PLEASE NOTE: The entire IRB protocol is reviewed at one level. The level of review will be the highest level required based on research activities.
Use the Exempt Application for submission of protocols. Exempt categories are defined in the Federal regulations governing research involving human subjects. These categories include the following:
For more details, please see Exemption Categories.
Research involving prisoners does not qualify for exempt status. Research involving other vulnerable subject populations may not qualify as exempt. Please contact the IRB Coordinator, at 864-656-0636 to discuss the specifics of your research study if you are not sure whether your study qualifies for exempt status.
Exemption may be determined only by the IRB/ORC. As per Federal guidance, determinations of exemption are not to be made by the investigator.
Use the Expedited and Full Review Application. This category includes research activities involving no more than “minimal risk” to subjects and falling within the defined Expedited Categories. “Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests” [45 CFR 46.102(i)]. The Expedited Categories include the following:
For more details, please see Expedited Categories.
Please note: Research involving prisoners does not qualify for expedited status.
Use the Expedited and Full Review Application . If your study does not qualify for exempt or expedited review, full review by the convened IRB is required. All required documents must be submitted to the Office of Research Compliance, 223 Brackett Hall, no later than 4:30 p.m. on the specified deadline date (IRB Meeting Schedule and Full Review Submission Deadlines). The IRB usually meets on the first Wednesday of each month.
When definite plans for the involvement of human subjects are not available and IRB review is needed to establish a funding account, then developmental approval may be sought. Please see our Developmental Approval Form for more information on this process. While developmental approval allows the establishment of an account, work with human subjects, human data, or specimens may not begin until final IRB approval of an Exempt or Expedited/Full Review Application.
If you will be conducting your research at another institution that has its own IRB or if you will be collaborating with researchers from another institution that has its own IRB, it may be possible to only have one IRB review of your protocol. However, deferral of the review to another IRB must be approved by the Clemson IRB. Please consult with Nalinee Patin, IRB Administrator, at (864) 656-0636 to discuss the possibility of deferral.
If Clemson University agrees to defer review of your protocol to the IRB of another institution, Federal regulations still hold Clemson University responsible for all human subjects research conducted by Clemson-affiliated personnel. Therefore, Clemson IRB policy requires submission of the other institution's application packet to the Clemson IRB CONCURRENT WITH submission of the same packet to the other IRB. The Clemson IRB must maintain complete records of the research being conducted by Clemson researchers. Submission of these protocols also allows the Clemson IRB staff to assist researchers with the sometimes complex process of working with multiple IRBs.
Please note that collaborative work involving researchers at other organizations, especially other organizations that have their own IRBs, may require additional time due to negotiating Individual Investigator Agreements, IRB Authorization Agreements (deferral agreements), and communications with additional parties.
The Clemson IRB has agreements in place to cooperate on IRB reviews with several institutions. The agreement with the Greenville Hospital System is the best-defined of these agreements. Information for Principal Investigators Submitting Biomedical Research Protocols to the GHS (Greenville Hospital System) IRB spells out the process for submitting a protocol to the GHS IRB. Clemson researchers planning to submit IRB applications to GHS or other institutions or to collaborate with researchers at other organizations should first contact Nalinee Patin, IRB Administrator, at 864-656-0636.