The better approach is to require disclosure of all financial arrangements, and leave it to the FDA to assess the meaning or effect of the arrangement. We do not support any options that would narrow the scope of this provision. Yet the burden need not be great. In our opinion, a clear, easy to follow rule that requires all financial arrangements between clinical investigator and sponsor to be disclosed would go far towards reducing the burden. Investigators would not have to analyze the various arrangements they may have with sponsors to determine which rise above various thresholds, nor would they have to make sure changes over time do not trigger a threshold.
Full disclosure has the benefit of ease of understanding.
Financial disclosure is a burden that most government and private institutions have already accepted. Many investigators already must make certain financial disclosures to the academic institutions with which they are affiliated. Several federal agencies, including the National Science Foundation and the National Institutes on Health require investigators to disclose significant financial interests prior to receiving research funding. Many medical journals including JAMA and the New England Journal of Medicine, require authors to list all affiliations with or financial involvements in any businesses that could be affected by their work. Any of these agencies or institutions could provide a model for a simple disclosure form that would reduce any minimal burden the rule might impose.