As part of the submission process for new or continuing studies, the Principal Investigator shall be asked to recommend whether the study, by its scope and protocol, falls into one of the specific review categories defined in 45 CFR 46 and 21 CFR 56. These categories are:
1) Exempt Review (does not apply to studies regulated by the FDA)
2) Expedited Review
3) Convened IRB Review
It is the responsibility of the Principal Investigator to understand and request an appropriate review category for his/her application. Investigators are urged to consult with HSRO regulatory staff before making their recommendations to the HSRO and the IRB regarding the review category.
The submissions and recommendations by the Principal Investigator are made to the HSRO where they are screened by trained HSRO staff who shall forward the recommendations of Principal Investigators and the recommendations made by them (the staff) on behalf of the HSRO to the IRB. Final decisions as to the review category of new or continuing studies shall be made by the IRB.
The HSRO recommends and the IRB determines review category on the basis of federal regulations and the guidance provided on the website of the Office for Human Research Protections (OHRP). Specific information on determining the review category for study applications is provided in subsequent sections of these policies.
Those studies recommended recommended and meeting criteria for exempt or expedited review shall be forwarded to the IRB chair or chair-designee for review. Chair-designees must be members or alternate members of the IRB. The IRB chair or chair-designee shall make the final decision as to whether the study may be reviewed within the proposed exempt or expedited category or whether the study should be deferred to the convened IRB.
IRB chairs and chair-designees shall conduct reviews of studies that fit within the exempt or expedited categories on behalf of the IRB. The applications of those studies that fit under the "Convened IRB Review" category shall be made available to all members of the IRB. IRB chairs/IRB-designees may determine that studies recommended for exempt or expedited review require convened IRB review. Conversely, the convened IRB may determine that studies recommended for "Convened IRB Review" require exempt or expedited review.