What's New in IRB

Guidance on the Submission of Research Site Letters

Revised Policies: The policy that describes the steps Clemson University (CU) Investigators must follow when submitting research protocols involving human subjects to the Greenville Hospital System (GHS) has been revised. All protocols being submitted to GHS for review must undergo administrative pre-submission review by the Office of Research Compliance at CU. This is due to the fact that the CU IRB is fully responsible for all research carried out by CU Investigators, even when their research studies have been reviewed by other IRBs. It also allows the CU IRB to comply with the federal requirement that it assure that resources are available from CU to proceed with the research. The PI must submit a copy of the application that is being submitted to GHS to the CU Office of Research Compliance, including a copy of the proposed consent forms(s), protocol, and any attachments, prior to its submission to GHS.

The full revised policy is available at: Information for Principal Investigators Submitting Biomedical Research Protocols to the Greenville Hospital System (GHS).

IRB Forms: Forms are updated on a regular basis. Researchers are encouraged not to save current forms for future use. Protocols submitted using older (out-of-date) forms will not be accepted.

Research Protocols Exempt from IRB Continuing Review: There have been many questions about research protocols that are exempt from IRB continuing review. In order to help you determine whether your research study meets the federally-defined criteria and to help you complete the necessary paperwork, please see our Exempt Research Help page. Even if your research study meets the federally approved criteria, you need to submit your research protocol to the Office of Research Compliance's IRB Office. Federal guidance states that Principal Investigators may not validate that protocols meet federal exemption criteria. The Chair of the IRB or his designees will make that determination. If validated, the research protocol is exempt from continuing review (at least on an annual basis) by the IRB. If you have questions, please contact the Office of Research Compliance at 864-656-6460.