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Office of Research

Forms & Documents

Please submit IRB forms/documents to irb@clemson.edu

  1. Adverse Event/Unanticipated Problem
  2. Amendment Request
  3. Closure Request (final report summary)
  4. Continuing Review
  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)
  6. Developmental Approval
  7. Exempt Review
  8. Exempt Protocol Extension Request
  9. Expedited Review
  10. Full Board Review
  11. HSSC Cooperative Review (GHS, MUSC, Palmetto Health, Spartanburg Regional, USC; for review by a non-HSSC organization, see Deferral Request section)
  12. 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)

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