Links updated 09/08

1. General
2. Human Subjects Research
3. Summary of Forms

A.  GENERAL

In the protection of human subjects, “conflict of interest in research” refers to situations in which financial or other personal considerations may compromise, or have the appearance of compromising, a researcher’s professional judgment in conducting or reporting research. A conflict of interest depends on the situation, and not on the actions or character of an individual investigator.

The federal Department of Health and Human Services (DHHS), from which Berkeley Lab holds its approval to conduct research involving human subjects, has issued guidance on Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subjects Protection.

B. HUMAN SUBJECTS RESEARCH

At Berkeley Lab, all protocols for research involving human subjects must first pass through the LBNL Human Subjects Quality Assurance Committee (HSQAC).  Final approval for the conduct of human subjects research is given by the joint Berkeley Lab — University of California at Berkeley Institutional Review Board, the Committee for Protection of Human Subjects (CPHS).  All human-subject reviews at Berkeley Lab flow through the HSQAC, which forwards completed applications to CPHS for final review and approval.

For all applications to the HSQAC/CPHS, the researcher should:

• Complete the LBNL Declaration—Principal Investigator’s List of Participants Who Must File Disclosures of Financial Interests (Form DFI-1); all persons identified on Form DFI-1 must complete the LBNL Disclosure of Financial Interests (Form DFI-2).  The list on Form DFI-1 should correspond with the NIH Key Personnel Form, if applicable.  If someone has a positive disclosure on Form DFI-2, that person must complete the LBNL Positive Disclosure of Financial Interests (Form DFI-3).  The HSQAC will forward any positive disclosures to the Conflict of Interest (COI) Coordinator for follow-up and review if needed.


• Respond promptly to requests for additional information from the COI Coordinator, as final approval of human subjects will be delayed, pending their review.

Review and Approval of the Disclosure of Financial Interest Form

When there is a positive disclosure, the HSQAC will forward the research protocol and the original disclosure forms to the Laboratory COI Coordinator, if the original has not already been sent.  The COI Coordinator will contact the researcher(s) identified by the form as having a potential conflict and make an initial determination of either:

• No Significant Financial Interest or Related Financial Interest is of concern.  In this case, no further COI review will be needed and human subjects review and approval may proceed.


• A Significant Financial Interest or Related Financial Interest may exist.  In this case, the COI Coordinator will inform the investigator of the need to file additional documentation, with a copy to the HSQAC’s administrative office, the Human and Animal Regulatory Committees office (HARC).

The COI Coordinator will inform the HARC office and the investigator of the outcome of the initial determination.  The COI Coordinator will coordinate any further review, and inform the HSQAC of the outcome.  Human subjects review and approval may proceed while the COI review is being completed, but final approval of the human subjects protocol will be withheld until COI review and approval has been completed.

C.  SUMMARY OF 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)*

*When there is a positive disclosure, the original disclosure forms go to the Conflict of Interest Coordinator, with a copy going to the Human Subjects Quality Assurance Committee (HSQAC).  For negative disclosures, the original goes to HSQAC.