Pursuing research that advances public health entails striving to be worthy of public trust. We know that our grantees work hard to ensure that research is carried out with the highest standards of integrity and is free of bias. Public and private research collaborations are increasingly complex, and so it is important for us to continuously evaluate how these relationships might affect NIH funded research. NIH, through the Department of Health and Human Services has issued an Advanced Notice of Proposed Rule Making (ANPRM). Through this Notice, we are seeking comments from the public on possible changes to the existing regulations that we often refer to as the “Financial Conflict of Interest” regulations. [ Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service (PHS) Funding Is Sought(42 C.F.R. Part 50, Subpart F) and Responsible Prospective Contractors (45 C.F.R. Part 94)].
These existing regulations were issued in 1995, and they established standards to ensure that there is no reasonable expectation that the design, conduct, or reporting of research funded under PHS grants or cooperative agreementswill biased by any conflicting interest on the part of the investigator. Since the publication of these regulations, the NIH has launched many initiatives to enhance effective oversight and regulatory compliance. The ANPRM strives to further this effort.
Through July 7, 2009, we are inviting your comments on all aspects of the regulation, with particular interest in the potential for expanding the scope of the regulation and disclosure of interests; the definition of “Significant Financial Interest”; identification and management of conflicts by institutions; assuring institutional compliance; requiring institutions to provide additional information to the PHS; and broadening the regulations to address institutional conflicts of interest.
NIH is committed to supporting research that is free of bias and is of the highest integrity. To that end, NIH will critically consider all comments received through the ANPRM process to shape how the current regulation can be enhanced to achieve its objective. If, after careful deliberations, there is a decision to chance the existing regulation, the next step in this process is the publication of a Notice of Proposed Rule Making (NPRM). We would then request and consider your comments on the proposed regulatory changes described in the NPRM prior to promulgating a new Final Rule.
We greatly value your insights and encourage you to participate in this public comment period.