Skip to main content

Information for submitting to the Greenville Health System IRB

The Greenville Health System (GHS) IRB will review research studies involving data collected from or about patients and/or staff of GHS or its entities. Additionally, Clemson University (CU) has an agreement with GHS for the review of biomedical and clinical research conducted by CU faculty, staff and students.

The term “biomedical research” is not easily defined but refers to laboratory-based and clinical research designed to define, treat, and / or prevent human diseases or conditions. It may include human participation, records-based studies, clinical samples, or technology development for clinical trials.

The Clemson University IRB is not registered with the FDA, as is now required for all IRBs that review “clinical investigations that are intended to support applications for research or marketing permits for FDA-regulated products” (21 CFR 56.106). Therefore, the CU IRB will ask the GHS IRB to serve as the lead IRB in the review of any CU-affiliated human subjects research involving the development of products to be regulated by the FDA.

Even if a particular study will collect non-medical data from healthy human subjects, it may fall within the regulatory definition of a “clinical investigation,” which is, “any experiment that involves a test article and one or more human subjects, and that either must meet the requirements for prior submission to FDA, or need not meet the requirements for prior submission but the results are intended to be later submitted to or held for inspection by FDA as part of an application for a research or market permit” [21 CFR 56.102(c)] (emphasis added).

It is important to note that the Clemson University IRB will still review some health-related research studies in the area of social and behavioral sciences. Principal Investigators (PIs) should contact the Office of Research Compliance (ORC) at CU for guidance.

  • How do I get started?
    To facilitate submission and timely review of research studies, please contact Clemson University’s IRB at IRB@clemson.edu to discuss the purpose of the project and to determine which institution should review the research study.
  • Will the Clemson University IRB look at my application?

    If the research falls under the scope of the GHS/Clemson “IRB Authorization Agreement,” the CU IRB will not conduct a complete review. In such cases, the GHS IRB will be the “lead IRB” or “IRB of Record” and will conduct the initial review, continuing review, review of amendments, and general oversight. However, the CU ORC will accept the GHS IRB’s reviews (via administrative review) and will keep complete records of the research study.

    All research studies involving the use of human subjects that are submitted to GHS under this agreement will undergo administrative review by Clemson’s ORC. After administrative review, the ORC will send an administrative review notification to the PI.

  • Who will serve as PI for the IRB study?

    If the GHS IRB will conduct the review of the study, in most cases a CU faculty member may serve as the PI on the study. However, who may serve as the PI on a study reviewed by the GHS IRB is subject to the policies of the GHS IRB.

    If your study involves interaction and/or intervention with patients, a GHS physician must be listed as an investigator.

    In some cases, there will be different PIs at GHS and at CU, due to the different policies governing who may serve as a PI at each institution.

    The CU PI must be qualified to serve as a PI under the CU research policy that defines the Assignment of the Principal Investigator/Project Director Role. In general, this includes all full-time regular faculty, visiting faculty/scientists during the time they are employed by the University, and full-time staff, including research faculty and post-doctoral scholars. This policy, however, does not allow a student to serve as the PI of his/her dissertation/thesis research, regardless of his/her employment status at CU. A variance procedure for others wishing to serve as CU PIs is also described in this document.

  • How do I prepare an application for the GHS IRB and CU ORC Administrative Review?

    To prepare an application for submission to the GHS IRB and CU ORC administrative review, complete the electronic application on the GHS eIRB site at http://eirb.healthsciencessc.org/. Demonstration videos are available at http://university.ghs.org/eirb/.

    Your registration will need to be confirmed by a GHS IRB staff before you may interact further with this system. Please contact the GHS IRB office at (864) 455-6607 for more information about the registration process.

    When entering study personnel into the eIRB system, add “Clemson IRB” to the Guest List on the study.

    Complete CU’s HSSC Cooperative Review Cover Sheet, available on the Forms page, and email it to IRB@clemson.edu concurrent with submission of the application to the GHS IRB.

  • How will the Clemson University ORC conduct the administrative review?

    Once the GHS IRB has approved the study, an ORC staff will conduct the administrative review.               

    If the CU IRB administrative review has revealed any concerns, these concerns will be communicated to CU PI and lead IRB staff at the same. After the ORC has completed its administrative review, the office will notify the PI and the appropriate GHS IRB coordinator.

  • When may I begin my research?
    When the GHS IRB has approved the study, CU researchers may begin conducting the study.
  • How do I know who to contact at GHS?
    The contact information for the GHS IRB coordinators are available on their website at http://university.ghs.org/research-protection/.
  • What kind of human subjects training will I need? Will my Clemson University CITI training be accepted?
    The GHS IRB and CU IRBs have agreed to accept each other’s required training. The eIRB system will automatically upload your CITI training information. If there are issues with your training, you may be required to manually upload a copy of your training certificate to the eIRB application.
  • How long will it take for GHS to conduct the review?
    Depending on the research you are proposing, the review process will vary and may require additional review by other committees/offices within GHS. Please contact the appropriate IRB committee coordinator, http://university.ghs.org/research-protection/, for specific information about their review process.
  • What are my responsibilities to Clemson University as a PI?
    A PI must obtain administrative review from CU ORC by submitting the HSSC Cooperative Review Cover Sheet, available on the Forms page, to the CU ORC for each eIRB application. The ORC will conduct an administrative review of the application materials.