TYPES OF REVIEWS

Initial Submissions:  There are three categories of review:  Exempt, Expedited, and Full Board (see Decision Charts).

The FORMS for submission are available on line ( IRB FORMS)

1. Exempt - exempt from the requirement for IRB approval when it is determined that research does not involve human subjects or the only involvement of human subjects is in one of the categories listed under 45 CFR 46 Section 101(b)(1)-(6) and 21 CFR 56.104(d) . Human subjects regulations do not apply to exempt projects. Any research project involving human subjects thought to be exempt must be submitted to the IRB for determination of exempt status.
2. Expedited - review of proposed research by the IRB Chair or a designated voting member or group of voting members, rather than by the entire committee. Federal rules permit Expedited review for certain kinds of research involving no more than minimal risk and for minor changes to previously approved research. (see Decision Charts)
3. Full Board - review of proposed research at a convened meeting where a valid quorum of IRB members is present.

ADDITIONAL REVIEWS

• Continuing review  - review that is conducted at intervals appropriate to the degree of risk, but at least once each year.
• Modification – during the course of a study there may be changes made to the protocol, consent form, HIPAA, addition or deletion of key personnel, increase of accrual, etc. that must be submitted to the IRB for approval before implementation.