Presentation is loading. Please wait.

Presentation is loading. Please wait.

Sponsored Programs at Penn

Similar presentations


Presentation on theme: "Sponsored Programs at Penn"— Presentation transcript:

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


Download ppt "Sponsored Programs at Penn"

Similar presentations


Ads by Google