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The federal regulations for the protection of human subjects in research require informed consent, with a few narrow exceptions. FDA regulations in 21 CFR 50.24 provides a narrow exception to the requirement for informed consent from each human subject, or his or her legally authorized representative, prior to initiation of an experimental intervention. The Department of Health and Human Services (DHHS) also outlines waiver criteria for DHHS funded research at [61 FR 51531].
The exception to the requirement for informed consent applies to a limited class of research activities involving human subjects who are in need of emergency medical intervention but who cannot give informed consent because of their life-threatening medical condition, and who do not have a legally authorized representative. The intent of the regulation is to allow research on life-threatening conditions for which available treatments are unproven or unsatisfactory and where it is not possible to obtain informed consent, while establishing additional protections to provide for safe and ethical studies.
Persons with life-threatening conditions who can neither give informed consent nor refuse enrollment are a vulnerable population. The FDA recognizes that the lack of autonomy and inability of subjects to give informed consent requires additional protective procedures in the review, approval, and operation of this research. The exception from the informed consent requirement is conditional upon documented findings by the IRB. Because these projects almost certainly represent situations of more than minimal risk and certain requirements are necessary to conduct this research at the UI, the investigator should call the HSO for guidance if s/he receives funding to conduct this type of research project.