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Research with Human SubjectsRP-11-004

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 the Indiana University that all research projects which involve human subjects shall be subject to review and approval by an appropriate Indiana University Institutional Review Board or, as appropriate, an officially appointed, Institutional Review Board registered with the Office of Human Research Protections (or other office designated by the United States Department of Health and Human Services) 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: http://researchcompliance.iu.edu/hso/index.html

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Definitions

For purposes of this policy, Human Subjects Research is defined as:

  • Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains:
  • Data through intervention or interaction with the individual, or
  • Identifiable private information
  • 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 and was last updated on 12/01/2010.

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