Blog Archives

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 month, NIH Principal Deputy Director Larry Tabak discussed the deliberations of a working group tasked with implementing the NGRI, including a number of concerns with the policy released in August. The working group recommends that NIH shift its policy away from the arbitrary 10-year cutoffs as set in the two definitions and instead place the focus on investigators who are the most “at risk” of losing their funding, regardless of age or years since degree. Another area for concern by the working group is that existing funds are to be used to fund awards to the determined investigators, possibly diverting funds away from established researchers. NIH will continue to refine the initiative over the coming months. The working group is expected to release its report in June.

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Posted in Issue 1 (January 9), Update, Volume 37 (2018)

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 and their impacts on the social science research community in a Hot Topic piece last year. All social and behavioral science researchers who have received NIH funding in the past, or who are looking to apply in the very near future, are strongly encouraged to review this information as your research may now fall under NIH’s revised definition of a “clinical trial” and require new steps to be taken. This policy impacts funding opportunity announcements with due dates of January 25, 2018 and beyond.

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Posted in Issue 1 (January 9), Update, Volume 37 (2018)

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 can be found here.

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Posted in Issue 22 (November 14), Update, Volume 36 (2017)

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.

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Posted in Issue 22 (November 14), Update, Volume 36 (2017)

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 unnecessarily burdened with requirements relating to conducting clinical trials that have nothing to do with their own research.” The organizations hope to work with NIH leadership to find a solution that addresses the concerns of the basic science community while still improving transparency for true clinical trial research.

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

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)

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