Director’s Voice Blog

Integration of Behavioral and Social Sciences Research at NIH. In this month’s blog, I want to share a brief summary of a recently completed report produced by a Council of Councils working group: Integration of Behavioral and Social Sciences Research at the National Institutes of Health (NIH) that was approved by the full Council. I encourage you to read the report if you are interested in a more thorough review of the working group’s methods, analyses, and recommendations.

The report was produced in response to Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Bill 2021 (H. Rpt. 116-450) from the House of Representatives where they direct the NIH Director “…to convene a special advisory panel of behavioral scientists and other community experts to complete an assessment providing recommendations on how to better integrate and realize the benefits to overall health from behavioral research at NIH.”

Read full blog.

Behavioral and Social Sciences Research Spotlights

 

Teaching patients to advocate and ask questions about their medical care can reduce the effects of implicit bias on doctor–patient interactions

Inequalities in medical treatment and health outcomes continue to exist between Black and White Americans, including among cancer patients. Disrupting the effects of implicit racial biases held by physicians can create more equitable interactions between patients and physicians. A recent study supported by the NCI sought to test the effectiveness of patient activation (i.e., patients asking targeted questions and advocating for themselves) to circumvent doctors’ racial biases that favor White (over Black) patients using a randomized field trial design.

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Informing youth about their hereditary breast and ovarian cancer risk does not adversely affect long-term lifestyle or quality of life

The psychosocial impact of a familial diagnosis and/or treatment of breast or ovarian cancer is known to be significant on adolescents and young adults (AYA). This impact may be particularly acute among AYAs raised in families in which BRCA genetic testing is pursued, or a positive BRCA1/BRCA2 status is revealed and disclosed. While the health implications of high-risk status among AYAs are clear, less is known about the factors that are associated with psychosocial or behavioral adaptations (i.e., health-promoting, and other risk-reducing behaviors) in the adolescent/young adult phase nor into adulthood. Recently published research supported by the NCI and NHGRI sought to (1) characterize these adaptations among AYA children of mothers who had previously undergone BRCA genetic testing, and (2) examine differences in adaptation-related outcomes based on AYA and maternal characteristics.

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Save-the-Date: NIH OBSSR Director’s Webinar featuring Dr. Emily Falk

OBSSR will host a director’s webinar on Tuesday, September 27, at 2:00 p.m. ET, featuring Emily Falk, Ph.D. Dr. Falk is a Professor of Communication, Psychology, and Marketing at the University of Pennsylvania; Director of Penn’s Communication Neuroscience Lab; and a Distinguished Fellow of the Annenberg Public Policy Center. She is an expert in the science of behavior change. Her research uses tools from psychology, neuroscience, and communication to examine what makes messages persuasive, why and how ideas spread, and what makes people effective communicators.

Registration information will be available soon on the OBSSR website. Go there now.

PhenX Social Determinants of Health Expansion Protocols – August 29 Deadline

The deadline has been extended for your feedback to help guide decisions about new measurement protocols to be included in the existing Social Determinants of Health (SDoH) Research collection in the PhenX (consensus measures for Phenotypes and eXposures) Toolkit. Your comments on any or all of the protocols are welcome. As you review them, consider whether the protocol is useful or not, and provide any additional comments.

The Social Determinants of Health Research Collection (https://www.phenxtoolkit.org/collections/view/6) was added to the Toolkit in 2020 and includes 19 protocols. The protocols are organized into Individual and Structural specialty collections. A Core SDoH Collection includes protocols from other domains in the PhenX Toolkit. The goal of this current SDoH work is to expand these existing collections.

The PhenX Toolkit (www.phenxtoolkit.org) is a freely available catalog of recommended, well-established, measurement protocols for use in biomedical studies involving human subjects. The goal of the Toolkit is to encourage use of common measures to help researchers effectively collaborate and share data.

Please respond by Monday, August 29, 2022. Collected responses are anonymous.

BRAIN issues new funding opportunity for the development of cutting-edge tools to understand the neural basis of behavior in humans

The NIH recently issued the BRAIN Initiative: Brain Behavior Quantification and Synchronization (BBQS) (R61/R33 Clinical Trial Optional) [RFA-MH-22-240] to support the development of cutting-edge tools for simultaneous, multimodal measurement of behavior within complex environments and integration of these tools with simultaneously recorded brain activity in humans.

Interested in learning more about this funding opportunity announcement (FOA)? Register today for the BBQS pre-application and technical assistance webinar on September 22, 2022. The registration deadline for this virtual event is September 20, 2022 at 11:59 p.m. ET. Zoom links will be sent to all registrants on September 21, 2022. If you want to learn more about BBQS, please visit the BBQS website for previous workshop recordings. Read more.

The NIH Common Fund wants your ideas

The NIH Common Fund is soliciting ideas for potential new scientific programs that may be supported in fiscal year 2025 or beyond. The Common Fund supports bold scientific programs that catalyze discovery across all biomedical and behavioral research. These programs create a space where investigators and multiple NIH Institutes and Centers collaborate on innovative research expected to address high priority challenges for the NIH as a whole and make a broader impact in the scientific community.

Common Fund programs:

  • Are trans-NIH (not disease-specific or relevant to the mission of only one or a few NIH Institutes or Centers)
  • Require a large, coordinated effort in which many investigators undertake research projects directed at a common goal
  • Have specific goals and deliverables that can be achieved in 5-10 years
  • Are sufficiently large and complex (with an approximate budget of $25-50 million/year for 5-10 years) to warrant a trans-NIH, coordinated approach

NIH encourages idea submissions that describe what you think is the greatest opportunity or challenge in biomedical research today and what makes it the right time to address this idea through a Common Fund program.

For more information about how to submit an idea, please see the request for information “NOT-RM-22-016: Soliciting ideas for new NIH Common Fund programs.

Responses must be received by 11:59:59 pm (ET) on Friday, September 30, 2022. Learn more.

NIAMS Requests Input on the NIAMS Strategic Plan for Fiscal Years 2025‒2029

The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) is updating its Strategic Plan to help guide the research it supports. The new plan, which will cover fiscal years 2025‒2029, will focus on cross-cutting thematic research opportunities where the Institute can be best positioned to make a difference in the lives of all Americans.

NIAMS invites feedback from researchers in academia and industry, health care professionals, patient advocates and health advocacy organizations, scientific or professional organizations, federal agencies, and other interested members of the public. Professional societies and patient organizations are strongly encouraged to submit a single response that reflects the views of their membership as a whole.

Responses can be submitted here and are due November 30, 2022.

NIGMS Program Outreach: Research on Interventions and SCISIPBIO

NIGMS Research on Interventions that Promote the Careers of Individuals in the Biomedical Research Enterprise (R01; PAR-21-269) program encourages studies on interventions for enhancing research-oriented individuals’ interest, motivation, persistence, and preparedness for careers in the biomedical research workforce. Program proposals must test an intervention’s effectiveness to increase success in the biomedical research workforce by using robust experimental  designs, such as randomized control trial approaches, case controls, or matched pair design. Many interventions and underlying assumptions can be complex in nature, and so we expect most studies will require a multidisciplinary approach. We strongly encourage collaboration efforts among biomedical researchers, educators, psychologists, sociologists, statisticians, and more as appropriate. NIGMS strongly encourages anyone interested in this funding opportunity to send a one-page-or-less summary of their research ideas, or Specific Aims page, to the program officers several weeks in advance of submitting an application. Potential applicants are also strongly encouraged to review the program webpage to watch a prospective applicant webinar, read Frequently Asked Questions, and browse active awards. For questions regarding R01 Intervention program, please contact the program officers, Sydella Blatch and Shakira Nelson.

The Science of Science Policy Approach to Analyzing and Innovating the Biomedical Research Enterprise (SCISIPBIO) program. This is a joint venture between NIGMS and the Social, Behavioral and Economic (SBE) Directorate of NSF. The SCISIPBIO program supports research that advances the scientific basis of science and innovation policy, with a focus on the biomedical sciences. This partnership will result in a portfolio of high-quality research to provide scientific analysis of important aspects of the biomedical research enterprise and efforts to foster a diverse, innovative, productive, and efficient scientific workforce, from which future scientific discoveries and leaders will emerge. For questions about SCISIPBIO, please contact Kenny Gibbs.

Webinar Recording: Leveraging Data-Driven Advanced Analytics and Artificial Intelligence Technologies to Address Social and Behavioral Determinants for Health Equity

On July 19, 2022, OBSSR hosted a director’s webinar featuring Irene Dankwa-Mullan M.D., M.P.H. Dr. Dankwa-Mullan is a nationally recognized industry physician and scientist, health equity thought leader, scholar, and author with over 20 years of diverse local-regional, national, and global leadership experience healthcare systems, businesses, and the community. She is currently Chief Health Equity Officer, Deputy Chief Health Officer at Merative (formerly IBM Watson Health).

This presentation describes the role of data-driven advanced analytics leveraging artificial intelligence (AI) technologies in providing insights for health equity. The talk includes current use of these AI-driven technologies, including tools that were implemented to address the COVID-19 pandemic. Go there now.

Improving active travel to school and its surveillance: an overlooked opportunity in health promotion and chronic disease prevention

A new commentary published this month in Translational Behavioral Medicine offers insights into strengthening surveillance and data collection of ATS behavior as well as ATS environmental, policy, and program supports. The paper, Improving active travel to school and its surveillance: an overlooked opportunity in health promotion and chronic disease prevention, arises from a workshop held in 2020 by the National Collaborative on Childhood Obesity Research (NCCOR), where experts came together to address key challenges related to measurement and surveillance of youth active travel to school. Read more.

HEALthy Brain and Child Development (HBCD) Study Website

The HEALthy Brain and Child Development (HBCD) Study Website is now live. This ambitious project, funded through a partnership of a dozen Institutes, Centers, and Offices of the National Institutes of Health, will enroll approximately 7,500 participating families from across the United States and follow them from pregnancy through early childhood. The HBCD Research Consortium consists of an Administrative Core, a Data Coordinating Center, and 25 research sites across the country. See more.

2022 NIH Behavioral and Social Sciences Research Festival

Save-the-date: Friday, December 2, 2022

The Annual NIH Behavioral and Social Sciences Research Festival will be hosted by OBSSR and the NIH Behavioral and Social Sciences Research Coordinating Committee. The purpose of the festival is to highlight recently funded behavioral and social sciences research that the NIH supports; bring together behavioral and social scientists within the NIH extramural and intramural communities to network with each other and share scientific ideas; and explore ways to advance behavioral and social sciences research.

Recently Published Funding Announcements

 

Notice of Pre-Application Webinar for the Prevention and Treatment through a Comprehensive Care Continuum for HIV-affected Adolescents in Resource Constrained Settings Implementation Science Network (PATC³H-IN) Funding Opportunity Announcements

FOA Number
NOT-HD-22-041

Purpose
This Notice provides information regarding the upcoming Pre-Application Webinar for the recently published Eunice Kennedy Shriver National Institute of Child Health and Human Development Funding Opportunity Announcements (FOAs) entitled Prevention and Treatment through a Comprehensive Care Continuum for HIV-affected Adolescents in Resource Constrained Settings Implementation Science Network (PATC³H-IN): RFA-HD-23-013 for the PATC³H-IN Clinical Research Centers (CRC) and RFA-HD-23-014 for the PATC³H-IN Coordination, Translation and Advanced Methods and Analytics Center (CTAMAC).

Webinar Information for the PATC³H-IN CRC and CTAMAC FOAs:
Date: September 15, 2022
Time: 9:00 – 11:00 AM ET

The webinar will be hosted through Zoom. Participants must register in advance for the webinar via the information below, after which a link to join the webinar will be e-mailed to the participant. Register in advance for this webinar:
https://nih.zoomgov.com/webinar/register/WN_W5hUWJxSTGW595Bh0iLEqA

After registering, you will receive a confirmation email containing information about joining the webinar.

View NOT-HD-22-041

Prevention and Treatment through a Comprehensive Care Continuum for HIV-affected Adolescents in Resource Constrained Settings Implementation Science Network (PATC³H-IN) Clinical Research Centers (UG1 Clinical Trial Optional)

FOA Number
RFA-HD-23-013

Key Dates
Open Date (Earliest Submission Date): November 6, 2022
Expiration Date: December 7, 2022

Purpose
This FOA invites applications to participate in a research program cooperative agreement to support the Prevention and Treatment through a Comprehensive Care Continuum for HIV-affected Adolescents in Resource Constrained Settings Implementation Science Network
(PATC3H-IN). The Network will expand and/or improve successes achieved by PATC3H to new geographic settings with limited implementation science (IS) research capacity and/or risk populations who are poorly represented in international adolescent HIV research (e.g. sexual and gender minorities; commercial sex workers; drug users) and stimulate much needed IS research in a neglected area of public health significance: prevention of new HIV infections among adolescents at risk and the identification of, and linkage and retention to care of and long-term viral suppression among youth living with HIV in low-to-middle income countries (LMICs). These settings must have an HIV epidemic density defined by UNAIDS estimates as either a country 1) in which at least 200,000 people are living with HIV and the number has not decreased by more than 5% over the last 2 consecutive years of available data or 2) has an HIV incidence among youth ages 10 to 24 years of 0.01% or more.

View RFA-HD-23-013

PATC3H Implementation Science Network (PATC3H-IN) Coordination, Translation and Advanced Methods and Analytics Center (UM2 Clinical Trial Optional)

FOA Number
RFA-HD-23-014

Key Dates
Open Date (Earliest Submission Date): November 6, 2022
Expiration Date: December 7, 2022

Purpose
This FOA invites applications to participate in a research program cooperative agreement to support the Prevention and Treatment through a Comprehensive Care Continuum for HIV-affected Adolescents in Resource Constrained Settings Implementation Science Network (PATC3H-IN). The Network will expand and/or improve successes achieved by PATC3H to new geographic settings with limited implementation science (IS) research capacity and/or risk populations who are poorly represented in international adolescent HIV research (e.g. sexual and gender minorities; commercial sex workers; drug users) and stimulate much needed IS research in a neglected area of public health significance: prevention of new HIV infections among adolescents at risk and the identification of, and linkage and retention to care of and long-term viral suppression among youth living with HIV in low-to-middle income countries (LMICs). These settings must have an HIV epidemic density defined by UNAIDS estimates as either a country 1) in which at least 200,000 people are living with HIV and the number has not decreased by more than 5% over the last 2 consecutive years of available data or 2) has an HIV incidence among youth ages 10 to 24 years of 0.01% or more.

View RFA-HD-23-014

Maternal Health Research Centers of Excellence (U54 Clinical Trial Optional)

FOA Number
RFA-HD-23-035

Key Dates
Open Date (Earliest Submission Date): November 2, 2022
Expiration Date: December 6, 2022

Purpose
This Funding Opportunity Announcement (FOA) invites applications to participate as a Research Center as part of the Maternal Health Research Centers of Excellence initiative. The purpose of this initiative is to generate innovative approaches to address preventable maternal mortality, decrease severe maternal morbidity, and promote maternal health equity in partnership with one or more populations that experience maternal health disparities, including but not limited to, Blacks/African Americans, Hispanics/Latinos, American Indians/Alaska Natives, Asian Americans, Native Hawaiians and other Pacific Islanders, socioeconomically disadvantaged populations, underserved rural populations (e.g., living in maternity care deserts), or sexual and gender minority (SGM) populations. Persons with disabilities are also a priority population.

View RFA-HD-23-035

Maternal Health Research Centers of Excellence Data Innovation and Coordinating Hub/Resource Center (U24 Clinical Trial Not Allowed)

FOA Number
RFA-HD-23-036

Key Dates
Open Date (Earliest Submission Date): November 2, 2022
Expiration Date: December 6, 2022

Purpose
This Funding Opportunity Announcement (FOA) seeks applications for the Data Innovation and Coordinating Hub/Resource Center (hereafter referred to as “the Innovation Hub”) for the Maternal Health Research Centers of Excellence initiative. This FOA runs in parallel with companion FOAs that seek applications for Research Centers of Excellence (RFA-HD-23-035) and an Implementation Science Hub/Resource Center (RFA-HD-23-037).

View RFA-HD-23-036

Maternal Health Research Centers of Excellence Implementation Science Hub/Resource Center (U24 Clinical Trial Optional)

FOA Number
RFA-HD-23-037

Key Dates
Open Date (Earliest Submission Date): November 2, 2022
Expiration Date: December 6, 2022

Purpose
This Funding Opportunity Announcement (FOA) seeks applications for the Implementation Science Hub/Resource Center for the Maternal Health Research Centers of Excellence initiative. This FOA runs in parallel with companion FOAs that seek applications for Research Centers of Excellence (RFA-HD-23-035) and a Data Innovation and Coordinating Hub/Resource Center (RFA-HD-23-036).

View RFA-HD-23-037

BRAIN Initiative: Brain Behavior Quantification and Synchronization
(R61/R33 Clinical Trial Optional)

FOA Number
RFA-MH-22-240

Key Dates
Open Date (Earliest Submission Date): January 15, 2023
Expiration Date: February 16, 2024

Purpose
This Funding Opportunity Announcement (FOA) supports the development and validation of next-generation tools, methods, and analytic approaches to precisely quantify behaviors and combine them with simultaneous recordings of brain activity in humans. Tools used for measuring and analyzing behavior should be multi-modal, with the appropriate accuracy, specificity, temporal resolution, and flexibility necessary for integration with existing tools used to measure and modulate the brain circuits that give rise to those behaviors.

View RFA-MH-22-240

Notice of Special Interest (NOSI): HEAL Initiative: Opioid Use Disorder Care Pathways for Individuals with Histories of Exposure to Violence

FOA Number
NOT-DA-23-007

Key Dates
First Available Due Date: October 12, 2022
Expiration Date: July 13, 2025

Purpose
The NIH HEAL initiative aims to speed the development and implementation of scientific solutions to the national opioid public health crisis by bolstering research across NIH to (1) improve treatment for opioid misuse and addiction and (2) enhance pain management. More information and periodic updates about the HEAL Initiative are available at: https://heal.nih.gov/.

View NOT-DA-23-007

 

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 2022.

Go There Now

 

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.

The DECISION SUPPORT TOOL: Features to Consider in Determining if
a Clinical Trial is Phase II or Phase III is the result of a working group led by OBSSR, with participants from other NIH 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). Data and safety monitoring are required for all clinical trials but for a Phase III trial, the constitution of a board is required.

Go There Now

 

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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