1. Exempt Unless otherwise required by Department or Agency heads, research activities in which the only involvement of human subjects will be in one or more of the following categories are exempt from this policy:  [Exemptions b(1-6)] [45 CFR 46.101(b)]  Exemption categories 1-5 are not applicable to research governed by FDA regulations (21 CFR 50.20)

2. Categories of Exempt Research 1. Research conducted in established educational settings, involving normal educational practices 2. Research involving the use of educational tests, survey procedures, interview procedures, or observation of public behavior 3. Same as # 2, but covers elected officials 4. Research involving use of existing data 5. Research and demonstration projects by approval of agency heads

3. Exempt if it is “ONLY”… Research in one or more exempt categories, for example, an anonymous survey of adults. AND NOT research in any covered research category, for example, collecting private identifiable data from future records.

4. What are the Covered Research Categories? Identifiable private information? Vulnerable populations? Subjects vulnerable to coercion or undue influence? Treatments or procedures? Incomplete Information? These types of activities would not qualify for exemption.

5. What research activities are eligible for expedited review? No more than Minimal Risk. Must fit one or more of the categories on the Expedited Review Categories List [Authority: 45 CFR 46.110 and 21 CFR 56.110] Minor changes in previously approved research during the period for which the approval is authorized

6. Minimal risk …means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological tests. (45 CFR 46.102(i))

7. Expedited Categories Clinical studies of drugs and medical devices only under specific conditions Collection of blood samples Biological specimens obtained by non-invasive means Collection of data through non-invasive procedures Materials collected solely for non-research purposes Collection of data from voice, video, etc. Research employing surveys, etc. (OMB Issue) Continuing review under specific conditions