Accessibility disclaimer: To obtain information contained in document files on this page in an accessible format please contact the IU Human Research Protection Program (HRPP) at (317) 274-8289 or via email at firstname.lastname@example.org
Human Subjects & IRB
Forms & Templates
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
- Submission Forms
- IRB Application Form for Studies migrated from KC IRB (identified by a 9 or 10 digit protocol number)
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 (v12/01/21) (Accessible 12/09/21)
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–Future Research (v12/01/21) (Accessible 12/09/21)
For use when the research only involves the collection, storage, or maintenance of information and biospecimens for future use, including creation of a database or biorepository.
Informed Consent Document Template–Social/Behavioral/Educational (SBE) (v07/01/21) (Accessible 07/16/21)
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)
- Study Information Sheet-Expedited Template (v07/01/21) (Accessible 07/06/21)
- Assent Template (v07/15) (Accessible 07/03/19)
- Non-English Informed Consent Documents
In order to promote readability of translated informed consent documents, the HRPP is no longer providing Spanish translations of the IU consent templates. If investigators anticipate enrolling subjects who do not speak English, the consent and other subject-facing documents should be translated as a whole, then submitted to the IRB for approval.
Translated short form consents are available below. Please review the HRPP Policy on Informed Consent carefully prior to use of a short form consent. Contact HRPP staff with any questions at email@example.com.
- Informed Consent Statement Short Form-Arabic (Accessible 07/22/19)
- Informed Consent Statement Short Form-Burmese (Accessible 07/22/19)
- Informed Consent Statement Short Form-Chinese (Accessible 07/22/19)
- Informed Consent Statement Short Form-French (Accessible 07/22/19)
- Informed Consent Statement Short Form-German (Accessible 07/22/19)
- Informed Consent Statement Short Form-Hakha Chin (Accessible 07/22/19)
- Informed Consent Statement Short Form-Russian (Accessible 07/16/21)
- Informed Consent Statement Short Form-Spanish (Accessible 07/22/19)
- Informed Consent Statement Short Form-Vietnamese (Accessible 07/16/21)
- 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)
IU Simon Cancer Center (IUSCC) Scientific Review Committee (SRC) is required for prospective cancer-related research utilizing IUSCC patients or resources.
For additional information on SRC review, go to: https://cancer.iu.edu/research-trials/trials/src-resources.shtml
Note: Documentation of SRC approval is required at time of IRB submission unless an exception has been granted.
- VA Informed Consent Template (v08/01/21) (Accessible 08/13/21)
- For the VA HIPAA Authorization Form and the VA Investigational Drug Information Record form, search the US Department of Veterans Affairs forms. To ensure you are directed to the correct form, type the form number in the search field.
|Form Number||Form Description|
|10-0493||VA HIPAA Authorization Form|
|10-9012||VA Investigational Drug Information Record|
To obtain additional documents, contact the VA compliance office or search the US Department of Veterans Affairs forms.
The Indiana University Human Research Protection Program (HRPP) provides administrative support to all IU campuses and maintains physical offices in two locations, Indianapolis and Bloomington.
Indianapolis (Main):Human Research Protection Program (HRPP)
Office of Research Compliance
Lockefield Village, 3rd Floor
980 Indiana Avenue
Indianapolis, Indiana 46202
- Phone: (317) 274-8289
- Email: firstname.lastname@example.org
Bloomington:Human Research Protection Program (HRPP)
Office of Research Compliance
2218 N. Dunn St.
Bloomington, Indiana 47408
- Phone: (812) 856-4242
- Email: email@example.com