The Institutional Review Board for the Protection of Human Subjects

* New Policies in Effect 9/1/2009 *

* Updated Protocol Deviation Policy *

"To Whom it May Concern" (Letter for Sponsors Regarding Adverse Event Reporting)

About the IRB (or IRBPHS)

The IRB is an administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of Upstate Medical University.

The SUNY Upstate Medical University IRB conducts its activities pursuant to the human subjects regulations of FDA and HHS where applicable, and consistent with such rules for all human subjects research, and consistent with the ICH guidance relating to GCP in human subjects research as it corresponds to the HHS and FDA Regulations.

Requirements for Review

Upstate policy and federal regulations require that all research involving human subjects, human tissue, surveys of human subjects, or medical records be reviewed and approved by the Upstate IRB prior to initiation of the research. This requirement applies to all human subject research conducted by faculty, on- and off-campus, whatever the funding support for the project.

Use & Disclosure of Protected Health Information

Upon IRB approval of a research study, the use and disclosure of individually identifiable health information created, received or maintained by University Hospital must conform to the SUNY Upstate Medical University Policy, Uses and Disclosures of PHI for Research Purposes. Such information can be requested from University Hospital by submitting the Patient Data/Information Request Form according to the process outlined in the policy.