January 6, 2014 - University of Pennsylvania

Dear Dr. Fluharty:

Thank you for your January 4, 2013 and May 21, 2013 responses to our request for IRB records and research consents to conduct an evaluation of your system for protecting human research subjects to ensure that it is in compliance with Department of Health and Human Services (HHS) regulations for the protection of human research subjects (45 CFR part 46). The evaluation was conducted as part of our program to evaluate human subject protection programs of institutions that receive HHS support for research for compliance with 45 CFR part 46.

Our evaluation involved a review of approximately fifty research consent documents, IRB meeting agendas and minutes from 9 IRB panels and IRB written procedures and electronic submission forms. Based on the information that we reviewed, your system for protecting human research subjects appears to be in compliance with Department of Health and Human Services (HHS) regulations for the protection of human research subjects (45 CFR part 46), and is appropriate under the University of Pennsylvania’s FWA. 

At this time, there should be no need for further involvement by our office in this matter.

We appreciate the continued commitment of your institution to the protection of human research subjects. Please do not hesitate to contact me should you have any questions.

Sincerely,

Lisa Buchanan, MAOM
Compliance Oversight Coordinator
1101 Wootton Parkway, Suite 200
Rockville, Maryland 20852
Telephone: 240-453-8298
FAX: 240-453-6909
E-mail: Lisa.Buchanan@hhs.gov

cc:
Ms. Tracy Ziolek, Director, Human Research Protections, University of Pennsylvania
Dr. Bruce Sachais, Chairperson, University of Pennsylvania IRB #1
Dr. Christopher Coleman, Chairperson, University of Pennsylvania IRB #2
Dr. Elliot Hersh, Chairperson, University of Pennsylvania IRB #3
Dr. Anne Keane, Chairperson, University of Pennsylvania IRB #4
Ms. Kimberly Craig, Chairperson, University of Pennsylvania IRB #5
Dr. Bernard Mason, Chairperson, University of Pennsylvania IRB #6
Dr. Emma Meagher, Chairperson, University of Pennsylvania IRB #7 & #9
Dr. John Holmes, Chairperson, University of Pennsylvania IRB #8

Dr. Margaret Hamburg, Commissioner, Food and Drug Administration (FDA)
Dr. Joanne Less, FDA
Dr. Michelle Bulls, Director of OPERA, Office of Extramural Research, National Institutes of Health (NIH)
Ms. Sarah Carr, Office of Science