POLICY STATEMENT

It is UAB policy that research may be conducted in emergency settings without the requirement of an informed consent process if the research meets the provisions of the HHS Emergency Research Consent Waiver (61 Fed. Reg. 51531, Oct. 2, 1996) and, if applicable, the provisions under the ICH-GCP (E6) guidelines (see GUI341), and if applicable, the provisions of the FDA exception from informed consent process requirements for emergency research at 21 CFR §50.24 and, if applicable, a waiver is obtained from the Secretary of Defense (see GUI339). Note: The research under this policy needs IRB review and approval and differs from the exemption from IRB review for emergency use of a test article.¹ This policy 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 do not have available a legally authorized person to represent them. (See also: PRO119 Procedure for Waiver to Informed Consent Process in Research Planned for Emergency Settings.)

For FDA-regulated research, protocols involving an exception to informed consent process under this policy must be performed under a separate IND application or IDE that clearly identifies such protocols as including subjects who are unable to consent. Such protocols may not be performed as part of a prior IND application or IDE or an amendment. Furthermore, the IRB must determine that the research activities meet one of the following sets of conditions to satisfy federal regulations:

• For research subject to FDA regulations, the IRB responsible for review, approval, and continuing review of the research activity has approved both the activity and a waiver of informed consent and found and documented that:
  • The research activity is subject to protection of human subjects regulations at 21 CFR Part 50 and will be performed under a separate IND or IDE which has clearly identified the protocols that would include subjects who are unable to consent, and
  • With the concurrence of a licensed physician who is a member of or consultant to the IRB and who is not otherwise participating in the clinical investigation, the requirements for an exception from informed consent process for research in emergency circumstances detailed in 21 CFR §50.24 are met in relation to these protocols; or

•  For research not subject to FDA regulations, the IRB responsible for review, approval, and continuing review of the research has approved both the research and a waiver of informed consent and found and documented that:
  • The research is not subject to FDA regulations at 21 CFR Part 50, and
  • The conditions in HHS Emergency Research Consent Waiver Section (b) have been met in relation to the research and reported these findings to OHRP.