Institutional Review Boards Flashcards
What is “Emergency Use”?
the use of a test article on a human subject in a life-threatening situation in which no standard acceptable treatment is available, and in which there is not sufficient time to obtain IRB approval
What is an “Institutional Review Board”?
any board, committee, or other group formally designated by an institution to review, to approve the initiation of, and to conduct periodic review of, biomedical research involving human subjects.
What is the primary purpose of an Institutional Review Board (IRB)?
to assure the protection of the rights and welfare of the human subjects
What is the definition of “IRB approval”?
the determination of the IRB that the clinical investigation has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and Federal requirements
When is an IRB review required (by law)?
any clinical investigation which must meet the requirements for prior submission to the FDA shall not be initiated unless that investigation has been reviewed and approved by, and remains subject to continuing review by, an IRB meeting the requirements of the code of federal regulations
the FDA may decide not to consider in support of an application for a research or marketing permit any data or information that has been derived from a clinical investigation that has not been approved by, and that was not subject to initial and continuing review by, an IRB meeting the requirements of this part.
Which clinical investigations are exempt from IRB review?
a-b) clinical investigations commenced before July 27th 1981 (they are subject to the requirements and IRB oversight according to the FDA requirements in effect before July 27th 1981)
c) emergency use of a test article, provided that it is reported to the IRB within 5 working days. Any subsequent use is subject to IRB review.
d) taste and food quality evaluations
