Created by on 7/12/2011 12:00:00 AM

On July 7th, the Institutes of Medicine (IOM) convened a meeting to discuss harmonization in methods for disclosing circumstances that may create conflicts of interest (COI). The daylong meeting was hosted by Dr. Bernard Lo, Chair of the IOM Committee on COI in Medical Research, Education, and Practice, and moderated by Dr. J. Michael McGinnis, IOM Senior Scholar. A broad array of representatives from stakeholder groups–including researchers, members of professional scientific societies, officials from academic medical centers, healthcare providers, and staff from the National Institutes of Health (NIH), Food and Drug Administration, and the Centers for Medicare and Medicaid Services (CMS)–participated in the discussion to initiate the consensus development process to establish a standardized content, format, and procedures for the disclosure of relationships with corporate interests. 

FASEB President Dr. Joseph C. LaManna was among those invited to speak at the meeting. In his remarks, LaManna stated FASEB’s belief that, “Maintaining public trust in medical research and preventing the introduction of bias is absolutely critical,” and that, “FASEB vigorously supports efforts to ensure that trust.” He also mentioned that FASEB has previously called for the development of a simple, electronic, universal reporting form that would reduce confusion and improve compliance. Dr. LaManna then described how government–industry relationships are an essential and beneficial part of modern biomedical science and the NIH mission. In offering FASEB’s support, he cautioned that the privacy and existing regulatory burdens of researchers “must be considered in the development of fair and effective standards.”

Among meeting attendees, there was broad support for the idea of harmonizing COI procedures and moving forward in the consensus development process. Attendees further recommended an online database to house disclosure data that could be extracted to meet needs of specific end users. One development that received considerable discussion was the Physician Payments Sunshine Act, which was passed as part of the healthcare reform package of 2009. The provision stipulates that manufacturers of a covered drug, device, biological, or medical supply must make annual disclosures of payments and other compensation to physicians and teaching hospitals receiving federal funds from CMS and other agencies. Many were concerned with how this would impact the research community and the IOM effort. To view the conference agenda, click here.


Dr. Joann A. Boughman, Executive Vice President of the American Society of Human Genetics (l) and Dr. Joseph C. LaManna, FASEB President (r), address the Institute of Medicine meeting on harmonizing the COI process.

Dr. Joseph C. LaManna, FASEB President (l) and Dr. Sally J. Rockey, NIH Deputy Director for Extramural Research (r), at the Institute of Medicine meeting on harmonizing the COI process.