PURPOSE

The exception from informed consent for planned research in emergency settings

SCOPE

This policy applies to planned research in emergency settings. This policy does not cover emergency use of a test article, which is addressed in IRB SOP 506: Emergency Use of a Test Article.

POLICY

The IRB may review and approve applications for planned use of a test article in an emergency setting. The IRB may approve a request for a waiver of informed consent for planned emergency research in accordance with the exception in FDA regulation [21 CFR 50.24] and under DHHS regulation [45 CFR 46.101(i)][1].

The Veterans Health Administration (VHA) does not conduct planned emergency research. VA researchers are not permitted to use these provisions.

Research subject to Department of Defense requirements is prohibited from using an exception from consent in emergency medicine research unless a waiver is obtained from the Secretary of Defense.

PROCEDURES

1. Procedure for Exception from Informed Consent (EFIC) Requirements for Planned Research in Emergency Settings
   1. If an investigator wishes to waive consent under this policy, the investigator must complete a Request for Waiver of the Informed Consent for Planned Emergency Research in ERICA.
   2. For research subject to FDA regulations – If the IRB approves a request for a waiver of informed consent for planned emergency research, all of the required determinations under 21 CFR 50.24 and in Federal Register, Vol. 61, No. 192, pp. 51531-51533, October 2, 1996 will be made by a convened IRB.
   3. For research not subject to FDA regulations – If the IRB approves a request for a waiver of informed consent for planned emergency research that is not subject to FDA regulations, all of the required determinations in Federal Register, Vol. 61, No. 192, pp. 51531-51533, October 2, 1996 will be made by a convened IRB.
   4. If an IRB determines that it cannot approve the proposed waiver of informed consent because the investigation does not meet the criteria in the exception provided in the federal regulations (as cited above) or because of other relevant ethical concerns, the IRB will document its findings and provide these findings promptly in writing to the investigator and to the sponsor.

Notes

[1] See http://www.hhs.gov/ohrp/policy/hsdc97-01.html