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DEPARTMENT: General Counsel (Administration)

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Policy Statement
Reason for Policy
Definitions
Procedure

Policy Statement

This Policy applies to (i)all faculty; (ii) all employees and non-employees who are involved in the design, conduct or reporting of research (including visiting investigators, trainees and affiliates); (iii) all employees and non-employees who are a principal investigator or who consent, recruit or evaluate the response of human subjects; and (iv) such other employees or non-employees as the President and Director of the Fred Hutchinson Cancer Research Center ("Director") may from time to time designate (all collectively referred to as "Scientific Staff.")

  1. PRINCIPLES

    1. Mission. The mission of the Fred Hutchinson Cancer Research Center ("Center") is the elimination of cancer and related diseases as causes of human suffering and death. An essential component of this mission is the transfer of knowledge and technology developed within the Center to products and practices that will reduce the burden of cancer-related illnesses.

    2. Primary Professional Obligation. The primary professional obligations of the membership of the Scientific Staff of the Center are to the Center and its goals and missions.

    3. Prohibition Against Improper Use of Confidential Information. Scientific Staff may not improperly disclose to third parties or use for their personal benefit confidential information (including confidential information of third parties) acquired by reason of their position at the Center. Special care must be taken to ensure that information from which the identity of patients can be determined is disclosed and used only in accordance with Center policies and applicable law.

    4. Openness in Research. The right and obligations of the Scientific Staff of the Center to publish and in other ways communicate results of their scientific findings is considered of paramount importance to the effective functioning of the Center, and to carrying out its missions and objectives. This includes the right to discuss internally the methods and results of their research with other Center scientists prior to their publication or public disclosure. Scientific Staff should not undertake research that is subject to unreasonable restrictions on its publication or disclosure or which otherwise unreasonably impairs their ability to communicate and discuss the results of their scientific findings.

    5. Participation in Professional, Scholarly and Public Activities. The Scientific Staff may hold office or serve on various committees or in other ways participate in professional associations and societies, and serve on editorial boards or other scholarly or advisory bodies related directly to their scientific work. In some instances, the Scientific Staff will be asked to volunteer their time in public activities or within philanthropic organizations. Consistent with maintaining their primary obligations to the Center, the Scientific Staff is encouraged to participate in these and other scholarly activities, which include presentations of their scientific work, lectures, seminars or short-course participation, and serving on scientific grant-review panels and site-visit teams.

    6. Prohibition of Payment for a Particular Result. Scientific Staff may not receive payments from any source conditioned upon a particular research result or tied to successful research outcomes.

    7. Prohibition of Certain Speaking Engagements. Scientific Staff shall not participate as a speaker for a Business Entity unless all lecture or presentation content is determined by the Scientific Staff member and reflects a balanced assessment of the current state of the relevant research developments and practice in the field (for example, science and treatment options). These speaking engagements are often called "Speakers Bureau" events. If participation in such speaking engagements is permitted, Scientific Staff members must make clear that the views expressed are their own and not those of the Center.

    8. Prohibition of Ghostwriting. Scientific Staff shall not be an author or co-author on papers or presentations ghostwritten by Business Entity (as defined by the Center's Conflict of Interest Policy) representatives. 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. A transparent writing collaboration with attribution between academic and industry investigators, medical writers, and/or technical experts is not ghostwriting.

    9. Financial Conflicts of Interest — General. The Scientific Staff's involvement with outside interests must not violate the Center's Conflict of Interest Policy or applicable government regulations. The Center's Conflict of Interest Policy and applicable regulations of the Public Health Services and the National Science Foundation require that certain transactions be reviewed and approved after full disclosure of all relevant facts to ensure that any conflict of interest is managed, reduced or eliminated to prevent bias, improper influence or misuse of Center or government resources. The Food and Drug Administration also requires disclosure of relevant financial interests. Scientific Staff with Significant Financial Interests (as defined by the Center's Conflict of Interest Policy) may need to have potential conflicts of interest managed, reduced or eliminated in accordance with this policy. The following situations create potential conflicts of interest that may need to be managed, reduced or eliminated:

      1. Significant or Prohibited Financial Interests of a member of the Scientific Staff (or his/her spouse, domestic partner or dependent child(ren)) that could directly and significantly affect or be affected by research in which that member of the Scientific Staff is involved.
      2. Any other Transaction involving the Center, in which a member of the Scientific Staff (or his/her spouse, domestic partner or dependent child(ren)) has or receives a Significant Financial Interest; and
      3. Any other transaction involving the Center and another entity in which a member of the Scientific Staff (or his/her spouse, domestic partner or dependent child(ren)) has or receives a significant financial interest or of which the member of the Scientific Staff (or his/her spouse, domestic partner or dependent child) is a trustee, director or officer.

      Significant Financial Interests are defined in the Center's Conflict of Interest Policy and include the following types of financial interests of Scientific Staff (or his/her spouse, domestic partner or dependent child(ren)): (a) if the entity is publicly-traded, compensation and/or an equity interest that exceeds $5,000 in a 12-month period; (b) if the entity is not publicly-traded, compensation that exceeds $5,000 in a 12-month period or any equity interest; and (c) intellectual property rights and interests. For purposes of this definition, compensation includes any type of payment such as consulting fees, expense reimbursement, honoraria, gifts or in-kind compensation; equity includes the value of any stock, stock option, partnership interest, or other ownership interest; and intellectual property rights and interests means payments or the right to receive payments in the future under any agreement (for example, an option or license agreement) relating to any technology, software or creative work.

    10. Conflicts of Interest — Human Subjects Research. The Center recognizes that research with human subjects is a privilege that imposes unique obligations. Because the welfare of human subjects is always of foremost concern, Scientific Staff with certain prohibited financial interests (as defined by the Center's Conflict of Interest Policy) may be unable to participate in human subjects research financed in whole or in part by funds administered by the Center.

      Members of the Scientific Staff may not "Participate in Human Subjects Research" (as defined in the Center's Conflict of Interest Policy) financed in whole or in part by funds administered by the Center (1) if that research is sponsored by or is designed to test a product or service of a for-profit entity in which that Scientific Staff member (or his/her or spouse, domestic partner or dependent child(ren)) has or receives a Prohibited Financial Interest or (2) if the Center's Conflict of Interest Committee otherwise determines that such a Prohibited Financial Interest directly and significantly affects or could be affected by the research in question. Prohibited Financial Interests are defined to mean (a) stock, stock options, partnership interests, or any other ownership interest in any amount in a for-profit entity except an interest in a publicly traded, diversified mutual fund; (b) royalties, fees or any other type of payment or the right to receive any such payment in the future under any agreement relating to any technology, software or creative work (whether or not patentable or copyrightable) that the Center's Conflict of Interest Committee determines is directly and significantly related to the research in question; (c) any type of payment from a for-profit company (including consulting fees, expense reimbursement or honoraria, gifts or in-kind compensation) that in the aggregate has in the prior calendar year or is expected to exceed $10,000 in the next 12 months. Payments under a multi-year agreement with a for-profit entity that are expected to exceed $10,000 over the term of the agreement will constitute a Prohibited Financial Interest unless the agreement can be terminated at the election of the staff member at least every 12 months and the payments under the agreement do not otherwise constitute a prohibited financial interest. The Center may disclose to prospective and current human subject research participants upon request the source and amount of payments received from for-profit entities by Center staff who Participate in Human Subjects Research.

    11. Technology Transfer. In carrying out the goals and missions of the Center, and importantly to provide incentives for the timely transfer of new technology and information such that it can be exploited for public good, incentives to the Scientific Staff are provided. These incentives are described explicitly in the Center policies and procedures governing the distribution of royalty and other income from patented and non-patented technology where appropriate arrangements have been made between an outside interest and the Center for sharing in the income derived from the results of research. Members of the Scientific Staff who Participate in Human Subjects Research as described in the Center's Conflict of Interest Policy that could directly and significantly affect or be affected by the interest in the licensed technology must either elect to forego receipt of their share of this income or discontinue such participation. All members of the Scientific Staff are required to acknowledge an understanding of and agree to be bound by the Center's Patent and Invention Policy.

    12. Appointments and Promotions. Policies and procedures governing appointments and promotions of the Scientific Staff include careful and periodic review of the accomplishments of the staff. It is definitely to the advantage of the Scientific Staff insofar as possible to pursue and receive outside sources of peer-reviewed support for their research activities, although significant support may accrue through non-peer-reviewed mechanisms that recognize the unique capabilities of the Scientific Staff and of the Center to perform certain kinds of research. It is the policy of the Center to maintain an appropriate balance between peer-reviewed and non-peer-reviewed research. Non-peer-reviewed research directed specifically toward product development, and conducted on research of outside interests, is generally considered to represent a less important use of the space and resources of the Center than is peer-reviewed research.

    13. Use of Human Specimens. Any use of human specimens collected at the Center or otherwise under the Center's control in commercially sponsored research or any transfer of such specimens to a commercial entity requires prior review and approval under the Center's Policy on Management of Tissue and Serum Collections in research collaborations with commercial entities.

  2. GUIDELINES

    The following guidelines have been developed to assist in the evaluation of arrangements between the Scientific Staff with outside interests and conflicts of interest that may arise from those arrangements.

    Members of the Scientific Staff must disclose their arrangements with outside entities and financial interests from or in outside entities as well as the arrangements and financial interests of his/her spouse, domestic partner or dependent child(ren). Scientific Staff must receive the necessary approvals before entering into certain arrangements with or acquiring certain financial interests from or in outside entities. Each division may adopt additional guidelines appropriate to the activities of that division, provided that any additional guidelines must be approved by the Director and can be no less restrictive than applicable Center policies and government regulations.

    1. Arrangements with Outside Entities. Any arrangement with an outside entity must have prospective benefits both to the member of the Scientific Staff and to the Center, and must comply with the Center's Policy on Conflicts of Interest and applicable government regulations on conflicts of interest.

    2. Conflicts of Interest. In the case of human subjects research as defined in the Center's Conflict of Interest Policy, members of the Scientific Staff with prohibited financial interests (See Section I.J. above) will not be allowed to participate in such human subjects research activity. "Human subjects research" includes research in which 1) data about living individuals is obtained by the Scientific Staff member through intervention or interaction; and 2) the Scientific Staff member has access to individually identifiable private information about the subjects. The term "participate" is defined in the Center's Conflict of Interest Policy as follows: "With respect to a specific IRB approved research protocol 1) acting as principal investigator for such protocol, 2) consenting human subjects to such protocol, 3) recruiting human subjects to such protocol, or 4) evaluating the response of human subjects enrolled on such protocol. In the case of research not involving human subjects research protocols or human subjects research protocols in which the Scientific Staff member is involved but not as a participant, the Center's Conflict of Interest Policy requires that any significant financial interest (See Section I.I. above) creating a conflict of interest be reduced, managed or eliminated. Frequently, conditions or restrictions are imposed. Examples include the following:

      1. Public disclosure of any significant financial interest including disclosure in any publication and/or presentation relating to the research.
      2. Monitoring of research by independent reviewers.
      3. Modification of the research plan.
      4. Disqualification from participation in all or a portion of the research by that member of the Scientific Staff.
      5. Divestiture of the significant financial interest in question.
      6. Severance of the relationship that creates the conflict of interest.

    3. Publication of Scientific Findings. Scientific Staff may not undertake research that is subject to unreasonable restrictions on its publication or disclosure or which otherwise unreasonably impairs their ability to communicate and discuss the results of their scientific findings. The following restrictions are considered reasonable: (1) delay of a publication or disclosure (normally not to exceed 60 days) for patenting purposes or to permit review and comment by a research sponsor; (2) delay of a publication or disclosure (normally not to exceed 60 days) when it is in the best interests of the research, such as in the case of a multi-site study requiring review of data by a publication committee; (3) nondisclosure of confidential information provided by a third party; and (4) requirements that confidential information provided by a third party be disclosed or used only as permitted by the third party. Restrictions on publications or public disclosures other than those referenced above must be approved by the Director or his or her designee.

    4. Limitation on Time Spent in Outside Activities. Scientific Staff who are assistant, associate and full members, associates, staff investigators, and other professional personnel employed on a full-time basis are expected to maintain a minimum 40-hour work week, exclusive of vacation periods. If such member of the Scientific Staff intends to spend in excess of one-half day (i.e., four hours) each seven-day week in activities with outside interests or intends to hold a management position with an outside interest, he or she must receive the prior written approval of the Center's Appointment and Promotions Committee.

    5. Practice of Medicine. Members of the Scientific Staff who are physicians will not engage in the practice of medicine other than under the rules and regulations of the division in which the individual holds a primary appointment or as otherwise expressly permitted by the Director.

    6. Management Positions in Outside Entities. Holding of management positions (such as president, chief executive officer, scientific director, member of the board of directors) or responsibility for management and other decisions within an outside interest are to be avoided. Under exceptional circumstances and with prior approval of the Center's Appointment and Promotions Committee, a member of the Scientific Staff may be granted a leave of absence for a reasonably short period of time (generally no more than one year) to assume such functions. The space and resources assigned to a member or members requesting such unique arrangements with an outside interest would need to be evaluated as to an appropriate disposition during such a leave of absence and as to any commitments for space and resources available after return from a leave of absence.

    7. Use of Center Space and Resources in Outside Entities. Activities with outside interests will generally not involve the use of Center space or resources. Center stationery will not be used in conjunction with activities for outside interests.

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Procedure(s)

  1. PRIOR APPROVAL, DISCLOSURE AND REVIEW PROCEDURES

    The Center has established a process for prior approval, disclosure and review of certain outside activities and financial interests to enforce the Center's Conflict of Interest Policy and comply with federal law. Disclosure of financial interests held or received by Scientific Staff [and their spouses, domestic partners and dependent child(ren)] will be reviewed by the Division Director, the Office of the General Counsel and the Director. Disclosure of financial interests held or received by Scientific Staff members [and their spouses, domestic partners and dependent child(ren)] in cases in which the Scientific Staff member is a participant in human subjects research may also be reviewed by the Center's Conflict of Interest Committee. The prior approval, disclosure and review process is described more fully below.

    1. Prior Approval of Outside Activities and Interests. Prior to engaging in certain outside activities or acquiring certain financial interests that are reasonably related to their Institutional Responsibilities, Scientific Staff must submit a Request for Prior Approval of Outside Activities and Financial Interests and receive permission from the Center. Prior approval is also required if the Scientific Staff member's spouse, domestic partner, or dependent children plan to engage in these activities or hold these types of financial interests. The types of situations requiring prior review and approval are:

      1. The initiation of any arrangement expected to result in a Significant Financial Interest.
      2. The initiation of any arrangement that will include travel paid on behalf of or reimbursed directly to the individual, regardless of whether any other compensation is anticipated.
      3. Serving as a director, trustee, officer, or in another leadership role of a for-profit entity.

      The Request for Prior Approval of Outside Activities and Financial Interests Form will solicit basic information about the proposed outside activity and/or the financial interest. If the request relates to approval of an outside activity involving consulting or service on an advisory board, for example, some of the information that will be requested includes the following:

      1. The nature of the relationship proposed.
      2. The short-term and long-term commitments of time and effort.
      3. All financial aspects, including all compensation, expense reimbursements, equity and any indirect and/or potential economic value from the proposed relationship. The Director or designee will apply a per-trip rate for the calculation of expense reimbursements.
      4. The expected benefit to the Scientific Staff member and to his/her spouse, domestic partner or dependent child(ren) (if applicable).
      5. The expected benefit to the Center.
      6. Whether the proposed arrangement or relationship could reasonably affect or be affected by the research being conducted at the Center by the Scientific Staff member or those under his/her direction or control.

      If the request relates to approval of an ownership interest (stock ownership) or intellectual property interest (patent license), information will be requested regarding any relationship of the interest in question to Center research activities, especially those involving human subjects.

    2. Disclosure of Financial Interests.

      1. Annual Disclosures. Upon commencement of employment and annually thereafter, Scientific Staff will be required to disclose the following information:
        1. Any leadership position [such as director, trustee, officer) held by the Scientific Staff [or his/her spouse, domestic partner or dependent child(ren)] of any for-profit or nonprofit entity whose activities could reasonably affect or be affected by the Scientific Staff's Institutional Responsibilities.
        2. All ownership interests (stocks, options, partnership interests) held by the Scientific Staff [or his/her spouse, domestic partner or dependent child(ren)] in any entity whose activities could reasonably affect or be affected by the Scientific Staff's Institutional Responsibilities.
        3. The receipt of income, or the right to receive income, by the Scientific Staff [or his/her spouse, domestic partner or dependent child(ren)] relating to intellectual property that is the subject of an agreement with an outside entity.
        4. Payments (such as consulting fees, honoraria, travel expenses paid or reimbursed) received by the Scientific Staff {or his/her spouse, domestic partner or dependent child(ren)} from any entity that could reasonably affect or be affected by the Scientific Staff's Institutional Responsibilities.
        5. Any other interest that could reasonably create a conflict of interest under the Center's Conflict of Interest Policy.

        These interests and arrangements must be summarized on the "Annual Summary of Outside Activities and Interests" Form.

      2. Research Funding Proposal Disclosures. On each application or proposal for external or internal research funding, the principal investigator will be required to list all individuals who will be responsible for the design, conduct or reporting of the research that is the subject of the funding proposal. All identified individuals will then be required to complete a project-specific disclosure form and, if necessary, an Annual Summary of Outside Activities and Interests Form. Before any funds can be expended, the Center Director or designee will certify that either 1) no conflict of interest exists that could directly or significantly affect or be affected by the design, conduct or reporting of the research; or 2) that any conflict of interest has been managed, reduced or eliminated in accordance with the Center's Conflict of Interest Policy and applicable federal law.

      3. Food and Drug Administration, or FDA, Disclosures. Members of the Scientific Staff engaged in research regulated by the Food and Drug Administration, or FDA, are required to disclose financial interests in and arrangements with the study sponsors.

      4. Affiliate Conflict Disclosures. Members of the Scientific Staff who hold appointments at affiliate institutions (such as the University of Washington or Seattle Children's Hospital) may be required to file disclosure forms at each institution and be subject to more than one conflict of interest policy.

    3. Review Procedures

      1. Review by Division Director and Office of the General Counsel. The Division Director(s) of the division in which the person holds a primary appointment or is employed will review all disclosure forms and requests to enter into arrangements with outside interests to determine whether any of the disclosures create a conflict of interest under the Center's Conflict of Interest Policy. If the Division Director determines that a conflict of interest involves human subjects research, he or she may refer the matter to the Conflict of Interest Committee (described below) for its review and recommendation to the Director. The Division Director may seek assistance from the Office of the General Counsel in evaluating the disclosure forms. The Office of the General Counsel will review and approve all requests for prior approval for outside activities and financial interests and will review all agreements related to such requests. If a Division Director identifies a conflict of interest or possible conflict of interest, the Division Director will discuss any proposed action with the individual involved and will make a recommendation as to how the conflict of interest should be managed, reduced or eliminated. If the individual involved does not agree with the recommendation of the Division Director, the Division Director will, upon the written request of the individual involved, refer the matter to the Conflict of Interest Committee. The recommendation of the Division Director or the Conflict of Interest Committee, as the case may be, and supporting material together with such reasonable information as the individual involved wishes to provide, will be forwarded to the Director for a final decision.

      2. Conflict of Interest Committee. The Conflict of Interest Committee, or COI Committee, may be consulted with respect to possible conflicts of interest at the request of the Division Director or Director relating to Scientific Staff especially those participating in human subjects research as defined in the Center's Conflict of Interest Policy. The COI Committee is composed of one trustee appointed by the chair of the Center's Board of Trustees, one member from each of the Center's scientific divisions appointed by the Division Director of each division, and such other members as the Director may select. The chair of the COI Committee will be selected by the Director, and the COI Committee will meet at least annually or more frequently as necessary. The primary role of the COI Committee shall be to determine whether the conflict of interest will trigger a prohibition of the Scientific Staff's participation in human subjects research and shall have such other duties as the Director may assign. The COI Committee will also consider challenges by Scientific Staff to determinations made by a Division Director with respect to a conflict of interest finding and the plan for the management, reduction or elimination of a conflict. The COI Committee shall establish such internal rules and procedures as it deems appropriate, subject to the Director's approval.

      3. Review by Director. The Director or designee will review the recommendation made by the Division Director or the COI Committee. If the Director believes that a conflict, not previously referred to the COI Committee, involves human subjects research, he may refer it to the COI Committee for its recommendation. Where necessary or appropriate, the Director will seek the advice of the Office of the General Counsel. The decision of the Director is final. Copies of all disclosure forms and prior approval requests will be maintained in the Office of the Director.

      4. Institutional Review Board, or IRB, Review. Research involving human subjects reviewed by a Center IRB requires confirmation that any conflicts of interest involving the principal investigator and other individuals covered by the Center's Conflict of Interest Policy and federal law have been managed, reduced or eliminated. Under certain circumstances, the IRB or IRB chairs will be informed about the manner in which a conflict of interest has been managed, reduced or eliminated.

  2. Miscellaneous Procedures

    1. Reporting to Funding Agencies and Disclosures. Review of financial disclosures is conducted in a confidential manner. However, under certain circumstances, information about certain financial interests and activities of Scientific Staff will be disclosed to comply with laws, regulations or Center policies. If required, the Center will notify the funding source for any affected research of an identified conflict of interest and any action taken to manage, reduce or eliminate it. Funding sources may also be entitled to request and receive additional information regarding identified conflicts. For example, the Public Health Service requires that prior to the expenditure of any funds under a PHS-funded research project, the Center must provide to the PHS-awarding component a report regarding any identified financial conflict of interest related to the research and ensure that the Center has implemented a management plan in accordance with PHS rules. The report must include sufficient information to enable the awarding component to understand the nature and extent of the financial conflict, including the name of the individual with the financial conflict of interest, the name of the outside entity in which the individual holds the conflicting interest, the nature of the financial interest, the value of the financial interest, a description of how the financial interest relates to the PHS-funded research, the basis for the Center's determination that the financial interest conflicts with the PHS-funded research, and the key elements of the conflict management plan. Under certain circumstances, certain financial interests and/or conflicts of interest of Scientific Staff will be disclosed in publications or presentations of research results or to prospective or current human subjects in clinical trials at the Center. Certain conflicts of interest will also be disclosed to the public. For example, the Public Health Service requires that the Center make available to the public key information about identified financial conflicts of interest related to PHS-funded research.

    2. Mandatory Training. All Scientific Staff must complete training regarding this policy and the Center's Conflict of Interest Policy at least once every four years. Training must also be completed when any of the following apply: (i) the Center revises its financial conflict of interest policies in any way that affects the requirements of Scientific Staff; (ii) new Scientific Staff join the Center; (iii) a member of the Scientific Staff has not complied with this policy or the Conflict of Interest Policy; or (iv) a member of the Scientific Staff has not complied with a conflict management plan.

    3. Enforcement

      1. Reporting Violations. If, at any time, a member of the Scientific Staff becomes aware of any arrangement with outside interests or of any conflict of interest which that member was required to disclose pursuant to Center policy and which was not disclosed, that member must immediately (and in no event, later than 15 days after becoming aware of the nondisclosure) disclose the matter to the Director's Office.

      2. Sanctions. Violations of this policy by members of the Scientific Staff will be reported to the Director for appropriate action. If a violation of this policy has biased the design, conduct or reporting of any government-funded research, the Director will determine what corrective action should be taken and will notify the awarding agency. The Director may, at his or her discretion, appoint an ad hoc committee to review the situation and determine what corrective action, if any, should be taken. Intentional violations of this policy or the Center's Conflict of Interest Policy may result in immediate suspension or dismissal in accordance with the Center's established personnel policies.

      3. Disclosure. In any case in which it is determined that a clinical research project to evaluate the safety or effectiveness of a drug, medical device or treatment which is funded by the Public Health Service or National Science Foundation has been designed, conducted or reported by a member of the Scientific Staff with a significant financial interest that was not disclosed or managed as required by applicable government regulations, the Center will require disclosure of the financial interest in each public presentation of the results of the research.

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References

Conflict of Interest

Institutional Conflict of Interest Policy

Policy on Management of Tissue and Serum Collection

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Contacts

Office of the General Counsel, 206.667.6458

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Approval

Responsible Official (Vice President or Senior Vice President):
Deputy Director and Executive Vice President

Manager responsible for policy:
Vice President, General Counsel

Effective Date:
June 9, 2015

Approval Date (this Version):
June 2015

Next Review Due:
June 2018

Revision/Review Dates:


Original Approval Date:
September 1983

This version reviewed and approved by specialty committee or specialty individual:

Reviewer
Vice President and General Counsel

Date Reviewed
6/2015