Search Results: nih

Ad Hoc Group for Medical Research Statement on President’s FY 2020 Budget for NIH

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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…

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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…

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Comment on the Proposed NIH Definition of “Behavioral and Social Sciences Research”

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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…

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December 2018 Headlines & Deep Dive on NIH Clinical Trials Policy

View the slides. COSSA’s December 2018 Headlines webchat featured a deep dive discussion with special guest Dr. William (Bill) Riley, Director of the Office of Behavioral and Social Sciences Research (OBSSR) at the National Institutes of Health (NIH), who gave an update on what’s new and exciting at OBSSR and discuss the next steps for NIH’s controversial clinical trials policy.

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Letter on NIH Clinical Trials Policy

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Statement on the NIH Definition of “Clinical Trials”

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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…

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NIH Seeks Input on BRAIN Initiative

The National Institutes of Health (NIH) is seeking feedback through November 15 on a Request for Information (RFI) on the next phase of the Brain Research Through Advancing Innovative Neurotechnologies (BRAIN) Initiative (NOT-NS-18-075). The agency is requesting input on the vision, priorities and goals outlined in the 2014 strategic plan, specifically in the following areas: ideas for new tools and technologies that have the potential to transform brain circuit research, questions about brain circuit function in humans or animal models that could be addressed with new technologies, considerations for data sharing infrastructure and policies, questions about ethical implications of BRAIN-supported…

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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. Back to this issue’s table…

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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…

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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…

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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…

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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…

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President’s FY 2019 Budget Request for HHS Agencies, NIH—Additional Details

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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…

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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…

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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…

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COSSA to Present 2018 Distinguished Service Award to Rep. Dan Lipinski, NIH’s Bill Riley

COSSA has named U.S. Representative Daniel Lipinski (D-IL) and Dr. William (Bill) Riley, Director of the Office of Behavioral and Social Sciences Research (OBSSR) at the National Institutes of Health (NIH), as the recipients of its 2018 Distinguished Service Award. The COSSA Distinguished Service Award recognizes leaders who have gone above and beyond to promote, protect, and advance the social and behavioral science research enterprise. Awardees are chosen by the COSSA Board of Directors, which represents COSSA’s governing member associations. The 2018 Distinguished Service Award will be officially presented at a reception on April 30, 2018 as part of COSSA’s…

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