The National Institutes of Health (NIH) published in the Federal Register on Friday, May 21, 2010 a Notice of Proposed Rulemaking (NPRM) outlining new Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is Sought and Responsible Prospective Contractors – NIH’s Financial Conflict of Interest policy (75FR 28688). The text of Federal Register notice is also available on the NIH conflicts of interest website. Comments are due July 21, 2010. This long anticipated proposed rule is a result of NIH’s consideration of the comments it received on the Advanced NPRM in May 2009. The description of the proposed revisions (Section II of the Supplemental Information in the Register notice) addresses the responses NIH received to the Advanced NPRM.
There are substantive and significant changes being proposed by NIH. Some of those changes have been anticipated by the research community; others have not. Some of the changes will require changes in how many research organizations have designed and implemented the current NIH requirements; others will not. It is important to remember that the proposed policy is NIH’s requirement and sets a minimum set of standards. Organizations can implement policies the meet and exceed these requirements. The reference to “minimum standards” is not to suggest that the current NIH policy is insufficient in achieving the goal of objectivity. Rather, it is to remind organizations of how NIH views the reporting requirements – for purposes of reporting to NIH and – under the proposed rule – posting to public websites, organizations must report on financial conflicts of interest (FCOI) according to the organization’s standards, if they are different. For example, the proposed rule lowers the threshold for a “significant financial interest” from $10,000 or equity interests of 5% to $5,000 total value in remuneration and/or equity in a publically traded company. If the organization sets a $0 value, the organization must report and post interests from $0. Continue reading “NIH Changes to Conflict of Interest Policy”