Research activities in which the only involvement of human subjects will be in one or more of the categories listed in 45 CFR 46.101 (b) (1-6) fall under exempt category. Applications for exempt projects are reviewed and approved administratively in the AHC IRB office. There are no submission deadlines for exempt projects. In addition the study is reviewed for HIPAA requirements.
Note: It is the AHC IRB and not the investigator, who determines whether a project falls into an exempt category.
- Examples: research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects; retrospective records review; educational tests, surveys, interviews; observation of public behavior.
Exempt Research Categories:
Certain categories of research may be reviewed through the expedited review procedure authorized in 45 CFR46.110 (revised in November 1998). Expedited studies cannot pose greater than minimal risk to subjects. Expedited studies are reviewed by the office staff prior to being sent for review by the AHC IRB Chair or the designated IRB members. There are no submission deadlines for expedited projects. In addition the study is reviewed for HIPAA requirements.
- Examples: prospective collection of biological specimens for research purposes by noninvasive means; collection of data through noninvasive procedures; research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes.
Expedited Research Categories:
Projects posing greater than minimal risk to subjects, as well as minimal risk projects that do not meet the expedited criteria, are reviewed by the full IRB at convened meetings. The AHC IRB uses the primary reviewer system and a simple majority vote is required for approval. Protocol submissions have to meet submission deadlines and have to include all necessary materials and signoffs. Incomplete submissions (even if they met submission deadline) will not be placed on the meeting agenda. The AHC IRB meetings are held twice a month with three rotating IRB panels. Please refer to the AHC IRB Meeting Schedule for meeting dates and submission deadlines.
Note: The standard requirements for informed consent (or its waiver, alteration, or exception) apply regardless of the type of review -- expedited or full board.
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