March 17, 2018

With Comment Period Closed, Will NIH Proposal Land in Court?

By LJ Staff

Congress last week again expressed its support for the proposal by the National Institutes of Health (NIH) to make the research it funds freely available via PubMed Central. Language in the Conference Report for the FY 2005 Consolidated Appropriations Act directed NIH "to give full and fair consideration to all comments before publishing its final policy." With the official comment period now closed for the NIH’s proposal, a quick survey of the comments filed reveals deep divisions among those submitting comments and raises a number of thorny questions, including questions over the proposal’s legality. In a legal analysis done by the American Physiological Society (APS) in conjunction with American Association of Immunologists (AAI), questions were raised regarding the plan’s infringement of "copyright interests," as well as a host of other bureaucratic federal rules.

In response, the legal scholars advising the Alliance for Taxpayer Access (ATA), a coalition supporting the NIH proposal, quickly dismissed the APS/AAI analysis. Michael Carroll, adviser to the Alliance for Taxpayer Access, and professor at Villanova University School of Law, said that the NIH has always had license to reproduce, publish, and archive the research results that it has paid for. Meanwhile, the APS/AAI comments cite other federal policies and regulations the NIH proposal seemingly violates, including the Freedom of Information Act and an OMB circular that says the NIH must perform a "cost comparison study."