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This tab collects information about the use of human subjects in the proposed research.

This tab can be completed by a Research Administrator or PI.

If there are human subjects involved, the protocol information is not mandatory until after the proposal is awarded by the sponsor. However, at the award stage, this information becomes mandatory and failure to provide it will prevent Penn State from accepting the award.

Submissions can be added manually via the "Add Study Manually" button or imported (based on the listed personnel on the IAF) via the "Import Study" button. Whether manually added or imported, expiration dates are not required to Start Workflow and not all submissions will have an expiration date. See IAF Data Entry - Add or Import Study for more information. 

  1. Does this research involve interaction or intervention with human subjects or the use of identifiable private human subjects data?: For more information on determining if the research proposed involves the use of human participants please review RP03, “The Use of Human Participants in Research” and the following Frequently Asked Questions. If you need additional assistance understanding your responsibilities under RP03 or what entails the use of human participants please contact the Institutional Review Board Administrative Staff at the Office for Research Protections (for University Park and all other campuses except the College of Medicine). Required to submit IAF. Answering “Yes” to this question triggers a compliance review.  (see “Add/Import Study”)
  2. Is this a cooperative group trial?: If the "Type of Project" is "Clinical Trial, select "Yes" if the proposed research is part of a cooperative group trial. The Clinical Trials Cooperative Group Program is designed to promote and support clinical trials (research studies) of new cancer treatments, explore methods of cancer prevention and early detection, and study quality-of-life and rehabilitation issues. Required to submit IAF.
    1. Group Name: Required to submit IAF. College of Medicine proposals only. 100 characters.