Convey: A Global Disclosure System Council of Science Editors 2015 Annual Meeting Heather H. Pierce, JD, MPH Senior Director, Science Policy Regulatory Counsel May 18, 2015 Institute of Medicine Report: Conflict of Interest in Medical Research, Education, and Practice Recommendation 3.3 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 standard content, a standard format, and standard procedures for the disclosure of financial relationships with industry. 2009 2011: IOM Holds a Multi-Stakeholder Event Goal: Identify key elements necessary to enable a reporting individual to provide data easily, and without repetition, to organizations requesting disclosure of relationships. Participants: 30 individual representatives • • • • Academic Medicine Journals Government (FDA, CMS, NIH) Professional Societies • • • • CME Community Industry Consumer Groups Physician Groups Working Groups on Definitions and Data Chaired by Allen Lichter (ASCO) and Ross McKinney (Duke) 1 2012: IOM Discussion Paper and JAMA Editorial “It is possible to create a more effective system for reporting COI disclosures.” “Substantial improvements can be made in the disclosure system by creating a centralized data repository that is governed in a manner that ensures data security while reducing the burden of disclosure for individuals and meeting the needs of all stakeholders.” 2013: IOM Convenes Implementation Working Group • Develops strategies for implementation and explores market and potential business model • Concludes that centralized disclosure system as described in discussion paper is feasible • Asks AAMC to consider developing the system Principles • Secure, user-controlled • Based on national data standards • Draws from single source of financial interests • Provides relevant disclosure information based on organization criteria and user assessment • Interoperable with COI management systems • Intuitive and easy to use for both individuals and subscribing organizations 2 From IOM Recommendation to Prototype • Secure, user-controlled platform drawing from single source of financial interests • Provides relevant disclosure information based on organization criteria and user assessment • Interoperable with COI management systems - based on national data standards • Intuitive and easy to use for both individuals and subscribing organizations © 3
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