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 (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). Effective October 1, 1995, the regulations require that principal investigators submitting applications to the PHS or NSF must identify at the time of proposal submission all UCSF participants in the project who have responsibility for the design, conduct or reporting of the research.

The federal requirements have also been adopted by other sponsors: American Cancer Society, American Heart Association, California Institute for Regenerative Medicine, UC Discovery Grants, and UCOP Special Research Programs (including: University AIDS, California Breast Cancer, and Tobacco Related Diseases research programs). Please make sure that the federal financial disclosure forms and the certification page are submitted with proposals for grants or contracts for funding from these entities.

Principal investigators are required to submit the original of the form “Federal Principal Investigator Certification Form”, along with a list of those participants who have financial interest(s) related to the proposed research project. Each participant who is listed must complete an original “Disclosure of Financial Interests” form. That federal disclosure form is attached to the certification form, all of which are submitted at the time of proposal submission for a federal grant or contract or a subcontract where there are federal flow through funds. Those participants who do not have financial interests do not need to complete and submit the federal disclosure form.

The certification and individual disclosures are required for all new, renewal, revision, supplement, and continuation applications to PHS or NSF 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. Institutional training grants and individual fellowships do not require disclosure.
Click here for the Disclosure Requirements chart.

Federal policy requires 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 awarding component 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
    

Updated January 2007