Categories of IRB Review

These categories serve as a basis for rating participant risk amongst a multitude of factors. Classification as one of these categories determines which sections of the regulations apply.

Briefly, exempt research means the study is exempted from the requirements of the federal regulations. However, the study must still meet specific criteria designed to protect the welfare of the participant. Exempt determination must be made by qualified IRB staff; you cannot make this determination based on your own evaluation.

Expedited research means the study is clearly classified as at least one of nine expedited categories. An expedited study will be reviewed by a single qualified member of IRB staff and will be processed on a rolling basis.

Full board research is reviewed by the convened panel because the study involves more than minimal risk to the participants. Full board research is reviewed during scheduled monthly meetings. There are specific deadlines by which a submission must be received. Only vetted full board submissions are presented to the board for review. Submissions that are incomplete, missing pertinent data, or otherwise not ready will be returned for modifications and will not be reviewed at the upcoming meeting.

An exempt classification indicates that your research clearly meets at least one of the six exemption categories outlined in the federal regulations. Exempt determination is granted by the IRB staff only. Exempt reviews are conducted on a first come, first serve basis. 

Once research has been exempted renewals via a Continuing Review submission are not required as there is no expiration date. The IRB does request that you submit an Amendment to report any changes, and submit a Final Review to close the study when research has been completed.

To receive an exempt determination, you should submit an Initial Application to the IRB office for review. Your submission packet should include (but is not limited to):

• Initial Application HRP-211: Form (only accessible from within eRA)
• HRP-503: TEMPLATE - Protocol
• Supporting Documents (recruitment flyers/emails/scripts, survey questions, interview scripts, etc.)

While a consent form is not mandatory for this submission, you should explain how you will address the consent process in your protocol document and attach any related documents. For example, if you will obtain verbal consent you will need to include the a copy of the script that you or your research team will read to the participant. The script should adequately address the criteria for approval with regard to the consent process.

Use HRP-312: WORKSHEET- Exemption Determination to compare your study against the criteria IRB staff use to determine exemptions.

An expedited classification indicates that your research clearly meets at least one of the nine expedited categories outlined in the federal regulations. Expedited review is conducted by a single reviewer as opposed to a full convened panel of reviewers. Expedited reviews are conducted on a first come, first serve basis. To submit a study for expedited review, submit an Initial Application via eRA. Your submission packet should include (but is not limited to):

• HRP-211: FORM - Initial Application (only accessible from within eRA)
• HRP-503: TEMPLATE - Protocol
• HRP-502- TEMPLATE - Consent Document
• Supporting Documents (recruitment flyers/emails/scripts, survey questions, interview scripts, screening documents, investigator brochures, package inserts, etc.)

Use HRP-313: WORKSHEET - Expedited Review to compare your study against the criteria IRB staff use to determine and review expedited research. (Note: This PDF must be downloaded in order to be properly viewed and utilized; it may not display in an online browser.)

A full board classification indicates that your study does not qualify for review using the expedited procedure and must be reviewed by a full convened panel of reviewers. Full board submissions must be received by 11:59PM for the current month’s submission deadline.  Panel meetings are held once a month per board. For a schedule of submission deadlines see the Submission Deadlines page.

Please note that if a submission is received by the deadline but a pre-review indicates that the submission is incomplete or missing relevant and vital information, the submission will not be reviewed at the upcoming meeting. Only vetted submissions will be scheduled for review by the convened panel.

A full board submission packet should include (but is not limited to):

• HRP-211: FORM – Initial Application (only accessible from within eRA)
• HRP-503: TEMPLATE - Protocol
• HRP-502- TEMPLATE - Consent Document
• Supporting Documents (recruitment flyers/emails/scripts, survey questions, interview scripts, screening documents, SARC reports, INDs, package inserts, etc.)

Once the submission has been reviewed, you will receive a letter of the decision that the board has agreed upon. This letter may be a request for modifications, deferral or approval.

Allow for up to 2 weeks to receive a letter before you contact the IRB office.