May 2019 HSPO update: College FWA updates; form FDA 1572 completion information

Penn State College of Medicine’s Institutional Review Board/Human Subjects Protection Office (IRB/HSPO) regularly shares updates to keep faculty and research staff informed of new information and changes. Updates are generally emailed and are also posted online.

FWA updates

The following changes have been made to Penn State College of Medicine Federalwide Assurance FWA00004251:

• Penn State Health is now listed as a component of Penn State College of Medicine.
• The Signatory Official or Institutional Official is now Candice A. Yekel, Associate Vice President for Research, Penn State University.

The FWA for Penn State Health Milton S. Hershey Medical Center will be deactivated and should not be referred to for future clinical research studies.

The IRB Assurance and Compliance Statement has been updated online to reflect these changes.

Form FDA 1572 completion

When completing form FDA 1572 for clinical research studies, the following information should be used for items 3 and 5:

• Item 3: Name and Address of Any Medical School, Hospital, or Other Research Facility where the clinical Investigations(s) will be conducted:
  • Penn State Health Milton S. Hershey Medical Center
    500 University Dr., P.O. Box 850
    Hershey, PA 17033
    USA
• Item 5: Name and Address of the Institutional Review Board (IRB) that is Responsible For Review and Approval of the Study(ies)
  • Penn State College of Medicine IRB – Human Subjects Protection Office
    90 Hope Dr., P.O. Box 855
    Mail Code A115
    Hershey, PA 17033
    USA

Upcoming IRB workshops

See a list of upcoming IRB workshops here.

For details

For questions regarding IRB/HSPO updates, please email the College of Medicine Human Subjects Protection Office at HSPO@pennstatehealth.psu.edu.

If you're having trouble accessing this content, or would like it in another format, please email the Penn State College of Medicine web department.