Monday, May 23, 2016

Democratic Committee Investigation Finds NFL Improperly Attempted to Influence NIH on Brain Injury Research

May 23, 2016

Report Concludes NIH Maintained the Integrity of the Grant Review Process But FNIH Did Not Properly Serve Its Role As Intermediary

Washington, DC – Congressman Frank Pallone, Jr. (NJ-6), the top Democrat on the House Energy and Commerce Committee released a report today concluding that the National Football League (NFL) improperly attempted to influence the grant review process for a National Institutes of Health (NIH) brain injury study that the NFL had agreed to fund as part of a $30 million donation.

Despite the NFL’s attempts to influence the applicant selection process, the report states that the integrity of NIH’s grant review process was preserved. The report also concludes the Foundation for NIH (FNIH), a non-profit charitable organization whose mission it is to direct funding from public and private donors to NIH projects, did not adequately fulfill its role of serving as an intermediary between NIH and the NFL.

The report is the result of an ongoing Democratic Committee staff investigation, which began shortly after ESPN published an article in December 2015 alleging that the NFL had backed out of funding a NIH study due to the League’s objections to the grantee selected by NIH to conduct the study.

“This investigation confirms the NFL inappropriately attempted to use its unrestricted gift as leverage to steer funding away from one of its critics,” Pallone said. “Since its research agreement with NIH was clear that it could not weigh in on the grant selection process, the NFL should never have tried to influence that process.”

“The NFL’s troublesome interactions with NIH fit a longstanding pattern of attempts to influence the scientific understanding of degenerative diseases and sports-related head trauma. The NFL must recognize the importance of this ongoing, impartial research, and live up to its funding commitments to NIH,” Pallone concluded.

The investigation found that:

1. The NFL improperly attempted to influence the grant selection process at NIH.
2. The NFL’s Head, Neck and Spine Committee members played an inappropriate role in attempting to influence the outcome of the grant selection process.
3. The NFL’s rationalization that the Boston University study did not match their request for a longitudinal study is unfounded.
4. FNIH did not adequately fulfill its role of serving as an intermediary between NIH and the NFL.
5. NIH leadership maintained the integrity of the science and the grant review process.
6. The NFL did not carry out its commitment to respect the science and prioritize health and safety.

The Democratic Committee staff offered several recommendations to address the investigation’s findings:

1. FNIH must establish clearer guidelines regarding donor communications with NIH.
2. FNIH must come to a mutual understanding with donors at the beginning of the process regarding their degree of influence over the research they are funding and remind donors that NIH policy prohibits them from exerting influence at any point in the grant decision-making process.
3. FNIH should provide donors with the clear, unambiguous language from the NIH Policy Manual, which states that a donor may not dictate terms that include “any delegation of NIH’s inherently governmental responsibilities or decision-making,” or “participation in peer review or otherwise exert real or potential influence in grant or contract decision-making.”

4. NIH and FNIH should jointly develop a process to address concerns about donors acting improperly.
5. The NFL, FNIH, and NIH should amend their current agreements to ensure that each party has a clear understanding of its role for the remainder of this partnership.

In September 2012, FNIH announced that the NFL had pledged $30 million in support of research on “serious medical conditions prominent in athletes” that are also relevant to the general population. The program involved agreements between NIH, the NFL, and FNIH, which made clear that NIH retained responsibility and control over the scientific aspects of the program, including the review and awarding of scientific grants. Over the course of the following year, NIH moved forward with four research plans funded by the NFL.

In 2014, NIH recommended a fifth study of high-risk adults to characterize Chronic Traumatic Encephalopathy (CTE) in individuals with a history of repetitive head impacts over a three- to five-year period. The study was expected to cost about $17.5 million, with $16.3 million coming from the NFL. The NFL agreed to the plan in July 2014.

In May 2015, after a grant review process, NIH’s National Institute of Neurological Disorders and Stroke (NINDS) determined that Dr. Robert Stern of Boston University, had the highest ranked proposal. The report details an attempt over three months by both the NFL and members of the NFL’s Head, Neck, and Spine Committee to argue that Dr. Stern was biased, and that the grant application process had been tainted by conflicts of interest.

At a September meeting, NIH decided to move forward with the BU proposal. NIH concluded that the CTE study was vitally important to public health and safety, and if necessary, NIH would fund it in its entirety using NINDS funds. Ultimately, NFL did not fund the study.

The Democratic Committee staff’s review included requests for information from NINDS at NIH, FNIH, and the NFL, briefings with staff from NIH, FNIH, and the NFL, as well as a review of relevant documents and communications.

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