Research in Emergency Settings


Revised federal regulations allow certain human research activities to be conducted in emergency settings and include subjects unable to consent for themselves when more than minimal risk is involved.

These regulations help facilitate potentially life-saving and life-enhancing research while protecting the rights and welfare of subjects. They were developed with input from a number of national organizations and physicians, including those involved in the treatment of cardiac arrest, stroke, head trauma, spinal cord injury, gunshot wounds and poisoning.

Most research in emergency settings falls under FDA regulations because it involves FDA regulated drugs, biologics or devices, but non-FDA regulated research may fall under OHRP requirements almost identical to the FDA regulations.

VA and DoD Exceptions: The Department of Veterans Affairs does not permit use of a waiver of informed consent for planned emergency research. The Department of Defense does not permit such a waiver unless a waiver is obtained from the Secretary of Defense.

IRB Application Requirements

If you wish to conduct research in an emergency setting when there may be more than minimal risk but participation in the research holds out the prospect of direct benefit to the subject, review the regulations below very carefully to make sure that the proposed research qualifies for a waiver of consent. As appropriate, also review the following guidelines on Surrogate Consent, Those with Cognitive Impairments, and Emergency Use and Compassionate Use of Experimental Drugs and Devices.

The following is a short summary of the major points that you will need to consider carefully and discuss in depth in the IRB Application/protocol in order to conduct the research. We encourage you to consult with the IRB when preparing your application.

1. Detailed Discussion of Regulatory Issues: Discuss and document the issues raised in section 50.24 (a) (1) through (5) in the IRB Application and protocol, when/where applicable.

2. Community Consultation: Consultation with appropriate community representatives will need to occur before the research begins (see paragraph 50.24 (a) (7) (i) below).

3. Public Disclosure: Appropriate public disclosure will need to occur prior to the initiation of the study, as well at the completion of the study (see paragraphs 50.24 (a) (7) (ii) and (iii) below).

4. Ongoing Attempts to Obtain Consent: Researchers conducting research that does not include the informed consent of all subjects should commit to providing information and attempting to obtain the consent from the subjects and/or the appropriate relatives or legally authorized representatives on an ongoing basis throughout the conduct of the research and at the conclusion of the research.

5. Summaries of Attempts to Obtain Consent: Investigators will need to document and summarize their attempts to contact family members to obtain their consent if obtaining informed consent is not feasible and a legally authorized representative is not reasonably available. This information will need to be submitted to the IRB at the time of continuing review (see paragraph 50.24 (a) (7) (v) below).

6. Separate IND or IDE: A separate investigational new drug application (IND) or investigational device exemption (IDE) will be needed (see section 50.24 (d) below).

7. Independent Data Monitoring Committee: An independent Data Monitoring Committee will need to be established (see paragraph 50.24 (a) (7) (iv) below).

Regulatory Requirements

Below are FDA regulations. See OHRP guidance on Emergency Research Informed Consent Requirements for research that is not regulated by the FDA. Provisions are essentially identical to the FDA regulations. However, the OHRP waiver does not apply to research involving prisoners, fetuses, pregnant women or in vitro fertilization; these restrictions are not included in the FDA regulation.


Last updated: June 4, 2021