Created by on 06/19/2012

On June 11th, the Institute of Medicine (IOM) convened a stakeholder meeting to discuss its ongoing effort to develop a harmonized system for the disclosure of information related to potential conflicts of interest (COI). The proposed system will likely serve as a centralized database for the collection of investigator COI disclosure information, which will be accessible by agencies, academic institutions, scholarly journals, and other organizational users. According to Allen Lichter, Chief Executive Officer of the American Society for Clinical Oncology and Chair of the IOM initiative’s Field Elements Working Group, the goal of the effort is to reduce the COI reporting burden on investigators and clinicians through the creation of “a central repository based upon common field definitions.” Senior IOM Scholar Michael McGinnis began the meeting with an overview of the IOM draft report on the harmonization of the COI disclosure process. Discussed within the draft report were an extensive list of potential disclosure field elements and issues related to data repository structure, function, support, and governance.
In advance of the meeting, the Federation of American Societies for Experimental Biology (FASEB) submitted formal comments on the draft recommendations. Those comments expressed FASEB’s appreciation for the IOM’s role in convening the stakeholder community and called on the IOM to consider several modifications. First, FASEB urged the establishment of the same de minimis threshold recently instituted by the Public Health Service ($5,000) to enhance adoption of the regulations by the scientific investigator community. Further, FASEB suggested that the reporting of pens, notepads, and other small items of negligible individual value should not be included in the determination of the composite value of remunerations. Similarly, the Federation also asked IOM to specify what levels of involvement in voluntary relationships will require reporting. Finally, FASEB urged the incorporation of mechanisms to provide periodic information update requests.
After the introductory comments by Dr. McGinnis and others, meeting participants were invited to share their comments. Much of the early discussion, lead by FASEB President-Elect Judith Bond, PhD, revolved around the baseline of reportable information and the inclusion of small items. In response, Dr. McGinnis clarified that, “this is just a template and that if end users to which the investigator intends to report do not require such information, then the investigator will not have to enter those fields.” Ross McKinney, Director of the Trent Center for Bioethics at Duke University and Chair of the IOM initiative’s Database Structure and Governance Working Group added, “the data entry form must be inclusive to function as a common framework.” He also emphasized that the system would use a hierarchical data entry model, not unlike TurboTax software, whereby the entry of specific responses guides and restricts subsequent prompts for information. There was general agreement regarding the need for unique identifiers, particularly because significant numbers of international investigators and clinicians would participate in the database. Meeting attendees also urged the IOM to provide specific use cases to show how the system would function.
Notwithstanding the requests for clarification of certain items, there was strong support for the IOM effort to harmonize the disclosure process and the specific recommendations put forth in the draft report. Among the strong supporters was the National Institutes of Health, represented by Dorit Zuk, Science Policy Advisor for Extramural Research.
Armed with the backing of meeting attendees representing a broad community of stakeholders, the IOM identified two areas of consensus regarding next steps. The first was the organization of a steering committee of experts and stakeholders to consider the development of a mock-version of the system using open source software. A second area of consensus was that the steering committee should develop a business model to examine the long term sustainability of the disclosure system. Although the goal is to reduce the burden for investigators, the challenge for the steering committee will be to create a product that provides a significant value to the targeted consumers: academic institutions, government agencies, and other end users of COI disclosure information.