Institutional Review Board
Thank you for your interest in conducting research at Covenant Medical Center. Covenant Medical Center only accepts research projects from privileged physicians, student employees, or medical students/medical residents who are enrolled in the CMU College of Medicine program. Below is a series of steps listed to help you through the many aspects of conducting research at this organization. Contact email@example.com (IRB Administrator) for further inquiries.
The information below is intended for Non-Student Investigators. If you are a Student Investigator and are interested in conducting a research project at Covenant Medical Center, please click the students link for specific requirements.
The Covenant HealthCare Institutional Review Board (IRB) uses IRBNet as a gateway for submission of protocols and communication.
Many of the forms you are required to complete (application, continuing review, revision of a protocol) are contained within the IRBNet site under the Forms and Templates Library, and can also be found here.
There are two types of applications (levels of IRB review): Exempt and Full Board/Expedited.
- If you are interacting with patients through intervention you will need to use the Full Board/Expedited Application. Survey projects may require full board or may be expedited. It depends on the study. Chart review/retrospective review generally will be an exempt or expedited review.
- If you are collecting data and performing chart review you should complete the "exempt determination tool" to see if you qualify for exempt status. If yes, use the Exempt Application. If you do not meet these criteria, please complete the Full Board/Expedited Application provided on the site. (All forms are under the Forms and Templates tab - see attachments).
Additional IRBNet Submission Forms
Note: Research which proposes to utilize Covenant resources (nursing time, inventory, equipment, rooms, etc.) need to be reviewed by other individuals at Covenant prior to submission to the Covenant IRB.
- Contact Ann Ostrander, Covenant Research Nurse, at firstname.lastname@example.org, or by phone at 989.583.6364.
Contract considerations - Ann Ostrander will help facilitate this process.
- Billing: Commercially sponsored studies need to be reviewed for billing and standard of care considerations.
- Finance: Finance department needs to review, approve, and sign off on the project.
- The Contract must be sent to the Business and Ethics Committee for review and signature.
- The Contract, protocol and informed consent documents must be reviewed by Covenant's legal department.
Please review the Covenant IRB Research Application Process, Investigator Responsibilities (all Investigators) and determine your Investigator type (if you are a student) prior to completing and uploading your project. Student investigators have additional requirements to complete prior to research submission.
Please upload the following documents:
- Your completed and signed application (electronic signature preferred)
- CV/resume of the investigator and that of any sub-investigators
- Data collection tool
- Protocol or Abstract (if applicable)
- Investigator Brochure (if applicable)
- FDA IND or IDE approval letter (if applicable)
- Any other applicable materials related to the study
- This IRB does require that you provide evidence of completion of a Human Subject Protection education. If you have completed CITI training, please upload the completion certificate. If you have not, you can receive CITI Training as a benefit of your employment at Covenant HealthCare. Visit the CITI training page for more information.
Communication with the Covenant IRB Office
- You need to use the “project email” tab within your project in IRBNet for all communication with this office. This will allow the IRB Office to track and audit our correspondence.
Timeline for Review
- Expedited or Exempt Review: You should have a decision letter from the IRB approximately one week after submission.
- Full Board Review: The IRB full board committee meets monthly.
Resources and References
Covenant Research Related Contacts