Disclosure Policy
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 the National Comprehensive Cancer Network’s
(NCCN’s) activities, including those of the 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 are qualified by training and experience in particular scientific or technical fields, or as authorities knowledgeable in the various disciplines and fields related to the scientific areas where expert advice
is needed. While they are strongly supported by the Member Institutions, they 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, 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, but not limited to, Scientific Advisory Boards, Request for Proposals (RFP) Development Teams, Protocol Development Teams,
Scientific Review Committees, International Research & Drug Development Scientific Group, Specialized Imaging Research Consortium Advisory Group, and any ad hoc committees with a scientific focus making decisions and recommendations related to
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 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
- 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:” 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:
- business or industry entities other than the NCCN 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 NCCN ORP scientific meeting.
- “Immediate Family means:” means spouse or the minor children of an NCCN ORP scientific committee member.
- “Disclosure of External Relationship Form” (the “DOER 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 DOER 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 external 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 external entity; or
- has a Direct Relationship with any other entity that has a Direct Relationship with the external entity (for example, when a NCCN Member Institution that employs an 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 guideline 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 guideline panel, he or she must complete a financial disclosure form (DOER form) prior to the scientific meeting.
- 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 DOER 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 external entity or potential investigator, except when requested by the NCCN 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 resolve the conflict in a manner that maintains the integrity of the scientific peer review process.
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 8.
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 DOER 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 DOER form by a specified deadline;
- Submission of an incomplete, erroneous, or misleading DOER 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.