New 08/06

1. General
2. Laboratory Reviewing Official
3. Independent Substantive Review Committee

A.  GENERAL

Several specific concerns and policy provisions pertain to all research project investigators involved in proposing, conducting, and/or reporting Laboratory research activities. Their roles can include Principal Investigator, Co-Principal Investigator, Independent Scientist, or Key Personnel, to name a few.  When such program researchers participate in a substantive way in the scientific development and/or execution of a project, they must avoid real or apparent conflict-of-interest (COI) situations.  A real or apparent COI situation may occur in a research program when there is less than clear and demonstrable separation between the individual researcher’s program interests and work efforts and the individual’s personal economic or business interests.  Generally, such researchers and the Laboratory are guided by seven principles:

1. Traditional conflict-of-interest situations should be avoided. These exist when a researcher may have the opportunity to influence Laboratory business decisions or research results in ways that could lead to personal gain or could advantage personal business interests.


2. The proposed research project should be appropriate to and consistent with the mission of the Laboratory.


3. The research and teaching environment of the Laboratory must be kept open.


4. Freedom to publish and disseminate research results must be preserved.


5. The highest ethical standards of scientific conduct and intellectual honesty must be ensured.


6. Any patent rights issues should be in compliance with DOE and University requirements.


7. Laboratory facilities and resources (supplies, equipment, facilities, staff time) must be appropriately used, with costs charged to the project sponsor.

B.  LABORATORY REVIEWING OFFICIAL

When there is convergence of a researcher’s private interests with his or her research interests, such that an independent observer might reasonably question whether the researcher’s Laboratory actions or decisions are improperly influenced by his or her personal considerations, the conflicts of interest (or perceptions of conflicts) must be addressed.  Policy requires a reviewing official to determine from the facts of each COI matter whether any reported personal interest would reasonably appear to be directly and significantly affected by the Laboratory research program and what steps should be taken to manage or eliminate the conflict.  For Laboratory research programs, the reviewing official is the Associate Laboratory Director for Operations (ALDO). The ALDO may employ an Independent Substantive Review Committee (ISRC) to assemble and analyze the facts of complex and challenging COI cases and to make recommendations to the ALDO and Laboratory management for managing and mitigating COI issues in such matters. Resulting management steps may include whether or not to accept funding and continue the research program of concern, to implement specific project staff assignments, or to initiate mitigating administrative actions that reduce the risk of or the severity of the conflicts.

C.  INDEPENDENT SUBSTANTIVE REVIEW COMMITTEE

The ALDO may appoint and charter an Independent Substantive Review Committee (ISRC) composed of experienced, knowledgeable, independent people appropriate for the case under review. The ISRC’s charge is to provide in-depth review of conflict-of-interest situations in which a project researcher discloses a positive financial interest in the sponsor of or in a business related to the subject research program. ISRC members are from scientific or engineering divisions appropriate to each case; and the Laboratory Counsel and the Laboratory Conflict of Interest Coordinator also act as ex officio ISRC members. The ISRC reviews the disclosure statement details and all relevant features of the research program, and recommends to the ALDO whether the project, research contract, science grant, Laboratory gift, or Cooperative Research and Development Agreement should be accepted, and any conditions or modifications that may be needed. Examples of conditions that may be imposed to mitigate COI concerns include public disclosure of private economic interests, independent monitoring and program oversight, research project plan changes, personnel reassignments, divestiture of conflicting financial interests, or severance of any relationships creating the real or apparent conflicts.