Federal Regulations

The National Science Foundation (NSF) and the Public Health Service (PHS) published final rules on "Objectivity in Research" in the Federal Register on June 19, 1995 (NSF rules) and July 11, 1995 (updated 2011) (PHS rules). The National Institutes of Health (NIH) reprinted the rules in the "NIH Guide for Grants and Contracts," Volume 24, Number 25, dated July 14, 1995 (NIH Guide).

Researchers are required to disclose financial interests and outside activities in accordance with federal and state regulations and university policies and procedures. Those who must disclose include anyone who has the responsibility for the design, conduct, or reporting of the research. Each researcher who has a positive disclosure must use the electronic disclosure system at the time of proposal submission for a federal grant or contract or a subcontract where there are federal flow through funds. Even if a researcher does not have financial interests, they must still log into the COI electronic system. Researchers must update any changes in their disclosures within 30 days of the change.

The certification and individual disclosures are required for all new, renewal, revision, supplement, and continuation applications to any federal agencies and as new Significant Financial Interests are obtained. Federal financial disclosures are required for Phase II Small Business Innovation Research (SBIR) (R44) and Small Business Technology Transfer (STTR) (R42) projects in collaboration with private entities. Phase I of both the SBIR (R43) and STTR (R41) programs are exempt from the federal requirements concerning disclosure of financial interests. 

Federal regulations require that UCSF do the following: (1) Collect disclosures at the time of proposal submission; (2) review the disclosures and determine whether any of the reported financial interests could directly and significantly affect the design, conduct, or reporting of the research; and, if so (3) report to the PHS or NSF or awarding agency the existence of such conflicting interest(s) prior to the expenditure of awarded funds.

The major Public Health Service funding components are as follows:

  • National Institutes of Health (NIH), including all divisions of NIH such as NIDA, NINDS, NIAID, NIA, and so forth.
  • Substance Abuse and Mental Health Services Administration (SAMHSA)
  • Assistant Secretary for Health
  • Agency for HealthCare Research and Quality (AHRQ)
  • Centers for Disease Control and Prevention (CDC)
  • Food and Drug Administration (FDA)
  • Centers for Medicare and Medicaid Services (CMS) [formerly HCFA]
  • Health Resources and Services Administration (HRSA)
    • Maternal and Child Health Bureau
    • Bureau of Health Professions
    • Bureau of Health Resources Development

The federal regulations have been adopted by other agencies:

  • American Cancer Society
  • American Heart Association
  • UC Discovery Grants
  • UCOP Special Programs: University AIDS, California Breast Cancer, Tobacco Related Diseases

The NIH has issued a Financial Conflict of Interest (FCOI) tutorial, which is located at http://grants.nih.gov/grants/policy/coi/tutorial2011/fcoi.htm . The NIH has also issued a ”Frequently Asked Questions” section, which is located at http://grants.nih.gov/grants/policy/coi/coi_faqs.htm