Exempt studies are so named because they are exempt from some of the federal regulations (refer to §46.104). However, they are not exempt from state laws, institutional policies, or the requirements for ethical research. UAB policy does not allow investigators to self-exempt their human subjects research. Instead, determining if a project is exempt, in most cases, is an administrative review process handled by the Office of the IRB or by an experienced member of the IRB.​
Only the IRB can assign Exempt status.
In order to obtain an exempt designation, the investigator must do the following:
- Determine that the proposed research activity fits entirely within one or more of the six categories of exemptions approved for use by the UAB IRB.
- Ensure all key personnel have completed current training in human subjects protections as required by the UAB IRB.
- Submit an initial application through IRAP, using the IRB ePortfolio.
- Fully describe the project so that the exemption criteria are clearly addressed, the reviewer can understand (i.e., lay language) the project being proposed, and the procedures and methodology are complete.
- Respond to requests for further information from the IRB reviewer.
- Not begin the project until the IRB has granted exempt determination.
NOTE: Any changes, additions, and deletions after the IRB exempt determination must be approved by the IRB before implementation of the changes.
Even when research is exempt from further requirements of federal regulations, basic ethical standards still apply.
- Although full written consent is not often required, most research included in the exemptions involve some form of interaction or intervention. Potential participants must be provided enough information to be able to choose whether or not to participate.
- Research data must be handled and stored securely, in compliance with UAB policy.
- ​Access to research data must be limited to study team members and other authorized personnel.
Applicability to Special Populations:
Pregnant women: This population may be included in each of the exemption categories.
Prisoners: This population may NOT be included in any of the exemption categories unless the research is aimed at a broader population and only incidentally includes prisoners.
Children: This population may be included in Categories 1, 4, 5, and 6. Children may also be included in Category 2(i) and 2(ii) if the research only involves educational tests or the observation of public behavior when the investigator does not participate in the activities being observed. Children may NOT be included in Category 2(iii) or 3.
There are no deadlines for submission of an Application for Exemption Review.
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