Preamble

The development of the NCCN Clinical Practice Guidelines in Oncology™ is a fundamental activity of the National Comprehensive Cancer Network.  These 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.  The NCCN depends on the Members of Guideline Panels and Task Forces (“Panel Members”) to reach decisions objectively, without being influenced or appearing to be influenced by conflicting interests.

The Panel Members are strongly supported by the NCCN Member Institution cancer centers.  Panel Members are chosen for the guideline panels by their institutions because they have demonstrated a high level of expertise in their disciplines.  Participation on an NCCN Clinical Practice Guidelines in Oncology panel is voluntary.  Panel Members are not paid for their involvement in guideline development.  Development of the guidelines is supported by NCCN Member Institution dues.  No industry support is accepted for any direct costs associated with the development of the guidelines.  NCCN does receive support from industry for distribution of the Complete Library of NCCN Clinical Practice Guidelines in Oncology on CD-ROM and in other media. 

While corporate and industry involvement plays a growing role in the support of oncology research, the financial incentives that accompany such involvement may lead to conflicts of interest.  The NCCN also recognizes that the majority of 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 Clinical Practice Guidelines in Oncology and NCCN Task Forces, thereby potentially affecting the integrity of the guidelines or task forces. 

This Policy has been developed to safeguard the integrity of the guidelines and task force development processes and to preserve the high level of confidence in the NCCN Clinical Practice Guidelines in Oncology that is found among oncology professionals and the public. This Policy is also designed to identify arrangements involving guidelines panel and task force Members who have a significant 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 on guideline development panels or task forces.  This Policy requires disclosure of external relationships and recusal of Panel Members with conflicting interests so that the integrity of Guidelines or Task Force reports is not compromised or diminished by conflicts or by the perception of conflicts.

This document has been adopted by the Board of Directors of the NCCN to provide guidance to the NCCN Governance Committee, NCCN Staff, the chairpersons of Panels, and Panel Members on how external relationships will be identified and disclosed and what actions a panel or task force 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 guideline panels, which are multidisciplinary expert panels convened for the purpose of developing the NCCN Clinical Practice Guidelines in Oncology™, and task forces, which are ad hoc panels convened for the purpose of identifying and evaluating special topics in oncology.

I.     Definitions

1. Conflicting Interest: "Conflicting Interest" means:

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

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

3. any other organizational affiliation, activity, transaction, or other interest which (i) could significantly impair the Panel Member’s objectivity or (ii) could create a significant unfair competitive advantage for the Panel Member or any organization with which the 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 any member of his or her immediate family:

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; or

3. receives compensation equal to or in excess of $10,000 per annum 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.

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

3. External Entities: “External Entities” means:

1. business or industry entities other than the Panel Member’s primary affiliation;

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

3. entities that may be financially advantaged or disadvantaged by the action of an NCCN guidelines panel or task force.

4. “Identification and Disclosure of Relationship with External Entities Form” (the “IDREE Form”) means the document available online and in hard copy which 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 IDREE form.

5. “Guideline Panels,” means multidisciplinary expert panels convened for the purpose of developing the NCCN Clinical Practice Guidelines in Oncology™

6. Indirect Relationship: A person has an "Indirect Relationship" with an 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 entity; or

2. has a Direct Relationship with any other entity that has a Direct Relationship with the entity (for example, when a Member Institution that employs a Panel Member has a direct relationship with industry).

7. Panel Member:  “Panel Member” means:

1. 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™;

2. any person who is appointed to serve on a Task Force.

8. Task Force means ad hoc panels convened for the purpose of identifying and evaluating special topics in oncology.

II.    Disclosure of External and Potentially Conflicting Interests

Panel Members are expected to disclose relationships in at least four instances:

A.        Upon Consideration for Appointment to a Panel

Prior to appointment to any Panel, the prospective nominee shall complete and submit the completed IDREE form.

B.         Annually

Each Panel Member shall update the information in his/her filed IDREE form or shall attest, upon notice of annual update, that there are no changes.

C.        At Each Meeting of a Panel

Prior to participating in a Guideline Panel or Task Force meeting, each Panel Member shall update the IDREE Form.

D.        Upon Changed Circumstances

Within two (2) weeks of any change in the information in a Panel Member’s filed IDREE Form he/she shall update the information on file with the NCCN.

A Panel Member’s identification and disclosure of a relationship does not preclude that Panel Member’s ability to act as a Panel Member. 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.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 paragraph III of this Policy, these disclosures will be reviewed prior to each Panel or Task Force meeting, and at least annually.  Panel Members are expected to make additional disclosures as set forth herein. The IDREE Form will be completed electronically, and the information contained therein will be held by the NCCN as confidential.

A list of all Panel Members’ relationships with external entities based on the collection of IDREE Forms will be furnished to all 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

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

IV.       Participation in and Exclusion from Panel and Task Force Discussions

A Panel Member who has been identified as having a significant and Direct or Indirect Relationship with an external entity which constitutes a Conflicting Interest shall not participate in the Panel’s discussion when the Panel’s action on the topic under discussion may advantage or disadvantage an industry entity, except when requested by the Panel Chair to participate for the purpose of providing or presenting information to the Panel.  Any Panel Member who is identified as having a Conflicting Interest shall not attempt to influence the Panel’s action with respect to the matter. The documentation of the Panel meeting shall reflect that the 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 a 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 Panel Member will consequentially be excluded from the relevant discussion and may be requested to leave the discussion room.

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

In the instance where a Panel Member disagrees with a decision reached by a panel or task force chair to excuse a Panel Member from discussion, that Panel Member may appeal the decision of the chair to the Governance Committee.

These principles pertain to Guidelines Panel and Task Force chairs as well. If a chair must be recused from discussion, he shall name a substitute chair from among the Panel Members in attendance to continue to 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 Governance Committee for resolution.  

V. Authority of the Guideline Panel or Task Force Chair

The chair of a Guideline Panel or Task Force shall be responsible for carrying out the oral disclosure of potential conflicts of interest at the start of Panel meetings as described in Section II and Section VI.(a).

The chair shall have the authority to request that a Panel Member not participate in the Panel’s discussion for any part of the discussion where the 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 a 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 Panel Member leave the discussion room.

VI.       Implementation of Internal and Public Disclosure

1. Internal Disclosure

The IDREE Form will be incorporated into an electronic system by which the Panel Members can disclose relationships on an annual basis and make additional disclosures at any time. The electronic form will ask individuals who are Panel Members of more than one panel to identify and disclose relationships and check the appropriate panels for which such a relationship may constitute a potential conflict of interest. Use of an electronic system with an accompanying secure NCCN database will reduce the paperwork burden on Panel Members.  Additionally, this database will allow the 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 Panel Members. Disclosure of a potential conflict to other Panel Members allows the Panel Members to evaluate the possible influence of the disclosed interest in the context of the panel’s discussion.

2. Public Disclosure

Significant external relationships will be disclosed to the public when the NCCN guidelines are published. Public disclosure acts to protect NCCN Panel Members against allegations of misconduct by identifying potential conflicts of interest that a 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 guidelines development process.

VII.     Sanctions

In the instance of a breach of this Policy, the Governance Committee may remove a Panel Member from a Guideline Panel or Task Force. Instances of breach of this Policy include the following:

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

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

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

Disagreements with sanctions may be appealed to the Governance Committee.

Identification and Disclosure of Relationships with External Entities Form

A complete description (Winn, 2003) of the process for the development of the NCCN Clinical Practice Guidelines in Oncology™ 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.