in the study.

Similarly, the Final Guidance also highlights certain changes to informed consent forms in ongoing studies that do not require IRB review. These include corrections of typographical and spelling errors, changes in contact information, and translation of consent forms into languages other than English.

Facilitating Subject Understanding of the Informed Consent Materials

In the Final Guidance, FDA encourages researchers to use innovative methods and technologies to help communicate with and educate research subjects. For example, the Final Guidance notes that in addition to pictures and diagrams, researchers or sponsors could use “other visual aids” (i.e., video aids) to educate research subjects. That said, according to the Final Guidance, “when written documentation of informed consent is required, informed consent cannot be obtained and documented by oral communication through the telephone alone.”

The Final Guidance also provides that IRBs can approve “reasonable procedures for ensuring that translations will be prepared by a qualified individual or entity, and that interpretation assistance is available.” This differs from the approach FDA articulated in the Draft Guidance, in which the Agency recommended that IRBs review and approve “all English and non-English language versions of any consent documents.”

Additional Modifications in the Final Guidance

  • FDA clarifies the means of communicating new information to subjects and accounting for subject withdrawal, such as through Consent Addendums and Information Sheets.
  • FDA emphasizes the importance of including cognitively impaired individuals in the informed consent discussions to the extent possible and giving them the opportunity to designate a legally authorized representative (LAR).
  • FDA addresses new flexibilities for sponsors and investigators in certain areas, such enrollment in multiple investigations, indirect costs related to study participation, risks in and benefits in standard of care, and unapproved uses consistent with standard of care.
  • FDA adds that IRBs have final responsibility for determining whether the informed consent process should include disclosure of investigators’ financial conflicts of interest.

Key Takeaways

The Final Guidance demonstrates FDA’s continued effort to modernize clinical research while simultaneously reducing administrative burden and protecting human subjects. Importantly, as stated in the Final Guidance, additional revisions to the Final Guidance may be needed if FDA finalizes its proposed regulations to harmonize the FDA regulations with those of the Federal Policy for the Protection of Human Subjects (i.e., the “Common Rule”) and its proposed regulation to permit a waiver of informed consent by IRBs.