Blog Archives

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 a primary reason. According to the report, funding shortages and instability has limited the research on firearm safety and storage that could have been conducted by the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), and the Department of Justice (DOJ).

The report cites an analysis published in the Journal of the American Medical Association that compared available funding and publication volume for research on various leading causes of death and found that “research on firearms receives disproportionately low funding and has fewer publications compared to other top causes of death.” The lack of funding can lead to shortage of expertise in the field. One researcher interviewed told the GAO that “he discourages new students from firearm research exclusively because they will not be able to make a living in that research area alone.” Further, a shortage of high-quality data on firearms exacerbates the difficulty of conducting research in this area. The CDC’s Behavioral Risk Factor Surveillance System (BRFSS) has not included questions related to firearm safety since 2004. However, the CDC does plan to add a module on firearms in the 2017 survey, on the recommendation of the National Academy of Medicine.

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Posted in Issue 21 (October 31), Update, Volume 36 (2017)

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 blog post and short video on October 11 that provides specific guidance on how to complete the new PHS Human Subjects and Clinical Trial Information form, which will now be required for all grant applications submitted on or after the January 25, 2018 due dates. All researchers are encouraged to familiarize themselves with the new form.

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Posted in Issue 19 (October 3), Update, Volume 36 (2017)

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

Hot Topic LogoThe 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 research community started to take notice of the potentially significant impacts this new definition could have on a variety of basic research activities funded by the NIH, which will now be considered clinical trials. Although it was developed with the traditional NIH biomedical research clinical trial in mind and in response to concerns about study results going unreported, the social and behavioral sciences are impacted as well.

The 2016 notice states that “the revision is designed to make the distinction between clinical trials and clinical research studies clearer and to enhance the precision of the information NIH collects, tracks, and reports on clinical trials.” While it further states that the intention is not to “expand the scope of the category of clinical trials,” the resulting policy does just that.

Read on for COSSA’s full analysis of the changes.

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Posted in Issue 19 (October 3), Update, Volume 36 (2017)

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 omnibus (see related article).

The next step for the bill is consideration by the full Senate. However, Congress recently struck a deal with the White House on a continuing resolution (CR) to keep the government funded into next fiscal year (which begins October 1) through December 8. This is intended to provide additional time for lawmakers to come to agreement on overall budget levels, including the spending caps that are currently casting a major shadow on the FY 2018 appropriations bills; the bills have been written to exceed the caps currently set in law, signaling that a budget deal could be negotiated in the weeks ahead.

Read on for COSSA’s analysis of the Senate 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 18 (September 19), Update, Volume 36 (2017)

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 research degree or end of post-graduate clinical training, whichever date is later, within the past 10 years and who has not previously competed successfully… for a substantial NIH independent research award.” An Early Established Investigator is a “program director/principal investigator who is within 10 years of receiving their first substantial, independent competing NIH R01-equivelent research award as an ESI.” Funding will be prioritized for an EEI if “(1) The EEI lost or is at risk for losing all NIH research support if not funded by competing awards this year, or (2) The EEI is supported by only one active award.”

The new policy will take effect this year (fiscal year 2017), with a goal of funding approximately 200 more ESI and EEI researchers (each) than were supported in FY 2016. Individual institute and center (IC) directors are tasked with determining how best to re-prioritize funding to enable these investments this year. A working group of the Advisory Committee to the Director (ACD), which advises the NIH Director, has been established to monitor the implementation of the new policy.

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Posted in Issue 17 (September 5), Update, Volume 36 (2017)

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 of biospecimens, and innovative data collection methodology associated with the cohort.

The deadline for comments has been extended to September 13.

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Posted in Issue 17 (September 5), Update, Volume 36 (2017)

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 Abuse (NIDA), and Joshua Gordon of the National Institute of Mental Health (NIMH).

As previously reported, the Trump Administration’s budget request for NIH seeks a cut of $7 billion or about 22 percent from current levels. The proposed reduction came at the same time Congress was putting the finishing touches on its $2 billion increase for the agency in FY 2017. NIH funding has long been one of the rare instances of unified, bipartisan support in Congress. In fact, at the outset of the hearing, LHHS Subcommittee Chairman Roy Blunt (R-MO) criticized the President’s request, stating that he “fundamentally disagree[s] with the proposed reduction.” While over the last two years Congress has worked to increase the NIH budget by more than 13 percent, the Administration offers a budget that would result in the loss of 90,000 jobs and $15.3 billion in economic activity, stated the chairman. Subcommittee Ranking Member Patty Murray (D-WA) added that the proposed cut would represent the lowest funding level for the agency since 2002. Other Subcommittee members expressed their objection to the request and pledged their support for increased NIH funding again in FY 2018. (more…)

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Posted in Issue 13 (June 27), Update, Volume 36 (2017)

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).

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Posted in Issue 12 (June 13), Update, Volume 36 (2017)

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 by NIH Principal Deputy Director Lawrence Tabak.

According to the NIH Director, NGRI will:

  • Make “substantial funds from NIH’s base budget” available to support “additional meritorious” ESI and mid-career investigators who are defined as individuals with less than ten years as a principal investigator and “are about to lose all NIH funding or are seeking a second award for highly meritorious research.” Beginning this year, total funding will be $210 million (the amount needed to fund these additional investigators in the first year) and gradually increase to approximately $1.1 billion per year, depending on available resources.
  • Track the impact of the 27 NIH institutes and centers funding decisions for early- and mid-career investigators “with fundable scores to ensure this new strategy is effectively implemented in all areas of research.”
  • Place greater emphasis on special awards with the aim of supporting early-career investigators “with applications that score in the top 25th percentile,” including such awards as: the NIH Common Fund New Innovator Awards, the National Institute of General Medical Sciences’ (NIGMS) Maximizing Investigators’ Research Award (MIRA), the National Institute of Arthritis and Musculoskeletal and Skin Diseases’ (NIAMS) Supplements to Advance Research (STAR) from Projects to Programs, and the National Institute of Dental and Craniofacial Research (NIDCR) Sustaining Outstanding Achievement in Research (SOAR) award.
  • “Encourage multiple approaches to develop and test metrics that can be used to assess the impact of NIH grant support on scientific progress.” In the short term, according to Tabak, the agency needs “validated metrics for output (productivity)” and metrics for grant support that are based on commitment and not on dollars. A working group of the ACD will review analyses and will be discussed at future ACD meetings.

NIH launched a new web page and will continue to receive feedback via the Open Mike blog or via email to publicinput@od.nih.gov. A recording of the discussion can be viewed via videocast on NIH’s website.

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Posted in Issue 12 (June 13), Update, Volume 36 (2017)

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 announced the appointments of Norman E. Sharpless as the next director of the National Cancer Institute (NCI) and Christine Hunter as Deputy Director of the Office of Behavioral and Social Sciences Research (OBSSR).

On June 12, Collins announced the appointment of Dr. Norman E.  Sharpless as the next NCI director. Dr. Sharpless is currently serving as the director of the University of North Carolina at Chapel Hill (UNC-CH) Lineberger (NCI-designated) Comprehensive Cancer Center and as the Wellcome Distinguished Professor in Cancer Research. Sharpless earned his undergraduate and medical degrees from UNC-CH and completed his medical residency at Massachusetts General Hospital and a fellowship in hematology/oncology at Dana-Farber/Partners Cancer Care.

OBSSR Director William Riley also recently announced the appointment of Christine Hunter as Deputy Director. She will begin her tenure August 7. Hunter is currently the Director of Behavioral Research at the National Institute of Diabetes & Digestive and Kidney Diseases (NIDDK) and is a Captain in the U.S. Public Health Service (PHS). At NIDDK, Dr. Hunter led the revision of the NIH Obesity Research Strategic Plan “and developed and led the NIDDK Centers for Diabetes Translation Research,” according to an announcement circulated to OBSSR staff.

Dr. Hunter serves on the National Collaborative on Childhood Obesity Research (NCCOR), the Opportunity Network for Basic Behavioral and Social Sciences Research (OppNet), the Science of Behavior Change (SOBC), and the Behavior and Environment Subcommittee of the NIH Obesity Research Task Force. As a member of the NIH Behavioral and Social Sciences Coordinating Committee, Dr. Hunter served on the NIH OBSSR Strategic Plan Working Group.

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Posted in Issue 12 (June 13), Update, Volume 36 (2017)

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