The American Society for Radiation Oncology (ASTRO) is dedicated to improving patient care through education, clinical practice, advancement of science and advocacy.
As a Society of professionals, ASTRO seeks to maintain the undisputed primacy of certain ethical interests: that the best interest of the patient is served in our clinical practice and advocacy, that educational activities are independent unbiased forums, that scientific studies and papers are conducted, reported and assessed on their merit with transparent intellectual rigor, and that the leadership of the Society give primacy to the interests of the Society in all matters relating to ASTRO.
There are many outside interests which are not inherently undesirable: the ownership of assets, institutional loyalty, personal satisfaction in the results of one's own research, commercial development of a new product and volunteer leadership in multiple organizations, to name a few. It is inevitable, however, that such other interests may compete with the primacy of ASTRO’s interests, or that they may appear to do so. That is the definition of conflict of interest. Conflict of interest, therefore, is inherent in professional life; it exists in the absence of wrongdoing, and responsible organizations must adopt a plan to prevent, identify and manage conflicts of interest.
Dealing with conflict of interest is a shared responsibility between the organization and the individual as they seek to fulfill their fiduciary duties to the organization and its members. Effective management of conflict of interest requires an environment in which the process is respected and regarded as essential to the maintenance of core values. It requires willing disclosure and a process to resolve conflicts. Most conflicts require only disclosure for their remedy. In other cases, recusal may be necessary. It may be, in other rare cases, that only elimination of the alternative interest may serve to manage the conflict.
When an individual agrees to serve in a volunteer capacity on behalf of ASTRO, certain duties automatically arise, including the duty to partner with ASTRO in eliminating undue influence and maintaining the integrity of ASTRO and the field of radiation oncology. Accordingly, this policy applies to the Board of Directors; committee chairs, vice-chairs and members; editors, faculty, authors, presenters and reviewers; senior ASTRO staff; and others representing ASTRO. A closely related obligation that individuals incur when they enter into a relationship with ASTRO is to maintain the confidentiality of information they obtain in their relationship with ASTRO. The potential for disclosure of confidential information is one of the possible ways in which a conflict of interest can arise.
The scope of review for the COI process encompasses covered individuals with respect to their involvement in ASTRO activities, including volunteer positions, participation in meetings and contribution to or review of oral or written materials. It does not have jurisdiction to address individuals’ behavior beyond their actions on behalf of ASTRO or in ASTRO activities.
ASTRO is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education to physicians. Accredited activities are planned in accordance with the ACCME Policies and Standards for Commercial Support, a component of which is to have effective Conflict of Interest Policies and Procedures. The ACCME Policies, as implemented by ASTRO, ensure that the content or format of CME activities and related materials promote improvement of or quality in health care and not a specific proprietary business interest or commercial bias.
ASTRO’s general Conflict of Interest Policy is set forth below. In addition, ASTRO also has separate Leadership Standards that supplement the standard policy for certain senior ASTRO leaders.
Conflict of Interest Policy and Procedure
I. Who is covered?
The ASTRO Conflict of Interest policies and procedures apply to persons who:
- Serve on the ASTRO Board of Directors;
- Participate in ASTRO Committees, task forces or in any volunteer activity in an official capacity for ASTRO, including representing ASTRO on any governmental or medical task forces, or advisory boards;
- Make presentations, or otherwise serve as faculty, at an ASTRO-sponsored meeting;
- Submit work for publication in any ASTRO-sponsored publication, or act as an editor or reviewer of the same; or
- ASTRO senior staff, as established under ASTRO employment policies.
II. What interests or relationships require disclosure?
The ASTRO Conflict of Interest Policy requires disclosure of the following types of interests or relationships. Individuals are required to disclose interests or relationships held by a covered individual, their spouse and any dependent family members. The parameters for disclosing interests are set broadly in order to gather the most complete information. However, disclosing the information requested on ASTRO’s Disclosure Statement does not mean that there is a conflict of interest. Only where there is a reasonable concern that there could be either an actual or a perceived conflict between the person’s other interests and their position or work for ASTRO will an interest be deemed a potential conflict of interest that must be addressed.
- Compensation Remuneration or Funding: Either monetary or in-kind, from an entity related to ASTRO or to research, practice, or education, in the field of oncology or radiation therapy,including consulting fees, honoraria, speaker’s bureau payments, reimbursement for travel or other expenses, research grant funding, in-kind donations or other payments viewed as compensation.
- There are a number of factors that may affect the analysis regarding compensation and potential COI. For example, there is a higher level of scrutiny applied where the entity providing the funding is a for-profit entity. However, funding from non-profits must still be disclosed and reviewed to determine whether there are potential conflicts.
- What if the compensation is donated to charity? If an IRS form 1099 is generated for the individual, it will be viewed as a financial interest, although the individual can note on their form that the proceeds were donated to charity. Where no 1099 is generated and the individual does not direct the donation, it will not be viewed as a financial interest, but should still be disclosed with notations explaining the nature of the relationship and the fact that the relationship is not a financial one.
- With respect to research grants, see the parameters laid out in ASTRO’s Policy on Research Funding.
- Employment Relationships: All full-time, part-time or contract based employment related to ASTRO, or to research, practice or education, in the field of oncology or radiation therapy, including faculty positions, employment positions in community or hospital-based practice, as well as contract service for radiation oncology practices or other specialty owned practices.
- Ownership or Investment Interests: All financial, ownership or investment interests, including stock, stock options, partnership interests, limited liability company interests, patents, licenses, royalties, or any other type of ownership or investment interest in an entity related to ASTRO or to research, practice or education, in the field of oncology or radiation therapy.
- With respect to ownership of stock or stock options, see the parameters laid out in ASTRO’s Policy on Stock Ownership.
- Leadership Positions in Other Organizations: Service as an officer, board member, committee chair or vice-chair or other position of leadership in all medical, professional or scientific corporations, organizations or societies.
- One of the fiduciary duties a volunteer owes to the Society is the duty of loyalty, having undivided allegiance to the Society when making decisions or taking actions affecting that Society. Serving in a leadership position in another organization does not, in and of itself, present a conflict of interest, however a possible conflict of interest could arise in situations when a volunteer has fiduciary or other obligations to another organization and those obligations conflict or compete with the interests of ASTRO. These conflicts typically arise when a matter presents at one organization that could affect the interests of the second. Serving concurrently two organizations that may have competing interest could cause a pervasive conflict situation and should be carefully considered.
III. What is the Disclosure Process?
- Fill out the Disclosure Form
Each individual will complete the ASTRO Disclosure Statement annually and will be required to update that form in the interim upon any material change in the status of items disclosed.
- Review of Disclosure Form and Ongoing COI Review
- Forms for all candidates for ASTRO elected positions, the ASTRO Board of Directors, certain appointed leadership positions, and all ASTRO committee chair, co-chair and vice-chair positions that do not fall within an ASTRO Council, as well as for positions in which candidates are to represent ASTRO on any outside committees, will be reviewed by the ASTRO Conflict of Interest Review Committee (COIRC). The COIRC will discuss disclosures and management of any potential conflicts with the Chair of the Board and CEO, and such disclosures and the proposed resolutions will be reported to the full Board of Directors, at which time any member of the Board may request further discussion of the issue. For disclosures or matters relating to the Chair, the President will take the role of the Chair for purposes of COI review and resolution.
- Council chairs will review the disclosure forms for the committee chairs, co-chairs and vice-chairs within their Council.
- All committee member forms will be reviewed by the respective committee chair, co-chairs or vice-chairs.
- All faculty, authors, presenters and reviewers’ forms will be reviewed by the chairs, co-chairs and vice chairs responsible for the programs and/or publications.
- All panels for ASTRO papers will be reviewed by the chairs, co-chairs and vice chairs leading their respective panels.
- Generally the parties responsible for the initial review of the disclosure forms will also serve as primary reviewer to address, resolve and/or manage any potential conflicts of interest that arise over the course of the year relating to that volunteer’s service in the designated position in accordance with ASTRO COI Policy, and with support from the ASTRO Conflict of Interest Review Committee (COIRC) discussed below. With respect to members of the Board of Directors, appointed leadership positions and ASTRO committee chair, co-chair and vice-chair positions that do not fall within an ASTRO Council, or persons representing ASTRO on any outside committees, the Chair of the ASTRO Board shall serve as primary reviewer for questions that arise upon assumption of the position, with support from the COIRC, and will report such decisions to the full Board, at which time any member of the Board may request further discussion of the issue.
IV. How are Potential Conflicts of Interest Addressed?
It is important to have a robust process for resolution of potential conflicts which will both meet ACCME requirements and the general requirements of the Society. If a potential conflict arising under the ASTRO Conflict of Interest Policy is flagged by the primary reviewer or raised in another manner, the primary reviewer will seek to address the concern using the following framework.
- Disclosure. All disclosures will be reviewed by the chair of the committee, meeting or event, or the editor of the ASTRO publication, looking at whether any of the disclosed relationships, positions or interests could relate to the work of the volunteer for ASTRO. If the information provided is deemed a potential conflict of interest by the primary reviewer, it should also be disclosed to the audience for, or other participants in, the meeting or election, or in the case of a publication, printed with the applicable material in the publication. Apparent or potential conflicts should be summarized by the chairs and shared with fellow members of the committee or paper. Where practical, the disclosure, along with any further steps taken to address the potential conflict, should be noted in the minutes of the proceedings. Where there are printed materials or electronic records, the disclosure should be included within that material. After disclosure has been made, the primary reviewer will determine whether further action is necessary to address the potential conflict, recognizing that disclosure alone may be sufficient.
- Abstention. One additional option that may be used to address a potential conflict is to ask the individual with the potential conflict to abstain from voting on matters related to the potential conflict.
- Recusal. In some cases, the primary reviewer may determine that it is necessary for the individual to refrain from any involvement in the discussion, writing or voting on matters related to the potential conflict. In general, this requires removal from the room or conference call where the matters are being discussed and voted upon.
- Altering control over content. In the case of a written or oral presentation, the primary reviewer could appoint another individual to exercise control over the content of the presentation.
- Altering the relationship. Where a potential conflict arises out of a relationship, one option that the individual could pursue would be to change his or her relationship with potentially conflicting interest to the extent that the primary reviewer believes that would address the potential conflict.
- Pervasive Conflict (requiring resignation from ASTRO position or the conflicting position). In rare instances, the potential for conflict may be so pervasive that none of the other options adequately resolve the potential conflict. In such cases, the primary reviewer will determine that the individual must make a choice and resign from one or the other of the relationships raising the pervasive conflict.
- Referral to the Conflict of Interest Review Committee (COIRC). The Board of Directors, the primary reviewer, the covered individual(s) involved, or any ASTRO member may refer a matter arising under the ASTRO Conflict of Interest Policy to the Conflict of Interest Review Committee. However, the decision of the primary reviewer stands and must be honored until confirmed or modified, if at all, by the Conflict of Interest Review Committee. In order to refer a matter to the COIRC, members must first exhaust the primary process for conflict of interest review established for each venue. For matters pertaining to members of the ASTRO Board of Directors, Editors-in-Chief of the IJROBP or PRO, or ASTRO Committee Chairs, the COIRC will prepare recommendations that will be presented as consent items to be ratified by the Board, however, any Board member may request further information and discussion under the Board of Directors Conflict Review Process adopted by the Board.
V. Conflict of Interest for the International Journal of Radiation Oncology, Biology, Physics (IJROBP) and the Practical Radiation Oncology Journal (PRO)
- IJROBP: The IJROBP is owned and published by Elsevier Publications. The relationship between ASTRO and Elsevier is regulated by a contract that, for tax and liability issues as well as concerns over academic freedom, limits the input that ASTRO has over editorial policy. The IRJOBP has adopted the guidelines of the ICMJE to regulate conflict of interests for its editors, reviewers and authors. These regulations available online at www.ICMJE.com.
- PRO: The PRO has adopted the guidelines of the ICMJE to regulate conflict of interests for its editors, reviewers and authors. These regulations available online at www.ICMJE.com.
- The ASTRO Board of Directors appreciates IRJOBP and PRO’s adoption of and adherence to the ICMJE standards; and requests further, for the purpose of protecting the integrity of the Society and goodwill, that the Editorial Boards of the IJROBP and the PRO make publication of conflict of interests mandatory in their journals, rather than leaving a decision on whether to publish to the discretion of the editors.
VI. What measures support this ongoing work to identify and address potential conflicts of interest?
Each year covered individuals will receive necessary forms and instructions regarding required disclosure documentation by paper or electronic form.
- Chairs of committees and programs, as well as other primary reviewers, should incorporate ongoing review of potential conflicts into their preparation for meetings, conference calls and committee work assignments, in order to identify and address any potential conflicts of interest.
- An announcement calling upon participating individuals to review and identify any potential conflicts of interest will be made at the beginning of each meeting or conference call. The announcement will also remind participants of their fiduciary obligations to give their service to ASTRO undivided loyalty, including confidentially of all non-public information.
- Disclosures for presenters at ASTRO Meetings will be published in the meeting’s final program.
- All those attending ASTRO functions, reviewing abstracts for ASTRO, or participating in ASTRO committee activities or other ASTRO-related activities will, at times, have access to information that is confidential in nature, such as non-public information of interest to an investing, licensing or commercial interest, or a research study that has not been published. Many discussions by committees or the Board are of a sensitive nature and must be handled on a confidential basis. At no time should any covered individual copy, transmit or otherwise distribute, either orally or in writing, any confidential ASTRO documents or information. Confidential information does not include information publicly known or available, information lawfully obtained from another source, or information independently created by a covered individual outside the scope of his or her participation on behalf of ASTRO and not derived from that participation or materials or information gained in that capacity.
- At the end of the conflict of interest disclosure statement there will be an additional statement that highlights the importance of maintaining the "Duty of Loyalty" to ASTRO, which includes confidentiality and putting the interests of ASTRO ahead of personal interests or interests of other societies. All volunteers will sign their disclosure statements with an attestation that they understand the importance of confidentiality.