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About ASTRO

Conflict of Interest Policy for RO-HAC

 

(Approved by the ASTRO Board of Directors on 9-20-2018)

 

The American Society for Radiation Oncology (ASTRO) implements a Conflict of Interest (COI) review of all Members of the Radiation Oncology Healthcare Advisory Council (RO-HAC) (“Members”) in accordance with ASTRO’s COI Policies. The mission and vision of RO-HAC is to provide radiation oncology-specific expertise to RO-ILS: Radiation Oncology Incident Learning System® by conducting data analysis on reported data.

The RO-HAC operates as part of Clarity PSO's patient safety evaluation system and is not subject to either ASTRO or any sponsoring/supporting societies review or oversight. It is ASTRO’s responsibility, with the help of sponsoring and supporting societies, to appoint eligible individuals to serve on the RO-HAC. Eligibility for selection and ongoing service on the RO-HAC is contingent on compliance with the ASTRO COI Policies throughout the term. ASTRO reserves the right to not appoint or to remove any RO-HAC Member in order to accomplish appropriate COI management in ASTRO’s sole discretion.

I. Disclosure

All prospective Members (including prospective Chair(s), Co-chair(s) and Vice-chair(s) (“Chairs”)) complete the ASTRO disclosure statement when applying for the RO-HAC and thereafter on an annual basis. On the disclosure form, they are required to report all relationships (both compensated and uncompensated) with Companies and other governmental, medical, professional, scientific, and other non-profit organizations for the period dating back one year from the time of disclosure, for themselves and immediate family members, defined to include a spouse, partner or any dependent family member(s). Relationships to be disclosed include, but are not limited to: employment, leadership positions, consulting or advisory roles, honoraria, speaker’s bureau, stock ownership, royalties, patents, research funding, travel expenses, and gifts or other payments, among others. The parameters for disclosing interests are broad to gather the most complete information. However, disclosing these relationships does not mean they constitute a COI. Only where there is a reasonable concern of either an actual or a perceived conflict will an interest be deemed a potential COI to be addressed. Certain types of relationships listed below in Section V have been determined to present an automatic pervasive conflict that would prevent an individual from serving on the RO-HAC while also maintaining such a relationship. All other disclosures are evaluated on a case by case basis.

Occasionally, an individual may have a relevant interest or relationship that is not easy to capture on the ASTRO disclosure form. 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 Chair(s) and ASTRO staff and where appropriate it may be added to the disclosure report and prompt COI response akin to those for financial relationships.

II. Companies

For purposes of the RO-HAC COI Policy, ASTRO adopts the following definition of Company: “Any proprietary entity developing, producing, marketing, or distributing goods or services related to oncology or radiation therapy, with the exemption of nonprofit or government organizations, or entities through which physicians provide clinical services directly to patients.” For RO-HAC, an oncology-specific PSO is an applicable Company.

III. Formation of the RO-HAC and Disclosure Review

Upon a vacancy on the RO-HAC, ASTRO releases a call for volunteers. One component of the RO-HAC application is completion of the ASTRO Disclosure Statement. Members serving on the RO-HAC are required to update their ASTRO Disclosure statement annually.

Additional information regarding individual disclosures may be requested to fully evaluate the relationship. For example, volunteers or Members reporting research funding may need to provide a description of the research and indicate in what capacity they are involved in the research (e.g., principal investigator, sub-investigator and/or receive salary support). Prior to final selection, ASTRO staff and RO-HAC Chair(s) review the disclosures provided by prospective and returning RO-HAC Members to identify any potential COIs. If a relationship is determined to be a COI concern, the volunteer or Member will be informed, and the concern must be addressed to ASTRO’s satisfaction prior to appointment or re-appointment to the RO-HAC. In ASTRO’s discretion, the candidate may be required to terminate the relationship of concern. In other cases, a relationship may pose a conflict that is too pervasive for RO-HAC membership.

Leadership of ASTRO’s Quality Council and the Clinical Affairs & Quality Committee (“Leadership”) reviews a report of all disclosures for selected RO-HAC Members. ASTRO staff, Leadership, or Chair(s) can also seek guidance from the Conflict of Interest Review Committee (COIRC).

A report of the RO-HAC Members’ disclosures is also shared within the RO-HAC and posted online for any RO-HAC continuing medical education content, as required by the Accreditation Council for Continuing Medical Education.

IV. Ongoing COI Disclosure and Review

Once all interests and relationships have been appropriately disclosed and reviewed in the annual disclosure process, it is the ongoing responsibility of each RO-HAC Member to obtain advance review of any new interests and relationships as they arise. Any new interests or relationships should be disclosed in writing to the RO-HAC Chair(s) and staff in advance. If a potential or new interest or relationship presents a COI concern, the Member will be informed and will need to satisfactorily resolve it, which may require that the Member decline the relationship if the Member wants to remain eligible for service on the RO-HAC.

The RO-HAC will be notified of any changes and an updated chart will be posted online to accompany RO-HAC-related continuing medical education.

V. Not Eligible to Serve on RO-HAC

While having a relationship with a Company or other organization does not necessarily mean that an individual is biased or has a COI, ASTRO’s policy is that certain relationships create potential COI that are inconsistent with ASTRO’s interest in promoting the actual and perceived independence of RO-HAC. Consequently, an individual is not eligible to serve on RO-HAC if any of the following apply to a RO-HAC member or their immediate family member:

  1. Participates on a speakers’ bureau, advisory board, or is otherwise engaged on an ongoing basis to represent a Company.
  2. Is employed by, or has been employed by, a Company, at any time during the year prior to appointment.
  3. Holds a significant ownership interest in a Company, including stock or stock options. However, this exempts mutual funds, retirement accounts, or trusts where the individual does not have control over the investment decisions.
  4. Holds a financial or other relationship with a Company or any other interest that, in ASTRO’s discretion, presents a risk of actual or perceived bias or could undermine public confidence in the RO-HAC.
  5. Is employed by or holds a financial relationship with an entity that would be prohibited from becoming a PSO by federal regulations (including but not limited to: health insurance issuer, accrediting or licensing body, enforcement or regulatory body, or an agent thereof). Examples of these entities include:
    • Departments of health
    • Radiation oncology benefit managers (ROBMs)
    • Carrier Advisory Committee (CAC), and
    • Accreditation programs
      • Radiation oncology-specific programs (e.g., ASTRO, ACRO, ACR)
      • Cancer-specific programs (e.g., Commission on Cancer (CoC), National Accreditation Program for Breast Cancer (NAPBC))

RO-HAC members are prohibited from acting as an accreditation surveyor or in other capacities involved in the development or operation of an accreditation program. RO-HAC members are allowed to participate in their institution’s preparation for obtaining accreditation.

VI. Additional Requirements Applicable to RO-HAC Members

RO-HAC members may not allow their name or RO-HAC position to be used to endorse or otherwise promote any Company or its products or services.