The development of the NCCN Clinical Practice Guidelines in Oncology™ 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 and NCCN Task Force Members (�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 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. 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 Clinical Practice Guidelines in Oncology™ and NCCN Task Forces, thereby potentially affecting the integrity of the NCCN Guidelines or NCCN Task Forces.

This policy has been developed to safeguard the integrity of the NCCN Guidelines and NCCN Task Force development processes and to preserve the high level of confidence in NCCN Clinical Practice Guidelines in Oncology™ that is found among oncology professionals and the public. This policy is also designed to identify arrangements involving NCCN Guidelines Panel Members and NCCN 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 the development of NCCN Guidelines Panels or NCCN Task Forces. This policy requires disclosure of external relationships and recusal of NCCN Guidelines Panel Members with conflicting interests so that the integrity of NCCN Guidelines or NCCN Task Force Reports is not compromised or diminished by conflicts or by the perception of conflicts.

This document has been adopted by the NCCN Board of Directors to provide guidance to NCCN Governance Committee, NCCN Staff, and the chairpersons of the NCCN Guidelines Panels, and NCCN Guidelines Panel Members on how external relationships will be identified and disclosed and what actions a NCCN Panel or NCCN 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 NCCN Task Forces, which are ad hoc panels convened for the purpose of identifying and evaluating special topics in oncology.

I. Definitions

Conflicting Interest: "Conflicting Interest" means:

any Direct or Indirect Relationship (as defined below) with any other entity that would be financially advantaged or disadvantaged by the action of the NCCN Guidelines Panel or NCCN Task Force in the matter under consideration;
any organizational affiliation, activity, transaction, or other interest which would cause a decision of the NCCN Guidelines Panel or NCCN Task Force to have a direct and significant 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;
any other organizational affiliation, activity, transaction, or other interest which (i) could significantly impair the NCCN Guidelines Panel Member�s objectivity or (ii) could create a significant 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).

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:

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;
is a director, officer or employee of the organization; or
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.
has a debt relationship of any kind with the organization, whether as lender, borrower, holder of debentures, or the like.
holds a patent, or any interest in a patent which is held, licensed or utilized by the organization.

External Entities: “External Entities” means:

business or industry entities other than the NCCN Guidelines Panel Member�s primary affiliation;
industrial entities conducting business in medical devices, diagnostics, drugs, and biologics;
entities that may be financially advantaged or disadvantaged by the action of an NCCN Guidelines Panel or NCCN Task Force.

“Identification and Disclosure of Relationship with External Entities Form” (the “IDREE 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 IDREE form.
“NCCN Guideline Panels,” means multidisciplinary expert panels convened for the purpose of developing the NCCN Clinical Practice Guidelines in Oncology™
Indirect Relationship: A person has an "Indirect Relationship" with an entity if he or she, or any member of his or her immediate family:

has a Direct Relationship with an organization that competes with the entity; or
has a Direct Relationship with any other entity that has a Direct Relationship with the entity (for example, when an NCCN Member Institution that employs a NCCN Guidelines Panel Member has a direct relationship with industry).

NCCN Guidelines Panel Member: “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™;
any person who is appointed to serve on an NCCN Task Force.

“NCCN 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

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

Upon Consideration for Appointment to a Panel

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

Annually

Each NCCN Guidelines 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.

At Each Meeting of a NCCN Guidelines Panel

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

Upon Changed Circumstances

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

A NCCN Guidelines Panel Member�s identification and disclosure of a relationship does not preclude that NCCN Guidelines Panel Member�s ability to act as a NCCN Guidelines 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. 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 paragraph III of this policy, these disclosures will be reviewed prior to each NCCN Guidelines Panel or NCCN Task Force meeting, and at least annually. NCCN Guidelines 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 NCCN as confidential.

A list of all NCCN Guidelines Panel Members� relationships with external entities based on the collection of IDREE 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

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 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 shall be noted to the NCCN Governance Committee and the relevant NCCN Guidelines Panel or NCCN Task Force chair. NCCN staff, after consultation with the relevant chair will prepare a summary of disclosed relationships for distribution at the NCCN Panel meeting.

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

A NCCN Guidelines 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 NCCN Guidelines Panel�s discussion when the NCCN Guidelines Panel�s action on the topic under discussion may advantage or disadvantage an industry 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 a 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 a 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 NCCN Task Force, 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 or NCCN Task Force. If the NCCN Guidelines Panel Member fails to resolve the conflict, the NCCN Governance Committee shall remove the NCCN Guidelines Panel Member.

In the instance where a NCCN Guidelines Panel Member disagrees with a decision reached by an NCCN Panel or NCCN Task Force chair to excuse a NCCN Guidelines Panel Member from discussion, that NCCN Guidelines Panel Member may appeal the decision of the chair to the NCCN Governance Committee.

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

V. Authority of the Guideline Panel or Task Force Chair

The chair of an NCCN Guidelines Panel or NCCN Task Force 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 VI.(a).

The chair shall have the authority to request that a 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 a 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.

VI. Implementation of Internal and Public Disclosure

Internal Disclosure

The IDREE Form will be incorporated into an electronic system by which the NCCN Guidelines Panel Members can disclose relationships on an annual basis and make additional disclosures at any time. The electronic form will ask individuals who are NCCN Guidelines 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 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.

Public Disclosure

Significant 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 a 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.

VII. Sanctions

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

Failure to submit a fully completed IDREE Form by a specified deadline;
Submission of an incomplete, erroneous, or misleading IDREE Form;
Any failure to disclose relationships with external entities as required by this policy.

Disagreements with sanctions may be appealed to the NCCN 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.

Disclosure Policy for the NCCN Oncology Research Program (ORP)

Integrity, objectivity, and absence of self-dealing are essential at all levels and in all aspects of NCCN�s activities, including those of the NCCN Oncology Research Program (ORP). NCCN and its employees are committed to conducting themselves and their activities in accordance with the highest standards of integrity and ethics.

Members of NCCN ORP scientific committees may face a real or apparent conflict of interest with a grantor, investigator or institution. In order to maintain the integrity of the NCCN ORP, and to comply with all applicable laws and regulations, it is essential that all members disclose their and their family members� financial interests related to research reviews or projects prior to their participation in any NCCN ORP scientific committee. Conflicts of Interest may include either financial (direct) or non-financial (indirect) interests. After disclosure, the NCCN can make an informed judgment about a particular activity and require appropriate oversight, limitations, or prohibitions in accordance with this policy.

I. Purpose

This policy sets forth principles and procedures to ensure that the personal financial interests of scientific committee members do not compromise the objectivity with which recommendations for research and approval of projects are made.

II. Scope

This policy applies to all members of NCCN ORP scientific committees, including Scientific Advisory Boards, RFP Development Teams, Protocol Development Teams, Scientific Review Committees and any ad hoc committees with a scientific focus making decisions and recommendations related to NCCN ORP research projects.

III. Definitions

The following definitions apply to this policy.

“NCCN ORP Member” means any person who has agreed to serve on a scientific board, committee or team that is convened for the purpose of reviewing industry scientific data and advising grantors and/or making decisions for funding research proposals related to an NCCN ORP research project.
“Conflicting Interest” means:

any Direct or Indirect Relationship (as defined below) with any other entity that would be financially advantaged or disadvantaged by the action of the NCCN ORP Member in the matter under consideration;
any organizational affiliation, activity, transaction, or other interest which would cause a decision of the NCCN ORP Member to have a direct and significant impact on the NCCN ORP research project or on others with whom the NCCN ORP Member has personal or professional relationships;
any other organizational affiliation, activity, transaction, or other interest which (a) could significantly impair the NCCN ORP Member�s objectivity or (b) could create a significant unfair competitive advantage for the NCCN ORP Member or any organization with which the NCCN ORP Member has a direct financial relationship (as defined below).

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:

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;
is a director, officer or employee of the organization; or
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;
has a debt relationship of any kind with the organization, whether as lender, borrower, holder of debentures, or the like;
holds a patent, or any interest in a patent which is held, licensed or utilized by the organization.

“External Entities” means:

business or industry entities other than the ORP Member�s primary affiliation;
industrial entities conducting business in medical devices, diagnostics, drugs, and biologics;
entities that may be financially advantaged or disadvantaged by the actions of an ORP scientific meeting.

“Immediate Family” means spouse, parents and grandparents, children and grandchildren, brothers and sisters, mother-in-law and father-in-law, brothers-in-law and sisters-in-law, daughters-in-law and sons-in-law.
“Identification and Disclosure of Relationship with External Entities (IDREE) Form” (the �IDREE Form�) means the document available online and in hard copy which NCCN ORP 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.
“NCCN ORP Scientific Committees” means multidisciplinary expert committees or boards convened for the purpose of making recommendations or decisions related to NCCN ORP research projects.
“Indirect Relationship”: A person has an "Indirect Relationship" with an entity if he or she, or any member of his or her immediate family:

has a Direct Relationship with an organization that competes with the entity; or
has a Direct Relationship with any other entity that has a Direct Relationship with the entity (for example, when a NCCN Member Institution that employs an NCCN ORP Member has a direct relationship with industry).

IV. Disclosure of External and Potentially Conflicting Interests

ORP Members shall have a duty to take the following actions:

If NCCN ORP Member is also a member of a NCCN Guidelines Panel, the panel disclosure posted on the NCCN site will be acceptable. If this disclosure is more than 1 year old, a new disclosure form will be completed and submitted.
If NCCN ORP Member is not a member of an NCCN Guidelines Panel, he or she must complete a financial disclosure form (IDREE form) prior to the scientific meeting.
Disclosure forms will be posted on the NCCN website.
Oral disclosures will also be given at the beginning of each meeting and documented in the meeting minutes or tape.
Participants will be recused from discussions at meetings where they have conflicts of interest or, in some circumstances, may have their appointment to the committee terminated.

V. Consideration of Conflicting Interests

Upon submission of the IDREE Form, the NCCN staff will review the relationships disclosed by NCCN ORP Members and shall compile the data set forth herein. Any potentially significant relationships shall be noted to the relevant NCCN ORP scientific meeting chair. NCCN staff, after consultation with the relevant chair, will prepare a summary of disclosed relationships for distribution at the NCCN ORP scientific meeting.

VI. Participation in and Exclusion from ORP Scientific Meeting Discussions

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

If the scientific meeting Chair determines that a Conflicting Interest of an NCCN ORP Member is of sufficient magnitude that it may interfere with his or her ability to function effectively as an NCCN ORP Member, the scientific meeting Chair shall request that the NCCN ORP Member either terminate the conflicting activity or association or resign from the NCCN ORP scientific committee or board. If the NCCN ORP Member fails to resolve the conflict, the scientific meeting Chair shall remove the NCCN ORP Member from the NCCN ORP scientific committee or board.

In the instance where an NCCN ORP Member disagrees with a decision reached by a scientific meeting Chair to either excuse an NCCN ORP Member from discussion or remove them from continued scientific committee or board service, that NCCN ORP Member may appeal the decision of the chair to the NCCN Governance Committee.

These principles pertain to scientific meeting Chairs as well. If a Chair must be recused from discussion, he shall name a substitute chair from among the committee members in attendance to continue to perform the Chair�s duties during the recusal.

VII. Authority of the Scientific Committee Chair

The Chair of an NCCN ORP scientific committee shall be responsible for carrying out the oral disclosure of potential conflicts of interest at the start of the meeting as described in Section 3 and Section 7.

The Chair shall have the authority to request that an NCCN ORP Member not participate in the committee�s discussion for any part of the discussion where the NCCN ORP 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 ORP 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 ORP Member leave the discussion room.

VIII. Implementation of Internal and Public Disclosure

The IDREE Form will be incorporated into an electronic system by which the NCCN ORP Members can disclose relationships on an annual basis and make additional disclosures at any time. The electronic form will ask individuals who are NCCN ORP Members of more than one NCCN ORP scientific committee to identify and disclose relationships and check the appropriate committees 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 NCCN ORP Members. Additionally, this database will allow NCCN to provide a list of relationships to each scientific committee so as to facilitate the oral disclosure of external relationships and support accountability among the NCCN ORP Members. Disclosure of a potential conflict to other NCCN ORP Members allows NCCN ORP Members to evaluate the possible influence of the disclosed interest in the context of the scientific committee�s discussion.

IX. Sanctions

In the instance of a breach of this policy, the relevant scientific meeting Chair may remove an NCCN ORP Member from an NCCN ORP scientific committee. Instances of breach of this policy include the following:

Failure to submit a fully completed IDREE Form by a specified deadline;
Submission of an incomplete, erroneous, or misleading IDREE Form;
Any failure to disclose relationships with external entities as required by this policy.

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

Identification and Disclosure of Relationships with External Entities Form

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