NCCN Disclosure Policies and Potential Conflicts of Interest

View the Disclosures of External Relationships for the following:

Disclosure Policy for the NCCN Guidelines Panels and NCCN Guidelines Steering Committee

The development of the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) is a fundamental activity of the NCCN. The NCCN Guidelines^® are updated at least annually in an evidence-based process integrated with the expert judgment of multidisciplinary panels of experts 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.

NCCN Guidelines Panel Members are chosen for the NCCN Guidelines Panels because they have a high level of expertise in the subject matter covered by the specific panel. Each NCCN Member Institution identifies an NCCN Guidelines Steering Committee Member who has the authority to appoint one member from their institution to each NCCN Guidelines Panel. From time to time, additional Panel Members are appointed to individual panels based upon need through consultation among NCCN Senior Leadership, Panel Chairs, and Guidelines Steering Committee Members. Participation on an NCCN Guidelines Panel is voluntary. NCCN Guidelines Panel Members are not financially compensated for their involvement in NCCN Guidelines development beyond their institutional salary support. No industry support is allowed for any activity that can impact the content of any NCCN Guideline.

NCCN recognizes that many NCCN Guidelines Panel Members have relationships with industry or organizations including consultation and conducting funded research in areas such as medical devices, diagnostics, drugs, and biologics. Panel Members, as faculty members of cancer centers, have a professional obligation to be actively engaged in research activity, including research funded by industry. Financial conflicts of interest have the potential to introduce bias into the development process of NCCN Guidelines, thereby potentially affecting the integrity of the NCCN Guidelines, and must therefore be carefully managed.

It is a priority for NCCN 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. Disclosure requirements are included for NCCN Guidelines Panel Members and for members of the NCCN Guidelines Steering Committee 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 during their participation in the development of the NCCN Guidelines. NCCN Guidelines Panel Members with conflicting interests may need to be recused from panel discussions or removed from a Guidelines Panel, so that the integrity of the NCCN Guidelines is not compromised or diminished by conflicts or by the perception of conflicts.

This policy refers to members of NCCN Guidelines Panels, which are multidisciplinary expert panels convened for the purpose of developing the NCCN Guidelines^®, and to members of the NCCN Guidelines Steering Committee, which is comprised of representatives from the NCCN Member Institutions who have the authority to appoint members of the NCCN Guidelines Panels.

I. Definitions

“Conflicting Interest” means:
1. any Direct or Indirect Relationship (as defined below) with an external entity that has an investigational or approved product that is used or being clinically evaluated in any area of cancer risk assessment, diagnosis, treatment, surveillance, or other area that is the subject of any NCCN Guideline;
2. any organizational affiliation, activity, transaction, or other interest which would cause a decision of the NCCN Guidelines Panel to have a real or potential economic impact on the NCCN Guidelines Panel Member, NCCN Guidelines Steering Committee Member, or on others with whom the NCCN Guidelines Panel Member or NCCN Guidelines Steering Committee 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 or NCCN Guidelines Steering Committee Member’s objectivity or (ii) could create an unfair competitive advantage for the NCCN Guidelines Panel Member, NCCN Guidelines Steering Committee Member, or any organization with which the NCCN Guidelines Panel Member or NCCN Guidelines Steering Committee Member has a direct financial relationship.

“Direct Relationship”: A person is considered to have a Direct Relationship with a person or Entity if they, their spouse, domestic partner, or dependent(s):
1. is a beneficial owner of any equity of the entity or organization, excluding equity held through a publicly traded mutual fund or exchange traded fund (ETF), ownership held in a blind trust, or ownership held through a vehicle over which the person has no knowledge nor control regarding termination or continuation of the equity relationship;
2. is a director, officer, or employee of the Entity or organization;
3. receives compensation for 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.

“Entity” means:
1. a for-profit entity conducting business related to medical devices, diagnostics, drugs, biologics, or other subject of the NCCN Guidelines;
2. a managed care organization or other healthcare payer; or
3. a for-profit health care entity.

“NCCN Guidelines Panel Member” means any person who is appointed to serve on a panel for the purpose of developing the NCCN Guidelines^®.

“Disclosure of External Relationships Form” (the “DOER Form”) means the online document which NCCN Guidelines Panel Members and NCCN Guidelines Steering Committee Members are required 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.

“Immediate Family” means the spouse, domestic partner, or dependent(s) of an NCCN Guidelines Panel Member or NCCN Guidelines Steering Committee Member.

“NCCN Guidelines Panels” means multidisciplinary expert panels convened for the purpose of developing the NCCN Guidelines^®.

“NCCN Guidelines Steering Committee” means the committee comprised of NCCN Member Institution representatives who have the authority to make appointments to the NCCN Guidelines Panels.

“Indirect Relationship”: A person has an Indirect Relationship with an external entity if they, their spouse, their domestic partner, or dependent(s):
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.

“Research”: An NCCN Guidelines Panel Member or NCCN Guidelines Steering Committee Member participates in Research if he or she:
1. is a Principal Investigator;
2. serves on a Data Safety Monitoring Board (DSMB);
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 Relationships

NCCN Guidelines Panel Members and NCCN Guidelines Steering Committee Members are required to disclose all Relationships, whether a Direct Relationship or Indirect Relationship, with an External Entity in at least three instances:

Upon consideration for appointment to a Panel or Steering Committee
Prior to appointment to any NCCN Guidelines Panel or NCCN Guidelines Steering Committee, the prospective nominee shall complete and submit the completed DOER Form.
Semiannually
Each NCCN Guidelines Panel Member and NCCN Guidelines Steering Committee 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.
At each meeting of an NCCN Guidelines Panel
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 or NCCN Guidelines Steering Committee Member’s identification and disclosure of a relationship does not automatically preclude the NCCN Guidelines Panel Member’s or NCCN Guidelines Steering Committee Member’s ability to serve unless the disclosed relationship exceeds the monetary thresholds set forth in Section V. Relationships with external entities are required to be disclosed even when it is not clear whether the relationship or affiliation constitutes an actual conflict of interest.

As set forth in Section III, disclosures will be reviewed prior to each NCCN Guidelines Panel meeting, and at least semiannually. NCCN Guidelines Panel Members and NCCN Guidelines Steering Committee Members are required 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.

NCCN Guidelines Panel Members’ relationships with external entities are communicated to all NCCN Guidelines Panel Members prior to Guidelines Panel discussions. This action will serve to augment the oral disclosure of potential conflicts at the start of panel discussions. Reported relationships and conflicts of interest will also be published by individual Panel Member and individual Guidelines Steering Committee Member on the publically accessible portion of the NCCN website.

III. Consideration of Conflicting Interests

At least 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 Chairs, Vice Chairs, and Members and NCCN Guidelines Steering Committee Members and shall compile the data set forth herein. Any potentially significant and conflicting 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 or Guidelines Steering Committee 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 (even if monetary amount falls below the ineligibility threshold – see below) 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 by the Panel Chair, Panel Vice Chair, or NCCN Staff.

If the NCCN Guidelines Panel Chair, NCCN Governance Committee, or NCCN Staff 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 an NCCN Guidelines Panel Member, the NCCN Senior Leadership or 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, 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 NCCN Senior Leadership or NCCN Governance Committee for resolution.

V. Ineligibility for NCCN Guidelines Panel or NCCN Guidelines Steering Committee Service

If an NCCN Guidelines Panel Member or prospective Member or an NCCN Guidelines Steering Committee Member or prospective Member has an equal to or greater than $20,000 conflicting interest from at least one single external entity, including the sum of income and equity holdings from said entity, or if their aggregate conflicting interest from all external entities is equal to or greater than $50,000 per year, the Member or proposed appointee will be deemed ineligible for continued service or for appointment. Conflicting interests may be self-disclosed by the Member or be disclosed by other means, such as by Open Payments or other reliable resources.

Participation in research is a responsibility and integral part of the duties of an academic faculty member. Therefore, funds for research activities 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 Member is personally compensated directly or via his or her institution for participation in the research, those funds are included in the limits.

Presentations at accredited continuing education (CE) events is often desirable for academic faculty members to provide impartial knowledge and resources for professional practice update and improvement. Such events must be accredited by:

the Accreditation Council for Continuing Medical Education (ACCME);

an ACCME-recognized State Medical Society;

the Accreditation Council for Pharmacy Education (ACPE);

the American Nurses Credentialing Center (ANCC);

the European Accreditation Council for Continuing Medical Education (EACCME);

the Canadian Committee on Accreditation of Continuing Medical Education (CACME);

and/or other internationally recognized CE accreditation body.

All CME activities certified for AMA Physician’s Recognition Award (PRA) category 1 credit are considered accredited. Honoraria received for speaking at accredited CE events, or for presentations at non-profit organizations such as accredited academic institutions or patient advocacy organizations, will not be included in monetary threshold calculations. However, payments from commercial entities for participation in non-accredited education/training programs will be counted toward conflict of interest threshold limits.

If an NCCN Guidelines Panel Member, prospective Member, or an NCCN Guidelines Steering Committee Member is requested to provide information regarding compliance with the NCCN Disclosure Policy or a potential financial threshold conflict, such individual will have 45 days to respond with information that would clarify any inconsistencies. Failure to respond within this timeframe will render the individual ineligible for continued service or for appointment.

If the NCCN Guidelines Panel Member or NCCN Guidelines Steering Committee Member subsequently demonstrates compliance with the requisite monetary threshold(s), reinstatement to the NCCN Guidelines Panel or NCCN Guidelines Steering Committee is possible after one year has elapsed from identification of the conflict if the disqualifying conflicting interest(s) were self-disclosed and after two years from identification if found by other means. If the NCCN Guidelines Panel Member in question is also the NCCN Guidelines Panel Chair, reinstatement to the NCCN Guidelines Panel is possible as above, and the individual regains eligibility for potential appointment to the role of Guidelines Panel Chair or Co-Chair after one year has elapsed from identification of the conflict if the disqualifying conflicting interest(s) were self-disclosed.

VI. Special Requirements of the NCCN Guidelines Panel Chairs and Vice Chairs

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 promotional or 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 an NCCN Guidelines Panel. NCCN Panel Chairs and Vice Chairs may not serve as a chair of an external panel or committee which is involved with the development of guidelines, pathways, and consensus statements related to cancer treatment for any organization or entity other than NCCN.

VII. Authority of the NCCN Guidelines Panel Chair, Vice Chair, and NCCN Staff

The NCCN Guidelines Panel Chair and Vice Chair are 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 IX (a).

The Chair and/or Vice Chair have the authority to request that an NCCN Guidelines Panel Member not participate in the Guidelines Panel’s discussion for any part of the discussion where the Panel Member’s external relationships may lead to a Conflicting Interest. The Chair also has 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 has the authority to ask the Panel Member to leave the discussion room. In addition, the senior NCCN Staff Member has the same authority as the Panel Chair to mitigate any perceived conflict of interest.

VIII. Participation of NCCN Guidelines Panel Members or Guidelines Steering Committee Members in Non-NCCN Guideline, Pathway, or Consensus Processes or Programs

NCCN Guidelines Panel Members are from time to time asked to serve concurrently in guideline, pathway, or consensus statement, processes or programs of other organizations. While this is often of value to both NCCN and the other organization, there are circumstances where such participation may provide potential for violating confidentiality processes, sharing of proprietary information, or for duplicating in whole or part the NCCN Panel membership or guideline. Therefore, NCCN requires prior notification when a Panel Member plans to or is serving as a participant in another organization’s guideline or pathway process including, but not limited to, developing, reviewing, and/or authoring guidelines, pathways, or consensus statements.

This information will be collected within the COI Disclosure and includes both present involvement as well as pending invitations prior to Panel Member participation in these activities with other organizations/entities. All such notifications will be reviewed by NCCN Headquarters. The Panel Member will be contacted, as needed, for review of the nature of involvement with the organization, overlap with the NCCN Panel, and the extent of other NCCN Panel Member involvement in the same outside organization process. In most cases, it is expected that the NCCN Panel Member will be allowed to continue NCCN service, acknowledging and honoring NCCN confidentiality agreements. However, based on the review of the potential conflict, in limited circumstances, the NCCN Panel Member(s) may be requested not to participate with such external entities or be disqualified from NCCN Panel participation. Should such external organization participation be discovered outside of the disclosure process, the Panel Member may be deemed ineligible for, and disqualified from, NCCN Panel membership.

This decision will be at the sole discretion of NCCN Headquarters should the Panel Member elect to work with a non-NCCN organization’s guideline, pathway, or consensus process or program. If removed from Panel membership, reinstatement is possible after two years, with each situation determined on a case-by-case basis.

Rationale:

1) The NCCN Clinical Practice Guidelines development and maintenance process follows a complex and well-vetted paradigm that has established widespread credibility and acceptance. It is the culmination of shared work by Panel Members from the NCCN Member Institutions, patient advocates, and NCCN staff. It is important to protect the intellectual property of the NCCN Guidelines content and the integrity of the Guidelines development process.

2) To be aware of, and minimize the potential for, variability of other guidelines with NCCN Clinical Practice Guidelines.

3) To maintain transparency.

4) To maintain consistency in application of this requirement.

5) It is not the intent of this policy to unduly limit the professional and societal impact of the experts who serve on NCCN Panels.

Scope of coverage of this requirement:

1) Applicable engagement includes participation in the development of guidelines, pathways, care recommendations or consensus statements/processes/programs/directives of other organizations/entities.

2) This document relates to both commercial (for-profit) or non-commercial (non-profit) entities, including, but not limited to, professional organizations, medical societies, hospital systems, health information technology and electronic health record entities, payers, or patient advocacy organizations.

3) This requirement will also be applied to Panel Members who are participating in such other non-NCCN guidelines-related activities at the time of the adoption of this policy.

Excluded from this requirement:

1) Panel Members who participate in non-commercial guidelines, pathways, or consensus statements/processes/programs within their own Member Institution, where use of such is limited to that institution.

2) Panel Members who contribute to academic publications (including on-line resources such as Up-To-Date) which use NCCN content, provided that such content is appropriately referenced and permission for use is granted through the permission request process: (https://www.nccn.org/guidelines/submissions-licensing-and-permissions/licensing-and-permissions).

Requirements if a Panel Member is approved to participate in such processes with other organizations/entities:

1) Panel Member will maintain strict confidentiality of NCCN Guideline(s) content or pending changes that are not publicly available (i.e., not yet been posted to the NCCN.org website).

2) Panel Member may share generalized information about the NCCN process for Guideline creation/maintenance (such as is delineated at https://www.nccn.org/guidelines/guidelines-process/development-and-update-of-guidelines) but should not divulge specifics of Guidelines Panel meeting deliberation beyond what is published through the NCCN transparency documents. (https://www.nccn.org/guidelines/guidelines-process/transparency-process-and-recommendations).

3) Panel Member does not provide permission or license for utilization of NCCN content (publicly available or not) in the product of other organizations/entities. Requests for permission or licensing should be directed to the NCCN Business Development team.

IX. Implementation of Internal and Public Disclosure

a. Internal disclosure

The Guidelines Panel Members and Guidelines Steering Committee Members are required to disclose relationships on a semiannual basis and make additional disclosures any time meaningful changes occur in their Conflicting Interests. The database will be used by NCCN to provide a list of relationships 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.

b. Public disclosure

Conflicting interests are publically available on the NCCN website. Public disclosure acts to protect Panel Members and Steering Committee Members against allegations of misconduct by identifying potential conflicts of interest. 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.

X. Sanctions

In the instance of a breach of this policy, NCCN Staff may remove a Guidelines Panel Member or Guidelines Steering Committee Member from any Guidelines Panel or Committee on which they serve. Instances of breach of this policy include the following:

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

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

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

Disagreements with sanctions or disqualifications may be appealed to the NCCN Governance Committee by notifying the NCCN Chief Executive Officer by letter or email within 30 days of their being notified of the sanction or disqualification.