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JNCCN — Journal of the National Comprehensive Cancer Network

About NCCN

NCCN Disclosure Policies and Potential Conflicts of Interest

View the Identifications and Disclosures of Relationships with External Entities for the following:

Disclosure of NCCN Organizational Relationships

NCCN Oncology Research Program (ORP) Disclosure Policy

Disclosure Policy for the NCCN Guidelines Panels

The development of the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) is a fundamental activity of the National Comprehensive Cancer Network. The NCCN Guidelines are updated at least annually in an evidence-based process integrated with the expert judgment of multidisciplinary panels of expert physicians from NCCN Member Institutions. NCCN depends on the NCCN Guidelines Panel Members to reach decisions objectively, without being influenced or appearing to be influenced by conflicting interests.

The NCCN Guidelines Panel Members are strongly supported by the NCCN Member Institutions. NCCN Guidelines Panel Members are chosen for the NCCN Guidelines Panel by each NCCN Member Institution because they have demonstrated a high level of expertise in their disciplines. Participation on an NCCN Guidelines Panel is voluntary. NCCN Guidelines Panel Members are not paid for their involvement in NCCN Guidelines development. Development of the NCCN Guidelines is supported by dues from the NCCN Member Institutions. No industry support is accepted for any direct costs associated with the development of the NCCN Guidelines. NCCN does receive support from industry for distribution of the Complete Library of NCCN Guidelines® on flash drives and in other media.

While corporate and industry involvement plays a growing role in the support of oncology research, the financial remuneration that might accompany such involvement may lead to conflicts of interest. NCCN also recognizes that the majority of NCCN Guidelines Panel Members have complex relationships with industry including conducting research in areas such as medical devices, diagnostics, drugs, and biologics. This research will lead to new clinical trials and advances in patient care. However, financial conflicts of interest have the potential to introduce biases into the development process of NCCN Guidelines, thereby potentially affecting the integrity of the NCCN Guidelines.

This policy has been developed to safeguard the integrity of the NCCN Guidelines development process and to preserve the high level of confidence in NCCN Guidelines that exists among oncology professionals and the public. This policy is also designed to identify arrangements involving NCCN Guidelines Panel Members who have a financial or fiduciary interest in an outside entity where such arrangements may represent a source of conflict or an appearance of conflict in the participation in the development of the NCCN Guidelines. This policy requires disclosure of external relationships and recusal of NCCN Guidelines Panel Members with conflicting interests so that the integrity of the NCCN Guidelines is not compromised or diminished by conflicts or by the perception of conflicts.

This document has been developed to provide guidance to the NCCN Governance Committee, NCCN Staff, the chairpersons of the NCCN Guidelines Panels, and the NCCN Guidelines Panel Members on how external relationships will be identified and disclosed and what actions an NCCN Guidelines Panel chair may take to safeguard the integrity of a discussion from conflicting interests. This document is also available to the public to assure them that NCCN takes seriously the obligation to provide full disclosure regarding the guideline development process and its integrity.

This policy refers to members of NCCN Guidelines Panels, which are multidisciplinary expert panels convened for the purpose of developing the NCCN Guidelines®.

 

I.     Definitions

  1. "Conflicting Interest" means:

    1. any Direct or Indirect Relationship (as defined below) with any other external entity that would be financially advantaged or disadvantaged by the action of an NCCN Guidelines Panel in a matter under consideration;

    2. any organizational affiliation, activity, transaction, or other interest which would cause a decision of the NCCN Guidelines Panel to have a direct economic impact (different in nature or scope from its effect on other NCCN Guidelines Panel Members) on the NCCN Guidelines Panel Member or on others with whom the NCCN Guidelines Panel Member has personal or professional relationships;

    3. any other organizational affiliation, activity, transaction, or other interest which (i) could impair the NCCN Guidelines Panel Member’s objectivity or (ii) could create an unfair competitive advantage for the NCCN Guidelines Panel Member or any organization with which the NCCN Guidelines Panel Member has a direct financial relationship (as defined below).

  2. Direct Relationship: A person is considered to have a "Direct Relationship" with a person or entity if he or she, or his or her spouse, domestic partner, or dependents:

    1. is a beneficial owner of any equity of the organization, excluding equity held through a publicly traded mutual fund, ownership held in a blind trust or ownership held through a vehicle over which the person has no control regarding termination or continuation of the equity relationship;

    2. is a director, officer or employee of the organization;

    3. receives compensation for services including, but not limited to, management or consulting services to the organization;

    4. has a debt relationship of any kind with the organization, whether as lender, borrower, holder of debentures, or the like; or

    5. holds a patent, or any interest in a patent which is held, licensed or utilized by the organization.

  3. External Entities” means:

    1. industrial entities conducting business in medical devices, diagnostics, drugs, and biologics;

    2. managed care organizations or other payers; or

    3. for-profit health care entities.

  4. Disclosure of External Relationships Form” (the “DOER Form”) means the document available online and in hard copy which NCCN Guidelines Panel Members are expected to complete and update in accordance with this policy and shall include all updates, addenda, and appended exhibits or explanations referred to in the DOER Form.

  5. Immediate Family” means the spouse, domestic partner, or dependents of an NCCN Guidelines Panel Member.

  6. NCCN Guidelines Panels” means multidisciplinary expert panels convened for the purpose of developing the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®).

  7. Indirect Relationship: A person has an "Indirect Relationship" with an external entity if he or she, or any member of his or her immediate family:

    1. has a Direct Relationship with an organization that competes with the external entity; or

    2. has a Direct Relationship with any other entity that has a Direct Relationship with the external entity.

  8. NCCN Guidelines Panel Member” means any person who is appointed to serve on a panel that is convened for the purpose of developing the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®).

  9. Research: An NCCN Guidelines Panel Member participates in “Research” if he or she:

    1. is a Principal Investigator;

    2. serves on a Data Safety Monitoring Board;

    3. conducts statistics and analysis; or

    4. engages in other activities associated with the review, implementation and conduct of clinical trials.

II.     Disclosure of External and Potentially Conflicting Interests

NCCN Guidelines Panel Members are expected to disclose relationships in at least three instances:

  1. Upon Consideration for Appointment to a Panel
  2. Prior to appointment to any NCCN Guidelines Panel, the prospective nominee shall complete and submit the completed DOER Form.

  3. Semiannually
  4. Each NCCN Guidelines Panel Member shall update the information in his or her filed DOER Form or shall attest, upon notice of semiannual update, that there are no changes.

  5. At Each Meeting of an NCCN Guidelines Panel
  6. Prior to participating in an NCCN Guidelines Panel meeting, each NCCN Guidelines Panel Member shall update the DOER Form.

An NCCN Guidelines Panel Member’s identification and disclosure of a relationship does not preclude that NCCN Guidelines Panel Member’s ability to act as an NCCN Guidelines Panel Member.  This is provided, however, that the disclosed relationship does not exceed the individual or aggregate annual monetary thresholds set forth in Section V.  Disclosed relationships with external entities will be evaluated for potential conflicts of interest by relevant NCCN committees of the Board and NCCN Staff as delegated by the committees of the Board. NCCN Guidelines Panel Members are expected to disclose a relationship with an external entity related to the discussion of a panel even when it is not clear whether the relationship or affiliation constitutes a conflicting interest.

As set forth in Section III of this policy, these disclosures will be reviewed prior to each NCCN Guidelines Panel meeting, and at least semiannually. NCCN Guidelines Panel Members are expected to make additional disclosures as set forth herein. The DOER Form will be completed electronically, and the information contained therein will be held by NCCN.

A list of all NCCN Guidelines Panel Members’ relationships with external entities based on the collection of DOER Forms will be furnished to all NCCN Guidelines Panel Members at the start of panel discussions. This action will serve to augment the oral disclosure of potential conflicts at the start of panel discussions.

III.     Consideration of Conflicting Interests

Semiannually upon submission of the DOER Form, and at other times as NCCN Staff or the relevant committee deems appropriate, the NCCN Staff, as delegated by the NCCN Governance Committee, will review the relationships disclosed by NCCN Guidelines Panel Members and shall compile the data set forth herein. Any potentially significant relationships as identified by NCCN staff shall be noted to the relevant NCCN Guidelines Panel chair. NCCN Staff will prepare a summary of disclosed relationships for distribution at the NCCN Panel meeting.

IV.     Participation in and Exclusion from NCCN Guidelines Panel Discussions

An NCCN Guidelines Panel Member who has been identified as having a Direct or Indirect Relationship with an external entity which constitutes a Conflicting Interest shall not participate in the NCCN Guidelines Panel’s discussion when the NCCN Guidelines Panel’s action on the topic under discussion may advantage or disadvantage an external entity, except when requested by the NCCN Guidelines Panel chair to participate for the purpose of providing or presenting information to the NCCN Guidelines Panel. Any NCCN Guidelines Panel Member who is identified as having a Conflicting Interest shall not attempt to influence the NCCN Guidelines Panel’s action with respect to the matter. The documentation of the NCCN Guidelines Panel meeting shall reflect that the NCCN Guidelines Panel Member refrained from discussing a matter due to an identified conflict of interest. Certain Direct Relationships are considered to be of such magnitude that they constitute a de facto Conflicting Interest. When an NCCN Guidelines Panel Member is a beneficial owner of any equity of the external organization or is a director or officer of the external organization, this Direct Relationship is considered to constitute a Conflicting Interest, and such NCCN Guidelines Panel Member will consequentially be excluded from the relevant discussion and may be requested to leave the discussion room.

If the NCCN Guidelines Panel chair or NCCN Governance Committee determines that a Conflicting Interest of an NCCN Guidelines Panel Member is of sufficient magnitude that it may require the NCCN Guidelines Panel Member to be excused too often from the discussions and decisions of the NCCN Guidelines Panel, or may otherwise interfere with his or her ability to function effectively as a NCCN Guidelines Panel Member, the NCCN Governance Committee shall request that the NCCN Guidelines Panel Member either terminate the conflicting activity or association or resign from the NCCN Guidelines Panel. If the NCCN Guidelines Panel Member fails to resolve the conflict, the NCCN Governance Committee shall resolve the conflict.

These principles pertain to NCCN Guidelines Panel chairs as well. If a chair must be recused from discussion, to the panel vice chair will perform the chair’s duties, during the recusal. If the chair develops a conflict which raises the issue of potential inability to continue to serve, the matter shall be brought to the NCCN Governance Committee for resolution.

V.     Ineligibility for Continued NCCN Guidelines Panel Service

If an NCCN Guidelines Panel Member has a disclosed individual annual financial relationship that is ≥ $20,000 or if his or her disclosed aggregate annual financial relationships are ≥ $50,000, the NCCN Guidelines Panel Member will be deemed ineligible for continued NCCN Guidelines Panel service. 

Because participation in clinical research is an integral part of the duties of an academic clinician, funds for clinical trials that are paid to the panel member’s institution are exempted from these limits, as are funds paid to the panel member for participation in a data safety monitoring board.  However, if a panel member is personally compensated for participation in a clinical trial, those funds are included in the limits.

If the NCCN Guidelines Panel Member subsequently demonstrates compliance with the requisite monetary threshold(s), reinstatement to the NCCN Guidelines Panel is possible after one year, at the discretion of the NCCN Guidelines Panel Member’s institution and the NCCN Guidelines Panel chair.  If the NCCN Guidelines Panel Member in question is also the NCCN Guidelines Panel chair, reinstatement to the NCCN Guidelines Panel is possible, but not to the NCCN Guidelines Panel chairmanship.

VI.     Special Requirements of the Panel Chair and Vice Chair

Panel chairs and vice chairs are permitted to participate in scientific advisory boards and to consult on product development strategies in a scientific capacity; however, they are not permitted to participate in any marketing focused activities, such as, participation in marketing advisory boards, speakers bureaus, or other non-scientific activities relating to products or services that might be considered by a NCCN Guidelines Panel.

VII.     Authority of the NCCN Guidelines Panel Chair

The chair of an NCCN Guidelines Panel shall be responsible for carrying out the oral disclosure of potential conflicts of interest at the start of NCCN Panel Meetings as described in Section II and Section VIII (a).

The chair shall have the authority to request that an NCCN Guidelines Panel Member not participate in the NCCN Guidelines Panel’s discussion for any part of the discussion where the NCCN Guidelines Panel Member’s external relationships may lead to a Conflicting Interest. The chair shall also have the authority to mitigate any conflict of interest by requesting that an NCCN Guidelines Panel Member who has been excused from discussion also leave the discussion room. In positions of equity ownership, the chair shall have the authority to ask that the NCCN Guidelines Panel Member leave the discussion room.

VIII.     Implementation of Internal and Public Disclosure

  1. Internal Disclosure

The DOER Form will be incorporated into an electronic system by which the NCCN Guidelines Panel Members can disclose relationships on an semiannual basis and make additional disclosures at any time. Use of an electronic system with an accompanying secure NCCN database will reduce the paperwork burden on NCCN Guidelines Panel Members. Additionally, this database will allow NCCN to provide a list of relationships to each panel so as to facilitate the oral disclosure of external relationships and support accountability among the NCCN Guidelines Panel Members. Disclosure of a potential conflict to other NCCN Guidelines Panel Members allows the NCCN Guidelines Panel Members to evaluate the possible influence of the disclosed interest in the context of the NCCN Panel’s discussion.

  1. Public Disclosure

External relationships will be disclosed to the public when the NCCN Guidelines are published. Public disclosure acts to protect NCCN Guidelines Panel Members against allegations of misconduct by identifying potential conflicts of interest that an NCCN Guidelines Panel Member may have or appear to have. Disclosing these relationships to the public precludes any appearance that potential conflicts may be hidden from the public and increases the transparency of the NCCN Guidelines development process.

IX.     Sanctions

In the instance of a breach of this policy, the NCCN Governance Committee may remove an NCCN Guidelines Panel Member from an NCCN Guidelines Panel. Instances of breach of this policy include the following:

  1. Failure to submit a fully completed DOER Form by a specified deadline;

  2. Submission of an incomplete, erroneous, or misleading DOER Form;

  3. Any failure to disclose relationships with external entities as required by this policy.

Disagreements with sanctions may be appealed to the NCCN Governance Committee.

Disclosure of External Relationships Form

More information about the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) is available for review. A listing of the organizations that have provided any financial support to the NCCN during the past two fiscal years is also available.

View the Identifications and Disclosures of Relationships with External Entities for the following:

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