Forms

Coming Soon: The new IRB electronic submission system, which will allow complete dynamic and electronic protocol submissions within InfoEd, will be available spring 2021. When this system is deployed, the IRB applications below will be transitioned to eForms within the new system and no longer available on the IRB website.

What Needs IRB Review

Resources for Resuming In-person Research

COVID-19 research resources are available here and on Occupational and Environmental Safety webpage.

  • Exempt

    Exempt categories are defined in the federal regulations governing research involving human subjects. There is no submission deadline for submitting Exempt applications. Submissions are processed as received. We recommend submitting your IRB packet at least 30 days before your anticipated start date.

    Exempt Research Application

    Additional Research Team Members Form

    Adult Informed Consent Templates
    Parents/Guardians and Minors Informed Consent Templates
  • Expedited

    Expedited categories are defined in the federal regulations governing research involving human subjects and includes research activities involving no more than “minimal risk” to subjects. “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(j)]. Research involving prisoners does not qualify for expedited review, a Full Board review is required.

    There is no submission deadline for submitting Expedited applications. Submissions are processed as received. We recommend submitting your IRB packet at least 45 days before your anticipated start date.

    Expedited Research Application

    Additional Research Team Members Form

    Minor Research Addendum

    Secondary Data Set Analysis Application – for use of existing data (datasets, documents, records or specimens) not publicly available.

    Informed Consent Templates for Social, Behavioral, Education Research (SBER)
    Informed Consent Templates for Research Involving Biospecimens or Drugs

    Minor Assent Template

    Debriefing Form - required for studies involving deception or concealment

  • Full

    If your study does not qualify for Exempt or Expedited review, then Full Board review by the convened IRB is required. All required documents must be submitted to the Office of Research Compliance no later than 4:30pm on the specified deadline date ( IRB Meeting Schedule and Full Review Submission Deadlines). It is recommended that you submit your IRB packet at least 60 days before your anticipated start date.

    Full Board Application

    Additional Research Team Members Form

    Minor Research Addendum

    Informed Consent Templates for Social, Behavioral, Education Research (SBER)
    Informed Consent Templates for Research Involving Biospecimens or Drugs

    Minor Assent Template

    Debriefing Form - required for studies involving deception or concealment

  • Developmental Approval

    For funded projects only. When definite plans for the involvement of human subjects are not yet available and IRB review is needed to establish a funding account, then developmental approval may be granted. While developmental approval allows the establishment of a funding account, work with human subjects, human data, or specimens may not begin until final IRB approval of an Exempt, Expedited, or Full Board review application. 

    There is no submission deadline for submitting Developmental Approval applications. Approvals will be granted for a maximum of one year. Extensions may be granted with a new timeline for the human subjects research activities within the protocol.

  • Deferral Request

    A deferral request is required if Clemson personnel will be involved in a multi-institutional research study and the Clemson IRB office will not be the IRB of record for the study.

    The IRB office recommends that Clemson personnel planning to collaborate with external researchers consult with the IRB office during the planning phase of the project to discuss the single IRB review process. Multi-institutional projects may require additional time to negotiate IRB agreements and communicate with collaborating institutions.

    If Clemson University agrees to rely on another IRB's approval, federal regulations still hold the university responsible for all human subjects research conducted by Clemson personnel (faculty, staff and students). The Clemson IRB office must maintain a record of all human subjects research involving Clemson personnel.

    Clemson IRB office approval is required before Clemson personnel may engage in human subjects research.

  • Amendments

    Any proposed change in a protocol, which affects the human participants, must be reviewed and approved by the IRB prior to implementation; except when an immediate change is necessary to eliminate a hazard to the participants, or to provide participants with new information on adverse event or research results considered essential to a participant's decision whether to continue participation.

    The principal investigator (PI) must submit the Amendment Request form, with a complete description of the changes, and attach new and/or revised document(s) with the request. Do not revise the initial IRB application or attach with request; initial applications may not be altered after approval is granted.

    All changes should be reported to the IRB (i.e., changes to study personnel should be submitted on the team member sheet, increase in enrollment, recruitment procedures or documents, incentives, informed consent process or document).

  • Reportable Event

    The Principal Investigator (PI) is responsible for reporting all events promptly to the IRB office at (864) 656-0636.

    Reportable events include unanticipated psychological discomfort, negative physical reactions, experience of side effects, reports to authorities, loss of consent forms and/or data collection instruments, or any other study-related events that deviate from the protocol, regulations, or policies.

    Reportable Event Form
    Unanticipated Problems Involving Risks and Adverse Events Guidance