Routing of Proposals Through the Office of Human Subjects Protection (OHSP)

If a Principal Investigator receives a sponsored grant award, the ORSP submits a copy of the award letter to the OHSP. The next phase in the process is for the proposal to be reviewed by the IRB Committee. The PI cannot begin recruiting subjects until the IRB Committee gives final approval. Many sponsors also require an approval letter from an IRB before they distribute funds to a PI.

Routing of proposals through the OHSP to UNC-CH IRBs (interim process)

The IRB Authorization Agreement between Shaw and UNC-CH allows Shaw investigators to utilize the UNC-CH IRBs for review and oversight of human subject research until Shaw establishes its own IRB. The process for IRB review will be as follows:

• If a proposal is awarded funding by a sponsor, the Shaw Office of Research and Sponsored Programs (ORSP) will notify the Principal Investigator (PI).
• The ORSP will also notify the Shaw Office of Human Subjects Protection (OHSP) of the award - NOTE: the Carolina-Shaw Partnership for the Elimination of Health Disparities office is currently working to develop the Shaw OHSP and Shaw IRB; in the interim, the OHSP duties will be completed by Tessa Walker.
• The OHSP will contact the PI and provide instructions on the UNC-CH IRB submission process and assistance with preparation of the following forms:
  1. IRB application
  2. Health Insurance Portability and Accountability Act (HIPAA) Authorization form
  3. Research Ethics Education Certificates for all people working on your project staff
  4. Consent form(s)
  5. Original protocol
  6. Questionnaires or survey instruments
  7. Recruitment materials
• The OHSP will submit all finalized paperwork to the appropriate UNC-CH IRB for review.
• The IRB will review the application for completeness. If not complete, the PI will receive notification from the IRB and will work with the OHSP to provide the required information.
• If the application is complete, the IRB will make the determination of the level of review required.
• The IRB will contact the PI with the results of the review process. PLEASE SUBMIT A COPY OF THIS AND ALL CORRESPONDENCE RECEIVED FROM THE IRB TO THE OHSP. Revisions may be required before the application is approved. The PI and OHSP will work together to make the appropriate revisions and resubmit the application to the IRB.
• Once the application is approved, the PI will receive an approval letter from the IRB.
• The OHSP will submit a copy of the approval letter to the sponsor and to the ORSP. The PI cannot begin work on the project until the ORSP receives the IRB approval letter.
• The ORSP will inform the Grants Accountant who will establish budget codes for the PI’s project.
• Any modifications to the protocol need to be approved by the IRB before the change can be implemented. These modifications may include revisions to the protocol, consent form, recruitment materials, survey instruments, phone scripts, training materials, brochures, posters, or changes in project staff. Please consult with the OHSP for assistance.
• IRB approvals are valid for a maximum of one year. The IRB will notify the PI that the approval period is due to expire. At that time, you will have to submit an IRB renewal if you wish to extend your project beyond one year. All projects that are allowed to expire will have to cease recruitment and all work on the project will have to stop. The OHSP is available for assistance with the renewal process to the UNC-CH IRB.
• PI’s must submit a copy of all correspondences received from the IRB to the Shaw OHSP.