Research Agreement Compliance
The Sponsored Programs office reviews proposals, awards and subawards to ensure the necessary compliance items are in place. However, the Sponsored Programs office is not responsible for overseeing the compliance processes at UC Davis.
Details on the compliance processes at UC Davis can be found as follows:
- Prohibition of use of “COVERED TELECOMMUNICATIONS EQUIPMENT OR SERVICES’’ by Federal Contractors.
Section 889 of the John S. McCain National Defense Authorization Act (NDAA; – Public Law 115-232) prohibits used of “Covered Telecommunications Equipment OR Services” by Federal Contractors. For this purpose, University is considered as a “Federal Contractor.”
The term ‘‘COVERED TELECOMMUNICATIONS EQUIPMENT OR SERVICES’’ means telecommunications or video surveillance equipment and/or services either produced or provided by or which uses substantial or essential components produced or provided by the following entities (or any subsidiary or affiliate of the entities):- Huawei Technologies Company
- ZTE Corporation
- Hytera Communications Corporation
- Hangzhou Hikvision Digital Technology Company
- Dahua Technology Company
- Any entity the US Government reasonably believes is owned, controlled by, or connected to the government of the People’s Republic of China
A list of the above companies, and their subsidiary or affiliates, as of December 2020
- Sponsor guidance on reporting and disclosing international involvement and activities
- Projects involving human subjects
- When needed, the Sponsored Programs will request the completed Protocol Certification Form. Through submission of the Protocol Certification Form, the Principal Investigator is certifying that valid Institutional Review Board (IRB) and/or Institutional Animal Care and Use Committee (IACUC) Protocols are in place for the proposed project.
- This form is required for projects involving human subjects if the project is newly proposed, a modified (renewed) Protocol on an already funded project and resubmissions, continuation, and supplemental awards/proposals (if the protocol dates on the previously-provided form are expired).
- When needed, the Sponsored Programs will request the completed Protocol Certification Form. Through submission of the Protocol Certification Form, the Principal Investigator is certifying that valid Institutional Review Board (IRB) and/or Institutional Animal Care and Use Committee (IACUC) Protocols are in place for the proposed project.
- Projects involving vertebrate animals
- When needed, the Sponsored Programs will request the completed Protocol Certification Form. Through submission of the Protocol Certification Form, the Principal Investigator is certifying that valid Institutional Review Board (IRB) and/or Institutional Animal Care and Use Committee (IACUC) Protocols are in place for the proposed project.
- This form is required for projects involving vertebrate animals after a new IACUC protocol is approved for a new project and after an amendment to add a funding agency to an existing IACUC protocol has been approved. By signing this form, the PI certifies congruency between the IACUC protocol(s) and the funded grant award(s).
- Projects using rDNA, pathogenic agents and/or other biohazardous material
- Projects involving human anatomical specimens
- NIH-funded projects involving human fetal tissue (HFT) obtained from elective abortion
- Projects involving human stem cells
- Projects with potential export control implications
- Financial Conflicts of Interest (COI)
NSF Code-of-Conduct Policy
NSF-Supported Conferences, Workshops, and Symposia
NIH Funded Research Use of Human Fetal Tissue Obtained from Elective Abortion
Please note that the following applies to NIH funded projects only.
Effective September 25, 2019, as detailed in NOT-OD-19-128, and NOT-OD-19-137 , NIH requires that, proposals for any project that involve Human Fetal Tissue (“HFT”) that NIH has defined as:
- the study, analysis, or use of human fetal tissue, cells, an/or derivatives,
- which are obtained from the process of elective abortions (“HFT”)
meet requirements detailed in the above two NIH notices.
To be in full compliance with the NIH requirements, all such proposals need to:
-
- Respond “Yes” to question #2 in the “Special Interest” section of the Proposal tab in Cayuse.
- In the Approach section of the proposal’s Research Strategy, justify the need for use of HFT, by including the specific heading “Human Fetal Tissue Research Approach” and within that section:
- Describe the proposed characteristics, procurement, and procedures for the research use of HFT. The description should be sufficiently detailed to permit meaningful evaluation by NIH and an ethics advisory board comprised of scientists, bio-ethicists and others as specified in section 492A of the Public Health Service Act.
- Justify the use of HFT by explaining, and including the following:
- Why the research goals cannot be accomplished using an alternative to HFT.
- What methods were used (e.g. literature review, preliminary data, etc.) to determine that alternatives could not be used.
- Results from a literature review used to provide justifications.
- Plans for the treatment of HFT and the disposal of HFT when research is complete.
- Description of planned written, voluntary, informed consent process for cell/tissue donation, or description and documentation of process if cells/tissue were already obtained.
- In the Other Attachments section of the R&R Other Project Information form:
- Provide the blank sample of the IRB approved consent form with the application. NIH requires that the blank PDF-formatted form be named ‘HFTSampleIRBConsentForm.pdf’; (note: a copy of the required form is at: https://research.ucdavis.edu/wp-content/uploads/HFTSampleIRBConsentForm.pdf), and
- A letter, signed by PD/PI, assuring that (a) the HFT donating organization or clinic adheres to the requirements of the informed consent process and that the HFT was not obtained or acquired for valuable consideration. The letter must be in PDF format, named “HFTComplianceAssurrance.pdf”.
- Note: Office of research will require that the PD/PI also provide a similar letter, signed by the authorized representative of the donating organization, attesting to the above, relying on which PD/PI has signed the above described NIH required letter.
- Modular budgets may not be used. Instead, utilize the R&R Budget Form.
- A line item must be added, titled “Human Fetal Tissue Costs”. Valuable consideration cannot be provided. NOTE: While the sale of HFT is prohibited, valuable consideration “does not include reasonable payments associated with the transportation, implantation, processing, preservation, quality control, or storage of human fetal tissue.” If donated or existing HFT is used, the line item costs should be indicated as a value of $0.00.
- Details regarding HFT must be specified in the Budget Justification, pursuant to the instructions.