Blog Archives

NIH Extends Enforcement Delay of Clinical Trials Policy Until September 2021

On July 24, the National Institutes of Health (NIH) released a notice announcing a further delay of enforcement of clinical trials reporting requirements for NIH-funded research designated as “basic experimental studies with humans.” The enforcement date, originally extended to September of this year, has been pushed to September 24, 2021. A blog post from the NIH Office of Science Policy describes the extension as necessary to address the challenges of reporting requirements for some researchers by continuing to search for common ground with the basic science community.

The notice is the latest iteration of NIH statements relating to changes to NIH’s clinical trial policy. As previously reported, NIH has established a new definition of “clinical trials” which includes some basic behavioral and social science research and mandates new reporting requirements. COSSA previously authored a Hot Topic piece detailing how the changes would affect basic research. Due to negative reactions from the basic science community on concerns of undue burden on the researchers, NIH announced a delay in the enforcement of the clinical trials policy and issued a Request for Information (RFI) to the community on best practices for implementing the policy. Read COSSA’s previous coverage for more details.

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Posted in Issue 16 (August 6), Update, Volume 38 (2019)

NIH Establishes Research Network on Opioid Use Disorder in the Criminal Justice System

The National Institutes of Health (NIH) and the National Institute on Drug Abuse (NIDA) announced the awarding of 12 grants to form the Justice Community Opioid Innovation Network (JCOIN), a network of institutions performing research on opioid use disorder in criminal justice settings. JCOIN will connect researchers, many of whom are social and behavioral scientists, with criminal justice stakeholders to help improve practices in responding to opioid abuse in high risk criminal justice institutions. The research institutions in JCOIN include treatment centers and universities – some of which are COSSA members. The network includes the following institutions:

  • New York State Psychiatric Institute
  • Baystate Medical Center
  • Friends Research Institute, Inc.
  • Texas Christian University
  • New York University School of Medicine
  • Brown University
  • University of Chicago
  • Chestnut Health Systems, Inc.
  • University of Kentucky
  • Yale University
  • George Mason University (as an un-funded coordinating body)

More information about JCOIN may be found on the NIDA website.

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Posted in Issue 16 (August 6), Update, Volume 38 (2019)

Administration Releases Updated Artificial Intelligence Research and Development Plan

On June 21, the Select Committee on Artificial Intelligence of the National Science and Technology Council (NSTC) released a 2019 update to its Artificial Intelligence (AI) Research and Development Plan. The first national AI R&D plan was released in 2016 and has been updated to include strategic priorities and accounts for new research and technologies in AI. The new strategic priorities include: making long-term investments in AI research; developing effective methods for human-AI collaboration; understanding and addressing the ethical, legal, and societal implications of AI; ensuring the safety and security of AI systems; developing shared public datasets and environments for AI training and testing; and expanding public-private partnerships to accelerate advances in AI; among others.

Artificial Intelligence is a priority of the Trump Administration and several federal research agencies, including the National Science Foundation (NSF) and National Institutes of Health (NIH), have incorporated and highlighted AI research and development at their agencies. More about the NIH AI initiatives can be found on the NIH website and more about the NSF AI initiatives can be found on the NSF website.

More information about the Trump Administration’s effort on AI can be found on the White House website.

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Posted in Issue 13 (June 25), Update, Volume 38 (2019)

COSSA Submits Testimony to Senate in Support of Funding for NIH, CDC, ED, BLS

As it does each year, COSSA submitted outside witness testimony to the Congressional Appropriations subcommittees responsible for funding federal agencies important to the social sciences. On June 3, COSSA submitted testimony to the Senate Appropriations Subcommittee on Labor, Health and Human Services, Education and Related Agencies calling for increased fiscal year (FY) 2020 funding for the National Institutes of Health (NIH), Agency for Healthcare Research and Quality (AHRQ), Centers for Disease Control and Prevention (CDC), National Center for Health Statistics (NCHS), the Bureau of Labor Statistics (BLS), Institute for Education Sciences (IES), and International Education and Foreign Language Programs (Title VI and Fulbright-Hays).

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Posted in Issue 12 (June 11), Update, Volume 38 (2019)

House Committee Approves FY 2020 Spending for NIH, CDC, BLS, AHRQ, ED

On May 8, the House Appropriations Committee approved its fiscal year (FY) 2020 Labor, Health and Human Services, Education, and Related Agencies (Labor-HHS) Appropriations Bill; the Labor-HHS Subcommittee advanced the bill on April 30. 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. In a departure from what has become regular practice, the Labor-HHS bill was one of the first out the gate this year; the often-contentious bill is typically considered later in the appropriations process once more bipartisan bills have been advanced.

At a glance…

  • The House bill includes a total of $41.084 billion for NIH in FY 2020, a $2 billion or 5 percent increase over the FY 2019 level.
  • The bill includes $8.2 billion for the CDC, a $920.6 million increase above the FY 2019 enacted level and $1.7 billion above the Administration’s request for FY 2020.
  • The House bill would provide $358.2 million for AHRQ in FY 2020, a 6 percent or $20.2 million increase compared to FY 2019.
  • The bill would provide BLS with $675.8 million, an increase of $60.8 million from FY 2019.
  • Within the Department of Education, the bill would provide $650 million to the IES, which would be a 5.6 percent increase compared to its FY 2019 enacted level and 24.6 percent above the FY 2020 funding request from the Administration.

Read on for COSSA’s full 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 10 (May 14), Update, Volume 38 (2019)

OBSSR Releases Revised Definition of “Behavioral and Social Sciences Research”

The Office of Behavioral and Social Sciences Research (OBSSR) within the National Institutes of Health (NIH) has completed its revision of NIH’s definition of “behavioral and social sciences research” (BSSR) (see previous coverage) after crowdsourcing input from stakeholders. The new definition begins:

“Behavioral and social sciences research at the National Institutes of Health involves the systematic study of behavioral1 and social2 phenomena relevant to health3.

1“Behavioral phenomena” refers to the observable actions of individuals or groups and to mental phenomena such as knowledge, attitudes, beliefs, motivations, perceptions, cognitions, and emotions.

2“Social phenomena” refers to the interactions between and among individuals, and to the characteristics, structures, and functions of social groups and institutions, such as families, communities, schools, and workplaces, as well as the physical, economic, cultural, and policy environments in which social and behavioral phenomena occur.

3”Health” refers to state of complete physical, mental, and social well-being and not merely the absence of disease or infirmity (as per WHO).”

The complete definition is posted on the OBSSR website. In an email message announcing the revision, the Office said that “some suggestions, although not reflected in the BSSR definition, will be used to for future blog post topics to share in-depth discussion of the areas of science that are included in the BSSR at NIH.”

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Posted in Issue 10 (May 14), Update, Volume 38 (2019)

OBSSR Seeks Examples of Behavioral and Social Science Accomplishments

The Office of Behavioral and Social Sciences Research (OBSSR) within the National Institutes of Health (NIH) is seeking contributions from the stakeholder community of examples of noteworthy advances in health that would not have been possible without the behavioral and social sciences. The project will be hosted on a crowdsourcing platform that will allow anyone to contribute an idea or vote on the best submissions. OBSSR is seeking as broad a list as possible—achievements do not need to have been funded by NIH or represent recent advances. More details are available in a blog post from OBSSR Director Bill Riley. Ideas can be submitted through the IdeaScale platform through July 31.

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Posted in Issue 9 (April 30), Update, Volume 38 (2019)

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)

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