Office of Research

Forms & Documents

  1. Amendment Request
  2. Adverse Event/Unanticipated Problem
  3. Continuing Review
  4. Developmental Approval
  5. Deferral Request (review by another organization's IRB)
  6. Exempt Review
  7. Expedited Review
  8. Full Board Review
  9. HSSC Cooperative Review
  10. Psychology 310 Course IRB Application
  11. Research Study Closure Request (final report summary)
  12. Reviewer Forms (IRB committee members only)

1.  Amendment Request

Amendment Review Process
Amendment Request (version 10/28/11)
Additional Research Team Members Form (version 5/13/09)
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 10/21/11)

2.  Adverse Event/Unanticipated Problem

Adverse Event/Unanticipated Problem Form

3.  Continuing Review of Expedited/Full Protocols

Continuing Review Process
Continuing Review (version 5/2/12)

4.  Developmental Approval

Developmental Review Process
Developmental Approval Form (version 2/3/12)

5.  Deferral Request (review by another organization's IRB)

Deferral Review Process
Deferral Request Cover Sheet (version 7/14/11)

6.  Exempt Review

Exempt Review Process
Exemption Categories
Exempt Research Application Form (version 3/2/12)
Exempt Review Cover Sheet (when using another institution's forms) (version 11/18/10)
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)
Informational Letter (no signature - default for exempt) (version 2/15/12)
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)

7.  Expedited Review

Expedited Review Process
Expedited Categories
Expedited Research Application Form (version 10/28/11)
Expedited Research Application Form - Data Set Analysis Only (version 10/28/11)
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) 
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) (version6/8/11)
Verbal Consent Script (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)

8.  Full Board Review

Full Board Review Process
IRB Meeting Schedule and Full Board Review Submission Deadlines
Full Board Application Form (version 10/28/11)
Full Board Application Form - Data Set Analysis Only (version 10/28/11)
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)
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)
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)

9.  HSSC Cooperative Review

HSSC IRB Request for Cooperative Review - Initial (version 9/1/11)
HSSC IRB Request for Cooperative Review - Post-Approval (version 9/1/11)
HSSC Cooperative Agreement - Institutional Review Boards  
HSSC IRB Cooperative Review SOPs  
GHS Submissions for Clemson Researchers
Deferral Request Cover Sheet (version 7/14/11) 

10.  Psychology 310 Course IRB Application

Psychology 310 Course IRB Application
Psychology 310 Course Informational Letter template

11.  Research Study Closure Request Form (final report summary)

Final Summary Report (version 10/28/11)

12.  Reviewer Forms for Expedited/Full Reviews (IRB committee members only)

Reviewer Form - Amendment (version 10/28/11)
Reviewer Form - Children
Reviewer Form - Cognitively Impaired
Reviewer Form - Continuing Review (version 11/4/11)
Reviewer Form - Data Set Analysis Only (version 10/28/11)
Reviewer Form - Expedited/Full (version 10/28/11) 
Reviewer Form - Informed Consent (version 10/28/11) 
Reviewer Form - Waiving Consent (version 2/25/11) 
Reviewer Form - Waiving Documentation of Informed Consent (version 2/25/11) 
Reviewer Form - Waiver of Elements of Informed Consent (version 2/25/11) 
Reviewer Form - Prisoners