University of Pittsburgh Human Research Protection Office (HRPO)

Initial Application for Pitt to Serve as the IRB of Record

Instructions for Use: To be completed when a Pitt/UPMC investigator is submitting an initial request for the Pitt IRB to serve as the IRB-of-record for a multi-centered research study.

Please email nd include the following:

  • This completed form
  • A protocol summary or the human subjects section of the grant application
  • An Appendix A form for each site you are requesting to rely on the Pitt IRB

IF ANY OF THE MATERIALS LISTED ABOVE ARE INCOMPLETE OR NOT PROVIDED AT THE TIME THIS REQUEST IS SUBMITTED, THE REQUEST WILL BE RETURNED WITHOUT REVIEW UNTIL A COMPLETE SUBMISSION IS RECEIVED BY OUR OFFICE.

*Important: you are required to complete a separate Appendix A formfor each collaborating institution
Pitt/UPMC Study Title: / Pitt/UPMC OSIRIS Study ID (if available):
Pitt/UPMC Principal Investigator:
Name and Degree: Email Address:
Department:
Contact Person:
Name: Email Address:
Department:
List Funding Source(s)
Federal Government-specify:
Other-specify: / Which research office is processing your funding (the grant or subcontract)? Only 1 can apply- if you are unsure please contact your
Department Grants Manager for clarification
Pitt Office of Research
Magee Women’s Research Institute
Is our local site the primary awardee for the funding of this project? Yes No
Why is the request being made:
Condition of funding External site(s) not engaged in human subjects research
Pitt PI relocating Other-specify:
What is the risk level of the study? Minimal Risk Greater Than Minimal Risk
At which local sites will research procedures be performed?Choose all that apply
Pitt
UPMC (including Magee Women’s Hospital)
Children’s Hospital
How many sites are you requesting the UPitt IRB to cover:
Does the study involve any vulnerable populations? If yes, indicate all that apply below.
Pregnant Women Children
Fetuses Decisionally impaired
Neonates Prisoners
Does the study involve the use of a device?Yes No
If yes, is there an Investigational Device Exemption (IDE )? Yes No
If yes, who holds the IDE:
Does the study involve the use of a drug?Yes No
If yes, is there an Investigational New Drug application (IND )? Yes No
If yes, who holds the IND:
Does the study involve an FDA exception from informed consent? Yes No

**********************************************************************************

Pitt HRPO Use Only
Agreement #: SP
Pitt HRPO Determination
Pitt IRB will serve as the IRB-of-Record for the collaboration named in this application / Yes
No
Not required because:
Collaborator is not engaged
Other (explain below)
Pitt HRPO Risk Assessment / Minimal risk
Greater than minimal risk

Page 1 of 2

Version4 _10.30.2017