On September 26, the House of Representatives approved (by a vote of 361-61) an appropriations bill that includes a $2 billion (5.4 percent) funding increase for NIH for fiscal year (FY) 2019, bringing the total NIH budget to $39.1 billion. The House action followed Senate approval of the same bill (by a vote of 93-7) eight days earlier. The $2 billion increase for NIH became official when President Trump signed the bill into law on September 28.

This is the fourth year in a row that NIH has received a significant budget increase, in part because of extraordinary support from the Chair and Ranking Member of both the House and Senate Labor, Health and Human Services, Education, and Related Agencies (Labor-HHS) Appropriations Subcommittees: Senators Roy Blunt (R-MO) and Patty Murray (D-WA), and Representatives Tom Cole (R-OK, 4^th) and Rosa DeLauro (D-CT, 3^rd). As a result, the NIH budget has increased by $9 billion (30 percent) since FY 2015. Notably, this is also the first time in 22 years that the NIH budget has been finalized by Congress before the beginning of the next fiscal year.

AAI strongly advocated for NIH to receive a funding increase of at least $2 billion for FY 2019, including circulating a FASEB e-action alert prior to the House vote that encouraged AAI members to contact their Congressperson to urge support for the funding bill.

The Centers for Disease Control and Prevention (CDC) received a total of $7.9 billion in the bill, on its face a $354 million decrease from FY 2018. However, the CDC budget was higher last year because of a one-time appropriation for new facilities; after accounting for this one-time transfer, the CDC budget actually increased this year by $126 million. The bill also creates a $50 million Infectious Disease Rapid Response Reserve Fund, which can only be tapped for a public health emergency, such as a pandemic.

The Labor-HHS bill was approved as part of an appropriations bill that also includes funding for the Department of Defense. Congress has now completed five of its 12 appropriations bills for FY 2019; the rest of the federal government will be funded under a Continuing Resolution that will support those agencies and programs at roughly last year’s funding levels until those seven appropriations bills are enacted (two of the agencies that have yet to receive a full-year appropriation for FY 2019 are the Food and Drug Administration and the National Science Foundation).

Summary of the Labor-HHS Section of the Bill

Report Language Accompanying the Bill (provisions related to NIH on pages 443-450)

The sixth annual Rally for Medical Research Hill Day (Rally Hill Day) took place on September 13, 2018. AAI was pleased to once again co-sponsor the event as a Bronze Supporter, and to support the participation of AAI member Claire Chougnet, Ph.D (AAI ’98), a Professor at Cincinnati Children’s Hospital. AAI Director of Public Policy and Government Affairs Lauren Gross, J.D., escorted Dr. Chougnet and several other Rally Hill Day participants to meetings with the Ohio Congressional delegation.

Nearly 350 organizations participated in Rally Hill Day, and though Hurricane Florence adversely impacted the travel plans of some attendees, the crowd was still large, and the event was by all accounts quite successful. The Hill Day itself began with a “Kick-off Breakfast,” including remarks by Representative Jamie Raskin (D-MD, 8th), whose district is home to both the NIH campus in Bethesda and the AAI office in Rockville. Rally Hill Day participants then participated in a full day of meetings, during which they thanked their Members of Congress for the recent robust funding increases for NIH, urged them to support another $2 billion increase for NIH for FY 2019, and expressed the importance of completing in a timely manner the appropriations bill that funds NIH.

At a Congressional reception the prior evening, attendees heard remarks from Senators Roy Blunt (R-MO) and Patty Murray (D-WA), Representative Kevin Yoder (R-KS, 3rd), and NIH Director Francis Collins, M.D., Ph.D. AAI President JoAnne Flynn, Ph.D., in a statement provided to Rally organizers about the importance of NIH research, said the following:

“NIH funding is crucial to immunologists’ efforts to understand how the immune system works and can be utilized to prevent, treat, and cure disease. Advances in immunotherapy, in which one’s own immune system is unleashed to fight disease, are rapidly transforming the treatment of cancer and offering hope that we might one day find a cure. NIH support of other immunological discoveries, which are advancing our understanding of both chronic diseases (including Alzheimer’s disease, type 1 diabetes, and heart disease) and infectious diseases (including influenza, HIV/AIDS, tuberculosis, and Zika) will help us address urgent health challenges in a world where disease knows no geographic boundaries.”

Rally for Medical Research Website

Rally Hill Day 2018 Video

NIH Director Francis Collins recently sent a letter to more than 10,000 U.S. research institutions and released a statement on “protecting the integrity of U.S. biomedical research” in response to concerns related to the security of intellectual property and peer review. He outlined three areas of specific concern:

* “failure by some researchers at NIH-funded institutions to disclose substantial contributions of resources from other organizations, including foreign governments, which threatens to distort decisions about the appropriate use of NIH funds
* diversion of intellectual property in grant applications or produced by NIH-supported biomedical research to other entities, including other countries*
* in some instances, sharing of confidential information by peer reviewers with others, including in some instances with foreign entities, or otherwise attempting to influence funding decisions.”

Collins said that, while there have been incidents that have led to these concerns, “the overwhelming majority of researchers participating on NIH grants, whether U.S. or foreign-born, are honest, hard-working contributors to the advancement of knowledge that benefits us all.”

To help identity actions NIH can take to address these concerns, a working group within the NIH Advisory Committee to the Director (ACD) was created. Specifically, the group will focus on ways to ensure the accurate reporting of research support, protect the integrity of peer review, and lessen risks to intellectual property security.

NIH Letter to Research Institutions

NIH Director’s Statement

ACD Working Group

President Trump recently issued a national biodefense strategy and signed a National Security Presidential Memorandum. In a statement, Trump said that the plan “will strengthen our Nation’s defenses against biological threats to health and safety” and that it will “promote a more efficient, coordinated, and accountable biodefense enterprise.”

The strategy is intended to protect against “the full range of biological threats, including those that are naturally occurring, deliberate, and accidental – a first for the [US] Government.” Implementation of the strategy will be led by Secretary of Health and Human Services (HHS) Alex Azar, J.D., who will also oversee a Cabinet-level steering committee. The committee will conduct a survey of response capabilities across the government, and its findings will help direct spending priorities. The strategy will likely take about a year to implement and will be reviewed annually.

President Trump’s Statement

National Biodefense Strategy

President Trump recently nominated meteorologist Kelvin Droegemeier, Ph.D., to be the Director of the Office of Science and Technology Policy (OSTP). The OSTP Director also typically serves as the science advisor to the President. The position has not been filled since the President took office about 19 months ago, marking the longest time a president has taken to appoint someone to the position since the office’s founding.

The nomination of Droegemeier, who holds a Ph.D. in atmospheric science, has been very well-received by the scientific community because of his background in both science and policy. He has been the Vice President for Research at the University of Oklahoma since 2009 and previously was a professor at the university. He was appointed to serve two terms on the National Science Board (which oversees the National Science Foundation), under Presidents George W. Bush and Barack Obama. He also served as the Oklahoma Cabinet Secretary of Science and Technology.

Following the announcement, the Senate Committee on Commerce, Science, and Transportation held a hearing on Droegemeier’s nomination. Committee members spoke highly of him: Committee Chair John Thune (R-SD) called him “eminently well qualified,” while Ranking Member Bill Nelson (D-FL) also praised his nomination. During the hearing, Droegemeier stressed that science is extremely important in guiding policy and that it must be free from political influence. The Committee subsequently approved his nomination; he is expected to be confirmed by the full Senate soon.

Droegemeier’s Nomination Hearing

Statement on the Droegemeier Nomination by NSF Director France Cordova

During the June meeting of the NIH Advisory Committee to the Director (ACD), the ACD Working Group on the NGRI presented its interim report. The Working Group, which is charged with providing “advice on the development, implementation, and analysis of the Next Gen policy to increase the number of NIH-funded ESIs [Early Stage Investigators] and EEIs [Early Established Investigators] and stabilize the career trajectory of scientists,” made several draft recommendations:

* Revise the original NGRI definitions
* Develop methods to support ESIs and “at-risk” investigators
* Enhance ESI diversity
* Optimize workforce stability
* Assess productivity using a multifaceted approach

In terms of modifying the original NGRI definitions, the Working Group believes that the definitions of ESIs and EEIs would not capture enough of the investigators in need and therefore should be broadened to increase flexibility. Possibilities include modifying the ESI status, originally defined as within 10 years of receiving a terminal degree, to 15 years, or to approximately six years after the date of one’s first independent position. Rather than targeting EEIs, defined as within 10 years of receiving an R01-equivalent award, the Working Group may recommend focusing on meritorious investigators across all career stages who are at risk of losing all funding.

The Working Group will consider input from stakeholders as it develops final recommendations, which will be presented at the December 2018 ACD meeting.

Along with stakeholder input, the Working Group will also consider recommendations directed to NIH in a recently-released report by The National Academies of Science, Engineering, and Medicine (NASEM), entitled “The Next Generation of Biomedical and Behavioral Researchers: Breaking Through.” The report, which was mandated by Congress in 2016, was issued following an 18-month study by a NASEM ad hoc committee (Committee on the Next Generation Researchers Initiative) to “examine the policy and programmatic steps that the nation can undertake to ensure the successful launch and sustainment of careers among the next generation of researchers....”

The full report recommends ways, including the following, that Congress, the NIH, research institutions, and principal investigators (PIs) can help sustain the biomedical research enterprise:

* Congress should establish a Biomedical Research Enterprise Council (public-private partnership of stakeholders to oversee implementation and ensure accountability).
* NIH should implement a three-year cap on postdoctoral researcher salary support from a PI’s research grant, as well as a five-year cap for total postdoctoral training.
* NIH should expand five-fold the number of individual research fellowship and career development awards.
* Institutions should implement a $1,000 annual fee on PIs for each postdoc supported on a research grant (for a mentorship and career guidance fund).

Presentation by NIH ACD Working Group

AAI recently submitted comments in response to a Request for Information (RFI) by NIH entitled “Animal Care and Use in Research” (Notice NOT-OD-18-152). The RFI was issued because of a provision in the 21st Century Cures Act that requires NIH, FDA, and the United States Department of Agriculture (USDA), to revise regulations and policies relating to the use of animals in research in order to reduce burden on investigators, while maintaining the protection of laboratory animals.

AAI agrees with several of the actions NIH proposes to reduce burden on investigators; these include allowing investigators to submit protocols for review using a risk-based methodology and using the same schedule for annual reporting to the Office of Laboratory Animal Welfare (OLAW) and USDA. AAI also makes additional recommendations not specifically mentioned in the RFI, including changing the Institutional Animal Care and Use Committee (IACUC) review time frame from the current three years to five years in order to match the time frame of most R01 grants.

AAI Response to NIH RFI on Reducing Burden in Animal Research

A new report from The National Academies of Science, Engineering, and Medicine (NASEM) has found sexual harassment of women to be “common” in science, engineering, and medicine. The report, entitled “Sexual Harassment of Women: Climate, Culture, and Consequences in Academic Science, Engineering, and Medicine,” finds “that the cumulative result of sexual harassment is significant damage to research integrity and a costly loss of talent in these academic fields.” Further, the report “urges institutions to consider sexual harassment equally important as research misconduct in terms of its effect on the integrity of research.”

The topic of sexual harassment was also discussed at the June meeting of the NIH Advisory Committee to the Director (ACD) by NIH Principal Deputy Director Lawrence Tabak, D.D.S., Ph.D. His presentation covered both the extramural and intramural workforce. Regarding the extramural community, Dr. Tabak reminded the ACD that NIH awards grants to institutions, not their employees, and awardees are responsible for those individual employees. He also emphasized the previously published NIH Notice relating to Title IX (Notice NOT-OD-15-152) and the NIH Notice regarding the institutional obligation to inform NIH about a change in investigator status (Notice NOT-OD-18-172). With respect to the intramural community, NIH has established an NIH Anti-Harassment Steering Committee that will oversee efforts to strengthen anti-harassment activities, such as updating reporting tools and policies and completing an NIH Workplace Climate and Harassment Survey.

ACD Presentation on NIH Sexual Harassment Policies and Procedures