Institutional Review Board
The Institutional Review Board (IRB) is the formal structure to review, approve, and monitor research conducted at St. Mary’s Health by physicians, nurses, or students. IRB meets quarterly on the 2nd Friday of the month at 7:00 a.m. in the Administrative Board Room.
Each principal investigator (PI) of a new application is required to introduce the study or project under review to the IRB at a regularly scheduled meeting.
New applications and annual reports are due three (3) weeks prior to the meeting.
All student projects, research or non-research, conducted on any of the St. Mary’s campuses, must have IRB approval before any data collection can be done. This includes collecting information from nurses, physicians, patients, medical records, or medical center databases.
|IRB Meeting Date
||Meeting Packet Deadline|
|March 11, 2016
||February 19, 2016
|June 10, 2016
||May 20, 2016
|September 9, 2016
||August 19, 2016
|December 9, 2016
||November 18, 2016
|March 10, 2017
||February 17, 2017
Categories for Review:
- Exempt: Research studies that do not qualify as research or do not include human subjects. Exempt status is not determined by the PI. Submit the appropriate application. In the cover letter please indicate your justification for the study meeting the criteria for exempt status. If the IRB grants exempt status, your project can commence and is no longer under IRB jurisdiction.
- Expedited: This is a quick review with turnaround time approximately seven (7) business days and must be requested in the cover letter. Research that meets the criteria for expedited approval, involves no more than minimal risk, or is minor changes of an already approved application. Student projects can be requested to have an expedited review. Temporary approval is given until the next IRB meeting. No data can be collected until approval letter is received. The PI or Project Leader is expected to present at the IRB meeting following the expedited approval date.
- Full: This review applies to all studies that are not considered exempt or have greater than minimal risks. The PI is expected to present study to IRB before any study data collection commences.
Steps for Approval:
- Understand the IRB guidelines by reading the St. Mary’s IRB policy.
- After your research plan is complete or your student project is written and has faculty approval, submit the appropriate application form.
- All PIs and Student Project Leaders must complete a human subject protection course and submit copies of documenting completion of the course. If you need assistance in finding a course, contact Rebecca P. Winsett,PhD, RN.
- Submit your completed application in one (1) single document. The order of the document is as follows:
- Cover letter
- Face page of IRB application with all appropriate signatures.
- IRB application
- Reference page
- Appendix 1 should be the copies of all human subject protection certificates of all personnel listed on the face page.
- If your study is supported by a grant or multi-center study, submit a copy of the grant application, or a copy of the multi-center study protocol. The multi-center study protocol is NOT your IRB application.
- Submit the application in a single document to the IRB via email. The document can be emailed to Sheila Hawes via email@example.com
- Once notified that you are on the IRB agenda, please attend the meeting to describe your study and answer questions of the IRB.
- Once approval is received, you may start your study or student project.
- During the first year of the study, the PI or Project Leader must submit a report at 6 and 12 months. To continue a study, an annual report must be submitted. No study may continue without annual IRB review.
- A closure form and an abstract of findings are submitted to close the study.
The following links are forms used to complete an IRB application. The IRB policy is included below for additional reference. If you need assistance, contact Rebecca P. Winsett,PhD, RN.