NIH

HOT TOPIC: New NIH “Clinical Trials” Definition to Impact Basic Social and Behavioral Science Research

The National Institutes of Health (NIH) has been working for the last few years to enhance its stewardship of and increase transparency over the clinical trials it funds. The agency, which is the largest funder of clinical trials in the U.S., issued a Notice of Revised NIH Definition of “Clinical Trial” (NOT-OD-15-015) in late 2014 laying out a new, expanded definition to govern which research projects are to be categorized as a “clinical trial” from here on out. While this change has been in process for the last few years, it wasn’t until more recently that the biomedical and behavioral…

Senate Labor-HHS-Education Bill Approved by Committee

On September 7, the Senate Appropriations Committee approved its fiscal year (FY) 2018 Labor, Health and Human Services, Education, and Related Agencies (Labor-HHS) Appropriations Bill; the Labor-HHS Subcommittee advanced the bill on September 5. This bill contains annual funding 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 Appropriations Committee passed its version of the bill on July 19; the bill recently passed the House as part of a 12-bill…

NIH Announces New Next Generation Researchers Policy

On August 31, the National Institutes of Health (NIH) announced a new policy aimed at increasing the number of early career investigators competing successfully for NIH grants. The Policy Supporting the Next Generation Researchers Initiative implements Section 2021 of the 21st Century Cures Act, enacted in late 2016, which calls for the agency to prioritize investment in the next generation of biomedical researchers. The Next Generation Researchers Policy sets two new definitions of early career investigators: Early Stage Investigators (ESIs) and Early Established Investigators (EEIs). Early Stage Investigators are defined as a “program director/principal investigator who has completed their terminal…

NIH Requests Information on ECHO-wide Cohort Data Collection Protocol

The National Institutes of Health (NIH) is seeking input into the development of the cohort data collection protocol for the Environmental influences on Child Health Outcomes (ECHO) program. ECHO was formed late last year to “investigate how exposure to a range of environmental factors in early development—from conception through early childhood–influences the health of children and adolescents.” ECHO represents the follow-on activity to the now-discontinued National Children’s Study. The Request for Information seeks comments on a number of aspects of the ECHO-wide cohort, which will entail data collection from 84 existing cohorts. Input is sought on the data elements, types…

Senate Subcommittee Discusses FY 2018 NIH Budget, Pledges Support

On June 22, the Senate Labor, Health and Human Services, Education and Related Agencies (LHHS) Appropriations Subcommittee held a hearing to discuss the fiscal year (FY) 2018 budget request for the National Institutes of Health (NIH). Appearing before the committee were NIH Director Francis Collins and six institute and center directors, including Douglas Lowy of the National Cancer Institute (NCI), Gary Gibbons of the National Heart, Lung, and Blood Institute (NHLBI), Anthony Fauci of the National Institute of Allergy and Infectious Diseases (NIAID), Richard Hodes of the National Institute of Aging (NIA), Nora Volkow of the National Institute on Drug…

COSSA Senate Testimony Calls for Funding for NIH, AHRQ, CDC, Education Programs

On June 2, COSSA submitted testimony to the Senate Appropriations Subcommittee on Labor, Health and Human Services, Education and Related Agencies for fiscal year (FY) 2018. The testimony calls for increased funding for the National Institutes of Health (NIH), Agency for Healthcare Research and Quality (AHRQ), Centers for Disease Control and Prevention (CDC) and National Center for Health Statistics (NCHS), Institute for Education Sciences (IES), and International Education and Foreign Language Programs (Title VI and Fulbright-Hays). Back to this issue’s table of contents.

NIH Suspends Recently-Announced Grant Support Index Policy, Launches “Next Generation Researchers Initiative”

On June 8, National Institutes of Health (NIH) Director Francis Collins announced that based on feedback from the scientific community in response to the May 2 proposed policy change to use a Grant Support Index (GSI) as a means to “optimize stewardship of tax payers’ dollars,” NIH has decided to take “a more focused approach to increase the number of NIH-funded early-staged an mid-care investigators (ESI).” Instead of the GSI, Collins announced the agency will implement a “Next Generation Researchers Initiative (NGRI).” The issue was discussed at the June 8 NIH Advisory Committee to Director (ACD) meeting following a presentation…

Collins to Stay on at NIH; Two Other Leadership Positions Announced

On June 6, the President announced that National Institutes of Health (NIH) Director Francis Collins will stay on as NIH director. As previously reported, Collins was asked to remain in the position in January by the new administration. Collins continues to enjoy support of the Republican leadership of committees with jurisdiction over the NIH. He was officially appointed to the post despite a May 22 letter from 41 conservative House members urging the President to appoint someone whose views are more aligned the Administration’s “pro-life direction,” citing embryonic stem cell research and human cloning as examples. In addition, NIH recently…

NIH-Supported Dissemination and Implementation Research Training Institute Seeks Applications

The National Institutes of Health (NIH), led by the National Cancer Institute (NCI) and in conjunction with the U.S. Department of Veterans Affairs, is supporting a training institute designed to provide participants with a “thorough grounding in conducting D&I [dissemination and implementation] research in health across all areas of health and health care.” The Training Institute for Dissemination and Implementation Research in Health (TIDIRH) is open to investigators at any career stage interested in conducting D&I research. The training will be conducted both online and a during two-day in-person training session in Bethesda, MD, from August 14 through December 1,…

House Appropriations Subcommittee Holds Oversight Hearing on Advances in Biomedical Research

On May 17, the House Appropriations Subcommittee on Labor, Health and Human Services, Education and Related Agencies (LHHS) held an oversight hearing to discuss the advances in biomedical research by the National Institutes of Health (NIH). NIH Director Francis Collins was accompanied by Institute directors Anthony Fauci (Allergy and Infectious Diseases), Gary Gibbons (Heart, Lung, and Blood), Joshua Gordon (Mental Health), Doug Lowy (Cancer), and Nora Volkow (Drug Abuse). Welcoming the agency before the Subcommittee, Chairman Tom Cole (R-OK) noted that “investment in NIH has been the key driver in making the United States the world leader of biomedical research…

NIH Announces Major Policy Shift: Agency to Impose Cap on R01s Held by Grantees

On May 2, National Institutes of Health (NIH) Director Francis Collins announced that the agency would be initiating a new approach to grant funding designed to “optimize stewardship of tax payers’ dollars.” Essentially, the new policy would limit the number of investigator-initiated (R01) grants held by grantees to three. According to NIH, this change would affect approximately 6 percent of current investigators but would free up resources to support nearly 1,600 additional grants. Announcing the policy change, Collins stressed that the new policy would ensure that the funds given by NIH “are producing the best results from our remarkable scientific…

OBSSR Holds 10th Matilda White Riley Behavioral and Social Sciences Honors; Mark Hayward Delivers 2017 Lecture

On April 25, the National Institutes of Health (NIH) Office of Behavioral and Social Sciences Research (OBSSR) hosted its 10th annual celebration honoring Matilda White Riley’s influence in social and behavioral sciences conducted and supported by the NIH. In 2016, OBSSR renamed the celebration Real Life, Labs, Research: Matilda White Riley Behavioral and Social Sciences Honors. The ceremony honors a “who’s who of behavioral and social science research,” noted current OBSSR director Bill Riley (no relation). Mark Hayward, Professor of Sociology, Centennial Commission Professor in the Liberal Arts, and director of the Population Health Initiative at the University of Texas…

NIH Office of AIDS Research Issues RFI on FY 2019 Trans-NIH Research Plan

The National Institutes of Health (NIH) Office of AIDS Research (OAR) has issued a request for information (RFI) (NOT-OD-17-053) seeking input from the scientific community on the development of the fiscal year (FY) 2019 Trans-NIH Plan for HIV-Related Research. OAR is statutorily required to develop an annual Trans-NIH Plan that serves as the framework for its trans-NIH HIV/AIDS research budget. As previously reported, in August 2015 NIH released a Notice, NIH HIV/AIDS Research Priorities and Guidelines for Determining AIDS Funding (NOT-OD-15-137), outlining its overarching HIV/AIDS research priorities along with the guidelines the agency will use to determine AIDS funding. High priority research…

HHS Secretary Appears Before House Appropriations Subcommittee, Suggests NIH Budget Cuts to Come From “Efficiencies” in Indirect Costs

On March 29, newly appointed Secretary of the U.S. Department of Health and Human Services (HHS) former Rep. Tom Price (R-GA) made his first appearance before the House Appropriations Subcommittee on Labor, Health and Human Services, Education and Related Agencies. Welcoming the Secretary, Subcommittee Chairman Tom Cole (R-OK) began the hearing by pointing out that the proposed cuts in the Budget Blueprint (aka “skinny budget”) released by the Administration on March 16 “are extensive and span the reach of [the] agency.” Cole asked Price how the Department intends to solve “some of the challenges” the budget poses to HHS, including…

Trump Administration Releases Preliminary Details on FY 2018 Budget

On March 16, the Trump Administration released preliminary, high-level details of its fiscal year (FY) 2018 budget request, referred to as a “skinny budget.” Full budget details are expected sometime in May. There are few surprises in the President’s “safety and security” budget blueprint. Major reductions are proposed for nondefense discretionary programs (including research accounts) in order to finance $54 billion in increases for the Department of Defense. Of course, to achieve such a reallocation, Congress would need to act to adjust the budget caps that are currently governing defense and nondefense discretionary spending; the President cannot unilaterally shift funds…

COSSA Testimony Calls for Funding for NIH, AHRQ, CDC, Education Programs

On March 8, COSSA submitted testimony to the House Appropriations Subcommittee on Labor, Health and Human Services, Education and Related Agencies for fiscal year (FY) 2018. The testimony calls for increased funding for the National Institutes of Health (NIH), Agency for Healthcare Research and Quality (AHRQ), Centers for Disease Control and Prevention (CDC) and National Center for Health Statistics (NCHS), Institute for Education Sciences (IES), and International Education and Foreign Language Programs (Title VI and Fulbright-Hays). Back to this issue’s table of contents.

OBSSR Director Comments on 2017-2021 Strategic Plan

National Institutes of Health (NIH) Office of Behavioral and Social Sciences Research Director William (Bill) Riley recently released commentaries on the office’s 2017-2021 Strategic Plan three scientific priorities. Priority One: Improve the synergy of basic and applied behavioral and social sciences research Priority Two: Enhance and promote the research infrastructure, methods, and measures needed to support a more cumulative and integrated approach to behavioral and social sciences research Priority Three: Facilitate the adoption of behavioral and social sciences research findings in health research and in practice. Back to this issue’s table of contents.

Ad Hoc Group Issues Statement Responding to the President’s FY 2018 Budget for NIH

COSSA, as a member of the steering committee of the Ad Hoc Group for Medical Research, joined a statement responding to the President’s FY 2018 budget request proposing a 18 percent cut to the NIH’s budget (see related article). The statement calls on “Congress to reject the inexplicable and impractical proposed cuts to NIH and to continue its tradition of investment in medical science.” The Group also stated that it looks “forward to working with lawmakers to finalize an FY 2017 spending package with $34.1 billion for NIH – as approved nearly unanimously by the Senate Appropriations Committee in June…

Friends of NIH Behavioral and Social Sciences Research Submit Statement in Support of OBSSR

On March 9, COSSA, as co-chair of the Friends of NIH Behavioral and Social Sciences Research (Friends of NIH BSSR) with the American Psychological Association (a COSSA founding member), submitted a statement for the record in support of the National Institutes of Health and its Office of Behavioral and Social Sciences Research (OBSSR). The statement emphasizes that the behavioral and social sciences are integral to the NIH mission and highlights the fact NIH supports behavioral and social science research throughout its 27 institutes and centers. The Friends of NIH BSSR is a coalition of professional organizations, scientific societies, and research…

Senate Committee Holds Hearing: “Saving Lives Through Medical Research”

While Congress has not yet completed its work on fiscal year (FY) 2017 appropriations, Congressional committees have begun holding hearing on agencies’ FY 2018 budgets. On March 8, the Senate Subcommittee on Labor, Health and Human Services, Education, and Related Agencies (Labor-HHS) held a hearing, “Saving Lives Through Medical Research,” to discuss the budget of the National Institutes of Health (NIH). Hearing witnesses included Thomas J. Grabowski, Jr., University of Washington School of Medicine; Timothy J. Eberlein, Washington University, St. Louis; Jennifer M. Sasser, University of Mississippi Medical Center; and Stacey Schultz-Cherry, St. Jude Children’s Research Hospital.

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