Final 2018 budget bill eases biomedical researchers' policy worries

Measure blocks changes to National Institutes of Health clinical trials policy and overhead payments, drops fetal tissue limits

the NIH building
Lydia Polimeni, National Institutes of Health

The 2018 omnibus spending bill released yesterday is cheering biomedical researchers. Not only because of the 8.8% raise it gives the National Institutes of Health (NIH)—its largest in 15 years—but also because it blocks or drops several proposed policy changes that had concerned the community.

The $3 billion boost, to $37 billion, is the biggest percent increase NIH has received since a 5-year effort to double the agency's budget ended in 2003. (That doesn't include 2 years of stimulus funding during the recession.) Research advocates credit the generous increase to strong bipartisan support for NIH as well as the recent budget agreement raising mandatory caps on spending. "This is extraordinary. We are tremendously grateful," says Jennifer Zeitzer, director of legislative relations for the Federation of American Societies for Experimental Biology in Bethesda, Maryland.

The bill includes $414 million in new funding for Alzheimer's disease research, a 30% increase. The Brain Research through Advancing Innovative Neurotechnologies Initiative receive $140 million more, for a total of $400 million. The All of Us precision medicine study gets a $60 million increase, to $290 million. The bill also provides $40 million in new funds for research on a universal flu vaccine, for $100 million in total. At least $500 million in new funds will be targeted to research on opioid addiction. An accompanying report calls for setting up a multi-institute Down syndrome initiative that has been championed by an advocacy group, but does not specify a funding amount.

Basic behavioral researchers are celebrating wording in the companion report regarding a hot-button issue at NIH last year: new reporting requirements for clinical trials that would apply to basic research studies with humans that don't test treatments and were not considered trials until now. Cognitive and brain scientists have warned that this expanded definition of a clinical trial didn't make sense and would stifle their research with red tape.

The report echoes their views: "There is concern that policy changes could have long-term, unintended consequences for this research, add unnecessary regulatory burdens, and substantially increase the number of studies in the database that are not clinical trials." It directs NIH to apply the new reporting rules only to studies that were already considered clinical trials and to delay adding basic studies while NIH consults with the community about more suitable ways to report their results. NIH must seek input and update Congress on its plans by 22 June.

"We are pleased," says cognitive psychologist Jeremy Wolfe of the Harvard University–affiliated Brigham and Women's Hospital in Boston, who led researchers' opposition to the broader clinical trials definition. "It may take a while to get such [an alternative reporting] process in place, but this certainly looks like a move in the right direction."

In another provision welcomed by the research community, the report rejects an effort by President Donald Trump's administration to slash the overhead payments that accompany NIH grants to universities. Like earlier House of Representatives and Senate versions of the bill, the report states that NIH cannot depart from its current method of negotiating those rates.

Finally, a proposal in the House version of the bill to bar NIH from funding research with human fetal tissue obtained from elective abortions does not appear in the omnibus bill. Nor does the omnibus bill or report mention a Senate plan to launch a pilot study to determine whether researchers could rely on fetal tissue from stillbirths and spontaneous abortions. That silence effectively ends, for now, any efforts by lawmakers to alter the current system for supplying fetal tissue for research.

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