Foundation for the National Institutes of Health (FNIH) Conflict of Interests Policy

Conflict of interests policy for work related to the foundation for the National Institutes of Health

I. Purpose & scope

 

This policy applies to all employees of Roche Molecular Diagnostics, Roche Tissue Diagnostics (Ventana Medical Systems) and Roche Sequencing Solutions, collectively known as Roche Molecular Solutions and referred to herein as “the Company”, and anyone acting on the Company’s behalf, e.g., contractors, temporary workers, consultants or contingent workers (“Company Representatives”).

As a non-U.S. government agency participating in activities for the Foundation for the National Institutes of Health (FNIH), the Company is required to implement a specific Conflict of Interests Policy. This policy provides guidance regarding potential conflict of interests related to scientific research initiatives managed by the Foundation for the National Institutes of Health (FNIH). The purposes of the policy are to:

  1. enable the recognition and disclosure of real or apparent conflict of interests;
  2. appropriately manage all such conflict of interests;
  3. ensure that decisions about a FNIH Initiative, and the use or disposition of the assets of, or available to a FNIH Initiative, are made honestly, prudently, and solely for the benefit of the FNIH Initiative; and
  4. ensure that decisions about a FNIH Initiative are not influenced by personal profit or benefit.

Employees and Company Representatives must comply with all other applicable Company policies regarding conflict of interests, including, but not limited to, the Code of Business Conduct and Roche Behaviour in Business.

 

II. Definitions

 

De minimis ownership interest: An ownership interest of an Interested Person that represents a beneficial ownership of less than $15,000 of any entity, or is otherwise determined by the FNIH Board of Directors, on the basis of the facts and circumstances, to be de minimis.

Financial interest: Direct or indirect compensation, including anything of monetary value, whether or not the value is readily ascertainable, such as gifts or favors that are not insubstantial.

FNIH initiative: A public-private partnership whereby the FNIH has the responsibility to facilitate and convene the partnership, create an infrastructure for the partnership, and provide support, where necessary, for the execution of the Initiative’s activities, with oversight provided by the FNIH Board of Directors.

Foundation business transaction: Past, present or future plans to do one or more of the following: (1) initiate, make the principal recommendation for, or approve a purchase, contract, or grant; (2) recommend or select a vendor, contractor, grantee; (3) draft or negotiate the terms of such a transaction; or (4) participate as a reviewer on a Peer Review Committee.

Interested person: Any member of a Governance Committee (i.e., Executive Committees, Steering Committees, etc.) convened by the FNIH to support the Initiative, or others who may act as project director, principal investigator, or other senior key personnel, including federal employees, consultants, advisors, and volunteers.

Related person: With respect to any Interested Person, either: (1) a natural person who is a parent, spouse, domestic partner, brother, sister, child, or grandchild, or any similar relationship by marriage; or (2) any corporation, partnership, limited liability company, trust or other entity in which the Interested Person or any natural person specified in clause (1) hereof holds a position of, or similar to, director, officer, employee, partner, stockholder, trustee, or beneficiary of a trust (other than a De Minimis Ownership Interest).

 

III. Conflict of interests

 

This guidance is established to avoid the possibility that members of any FNIH Governance Committee, i.e., Executive Committee, Steering Committee, Peer Review Committee, etc. (“Committee”), including federal employees, consultants, advisors, and volunteers, receive an inappropriate benefit from their activities related to the FNIH Initiative.

Interested Persons must disclose their personal relationship or financial interest in entities doing business with or related to the FNIH Initiative, and must also refrain from participating in decisions which affect those transactions, unless approved by the Director of NIH. Interested Person relationships do not necessarily preclude participation in transactions, so long as the relationship is clearly disclosed and the FNIH retains final approval to manage any real or perceived conflict of interests. In addition to disclosing an actual conflict of interests, Interested Persons must also avoid actions that could be perceived or interpreted to be in conflict with the best interest of the FNIH Initiative.

A. FNIH Governance Committee members. Any member of a Committee convened in support of a FNIH Initiative who may be involved in or aware of a Business Transaction in which there is a possible conflict of interests shall promptly notify the FNIH Executive Director or the Chairman of the specific Committee, who shall then promptly notify the Chairman of the FNIH Board of Directors. The Committee chair will disclose any potential conflict of interests to Committee members at a convened meeting before conducting a vote on any Business Transaction affecting the Initiative, and the disclosure will be recorded in the meeting minutes.

B. Determining conflict of interests. Each Interested Person must report to the Committee chair any conduct or activity that appears to contradict this policy. After a conflict or a potential conflict of interests is disclosed, the FNIH Board of Directors, or an authorized Committee thereof, in the absence of the Interested Person subject to such conflict or apparent conflict, shall determine the following: (1) whether the conflict of interests or the appearance of a conflict of interests exists, (2) if it exists, whether it is material, and (3) how it is to be managed or eliminated. With the approval of the FNIH Chairman of the Board, a Committee member with a conflict of interests may participate in deliberations but shall recuse him/herself from voting on any such transaction, or using personal influence in any way in the matter. The decision by the FNIH Board of Directors on these matters will rest in their sole discretion. The Chairman of the Board shall be responsible for the application and interpretation of this policy as it relates to Committee members.

C. Examples of areas where conflict of interests may arise. The following are some examples of potential conflicting interests:

  • Persons and firms supplying goods and services used in connection with the Initiative;
  • Persons and firms from whom property or equipment is leased for the Initiative;
  • Persons and firms who are, or are planning to, make gifts, purchases or sales of real estate, security, or other property in connection with the Initiative;
  • Competing organizations;
  • Agencies, organizations, and associations that affect the Initiative; and
  • Related persons, friends and employees.

D. Potential financial conflict of interests. Potential financial conflicts of interests include, but are not limited to:

  • Contracting to purchase goods, services, or property from a participant in the Initiative or a director, officer, staff member of such participant, or a Related Person of any of these;
  • Engaging in any financial, business, or other relationships with current or potential recipients of grants made in connection with the Initiative;
  • Owning stock, holding debt, or other proprietary interests in any third party dealing with the Initiative;
  • Engaging in outside activity, such as serving on the Board of an organization that is a current or potential recipient of grants made in connection with the Initiative;
  • A Related Person being associated with a recipient of a grant made, or the counterparty to a contract made, in connection with the Initiative;
  • Accepting, in any form, compensation or gift from current or potential recipients of grants made, or counterparties to contracts made, in connection with the Initiative, or providing gifts or favors to others where these might appear to improperly influence others in their relations with the Initiative;
  • Using the time, personnel, equipment or supplies devoted to the Initiative, or the goodwill associated with the Initiative, for other activities, programs and purposes approved in connection with the Initiative.

A Committee member whose personal financial interests could be positively or adversely affected by the acceptance, holding, or disposition of a particular gift from a donor in connection with the Initiative must inform the FNIH Executive Director or Committee chair of his/her potential conflict of interest; refrain from seeking, obtaining, or reviewing non-public information about the gift; and, until a decision on the conflict is made by the FNIH Board, abstain from discussing or voting on acceptance of the gift.


E. Potential non-financial conflicts of interests. Potential non-financial conflicts of interests include, but are not limited to:

  • An Interested Person who seeks preferential treatment in connection with the Initiative for her/himself, a Related Person, or business associate.
  • An Interested Person who uses confidential information obtained in connection with the Initiative for his/her benefit, or for the benefit of a Related Person, business associate, or other organization.

F. Violations of conflict of interests policy. If the FNIH Board of Directors has reason to believe that an Interested Person has failed to disclose an actual or potential conflict of interests, the Board shall inform the Interested Person of the basis for such belief and afford the Interested Person an opportunity to explain the alleged failure to disclose. If, after consideration of the response of the Interested Person and conducting further investigation as may be warranted in the circumstances, the Board shall determine whether the Interested Person knowingly or intentionally failed to disclose an actual or possible conflict of interests, and take appropriate disciplinary and corrective action.

G. Annual reporting. The FNIH requires members of Committees to annually sign a statement, due on the day of the first Committee meeting each year, which affirms that the member:

  • Received a copy of the conflict of interests policy;
  • Received and reviewed a listing of all current funders, grantees, and contractors related to the Initiative, if any;
  • Read and understands the policy; and
  • Agreed to comply with the policy.

 

IV. Asking questions or reporting possible violations

 

If you have questions regarding whether a particular activity is permissible or the practice is not specifically allowed by this policy, contact the Legal Department or Compliance & Ethics before engaging in the activity. If you have questions regarding conduct potentially inconsistent with this policy, contact your manager, the Legal Department, Compliance & Ethics, or the Ethics and Compliance Helpline (1-866-313-9356).

 

Other related materials

 

Roche Group Code of Conduct
U.S. Diagnostics Code of Business Conduct
Roche Behaviour in Business