Human Subjects Committee
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. The definition for research as per the OHRP is: a systematic investigation designed to develop or contribute to generalizable knowledge while obtaining information about and having interaction or intervention with living individuals. 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.
Forms:
There are several new forms that have been adapted with cooperation from IU Bloomington 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. If you have any questions about the above policies or the forms, please contact Kim Rutherford, Lindenwood Hall 326, - E-mail: kimruthe@iun.edu or (219) 981-5646.
Amendments
Close Out Report
- Close Out Report (formerly known as Termination Report)
Continuing Review
Exempt Reviews:
Expedited and Full Reviews:
- Documentation of Review and Approval
- Expedited Research Checklist
- Informed Consent Statement
- Summary Safeguard Statement
