Proposal Compliance Items
The Sponsored Programs Office (SPO) reviews proposals, awards and subawards to ensure necessary compliance items are in place. However, SPO is not responsible for overseeing the compliance processes at UC Davis.
Projects Involving Human Subjects
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- Institutional Review Board (IRB) protocols
- Does my project need review by the IRB (Institutional Review Board)?
- Before submitting an IRB application for initial review, first determine if IRB review is required for your project.
- IRBNet – Online system to submit a human subjects protocol for IRB review/approval.
- For each approved IRB protocol, SPO will additionally request a completed Protocol Certification Form, by which the Principal Investigator (PI) certifies that the indicated protocols apply to the proposed project.
- Additional NIH information on Human Subjects Research
- The Proposal Development Services team has templates and resources to help you write the Human Subjects section of your grant proposal (CAS Authentication required)
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Projects Involving Vertebrate Animals
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- Institutional Animal Care and Use Committee (IACUC) protocols
- IACUC Protocols and Amendments submission system
- The IACUC protocol requirement does NOT apply to invertebrate animals nor to research that involves only animal tissues.
- For each approved IACUC protocol, SPO will additionally request a completed Protocol Certification Form, by which the PI certifies that the indicated protocols apply to the proposed project.
- The UC Davis IACUC approval number for Vertebrate Animal research can be found on our Institutional Information page
- Additional information is provided by the NIH Office of Laboratory Animal Welfare Vertebrate Animals Section
- The Proposal Development Services team has templates and resources to help you write the Vertebrate Animals section of your grant proposal (CAS Authentication required)
- Institutional Animal Care and Use Committee (IACUC) protocols
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Other Compliance Items
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- Financial Conflicts of Interest (COI)
- Projects using rDNA, pathogenic agents and/or other biohazardous material
- Projects involving human anatomical specimens
- Projects involving human stem cells
- NIH-funded projects involving human fetal tissue (HFT) obtained from elective abortion (Click to jump down to section)
- Projects with potential export control implications
- Prohibition of use of Covered Telecommunications Equipment or Services by Federal Contractors (Click to jump down to section)
- NSF Code-of-Conduct Policy (Click to jump down to section)
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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:
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- 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:
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- 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: /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.
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 use 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):
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- 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
NSF Code-of-Conduct Policy
NSF-Supported Conferences, Workshops, and Symposia
It is National Science Foundation policy to foster harassment-free environments wherever science is conducted, including at NSF-sponsored conferences, workshops, and symposia. The NSF Proposal Award Policy and Procedure Guide (PAPPG), effective February 25, 2019, requires applicants requesting NSF funds for the purpose of carrying out conferences, workshops, and symposia to have a policy or code-of-conduct that addresses sexual harassment, other forms of harassment, or sexual assault, and that includes clear and accessible means of reporting violations of the policy or code-of-conduct.
Recipients of NSF funds to carry out conferences, workshops, and symposia must also provide this policy or code of conduct to all event participants prior to the event and at the conference/workshop/symposium itself.
The following message complies with the above NSF requirements and has been approved for distribution by the UC Davis Harassment & Discrimination Assistance and Prevention Program (HDAPP). This message should be provided to all participants prior to and during NSF-supported conferences, symposia, and workshops carried out after February 25, 2019.
Code of Conduct Regarding Sexual and Other Forms of Harassment
Dear Participant:
This conference/workshop/symposium is supported all or in part by the National Science Foundation under Award No. ________.
We are required by the NSF Proposal & Award Policies & Procedures Guide (Chapter II.E.7), effective February 25, 2019, to provide all event participants with information on the University’s policy on sexual and other forms of harassment or sexual assault as well as directions on how to report any violations of this policy. For purposes of this requirement, “other forms of harassment” is defined as “non-gender or non-sex-based harassment of individuals protected under federal civil rights laws, as set forth in organizational policies or codes of conduct, statutes, regulations, or executive orders.”
The University of California is committed to creating and maintaining a community dedicated to the advancement, application, and transmission of knowledge and creative endeavors through academic excellence, where all individuals who participate in University programs and activities can work and learn together in an atmosphere free of harassment, exploitation, or intimidation.
The University has general policies prohibiting harassment and discrimination on the basis of protected categories, including the University of California Policy on Discrimination, Harassment, and Affirmative Action in the Workplace (https://policy.ucop.edu/doc/4000376/DiscHarassAffirmAction), Student Code of Conduct (https://policy.ucop.edu/doc/2710530/PACAOS-100). The University of California Sexual Violence and Sexual Harassment Policy (http://policy.ucop.edu/doc/4000385/SHSV.pdf) (“Policy”) is specifically focused on sexual violence and sexual harassment, retaliation, and other behavior that violates University policy (“Prohibited Conduct”). THIS POLICY APPLIES TO THIS EVENT AND ALL EVENT ATTENDEES MUST CONFORM THEIR BEHAVIOR WITH THE POLICY. The Policy outlines the University’s responsibilities and procedures related to Prohibited Conduct in order to ensure an equitable and inclusive education and employment environment free of sexual violence and sexual harassment. The Policy defines conduct prohibited by the University of California and explains the administrative procedures the University uses to resolve reports of Prohibited Conduct. The Policy applies to all University employees as well as undergraduate, graduate, and professional students. The Policy applies at all University campuses, Medical Centers, the Office of the President, Agriculture and Natural Resources, and to all University programs and activities.
Confidential resources are also available to those who have experienced sexual harassment, sexual violence, or other Prohibited Conduct in connection with this event. Advocates can be reached 24 hours a day through UC Davis’s Harassment & Discrimination Assistance and Prevention Program (“HDAPP”): (530) 747-3864. Anonymous reports to HDAPP may be made by calling (530) 747-3865. For non-urgent questions or appointments, contact HDAPP at (530) 747-3864 or [email protected].
Reports to law enforcement can be made to UC Davis’s police department (UCDPD) for on-campus incidents or to the local department where the incident occurred. A confidential advocate from HDAPP or UCDPD staff can help determine which police department to contact. In an emergency, dial 911, or to reach UCDPD’s emergency line call (530) 754-2677. Reports to UCDPD can be made in person at 625 Kleiber Hall, Davis, CA 95616, or by phone (530) 754-2677.
The full text of the University’s Sexual Violence and Sexual Harassment Policy may be reviewed on the UC Office of the President website (https://policy.ucop.edu/doc/4000385/SVSH). The University will respond promptly and effectively to reports of Prohibited Conduct and will take appropriate action to prevent, to correct, and when necessary and possible, to discipline behavior that violates the UC Policy on Sexual Violence and Sexual Harassment.
Questions regarding the distribution of the message should be sent to Sponsored Programs at [email protected].