RPM | REQUIREMENTS AND POLICIES MANUAL

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    Title:

    Conflict of Interest in Research – CRADAs

    Publication date:

    7/8/2020

    Effective date:

    11/30/2009

    BRIEF

    Policy Summary

    Each Berkeley Lab employee participating in the conception, preparation, negotiation, approval, or execution of a Cooperative Research and Development Agreement (CRADA) must disclose a financial interest in any entity, other than the University of California, that has an interest in the CRADA.

    Who Should Read This Policy

    This policy primarily affects employees who have any involvement in CRADAs.

    To Read the Full Policy, Go To:

    The POLICY tab on this wiki page

    Contact Information

    Research Integrity Office
    [email protected]

    Title:

    Conflict of Interest in Research – CRADAs

    Publication date:

    7/8/2020

    Effective date:

    11/30/2009

    POLICY

    A. Purpose

    Lawrence Berkeley National Laboratory (Berkeley Lab) must ensure that the financial interests of its employees do not present a conflict of interest in the preparation, negotiation, or approval of a CRADA.

    B. Persons Affected

    This policy applies to employees involved in the preparation, negotiation, or approval of a CRADA.

    C. Exceptions

    The DOE contracting officer may approve exceptions.

    D. Policy Statement

    1. Each employee who has a substantial role in the preparation, negotiation, or approval of a CRADA (typically the principal investigator, division director or designee, Strategic Partnerships Office (SPO) Manager, SPO Contracts Officer, Licensing Manager, Patent Department reviewer, and Laboratory Director) must disclose financial interests in any entity that has a substantial role in the CRADA. If an employee holds any financial interest in an entity related to the CRADA, Berkeley Lab must ensure that the employee does not have a substantial role (including an advisory role) in the preparation, negotiation, or approval of the CRADA.
    2. Disclosures are required for all new and amendment CRADA proposals.
    3. The Research and Institutional Integrity Office will review all disclosures of financial interest in a CRADA.
    4. For CRADAs in which the partner is providing funds to Berkeley Lab, the Political Reform Act of 1974 also applies. In such cases, the principal investigator must also complete the Statement of Economic Interests for Principal Investigators (California Form 700-U). Additional financial disclosure rules may apply, depending on the origin of the partner's funding.

    E. Roles and Responsibilities

    Each employee who has a substantial role in the preparation, negotiation, or approval of a CRADA is required to disclose financial interests in any entity that has a substantial role in the CRADA by completing an LBNL Cooperative Research and Development Agreement Statement of Economic Interest form.

    The Research and Institutional Integrity Office manages the review process for disclosures of financial interest related to CRADAs, and coordinates review by the DOE contracting officer of any such disclosures.

    F. Definitions/Acronyms

    None

    G. Recordkeeping Requirements

    None

    H. Implementing Documents

    Document number

    Title

    Type


    LBNL CRADA Statement of Economic Interest

    Form

    California Form 700-U

    Statement of Economic Interests for Principal Investigators

    Form


    Addendum to Statement of Economic Interests for Principal Investigators

    Form

    I. Contact Information

    Research Integrity Office
    [email protected]

    Revision History

    Date

    Revision

    By Whom

    Revision Description

    Section(s) Affected

    Change Type

    1/2/2012

    0

    Stoufer

    Rewrite for wiki (brief)

    All

    Minor

    9/25/2012

    1

    Stoufer

    Rewrite for wiki (policy)

    All

    Minor

    7/8/2020 1.1 Stoufer Update source requirements, contact information, office names All Minor
    12/16/2020
    D. Soustin Updated Contract 31 I clause numbers as per mod 1105 Source Requirement Documents Editorial

    DOCUMENT INFORMATION

    Title:

    Conflict of Interest in Research – CRADAs

    Document number

    05.02.003.000

    Revision number

    1.1

    Publication date:

    7/8/2020

    Effective date:

    11/30/2009

    Next review date:

    7/8/2025

    Policy Area:

    COI in Research

    RPM Section (home)

    Conflict of Interest

    RPM Section (cross-reference)

    Section 10.08

    Functional Division

    Research and Institutional Integrity Office

    Prior reference information (optional)

    Section 10.08

    Source Requirements Documents

    Contract 31, Clause I.138, DEAR 970.5227-3, Technology Transfer Mission (AUG 2019) [SC alternate 2018] (prev. I.092)

    Implementing Documents

    Document number

    Title

    Type


    LBNL CRADA Statement of Economic Interest

    Form

    California Form 700-U

    Statement of Economic Interests for Principal Investigators

    Form


    Addendum to Statement of Economic Interests for Principal Investigators

    Form



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