Forms & Documents
Please submit IRB forms/documents to irb@clemson.edu
- Adverse Event/Unanticipated Problem
- Amendment Request
- Closure Request (final report summary)
- Continuing Review
- Deferral Request (review by another organization's IRB; for review by another HSSC Organization - GHS, MUSC, Palmetto Health, Spartanburg Regional, USC, see HSSC Cooperative Review section)
- Developmental Approval
- Exempt Review
- Exempt Protocol Extension Request
- Expedited Review
- Full Board Review
- HSSC Cooperative Review (GHS, MUSC, Palmetto Health, Spartanburg Regional, USC; for review by a non-HSSC organization, see Deferral Request section)
- Reviewer Forms (IRB committee members only)
1. Adverse Event/Unanticipated Problem
Adverse Event/Unanticipated Problem Form (version 8/9/13)
2. Amendment Request
Amendment Review Process
Amendment Request (version 8/9/13)
Additional Research Team Members Form (version 8/9/13)
Waiver of Consent Addendum (expedited/full review protocols only) (version 10/21/11)
Waiver of Documentation of Consent Addendum (expedited/full review protocols only) (version 10/21/11)
Waiver of Elements of Consent Addendum (expedited/full review protocols only) (version 8/9/13)
3. Closure Request (final report summary)
Final Summary Report (version 8/9/13) Continuing Review of Expedited/Full Protocols
4. Continuing Review of Expedited/Full Protocols
Continuing Review Process
Continuing Review (version 8/17/12)
5. Deferral Request (review by another organization's IRB; for review by another HSSC Organization - GHS, MUSC, Palmetto Health, Spartanburg Regional, USC - see HSSC Cooperative Review section)
Deferral Review Process
Deferral Request Cover Sheet (version 6/7/12)
6. Developmental Approval
Developmental Review Process
Developmental Approval Form (version 8/9/13)
7. Exempt Review
Exempt Review Process
Exemption Categories
Exempt Research Application Form (version 6/1/13)
Exempt Review Cover Sheet (when using another institution's forms) (version 8/9/13)
Oconee Medical Center Research Application (use in conjunction with CU IRB application) (version 5/4/12)
Additional Research Team Members Form (version 5/13/09)
Information Letter (no signature - default for exempt) (version 2/15/12)
Information Letter (online research template) (version 6/24/13)
Informed Consent - Adult (signature/using student education records) (version 2/15/12)
Parent Permission (no signature - default for exempt) (version 2/15/12)
Parent Permission (signature/using student education records) (version 2/15/12)
Child/Minor Assent (no signature - default for exempt) (version 6/8/11)
Child/Minor Assent (signature) (version 6/8/11)
Verbal Consent Script (version 1/23/12)
Additional Information/Permission to Use Information Collected in a Research Study (version 2/15/12)
8. Exempt Extension Review Process
Exempt Extension Review Process
Exempt Protocol Extension Request Form (version 8/9/13)
9. Expedited Review
Expedited Review Process
Expedited Categories
Expedited Research Application Form (version 9/7/12)
Expedited Research Application Form - Data Set Analysis Only (used for large data sets where licensing or data sharing agreements will be executed) (version 9/7/12)
Oconee Medical Center Research Application (use in conjunction with CU IRB application) (version 5/4/12)
Informed Consent - Adult (signature - default for expedited/full board) (version 2/15/12)
Information Letter (no signature/requesting a waiver of documentation of consent) (version 2/15/12)
Information Letter (online research template/requesting a waiver of documentation of consent) (version 6/24/13)
Parent Permission (signature - default for expedited/full board) (version 2/15/12)
Parent Permission (no signature/requesting a waiver of documentation of consent) (version 2/15/12)
Child/Minor Assent (signature - default for expedited/full board) (version 6/8/11)
Child/Minor Assent (no signature) (version6/8/11)
Child Research Addendum (version 8/13/12)
Verbal Consent Script (may require waiver of some elements of informed consent) (version 1/23/12)
Additional Information/Permission to Use Information Collected in a Research Study (version 2/15/12)
Additional Research Team Members Form (version 5/13/09)
10. Full Board Review
Full Board Review Process
IRB Meeting Schedule and Full Board Review Submission Deadlines
Full Board Application Form (version 9/7/12)
Full Board Application Form - Data Set Analysis Only (used for large data sets where licensing or data sharing agreements will be executed) (version 9/7/12)
Oconee Medical Center Research Application (use in conjunction with CU IRB application) (version 9/26/13)
Informed Consent - Adult (signature - default for expedited/full board) (version 2/15/12)
Informational Letter (no signature/requesting a waiver of documentation of consent) (version 2/15/12)
Parent Permission (signature - default for expedited/full board) (version 2/15/12)
Parent Permission (no signature/requesting a waiver of documentation of consent) (version 2/15/12)
Child/Minor Assent (signature - default for expedited/full board) (version 6/8/11)
Child/Minor Assent (no signature) (version 6/8/11)
Child Research Addendum (version 8/13/12)
Additional Information/Permission to Use Information Collected in a Research Study (version 2/15/12)
Prisoner Research Addendum (version 4/20/09)
Additional Research Team Members Form (version 5/13/09)
11. HSSC (Health Sciences South Carolina) Cooperative Review (GHS, MUSC, Palmetto Health, Spartanburg Regional, USC; for review by a non-HSSC organization, see Deferral Request section)
GHS Submissions Guidance for Clemson Researchers (version 9/10/14)
GHS - Deferral Request Cover Sheet (version 4/14/14)
HSSC Submissions Flowchart for Clemson Researchers (version 9/12/14)
HSSC Cooperative Agreement - Institutional Review Boards
HSSC IRB Cooperative Review SOPs
12. Reviewer Forms for Expedited/Full Reviews (IRB committee members only)
Reviewer Form - Amendment (version 10/28/11)
Reviewer Form - Children (version 2/7/14)
Reviewer Form - Cognitively Impaired (version 2/6/14)
Reviewer Form - Continuing Review (version 11/4/11)
Reviewer Form - Data Set Analysis Only (version 10/28/11)
Reviewer Form - Expedited/Full (version 8/9/13)
Reviewer Form - Informed Consent (version 8/9/13)
Reviewer Form - Waiving Consent (version 2/6/14)
Reviewer Form - Waiving Documentation of Informed Consent (version 2/6/14)
Reviewer Form - Waiver of Elements of Informed Consent (version 2/7/14)
Reviewer Form - Prisoners (version 2/6/14)