Director’s Voice Blog

Celebrating a Career in the Behavioral and Social Sciences at NIH. When I took on the role of Acting Director of OBSSR, I was daunted by multiple responsibilities that came with the role, but particularly the task of writing a monthly blog. However, time flies and I can’t believe that this is blog number 17! I hope some of them have been useful and informative for you. I will be retiring from NIH soon to take on new challenges and experience new adventures. In this blog, I want to reflect on the role of the behavioral and social sciences research at NIH and how I have seen it grow and flourish over time.

Prior to joining NIH as a Public Health Service officer in 2006, I spent 10 years as an active-duty clinical health psychologist in the U.S. Air Force. My career jump to NIH was based on my excitement about being able to contribute to shaping and advancing the behavioral and social science research (BSSR) vision and initiatives.
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Behavioral and Social Sciences Research Spotlights

Using machine learning with electronic health records to help predict opioid use disorder among U.S. veterans
Although opioid prescription rates have decreased since 2012, many patients still receive opioids and are on long-term opioid therapy. It is estimated that one out of four patients receiving long-term opioid therapy in primary care have opioid use disorder (OUD) and 4.7% of all pain patients prescribed an opioid will develop prescription OUD. Because of challenges in identifying patients with OUD, these are likely underestimates of the true rates of OUD in the population. Being able to accurately predict the potential for developing OUD could enhance efforts to prioritize prevention of opioid overdoses, as well as other adverse health outcomes related to opioid misuse and dependence.
Recently published research supported by NIMH and others utilized electronic health records (EHRs) from the Veterans Health Administration (VHA) to explore factors predicting OUD during the period when opioid prescribing was increasing (2000-2012) compared to when it was decreasing (2013-2021).
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Brain maturation sequence sheds light on youth sensitivity to neighborhood impacts through adolescence
In a recent study, researchers supported by NIMH, NIDA, NINDS, NIBIB, NSF, and others, investigated how developmental processes from ages 8 to 23 occur across the human brain using magnetic resonance imaging (MRI). Over the course of development, it has been the general understanding that children have higher brain plasticity than adults. Brain plasticity refers to the capacity for neural connections and pathways in the brain to change or reorganize in response to internal biological signals or the external environment. Prior studies in animal models have shown that intrinsic brain activity, which occurs when the brain is at rest, or not being engaged by external stimuli or a mental task, is higher and more synchronized when a brain region is less developed and more plastic. As a result, measurements of brain activity waves show an increase in amplitude (or height). Using this information, allowed for the research team to study a functional marker of brain plasticity safely and non-invasively in youth and young adults.
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Study finds increase in smoking prevalence and age of initiation among US young adults from 2002 to 2019
Tobacco use is the leading cause of preventable death in the United States, which has driven several decades’ worth of public health efforts regarding prevention of smoking initiation, particularly among adolescents who are more likely to engage in risky behaviors. These prevention efforts have resulted in a significant decrease in the prevalence of smoking among adolescents in the United States. However, recent studies have also shown that the average age of smoking initiation has increased; in fact, the proportion of young adults beginning to smoke (among all US young adults who report tobacco use) has doubled from 20% to 40% over a 16-year period. It is less clear whether there are sociodemographic differences among young adults in the US with respect to smoking initiation.
A recent study supported by NCI, NIDA, and the FDA aimed to pursue this next level of inquiry by investigating whether prevalence of smoking and smoking initiation differs by race, ethnicity, and education among young adults (ages 21 to 25 years) in the US between 2002 and 2019.
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NEWS and EVENTS

Unleashing the Power of Prevention To Enhance Well-Being Across the Lifespan
May 25, 2023
12:00 p.m. – 1:15 p.m. ET

Speaker: Margaret Kuklinski, Ph.D., University of Washington School of Social Work

How can we promote well-being in young people and prevent problems before they begin? It’s a crucial and timely question, and it has spurred study and discovery of risks to and protective factors for young people’s development. This area of research has also led to tested, effective preventive interventions showing better outcomes that in some cases have lasted for decades and across generations.

In her talk, Dr. Margaret Kuklinski will trace the evolution of prevention science and share the latest findings from longitudinal intervention studies based on the Social Development Strategy. Examples include Guiding Good Choices, a program for parents and caregivers to help them support positive development and the prevention of behavioral problems in their children, and Communities That Care, a prevention system. Dr. Kuklinski will also describe what is needed to increase the equitable reach and impact of effective health promotion and prevention approaches.
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Virtual Workshop: Advancing the science of aggression across species and disciplines
On June 14 and 15, 2023, (1:00 – 5:00 p.m. ET each day) OBSSR and collaborating NIH ICOs will host a virtual workshop, Advancing the science of aggression across species and disciplines. The workshop will be available for live public viewing on the NIH Videocast. Goals of the workshop include bringing together both animal and human aggression researchers from various backgrounds to facilitate dialogue across disciplines, individual and interpersonal levels of analysis, lifespan, and disorders/diseases; identifying barriers and potential solutions to move research on basic mechanisms of aggression and health to inform intervention development as well as identify opportunities for more use-inspired basic research; and identifying research gaps and opportunities in the science of aggression and health in the service of advancing progress in prevention, assessment, and treatment.

Plenary Speakers:
Dayu Lin, Ph.D., NYU Grossman School of Medicine
Terrie E. Moffitt, Ph.D., Duke University, King’s College London
L. Syd M Johnson, Upstate Medical University
Celia Fisher, Fordham University

Registration is not required. This virtual workshop will be live streamed through NIH Videocast. Participants will have the opportunity to ask questions through the live videocast.

June 14, 2023: https://videocast.nih.gov/watch=49267
June 15, 2023: https://videocast.nih.gov/watch=49269
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Webinar: NIH Research Enhancement Award (R15)…What You Need to Know!
NIH is hosting a webinar NIH Research Enhancement Award (R15) …What You Need to Know! on June 15, 2023 at 2:30 pm ET. This webinar will explore how R15 programs can be leveraged to unlock the potential of educational institutions in conducting meritorious research, exposing students to research opportunities, and strengthening the overall research environment.

R15 grant programs support small-scale research projects at educational institutions that provide baccalaureate or advanced degrees for a significant number of the Nation’s research scientists but that have not been major recipients of NIH support. The R15 award includes two programs:

  • AREA: Academic Research Enhancement Award for Undergraduate-Focused Institutions
  • REAP: Research Enhancement Award Program for Health Professionals and Graduate Schools

    Register

HHS Launches the Children and Youth Resilience Challenge
The Resilience Challenge will award prizes to innovative, community-led solutions that:

  • Promote resilience and advance mental health and well-being
  • Reduce the risk for negative mental health outcomes among children and youth
  • Promote positive strategies and solutions that help children and youth thrive
  • Identify and elevate promising practices that promote culturally and linguistically responsive protective factors

The Resilience Challenge will include a proposal phase and a pilot phase for selected finalists. The 14 Phase 1 finalists will receive $25,000 each in the fall of 2023. One grand prize winner will receive $300,000 and up to two runners-up will receive $175,000 each in the spring of 2024. Proposals are due by 11:59 p.m. EDT on Friday, July 7, 2023.

Contact ResilienceChallenge@hhs.gov for questions.
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NIH Institutional Excellence in Diversity, Equity, Inclusion, and Accessibility in Biomedical and Behavioral Research Prize Competition
NIH is now accepting submissions for a new initiative that rewards effective strategies for enhancing diversity, equity, inclusion, and accessibility (DEIA) in research environments: the NIH Institutional Excellence in Diversity, Equity, Inclusion, and Accessibility (DEIA) in Biomedical and Behavioral Research Prize Competition.

The prize competition will recognize and reward biomedical and behavioral science institutions that have identified gaps in DEIA and designed, implemented, and evaluated interventions to address them. It also aims to identify effective practices for enhancing DEIA within faculty, postdoctoral scholars, and student bodies that can be feasibly disseminated for adoption by other institutions.

NIH will award up to 10 prizes of $100,000 each through the competition. Up to half of the prizes will be set aside for consideration for limited-resourced institutions. NIH may also recognize additional entries as honorable mentions with nonmonetary awards.

Prospective applicants are strongly encouraged to attend the prize competition preregistration webinar on May 17, 2023.

Visit the Prize Competition website to review the eligibility and participation rules and to submit a written entry. The deadline to apply is September 26, 2023.
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NIH Music-Based Intervention Toolkit: Music-Based Interventions for Brain Disorders of Aging
Music-based interventions (MBIs) show promise for managing symptoms of various brain disorders. To fully realize the potential of MBIs and dispel the outdated misconception that MBIs are rooted in soft science, the NIH is promoting rigorously designed, well-powered MBI clinical trials. The pressing need of guidelines for scientifically rigorous studies with enhanced data collection brought together the Renée Fleming Foundation, the Foundation for the NIH, the Trans-NIH Music and Health Working Group, and an interdisciplinary scientific expert panel to create the NIH MBI Toolkit for research on music and health across the lifespan. The Toolkit defines the building blocks of MBIs, including a consolidated set of common data elements for MBI protocols, and core datasets of outcome measures and biomarkers for brain disorders of aging that researchers may select for their studies. Utilization of the guiding principles in this Toolkit will be strongly recommended for NIH-funded studies of MBIs.
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Recently Published Funding Opportunities

 

Emergency Award: Novel Insights through Cross-Site Analyses of Existing RADx-UP Data
(R21 Clinical Trial Not Allowed)

NOFO Number
RFA-OD-23-050

Key Dates
Open Date (Earliest Submission Date): June 2, 2023
Expiration Date: July 4, 2023

Purpose
This notice of funding opportunity (NOFO) will support analyses of existing RADx-UP data by proposing novel questions related to SARS-CoV-2 testing and health disparities. These projects will explore important questions focused on COVID-19 testing access and uptake, factors affecting testing and related COVID-19 outcomes, and meta-analyses of specific COVID-19 response and intervention approaches within and across populations.

View RFA-OD-23-050

 

Emergency Award: RADx-®UP Dissemination and Implementation (D&I) Research on COVID-19 Testing Interventions among Underserved and Vulnerable Populations
(R01 Clinical Trial Optional)

NOFO Number
RFA-OD-23-051

Key Dates
Open Date (Earliest Submission Date): June 9, 2023
Expiration Date: July 11, 2023

Purpose
The purpose of this notice of funding opportunity (NOFO) is to support dissemination and implementation (D&I) research focused on increasing access to and uptake of coronavirus disease 2019 (COVID-19) testing interventions – with the goal of reducing COVID-19 disparities and promoting health equity among underserved and vulnerable populations. This NOFO will support D&I research on how evidence-based practices, interventions, and policies are effectively translated to and used in real-world settings.

View RFA-OD-23-051

 

BRAIN Initiative: Exploratory Team-Research BRAIN Circuit Programs – eTeamBCP
(U01 Clinical Trials Optional)

NOFO Number
RFA-NS-23-025

Key Dates
Open Date (Earliest Submission Date): May 15, 2023
Expiration Date: June 15, 2024

Purpose
This notice of funding opportunity (NOFO) is designed to support teams of three or more (up to six) PDs/PIs that seek to cross boundaries of interdisciplinary collaboration to elucidate the contributions of dynamic circuit activity to a specific behavioral or neural system. Applications are encouraged to propose adventurous and challenging goals that can only be tackled by a synergistic team-based approach and have the potential to be transformative and/or to enable significant advances.

View RFA-NS-23-025

 

BRAIN Initiative: Targeted BRAIN Circuits Projects- TargetedBCP
(R01 Clinical Trial Not Allowed)

NOFO Number
RFA-NS-23-024

Key Dates
Open Date (Earliest Submission Date): May 30, 2023
Expiration Date: October 3, 2024

Purpose
This notice of funding opportunity (NOFO) solicits applications for research projects that seek to understand how circuit activity gives rise to mental experience and behavior using innovative, methodologically-integrated approaches. The goal is to support adventurous projects that can realize a potentially transformative outcome within 5 years.

View RFA-NS-23-024

 

BRAIN Initiative: Targeted BRAIN Circuits Planning Projects – TargetedBCPP
(R34 Clinical Trials Not Allowed)

NOFO Number
RFA-NS-23-023

Key Dates
Open Date (Earliest Submission Date): May 30, 2023
Expiration Date: October 3, 2024

Purpose
This R34 notice of funding opportunity (NOFO) solicits applications that offer a limited scope of aims and an approach that will establish feasibility, validity, or other technically qualifying results that, if successful, would support, enable, and/or lay the groundwork for a potential, subsequent Targeted BRAIN Circuits Projects – Targeted BCP R01, as described in the companion NOFO (RFA-NS-23-024). Applications should be adventurous, exploratory research projects that use innovative, methodologically-integrated approaches to understand how circuit activity gives rise to mental experience and behavior.

View RFA-NS-23-023

 

NIH Blueprint for Neuroscience Research: Tools and Technologies to Explore Nervous System Biomolecular Condensates
(R21 Clinical Trial Not Allowed)

NOFO Number
RFA-DA-24-039

Key Dates
Open Date (Earliest Submission Date): October 14, 2023
Expiration Date: November 15, 2023

Purpose
The purpose of this notice of funding opportunity (NOFO) is to support the development of innovative tools and/or technologies to monitor or manipulate biomolecular condensates (BMCs) in vivo and enable investigators to adopt these tools to answer outstanding questions in basic neuroscience. This research will transform our understanding of the mechanistic role of BMCs in human nervous system health and disease and may serve as the foundation for the development of novel BMC-based therapeutics.

View RFA-DA-24-039

 

BRAIN Initiative: Research Resource Grants for Technology Integration and Dissemination
(U24 Clinical Trial Not Allowed)

NOFO Number
RFA-NS-23-026

Key Dates
Open Date (Earliest Submission Date): May 14, 2023
Expiration Date: October 12, 2024

Purpose
This notice of funding opportunity (NOFO) supports efforts to disseminate resources for integration into neuroscience research practice. The resource(s) should be relevant to the goals of the BRAIN Initiative as outlined in the “BRAIN 2025: A Scientific Vision” and “The BRAIN Initiative 2.0: From Cells to Circuits, Toward Cures” and shared broadly to the neuroscience community.

View RFA-NS-23-026

 

Notice of Intent to Publish a Funding Opportunity Announcement for NIH Blueprint and BRAIN Initiative Program for Enhancing Neuroscience Diversity through Undergraduate Research Education Experiences (BP BRAIN-ENDURE)
(R25 Clinical Trial Not Allowed)

Notice Number
NOT-NS-23-048

Key Dates
Estimated Publication Date of funding announcement: August 1, 2023
First Estimated Application Due Date: February 8, 2024
Earliest Estimated Start Date: December 2, 2024

Purpose
NIH Blueprint for Neuroscience Research and BRAIN Initiative intends to reissue a Notice of Funding Opportunity (NOFO) for receipt of new and renewal applications for its research education program for neuroscience focused undergraduates. The overall objective of this funding opportunity will be to increase the number of undergraduate participants from diverse backgrounds, including individuals from underrepresented groups who successfully enter and complete Ph.D. degree programs in the neurosciences. To accomplish this goal, this initiative would support the development of collaborative research education partnerships to increase participant’s awareness and interest in the neurosciences, develop participants’ scientific knowledge and research skills that would allow them to progress and transition to more advanced neuroscience related research education and training activities, and establish working networks within existing Ph.D. degree granting and NIH-supported predoctoral T32 neuroscience programs.

View NOT-NS-23-048

BSSR Accomplishments

 

The NIH has been an instrumental leader in shaping and supporting behavioral and social sciences research (BSSR) to improve the nation’s health. Integrated with advances in other scientific disciplines, BSSR has made substantial contributions to the prevention or treatment of numerous physical health and mental health conditions.

In collaboration with subject matter experts from Institutes, Centers, and Offices across NIH, OBSSR has summarized some of the important scientific advances that demonstrate the valuable contribution of BSSR across various health conditions and behaviors. These summaries are provided as fact sheets (PowerPoint slides forthcoming) that highlight a significant public health problem and the corresponding BSSR-informed approaches used to address the problem. Various audiences such as academic researchers, public health organizations, and other health federal agencies, may find these materials useful to demonstrate to their stakeholders the importance of BSSR to the health of the United States population.

These new BSSR accomplishment resources are available on the OBSSR website:

Improving Sleep
Managing Chronic Pain
Preventing and Treating Diabetes
Preventing Intimate Partner Violence 
Reducing Teen Pregnancy
Reducing Tobacco Use

Treating Depression
Treating Obsessive-Compulsive Disorder
Treating Phobias
Treating Post-Traumatic Stress Disorder

Additional BSSR accomplishments will be added to the website in 2024.

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BSSR Clinical Trials Resources

 

Clinical Trials Protocol Template for the Behavioral and Social Sciences

The Clinical Trials Protocol Template for the Behavioral and Social Sciences is a resource for communicating the science, methods, and operations of a clinical trial. This template is a suggested format for clinical trials that are testing a behavioral or social intervention or experimental manipulation. Use of the protocol template is encouraged but not required.

The Behavioral and Social Clinical Trials Template was derived from the successful NIH-FDA Phase 2/3 IND-IDE Clinical Trial Template but was adapted to include terminology and approaches used by behavioral and social scientists.

While the template is a suggested format for clinical trials that are testing a behavioral or social intervention or manipulation for which a stand-alone clinical protocol is required, the template can also be a useful tool for those trials funded by NIH Institutes or Centers that do not require stand-alone clinical protocols. Using the template to anticipate decision points and potential challenges before a study launches can help avoid subsequent delays and problems.

Decision Support Tool: Features to Consider in Determining If a Clinical Trial is Phase II or Phase III

This document is the result of a working group led by OBSSR, with participants from other Institutes, Centers, and Offices. It is a designed to be a resource to help investigators, program officers, and reviewers determine if a behavioral or social science study is better characterized as a Phase II or a Phase III clinical trial. Distinguishing earlier phases of clinical trials (Phase 0 or I) is not usually difficult but distinguishing between a Phase II and III study can be more challenging, particularly for non-drug trials. Being thoughtful about this distinction is important for a variety of reasons, not least of which is that a Phase III designation for an NIH funded clinical trial generally requires following additional policies and practices beyond those that already apply to Phase II clinical trials, such as the requirement for valid analysis and for a Data and Safety Monitoring Board (DSMB).

Phase III Trials 

NIH’s definition of a Phase III clinical trial is quite broad, including drug studies, device studies, behavioral interventions, epidemiological studies, community trials, and more. Phase III trials are usually large, prospective trials that compare two or more interventions against other standard or experimental interventions. In this next episode of our NIH All About Grants podcast (MP3 / Transcript) we explain what a Phase III trial is, how it compares to other types of clinical trials, considerations for your application and its review, how these studies influence standards of care, helpful tools and other resources, and much more. The guests include Ms. Dawn Corbett, NIH’s Inclusion Policy Officer, and Dr. Christine Hunter, OBSSR Acting Director.

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Social and Behavioral Good Clinical Practice eCourse

 

In September 2016, the NIH issued a Policy on Good Clinical Practice (GCP) Training for NIH Awardees Involved in NIH-funded Clinical Trials. GCP is an international ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials. The principles of GCP help assure the safety, integrity, and quality of clinical trials. Investigators and clinical trial staff who are competent in GCP principles will be better able to assure that the rights, safety, and well-being of human subjects are protected; that clinical trials are conducted in accordance with approved plans and with rigor and integrity; and that data derived from clinical trials are reliable.

Extramural Researchers can go here to take the course.
NIH Employees can go here to take the course. (NIH login required)
Educational Facilities can Download the Good Clinical Practices for Social and Behavioral Sciences Course for your educational facility’s Learning Management System (LMS).

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