NIH
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…
House Members Join Together to Support NIH, Title VI International Education in Dear Colleague Letters
As Congress begins deliberations on fiscal year (FY) 2019 spending, groups of Representatives have joined together to express their support for federal programs, including those important to the social and behavioral sciences. A bipartisan group of 82 representatives signed on to a “Dear Colleague letter” in support of the Department of Education’s Fulbright-Hays and Title VI international education programs. The letter calls for at least $72.16 million for the two programs. Separately, a bipartisan group of 209 Representatives also joined together to express support, and request $38.4 billion, for the National Institutes of Health (NIH). Back to this issue’s table…
OBSSR Soliciting Papers for 11th Annual Matilda White Riley Honors
The Office of Behavioral and Social Sciences Research (OBSSR) at the National Institutes of Health (NIH) is seeking paper submissions for its Early Stage Investigator Paper Competition as part of the 11th Annual Matilda White Riley Behavioral and Social Science Honors. Early stage investigators are encouraged to submit one published article from 2017 that reflects social and behavioral science advancements helping to enhance life, lengthen life, reduce illness, and reduce disability. Honorees will present their findings on May 31, 2018 in a public event on the NIH campus. Submissions are due by February 18 and more information can be found…
NIH Continues to Tweak Policy for Investing in Young Researchers
As previously reported, the National Institutes of Health (NIH) announced over the summer a new policy aimed at increasing the number of early career investigators competing successfully for NIH grants. The Next Generation Researchers Initiative (NGRI) included two new definitions of early career investigators: Early Stage Investigators (ESIs) would include researchers who completed their degrees within the last 10 years and have not yet received their first NIH grant; Early Established Investigators (EEIs) would have to be within 10 years of receiving their first independent R01-equivelent research award. In a presentation to the NIH Advisory Committee to the Director last…
NIH “Clinical Trials” Definition Moving Forward: Researchers Take Notice
As previously reported, 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. In a recent blog post, Mike Lauer, Deputy Director for Extramural Research, explained that while no changes have been made to the definition of a clinical trial, which is the primary area of concern for the social science community, the case studies developed by NIH to help investigators determine whether their research would now fall under the new definition have been updated and clarified. COSSA described the planned changes…
OBSSR to Host Annual Research Festival on December 8
The National Institutes of Health (NIH) Office of Behavioral and Social Sciences Research (OBSSR) is hosting the “NIH Behavioral and Social Science Research Festival: Connecting People to Advance Health” on Friday, December 8. The festival will bring together behavioral and social scientists from inside and outside NIH to network, collaborate, and share ideas. The agenda will include a keynote address from Dr. Eliseo Perez-Stable of the National Institute on Minority Health and Health Disparities as well as plenary sessions on international research, behavioral neuroscience, and social factors and health. This event will not be webcast. More details and registration information…
NIA Releases Request for Information on Challenge Prize for Alzheimer’s Research
On November 2, the National Institute on Aging (NIA) of the National Institutes of Health (NIH) released a Request for Information (RFI) to solicit feedback and ideas for a Challenge Prize on Alzheimer’s and related dementias research. This Challenge Prize is being conducted as part of the implementation of the 21st Century Cures Act and is the first Challenge Prize from the NIA. The institute is requesting suggestions for what prize goals should be established and other specific ideas for what should be considered in the Challenge Prize. Responses must be submitted by December 31. Back to this issue’s table…
COSSA Joins Societies in Requesting Changes to NIH Clinical Trial Policy
In a letter sent to National Institutes of Health (NIH) Director Francis Collins on October 27, COSSA and 21 other scientific societies and associations requested that NIH revisit a new policy that alters the definition of “clinical trials” funded by the agency and institutes new reporting requirements for such research (see COSSA’s coverage of this issue). While the letter is supportive of the goal of enhancing transparency of NIH-funded research, including introducing registration and reporting requirements, the signatories express concern that “basic science research is being redefined as a clinical trial at NIH and that “basic science investigators will be…
Labor, Health and Human Services Subcommittee Holds Hearing on Indirect Costs of Research
The House Appropriations Subcommittee on Labor, Health and Human Services, and Education held a hearing on October 24 on the role of facilities and administrative costs (also known as indirect costs) in supporting NIH-funded research. The hearing included testimony from Dr. Kelvin Droegemeier, Vice President of Research at the University of Oklahoma; Dr. Gary Gilliland, President of the Fred Hutchinson Cancer Research Center; Dr. Bruce Liang, Dean of the University of Connecticut School of Medicine; and Dr. Keith Yamamoto, Vice Chancellor for Science Policy and Strategy at the University of California, San Francisco. Dr. Droegemeier’s written testimony included a history…
GAO Report on Firearm Storage Highlights Lack of Federal Funding for Gun Research
The Government Accountability Office (GAO) recently released a report entitled Personal Firearms: Programs that Promote Safe Storage and Research on Their Effectiveness that compiles information on public and non-profit programs promoting safe storage of personal firearms and the results of research on the effectiveness of such programs. The report was produced at the request of 19 Democratic senators, including Sen. Patty Murray (D-WA), the Ranking Member of the Committee on Health, Education, Labor, and Pensions (HELP). The report finds that “there is relatively little research on safe firearm storage,” and that “lack of funding and data” is often cited as…
NIH Provides Guidance on New Human Subjects, Clinical Trials Form
As previously reported, 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. COSSA described the planned changes and their impact on the social science research community in a Hot Topic piece earlier this month. All social and behavioral science researchers who have received NIH funding in the past, or who are looking to apply in the future, are strongly encouraged to review this information as your research may now fall under NIH’s revised definition of a “clinical trial.” NIH released a…