Harmonizing the Conflict of Interest Disclosure Process

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In 2009, the IOM Committee on Conflict of Interest in Medical Research, Education, and Practice recommended approaches to managing conflicts of interest without stifling fruitful collaborations.  One concern identified by the Committee was the substantial and possibly unnecessary burden placed on health care professionals and biomedical researchers by frequent, repetitive, inconsistently configured, and time-consuming COI disclosure processes required by academic institutions, research organizations, funding organizations, journals, CME providers, professional societies, federal agencies, advisory committees, and more. The Committee recommended simplifying the process, urging “national organizations that represent academic medical centers, other health care providers, and physicians and researchers should convene a broad-based consensus development process to establish a standard content, a standard format, and standard procedures for the disclosure of financial relationships with industry.” Viewing this recommendation as a priority issue for follow up, IOM President Harvey Fineberg hosted a meeting in August of 2010, bringing together representatives from national organizations representing key stakeholders to share perspectives on harmonization of COI disclosure. Strong interest was expressed in moving forward on the possibility.

To continue progress on this front, in July of 2011 the IOM Roundtable on Value & Science Driven Health Care convened a COI multi-stakeholder working group in a cooperative effort to identify common elements and standardized approaches to satisfy conflict of interest disclosure requirements in health care and the biomedical sciences. During the meeting, participants worked to: 1) identify stakeholder organizations—representing both those organizations requiring disclosures, and those filing them; 2) review a representative sample of information required in existing practices; 3) identify and consider the issues, barriers, and challenges to streamlining and harmonizing the COI disclosure process; 4) propose elements of a common approach as the recommended product of the stakeholder organizations; and 5) present to representatives of key requiring organizations options for consideration and follow up. Participants noted that additional working group actitity—especially around the issues of field definitions and data repository and retrieval—would be necessary to accelerate progress toward harmonized COI disclosure in a timely manner.


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