The American Society for Radiation Oncology (ASTRO) conducts a Conflict of Interest (COI) review of all panel members and expert reviewers for ASTRO Formal Papers in accordance with ASTRO’s Conflict of Interest Policies (COI Policies). ASTRO Formal Papers are defined as papers that represent a formal position of ASTRO and that are intended to be published in a public venue (ASTRO Papers), such as Clinical Practice Guidelines and White Papers. The ASTRO COI policy seeks to comply with the principles set forth in the Institute of Medicine’s “Standards for Developing Trustworthy Clinical Practice Guidelines” and the Council for Medical Specialty Society’s “Code for Interactions with Companies” and “Principles for the Development of Specialty Society Guidelines.”
ASTRO requires disclosure statements from all individuals involved in drafting, reviewing and approving ASTRO Papers. A primary purpose of ASTRO COI review is to identify relationships between these individuals and companies that could reasonably be affected by the content of the Paper.
I. Affected Companies
Commercial entities with products affected by an ASTRO Paper are considered “affected companies” for purposes of conflict of interest review under ASTRO COI policies. A commercial entity is an affected company if there is a reasonable likelihood of direct regulatory or commercial impact, either positive or negative, on the entity or its product as a result of recommendations made in the Paper (“Affected Company”) .
II. Chairs and Co-Chairs of ASTRO Papers
Under ASTRO’s COI Policies, Chairs and Co-Chairs (“Chairs or Panel Chairs”) of ASTRO Papers shall not have any financial relationships, including but not limited to consulting relationships, ownership interests, such as stock or stock options in, or research funding (“Financial Relationships”) , with Affected Companies. The Chairs of any panel charged with developing an ASTRO Paper must have been free of these interests and relationships for one year prior to appointment to this position and must agree to remain free of these interests and relationships at all times during the panel’s work and through one year after the Paper is published.
For the remainder of the panel as well, ideally, there would be no such Financial Relationships with Affected Companies. However, in some circumstances it may be difficult to obtain the necessary expertise without members who have such relationships. In these cases, it may be acceptable to allow participation by a minority of members with some such relationships, but only in compliance with specified procedures.
IV. Formation of the Panel
At the time the panel is formed, ASTRO staff will work with the appropriate ASTRO Committees to identify Panel Chairs who do not have, and for the preceding one year period have not had, Financial Relationships with Affected Companies. Working with the Panel Chairs and the appropriate ASTRO Committees, ASTRO staff will then compile a proposed list of other panel members who will complete the required disclosure forms and undergo review for potential COIs. The Panel Chairs and ASTRO staff will seek to further specify which companies and/or categories of companies would reasonably be affected by the content of the Paper, the Affected Companies, and to review the disclosures provided by all prospective panel members to identify any potential COIs. If subsequent changes in the marketplace, in the focus of the Paper, or in other circumstances, suggest that additional companies might be impacted by the Paper, the Panel Chairs must report this to ASTRO to allow appropriate review for any new potential COIs.
V. Disclosure, Review and Composition
All prospective panel members, including prospective panel Chairs, must complete the ASTRO disclosure statement which requires disclosure of employment, leadership positions, consulting or advisory roles, honoraria, stock ownership, royalties, patents, research funding, travel expenses, gifts or other payments received by the panel member or immediate family members.
Prospective panel members make their disclosure at the time of nomination to the panel and report all such relationships for the period dating back one year from the time of disclosure. They also are required to update their disclosure statements promptly if there are changes.
ASTRO staff, working with the Panel Chairs will prepare reports identifying these disclosures, with particular attention to any relationships with Affected Companies. These reports will be reviewed by the ASTRO Conflict of Interest Review Committee, who will advise the Panel Chairs regarding any potential conflicts that need to be addressed. The final report, identifying all disclosures, as well as any COIs and the measures necessary to address them, will be shared with the Panel members and all other participants in the Paper development process, and the relevant disclosures will be published with the Paper. There are certain relationships listed in Section VII below that make an individual ineligible to serve on a Panel.
Occasionally, an individual may have a relevant interest or relationship that is not included on the ASTRO disclosure form or does not appear to be a financial interest; these may include intellectual property interests that have not yet yielded royalties or payments, strong professional or research opinions, other uncompensated relationships, past work or relationships, or an outside affiliation. In these situations, the interest should be disclosed to the panel chair or appropriate ASTRO staff member and where appropriate it may be added to the disclosure report and prompt COI response akin to those for financial relationships.
At least 51 percent of those selected to serve on the panel will have no Financial Relationships with Affected Companies from the start of panel deliberations through publication of the Paper. For the remaining 49 percent, such Financial Relationships do not preclude panel membership, but, all such relationships must be carefully reviewed by the Panel Chairs to determine the extent to which the specific panelist is needed on the Paper, the impact of including/excluding the panelist, and proposed methods to manage the potential COI. These determinations will be approved by the ASTRO Conflict of Interest Committee and ASTRO Legal Counsel.
VI. Expert Reviewers
Expert reviewers are also required to fill out ASTRO disclosure statements and undergo COI review prior to their service as expert reviewer for the Paper. Like the review of the writing panel, these disclosures will be compiled into a disclosure report that identifies all disclosures made by the reviewers, including any relationships with Affected Companies as defined above.
ASTRO staff, working with the Panel Chairs will prepare reports identifying these disclosures, with particular attention to any relationships with Affected Companies. These reports will be reviewed by the ASTRO Conflict of Interest Review Committee, who will advise the Panel Chairs regarding any COI issues to be addressed. The final report, identifying all disclosures, as well as any COIs and the measures necessary to address them will be shared with the panel members and all other participants in the Paper development process, and the relevant disclosures will be published with the Paper. There are certain relationships listed in Section VII below that make an individual ineligible to serve as an expert reviewer.
VII. Not Eligible to Serve on Panel or as Expert Reviewer
While having a relationship with an Affected Company does not necessarily mean that an individual is biased or has a conflict of interest, ASTRO’s policy is that certain financial relationships create potential conflicts of interest that are not capable of being effectively managed and are therefore inconsistent with ASTRO’s interest in promoting the actual and perceived independence of its Paper development process. Consequently, an individual is not eligible to serve on a panel if he or she:
- Participates in a speakers’ bureau on behalf of, serves on an advisory board of, or is otherwise engaged on an ongoing basis to represent an Affected Company, regardless of the subject;
- Is employed by an Affected Company, or has been employed by an Affected Company at any time during the year prior to appointment to the panel and continuing for one year after the publication of the Paper;
- Holds a significant ownership interest in an Affected Company; or
- Holds a financial or other relationship with an Affected Company or any other interest that, in ASTRO’s discretion, presents a risk of actual or perceived bias that cannot be effectively managed or could undermine public confidence in the Paper.
The definition of Affected Company excludes non-profit or governmental organizations, or entities through which physicians provide clinical services directly to patients.
The definition of ownership interests excludes interests in diversified funds whose holdings cannot be controlled by the disclosing individual, or individual’s spouse or dependent child.