Accessibility disclaimer: To obtain information contained in document files on this page in an accessible format please contact the IU Human Subjects Office at (317) 274-8289 or via email at firstname.lastname@example.org
Human Subjects & IRB
Forms & Templates
- Drug or Biological Products Form (v01/21/19)
- Medical Device Form (v01/21/19)
- Non-Affiliated Research Personnel Attestation (v01/21/19) (Accessible 07/22/19)
- Agreement to Extend FWA to Non-Affiliated Research Personnel (v01/21/19) (Accessible 07/18/19)
- Request for Waiver of Informed Consent for Planned Emergency Research (v09/01/10) (Accessible 07/22/19)
Informed Consent Templates
For instructions and guidance on writing informed consent documents, see IU HRPP Guidance on Informed Consent. Please note that you are strongly encouraged to utilize sponsor-created consent templates. If an informed consent template is available for your study, please use it.
- Informed Consent Document Template–Biomedical (v04/25/19)
For use when the research primarily involves the study of specific diseases and conditions (mental or physical), including detection, cause, prophylaxis, treatment and rehabilitation of persons; the design of methods, drugs and devices used to diagnose, support and maintain the individual during and after treatment for specific diseases or conditions; or the scientific investigation required to understand the underlying life processes which affect disease and human well-being, including such areas as cellular and molecular bases of diseases, genetics, immunology.
- Informed Consent Document Template–Future Research (v01/21/19) (Accessible 07/22/19)
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–Informational Risks Only (v01/21/19) (Accessible 07/22/19)
For use when the research involves only collection of information or biospecimens and when the only risk of the research is the potential for harm from disclosure of information about an identified individual.
Informed Consent Document Template–Social/Behavioral/Educational (SBE) (v01/21/19) (Accessible 07/22/19)
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.In order to promote cohesion of informed consent documents, HSO is no longer providing Spanish translations of the IU templates. If investigators anticipate enrolling subjects who do not speak English, relevant recruitment and enrollment documents should be translated as a whole, then submitted to the IRB for approval.
- 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
- Informed Consent Statement Short Form-Spanish (Accessible 07/22/19)
- Informed Consent Statement Short Form-Vietnamese
- Study Information Sheet-Exempt Template (v01/21/19) (Accessible 07/22/19)
- Study Information Sheet-Expedited Template (v01/21/19) (Accessible 07/22/19)
- Assent Template (v07/15) (Accessible 07/03/19)
- Protocol Template (v07/01/18)
- HIPAA Authorization Template (v01/21/19) (Accessible 10/25/19)
NOTE: This is the standard HIPAA Authorization form. Use when access to subjects' medical records is necessary.
- HIPAA Authorization Template - Spanish (v01/21/19) (Accessible 07/18/19)
- HIPAA Authorization Template - No Medical Record Access (v01/21/19)
NOTE: This HIPAA Authorization does NOT allow access to subjects' medical records. Only PHI obtained directly from the subject may be used for research.
- HIPAA Authorization Template - No Medical Record Access - 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)
- NIH sIRB–Communication Plan Template (v01/25/18) (Accessible 07/22/19)
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 (v01/21/19)
- VA HIPAA Authorization Form (v09/15)
- VA Security/Privacy Checklist (v02/12/14)
- VA Investigational Drug Information Record–VA Form 10-9012
Contact the VA compliance office to request additional documents, or search VA documents at https://www.va.gov/vaforms/
The Indiana University Human Subjects Office provides administrative support to all IU campuses and maintains physical offices in two locations, Indianapolis and Bloomington.
Indianapolis (Main):Human Subjects Office
Office of Research Compliance
Lockefield Village, 3rd Floor
980 Indiana Avenue
Indianapolis, Indiana 46202
- Phone: (317) 274-8289
- Email: email@example.com
Bloomington:Human Subjects Office
Office of Research Compliance
2218 N. Dunn St.
Bloomington, Indiana 47408
- Phone: (812) 856-4242
- Email: firstname.lastname@example.org