Types of Reviews

The IRB has the authority to provide the following types of review - please contact the IRB office for questions or assistance...

Compassionate/Expanded Use -

  • A process through which IRB approval can be obtained for a single patient use of an investigational drug, device or biological product, in a situation that is not life threatening, and all other means of treatment have been exhausted.  Review of compassionate/expanded use must be conducted at a full board (convened) meeting.

Emergency Use

  • A process through which IRB acknowledgment can be obtained for the of use of an investigational drug, device, or biological product for a single patient, who is who is an immediately life-threatening. 

Exempt Determination

  • A process through which the IRB determines if a reserach project  meets the criteria for an exempt determination (45 CFR 46.101(b).

Expedited Review

  • A process through which IRB approval can be obtained for a clinical trial with no more than minimal risk to human subjects.  Expedited reviews do not require full board review and are reviewed by the IRB on a first come, first served basis.

Facilitated Review

  •  A process through which IRB approval can be obtained for a clinical trial for which IRB has previously provided initial full board review and approval for a different investigator/reserach site.
  • Contact the IRB for assistance -- institutional.review.board@providence.org

Full Board Review

  • A process through which IRB approval can be obtained for a clinical trial with greater than minimal risk to human subjects.  Review must be conducted at a full board (convened) meeting and the investigator must present the study at the board meeting. 

The IRB is authorized to approve, disapprove, or approve "with modifications" clinical trials that involve human subjects and are to be conducted in any of the Providence Health Care Facility and the Providence Medical Group. The IRB may review clinical trials for community investigators on a case by case basis.