NIH Moves to Protect Research Integrity

On August 23, 2018, NIH Director Francis Collins issued a statement on protecting the integrity of U.S. biomedical research. After declaring that NIH research is “built on the bedrock principles of scientific excellence, unassailable integrity, and fair competition,” Collins went on to say that “the robustness of the biomedical research enterprise is under constant threat by risks to the security of intellectual property and the integrity of peer review.”

Collins outlined three areas of concern: The first is the failure of some NIH-funded researchers to “disclose substantial contributions of resources from other organizations, including foreign governments. This failure “threatens to distort decisions about the appropriate use of NIH funds.” The second is the “diversion of intellectual property in grant applications or produced by NIH-supported biomedical research to other entities, including other countries.” The third concern involves instances where peer reviewers have shared confidential information with others, “including in some instances with foreign entities, or otherwise attempting to influence funding decisions.”

On August 23, Collins also discussed these issues in his opening statement before the Senate Committee on Health, Education, Labor, and Pensions (HELP). The hearing had been called to review progress on the goals of the 21st Century Cures act, but Collins used the occasion to note the existence and increasing magnitude of these threats. HELP Committee Chair Sen. Lamar Alexander acknowledged the important contributions of foreign-born researchers but expressed concern that certain countries have taken advantage of U.S. investments in science and technology. Previously-reported cases of data or intellectual property diversions seem to have involved engineering and the physical sciences, but in an August 31 Science article (Amid fears of idea theft, NIH targets foreign funding links), Jocelyn Kaiser and David Malakoff reported that due to widening concerns about the problem, the FBI has begun briefing university officials on information security issues. Collins told Science that NIH’s actions were not prompted by “some big explosive episode,” but rather a “gathering sense that it’s time to take action.”

A few days earlier, on August 20, Collins took the extraordinary step of sending a letter to more than 10,000 research institutions, urging them to ensure that NIH grantees are reporting foreign funding for their work or if they have a second laboratory in another country. Collins has appointed a working group of the Director’s Advisory Committee that will “tap experts in academic research and security” to do the following:

  1. Improve accurate reporting of all sources of research support, financial interests, and relevant affiliations;
  2. Mitigate the risk to IP [Intellectual Property] security while continuing NIH’s long tradition of collaborations with foreign scientists and institutions; and
  3. Explore additional steps to protect the integrity of peer review.