SITC Financial Conflicts of Interest (FCOI) Policy
The Society for Immunotherapy of Cancer (SITC) is the world’s leading member-driven organization specifically dedicated to improving cancer patient outcomes by advancing the science and application of cancer immunotherapy. SITC is not-for-profit medical professional society of influential research scientists, physician scientists, clinicians, patients, patient advocates, government representatives and industry leaders dedicated to improving cancer patient outcomes by advancing the science and application of cancer immunotherapy. It is the mission of the Society for Immunotherapy of Cancer to improve cancer patient outcomes by advancing the science, development and application of cancer immunology and immunotherapy through our core values of interaction/integration, innovation, translation and leadership in the field.Policies/Processes
The affairs of the Society for Immunotherapy of Cancer (SITC) shall be conducted with concern for the avoidance of any real or apparent conflict of interest on the part of its investigators (PI, faculty, planners, and/or managers). Representatives of SITC should make known to the appropriate person (usually the president and or executive director) a conflict of interest that they might have on any matter under consideration by a group in which they participate. Those who have a conflict of interest on a matter, which comes to vote, shall not vote on any motion which involves the matter.
An actual conflict of interest arises when a person is in a position that requires the exercise of judgment on behalf of SITC and the person also has financial, professional or personal interests (either the person’s own or an interest that is attributed to the person by virtue of interests held by a spouse, partner, minor children or someone with whom income is directly shared) of the sort that is likely to, or does directly, interfere with the exercise of the individual’s judgment on behalf of SITC.
The appearance of a conflict of interest is present if there is a potential for the financial, professional or personal interests of a person (either the person’s own or an interest that is attributed to the person by virtue of interests held by a spouse, partner, minor children or someone with whom income is directly shared) to be at odds with the person’s obligation to SITC and the circumstances are such that a reasonable person with knowledge of the relevant facts would question the person's ability to act in SITC’s best interests and not be compromised by that person’s financial, professional or personal interests.
SITC representatives with a conflict may be leading experts on the subject matter under consideration, and SITC should have the benefit of their expertise. Therefore, members with a conflict of interest may be permitted to participate in consideration of a matter, but only after their conflict on that matter has been made known. It is not necessary that all details of the conflict be divulged to the rest of the group. However, it is necessary that all the discussants know enough so that they can receive the comments from the members with a conflict in their proper context. If it is determined that due to the conflict it is inappropriate for the member(s) to contribute to the conversation, the president or presiding officer, or committee chair persons will make that determination
Per NIH requirements, SITC complies with all requirements of 42 CFR 50, Subpart F, "Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought" (FCOI Regulation), as implemented in the 2011 Final Rule for grants and cooperative agreements.
SITC provides this Financial Conflicts of Interest (FCOI) policy to all investigators who affect the content of an educational activity and are required to disclose their own financial relationships; as well as relationships to products or devices their spouse/life partner have with commercial interests related to the content of the activity of any amount over the past 12 months.
SITC requires disclosure form completion from investigators, as a way to comply with NIH requirements and ensure they are informed of our policy, their disclosure responsibilities, and the federal regulation. Disclosure form completion is required: (1) No later than at the time of application for PHS-funded research; (2) At least annually during the period of the award; and (3) Within 30 days of discovering or acquiring a new significant financial interest (SFI).
The SITC President and/or Executive Director shall review disclosure forms, determine if relevant SFIs and FCOIs exist, and implement and monitor management plans for actual SFIs and FCOIs; these steps shall be guided by the SITC Board of Directors’ conflict disclosure guidelines.
The Executive Director, along with the FCOI Assistant, shall send any required FCOI reports to NIH, according to the regulation. This includes but is not limited to annual reports, mitigation reports, and any findings of bias. Further, when requested, the Executive Director will promptly make information available to the NIH/HHS relating to any investigator disclosure of financial interests and SITC’s review of, and response to, such disclosure, whether or not the disclosure resulted in SITC’s determination of an FCOI.
SITC National Office shall maintain all FCOI-related records that meet or exceed the regulatory requirements: For at least three (3) years from the date the final expenditures report is submitted to the PHS (NIH); and From other dates specified in 45 CFR 75.361, where applicable.
Those in non-compliance with this policy and disclosure requirements may result in removal of an investigator from the relevant grant or project. After a determination of non-compliance, the SITC Executive Committee shall complete and document a retrospective review within 120 days. SITC does not apply for or receive grants for clinical research; as such, additional DHHS non-compliance reporting requirements do not apply.
SITC shall meet all subrecipient FCOI requirements, as applicable.
This policy is publicly posted on the SITC website. SITC will also publicly post any information concerning
identified FCOIs, in accordance with the regulation.
Additional Conflicts for Consideration
In addition to the above mentioned disclosure, the IRS requires disclosure if any of the organization’s officers, directors, trustees, or key employees, had a family relationship or business relationship with another of the organization’s officers, directors, trustees, or key employees, at any time during the organization’s tax year. For each family and business relationship, identify the persons and describe their relationship. It is sufficient to enter “family relationship” or “business relationship” without greater detail.
Investigators are those:
· defined as the PD/PI and any other person, regardless of title or position;
· who are responsible for the design, conduct, or reporting of research funded by PHS, or proposed for such
· and may include, for example, collaborators or consultants.
Definition of Financial Relationship
Financial relationships are those relationships in which the individual benefits by receiving a salary, royalty, intellectual property rights, consulting fee, honoraria for promotional speakers’ bureau, ownership interest (e.g., stocks, stock options or other ownership interest, excluding diversified mutual funds), or other financial benefit. Financial benefits are usually associated with roles such as employment, management position, independent contractor (including contracted research), consulting, speaking and teaching, membership on advisory committees or review panels, board membership, and other activities from which remuneration is received, or expected. ACCME considers relationships of the person involved in the CME activity to include financial relationships of a spouse or partner. Contracted research includes research funding where the institution gets the grant, manages the funds and the person is the principal or named investigator on the grant. There is no minimum dollar amount for relationships.
Definition of Commercial Interest
A commercial interest is any entity producing, marketing, re-selling, or distributing health care goods or services consumed by, or used on, patients. Providers of clinical service directly to patients are not commercial interests (unless the provider of clinical service is owned, or controlled by, a commercial interest).
Other Possible Financial Conflicts
o Paid consultancy or expert testimony within the past two years
o Research funding (identify subject matter and funding organization, if permissible)
o Honoraria, stipends, or gifts exceeding $100 in value per engagement directly received from an entity
Additionally, the 2011 revised regulation defines a “significant financial interest” as follows:
(1) A financial interest consisting of one or more of the following interests of the Investigator (and those of the
Investigator’s spouse and dependent children) that reasonably appears to be related to the Investigator’s
(i) With regard to any publicly traded entity, a significant financial interest exists if the value of any
remuneration received from the entity in the twelve months preceding the disclosure and the
value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds
$5,000. For purposes of this definition, remuneration includes salary and any payment for
services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship);
equity interest includes any stock, stock option, or other ownership interest, as determined
through reference to public prices or other reasonable measures of fair market value;
(ii) With regard to any non-publicly traded entity, a significant financial interest exists if the value of any
remuneration received from the entity in the twelve months preceding the disclosure, when
aggregated, exceeds $5,000, or when the Investigator (or the Investigator’s spouse or dependent
children) holds any equity interest (e.g., stock, stock option, or other ownership interest); or
(iii) Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.
(2) Investigators also must disclose the occurrence of any reimbursed or sponsored travel (i.e., that which is paid on behalf of that individual and not reimbursed to the them so that the exact monetary value may not be readily available), related to their institutional responsibilities; provided, however, that this disclosure requirement does not apply to travel that is reimbursed or sponsored by a federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education. The Institution’s FCOI policy will specify the details of this disclosure, which will include, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration. In accordance with the Institution’s FCOI policy, the institutional official(s) will determine if further information is needed, including a determination or disclosure of monetary value, in order to determine whether the travel constitutes an FCOI with the PHS-funded research.
(3) The term significant financial interest does not include the following types of financial interests: salary, royalties, or other remuneration paid by the Institution to the investigator if they are currently employed or otherwise appointed by the Institution, including intellectual property rights assigned to the Institution and agreements to share in royalties related to such rights; any ownership interest in the Institution held by the Investigator, if the Institution is a commercial or for-profit organization; income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made in these vehicles; income from seminars, lectures, or teaching engagements sponsored by a federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education; or income from service on advisory committees or review panels for a federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education.
SITC defines “business relationships” between two persons to include any of the following:
- One person is employed by the other in a sole proprietorship or by an organization with which the other is associated as a trustee, director, officer, key employee, or greater-than-35% owner.
- One person is transacting business with the other (other than in the ordinary course of either party’s business on the same terms as are generally offered to the public), directly or indirectly, in one or more contracts of sale, lease, license, loan, performance of services, or other transaction involving transfers of cash or property valued in excess of $10,000 in the aggregate during the organization’s tax year. Indirect transactions are transactions with an organization with which the one person is associated as a trustee, director, officer, key employee, or greater-than-35% owner. Such transactions do not include charitable contributions to tax-exempt organizations.
- The two persons are each a director, trustee, officer, or greater than 10% owner in the same business or investment entity (but not in the same tax-exempt organization).
Ownership is measured by stock ownership (either voting power or value) of a corporation, profits or capital interest in a partnership or limited liability company, membership interest in a nonprofit organization, or beneficial interest in a trust. Ownership includes indirect ownership (for example, ownership in an entity that has ownership in the entity in question); there may be ownership through multiple tiers of entities.
Privileged relationship exception: A “business relationship” does not include a relationship between an attorney and client, a medical professional (including psychologist) and patient, or a priest/clergy and penitent/communicant.
END OF POLICY