Links updated 09/08

1. General
2. Process
3. Work for Others from PHS/NSF Flow-Through Funding
4. Forms
5. Related Links

A.  GENERAL

Federal Regulations

The National Science Foundation (NSF) and the Public Health Service (PHS) published regulations in the Federal Register, effective October 1, 1995, requiring principal investigators and participants who are responsible for the design, conduct, or reporting of the research to disclose project-related financial interests at the time of proposal submission.  Other agencies that have also adopted the federal requirement are the American Cancer Society (ACS), American Heart Association (AHA), UC Discovery Grants, and University of California Office of the President (UCOP) Special Programs (which include the California Breast Cancer Research Program and the Tobacco-Related Disease Research Program).

The major Public Health Service funding components are:

• National Institutes of Health (NIH), including all divisions of NIH such as the National Cancer Institute (NCI), National Institute of General Medical Sciences (NIGMS), the National Eye Institute (NEI), the National Institute on Aging (NIA), and so forth.


• Centers for Disease Control and Prevention (CDC)


• Food and Drug Administration (FDA)

B. PROCESS

Principal Investigators and participants (herein called Key Personnel) who are responsible for the design, conduct or reporting of the research must complete financial disclosures for all new, amendment, non-competing continuation, and renewal proposals. 

The Principal Investigator first completes the LBNL Declaration (Form DFI-1) by identifying the Key Personnel in their research project.  The PI and those listed on Form DFI-1 then each complete the LBNL Disclosure of Financial Interest (Form DFI-2), disclosing whether they have financial interests related to the research project.  If there is a positive disclosure, the individual indicating so will need to complete the LBNL Positive Disclosure of Financial Interest (Form DFI-3).  Positive disclosures will be reviewed by the Conflict of Interest Coordinator, and a determination will be made by the Associate Laboratory Director for Operations.

For positive disclosures, original forms must be sent to the Laboratory Conflict of Interest Coordinator, with a copy to the Sponsored Projects Office (SPO).  For negative disclosures, original forms should be sent to SPO.

If the research involves human subjects, only one set of conflict-of-interest forms need to be completed.  The Human Subjects Quality Assurance Committee (HSQAC) and SPO are using the same set of forms for research-related conflict-of-interest disclosures.  For negative disclosures, the original forms go to the Sponsored Projects Office (SPO), and a copy should accompany the application to HSQAC.  For positive disclosures, the original forms should go to the Conflict of Interest Coordinator, and copies of the disclosure should go to SPO and HSQAC.

C.  WORK FOR OTHERS FROM PHS/NSF FLOW-THROUGH FUNDING

Disclosure is required when LBNL is proposing a Work for Others agreement with an entity who is receiving its funding from PHS/NIH (except for Phase I SBIR/ STTR), NSF, or the other agencies mentioned in Paragraph (A) above.

When LBNL is proposing a Work for Others agreement with an entity who is receiving its funding from PHS/NIH, NSF, or the other agencies mentioned in Paragraph (A) above, federal and State forms are to be completed as in the following examples:

1. LBNL receives funding from Chiron. Chiron receives its funding from NIH. LBNL must collect both the state disclosure (Form 700-U) from the PI at LBNL, and the disclosures of financial interest (Form DFI-1, DFI-2, and DFI-3, if applicable) from the PI and all the participants. Chiron is a nongovernmental entity, and is not exempt.


2. LBNL receives funding from the American Heart Association (AHA), which receives its funding from NIH. LBNL must collect the disclosures of financial interest (Form DFI-1, DFI-2, and DFI-3, if applicable). The AHA is on the State of California exempt list, so the state disclosure (Form 700-U) does not need to be completed.


3. LBNL receives funding from The Parkinson Disease Foundation (PDF). PDF receives its funding from the NIH. PDF is a nonprofit entity, but is not on the state exempt list. LBNL must collect both the state disclosure (Form 700-U) and disclosures of financial interests (Form DFI-1, DFI-2, and DFI-3, if applicable)

D.  FORMS

• LBNL Declaration — Principal Investigator’s List of Participants Who Must File Disclosures of Financial Interest (Form DFI-1)


• LBNL Disclosure of Financial Interest (Form DFI-2)*


• LBNL Positive Disclosure of Financial Interest (Form DFI-3)*

*If there is a positive disclosure, the original forms should be sent to the Laboratory Conflict of Interest Coordinator.

E.  RELATED LINKS

• National Institutes of Health Conflict of Interest


• National Science Foundation Conflict of Interest


• Conflict of Interest Web Resources