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labelBrief

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]

Card
labelPolicy

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

7/8/20201.1StouferUpdate source requirements, contact information, office namesAllMinor
12/16/2020
D. SoustinUpdated Contract 31 I clause numbers as per mod 1105Source Requirement DocumentsEditorial
Card
labelDocument Information

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
Anchor
_GoBack
_GoBack

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

buildershow-showif
grouprpm2-admins
Card
labelAdditional Information

ADDITIONAL 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

Author name/contact info

M. Stoufer



Revision 0 publication date

1/2/2012

Retirement date

n/a

Prior reference information (optional)




Inputs from more than one Functional Area?

No

List additional Functional Areas & contacts




Inputs from more than one Policy Area?

No

List additional Policy Areas & contacts




30-day notification needed?

No

30-day start date

n/a

30-day end date

n/a



LDAP protected?

No



Need TABL reminders?

No

Frequency

n/a

Brief reminder text:

n/a



Approval Sheet for this revision received (date)
[Note: author is responsible}


Key labels/tags:

  • (Policy Area 1), (Policy Area 2), (Section)

New terms that need to be added to Glossary/Acronym list:

  • (list items not found and context (Policy Area name) – full definition would be included in Policy)

Implementing Documents restricted to department/functional use

(optional – these will be used for tracing between requirements and associated documents)

Document number

Title







Side bars:
Side bar 1 location (cite by Policy Section # - for example: Section D.2.a)
Sidebar 1 text:
Sidebar 2 location
Sidebar 2 text:
Sidebar 3 location
Sidebar 3 text: