NUMBER 91-01


May 15, 1991


Dear Colleague:

This letter is being forwarded to Institutional Officials and Institutional Review Board (IRB) chairs through out the country. Its purpose is to clarify requirements in the HHS regulations for the protection of human research subjects (45 CFR Part 46) concerning provisions for emergency medical care.

Your attention is called to two provisions in the regulations. First, 46.116(f) states: "...nothing in these regulations is intended to limit the authority of a physician to provide emergency medical care..." This provision makes it clear that the regulations are not intended to interfere with the provision of emergency care for patients who need such care. Second, 46.103(b) states: "The Department will conduct or fund research covered by these regulations only if the institution has certified to the Secretary that the research has been reviewed and approved by an IRB..." This provision calls for IRB review and approval prior to initiation of the research.

These regulatory provisions accomplish two objectives. The first objective is to make clear that emergency medical care for patients may be provided without regard to IRB review and approval. The second objective is to require IRB review and approval prior to initiation of research involving human subjects. Confusion can arise when both objectives appear to pertain to the needs of the same person. The National Institutes of Health's (NIH) Office for Protection from Research Risks (OPRR) is, therefore, providing the following clarification. Whenever emergency care is initiated without prior IRB review and approval, the patient may not be considered to be a research subject. Such emergency care may not be claimed as research, nor may the outcome of such care be included in any report of a research activity. Simply stated: HHS regulations for the protection of human subjects do not permit research activities to be started, even in emergency, without prior IRB review and approval.

IF the emergency care involves drugs, devices, or biologics that are considered to be investigational by the Food and Drug Administration (FDA), then it may be necessary to meet FDA requirements to use the investigational article for emergency purposes.

OPRR believes that a number of institutions have not clearly understood these requirements. Each institution is therefore requested to review its procedures and, if necessary, to modify them in order to come into compliance with these requirements. Furthermore, institutions with approved Multiple Project Assurances should modify them as necessary to reflect the interpretation of the regulations set forth above.

Modifications should be forwarded to the Assurance Branch; Division of Human Subject Protections, Office for Protection from Research Risks; National Institutes of Health; Bethesda, Maryland 20892
--Attn. Dr. Duncan.

Your attention to this important matter is greatly appreciated.


F. William Dommel, Jr., J.D.
Division of Human Subject Protections
Office for Protection from Research Risks
Charles R. McCarthy, Ph.D.
Office for Protection from Research Risks