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 execution by offices outside of the IRB. Patrick Stanko is the main IRB contact for general questions about agreements.

Agreements for the Sharing of Data and Specimens

Investigators are responsible for informing the IRB of any disclosures of participant data or samples outside the institution. This should be reflected in the HSERA application and/or a standalone protocol, if one exists. Likewise, best practice calls for informing participants of such disclosures, unless the IRB has approved a waiver of informed consent / HIPAA authorization. 

There are different agreements required to be executed for the sharing of data and specimens. Some common examples are:

  • Data Use Agreement (DUA): a written agreement that establishes how a limited dataset will be transferred from a HIPAA 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 dataset excludes all Protected Health Information (PHI) except for the following: (1) elements of dates including age and (2) geographic information at the zip code, town or city level.
  • Business Associates Agreement (BAA): a written agreement that establishes how a dataset with identifiable protected health information (PHI) will be transferred from a HIPAA covered entity to an intended recipient and establishes the ways in which the information may be used and how it will be protected. 
  • Material Transfer Agreement: a written agreement that establishes how specimens will be transferred  to an intended recipient 

All agreements are executed through Penn ERA or the Penn Research Inventory System (RIS). All agreements are executed by the contract offices below: 

Please note: All questions about contract and agreement execution should be directed to the applicable contracts office. 

For more information about sharing Data and Specimens outside of Penn Medicine, please see https://irb.upenn.edu/announcements/penn-medicine-guidance-sharing-data-and-biological-samples-third-parties. Questions about the guidance should be directed to the contacts designated within the Guidance document. Questions about contract execution process should be directed to the appropriate contracting office.

PI Acknowledgement of Responsibilities in Biomedical Research

The Principal Investigator is responsible for:

  • Ensuring that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations;
  • Protecting the rights, safety, and welfare of subjects under the investigator's care; and
  • The control of drugs under investigation.

The Principal Investigator's Acknowledgement of Responsibilities document has been developed as a reminder of the responsibilities of the principal investigator in a biomedical research study.

Cooperative IRB Agreement: CHOP/Penn

Investigators are encouraged to review the CHOP/Penn IRB Cooperative Agreement to determine if their study is eligible for consideration under the agreement.

NOTE: Starting July 1, 2022, all new requests to rely on the CHOP IRB must be submitted in HSERA and follow the IRB reliance procedures outlined on the IRB website:  https://irb.upenn.edu/reliance-agreements. These requests will no longer be accepted and processed via email with the new fiscal year. Please email Patrick Stanko with any associated questions about submitting reliance agreements. 

NOTE: Studies where Penn will rely on the CHOP IRB but where Princeton Health is site, a reliance agreement application is required to be submitted in HSERA for the Princeton Health site. Guidance is available online here: https://irb.upenn.edu/reliance-agreements.

For further assistance, please contact: Patrick Stanko.

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.

Download IAA Template Document

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.

Prior to requesting any reliance agreement, please review the complete information about various types of reliance agreements on the How to Submit: Reliance Agreements page of this website.

For additional assistance, please contact: Patrick Stanko

Individual Investigator Agreement for External Independent Investigators

The Individual Investigator Agreement Template allows the extension of Penn's Federalwide Assurance (FWA) to cover external collaborating investigators engaged in non-exempt human subjects' research (e.g. physicians in private practice or individuals employed by institutions that do not routinely conduct research, etc.). 

If the investigator is affiliated with an institution that has an FWA and is acting as an employee or agent of that assured institution with respect to their involvement in the research, a reliance agreement / IRB Authorization Agreement (IAA) should be considered. Please review information on the OHRP website and consult with Penn's Reliance Manager Patrick Stanko, as needed. 

If an Individual Investigator Agreement is the appropriate pathway the following is required: 

  1. Submit a copy of the Individual Investigator Agreement completed and signed by the external collaborating investigator(s). If there is more than one external collaborating investigator, please combine all completed agreements into 1 PDF to facilitate Penn IRB signing. 
  2. Submit a copy of the external collaborating investigator(s)' completed Human Subjects Research training. See: https://irb.upenn.edu/mission-institutional-review-board-irb/guidance/citi-human-research-protections-training for acceptable training documentation.

Good Shepherd Penn Partner (GSPP) Research

Download Document

For additional information, please contact: gsppresearchcommittee@uphs.upenn.edu