in exempt categories do not need to be approved by the full IRB, the Belmont Report principles of respect for persons, beneficence and justice still apply.
Studies involving pregnant women, fetuses, and neonates are eligible for exempt status under all eight categories. The exemptions do not apply to research involving prisoners except “for research aimed at involving a broader subject population that only incidentally includes prisoners.” All research involving prisoners requires obtaining a certification from OHRP and must be reviewed by the convened IRB. Research that involves children and falls into categories 1, 2, and 4–8 may be found to be exempt by the IRB. However, exemption category 2, pertaining to survey or interview procedures or observations of public behavior, does not apply to research involving children, except for research involving public behavior when the researcher does not participate in the activities being observed.
Researchers seeking a determination of exempt status will complete an application for exemption and submit to the OSP. The HRPP specialist or another OSP staff member designated as alternate IRB member are the primary reviewers tasked with making exemption determinations. OSP staff may assign submissions to the IRB Chair or another IRB member to assist with or conduct the exemption review as needed or if specific expertise is required. OSP staff members who have a conflict of interest related to a specific application should assign the application to another reviewer.
Following review, the IRB reviewer will make one of the following recommendations, and OSP will notify the researchers of the IRB reviewer's decision by email:
APPROVED. IRB approval indicates that the IRB reviewer(s) concluded the research protocols meet the federal criteria for approval. OSP staff process the determination and the researcher is provided with an approval letter and, if applicable and practicable, stamped informed consent/assent documents.
REVISIONS and/or ADDITIONAL INFORMATION REQUIRED. The IRB reviewer(s) withhold approval pending submission of revisions or additional information. OSP provides the request for revisions to the researcher, and the researcher responds and re-submits the application within 90 days of receiving the requested revisions.
EXPEDITED or FULL REVIEW REQUIRED. The IRB reviewer may determine the protocol requires expedited or full review by the IRB.
When the IRB has certified a project as exempt, the IRB does not require continuation or annual administrative reviews. The exemption approval can be in effect for up to three years. After three years, if the research is still ongoing, researchers are required to submit a new application for determination of exempt status.
The IRB or OSP staff will not consider any research exempt that involves prisoners,