Director’s Voice Blog

Celebrating the Behavioral and Social Sciences Supported by NIH. On the afternoons of November 18th and 19th, the NIH Behavioral and Social Sciences Research Coordinating Committee will be hosting its sixth NIH Behavioral and Social Sciences Research Festival.  This annual event provides a venue for the NIH Institutes and Centers to highlight a few of the many recent NIH grant awardees who advance and accelerate the research on the behavioral and social contributions to health.

This year, our keynote speaker will be Shannon Zenk, Ph.D., M.P.H., RN, FAAN, the recently appointed Director of the National Institute of Nursing Research. Dr. Zenk joined NINR in September 2020, following a 14-year career as a faculty member at the University of Illinois Chicago (UIC) College of Nursing and the UIC Institute for Health Research and Policy. Her research focuses on community environments as a social determinant of health and health inequities. Dr. Zenk’s keynote will kick off Day 2 of the festival (Nov. 19 at 1:00pm ET), and we all look forward to her perspectives on health inequities, community environments, and the future directions of NINR.

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Behavioral and Social Sciences Research Spotlights

 

Development of brain’s emotion circuitry is altered by early-life abuse

Childhood abuse is a major contributor to the development of psychopathology, but the impact of abuse on particular brain circuit development and its combined contribution to later psychopathology is not well known. In a study funded by NIMH, NCATS, NSF, and other funders, researchers found that girls who experienced childhood abuse had altered brain development patterns depending on whether they developed psychiatric symptoms later in life.

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Promoting physical exercise by applying engineering tools to personalize fitness tracker messages

Is it possible to create a personalized approach to health messaging that will promote more physical activity based on individual (or person-specific) behavior? Sponsored by the NHLBI and the NSF, a recent study tested this question by studying physical activity of 45 young adults in response to a variety of messaging approaches. The novelty of this paper is that the researchers were able to evaluate new mathematical models of human behavior through controlled system engineering tools to design feedback based on the current state of the individual. With accumulating data feedback, the model determined the best time to send a message to impact physical activity.

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Certain personality traits linked to Alzheimer’s disease risk

In a recently published research, researchers supported by the NIA found that changes in the brain associated with Alzheimer’s disease (AD) are correlated with an individuals’ personality traits. In this study, the researcher looked at the underlying neuropathological changes in the brain and examined how these changes were related to personality traits prior to any clinical diagnosis of dementia. Based on previous research, they focused on two personality traits previously linked to the risk of dementia: neuroticism, which measures a predisposition for negative emotions, and conscientiousness, which measures the tendency to be responsible, careful, and goal oriented.

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News and Events

Register and View Agenda: NIH Behavioral and Social Sciences Research Festival

Join OBSSR virtually on Thursday, November 18 and Friday, November 19, from 1:00 p.m. to 4:30 p.m. EST each day, for the annual NIH Behavioral and Social Sciences Research (BSSR) Festival. Register to attend and view the festival agenda and speaker biographies: https://www.scgcorp.com/obssrfest2021/Registration

The festival, hosted by OBSSR and in collaboration with the NIH BSSR Coordinating Committee, will showcase exciting research results, emerging areas, and innovations in health related BSSR. Presenters were selected from nominations made by various NIH Institutes and Centers to highlight impactful BSSR funded across NIH.

NIH Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI) Director James M. Anderson, M.D., Ph.D., will deliver opening remarks at the festival, and will be followed by a State of Behavioral and Social Sciences Research at the NIH presentation by OBSSR Director William T. Riley, Ph.D. Day 2 of the festival will feature a keynote address by the NINR Director Shannon N. Zenk, Ph.D., M.P.H., RN, FAAN. View the full agenda: https://www.scgcorp.com/obssrfest2021/Agenda

If you have a disability and require reasonable accommodations to participate in this event, please contact Danielle Johnikin at (301) 670-4990 or djohnikin@scgcorp.com and/or the Federal Relay at 1-800-877-8339.

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Provide Input on A New NIH Common Fund Program

On November 4, 9, 10, 16 and 18, the NIH Common Fund’s Transformative Research to Address Health Disparities and Advance Health Equity Initiative working group will host a Community Listening Session.

The listening sessions series will bring together members from various stakeholder groups including community-based organizations, tribal communities and organizations, faith-based organizations, advocacy organizations, professional societies, foundations, colleges and universities to help identify new solutions and inform a coordinated program of health disparities and health equity research supported through the NIH Common Fund. Members of these groups are invited to give their input on opportunities, challenges, and community needs related to interventions targeting social determinant factors that influence health disparities and share ideas on innovative approaches to this type of research in which community members are actively engaged in the research process.

To participate and learn more about series visit: https://hd-transformation-engagements.com/.

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2022 Summer Institute on Randomized Behavioral Clinical Trials

The 22nd Summer Institute on Randomized Behavioral Clinical Trials will be held July 14 – 23, 2022 at the Bolger Hotel and Conference Center in Potomac, Maryland. The Institute is sponsored by OBSSR and the National Heart, Lung, and Blood Institute (NHLBI).

The application period opens November 15, 2021. Applications are due by February 15, 2022.

Objective
The Summer Institute provides an intermediate/advanced course in planning, designing, and conducting high-impact randomized controlled trials of health-related behavioral interventions. It emphasizes programmatic research and prepares fellows to lead or collaborate on rigorous, high-impact behavioral trials and on systematic efforts to develop and improve health-related behavioral interventions. The Institute’s long-term goal is to build an outstanding scientific workforce that is able to plan and conduct the kinds of clinical trials that can change practice guidelines, health care policies, and third-party coverage for health-related behavioral interventions, and that can help to increase the role of evidence-based behavioral interventions in clinical and preventive services.

By the end of this course, participants will be able to:

  1. Evaluate the evidentiary requirements of health care gatekeepers and the needs of stakeholders in health-related behavioral interventions.
  2. Formulate long-term goals for high-impact health-related behavioral intervention research programs.
  3. Use the best-fitting translational research models and intervention optimization frameworks to plan and conduct intervention research programs.
  4. Incorporate basic behavioral and social science findings and advanced methodologies in this research.
  5. Understand the role of interdisciplinary team science in high-impact behavioral intervention research.
  6. Produce a plan to disseminate the knowledge gained in this course.

Please send questions about the Summer Institute to Kenneth Freedland, Ph.D., Program Director, at freedlak@wustl.edu.

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Ending Sexual Harassment in Science: Designing and Administering a Survey That Can Lead to an Improved Organizational Climate

This Academic Medicine article is co-authored by Hannah A. Valantine, M.D. Charlene E. Le Fauve, Ph.D., Kathryn A. Morris, M.P.H., and William T. Riley, Ph.D.

Workplace harassment, particularly sexual harassment, has substantial negative implications for individuals and organizations and for scientific advancement. The National Institutes of Health (NIH) is uniquely positioned to lead the effort to prevent sexual harassment in the scientific community and mitigate its detrimental effects. Recognizing the need for benchmark data, NIH developed and validated the 2019 NIH Workplace Climate and Harassment Survey. The goal was to use best practices in survey design methods to create an instrument for rigorous assessment of harassment incidence and organizational climate predictors of sexual harassment in scientific research environments.

This article summarizes the processes used to design and administer the NIH survey and provides brief descriptions of 3 products of the process developed to guide scientific institutions wishing to embark on a data-driven approach to assess and prevent harassment: a document detailing survey development and methods; a survey implementation guide; and the key findings obtained from the survey, including recommendations for interventions targeting organizational climate at NIH and limitations of the survey.

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NCI Welcomes Letters of Interest for Branch Chief position in Tobacco Control Research Branch

The Behavioral Research Program (BRP) within the National Cancer Institute’s Division of Cancer Control and Population Sciences welcomes letters of interest from senior scientists to serve as Branch Chief of the Tobacco Control Research Branch (TCRB).

TCRB leads and collaborates on research and disseminates evidence-based findings on prevention, treatment, and control of tobacco use.

Current scientific priorities include research on tobacco cessation interventions at the individual, system, and population levels (including cessation among cancer patients and survivors); tobacco control interventions for underserved and at-risk populations; etiology and determinants of tobacco use, nicotine dependence, and cessation; use of policy and media to reduce tobacco use; and use of tobacco prevention and control research to promote health equity and reduce disparities in health outcomes.

Please submit a letter of interest and CV by December 15, 2021, to the search committee chair, Linda Nebeling, Deputy Associate Director for Behavioral Research (nebelinl@mail.nih.gov).

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Adherence Research Solicitation: NOSI on Improving Patient Adherence to Treatment and Prevention Regimens to Promote Health

[NOT-OD-21-100] Establishing adherence to and maintenance of health promoting regimens continues to be a significant public health problem. Fourteen NIH Institutes, Centers, and Offices have therefore partnered with OBSSR on a call for the next generation of adherence research. This Notice of Special Interest (NOSI) seeks research grant applications addressing patient adherence to treatment and prevention regimens to promote health outcomes. Applications may address healthcare regimen initiation, implementation, and/or persistence. Descriptive and intervention research may address adherence determinants at one or more levels of ecologic influence, including the patient, caregiver/family, provider, healthcare system, and community levels.

The NOSI describes specific adherence research priorities for each participating NIH Institute and Center, as well as their associated Funding Opportunity Announcements. As risk factors for non-adherence and poor disease outcomes have been exacerbated during the Covid pandemic, this NOSI also seeks applications that focus on the effects of Social Determinants of Health and populations with health disparities. Please direct research concepts and questions regarding this NOSI to the Program Officers listed in the Notice.

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2021 GSS Cross-Sectional Data Release

The 2021 cross-sectional data for the General Social Survey (GSS), along with the GSS cumulative cross-sectional file, is now available at gss.norc.org. The 2021 GSS was fielded during the COVID-19 pandemic. This necessitated changes in data collection procedures, but also offers vital data about potential social and economic impacts of the pandemic. OBSSR has supported the inclusion of the PROMIS Global Physical Health and Global Mental Health items as part of the GSS.

The new 2021 data can be downloaded at https://gss.norc.org/Get-The-Data along with the methodological primer and codebook.

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Recently Published Funding Announcements

NIH Blueprint for Neuroscience Research Short Courses in Neurotherapeutics Development (R25 Clinical Trial Not Allowed)

FOA Number
RFA-NS-21-025

Key Dates
Open Date (Earliest Submission Date): November 9, 2021
Expiration Date: December 10, 2021

Purpose
The NIH Research Education Program (R25) supports research education activities in the mission areas of the NIH.  The overarching goal of this R25 program is to support educational activities that complement and/or enhance the training of a workforce to meet the nation’s biomedical, behavioral and clinical research needs.

To accomplish the stated over-arching goal, this FOA will support creative educational activities with a primary focus on:

  • Courses for Skills Development

This FOA invites Research Education Grant (R25) applications to develop and implement short courses on neurotherapeutics development for academic neuroscientists. The short courses should provide participants with a sufficient overview of the neurotherapeutics development process to (1) understand the steps required for therapeutics development, (2) anticipate and overcome common challenges in the process, and (3) interact effectively with collaborators who have expertise in various aspects of therapeutics development. The short courses should primarily target independent academic neuroscience researchers and senior post-doctoral fellows interested in incorporating treatment development into their research programs.

View RFA-NS-21-025

HEAL Initiative: Advancing Health Equity in Pain Management (R61/R33 Clinical Trial Required)

FOA Number
RFA-NS-22-002

Key Dates
Open Date (Earliest Submission Date): November 9, 2021
Expiration Date: December 10, 2021

Purpose
The purpose of this Funding Opportunity Announcement (FOA) is to solicit applications to accelerate development, testing and implementation of evidence-based interventions—that are culturally and linguistically appropriate for NIH-designated populations that experience health disparities (HDPs) in the United States—to mitigate disparities in provision of care and treatment decisions, reduce susceptibility to chronic pain and improve patient outcomes. Expected outcomes of this initiative include evidence-based interventions that mitigate: 1) the effects of bias, stigma and discrimination at multiple levels, and/or 2) socioeconomic, environmental and other barriers to quality pain assessment, treatment and management. Studies that address multiple socioecological domains and levels of influence (e.g. organizational/institutional, community/neighborhood, societal) to advance health equity and mitigate health disparities in pain management are of higher priority. Studies must address research topics within the mission and research interests of participating NIH Institutes and Centers.

View RFA-NS-22-002

NIH Health Care Systems Research Collaboratory – Pragmatic and Implementation Trials of Embedded Interventions (UG3/UH3, Clinical Trials Optional)

FOA Number
RFA-AT-22-001

Key Dates
Open Date (Earliest Submission Date): November 15, 2021
Expiration Date: June 18, 2022

Purpose
This Funding Opportunity Announcement (FOA) encourages UG3/UH3 phased cooperative research applications to conduct efficient, large-scale pragmatic or implementation trials to improve health and care delivery, with a particular focus on health care systems (HCS) with less historical involvement in research studies focused on improving health outcomes for US patient populations. Awards made under this FOA will initially support a one-year milestone-driven planning phase (UG3), with possible transition to a trial conduct phase (UH3). UG3 projects that have met the scientific milestone and feasibility requirements may transition to the UH3 phase. The UG3/UH3 application must be submitted as a single application, following the instructions described in this FOA.

View RFA-AT-22-001

Maximizing Opportunities for Scientific and Academic Independent Careers (MOSAIC) Institutionally-Focused Research Education Award to Promote Diversity (UE5 – Clinical Trial Not Allowed)

FOA Number
PAR-21-277

Key Dates
Open Date (Earliest Submission Date): October 18, 2021
Expiration Date: November 16, 2023

Purpose
The NIH Research Education Program (R25) supports research education activities in the mission areas of the NIH.  The overarching goal of this NIH MOSAIC UE5 program is to support educational activities that encourage individuals from diverse backgrounds, including those from groups underrepresented in the biomedical and behavioral sciences, to pursue further studies or careers in research

To accomplish the stated over-arching goal, this FOA will support creative educational activities with a primary focus on:

  • Courses for Skills Development
  • Mentoring Activities

Applications are encouraged from organizations of biomedical researchers (e.g., scientific societies) with a membership of scientists conducting research within the mission areas of participating NIH Institutes and Centers, experience serving as a centralized entity to enhance scientific communication and networking among scientists conducting research, an established record of providing professional development and networking activities for the next generation of biomedical researchers, and a demonstrated commitment to enhancing the diversity of the biomedical research workforce.

The program provides support for well-designed courses for skills development and mentoring activities to prepare cohorts of postdoctoral and early-career faculty scholars supported by MOSAIC K99/R00 awards to transition into, succeed, and advance in independent, tenure-track or equivalent, research-intensive faculty careers.

Awardee organizations must provide career development and mentoring activities aligned with and appropriate for the disciplinary backgrounds of scholars supported through the MOSAIC K99/R00 program. Areas of programmatic need will be indicated through Notices of Special Interest (NOSIs) released annually by NIH. Applications that do not address the program areas of need specified in the NOSI will be considered non-responsive and will not be reviewed.

View PAR-21-277

Research on Biopsychosocial Factors of Social Connectedness and Isolation on Health, Wellbeing, Illness, and Recovery (R01 Basic Experimental Studies with Humans Required)

FOA Number
PAR-21-349

Key Dates
Open Date (Earliest Submission Date): May 21, 2022
Expiration Date: June 22, 2024

Purpose
This funding opportunity announcement (FOA) invites research projects that seek to explain the underlying mechanisms, processes, and trajectories of social relationships and how these factors affect outcomes in human health, illness, recovery, and overall wellbeing. Types of projects submitted under this FOA include studies that prospectively assign human participants to conditions (i.e., experimentally manipulate independent variables) and that assess biomedical and/or behavioral outcomes in humans to understand fundamental aspects of phenomena related to social connectedness and isolation. NIH considers such studies as Basic Experimental Studies with Humans (BESH) that are prospective basic science studies involving human participants that meet the NIH definition of basic research and fall within the NIH definition of clinical trials (see, e.g., NOT-OD-19-024). Applications should not propose a goal of clinical outcomes or products. Applications that propose studies including model animal research or observational studies involving humans should submit under the companion FOA, PAR-21-350 “Research on Biopsychosocial Factors of Social Connectedness and Isolation on Health, Wellbeing, Illness, and Recovery (R01 Clinical Trials Not Allowed).

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Research on Biopsychosocial Factors of Social Connectedness and Isolation on Health, Wellbeing, Illness, and Recovery (R01 Clinical Trials Not Allowed)

FOA Number
PAR-21-350

Key Dates
Open Date (Earliest Submission Date): May 21, 2022
Expiration Date: June 22, 2024

Purpose
This funding opportunity announcement (FOA) invites research projects that seek to model the underlying mechanisms, processes, and trajectories of social relationships and how these factors affect outcomes in health, illness, recovery, and overall wellbeing. Both animal model and human subjects research projects are welcome; however, clinical trials are not allowed. Researchers proposing Basic Experimental Studies with Humans (BESH) should consider the companion FOA, PAR-21-349, “Research on Biopsychosocial Factors of Social Connectedness and Isolation on Health, Wellbeing, Illness, and Recovery (R01 Basic Experimental Studies with Humans Required)”.

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Research on Biopsychosocial Factors of Social Connectedness and Isolation on Health, Wellbeing, Illness, and Recovery (R01 Clinical Trial Required)

FOA Number
PAR-21-352

Key Dates
Open Date (Earliest Submission Date): May 21, 2022
Expiration Date: September 8, 2024

Purpose
This funding opportunity announcement (FOA) invites research projects that seek to explain the underlying mechanisms, processes, and trajectories of social relationships and how these factors affect outcomes in human health, illness, recovery, and overall wellbeing. Types of projects submitted under this FOA include mechanistic studies that are classified as clinical trials. Mechanistic studies are defined as studies with the objective to understand the mechanism(s) of action of an intervention, a biological or behavioral process, or the pathophysiology of a disease/condition. See NOT-AT-20-001 and NOT-MH-19-006 for examples of clinical trials that are/are not considered mechanistic studies. Clinical trials that propose to influence a clinical outcome, test safety or feasibility of an intervention, demonstrate the clinical efficacy or effectiveness of an intervention, or analyze the effect size of an intervention on clinical outcomes are ineligible for this FOA. Types of studies that should submit under this FOA include clinical trials that assess biomedical or behavioral outcomes in humans for the purpose of understanding the fundamental aspects of phenomena without specific application towards processes or products in mind. Researchers proposing basic science experimental studies involving human participants should consider this FOA’s companion for basic experimental studies with humans, PAR-21-349, “Research on Health, Wellbeing, Illness, and Recovery (R01 Basic Experimental Studies with Humans Required).” Applications proposing studies that include, but are not limited to, model animal research or observational studies involving humans should submit under the companion FOA, PAR-21-350, “Research on Biopsychosocial Factors of Social Connectedness and Isolation on Health, Wellbeing, Illness, and Recovery (R01 Clinical Trials Not Allowed).

View PAR-21-352

 

BSSR Clinical Trials Resources

 

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.

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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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