The IRB/HSPC review process, from initial application to approval, can take several weeks. Therefore, it is important to plan accordingly to ensure that sufficient time is allotted for protocol review before research is scheduled to begin. Many studies (particularly when the Principal Investigator is a student or a novice researcher) are not approved upon the first submission.
The IRB Administrator will screen the application and communicate to the Principal Investigator, and Faculty Advisor as applicable, if any required material is missing.
When the complete application is received, the IRB Chair or their designee determines whether the protocol is eligible for exempt, expedited, or full board review. Most minimal risk studies can be classified as exempt or expedited.
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 examinations or tests. §46.102(j).
Exempt Research Review
Studies that meet the criteria for a federal exemption category (45 CFT 46.104) may be granted a determination of exemption. Studies receiving an exempt determination are not subject to Continuing Review. Amendments are required to be submitted to IRB/HSPC only if changes to the study alter the exemption criteria. An exempt determination does not lessen the researcher’s ethical obligations to subjects as articulated in the Belmont Report or to the codes of conduct of specific disciplines.
Expedited Research Review
Studies that qualify for one or more of the federal Expedited Review Categories may be reviewed by an expediting reviewer assigned by the IRB Chair. The IRB Chair will communicate the results of the review to the researcher in writing and may request revisions to the application or clarifications to satisfy reviewer concerns. Only the full board has the authority to disapprove a study. Most studies that qualify for expedited review do not require Continuing Review.
Applications requiring full board review (those that are greater than minimal risk or expedited review applications that are not approved) are placed on the agenda of the next full board meeting. IRB/HSPC is scheduled to meet monthly three weeks following the submission deadline. Application materials are distributed to IRB members approximately 7 days prior to any scheduled full board meeting to give members time to review the materials and to develop their recommendations.
The IRB Chair notifies the Principal Investigator of the meeting results via email, After the Principal Investigator responds to any issues or revisions required by the full board, if necessary, the Chair will notify the Principal Investigator of approval or disapproval in writing.