Blog Archives

Congress Holds Hearings on FY 2020 NIH Budget

On April 2, the House 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) 2020 budget request on April 2. Present were NIH Director Francis Collins, National Institute of Child Health and Human Development (NICHD) Director Diana Bianchi, National Institute of Allergy and Infectious Diseases (NIAID) Director Anthony Fauci, National Heart Lung and Blood Institute (NHLBI) Director Gary Gibbons, National Cancer Institute (NCI) Deputy Director Doug Lowy, and National Institute on Drug Abuse (NIDA) Director Nora Volkow. Members from both parties praised NIH for its accomplishments, solidifying its position as a bipartisan priority.

Full Committee Chair Nita Lowey (D-NY), Subcommittee Chair Rosa DeLauro (D-CT), Ranking Member Tom Cole (R-OK), and other members of the subcommittee expressed concern with the $4.9 billion cut recommended in the President’s FY 2020 budget request, especially in contrast to the $2 billion increase NIH received from Congress in FY 2019. Committee members questioned the witnesses on the health trends associated with e-cigarettes and vaping, Schedule 1 substance research, the growing measles epidemic, health disparities among women and minorities, and NIH’s testing of medical treatments on animals. A written statement from Collins, along with a recording of the hearing can be found on the committee’s website.

The following week on April 11, the Senate Appropriations LHHS Subcommittee held its budget hearing with NIH leaders, including Drs. Collins, Fauci, Lowy, and Volkow, as well as National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Director Griffin Rodgers, National Institute of General Medical Sciences (NIGMS) Director Jon Lorsch, and National Institute on Aging (NIA) Director Richard Hodes. As in the House, NIH received bipartisan praise from Subcommittee members. Several senators, including Full Committee Chair Richard Shelby (R-AL), Subcommittee Chair Roy Blunt (R-MO), Ranking Member Patty Murray (D-WA) expressed concern with the cut in the President’s 2020 budget. Committee members questioned the witnesses on NIH activities relating to foreign government espionage and theft of research, preventing sexual harassment in research settings, NIH’s relationship with private research entities, developing young scientists, the opioid epidemic, and the growing measles epidemic. Written statements from Blunt and Collins, along with a recording of the hearing can be found on the committee’s website.

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Posted in Issue 8 (April 16), Update, Volume 38 (2019)

NIH Seeks Input on the Need for an Administrative Data Enclave

The National Institutes of Health (NIH) has issued a Request for Information (RFI) on the potential development of a secure data enclave within the NIH using existing funds. This enclave would allow approved research organizations to access sensitive non-public NIH information such as information on peer review outcomes, grant progress reports, and demographic information of NIH grant applicants. NIH approval would be required for researchers to access the data. The NIH is seeking information about this proposed data enclave including examples of research that is currently not pursuable without such access, whether the benefits of a data enclave are worth the opportunity cost of the necessary NIH funds, preferences about accessing a data enclave virtually or in a designated physical location, quantity of “seats” of researchers given access to the data enclave, examples of high level data protection procedures, and examples of potential research outputs from a data enclave. NIH’s Deputy Director for Extramural Research Mike Lauer published a blog post discussing the RFI in greater detail. Responses can be submitted here by May 30, 2019.

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Posted in Issue 5 (March 5), Update, Volume 38 (2019)

NIH Publishes Update on Efforts to Address Sexual Harassment in Science

On February 28, the Office of the Director of the National Institutes of Health (NIH) released an update on efforts underway at NIH to address sexual harassment in science. The update outlines that, following the National Academies of Sciences’ report on sexual harassment of women in science, NIH established the Working Group of the Advisory Committee to the Director (ACD) on Changing the Culture to End Sexual Harassment. The task of the working group is to assess the current state of sexual harassment, advise on accountability measures, propose policies, and develop strategies for encouraging research on anti-harassment policies and measures of their effectiveness. The Working Group met for the first time this month and will report interim recommendations in June and provide a final report and recommendations to the ACD in December. The update also lists several themes that will be at the center of the working group’s recommendations including demonstrating accountability and transparency, clarifying expectations for institutions and investigators to ensure a safe workplace and inform the agency, providing clear channels of communication to NIH, and listening to victims and survivors of sexual harassment and incorporating their perspectives into future actions. More information can be found in the NIH website.

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Posted in Issue 5 (March 5), Update, Volume 38 (2019)

COSSA Submits Comments on Draft NICHD Strategic Plan

On January 2, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) released a request for information (RFI) to accompany the institute’s strategic plan for the next five years, allowing the community to comment on the scientific themes, goals, and opportunities under consideration in the new plan. On February 15, COSSA submitted an official response to the RFI on behalf of the social and behavioral science community. COSSA’s comments included the following recommendations:

  • The Strategic Plan should focus on the “whole person,” to include research on development at the molecular, cellular, social, environmental, behavioral, biobehavioral, and other levels.
  • The Strategic Plan should not overlook the importance of research at all stages of child development, from prenatal/infancy through adolescence, and in normative and non-normative or at-risk environments.
  • The Strategic Plan should strongly emphasize research on social determinants of health.

More information about the NICHD strategic plan can be found on the institute’s website; COSSA’s comments can be found here.

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Posted in Issue 4 (February 19), Update, Volume 38 (2019)

NIH Requests Input on Updated Definition of “Behavioral and Social Sciences Research”

On January 14, the National Institutes of Health (NIH) issued a request for information (RFI): Request for Information (RFI): Input on Revised Definition of Behavioral and Social Sciences Research at NIH (NOT-OD-19-032). NIH’s Office of Behavioral and Social Sciences Research (OBSSR) is in the process of updating the definition of “behavioral and social sciences research” (BSSSR) that it uses to assess and monitor NIH BSSR funding. The current definition was originally developed in 1996 but has been updated periodically since then. Like the current definition, the proposed definition is somewhat lengthy (the full definition is included in the RFI). It begins:

“The behavioral and social sciences at the NIH include a multi-disciplinary set of research disciplines that have in common the study of behavior and social processes relevant to health.

“BSSR at the NIH involves the systematic study of behavioral and social phenomena, as well as their causes and consequences:

    • ‘Behavioral’ refers to overt or observable actions and to mental phenomena such as knowledge, attitudes, beliefs, cognitions, and emotions that are inferred from behavior.
    • ‘Social’ refer to the interactions between and among individuals, and to the activities of social groups, institutions, and environments, including family, community, school, workplace, economic, cultural, and policy environments.”

NIH is interested in comments that discuss whether the new definition is clear, whether it captures the full range of the NIH’s health-related behavioral and social sciences research, and how well it distinguishes BSSR from other disciplines of research. Comments will be collected through OBSSR’s crowdsourcing IdeaScale website and must be submitted by February 22, 2019.

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Posted in Issue 2 (January 22), Update, Volume 38 (2019)

White House Science Council Seeks Feedback on Opioid R&D Roadmap

The White House National Science and Technology Council is accepting comments on a report, Health Research and Development to Stem the Opioid Crisis: A National Roadmap. The report was produced by the Opioid Fast Track Action Committee (FTAC), co-chaired by Fay Lomax Cook, former Assistant Director for Social, Behavioral, and Economic Sciences (SBE) at the National Science Foundation (NSF), and Wilson M. Compton, Deputy Director of the National Institute on Drug Abuse (NIDA) within the National Institutes of Health (NIH). The report is intended to support the federal response to the opioid crisis by identifying areas for research and development (R&D) to address knowledge gaps related to opioid use, abuse, and treatment as well as opportunities for improving coordination of related federal R&D efforts.  The report describes seven overarching areas of R&D, including several with direct relevance to the social and behavioral sciences: Biology and Chemistry of Pain and Opioid Addiction, Non-Biological Contributors to Opioid Addiction, Pain Management, Prevention of Opioid Addiction, Treatment of Opioid Addiction and Withdrawal, Overdose Prevention and Recovery, and Community Consequences of Opioid Addiction. Comments are due by December 5, 2018. Instructions for responding are posted on the NIH website.

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Posted in Issue 22 (November 13), Update, Volume 37 (2018)

COSSA Encourages Response to NIH Clinical Trials RFI

As previously reported, the National Institutes of Health (NIH) has been taking steps in recent years to enhance its stewardship of and increase transparency over the clinical trials it funds. This has included the development of a new, expanded definition of the term “clinical trial,” which now applies to all research involving human subjects that involves a prospective experimental manipulation of an independent variable, and triggers the need for researchers to adhere to a number of new registering and reporting requirements using clinicaltrials.gov (see COSSA’s Hot Topic piece for details). Many basic behavioral and social science studies will be caught up in these new requirements.

NIH released a Request for Information (RFI) (NOT-OD-18-217) in September seeking input on the standards NIH should use in registration and results reporting for prospective basic science studies involving human participants (see COSSA’s previous coverage of the RFI). COSSA has issued an Action Alert to assist stakeholders concerned about this revised “clinical trials” definition in responding to the RFI. The alert includes additional context on the NIH clinical trials policy, a step-by-step guide to responding to the RFI, and sample text respondents can use in submitting their comments. Responses to the RFI are due by November 12, 2018. COSSA encourages individuals concerned about this policy to respond and share the action alert widely.

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Posted in Issue 21 (October 30), Update, Volume 37 (2018)

Trump Signs Labor-HHS Bill/CR, Pushing Remaining FY19 Spending to Dec 7

On September 28, President Trump signed into law a fiscal year (FY) 2019 funding package containing two of twelve appropriations bills, the Defense Appropriations bill and the Labor, Health and Human Services, Education Appropriations bill. The bill had been passed earlier in the week by the House of Representatives. Of particular interest to the social science community, the Labor-HHS bill contains next year’s final appropriation 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 passage of the Labor-HHS bill marks the first time in more than 20 years that this bill, which tends to be one of the most divisive among Republicans and Democrats, will be signed into law on time.

The package also includes a continuing resolution (CR) that will keep the rest of the government operating until December 7 (the new fiscal year begins next week on October 1). Congress will return after the November midterm elections and attempt to complete its work on next year’s spending bills. Notably, still pending is the Commerce, Justice, Science (CJS) Appropriations bill, which is responsible for funding the National Science Foundation and the Census Bureau, among other programs; neither the House or Senate have taken up the bill outside of committee.

Read on for COSSA’s analysis of the final FY 2019 funding levels 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 19 (October 2), Update, Volume 37 (2018)

NIH Studying Impacts of Recent Hurricanes on Health Risks and Resilience

The National Institutes of Health (NIH) has announced eight awards that will support researchers examining the health impacts of hurricanes Maria and Irma on Puerto Rico and the U.S. Virgin Islands in 2017. The grants, which are funded through the National Institute on Minority Health and Health Disparities (NIMHD), will focus on the impacts of psychosocial stressors related to the recent hurricanes, “such as grief, separation from home and loved ones, loss of income, and limited access to medical care.” More information and a full list of the grantees are available on the NIH website.

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Posted in Issue 19 (October 2), Update, Volume 37 (2018)

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)

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