The American Society of Clinical Oncology (ASCO) recently submitted its comments to the National Institutes of Health (NIH) regarding the agency’s proposed new rules to amend its regulations on the Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service (PHS) Funding is Sought and Responsible Prospective Contractors.
Although ASCO commended the Department of Health and Human Services (HHS) for issuing this proposed amendment and supported several of the changes, the organization also had various concerns. In particular, ASCO is concerned with proposals to
– Include “travel reimbursement” as a “payment of service;” and
– Adopt a definition of “manage” that appears to imply that only the reduction or elimination of a financial conflict of interest (FCOI) is an acceptable management strategy for FCOIs.
With respect to travel reimbursement, ASCO asserted that “the proposed change would treat travel reimbursement as a “financial interest” and therefore would require investigators to report travel reimbursement that exceeds the reporting threshold.” Consequently, ASCO contended “that travel reimbursement should not be considered a payment for service because it is reimbursement for the investigator’s travel costs.” They further maintained that “reimbursement of travel expenses is revenue-neutral because it is designed to cover costs incurred by the investigator for travel, not to provide payment.”
This issue was especially important because “in the context of non-profit organizations, the work of ASCO would not be possible without members who are willing to donate their expertise and time.” As result, ASCO pointed out that “if investigators are required to report travel reimbursement as payment, it may discourage their involvement,” especially since volunteer service (in the case of organizations like ASCO, this service is usually uncompensated) involving travel leads to time away from remunerated employment.
Another reason why ASCO addressed its concern about travel reimbursement is because “there are many instances in which the investigator has no control over the cost of the travel because the arrangements are made directly for him or her.” In addition, the proposed rule also “has the potential of unfairly disadvantaging individuals who must travel longer distances to attend a meeting or function, including those from remote areas.”
Since ASCO finds “significant value in including investigators who represent a broad range of geographic and cultural perspectives in its educational and scientific programs, they noted to HHS that “reimbursement of travel expenses should be viewed as a reasonable cost of conducting business, and – therefore – be removed from the definition of financial interests.”
ASCO also noted in its comments that “HHS should make a significant change to its proposed definition of the word “manage.” Specifically, ASCO wants additional language added to the definition that lists other mechanisms for managing a conflict of interest, since the proposed definition (“To take action to address a financial conflict of interest, which includes reducing or eliminating the financial conflict of interest, to ensure that the design, conduct, or reporting of research is free from bias or the appearance of bias”) appears to endorse reduction or elimination as the only management strategies.
In fact, ASCO asserted “that disclosing a conflict is a valid option for management of some FCOIs.” They acknowledged that this “disclosure can occur to the institution, to the potential trial participants, and/or to the research community in the context of presentation or publication, depending on the circumstances.”
Another method of management is “peer review, which helps protect the integrity of the data presented in situations where FCOIs are present –regardless of whether the FCOIs are reduced or eliminated.”
Adding both of these methods is important and will be extremely effective since “disclosure and peer review are widely accepted management techniques promoted by organizations such as the Accreditation Council for Continuing Medical Education (ACCME) and the International Committee of Medical Journal Editors (ICMJE).”
Moving along, ASCO strongly urged that HHS “ensure that there is full harmonization among all federal reporting requirements, including those issued by NIH, Office for Human Research Protections (OHRP), Food and Drug Administration (FDA), and the Physician Payment Sunshine (PPS) provisions that will be implemented by HHS in March 2013. Specifically, they recognized the importance of promoting consistency and transparency across reporting requirements.
Next, ASCO encouraged “HHS to exclude reporting of financial interest in diversified funds not controlled by the individual, such as a mutual fund. They make this recommendation because these investments are outside the control of the investigator, and typically encompass the types of firewalls that guard against FCOIs.
With respect to non-profit entities, ASCO recommended that “if income from NPOs (other than institutions of higher education) is no longer excluded from the definition of Significant Financial Interest, that HHS exclude the following payments from NPOs from the disclosure requirements:
– Reimbursements associated with the reasonable costs of travel, which can vary greatly depending on the residence of the volunteer;
– Reimbursement that is provided for presentations that offer continuing medical education (CME) credit to participants and are therefore subject to the rigorous conflict of interest disclosure and management requirements of the ACCME; and
– Research grants received from non-profit entities that make funding decisions using an independent peer-review process similar to that of the NIH.
Another concern voiced by ASCO dealt with making a 30-day disclosure period for new interests a part of the regulatory requirements. Specifically, ASCO is “concerned that the 30-day period is too short and that by establishing a specific timeframe in regulations, HHS is posing a regulatory requirement that will have to be monitored and enforced.” ASCO disagrees with this proposal because it is not a wise use of HHS or institutional resources. Instead, ASCO wants HHS to exclude specific reporting timeframes from the regulation and to instead include this language in guidance about the regulation. Institutions are already motivated to implement their own policies and therefore a specific and enforceable time requirement is unnecessary.
Accordingly, ASCO encouraged HHS for further clarification of the new definition of “financial interest.” Specifically, they asserted that the regulations should limit reporting on interests with “potential monetary value” to reporting on:
– Equity interests of non-publicly traded entities (e.g., stock, stock option, or other ownership interest);
– Intellectual property rights (e.g., patents, copyrights);
– Royalties associated with property rights; and
– Agreements to share in royalties.
On the subject of reporting, ASCO encouraged HHS to develop a computerized mechanism for collecting and reviewing financial disclosures that should promote consistency across institutions and reduce some of the institutional burden (resources and staff time) associated with these regulations. They also noted that the HHS-developed software should also include a template for meeting the new requirement of disclosing conflicts on a public website.
But with respect to training investigators regarding regulatory requirements and the institution’s COI policy, ASCO noted that such training may become cumbersome and inefficient due to the number and frequency of trainings investigators must undergo to remain in compliance with various regulations. Instead, ASCO recommended that after completion of the initial COI education program, HHS permit institutions to offer abbreviated refresher training as an option for meeting compliance.
Conclusion
In making his closing remarks, ASCO president George W. Sledge, Jr., MD, noted that “a uniform, easy to use system is the key to meaningful disclosure that adds value to the research system and is not burdensome to investigators, institutions or regulators.” To create such a system, ASCO asked that HHS convene experts and work with its agencies to engage in a national discussion that will help develop consensus on effective approaches for collecting and evaluating disclosures.
HHS should listen to this request because as ASCO points out, “the ambiguity of the currently proposed language is likely to lead to undesirable variability in interpretation across institutions,” and “it is unrealistic to request Investigators to reduce or eliminate all COIs.”