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.

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.

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 irb@iu.edu.

IRB Templates

Non-Affiliated Personnel Attestations

Additional Resources

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.

Form NumberForm Description
10-0493VA HIPAA Authorization Form
10-9012VA Investigational Drug Information Record

To obtain additional documents, contact the VA compliance office or search the US Department of Veterans Affairs forms.

Contact

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
Indiana University
Lockefield Village, 3rd Floor
980 Indiana Avenue
Indianapolis, Indiana 46202
  • Phone: (317) 274-8289
  • Email: irb@iu.edu

Bloomington:

Human Research Protection Program (HRPP)
Office of Research Compliance
Indiana University
2218 N. Dunn St.
Bloomington, Indiana 47408
  • Phone: (812) 856-4242
  • Email: irb@iu.edu