Human Subjects Committee


HSC Forms

The Office for Human Research Protections (OHRP) provides the Human Subjects Committee (HSC) with criteria to use when deciding whether or not an activity is research and if it involves human subjects.

If the activity is deemed research, the next step is to determine what category of review is necessary. All research studies being conducted using human subjects must be submitted to the Research Compliance Coordinator in the Human Subjects Committee office.

There are a series of forms to assist the Principal Investigator (PI) with this task. Further, any PI whose study is being submitted to any Health and Human Services (HHS) agency for funding must submit the identical information to the Human Subjects Committee (HSC) as was submitted in the grant application. A copy of the grant application must be provided with the HSC application. The agencies involved include: CFDCP, HRSA, FDA, NIH and its sub agencies among several others. If you are unsure as to whether an agency is part of HHS, call the Committee office.

There are several new forms that have been adapted with cooperation from IU Office of Research Administration to promote uniformity across all regional campuses. Some of the forms appear lengthier, but will help you, the PI, with the process and the HSC with the review.  All forms are listed with what needs to be completed and submitted. As of October 15, 2014, Reviewer Checklists need to be submitted with your completed application.  Please click on the link to the Office of Research Administration to find the necessary forms. Contact the HSC office at (219) 981-5646 with any questions.


  • Amendment Form

Close Out Report

  • Close Out Report

Study Renewal

  • Study Renewal - Closed to Enrollment
  • Study Renewal - Open to Enrollment

Exempt Reviews:

(Please complete all forms under this section)

  • Exempt Research Checklist
  • Documentation of Review and Approval
  • Study Information Sheet

Expedited and Full Reviews:

(Please complete all forms under this section)

  • Documentation of Review and Approval
  • Expedited Research Checklist
  • Informed Consent Statement
  • Summary Safeguard Statement

Prompt Reporting Issues

  • Noncompliance Report
  • Prompt Reporting Form

Special Populations

(Please complete forms as needed in this section)

  • Assent to Participate
  • Children Request Form
  • Cognitively Impaired in Research Request Form
  • Non-Human Subjects Research
  • Pregnant Women Request Form

Reviewer Checklists

(The IUN IRB use the reviewer checklists (RVC) below when reviewing IRB submissions to ensure that research is conductedin compliance with all relevant laws, regulations and accredidation standards.)

  • Exempt Study
  • Expedited and Full Board Review Studies
  • Amendment
  • Study Renewal

Forms can be found at the following link:

Office of Research Administration