EXEMPT DETERMINATIONS AND LIMITED IRB REVIEW

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EXEMPT DETERMINATIONS AND LIMITED IRB REVIEW October 4, 2023 Objectives Remind study teams what does require review by the IRB Describe the levels of IRB review Define the categories of Exempt Determinations Outline the IRB review process

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EXEMPT DETERMINATIONS AND LIMITED IRB REVIEW October 4, 2023<br>
02
Objectives Remind study teams what does require review by the IRB
Describe the levels of IRB review
Define the categories of Exempt Determinations
Outline the IRB review process and limited IRB review 2<br>
03
REFRESHER: Does the Study Require IRB Review? 3 If the study meets both of the following definitions, then it requires IRB review:

Is it Research?
A systematic investigation, including development, testing, and evaluation, designed to develop or contribute to generalizable knowledge (HHS Common Rule)

Any experiment that involves a test article and one or more human subjects, and that either must meet the requirements for prior submission to the Food and Drug Administration (FDA)

Does it involve Human Subjects?
A living individual about whom an investigator conducting research:
Obtains information or biospecimens through intervention or interaction with the individual, AND uses, studies, or analyzes the information or biospecimens; OR
Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens (HHS Common Rule)

An individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy individual or a patient (FDA)<br>