FDA Guidance on Exception from Informed Consent


Readers may be interested to know that the U.S. Department of Health & Human Services, Food & Drug Administration has recently published, along with the office of good clinical practice, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, and Center for Devices and Radiological Health, a set of non-binding recommendations entitled, "Guidance for Institutional Review Boards, Clinical Investigators and Sponsors on Exception from Informed Consent Requirements for Emergency Research." This document was issued in 3/2011 and is 55-pages.

The document includes a number of points under general discussion, qualifications for a study to be conducted, under the qualifying criteria for emergency research, study designed therapeutic window issues, IRB sponsor and clinical investigator responsibilities, Community Consultation Issues, public disclosure, compact of legally authorized representatives or family members, data monitoring committee, and further information contacts. Emergency research investigations involve those studies with human subjects to have life threatening medical conditions that necessitate urgent intervention for which available treatments are unproven or unsatisfactory and who, because of their condition, (i.e. traumatic brain injury) cannot provide informed consent.

The research must have the prospect of direct benefit to the patient and must involve an investigational product. To be effective, it must be administered before informed consent from the subject or the legally authorized representative can be obtained and in which there is no reasonable way to identify prospectively individuals likely to become eligible for participation.

The document does not establish legally enforceable responsibilities and should be viewed only as a set of recommendations unless specific regulatory or statutory requirements are cited. It is recommended that any brain injury researcher involved with human clinical research review this document, as it provides a very thoughtful and cogent review of the subject matter with an excellent framework for addressing this controversial area of human research. For more information on this document, click here.