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Conflict of Interest in Research - Private Sponsors

    Title:

    Conflict of Interest in Research – Private Sponsors

    Publication date:

    9/20/2012

    Effective date:

    1/22/2010

    BRIEF

    Policy Summary

    Berkeley Lab requires principal investigators (PIs) to disclose financial interests in nongovernmental entities that sponsor the PI's research or provide research gifts to the PI.

    Who Should Read This Policy

    This policy applies to all principal investigators who propose or conduct research or receive research gifts funded by a nongovernmental entity.

    To Read the Full Policy, Go To:

    The POLICY tab on this wiki page

    Contact Information

    Research and Institutional Integrity Office
    RIIO@lbl.gov

    Title:

    Conflict of Interest in Research – Private Sponsors

    Publication date:

    9/20/2012

    Effective date:

    1/22/2010

    POLICY

    A. Purpose

    This policy ensures that Lawrence Berkeley National Laboratory (Berkeley Lab) research sponsored by nongovernemental entities is not biased by the principal investigator's financial interests.

    B. Persons Affected

    This policy applies to all principal investigators who propose research or receive research gifts funded by a nongovernmental entity.

    C. Exceptions

    None

    D. Policy Statement

    1. General
      1. The California Political Reform Act of 1974 and UC Policy require a principal investigator who proposes or conducts a research project or who receives a gift funded by a nongovernmental agency to disclose financial interests in the sponsor at the time of proposal submission or receipt of the gift.
      2. When Berkeley Lab proposes a Work for Others agreement with an entity that is receiving its funding from another organization, additional financial disclosure rules may apply.
    2. Process
      1. Principal investigators must submit the original Statement of Economic Interests for Principal Investigators (California Form 700-U) at the time of proposal submission or receipt of the gift.
      2. When Berkeley Lab proposes a Work for Others agreement with an entity that is receiving its funding from another organization, federal and state forms must be completed as in the following examples:
        1. Berkeley Lab receives funding from Chiron. Chiron receives its funding from the National Institutes of Health (NIH). Berkeley Lab must collect both the state disclosure (California Form 700-U) from the principal investigator at Berkeley Lab, and disclosures of financial interest (Forms DFI-1-PHS, DFI-2-PHS, and DFI-3-PHS, if applicable) from the principal investigator and all participants. Chiron is a nongovernmental entity, and is not exempt from state of California disclosure requirements.
        2. Berkeley Lab receives funding from the American Heart Association (AHA). The AHA receives its funding from NIH. Berkeley Lab must collect disclosures of financial interest (Forms DFI-1-PHS, DFI-2-PHS, and DFI-3-PHS, if applicable). The AHA is on the state of California exempt list, so the state disclosure (California Form 700-U) does not need to be completed.
        3. Berkeley Lab receives funding from the Parkinson's Disease Foundation (PDF). PDF receives its funding from the NIH. PDF is a nonprofit entity, but is not on the state of California exempt list. Berkeley Lab must collect both the state disclosure (California Form 700-U) and disclosures of financial interest (Forms DFI-1-PHS, DFI-2-PHS, and DFI-3-PHS, if applicable).
      3. Financial disclosures are required for all new, amendment, noncompeting continuation, and renewal proposals.
      4. The Research and Institutional Integrity Office will review all disclosures of financial interest related to sponsored research.

    E. Roles and Responsibilities

    Principal investigators must disclose financial interests in any nongovernmental sponsor of research by completing a Statement of Economic Interests for Principal Investigators (California Form 700-U).

    The Research and Institutional Integrity Office must review all disclosures of financial interest related to sponsored research.

    F. Definitions/Acronyms

    None

    G. Recordkeeping Requirements

    Not applicable

    H. Implementing Documents

    Document Number

    Title

    Type

    California Form 700-U

    Statement of Economic Interests for Principal Investigators

    Form

     

    Addendum to Statement of Economic Interests for Principal Investigators

    Form

    Form DFI-1

    Lawrence Berkeley National Laboratory Declaration – Principal Investigator's List of Participants Who Must File Disclosures of Financial Interest

    Form

    Form DFI-2

    Lawrence Berkeley National Laboratory Disclosure of Financial Interests

    Form

    Form DFI-3

    Lawrence Berkeley National Laboratory Positive Disclosure of Financial Interests

    Form

    Form DFI-1 PHS

    Lawrence Berkeley National Laboratory Declaration – Principal Investigator's List of Participants Who Must File
    Disclosures of Financial Interest (for PHS/NIH proposals submitted on or after August 24, 2012)

    Form

    Form DFI-2 PHS

    Lawrence Berkeley National Laboratory Disclosure of Financial Interests in PHS-Funded Research

    Form

    Form DFI-3 PHS

    Lawrence Berkeley National Laboratory Positive Disclosure of Financial Interests in PHS-Funded Research

    Form

    I. Contact Information

    Research and Institutional Integrity Office
    RIIO@lbl.gov

    J. Revision History

    Date

    Revision

    By Whom

    Revision Description

    Section(s) Affected

    Change Type

    1/2/2012

    0

    Stoufer

    Rewrite for wiki (brief)

    all

    Minor

    9/20/2012

    1

    Stoufer

    Rewrite for wiki (policy)

    all

    Minor

    DOCUMENT INFORMATION

    Title:

    Conflict of Interest in Research – Private Sponsors

    Document number

    05.02.002.000

    Revision number

    1

    Publication date:

    9/20/2012

    Effective date:

    1/22/2010

    Next review date:

    9/20/2015

    Policy Area:

    COI in Research

    RPM Section (home)

    Conflict of Interest

    RPM Section (cross-reference)

    Section 10.07

    Functional Division

    Research and Institutional Integrity Office

    Prior reference information (optional)

    Section 10.07

    Source Requirements Documents

    Implementing Documents

    Document Number

    Title

    Type

    California Form 700-U

    Statement of Economic Interests for Principal Investigators

    Form

     

    Addendum to Statement of Economic Interests for Principal Investigators

    Form

    Form DFI-1

    Lawrence Berkeley National Laboratory Declaration – Principal Investigator's List of Participants Who Must File Disclosures of Financial Interest

    Form

    Form DFI-2

    Lawrence Berkeley National Laboratory Disclosure of Financial Interests

    Form

    Form DFI-3

    Lawrence Berkeley National Laboratory Positive Disclosure of Financial Interests

    Form

    Form DFI-1 PHS

    Lawrence Berkeley National Laboratory Declaration – Principal Investigator's List of Participants Who Must File
    Disclosures of Financial Interest (for PHS/NIH proposals submitted on or after August 24, 2012)

    Form

    Form DFI-2 PHS

    Lawrence Berkeley National Laboratory Disclosure of Financial Interests in PHS-Funded Research

    Form

    Form DFI-3 PHS

    Lawrence Berkeley National Laboratory Positive Disclosure of Financial Interests in PHS-Funded Research

    Form

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