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Human Subjects

IRB Forms & Checklists

Where to Submit

All study submissions should be made via the OneStart - KC IRB portal.

Other communication with the Human Subjects Office is still done through email via IRB@IU.edu, or directly with the appropriate staff member.

Please use the following format in the subject line of all emails:

Study Number – PI Name – Type of Submission - PI's Department

Examples:

0000-00 – Dr. Jane Doe – Amendment – Neurology
0000-00 – Dr. Jane Doe – New Study  – Physics
0000-00 – Dr. Jane Doe – Renewal  – English
0000-00 – Dr. Jane Doe – Gen Info  – Pediatrics

IRB Forms

Please use the list below to download appropriate forms for your submission. See the submissions section for additional instructions regarding level of review and required forms. Please be sure to download forms directly for each new study submission, as new studies must be submitted using the most recent version posted on the HSO website (as of submission date).

IRB forms undergo constant revision to ensure compliance with federal regulations and accreditation requirements. If an updated version of a form is available, investigators DO NOT need to update their currently approved documents UNLESS the study is open to enrollment AND the currently approved documents do not list the version date listed below. If the study is open to enrollment and the currently approved document is not the version listed below, please download, complete, and submit the new version at time of renewal.

  • Summary Safeguard Statement v09/01/2010 or later
  • HIPAA & Recruitment  Checklist v09/01/2010 or later
  • Request Form for Research Involving Children v09/01/2010 or later

NEW FORM: All active studies involving drugs, biological products, or devices which have a currently approved Summary Safeguard Statement (v01/01/12) or earlier, must download, complete, and submit the Test Articles Supplement at time of renewal, regardless of enrollment status.


Forms By Category:     View Forms Alphabetically Expand all Expand All Close All
  New Research Submissions:

 Exempt Research Studies

Expedited and Full Board Research Studies

 Applications for Non-Research Student Projects and Non-Human Subjects Research


  Renewal & Closeout:

  Amendment to Change Existing Study:

  Vulnerable Populations forms:

  Noncompliance & Prompt Reporting:







Reviewer Checklists

The IU IRB members use the reviewer checklists (RVC) below when reviewing IRB submissions to ensure that research is conducted in compliance with all relevant laws, regulations, and accreditation standards.

Documents: