The nation is moving toward a healthcare system in which research is integrated with patient care, according to a new discussion paper on healthcare conflict-of-interest reporting released by the Institute of Medicine
, and this makes the need for harmonizing the industry's current “fragmented and burdensome” reporting requirements both “urgent and compelling.”
“Harmonizing Reporting on Potential Conflicts of Interest: A Common Disclosure Process for Health Care and Life Sciences” follows up on the 2009 IOM report, “Conflict of Interest in Medical Research, Education and Practice
,” which defined conflict of interest as: “circumstances that create a risk that professional judgments or actions regarding a primary interest will be unduly influenced by a secondary interest.” Primary interests are described as being related to research, patient care and medical education, and secondary interests are defined as relating to an individual's financial, professional, political or interpersonal gain.
The paper also notes how the Patient Protection and Affordable Care Act incorporated legislation known as the Physician Payments Sunshine Act. Although it was signed into law in 2010 and a proposed rule was released last December
, a final rule has yet to be released
. But rather than bringing clarity to the issue, the IOM paper states that “It is anticipated that the law may add to complexity in reporting, largely due to challenges in reconciling individuals' reports with those of manufacturers.”
The paper cites a 2011 report which found that 42% of a U.S. scientist's time is spent on administrative tasks, with much of this burden spent on redundant reporting. An IOM work group reviewed 23 sample disclosure forms from federal agencies, academic institutions, medical journals, continuing medical education providers and professional organizations and found “substantial differences” and “incompletely aligned data elements” among the sample formats.
The paper suggests that only data that is applicable to the individual's particular circumstances be requested; that—when requesting information on conflicts relating to family members—the potential for bias, the closeness of the personal relationship and magnitude of financial relationship be considered; and that data fields provide an “other” option with the opportunity to provide specific details.
As most conflict-of-interest reports are stored in databases “with little ability to interact,” the paper also recommends the creation of either a centralized data repository or federal data system to store reports with the data “fully controlled by the reporting individual.” Although the paper does not endorse one system over the other, it does state that cloud-based applications “are superior” to Web-based systems.
The paper concludes with an announcement that the IOM has agreed to organize and host a steering group to carry out the design, implementation and governance options of a harmonized system and database.
The paper notes that it is the product of 30 authors who participated in a best-practices innovation collaborative and is meant to stimulate discussion and does not necessarily reflect the views of the IOM or the authors' organizations.