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I. Purpose: Fred Hutch Scientific Staff have a primary obligation to conduct their research according to the highest ethical standards and to focus their professional activities in ways that support the mission of Fred Hutch. As part of this obligation, Fred Hutch expects that Scientific Staff will apply their time and effort appropriately, use Fred Hutch resources responsibly, and avoid any interaction that creates, or appears to create, a Conflict of Interest or Conflict of Commitment.
The purpose of this policy is to establish standards for disclosing, reviewing, and managing certain Financial Interests and Outside Activities of Scientific Staff. Scientific Staff funded by the Public Health Service (PHS) and/or other federal agencies or entities that abide by PHS Conflict of Interest regulations are subject to additional requirements as specified in this policy.
II. Scope: This policy applies to all Scientific Staff, including:
III. What to Disclose: All Scientific Staff members are required to disclose to Fred Hutch and, as appropriate, obtain Prior Approval for their Outside Activities and Financial Interests (and those of their Family Members) that are or reasonably appear to be related to their Institutional Responsibilities. Examples of such Outside Activities and Financial Interests include, but are not limited to:
Any of the foregoing types of support that are provided indirectly to a Scientific Staff member, such as through an entity controlled by the Scientific Staff member, also constitute Foreign Support.
IV. When to Disclose: Scientific Staff members are required to disclose to Fred Hutch their Outside Activities and Financial Interests (and those of his/her Family Member) that are or reasonably appear to be related to their Institutional Responsibilities at the following times:
Scientific Staff members with appointments at affiliated institutions, such as the University of Washington or Seattle Children’s Hospital, may be required to file disclosure forms at each institution and may be subject to more than one conflict of interest policy.
Additionally, Scientific Staff members must request Prior Approval for Outside Activities, as defined in this policy. If Prior Approval is not sought, then as soon as the oversight is realized, approval must be requested in accordance with the procedures set forth in this Policy for Prior Approval. Fred Hutch may require the cessation of the Outside Activity pending review and disposition of the Outside Activity in accordance with this Policy. The repeated failure to seek Prior Approval of Outside Activities may result in disciplinary action.
V. External Time Allowance. Scientific Staff members employed on a full-time basis are expected to maintain a minimum 40-hour work week, exclusive of vacation periods. Those Scientific Staff members may seek prior approval from their Senior Vice President/Division Director to spend up to one half-day per week (four hours) engaged in allowable Outside Activities. Scientific Staff members who are not employed (or engaged in Non-Employee activities) on a full-time basis may also be permitted to engage in allowable Outside Activities, depending on the facts and circumstances of each case. The determination shall be made by the Senior Vice President/Division Director in consultation with the Deputy Director and the Vice President Research Administration and Faculty Affairs. Participation in federal agency committees (such as NIH peer review panels) or activities associated with non-profit professional associations related to one’s clinical or scientific expertise (such as the American Society of Clinical Oncology (ASCO)) are considered part of Scientific Staff members’ Institutional Responsibilities and are not considered to be Outside Activities for the purposes of this policy.
VI. Foreign Activities. Outside Activities involving foreign governments, agencies, entities, institutions, or persons, or Outside Activities occurring in foreign countries must, in all cases, be approved in advance by Fred Hutch.
VII. Prohibited Activities: Certain activities or Financial Interests are prohibited because, by their very nature, they conflict with fundamental values of scientific integrity and/or the mission of Fred Hutch. These include the following:
VIII. Discouraged Activities, subject to additional review: Certain Outside Activities result in Conflicts of Interest or Conflicts of Commitment which are difficult to mitigate or manage. Therefore, Fred Hutch strongly discourages Scientific Staff members from engaging in the following Outside Activities. Any such proposed Outside Activities must be submitted for additional review for exceptional circumstances and, where approved, will be actively managed.
IX. Review of Disclosures: Disclosures of Financial Interests and Outside Activities will be reviewed according to the implementing procedures for this policy and as developed by the Vice President for Research Administration and Faculty Affairs, the Senior Vice Presidents/Division Directors, and the Deputy Director or designee. In reviewing disclosures, Fred Hutch considers the nature and extent of Scientific Staff member’s Financial Interests and Outside Activities in relation to their Institutional Responsibilities and considers any sources of bias that could unduly influence decision-making or undermine research integrity.
X. Management of Conflicts of Interest: In the case of Human Subjects Research, Scientific Staff with Prohibited Financial Interests, as defined in this policy , will not be allowed to act as protocol Principal Investigator; recruit human subjects to participate in the study; consent human subjects to participate in the study; or evaluate the responses of human subjects in the study.
In other cases, Scientific Staff with Significant Financial Interests resulting in a Conflict of Interest will be subject to a conflict management plan to reduce, mitigate, or eliminate the Conflict of Interest, as described in the implementing procedures of this policy.
The conflict management plan is approved by the Vice President Research Administration and Faculty Affairs. Appeals may be made to the President and Director or designee, in writing, for final decision.
XI. External Reporting Requirements: Reviews of financial disclosures and Prior Approval requests are conducted in a confidential manner, but information may be shared internally, as necessary, for institutional purposes, including with the Institutional Review Board (IRB), Internal Audit, the Office of General Counsel, and Human Resources. Moreover, under certain circumstances, information about the Outside Activities and certain Financial Interests of Scientific Staff may be disclosed externally to comply with laws, regulations, or Fred Hutch policies. Some external sponsors, such as PHS, require Fred Hutch to provide initial and ongoing reports relative to Scientific Staff Conflict of Interest determinations as they relate to specific research activities. For Conflicts of Interest related to PHS-funded research, Fred Hutch must perform the required conflict of interest reporting prior to the expenditure of funds for new projects, within 60 days of a newly-determined Conflict of Interest, and on an annual basis thereafter, prior to progress report submission, during the life of the project. Additionally, PHS requires Fred Hutch to make public, upon request, specific information regarding Conflicts of Interest determined for senior and key personnel on PHS-funded projects. Fred Hutch will make a good faith effort to notify any individuals for whom such a request has been received prior to releasing the information. Under certain circumstances, certain financial interests and/or conflicts of interest of Scientific Staff will be disclosed to prospective or current human subjects in clinical trials at Fred Hutch.
XII. Mandatory training: All Scientific Staff must complete Conflict of Interest training at least once every four years, as required by PHS. Additionally, training must occur when:
XIII. Compliance and Enforcement: The COI administrator, as well as Fred Hutch Internal Audit, will routinely monitor and audit compliance with the conditions of this policy and other related policies using risk-based and random approaches to:
External and/or publicly available information may also be used to compare with disclosures made to Fred Hutch.
Failure to comply with any aspect of this policy may result in disciplinary action, up to and including termination of employment.
Affiliate: An individual who has been granted access to Fred Hutch facilities and resources at the request of a Fred Hutch representative. See the definition of Non-Employee for further information.
Business Entity: A sole proprietorship, corporation, limited liability company, trust, joint venture, or any other form of enterprise, whether conducted for profit or not.
Conflict of Commitment: A situation in which the Outside Activities of a Scientific Staff member interfere, or appear to interfere, with the ability to perform his/her Institutional Responsibilities at Fred Hutch. Typically, this involves activities that exceed permitted time limits of four (4) hours per week in total or activities that, by their nature, run counter to the mission of Fred Hutch.
Conflict of Interest: A situation in which the Outside Activities and/or certain Financial Interests
(i.e., Prohibited or Significant Financial Interests) of a Scientific Staff member (or his/her Family Member) as defined in this policy, conflict, or reasonably appear to conflict, with the Institutional Responsibilities of the Scientific Staff member.
Family Member: For the purposes of this policy, a Family Member is the spouse, domestic partner, or dependent child of a Scientific Staff member.
Financial Interest: For the purposes of this policy, a Financial Interest is defined as:
Founder (and Co-Founder): Any person who is (1) instrumental in the creation of a Spin-off, including (a) business-related activities, such as writing or advising on a business plan, formation of a management team, securing of funding; or (b) science-related activities, such as being a named inventor on licensed intellectual property or serving as a scientific advisor, and (2) granted equity or equity-like instruments (e.g. options, warrants) within the first year of initial funding of such Spin-off.
Ghostwriting: “Ghostwriting” is defined as the provision of written or oral material that is officially credited to someone other than the writer(s) of the material.
Human Subjects Research: For the purposes of this policy, Human Subjects Research means an interventional human research protocol subject to review by a duly constituted institutional review board (IRB) convening as a full committee. This typically involves, but is not limited to, studies that are considered greater than minimal risk.
Institutional Responsibilities: For the purposes of this policy, Institutional Responsibilities broadly encompass all of the conduct and activities that are within the course and scope of a Scientific Staff member’s duties, responsibilities, and activities on behalf of or in relation to Fred Hutch and includes without limitation the design, conduct, reporting, review or oversight of research, teaching, committee membership, management and administrative duties, mentoring or supervision of trainees or students, and any other professional responsibility carried out in furtherance of Fred Hutch business, programs, and activities.
Investigator: The project director or principal investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by the PHS (e.g., NIH), or proposed for such funding, which may include, for example, collaborators or consultants.
Non-Employee: A Non-Employee (also referred to as an Affiliate) is an individual who has been granted access to Fred Hutch facilities and resources at the request of a Fred Hutch representative. Non-employees include:
Outside Activity: For the purposes of this policy, an Outside Activity is defined as any activity related to the Institutional Responsibilities of a Scientific Staff member but falling outside the normal scope and course of his/her Fred Hutch employment. This includes consulting for outside entities, participating on the boards of other organizations, and teaching engagements, other than teaching engagements on behalf of the University of Washington, Seattle Children’s Hospital, or Seattle Cancer Care Alliance. Outside Activity includes service in a leadership position (such as a director, trustee or officer) for any non-profit or for-profit entity, whether such service is compensated or not.
Prior Approval: For purposes of this policy, Prior Approval is the process through which a Scientific Staff member seeks review and approval by the relevant Senior Vice President/Division Director of requests to engage in Outside Activities or to receive a Financial Interest that is reasonably related to their Institutional Responsibilities. Review and approval are also required if the Scientific Staff member’s Family Member engages in such Outside Activities or holds such Financial Interest. This review and approval must occur prior to the onset of the Outside Activity or the receipt of such Financial Interest to the fullest extent possible. Prior Approval of certain Outside Activities will also require review and approval by the Fred Hutch Appointments and Promotions Committee.
Prohibited Financial Interest: A Financial Interest consisting of one or more of the following interests of a Scientific Staff member or his/her Family Member:
Related Entity: Any parent entity, subsidiary, or affiliate to a Business Entity, and any business, corporation, partnership, limited liability company or other entity in which the Business Entity, or the parent entity, subsidiary, or affiliate of the Business Entity holds a substantial ownership interest, directly or indirectly.
Significant Financial Interest: A Financial Interest consisting of one or more of the following interests of a Scientific Staff member or his/her Family Member:
The term Significant Financial Interest does not include:
Spin-Off Company: A for-profit Business entity that is directly or indirectly controlled by Fred Hutch, and/or whose business plan is based substantially on intellectual property that is licensed or otherwise obtained from Fred Hutch. The Executive Committee of the Board of Trustees may at any time and in its sole discretion determine that a Business Entity is no longer a Spin-Off Company for the purposes of this Policy.