Human Subjects & IRB

Kuali Protocols Form Guides

All IRB submissions must be created in Kuali Protocols.  The below Form Guides are meant as a tool for researchers to understand what information may need to be collected to complete the online IRB application in Kuali Protocols. The Form Guides are organized by Protocol Type and Submission Type.  Additional information on creating and submitting an IRB application in Kuali Protocols can be found in the Kuali Protocols instructional guides.

• IRB Application Form by Protocol Type
  • Expedited/Full Board (Accessible 08/04/23)
  • Exempt (Accessible 08/07/23)
  • Request to Rely (Accessible 08/03/23)
  • Not Human Subjects Research (Accessible 08/03/23)
  • Humanitarian Use Device (HUD) (Accessible 08/02/23)
  • Emergency Use (Accessible 08/02/23)

• Submission Forms
  • Amendment (Accessible 05/21/21)
  • Renewal (Accessible 08/16/22)
  • Reportable Event (Accessible 08/03/23)
  • Closeout (Accessible 08/16/22)

Informed Consent Templates

You are strongly encouraged to utilize sponsor-provided consent templates. If an informed consent template is not available for your study, the templates below can be used. For instructions and tips on writing informed consent documents, see IU HRPP Guidance on Informed Consent.

• Informed Consent Document Template–Biomedical (v10/01/23) (Accessible 10/04/23)

  For use when the research primarily involves the study of specific diseases and conditions (mental or physical), treatment of diseases or conditions, or when the research is conducted in a patient treatment setting.

• Informed Consent Document Template–Social/Behavioral/Educational (SBE) (v10/01/23) (Accessible 10/04/23)

  For use when the research focuses primarily on the understanding of social, behavioral, or educational processes, including research on human attitudes, beliefs, and behaviors as well as institutional and social function and processes.

• Study Information Sheet-Exempt Template (v01/19/21)  (Accessible 07/06/21)
• Assent Template (v10/01/23) (Accessible 10/04/23)
• Informed Consent (and Authorization) Template – Expanded Access
  (v10/01/23)  (Accessible 10/04/23)

  For use when treatment is being provided to a patient via an expanded access protocol.

• Non-English Informed Consent Documents

IRB Templates

• Protocol Template (v07/01/18) (Accessible 04/12/21)
• HIPAA Authorization Template (v01/21/19) (Accessible 10/25/19)

  NOTE: IU no longer requires a standalone HIPAA Authorization document.  Authorization language can be incorporated into the Informed Consent Statement.  See Informed Consent Document Template – Biomedical above for suggested language.

• HIPAA Authorization Template - Spanish (v01/21/19) (Accessible 07/18/19)
• HIPAA Authorization Template - Minors (v01/21/19) (Accessible 07/03/19)
• HIPAA Authorization Template - Minors - Spanish (v01/21/19) (Accessible 07/03/19)
• Case Study Consent/Authorization Template (v12/01/21) (Accessible 12/09/21)
• NIH sIRB–Communication Plan Template (v01/25/18) (Accessible 07/22/19)

Non-Affiliated Personnel Attestations

• Non-Affiliated Research Personnel Attestation (v01/21/19) (Accessible 07/22/19)
• Exempt Non-Affiliated Research Personnel Attestation (v11/5/19) (Accessible 07/16/21)
• Agreement to Extend FWA to Non-Affiliated Research Personnel (v07/01/2020)  (Accessible 07/16/21)

Additional Resources