Forms

What Needs IRB Review

Exempt categories are defined in the federal regulations governing research involving human subjects. There is no submission deadline for submitting Exempt applications. Reviews are usually completed within 14 days of receipt. It is recommended that you submit your IRB packet at least a month before your anticipated start date.

Exempt Research Application Form
Additional Research Team Members Form

Adult Informed Consent Templates

Information Letter - No Signature 
Information Letter for Online Studies
Informed Consent  with Signature Section for Studies Using Student Educational Records
Oral Consent Script
Debriefing/Permission to Use Information Collected in a Research Study

Parents/Guardians and Minors Informed Consent Templates

Parent Permission - No Signature
Parent Permission with Signature Section for Studies Using Student Educational Records 
Child/Minor Assent

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(i)]. Research involving prisoners does not qualify for expedited review, a Full Board review is required.

There is no submission deadline for submitting Expedited applications. Reviews are usually completed within 4-6 weeks of receipt. It is recommended that you submit your IRB packet at least 45 days before your anticipated start date.

Expedited Research Application Form
Secondary Data Set Analysis Only Application Form - for research involving existing materials (data, documents, records, or specimens) that includes or will be linked to identifiable private information
Additional Research Team Members Form
Child Research Addendum - additional form required for research involving children/minors

Adult Informed Consent Templates

Informed Consent with Signature Section
Information Letter -No Signature (waiver of documentation of informed consent is required to use this template) 
Information Letter for Online Studies (waiver of documentation of informed consent is required to use this template)
Oral Consent Script (waiver of documentation of informed consent is required to use this template; additional consent waivers may be required)
Debriefing/Permission to Use Information Collected in a Research Study

Parents/Guardians and Minors Informed Consent Templates

Parent Permission with Signature Section
Parent Permission - No Signature (waiver of documentation of informed consent is required to use this template)
Child/Minor Assent with Signature Section
Child/Minor Assent - No Signature

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 Form
Additional Research Team Members Form
Child Research Addendum - additional form required for research involving children/minors
Prisoner Research Addendum

Adult Informed Consent Templates

Informed Consent with Signature Section
Informational Letter - No Signature (waiver of documentation of informed consent is required to use this template)
Additional Information/Permission to Use Information Collected in a Research Study

Parents/Guardians and Minors Informed Consent Templates

Parent Permission with Signature Section
Parent Permission - No Signature (waiver of documentation of informed consent is required to use this template) 
Child/Minor Assent with Signature Section
Child/Minor Assent - No Signature

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. 

If you will be collaborating with researchers from another institution (external researchers), it may be possible to have a single IRB review the protocol. However, relying on another IRB's approval must be approved by the Clemson IRB. Researchers planning to collaborate with external researchers are encouraged to consult with Nalinee Patin, IRB Administrator, at (864) 656-0636 during the planning phase of the project. 

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 affiliated personnel (faculty, staff, and students). The Clemson IRB must maintain complete records of the research being conducted by Clemson researchers. Collaborative projects may require additional time due to negotiating Individual Investigator Agreements, IRB Authorization Agreements (reliance agreements), and communications with additional parties.

Clemson requires a concurrent submission for all collaborative projects: Deferral Request Coversheet for non-HSSC instiutions

Cooperative Review for Health Sciences South Carolina (HSSC) Institutions

Clemson University has agreements in place to cooperate on IRB reviews with several institutions in South Carolina. To facilitate submission and timely review of research studies, please contact Nalinee Patin to discuss the project and to determine which HSSC institution should be the lead reviewer for the research study.

HSSC Cooperative Review Coversheet
HSSC Submission Flowchart
Information for Principal Investigators Submitting Biomedical Research Protocols to the Greenville Health System (GHS) IRB - outlines the concurrent submission process

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, increase in enrollment, recruitment procedures or documents, incentives, informed consent process or document). Significant changes to the protocol may require a new application. 

It is the responsibility of the principal investigator (PI) to report all adverse events and/or unanticipated problems regarding an approved research study promptly to the IRB office at (864) 656-0636.

Unanticipated Problem/Adverse Event Form
Unanticipated Problems Involving Risks and Adverse Events Guidance