In April, ASCO released its updated conflict of interest policy in the development and presentation of scientific research and educational content. The revised policy is designed to increase transparency in financial relationships between individuals and health-care companies and impose new restrictions for authors of original research who publish in or present at ASCO forums.
Policy Background
Published in the Journal of Clinical Oncology (JCO),1 the American Society of Clinical Oncology Policy for Relationships with Companies provides new conflict of interest guidelines for individuals who take part in the planning, authorship, peer review, or presentation of programs or content through ASCO channels. This includes ASCO members and volunteers, and the Society’s affiliates, including the Conquer Cancer Foundation and the Institute for Clinical Excellence, and for content appearing in JCO and the Journal of Oncology Practice (JOP) or at ASCO scientific meetings.
In a 2009 Institute of Medicine (IOM) report,2 which presented principles for analyzing financial conflicts of interest in medical research, education, and practice, conflict of interest is defined as “not an actual occurrence of bias or a corrupt decision, but, rather, a set of circumstances that past experience and other evidence have shown poses a risk that primary interests may be compromised by secondary interests.”
ASCO first enacted a conflict of interest policy in 1994 and released revised versions in 1996, 2002, and 2005. The new policy builds on the requirements established in the 2005 policy to increase transparency in relationships with companies. It comes at a time when many other health-care organizations, including research facilities and teaching hospitals have improved their conflict of interest policies and some states and the federal government have enacted regulations requiring the public reporting of payments to physicians by companies.
Promoting Independence
ASCO’s Policy for Relationships with Companies applies to all individuals who engage in ASCO volunteer activities, present research findings through ASCO’s continuing medical education programs, and develop ASCO clinical practice guidelines, and authors who submit abstracts and publish in JCO and JOP.
Unlike the 2005 policy, which required authors, presenters, and ASCO volunteers to complete a separate disclosure for each ASCO activity, the new conflict of interest policy establishes a “general disclosure” requirement that allows the gathering of a range of information regarding an individual’s interactions with companies. The information to be disclosed includes eight areas of financial relationships with companies: compensation received for employment, leadership positions, consulting activities, speaking engagements, and expert testimony; as well as ownership interests, research funding, either to the individual or the institution, and licensing fees and royalties associated with intellectual property interests.
While the article published in JCO outlining the details for ASCO’s new policy states that the restrictions on certain relationships with companies “does not create a presumption of impropriety in the existence of these relationships,” it reiterates that “ASCO’s policy is that certain financial relationships give rise to conflicts of interest that are not capable of being effectively managed and are, in fact, inconsistent with actual and perceived independence. Individuals who are free of these relationships should play a key role in the authorship of original research submitted to ASCO meetings or to JCO and JOP.”
Policy on Original Research
To promote objectivity and balance in the research that is presented at ASCO educational and scientific meetings and published in JCO and JOP, the new guidelines also require that first, last, and corresponding authors of original research meet a clear standard of financial independence from commercial funders of their research. The new policy regarding original research in ASCO educational or scientific programs is as follows:
Abstracts and articles concerning original research are not eligible for inclusion if the first, last, or corresponding author has:
- Participated in a speakers’ bureau (on any subject) on behalf of the company sponsor of that original research at any time during the 2 years before submission of the abstract
- Held an employment relationship with the company sponsor of that research at any time during the 2 years before submission of the abstract
- Held a significant ownership interest in the company sponsor of that research at any time during the 2 years before submission of the abstract
The same stipulations for first, last, or corresponding author apply to manuscripts, including articles and abstracts, concerning original research published in JCO or JOP. There is a narrow exemption to the authorship restrictions for certain types of articles in JOP. These submissions will be monitored through disclosure, peer review, and editorial management.
Although ASCO’s new conflict of interest policy became effective on April 22 with the publication of the guidelines online in JCO, the author restrictions on original research come into effect on April 22, 2014, and will only apply to original research initiated after that date.
Potential Sanctions
Failure to comply with the new policy requirements may result in sanctions, including exclusion from submitting abstracts or presenting at Society CME activities; exclusion from publishing in ASCO publications; exclusion or removal from participation on ASCO committees, editorial boards, clinical practice guideline panels, and other volunteer positions; and censure, suspension, or revocation of ASCO membership.
“As a leading source of evidence-based cancer information worldwide, ASCO deeply values the trust of its members, the wider oncology community, and the public,” said ASCO President Sandra M. Swain, MD, FACP. “In adopting this new conflict of interest policy, ASCO’s goal is to recognize beneficial collaborations that advance scientific progress, while remaining vigilant about the potential for bias in science and professional education. ASCO remains committed to maintaining an objective voice in all of its scientific and educational pursuits. We look forward to working with the oncology community in fully implementing this new policy.”
To learn more about the new ASCO Policy for Relationships with Companies, visit asco.org/rwc. ■
References
1. American Society of Clinical Oncology: Policy for relationships with companies. J Clin Oncol. April 22, 2013 (early release online).
2. Institute of Medicine: Conflict of interest in medical research, education, and practice. Released April 21, 2009. Available at iom.edu/reports/2009/conflict-of-interest-in-medical-research-education-and-practice.aspx.
