1. Sponsored Programs at Penn
Other regulatory and administrative considerations

2. Many federal regulatory requirements
In addition to the Uniform Guidance, research activities must conform with sponsor requirements for other areas such as research involving human or animal subjects, the use of recombinant DNA or pathogenic materials, and the management of conflicts of interest. Research activities must also be compliant with local state and federal laws, including Export Control regulations, as well as any applicable foreign laws for international activities. This discussion is a brief introduction to some of these areas and provides links to the responsible offices.

3. Federal Oversight
Public health Service (PHS) provides oversight of the use of animals and Health and Human Services (HHS) over human subjects in federally sponsored research. Institutions applying for and receiving federal funds file assurances that the work will be conducted with appropriate oversight and in compliance with regulatory requirements.
Animal research is overseen by the Office of Laboratory Animal Welfare (OLAW)
Animal Welfare Assurance D
Human research is overseen by the Office of Human Research Protections (OHRP)
Federalwide Assurance FWA
Current assurances are available at

4. Office of Regulatory Affairs at Penn
Institutional Review Board (IRB) reviews and approves human subjects research
Protocols submitted through HS-ERA
Approval required generally “Just in Time,” not at the time of research proposal submission to sponsor
Certification of training required by sponsors
Animal Care and Use Committee (IACUC) reviews and approves vertebrate animal research
Protocols submitted through ARIES
Approval can be granted “Just in Time”
Non-competing continuations must have valid approval date at time of submission

5. NIH Requirements for Vertebrate Animal Use at Subrecipient Institutions
Prime awardee remains responsible for the animal use: Prime submission needs to indicate animal use
All subrecipients that will house or perform experiments using live animals must have a valid Assurance
Animal protocol must be approved by the IACUC at the Prime awardee or that IACUC must delegate/approve the review at the subrecipient institution
For foreign subrecipients, the Prime awardee IACUC must review and approve the animal use protocol

6. Financial Conflicts of Interest
Most sponsors require that grantees have policies for managing conflicts of interest. At Penn, the Research Integrity Office manages FCOI.
PHS-FITS Investigator Disclosure Link:
PHS-FITS Administrator Disclosure Link:
Access the FCOI training in KnowledgeLink at:
Accounts for NIH and other awards requiring compliance with PHS conflict of interest policy will not be established prior to disclosure

7. Export Control Laws
Federal regulations governing how items, technology, and data may be exported from the United States or shared with foreign persons within the United States
Export control laws come into play in a variety of situations, including:
Research contracts/projects:
International shipping:
International travel and collaboration:
At Penn, ORS manages export compliance issues

8. Reporting Non-Compliance
Responsible Offices
ORS
IRB
IACUC
Office of General Counsel
215-P-Comply

9. Penn Administrative Requirements
Open Identification of Sponsors
Unrestricted dissemination of all findings
Resources or data sources on which research is wholly dependent must be free of control by sponsor
No conditions which would jeopardize the University’s commitment to non-discrimination
Sponsor shall not ordinarily participate in the selection of person to work on a project
Contracts must not allow the use of the University’s name for commercial purposes unless specifically approved by President

10. Administrative Requirements (cont.)
Ownership of Intellectual Property is governed by University Patent policy and terms of the sponsored research agreement
University does not warrant results
University does not normally indemnify sponsors
University does not accept agreements which require access to classified data