Research with Human Subjects

Scope

This policy applies to all Indiana University faculty, staff, and students involved in research with human subjects.

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Policy Statement

It is the policy of Indiana University that all research involving human subjects shall be subject to review or granted exemption by an appropriate Indiana University Institutional Review Board or designee prior to project initiation and without respect to funding or the source of funding.

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Reason for Policy

To foster the practice of research that meets the highest ethical standards and adheres to all applicable laws, principles, best practices and policies related to research with human subjects.

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Procedures

See Compliance Services: Human Subjects/IRB on the website of the Office of Research Compliance: https://research.iu.edu/compliance/human-subjects/index.html 

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Definitions

For purposes of this policy:

• Human subject means a living individual about whom an investigator (whether professional or student) conducting research:
• • • Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or

• • • Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

• Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

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Sanctions

University faculty, staff, and students that are found to be in violation of this policy may be subject to sanctions relating to their participation in research with human subjects.

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History

This policy became effective on 12/01/2010.

This policy was updated in January 2019.

A substantive review of the policy was conducted by IU Research and a non-substantive change to the responsible office title was made in March 2024.

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