Office of Research Research Agreement Compliance - Office of Research

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:


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:

    1. Respond “Yes” to question #2 in the “Special Interest” section of the Proposal tab in Cayuse.
    2. 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.
    3. 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.
    4. 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.