This page provides guidance about the various types of agreements that are commonly used in human subjects research at Penn. Please note that some of these agreements require assessment by offices outside of the IRB. Patrick Stanko is the main IRB contact for general questions about agreements.
PI Acknowledgement of Responsibilities
The Principal Investigator is responsible for ensuring that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations; for protecting the rights, safety, and welfare of subjects under the investigator's care; and for the control of drugs under investigation. The following document has been developed as a reminder of the responsibilities of the principal investigator in a biomedical research study.
Cooperative Agreement: CHOP/Penn
IRB Authorization Agreement (IAA) / Reliance Agreements
If 2 or more federally assured institutions collaborate on human subjects research, the institutions may designate a single IRB of record that would be responsible for the initial review and continuing oversight of the research in order to avoid duplicative IRB reviews.
This relationship (referred to as a Reliance Agreement) between the IRB of Record and Relying IRB is established via the IRB Authorization Agreement (IAA) which is a written agreement that describes the roles and responsibilities of each institution.
This document can be used when asking the Penn IRB to serve as the IRB of record OR when asking the the Penn IRB to rely on another IRB.
The guidance documents provided below include detailed information about entering into reliance agreements. Please also see the "How to Submit:Reliance Agreements" page of this website for complete information.
- How to apply for external IRB review
- Requirements for external consent templates
- External IRB Review FAQ
- Penn as Central IRB FAQ
- Post-Approval Submission Guidance
- Creating Multi-Site Consent Templates Guidance
For additional assistance, please contact: Patrick Stanko
Individual Investigator Agreement
This agreement allows the extension of Penn's Federalwide Assurance (FWA) to cover external independent investigators engaged in non-exempt Penn research who do not work at an FWA covered institution (e.g. physicians in private practice). Additional information can be found on the OHRP website.
Data Use Agreement (DUA)
A Data Use Agreement (DUA) is a written agreement that establishes how a limited data set will be transferred from a covered entity to an intended recipient and establishes the ways in which the information may be used and how it will be protected.
A limited data set excludes all Protected Health Information (PHI) except for the following: (1) date and (2) geographic information at the zip code, town or city level.
Please note: All Data use agreements should be implemented by contacting Office of Research Services (ORS), Click here for their website.
Good Shepherd Penn Partner (GSPP) Research