Application
Faculty members, staff members, or students who are planning research projects involving human subjects are responsible for beginning the review process by submitting an IRB Application. The Chair of the IRB has been designated to oversee initial reviews at the College.
Review
The Chair assigns the proposal to one of three categories once you determine your level of review (risk):
- Level I: Exempt (no foreseeable risk),
- Level II: Expedited Review (minimal risk), and
- Level III: Full Board Review (more than minimal risk and protected subjects).
It is expected that most research projects may well fall into the Exempt category. Research in this category requires no further review beyond the initial review level. Those proposals the Chair decides require Expedited Review will be forwarded to one member of the IRB who then has responsibility for the review of that proposal. Proposals judged by the Chair to require Full review will be forwarded to all members of the IRB, and the IRB as a whole will perform the review. All research proposals evaluated by the Chair, by one other member, or the full IRB are done so with regard to the degree of “risk,” if any, to human subjects.
Outcomes
There are four possible outcomes to a review:
- Approved: No further action is required from the investigator prior to initiating the study.
- Approved if Designated Changes are Made: The investigator may initiate the study after requested changes are made, and the IRB receives these revisions and notifies the investigator that he or she may proceed.
- Revise and Resubmit: More extensive changes are required before the study may begin. Additional information must be submitted to the IRB prior to approval.
- Denied: The proposed research, because of the level of risk involved, cannot be initiated.
Expiration and Renewal
Research approved by the IRB that is continuing must be re-reviewed and recertified on an annual basis by the IRB.