Body
Title
Office of Human Research Ethics SOP 1601: Sponsored Research
1. Purpose
It is the University of North Carolina at Chapel Hill ("UNC-Chapel Hill" or "University") policy that any sponsored research conducted under the auspices of UNC-Chapel Hill is conducted in accordance with federal guidelines and ethical standards.
This SOP describes the procedures required to ensure that all sponsored research meets University requirements.
2. Procedure
2.1 Responsibility
2.1.1 Subject injury language: Informed consent documents for UNC-Chapel Hill clinical trials must contain subject injury language. Subject injury language must be reviewed by the UNC-Chapel Hill Office of Clinical Trials (OCT). UNC-Chapel Hill investigators must contact the OCT for subject injury language review and upload a copy of the OCT’s subject injury language approval memo in the initial IRBIS application. IRB reviewers are responsible for reviewing the subject injury language approval memo to ensure that the informed consent document includes subject injury language that is consistent with that in the OCT approval memo in initial applications, modifications, and renewals. If subject injury language in the consent document is not consistent with that in the OCT approval memo, UNC-Chapel Hill investigators must either update the consent document or obtain and provide an updated memo from the OCT.
2.1.2 Other contractual obligations: Sponsor grants, contracts, and other written agreements will be reviewed for the following by the Office of Sponsored Programs and/or the Office of Industry Contracting, including consultation with the IRB, as necessary:
- All sponsor contracts have a written agreement with the Sponsor that addresses medical care for research participants with a research-related injury, when appropriate including who will provide care and who is responsible to pay for it.
- In studies where Sponsors conduct research site monitoring visits or conduct monitoring activities remotely, the sponsor contracts have a written agreement with the Sponsor that the Sponsor promptly (no longer than within 30 days) reports to the UNC-Chapel Hill findings that could affect the safety of participants, influence the conduct of the study, or alter the IRB’s approval to continue the study.
- When the Sponsor has the responsibility to conduct data and safety monitoring, the sponsor contracts have a written agreement with the Sponsor that addresses provisions for monitoring the data to ensure the safety of participants and for providing data and safety monitoring reports to UNC-Chapel Hill. Contracts or other funding agreements specify the time frame for providing routine and urgent data and safety monitoring reports to the organization as indicated in the data and safety monitoring plan approved by the IRB. Investigators or the organization conducting the research are required to forward this information to the IRB.
- Sponsor contracts have a written agreement with the Sponsor about plans for disseminating findings from the research and the roles that investigators and Sponsors will play in the publication or disclosure of results.
- When participant safety could be directly affected by study results after the study has ended, the sponsor contracts have a written agreement with the Sponsor that the investigator or UNC-Chapel Hill will be notified of the results in order to consider informing participants. Contracts or other funding agreements specify a timeframe after closure of the study during which the sponsor will communicate such findings (e.g., two years). This should be based on the appropriate timeframe for each individual study.
2.1.3 Finder’s fees and bonus payments: Payment in exchange for referrals of prospective participants from investigators (physicians) (“finder’s fees”) is not permitted. Similarly, payments designed to accelerate recruitment that are tied to the rate or timing of enrollment (“bonus payments”) are also not permitted.
Contact Information
Policy Contact
Name: Kimberly Brownley
Title: Associate Director of Policy and Initiative
Unit: Office of Human Research Ethics (OHRE)
Email: kim_brownley@med.unc.edu