Issue 16 (August 6)


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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August’s Headlines Webchat to Feature Deep Dive on Effectively Advocating from Home

headlines bannerCOSSA members are encouraged to sign up for the monthly Headlines webchat on Thursday, August 8, in which COSSA staff will recap the most important social and behavioral science news from the past month and answer participants’ questions. The August chat will feature a deep dive discussion on how to advocate for social science without having to travel to DC. Individuals employed by or affiliated with a COSSA member organization or university can register for the webchat here.

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AAPSS Answers “Why Social Science?

why-social-scienceThe latest Why Social Science? guest post comes from Tom Kecskemethy, Executive Director of the American Academy of Political and Social Science (AAPSS), who writes about how social science can guide us toward practical solutions to social problems. Read it here and subscribe.

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Budget Deal Signed; Congress Leaves for Summer Recess with FY 2020 Outcome Unknown

On August 2, President Trump signed a two-year budget agreement that provides federal programs relief from automatic spending cuts set to take effect in fiscal years (FY) 2020 and 2021 as well as raises the debt ceiling for two years. The deal allows Congress to appropriate spending increases for defense and non-defense discretionary programs, including for research, healthcare, and the upcoming 2020 Census. The passage of the budget deal clears the way for Congress to pass FY 2020 funding bills when it returns in September from its annual summer recess, but it will have to act quickly to avert a government shutdown on October 1. As COSSA has reported, the House of Representatives has nearly completed its work on FY 2020 appropriations, but the Senate delayed considering any spending bills until a deal was reached to address the limits discretionary spending. The Senate is now expected to start working in haste to draft spending bills after it returns from recess.

COSSA has also released an Action Alert for COSSA Members to communicate directly with their Senators to urge them to support social science research funding.

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House Subcommittee Holds OSTP Oversight Hearing; Senate Confirms Nominee for Chief Technology Officer

On July 24, the House Appropriations Subcommittee on Commerce, Justice, Science and Related Agencies (CJS) held an oversight hearing with the director of the White House Office of Science and Technology Policy (OSTP), Kelvin Droegemeier. Members of the Subcommittee questioned Droegemeier on a variety of topics including the White House’s position on the human impacts of climate change, Trump administration priorities in research and development, the recent activities of several OSTP joint committees, ethical concerns such as foreign interference in research and bias in artificial intelligence, and potential partnerships between OSTP and other federal agencies. Drogemeier has been a vocal proponent of social and behavioral science research and cited the importance of “tackling the social and behavioral science dimensions” of critical issues. A recording of the hearing can be found on the CJS Subcommittee website.

Later that day, the Senate Committee on Commerce, Science, and Transportation (CST) held a hearing concerning the nominations for several appointed positions including that of Michael Kratsios, nominee for Associate Director and Chief Technology Officer at OSTP. A week later on August 1, the full Senate officially confirmed Kratsios by voice vote to be the first Chief Technology Officer since 2017. Kratsios, who has been the de facto technology adviser at OSTP for two years, discussed with Committee Members his past work and policy plan for emerging technologies such as artificial intelligence and 5G technology. The full nominations hearing can be found on the CST Committee website.

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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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National Academies Releases Report on The Promise of Adolescence

The National Academies of Sciences, Engineering, and Medicine (NASEM) recently published a consensus study report on  The Promise of Adolescence: Realizing Opportunity for All Youth, which details the neurobiological as well as the social and economic factors that affect adolescent mental and physical well-being and development. The report defines adolescence as beginning with the onset of puberty and ending in the mid-20s, and it claims that key areas of the brain mature and develop during this time. This process is impacted both by the biological components of development as well as the environmental factors and stressors surrounding it, which supports an epigenetic view on adolescence. After determining the biological and genetic components, this report delves into several policy recommendations regarding programs and policies affecting adolescents to bolster their mental and physical health as well as complement their natural brain development.

The policy recommendations surround four critical areas: education, the health system, the child welfare system, and the justice system. Within education, the report details the need to rectify disparities in resources, teach practical knowledge and emotional adaptability, and foster culturally sensitive learning environments, among others. Recommendations for the health system focus not just on providing adequate access to healthcare, but also on fostering independence among adolescents, improving training of providers, and supporting more data collection and research on adolescent-specific health services. The racial disparities and disconnect of systems related to child welfare and justice systems are also emphasized in this report, with calls for enacting policies that best support growth rather than establishing punitive and antagonistic measures.

This report hopes to highlight the collective responsibility that the U.S. has to build systems that support and promote resiliency and positive adolescent development so that young people can grow successfully.

More information about the report can be found on the NASEM website.

This article was contributed by COSSA’s summer intern, Joanna Hua of Cornell University.

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