Statement of Compliance

The UPIKE IRB is duly constituted (Fulfilling FDA requirements for diversity), allows only those IRB members who are independent of the investigator and the sponsor of the trial to vote/provide opinion on the trial, has written procedures, prepares written minutes of convened meetings, and retains records pertaining to the review and approval process of human subjects projects; all in compliance with all U.S. regulatory requirements related to the protection of human research participants. Specifically, the IRB complies 45 CFR 46, 21 CFR 50, 21 CFR 56, 21 CFR 312, 21 CFR 812, and 45 CFR 164.508-514. In addition, the IRB complies with International Conference on Harmonization (ICH) E6, Good Clinical Practice (GCP) guidelines, to the extent required by the U.S. Food and Drug Administration. The IRB applies the ethical principles of the Belmont Report and other ethical standards recognized by federal departments and agencies that have adopted federal policies for the protection of human subjects.

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