Recommendations for Implementation of Community Consultation and Public Disclosure Under the Food and Drug Administration’s “Exception From Informed Consent Requirements for Emergency Research”

Abstract

In addition to the usual requirement of appropriate study design and institutional review board (IRB) approval, research studies performed under the Food and Drug Administration (FDA) and Department of Health and Human Services regulations regarding “Informed Consent and Waiver of Informed Consent Requirements in Certain Emergency Research” (21 CFR §50.24)1 require community consultation and public disclosure. This special report discusses the general issues related to consent in emergency circumstances and provides a template to help IRBs implement community consultation and public disclosure appropriately. A portion of the material in this special report was presented as testimony by Dr Halperin on October 11, 2006, at the FDA’s public hearing on “Draft Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Exception From Informed Consent Requirements for Emergency Research.” More than 300 000 Americans die each year due to catastrophic medical and surgical emergencies.2,3 New interventions based on sound research could save lives. These research studies must be done within an ethical framework that traditionally includes obtaining prospective informed consent from the research subject. The ethical framework for the conduct of human research began with the development of the Nuremberg Code4,5 in 1949. This code states that (1) informed consent of volunteers must be obtained without coercion of any form, (2) human experiments should be based on prior animal experiments, (3) the anticipated scientific results should justify the experiment, (4) only qualified scientists should conduct medical research, (5) physical and mental suffering should be avoided, and (6) no expectation of death or disabling injury should be expected from the research study. The Declaration of Helsinki6 was issued in 1964 and defines rules for clinical research. It repeats the ethical concerns stated in the Nuremberg Code but also gives a provision for enrolling certain patients in clinical research without …