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By Jeannie Baumann
Jan. 8 — Allegations that the NFL tried to limit the use of grant money it provided to the NIH for a brain injury study has caught the attention of some House Democrats, who have initiated an inquiry, according to a Jan. 7 letter.
Democratic leaders on the House Energy and Commerce Committee—the committee that generated the 21st Century Cures bill (H.R. 6)—sent one letter to the National Institutes of Health and another to the agency's nonprofit Foundation for the NIH, which manages donations. They expressed their concern that outside entities may have “veto power” over NIH grants.
“The NIH's independent peer review process forms the cornerstone of the NIH research mission and ensures that applications submitted to the NIH are evaluated by scientific experts in a manner free of inappropriate influences or bias,” the lawmakers wrote in both letters. “We are concerned about the potential implications of outside entities attempting to exercise ‘veto power' or other influence over the selection of NIH research applicants.”
At issue are charges that the National Football League pulled out part of a $30 million donation made in 2012 because the league didn't approve of where the money was going—allegations the NFL has disputed. First reported by ESPN, the grant in question was a $16 million brain injury research award to Boston University neurologist Robert A. Stern, whose past work has criticized the NFL.
Boston University spokeswoman Gina DiGravio-Wilczewski referred questions regarding funding to the NFL and the NIH in a Jan. 8 e-mail to Bloomberg BNA.
But she but forwarded a university statement from December explaining that the $16 million award to Stern from the NIH National Institute of Neurological Disorders and Stroke was for a seven-year, multisite study to compare the brain health of former NFL and college football players to a control group of individuals without any history of contact sports or brain injury.
A December NFL statement said that the league's $30 million donation to the foundation in 2012 “continues unchanged” and that the league has no veto power and “[n]othing was pulled from the BU study.”
“We both value and understand the importance of independent research. We are committed to helping accelerate research to help find answers,” the NFL said.
The foundation also said in a statement that the “NIH made the decision to fund this study in its entirety.”
Abbey Meltzer, an FNIH spokeswoman, told Bloomberg BNA on Jan. 8 that the foundation “by policy and practice ensures that NIH research is conducted without bias or funders’ influence. This is critical for the advancement of knowledge and the benefit of patients. And it, of course, holds true for the Sports and Health Research Program (SHRP),” a partnership between the NFL and the FNIH that grew out of the 2012 donation, she said.
Under the SHRP, Meltzer said, the foundation, the NIH and the NFL discuss areas of interest to develop a research plan, from which the NIH issues requests for applications and awards grants using its standard review procedures. She said the foundation then transfers funds to the NIH to cover the awards, at which point the NIH treats the money as appropriated dollars and federal rules apply.
Lawmakers asked both NIH Director Francis S. Collins and the executive director of the FNIH to provide by Feb. 1 all documentation and agreements related to the $30 million donation in 2012 as well as more information on the agency's process generally for receiving donations.
An NIH spokeswoman said the agency will respond to the congressional inquiry and directed any questions about the grant to the FNIH; Meltzer also said the foundation will respond to the lawmakers' request promptly.
Kate Gallin Heffernan, an attorney at Verrill Dana in Boston whose work includes research contracts at universities and academic medical centers, told Bloomberg BNA that depending on the terms of the grant, this case raises public policy and ethics questions that may need further evaluation.
When industry sponsors provide research funding to institutions, she said, the funding can come with various terms or conditions—even if the money is a gift—if that language is included in the funding agreement.
“So the terms of that agreement are really critical to understanding what type of input, if any, the NFL was permitted to have with respect to the ways in which the money was used,” she said. “If they had certain rights, then exercising those rights may not be a legal problem per se, but it certainly could be a [public relations] problem given the type of media coverage this has garnered.”
An interesting ancillary issue, Heffernan said, is the relatively thin line between grant restrictions and maintenance of academic freedom. If the terms of the award contract allow a research sponsor to approve selection of the principal investigator, then it would be allowable for the funder to make those determinations, she said. But it would be inconsistent with research ethics and acceptable standards for the terms of the research grant to give the research funder veto rights over the publication of any results derived from the work that's carried out with the money, she said.
In 2005, as part of a broader effort to tighten its ethics rules, the NIH required that if it received a grant from a substantially affected organization to provide continuing medical education or conduct academic work, that grant must be in the form of an unrestricted financial contribution .
“If the funds were unrestricted then they really become government money,” Heffernan said. “And it would be inappropriate for the NIH to make those decisions as a result of pressure brought to bear by an external private organization. Although I don't know off-hand a legal basis for objecting to the NIH negotiating the receipt of funds that come with certain conditions, it is arguably a public policy question that Congress may also be interested in exploring.”
The letters were signed by top Democrats on the House Energy and Commerce Committee, including Ranking Member Frank Pallone Jr. (D-N.J.) and Reps. Gene Green (D-Texas), Jan Schakowsky (D-Ill.) and Diana DeGette (D-Colo.). DeGette was the lead Democrat on the House-passed 21st Century Cures bill.
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