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 . 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.
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. 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. Your attention to this important matter is greatly appreciated.