Blog Archives

NIH Releases RFI, Delays Enforcement of New Clinical Trials Policy

On July 20, the National Institutes of Health (NIH) issued a Guide Notice (NOT-OD-18-212) outlining its plans to delay enforcement of key clinical trials reporting requirements for projects traditionally considered basic research.

The Notice, Delayed Enforcement and Short-Term Flexibilities for Some Requirements Affecting Prospective Basic Science Studies Involving Human Participants, follows months of feedback and pressure on NIH from the external research community, including COSSA and several COSSA members, to rescind or at least delay implementation of NIH’s clinical trials policy announced in 2016. As previously reported, in an effort to enhance its stewardship of and increase transparency over the clinical trials it funds, NIH established a new definition of “clinical trials,” which now captures some basic behavioral and social sciences research and comes with new reporting requirements (see COSSA’s Hot Topic piece for details).

NIH has now released a Request for Information (RFI) (NOT-OD-18-217) seeking input on the standards NIH should use in registration and results reporting for prospective basic science studies involving human participants. A blog post from the NIH Office of Extramural Research outlines the following specific topics for which the RFI is seeking comments:

  • “Examples of prospective basic science studies involving human participants that pose the greatest challenges in meeting the registration and results information submission requirements at ClinicalTrials.gov, including specific reasons for these challenges (e.g., specific data elements);
  • Strengths and weaknesses of potential alternative platforms that might function as conduits for timely registration and reporting of prospective basic science studies involving human participants;
  • Additional data elements or modification to existing data elements that could be applied to ClinicalTrials.gov to better meet the needs of the public and of researchers in assuring timely registration and results information submission of prospective basic science studies involving human participants;
  • Other existing reporting standards for prospective basic science studies involving human participants and how such standards would fulfill the aims described in the NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information; and
  • Any other point the respondent feels is relevant for NIH to consider in implementing this policy for timely registration and reporting of prospective basic science studies involving human participants.”

Responses to the RFI must be submitted by November 12, 2018.

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Posted in Issue 17 (September 4), Update, Volume 37 (2018)

Senate HELP Committee Hears Update on NIH Cures Implementation

On August 23, the Senate Health, Education, Labor and Pensions (HELP) Committee held an oversight hearing featuring leadership from the National Institutes of Health (NIH). The hearing, Prioritizing Cures: Science and Stewardship at the National Institutes of Health, was chaired by HELP Committee Chairman Lamar Alexander (R-TN) and included testimony from NIH Director Francis Collins. Dr. Collins was joined by Diana Bianchi, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Anthony Fauci, National Institute of Allergy and Infectious Diseases (NIAID); Richard Hodes, National Institute on Aging (NIA); and Norman Sharpless, National Cancer Institute (NCI). A similar hearing was held in the House in July.

 

In his opening statement, Chairman Alexander acknowledged the continued enthusiastic, bipartisan support for NIH, evidenced by the passage of the 21st Century Cures Act in 2016 and by substantial budgetary increases provided to the agency over the last four years (see COSSA’s funding analysis for details). He further stated, “It’s hard to think of a major scientific advancement since World War II that has not been supported by federal research funding. But we’re not the only country that’s figured that out. Other countries have seen that investments in basic research can lead to breathtaking new discoveries,” pointing specifically to China.

Chairman Alexander raised concern about reports that some federally funded research is being conducted by “bad actor” foreign nationals who may be trying to assert undue foreign influence on NIH research. Dr. Collins explained that through an internal investigation, NIH found that the risks to the security of intellectual property and the integrity of the peer review process are increasing in magnitude. In response, Dr. Collins recently wrote to 10,000 NIH grantee institutions requesting that they “review their records for evidence of malfeasance,” specifically: (1) failure by researchers to disclose substantial contributions of resources from other organizations, including foreign governments; (2) diversion of intellectual property to other entities, including foreign governments; and (3) failure by some peer reviewers to keep grant applications confidential or other attempts to influence funding decisions. In addition, Dr. Collins has formed a Working Group on Foreign Influences on Research Integrity, which will continue to look at these challenges.

Dr. Collins used his prepared remarks to highlight NIH advancements made possible with the infusion of new funds from the 21st Century Cures Act. He outlined what he called the five keys to success in science today. They include: (1) a stable trajectory of support (i.e. funding); (2) a vibrant workforce (e.g. training programs); (3) computational power, which is enabling activities like the BRAIN initiative and the All of Us Precision Medicine Initiative; (4) new technologies and facilities; and (5) scientific inspiration.

Of particular interest to the social and behavioral science community, Senator Michael Bennet (D-CO) asked about whether our society is becoming addicted to technology and about the public health effects of social networking, citing findings from a recent study on daily use of technology and social media among teens (Psychology of Popular Media Culture, APA). Senator Bennet called for more priority to be placed on research in these areas and asked what NIH is doing in this space. Dr. Collins cited the Adolescent Brain Cognitive Development (ABCD) Study, which will follow 10,000 children ages 9-10 into early adulthood, studying brain, social, cognitive and emotional development and the factors that influence them. The issue of “screen time” is among the factors to be studied. In addition, Dr. Bianchi mentioned a recent NICHD workshop looking at new research directions in these areas, including early childhood language development, reading comprehension, parent-child interactions, and technology addiction.

Other Senators asked questions on a variety of specific diseases and topics of interest to them, including opioid and other addictions, the societal costs of obesity, development of a universal flu vaccine, maternal health, and bolstering researchers from underrepresented groups.

Dr. Collins’ testimony and a video of the hearing can be found on the HELP Committee website.

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Posted in Issue 17 (September 4), Update, Volume 37 (2018)

House Holds Hearing on Cures Implementation

On July 25, the House Energy and Commerce Subcommittee on Health held an oversight hearing on 21st Century Cures Implementation: Updates from FDA and NIH. The 21st Century Cures Act is legislation enacted in 2016 that, among other things, provides for additional funding for biomedical research at the National Institutes of Health (NIH). Authorized in the act, the Cures funding is provided through the annual appropriations bills to boost funding for priority research in areas, including the Beau Biden Cancer Moonshot initiative, the BRAIN initiative, and the All of Us Precision Medicine Initiative. The hearing offered an update from agency officials on the progress of the Cures investments. Witnesses included Francis Collins, Director, National Institutes of Health; Stephanie Devaney, Deputy Director, NIH All of Us Research Program; Scott Gottlieb, Commissioner, Food and Drug Administration; and Norman Sharpless Director, National Cancer Institute. A related hearing on the mental health provisions within Cures was held on July 19.

In his prepared remarks, Dr. Collins highlighted NIH’s efforts and successes through the Cancer Moonshot and the All of Us Precision Medicine Initiative, both made possible through Cures Act investments. Committee members asked questions on a variety of topics, including concerns about privacy of patients and patient data within the All of Us program, NIH’s efforts to relieve administrative burden on investigators, and progress made toward cures and treatments for specific diseases and conditions.

Video of the hearing and witness testimony can be found on the Energy and Commerce Committee website.

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Posted in Issue 16 (August 7), Update, Volume 37 (2018)

House Committee Approves FY 2019 Labor-HHS-Education Funding

On July 11, the full House Appropriations Committee approved its fiscal year (FY) 2019 Labor, Health and Human Services, Education, and Related Agencies (Labor-HHS) Appropriations Bill; the Labor-HHS Subcommittee advanced the bill on June 15. This bill contains annual funding proposals for the National Institutes of Health (NIH), Department of Education (ED), Centers for Disease Control and Prevention (CDC), Agency for Healthcare Research and Quality (AHRQ), and Bureau of Labor Statistics (BLS), among other federal departments and agencies.

The Senate Appropriations Committee reported its version of the bill on June 28 (more here).

At a Glance…

  • The House bill includes a total of $38.334 billion for NIH in FY 2019, a $1.25 billion or 3.4 percent increase over the FY 2018 level. This amount is 10.8 percent over the President’s request, but nearly 2 percent below the Senate bill.
  • The bill would allocate $7.58 billion to the CDC, a cut of $422.9 million compared to FY 2018 and about $230 million less than the amount proposed by the Senate bill.
  • The House bill includes $334 million for AHRQ, flat with the FY 2018 enacted level and the same as the amount proposed by the Senate. The bill does not accept the Administration’s proposed consolidation of AHRQ as a new institute within the NIH.
  • The House bill would provide flat funding for BLS at $612 million, $3 million less than the amount proposed by the Senate, but still more than the amount requested by the Administration.
  • Within the Department of Education, the bill would provide $613.5 million to the Institute of Education Sciences (IES), which would be flat with its FY 2018 appropriation and 17.6 percent above the FY 2019 funding request from the Administration.

At time of publication, the House and Senate Appropriations Committees have reported out 23 of the 24-fiscal year (FY) 2019 appropriations bills, twelve bills each for the House and Senate. This represents significant progress in appropriations compared to the last few fiscal years, likely thanks to a top-line spending deal struck earlier this year. However, the House of Representatives will leave D.C. for August recess starting July 30, giving them only 14 working days to approve spending bills and reconcile differences with the Senate before the government shuts down on October 1. The Senate will stay in session for much of the month of August to complete work on approving presidential nominees and vote on some of the remaining spending bills. So far, the full House has approved five of the twelve spending bills, while the Senate has only approved three. Keep up with COSSA’s coverage of FY 2019 appropriations here.

Read on for COSSA’s analysis of the House Appropriations Committee’s proposals for the National Institutes of Health, Centers for Disease Control and Prevention, Agency for Healthcare Research and Quality, Bureau of Labor Statistics, and Department of Education.

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Posted in Issue 15 (July 24), Update, Volume 37 (2018)

Senate Appropriations Committee Passes FY 2019 Labor, Health Human Services, Education Bill

On June 28, the full Senate Appropriations Committee approved its fiscal year (FY) 2019 Labor, Health and Human Services, Education, and Related Agencies (Labor-HHS) Appropriations Bill; the Labor-HHS Subcommittee advanced the bill on June 26. This bill contains annual funding proposals for the National Institutes of Health (NIH), Department of Education (ED), Centers for Disease Control and Prevention (CDC), Agency for Healthcare Research and Quality (AHRQ), and Bureau of Labor Statistics (BLS), among other federal departments and agencies.

The House Labor-HHS Subcommittee marked up its version of the bill on June 15 and released the bill text and accompanying report soon after; however, the full House Appropriations Committee has postponed its markup of the bill indefinitely due to reported disagreements on a number of policy issues in the bill. Therefore, this report simply summarizes the Senate’s Labor-HHS proposals and does not make comparisons to the House levels.

At a Glance…

  • The Senate bill includes a total of $39.084 billion for NIH in FY 2019, a $2 billion increase over the FY 2018 level. If enacted, NIH will have received a total of $9 billion in increases over the last four years, a 30 percent increase over that period.
  • The bill would allocate $7.8 billion to the CDC, a cut of about $193 million compared to FY 2018, but more than $2 billion above the amount proposed by the Administration.
  • The Senate bill includes $334 million for AHRQ, flat with the FY 2018 enacted level. The bill “does not support” the Administration’s proposed consolidation of AHRQ as a new institute within the NIH.
  • Within the Department of Education, the Senate bill would provide $615.5 million to IES, which would be a 0.3 percent increase in funding compared to its FY 2018 appropriation and 18 percent above the FY 2019 funding request from the Administration.

The next step for the bill is consideration by the full Senate. It remains to be seen whether or how Senate leadership will proceed with the individual appropriations bills this year. Given the fast-approaching November midterm elections and other legislative priorities, not to mention the need to confirm a new Supreme Court Justice, it is increasingly likely that FY 2019 will begin under a continuing resolution (CR) on October 1, 2018.

Read on for COSSA’s analysis of the Senate Appropriations Committee’s proposals for the National Institutes of Health, Department of Education, Centers for Disease Control and Prevention, Agency for Healthcare Research and Quality, and Bureau of Labor Statistics.

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Posted in Issue 14 (July 10), Update, Volume 37 (2018)

NIH Releases Data Science Strategic Plan

On June 4, the National Institutes of Health (NIH) released its first strategic plan for data science. The strategic plan will serve as a roadmap for modernizing the NIH-supported biomedical data science ecosystem and provide leadership within the broader biomedical research data community. NIH will begin implementing the plan over the next year and focus on usability of NIH-funded biomedical data sets and resources, integration of existing data management tools and development of new ones, and the growing costs of data management. NIH will seek community input during the implementation phase and plans to hire a Chief Data Strategist to help advance data science across the intramural and extramural research communities. Read more here.

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Posted in Issue 12 (June 12), Update, Volume 37 (2018)

Senate Subcommittee Holds Hearing on 2019 NIH Budget

The Senate Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies (LHHS) hosted leadership from the National Institutes of Health (NIH) to testify on the agency’s fiscal year (FY) 2019 budget request. NIH Director Francis Collins, National Institute of Neurological Disorders and Stroke Director Walter Koroshetz, National Institute of Allergy and Infectious Diseases Director Anthony Fauci, National Cancer Institute Director Norman Sharpless, and National Institute on Drug Abuse Director Nora Volkow all testified. Senators from both parties praised NIH for its accomplishments, further solidifying its position as a bipartisan priority. Subcommittee Chair Roy Blunt (R-MO), Ranking Member Patty Murray (D-WA), and other members of the subcommittee expressed concern with the $2 billion cut recommended in the President’s FY 2019 budget request, especially in contrast to the $3 billion increase NIH received from Congress in the FY 2018 omnibus spending bill. Committee members questioned witnesses on NIH activities related to the opioid epidemic, a universal flu vaccine, immunotherapy, the recent outbreak of Ebola in the Democratic Republic of the Congo, and a recent scandal at NIH regarding an alcohol industry-financed study of the health affects of alcohol. Written statements from Blunt and Collins, along with a recording of the hearing can be found on the committee’s website. COSSA’s coverage of FY 2019 funding is available here.

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Posted in Issue 11 (May 29), Update, Volume 37 (2018)

House Subcommittee Discusses 2019 NIH Budget

On April 11, the House Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies (LHHS) heard testimony from leadership of the National Institutes of Health (NIH) on the fiscal year (FY) 2019 NIH budget request. NIH Director Francis Collins, National Institute of Child Health and Human Development Director Diana Bianchi, National Institute of Allergy and Infectious Diseases Director Anthony Fauci, National Cancer Institute Director Norman Sharpless, and National Institute on Drug Abuse Director Nora Volkow all testified at the hearing. NIH was lauded for its accomplishments by members of both parties, further solidifying its position as a bi-partisan priority. Subcommittee Chair Tom Cole (R-OK), Ranking Member Rosa DeLauro (D-CT), and other members of the subcommittee expressed concern with the $2 billion cut recommended in the President’s FY 2019 budget request, in stark contrast to the $3 billion increase NIH received in the omnibus FY 2018 spending bill. Committee members also discussed NIH activities related to the opioid epidemic, the flu vaccine, medical and recreational marijuana, and cancer detection. A recording of the hearing and written statements from Collins and Cole can be found on the House Appropriations Committee’s website. COSSA’s coverage of FY 2019 funding is available here.

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Posted in Issue 8 (April 17), Update, Volume 37 (2018)

NIH Launches HEAL Initiative to Address the Opioid Epidemic

On April 4, the National Institutes of Health (NIH) announced a new effort to accelerate progress toward addressing the opioid addiction crisis. The Helping to End Addiction Long-term (HEAL) Initiative will use the increase in NIH funding provided by the FY 2018 omnibus bill to nearly double funding for research on opioid misuse/addiction and pain compared to FY 2016 ($1.1 billion compared to $600 million). The initiative will fund research in two broad areas: (1) Prevent addiction through enhanced pain management, and (2) Improve treatments for opioid misuse disorder and addiction. Within the preventing addiction portfolio, NIH proposes to launch a longitudinal study to follow patients at risk for chronic pain and to fund research on understanding “the genetic and social factors that put patients at risk for opioid misuse and addiction.” As part of its improving addiction treatment efforts, the Institute also plans to “assess the additive role of social and behavioral interventions” to Medication Assisted Treatment (MAT) programs. More information about the initiative is posted on the NIH website.

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Posted in Issue 8 (April 17), Update, Volume 37 (2018)

NIH Takes Next Steps in Agency Reorganization Plans

As part of the Trump Administration’s government reform agenda, including its comprehensive plan for reorganizing the executive branch and reducing the federal civilian workforce, the Department of Health and Human Services (HHS) has created an initiative called ReImagine HHS. As part of this initiative, the National Institutes of Health (NIH) launched Optimize NIH in December 2017 to improve organizational effectiveness and performance. NIH is working to equilibrate workload distribution across scientific review and grants and program management functions and anticipates that the Optimize NIH effort will be fully implemented over the next two to three years. Research functions are not expected to be among the first areas addressed as part of the activity. Rather, NIH will be looking at ways to streamline communications, ethics, and Freedom of Information Act requests across the agency.

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Posted in Issue 8 (April 17), Update, Volume 37 (2018)

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