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Category: Grants

NIH & FDA Director Nominees Advance

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Dr. Jay Bhattacharya, President Trump’s pick to lead the National Institutes of Health, was advanced by the Senate Health, Education, Labor and Pensions Committee. The Committee voted 12-11 along party lines, with all Republicans voting in favor and all Democrats voting against.

Similarly, Trump’s pick to head the Food and Drug Administration, Marty Makary, was advanced out of the committee by a 14-9 vote, with Democrats Maggie Hassan of New Hampshire and John Hickenlooper of Colorado joining all Republicans in voting to advance.

Bhattacharya and Makary will now appear for a confirmation vote before the entire Senate, with the Republican majority all but ensuring that they will be confirmed.

Multiple Lawsuits Filed Against NIH Indirect Cost Move

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On Monday, two separate lawsuits were filed in response to a policy change from the National Institutes of Health (NIH) announced late Friday. In the first suit, filed Monday morning, attorneys general from 22 states, including Washington, sought to prevent NIH’s move to unilaterally lower the “indirect cost” rates on research grants to 15 percent.

The action in question occurred Friday evening, when the NIH announced a significant reduction in grant funding for research institutions. The announcement declared that the NIH will limit the amount granted to research universities for indirect costs at 15 percent moving forward, on both future and existing grants.

Indirect costs, also referred to as “facilities and administration” (F&A) costs, are the essential-but-behind-the-scenes costs of conducting research. These costs include, but are not limited to, laboratory materials, high-speed data processing, security protections, patient safety, radiation safety and hazardous waste disposal, personnel required to support administrative and compliance work, and many other necessary activities.

Typically, when the government provides a grant to a research university, it includes support for both direct and indirect costs. The indirect cost rates are based on allowable direct costs of research that can be assigned to a research grant. Historically, the federal government has reimbursed the university for a percentage of these allowable direct costs. Indirect costs are never fully reimbursed by the federal government, meaning full costs of research are never fully recovered by the institution performing the research. The level of F&A expenses that the federal government covers for each institution is determined by either the Department of Defense Office of Naval Research or the Department of Health and Human Services and is reviewed every 2 to 4 years through a comprehensive negotiation process.

Late last evening, the court in Massachusetts issued a temporary restraining order against the NIH in response to the suit.

Given the potential implications of such a move by the NIH, three higher education associations in which UW is active—the Association of American Universities (AAU), Association of Public and Land-grant Universities (APLU), and American Council on Education (ACE)—took the unprecedented step of also filing a separate lawsuit against the agency Monday evening. The suit seeks a temporary restraining order as well as an injunction against the NIH.

Currently, as a result of the language in funding bills for the NIH dating back to FY2017, the NIH is prohibited from lowering the indirect cost rates unilaterally.

The NIH’s move has received criticism from several Members of the Senate, including Republicans. Appropriations Committee Chair Susan Collins (R-ME), has issued a statement strongly opposing the NIH move. Republican Senator Katie Britt of Alabama issued a statement encouraging the agency to take a “smart, targeted approach…in order to not hinder life-saving, groundbreaking research at high-achieving institutions…”

Over the weekend, Sen. Patty Murray of Washington, the Ranking Member of the Appropriations Committee, issued a statement raising strong objections about the NIH move.

Please continue to check back here for additional updates.

Federal Funding Freeze Rescinded

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A controversial memo released by the Trump Administration last week has been rescinded after a federal judge in Rhode Island temporarily blocked it. Just over a week after the inauguration, the new administration announced that it would temporarily halt federal payments to ensure that they were ideologically aligned with the administration’s priorities. The order caused wide-spread concern before U.S. District Chief Judge John McConnel of Rhode Island granted the request for a temporary restraining order sought by a coalition of Democratic-led states, preventing the now-rescinded memo from taking effect. Links to the documents can be found below.

Temporary Restraining Order

Original Office of Management and Budget Memo

 

 

 

 

Trump Picks Jay Bhattacharya to lead NIH

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President-elect Donald Trump has nominated Dr. Jay Bhattacharya to be his Director of the National Institutes of Health (NIH). The NIH is the nation’s leading public research agency. Research supported by the agency has led to more than 100 Nobel Prizes and over 99 percent of the drugs approved by federal regulators from 2010 to 2019. The agency gives out roughly $25 billion in research grants to universities each year. The UW is one of the top recipients of NIH grant funding.

Dr. Bhattacharya, a Stanford physician and economist, gained prominence during the pandemic for his criticism of lockdown procedures. According to his Stanford colleagues, Bhattacharya has been described as warm and intellectually curious, and supportive of their pursuits. It wasn’t until the Covid pandemic that Bhattacharya gained national prominence and attracted controversy. During the pandemic, Dr. Bhattacharya called for “an absolute revamping of the scientific community,” and has promised to “reform American scientific institutions so that they are worthy of trust again.”

In October 2020, along with two fellow academics, he co-wrote the Great Barrington Declaration. The declaration called on public health officials to roll back Covid lockdowns. The proposal advocated for “herd immunity” as the most effective way for handling the pandemic and advocated for a new approach that would “allow those who are at minimal risk of death to live their lives normally and build up immunity to the virus through natural infection, while better protecting those who are at highest risk.” The declaration sparked an intense negative reaction from the public health establishment.

Since the pandemic, Dr. Bhattacharya has often found himself in conflict with many of the organization’s leaders. Following his authoring of the Great Barrington Declaration, he accused the government of working with social media companies to suppress his views, though a recent Supreme Court ruling found that this claim was false. Still, Bhattacharya has argued that his experiences in recent years have taught him that agency officials, notably Dr. Anthony Fauci, have amassed too much power.

He recently told the Washington Post that he would “restructure the NIH to allow there to be many more centers of power, so that you couldn’t have a small number of scientific bureaucrats dominating a field for a very long time.” To do so, he proposed term limits for scientists running various research centers and shrinking the number of institutes from 27 to 15. He also has said that one of his main goals would be working to rebuild public trust in the American public health establishment, which he has lost “almost all confidence in.”

Other potential priorities floated by Bhattacharya include reducing the amount of NIH grant money that pays for publication in journals, funding studies to replicate the work of scientists in order to root out fraud and encouraging a more open discussion of scientific ideas by publishing studies alongside comments by named reviewers.

Bhattacharya will need to be confirmed by the Senate before officially taking the post.

Read more here and here.

 

 

OSTP Releases Guidance for U.S. Scientific Research Security That Preserves International Collaboration

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Today the National Science and Technology Council, Joint Committee on the Research Environment (JCORE), released guidance for Federal departments and agencies on implementing National Security Presidential Memorandum 33 (NSPM-33) on National Security Strategy for U.S. Government-Supported Research and Development.

The guidance addresses the below key elements of NSPM-33:

1) disclosure requirements and standardization;

2) digital persistent identifiers;

3) consequences for violation of disclosure requirements;

4) information sharing; and

5) research security programs.

As a next step, Dr. Eric Lander, Director of the White House Office of Science and Technology Policy, is directing agencies to develop model grant applications and instructions within 120 days that can be used by any funding agency.

In a press statement, Dr. Lander said “the implementation guidance reflects the principles I laid out in August: to protect America’s security and openness, to be clear so that well-intentioned researchers can easily and properly comply, and to ensure that policies do not fuel xenophobia or prejudice.”

You can read the full guidance here.