Policies & Regulations - Office of Research (2024)

Review the policies and regulations which govern the conduct of research at UC Davis:

• • Biological Safety/ Biohazard Use
  • Conflicts of Interest in Research
  • Export Control
  • Human Anatomical Specimen and Tissue Oversight
  • IRB Administration
  • Intellectual Property (Tech Transfer)
  • Organized Research
  • Research Misconduct
  • Stem Cell Research

For additional information please contact the responsible OR unit.

Oversight of the Animal Care and Use program is the responsibility of theInstitutional Animal Care and Use Committee (IACUC).

Biological Safety/Biohazard Use

Oversight of the use of infectious biological agents, recombinant DNA/RNA, and the propagation and release of recombinant organisms including plants, animals and microbial agents is the responsibility of UC Davis Safety Services.

Conflicts of Interest in Research

The Research Ethics and Compliance Office (RECO)provides administrative support on issues pertaining to financial conflicts of interest and supports the Conflict of Interest Committee (COIC).

UC Davis Policies

• • PPM 230-05
    UC Davis Policy on Individual and Institutional Conflicts of Interest involving Research
  • Exhibit A
    UC Davis Procedures for Reporting, Reviewing, and Managing Conflicts of Interest in Research
  • PPM 230-07
    UC Davis Policy on Public Health Service Regulations on Objectivity in Research
  • PPM 380-16
    Conflict of Interest for Personnel
  • APM UCD-025
    Conflict of Commitment and Outside Activities of Faculty Members

UC Systemwide Policies

• • Conflict of Interest webpage – UCOP Research Policy Analysis and Coordination (RPAC)
    • Disclosure of Financial Interests & Management of Conflicts of Interest, Public Health Service Research Awards
    • Conflict of Interest (COI) Policy and Compendium of Specialized University Policies, Guidelines, and Regulations Related to COI
    • Guidelines for Disclosure and Review of Principal Investigator’s Financial Interest in Private Sponsors of Research
    • Disclosure of Financial Interests and Management of Conflicts of Interest, NSF and NASA Awards
    • Conflict of Commitment and Outside Activities of Faculty Members
    • Memo 23-03: Guidance on Managing Conflict of Interest in License Agreements
  • Administrative Records Relating to Research: Retention and Disposition Requirements

California State Laws and Regulations

• • Political Reform Act
  • Proposition 209California Civil Rights Initiative
  • California Code of Regulations, Regulations of the Fair Political Practices Committee
    • Specifically see Chapter 7, 18702.4.pdfArticle 1, 18702.4 and Chapter 7, Article 3, 18755

Federal Laws and Regulations

• • Title 21, Part 54
    Financial Disclosure by Clinical Investigators
  • Title 42, Part 50
    Section 50.604, Institutional Responsibility Regarding Conflicting Interests of Investigators
  • Title 45, Part 94
    Responsible Prospective Contractors

• Other Resources

• • Association of American Universities (AAU)
    • Task Force on Research Accountability: Report on Individual and Institutional Conflict of Interest (October 2001)
  • Federation of American Societies for Experimental Biology (FASEB)
    • Shared Responsibility, Individual Integrity: Scientists Addressing Conflicts of Interest in Biomedical Research (July 2006)
  • Association of American Medical Colleges (AAMC)
    • Protecting Subjects, Preserving Trust, Promoting Progress- Policy and Guidelines for the Oversight of Financial Interests in Human Subjects Research (December 2001)

Contract & Grant Administration (Sponsored Programs Office)

The Sponsored Programs Office (SPO) provides administrative support on issues pertaining to contract and grant administration.

UC Davis Policies and Regulations

• • Acceptable Signatures (PDF)
  • Charging Administrative Costs to Federal Awards
  • Definition of Equipment(Capital Asset & Equipment Management)
  • Safety Services: Research Policies, Regulations and Guidelines
  • Indirect Costs/Facilities & Administrative (F&A) Costs
    • Primate Center B-Indirect Cost Rate
    • Indirect Cost Rate Applicable to Clinical Trials
  • Nonresident Supplemental Tuition Remission Policy(Graduate Studies)
  • Principal Investigator (PI) Eligibility to Submit Proposals
  • UC Davis A-133 Audit information (PDF)
  • Contracts and Grants (UCD Finance & Business)

UC Systemwide Policies

• • Administrative Records Relating to Research: Retention and Disposition Requirements (PDF)
  • Cost Sharing
  • Research Policy Analysis and Coordination (RPAC) Office
    • UC Contract and Grant Manual
      • 1-300 President’s Duties and Statements on Academic Policy
      • 1-500 Principal Investigator Guidelines
      • 21-430 Indemnification and Third Party Liability
    • California Model Agreement Guide
      • Indirect Costs: Agreements with the State of California
    • Requirement to Submit Proposals and to Receive Awards for Grants and Contracts through the University
  • UCOP Guidance on Consulting with Industry (PDF)

California State Laws and Regulations

• • State Administrative Manual
  • State Contracting Manual
  • Senate Resolution 66 (PDF)

Federal Laws and Regulations

• • Office of Management & Budget (OMB) Circulars
  • Code of Federal Regulations
  • Federal Register
  • Federal Acquisition Regulations (FAR)
  • Federal Demonstration Partnership (FDP)

Export Control

The Research Ethics and Compliance Office (RECO)provides administrative support on issues pertaining to export control. For inquiries please contact Export Control.

Federal laws and Regulations

• • U.S. Department of Commerce, Bureau of Industry and Security Export Administration Regulations (15 CFR Parts 700-799)
  • PPM 430-10

Human Anatomical Specimen and Tissue Oversight

TheResearch Ethics and Compliance Office (RECO)provides administrative support on issues pertaining to theHuman Anatomical Specimen and Tissue Oversight Committee (HASTOC).

UC Davis Policies

• • PPM 220-03
    UC Davis Policy on Anatomical Specimens

UC Systemwide Policies

• • Policy on Anatomical Materials Programs
  • Policy and Procedures on Curation and Repatriation of Human Remains and Cultural Items

California State Law and Regulations

• • California Native American Graves Protection and Repatriation Act, California Health and Safety Code Sections 8010-8030

Federal Law and Regulations

• • Native American Graves Protection and Repatriation Act, 25 U.S.C. 3001 et seq

IRB Administration

The IRB Administrationprovides administrative support on issues pertaining to human research protection and supports the UC Davis Institutional Review Board (IRB).

UC Davis Policies

• • Policy and procedure manual, Section 240 “Research Involving Human Subjects”
  • IRB Administration Standard Operating Procedures

UC Systemwide Policies

• • UCOP Policies on Research (including human subjects)
  • UC Contracts and Grants Manual, Chapter 18, Sections 100 through 999
  • Administrative Records Relating to Research: Retention and Disposition Requirements

California State Laws and Regulations

• • California Health and Safety Code Section 24170-24179.5 (PDF) (Effective 4/03/2006)

Federal Laws and Regulations

• • Federalwide Assurance UC Davis’ Federalwide Assurance Number (FWA#) is 00004557, and is approved up to January 5, 2024.The University of California, Davis, in accordance with its Federalwide Assurance (FWA00004557) with the Department of Health & Human Services, adheres to all federal and state regulations related to the protection of human research subjects, including 45 CFR 46 (“The Common Rule”), 21 CFR 50, 21 CFR 56for FDA regulated products, and the principles of The Belmont Report and Institutional policies and procedures. In addition, the International Conference on Harmonization, Good Clinical Practice (ICH GCP) principles are adhered to insofar as they parallel the previously mentioned regulations and policies.
  • Terms of Assurance
  • Office of Human Research Protections (OHRP)
    • DHHS-OHRP Regulations – 45 CFR 46
  • U.S. Food and Drug Administration (FDA)
    • FDA Regulations – 21 CFR 56

Intellectual Property Management (Tech Transfer)

UC Davis Policies

• • Copyright (PPM 250-01)
  • Course Materials Fees and Services Fees (PPM 330-86)
  • Digital Millennium Copyright Act (DMCA) (PPM 250-05)
  • Intellectual Property (PPM Section 250)
  • Publication Rights (PPM 230-10)
  • Sales of Instructional Materials (PPM 210-80)
  • Sales of University Goods and Services to Non-university Users (PPM 340-09)
  • Use of the University’s Name, Seal, and other Trademarks (PPM 310-65)
  • WWW Graphics Standards (PPM 310-70)

UC Systemwide Policies

• • Accepting Equity When Licensing University Technology (2008)
  • Conflict of Commitment and Outside Activities of Faculty Members (APM 025) (1/21/2011)
  • Copyright Policies
    • Digital Millennium Copyright Act (1999)
    • Open Access Policy for the Academic Senate of the University of California (2013)
    • Policy for Off-Air Recording of Broadcast Programming for Educational Purposes (1985)
    • Policy and Guidelines on the Reproduction of Copyrighted Materials for Teaching and Research (1986)
    • Policy on Copyright Ownership (1992)
    • Policy on Ownership of Course Materials (2003)
    • Policy on Use of Recordings of Course Presentations (2005)
  • Special Services to Individuals and Organizations (APM 020) (6/23/1958)
  • University of California Patent Policy (10/1/1997)

Organized Research

The Research Unit Development unit provides administrative support on issues pertaining to Organized Research.

UC Davis Policies

• • Davis Division of the Academic Senate, Policy for the Review & Approval of an Organized Research Unit
  • PPM 220-01
    UC Davis Policy on Organized Research
  • Academic Personnel Manual, Appendix II-C
    UC Davis Appointment and Review of Directors of Organized Research Units

UC Systemwide Policies

• • UCOP Policy on Administration of Organized Research Units
  • UCOP Policy 2307, Organized Research Units
  • UCOP Compendium: Universitywide Review Process for Research Units

Research Misconduct

The Research Ethics and Compliance Office (RECO) provides administrative support on issues pertaining to research misconduct.

UC Davis Policies

• • PPM 220-05
    UC Davis Policy on Integrity in Research
  • PPM 220-05, Exhibit A
    UC Davis Policy on Procedure for Conducting the Inquiry
  • PPM 220-05, Exhibit B
    UC Davis Policy on Procedure for Conducting the Investigation

UC Systemwide Policies

• • UCOP Policy on Integrity in Research

Federal Law and Regulations

• • Public Health Service Policies on Research Misconduct; Final Rule, Federal Register, Vol. 70, No. 94, May 17, 2005, 42 CFR Parts 50 and 93

Stem Cell Research

The Research Ethics and Compliance Office (RECO)provides administrative support on issues pertaining to stem cell research and supports the Stem Cell Research Oversight committee.

UC Davis Policies

• • PPM 220-02
    UC Davis Policy on Human Stem Cell Research

California State Law and Regulations

• • Health & Safety Code, Sections 125118-125119.5, California Embryonic Stem Cell Guidelines
  • Health & Safety Code, Sections 125300-125320, Embryo Registry
  • Health & Safety Code, Sections 125330-125355, Procuring of Oocvytes for Research
  • California Code of Regulations,Title 17, Section 100010-100110
  • CIRM funded Research (California Code of Regulations, Title 17, Section 100070)

Federal Laws and Regulations

• • Presidential Executive Order 13435
  • National Institutes of Health (NIH):Policy on Stem Cell Research
  • National Institutes of Health (NIH): Guidelines on Human Stem Cell Research
  • National Institutes of Health (NIH): Stem Cell Information
  • OMB Circular A-21: Cost Principles for Educational Institutions