December 22, 2023
Director's Voice Blog
2023: Looking back, Diving In.
In this last blog of the calendar year, I will consider some of the highlights of the Office in my first few months as Director as well as our plans for the start of the new year.
First, by way of introduction, I wanted to share a little bit about myself. Prior to my appointment at OBSSR on July 30 of this year, I had served on the faculty at the University of Washington (UW) in Seattle for 23 years. I was Director of Clinical Training in the UW Department of Psychology and directed two research centers on mental health and HIV as well research projects in the U.S., China, and Africa. A recipient of NIH funding for over 25 consecutive years, I led research on health disparities and resilience among populations that have been socially marginalized, including clinical trials evaluating novel interventions for persons with HIV and other chronic illnesses, Latinx, LGBTQI+, and indigenous peoples (see a brief biography here).
Behavioral and Social Sciences Research Spotlights
Caregiving as a chronic stressor detrimental to mental health – or not?
Contrary to the common belief that caregiving is always stressful and harms mental health, recent studies are shedding light on its potential health benefits. A recent study funded by NIA explored how family health issues may influence the connection between caregiving and mental well-being. Focusing on adult children providing care to aging mothers, the research aimed to 1) clarify whether previous studies linking caregiving to depression might be misleading and 2) explore if caregiving for aging mothers could have mental health benefits.
Adoption and scaling up of overdose education and naloxone distribution through a “hub with many spokes” model
As part of the HEALing Communities Study clinical trial, researchers supported by NIDA set out to demonstrate the feasibility of a “hub with many spokes” model for scaling up channels of delivery for proven medical intervention to prevent overdose deaths in representative communities most effected by the opioid pandemic.
News and Events
Brain Behavior Quantification and Synchronization Program Webpage Now Available
The Brain Behavior Quantification and Synchronization (BBQS) program is a basic research effort to develop new tools and approaches in support of a more comprehensive mechanistic understanding of the neural basis of behavior. The NIH BRAIN Initiative has issued new funding opportunity announcements to support the development and validation of next-generation tools, methods, and analytic approaches to precisely quantify complex behaviors and combine them with simultaneous recordings of brain activity.
Re-cap: Understanding and Addressing the Health Impacts of Online Abuse and Harassment Workshop
The White House Task Force to Address Online Harassment and Abuse was established via Presidential Memorandum on June 16, 2022 to address online harassment and abuse, specifically technology-facilitated gender-based violence. In consultation with survivors, advocates, educators, experts from diverse fields, and the private sector, the Task Force will develop specific recommendations to improve prevention, response, and protection efforts through programs and policies in the United States and globally.
As part of this effort, NIH hosted a virtual scientific workshop on December 7 – 8, 2023 to identify gaps, opportunities, and challenges in advancing a research agenda to better understand the clinical, health, and developmental impacts of online harassment and abuse and develop innovative prevention and intervention efforts. A recording of the two-day workshop is now available for viewing (Day 1 and Day 2).
Re-cap: Music as Medicine: The Science and Clinical Practice Workshop
The 2023 Sound Health Initiative workshop on “Music as Medicine: The Science and Clinical Practice”, took place December 14 – 15, 2023. A recording of the two-day workshop is now available for viewing (Day 1 and Day 2).
The Music as Medicine workshop was co-organized and co-sponsored by the National Institutes of Health (NIH) and the National Endowment for the Arts (NEA) and jointly organized by NIH, the NEA, the Renée Fleming Foundation, and the John F. Kennedy Center for the Performing Arts. The goals of this workshop were to highlight accomplishments from the last six years in advancing scientific research on music and health and to develop a blueprint for the next phase of research and building the research community. The workshop was co-chaired by Dr. Francis Collins, former NIH director, and Ms. Renée Fleming, a renowned American soprano, both of whom delivered keynote speeches.
Recently Published Funding Opportunities
Career Enhancement Award to Advance Research on Firearm Injury and Mortality Prevention (K18 Independent Clinical Trial Not Allowed)
Funding Opportunity Number (FON) Number
PAR-24-070
Key Dates
Open Date (Earliest Submission Date): February 15, 2024
Expiration Date: March 16, 2024
Purpose
This NIH Research Career Enhancement Award (K18) program invites applications from experienced investigators seeking to redirect or expand research programs through the acquisition of new skills and knowledge in the area of firearm mortality and injury prevention research, which is beyond and complementary to their current areas of expertise. The program will support research training and career development experiences and a small-scale research project that will provide experienced investigators with the scientific competencies required to conduct research relevant to firearm morality and injury prevention research. Eligible candidates are independent investigators at any faculty rank or level.
The proposed project must be related to the programmatic interests of one or more of the participating NIH Institutes and Centers (ICs) based on their scientific missions.
This Notice of Funding Opportunity (NOFO) is designed specifically for applicants proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary clinical trial. Under this NOFO applicants are permitted to propose a research experience in a clinical trial led by a mentor or co-mentor. Those proposing a clinical trial or an ancillary clinical trial as lead investigator, should apply to the companion NOFO PAR-24-073.
Career Enhancement Award to Advance Research on Firearm Injury and Mortality Prevention (K18 Independent Clinical Trial Required)
Funding Opportunity Number (FON) Number
PAR-24-073
Key Dates
Open Date (Earliest Submission Date): February 15, 2024
Expiration Date: March 16, 2024
Purpose
This NIH Research Career Enhancement Award (K18) program invites applications from experienced investigators seeking to redirect or expand their research programs through the acquisition of new skills and knowledge in the area of firearm mortality and injury prevention research, which is beyond and complementary to their current areas of expertise. The program will support research training and career development experiences and a small-scale research project that will provide experienced investigators with the scientific competencies required to conduct research relevant to firearm morality and injury prevention research. Eligible candidates are independent investigators at any faculty rank or level.
The proposed project must be related to the programmatic interests of one or more of the participating NIH Institutes and Centers (ICs) based on their scientific missions.
This Notice of Funding Opportunity (NOFO) is designed specifically for applicants proposing to serve as the lead investigator of an independent clinical trial, a clinical trial feasibility study, or a separate ancillary study to an existing trial, as part of their research and career development. Applicants not planning an independent clinical trial, or proposing to gain research experience in a clinical trial led by another investigator, must apply to companion NOFO PAR-24-070.
BRAIN Initiative: Brain-Behavior Quantification and Synchronization—Transformative and Integrative Models of Behavior at the Organismal Level (R34 Clinical Trial Optional)
NOFO Number
RFA-DA-24-042
Key Dates
Open Date (Earliest Submission Date): January 15, 2024
Application Due Date: February 15, 2024
Purpose
This notice of funding opportunity (NOFO) seeks applications proposing a set of planning activities that will lay the groundwork for a scientific project aimed at integrating complementary theories and methods to 1) develop, validate, and apply cutting-edge tools and methods for minimally invasive, multi-dimensional, high-resolution measurement of behavior at the level of the organism, with synchronous capture of changes in the organism’s social or physical environment; and 2) develop data science and computational methods that allow for integration of multidimensional behavioral and environmental data representing multiple timescales, and that will establish of a conceptual and/or computational model of behavior as a complex dynamic system. Prospective projects are expected to be designed with the potential to integrate synchronously recorded neural data and/or inform existing models of neurobehavioral function, such as those developed with the support of the NIH BRAIN Initiative. The purpose of this R34 planning grant opportunity is to support planning and development of the research framework, design, and approach, including activities that will establish feasibility, validity, and/or other technically qualifying results that, if successful, would support a competitive application for a U01, or equivalent, NIH research award.
Applications should be submitted by multi-disciplinary teams with expertise spanning behavior and behavioral measurement, neurobiology, social systems, computer/data systems, engineering, biostatistics, neuroethics, and artificial intelligence. Please reach out to [email protected] or the scientific contact listed in the funding opportunity with any questions, and check the NIH BRAIN Initiative website (https://braininitiative.nih.gov/) for future funding opportunities in this space.
Request for Information: BRAIN Initiative: Brain Behavior Quantification and Synchronization: Guidance for Opportunities in Development of Sensor Technology Hubs
Notice Number
NOT-MH-24-125
Key Dates
Release Date: November 13, 2023
Response Date: December 29, 2023
Purpose
NIH is requesting information about how sensor technology hubs might advance the goals of the Brain Behavior Quantification and Synchronization (BBQS) program of the NIH BRAIN Initiative. The hubs would be used to evaluate sensor technology in a certain measurement modality, for example, temperature, pressure, inertial or electrochemical mode. The BRAIN Initiative BBQS funding opportunities support 1) the development of tools for simultaneous, multimodal measurement of behavior within complex, dynamic physical and/or social environments, 2) the synchronization of these behavioral data with simultaneously-recorded brain activity; and 3) the development of novel conceptual and computational models that capture dynamic neural-behavioral-environmental, and temporal relationships. This RFI focuses exclusively on the evaluation of sensor technology related to the BBQS program and follows a recent workshop BBQS Workshop May 2023.
Ethical, Legal and Social Implications (ELSI) Research (R01 Clinical Trial Optional)
NOFO Number
PAR-23-293
Key Dates
Open Date (Earliest Submission Date): January 19, 2024
Expiration Date: November 19, 2026
Purpose
To study the ethical, legal and social implications (ELSI) of human genetic or genomic research. Applications may propose studies using either single or mixed methods. Approaches may include but are not limited to empirical qualitative and quantitative methods, and conceptual, legal, and normative analyses. Applied research designed to address ELSI issues in genetics and genomics will also be considered responsive. Direct engagement with communities and other interested groups is encouraged, but not required.
Ethical, Legal and Social Implications (ELSI) Exploratory/Developmental Research Grant (R21 Clinical Trial Optional)
NOFO Number
PAR-23-294
Key Dates
Open Date (Earliest Submission Date): January 19, 2024
Expiration Date: November 19, 2026
Purpose
To study the ethical, legal and social implications (ELSI) of human genetic or genomic research. Applications may propose studies using either single or mixed methods, that break new ground, extend previous discoveries in new directions, or develop preliminary data in preparation for larger studies. Approaches may include but are not limited to empirical qualitative and quantitative methods, and conceptual, legal, and normative analyses. Applied research designed to address ELSI issues in genetics and genomics will also be considered responsive. Direct engagement with communities and other stakeholders is encouraged, but not required.
Ethical, Legal and Social Implications (ELSI) Small Research Grant (R03 Clinical Trial Optional)
NOFO Number
PAR-23-295
Key Dates
Open Date (Earliest Submission Date): January 19, 2024
Expiration Date: November 17, 2026
Purpose
To study the ethical, legal and social implications (ELSI) of human genetic or genomic research. These applications should be for small, self-contained research projects, such as those that involve single investigators. Of particular interest are projects that propose normative or conceptual analyses, including focused legal, economic, philosophical, anthropological, or historical analyses of new or emerging issues. This mechanism can also be used for the collection of preliminary data and the secondary analysis of existing data. Applications may propose studies using either single or mixed methods. Applied research designed to address ELSI issues in genetics and genomics will also be considered responsive. Direct engagement with communities and other stakeholders is encouraged, but not required.
Screening, Brief Intervention and Referral to Treatment or Prevention (SBIRT/P) for alcohol, tobacco, and other drugs (ATOD) use and misuse in adult populations that experience health disparities (R01, Clinical Trial Required)
NOFO Number
PAR-23-270
Key Dates
Open Date (Earliest Submission Date): January 5, 2024
Expiration Date: May 08, 2027
Purpose
To test innovative approaches to implementing SBIRT/P for alcohol, tobacco, and other drugs (ATOD) use and misuse in adult populations that experience health disparities. SBIRT/P, (a term used for purposes of this funding announcement), involves screening individuals for risk of ATOD use and misuse, briefly intervening with a conversation about harmful substance use, and referring individuals for treatment or preventive services, as needed. Proposed research should include prospective tests of SBIRT/P and should leverage collaborations with healthcare and community partners Specific research interests of participating NIH ICOs are detailed within.
Notice of Special Interest (NOSI): Administrative Supplements to Recognize Excellence in Diversity, Equity, Inclusion, and Accessibility (DEIA) Mentorship
Notice Number
NOT-OD-24-001
Key Dates
First Available Due Date: February 16, 2024
Expiration Date: February 17, 2024
Purpose
To support administrative supplements to existing NIH awards to support scientists who have demonstrated compelling commitments and contributions to mentorship and enhancing diversity, equity, inclusion, and accessibility (DEIA) in the biomedical sciences. Funds will support ongoing and future efforts.
The biomedical research enterprise includes a range of research, including basic science, behavioral and social science, and clinical research and will be described hereafter as biomedical research. Excellent mentorship and superior training are critical to developing exceptional future scientists and building a diverse scientific workforce in the U.S. However, these efforts may not always be appropriately recognized or well compensated. As such, the intent of this NOSI is to reach those individuals with limited NIH support.
Mentoring can be defined as “a professional, working alliance in which individuals work together over time to support the personal and professional growth, development, and success of the relational partners through the provision of career and psychosocial support” (NASEM, 2019). Mentorship provides psychosocial and career support, self-efficacy, and science identity; it is also culturally responsive (NASEM, 2019). To date, NIH has supported such efforts via NOT-OD-22-057 and NOT-OD-23-002. This Notice of Special Interest aims to continue this program into Fiscal Year 2024.
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 2023.
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, former OBSSR Acting Director.
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).