Director’s Voice Blog
NIH Awards Additional Research and Training Grants to Support Firearm Injury and Mortality Prevention Science. Firearms deaths constitute an urgent and significant public health crisis. The overall death rate by firearms was up 21 percent and the rate of homicides by firearms was up 35 percent from 2019-2022. Additionally, firearm-related suicides increased to their highest ever recorded level in 2022, and firearms remain the leading cause of death for children and youth ages 1-19. Significant disparities by race, ethnicity, and poverty remain. For example, in 2022, firearm suicide rates among Black youth (ages 10-19) surpassed that of White youth for the first time.
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Behavioral and Social Sciences Research Spotlights
Tracking and characterizing longitudinal change in physical activity behaviors among study participants from different sociodemographic backgrounds
Encouraging physical activity is a well-established public health strategy that effectively supports disease prevention and health promotion across all age groups. In the US, Hispanic/Latino communities are part of a large minority population that experiences the burden of increased risk factors for cardiometabolic disease at disproportionate rates, and thus may benefit from strategies that support increased physical activity. In a recent publication supported by NHLBI, NIDDK, NCI, and others, researchers conducted a longitudinal study to assess correlates of physical activity patterns among adult participants of the Hispanic Community Health Study/Study of Latinos (HCHS/SOL) as well as among adult participants of the Framingham Heart Study (FHS), who are primarily white and non-Hispanic.
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Insights and strategies for improving equity in graduate school admissions: a program review
The path to becoming a scientist involves many milestones, beginning with admission into to graduate school. This application process is often a difficult hurdle for students from historically minoritized backgrounds, thus reinforcing the current lack of diversity in the areas of science, technology, engineering, and math (STEM). To help address this disparity, a group of STEM professionals who received support from NIAID, NIDA, NEI, NIA, and others, sought to determine areas in graduate school admissions that could be improved to promote equity and inclusion, by designing and running a graduate student application assistance program (AAP) called the Científico Latino Graduate Student Mentorship Initiative (CL-GSMI).
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Using community-based geographical information system (GIS) to recruit older Asian Americans in an Alzheimer’s disease study
It is well established that the literature on Alzheimer’s Disease (AD) carries a bias towards study populations with White ancestry, and that there are significant gaps in minority enrollment in AD studies. Supported by NIA, researchers sought to respond to the gaps in data regarding Asian American elder populations by addressing barriers to reaching these community members, which include low levels of contact with the healthcare system, language, health beliefs and attitudes. The objective of this pilot study was to utilize a novel community-based geographical information system (GIS) to recruit 60 participants aged 60 and older of Korean heritage to study genetic and lifestyle AD risk factors, and to establish blood biomarker levels for AD diagnosis, as part of Asian Cohort for Alzheimer’s Disease (ACAD).
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News and Events
Understanding and Addressing the Health Impacts of Online Abuse and Harassment Workshop
Thursday, December 7
12:00 p.m. – 4:00 p.m. ET (9:00 a.m. – 1:00 p.m. PT)
NIH Videocast Link Day 1: https://videocast.nih.gov/watch=52604
Friday, December 8
12:00 p.m. – 3:00 p.m. ET (9:00 a.m. – 12:00 p.m. PT)
NIH Videocast Link Day 2: https://videocast.nih.gov/watch=52606
Workshop Overview: The White House Task 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 is hosting a virtual scientific workshop 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.
Agenda: https://www.scgcorp.com/onlineharassmentwksh/Agenda
Music as Medicine: The Science and Clinical Practice Workshop
The workshop “Music as Medicine: The Science and Clinical Practice,” taking place December 14–15, 2023, aims to highlight accomplishments from the last 6 years in advancing scientific research on music and health, develop a blueprint for the next phase of research, and further build the research community.
The workshop is 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 workshop is cochaired by Dr. Francis Collins, former NIH director, and Ms. Renée Fleming, the renowned soprano and arts and health advocate, both of whom will deliver keynote speeches.
NIH Seeking Comment on Draft Scientific Integrity Policy
NIH recently released the Draft Scientific Integrity Policy of the National Institutes of Health for public comment. The draft policy articulates the procedures and processes in place at NIH that help maintain rigorous scientific integrity practices. Additionally, the draft policy proposes several new functions to further enhance scientific integrity at NIH and throughout the biomedical research enterprise.
The draft policy incorporates and is responsive to the principles and directives of the Presidential Memorandum on Restoring Trust in Government Through Scientific Integrity and Evidence-Based Policymaking, Protecting the Integrity of Government Science, and A Framework for Federal Scientific Integrity Policy and Practice.
The full draft policy can be viewed here. Comments on the draft policy will be accepted until November 9, 2023.
Kids Online Health and Safety Request for Comment
On behalf of the Department of Commerce and in conjunction with the other members of the United States government’s Task Force on Kids Online Health & Safety, the National Telecommunications and Information Administration (NTIA) is working to promote a healthier, safer and more private experience for minors accessing online platforms.
Written comments in response to the RFC must be provided to NTIA by November 16, 2023, 45 days from the date of publication in the Federal Register. Comments submitted in response to the RFC will be made publicly available via the Regulations.gov website.
Comments should respond to questions posed in the RFC, and commenters are encouraged to correlate the content of their comments to the pillars and questions set forth in the RFC. Commenters need not respond to every question. Comments should be typed, double-spaced, and signed and dated by the filing party or a legal representative of that party.
NIH ORBIT Institute Now Accepting Applications for the 2024 ORBIT Institute Cohort
The NIH-funded short course, ORBIT Institute: Developing Behavioral Treatments to Improve Health, consists of an in-person workshop, followed by a series of bi-weekly webinars (via FSU Zoom) and related activities, and an individual consultation with one ORBIT Core Faculty member. The 2024 in-person workshop agenda will be posted soon.
This course will be open to scientists with an interest in behavioral treatment development to improve health behaviors. While applied behavioral and social scientists are the focus, basic scientists and methods experts are encouraged to apply as well.
If you have additional questions, please contact the ORBIT team at orbit.institute@med.fsu.edu or 850-644-2334.
Application Deadline: November 30, 2023
NIH designates people with disabilities as population with health disparities
Eliseo J. Pérez-Stable, M.D., director of the National Institute on Minority Health and Health Disparities (NIMHD), designated people with disabilities as a population with health disparities for research supported by the National Institutes of Health. The decision was made in consultation with Robert Otto Valdez, Ph.D., the director of the Agency for Healthcare Research and Quality, after careful consideration of a report delivered by an NIMHD advisory council, input from the disability community and a review of the science and evidence. A report issued in December 2022 by the Advisory Committee to the (NIH) Director (ACD), informed by the work of the Subgroup on Individuals with Disabilities, explored similar issues faced by people with disabilities. The designation is one of several steps NIH is taking to address health disparities faced by people with disabilities and ensure their representation in NIH research.
NIH launches community-led research program to advance health equity
NIH is funding a first-of-its-kind community-led research program to study ways to address the underlying structural factors within communities that affect health, such as access to safe spaces, healthy food, employment opportunities, transportation, and quality health care. Through the NIH Common Fund Community Partnerships to Advance Science for Society (ComPASS) program, NIH made 26 awards to community organizations and a coordinating center, totaling approximately $171 million over five years, pending the availability of funds. Through these awards, ComPASS will enable research into sustainable solutions that promote health equity to create lasting change in communities across the nation. General overview of ComPASS: https://www.youtube.com/watch?v=PVQVYQBh6KM.
NIH to address unmet clinical needs in testing, monitoring, and treatment technologies
NIH will advance the development of home-based and point-of-care health technologies with awards to six technology research and development centers around the country. The centers comprise the Point of Care Technology Research Network (POCTRN) and will parlay the momentum of the original network established in 2007 by the National Institute of Biomedical Imaging and Bioengineering (NIBIB). In the first year of the new five-year grant period, these six centers will share $9.6 million in total awards. Through technological advances, health care can be delivered closer to the patient, leading to more timely and convenient care and ultimately better outcomes.
Recently Published Funding Opportunities
Career Enhancement Award to Advance the Study of Intimate Partner Violence (IPV) in the Context of Maternal Morbidity and Mortality Research (K18 Clinical Trial Not Allowed)
NOFO Number
RFA-OD-24-001
Key Dates
Open Date (Earliest Submission Date): November 1, 2023
Expiration Date: December 2, 2023
Purpose
To advance the goals of the NIH Implementing a Maternal health and PRegnancy Outcomes Vision for Everyone (IMPROVE) Initiative, this NIH Research Career Enhancement Award (K18) invites experienced investigators in maternal morbidity and mortality research seeking to expand their research programs through the acquisition of new skills and knowledge in the area of intimate partner (and related) violence (IPV) to work with their institutions to submit an application for support.
R25 for Short Courses on Techniques for Measuring Intimate Partner Violence (IPV) in Different Populations (R25 Clinical Trial Not Allowed)
NOFO Number
RFA-OD-24-002
Key Dates
Open Date (Earliest Submission Date): November 1, 2023
Expiration Date: December 2, 2023
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 foster a better understanding of biomedical, behavioral, and clinical research and its implications. To accomplish the stated over-arching goal, this NOFO will support educational activities with a primary focus on: Courses for Skills Development.
Notice of Intent to Publish a Funding Opportunity Announcement for Career Enhancement Awards to Advance Research on Firearm Injury and Mortality Prevention
Notice Number
NOT-OD-23-192
Key Dates
Estimated Publication Date of Notice of Funding Opportunity: December 12, 2023
First Estimated Application Due Date: March 12, 2024
Earliest Estimated Start Date: October 1, 2024
Purpose
OBSSR, with other NIH Institutes, Centers and Offices (ICOs), intends to publish a Notice of Funding Opportunity (NOFO) to solicit 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. Given that violence and suicide have a number of causes, NIH will take a comprehensive approach to studying these underlying causes and evidence-based methods of prevention of injury, including crime prevention.
This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects.
The NOFO is expected to be published in Winter 2023/2024 with an expected application due date in Spring 2024.
Request for Information: Developing Consent Language for Research Using Digital Health Technologies
Notice Number
NOT-OD-24-002
Key Dates
Release Date: October 11, 2023
Response Date: December 12, 2023
Purpose
NIH is requesting information on the utility and useability of sample language and accompanying considerations developed for use in informed consent documents for digital health technologies utilized in research.
Request for Information (RFI): Environmental Justice Research Gaps, Opportunities and Capacity Building
Notice Number
NOT-ES-23-016
Key Dates
Release Date: October 4, 2023
Response Date: December 15, 2023
Purpose
The National Institutes of Health (NIH) Environmental Justice Working Group invites feedback on the approaches NIH Institutes, Centers, and Offices can take to support research and capacity building efforts to advance environmental justice in the U.S. and globally. Additionally, Request for Information (RFI) responses will enable the NIH Environmental Justice Working Group to be responsive to Executive Order 14096 on Revitalizing Our Nation’s Commitment to Environmental Justice for All, and to synergize NIH efforts with other Federal Agencies in a whole-of-government approach to advance environmental justice.
HEAL Initiative: Research to Increase Implementation of Substance Use Preventive Services (R61/R33 Clinical Trial Optional)
NOFO Number
RFA-DA-24-066
Key Dates
Open Date (Earliest Submission Date): December 17, 2023
Expiration Date: January 17, 2026
Purpose
Despite an evidence base of effective programs to prevent the initiation of substance use, misuse and disorder, a substantial research to practice gap exists. The goal of this initiative is to support projects that fill this research to practice gap, improving public health and responding to the opioid crisis by increasing knowledge pertaining to the delivery of prevention services. This notice of funding opportunity (NOFO) solicits applications to address understudied areas of opportunity that, if researched, could create the foundation needed to inform a prevention infrastructure for ongoing delivery and sustainment of interventions to prevent opioid and other substance misuse and use disorders. This NOFO invites projects for which preliminary or feasibility data is not available. This NOFO is a companion to RFA-DA-24-067 which solicits applications for which pilot data is available.
HEAL Initiative: Research to Increase Implementation of Substance Use Preventive Services (R01 Clinical Trial Optional)
NOFO Number
RFA-DA-24-067
Key Dates
Open Date (Earliest Submission Date): December 17, 2023
Expiration Date: January 17, 2026
Purpose
Despite an evidence base of effective programs to prevent the initiation of substance use, misuse and disorder, a substantial research to practice gap exists. The goal of this initiative is to support projects that fill this research to practice gap, improving public health and responding to the opioid crisis by increasing knowledge pertaining to the delivery of prevention services. This notice of funding opportunity (NOFO) solicits applications to address understudied areas of opportunity that, if researched, could create the foundation needed to inform a prevention infrastructure for ongoing delivery and sustainment of interventions to prevent opioid and other substance misuse and use disorders. This NOFO invites projects for which preliminary or feasibility data is available. This NOFO is a companion to RFA-DA-24-066 which solicits applications for which pilot data is unavailable.
BRAIN Initiative: New Concepts and Early-Stage Research for Recording and Modulation in the Nervous System (R21) (Clinical Trial Not Allowed)
NOFO Number
RFA-EY-23-001
Key Dates
Open Date (Earliest Submission Date): October 12, 2023
Expiration Date: June 16, 2026
Purpose
This NOFO seeks applications for unique and innovative recording and/or modulation technologies that are in the earliest stage of development, including new and untested ideas that are in the initial stages of conceptualization. Some projects may aim to increase recording or modulation capabilities by many orders of magnitude, while others may aim to improve the precision and selectivity of recording or modulation (also referred to as stimulation, perturbation, or manipulation). A wide range of modalities are appropriate including acoustic, chemical, electrical, magnetic, and optical, as well as the use of genetic tools.
Health and Health Care Disparities Among Persons Living with Disabilities (R01 – Clinical Trials Optional)
NOFO Number
PAR-23-309
Key Dates
Open Date (Earliest Submission Date): January 5, 2024
Expiration Date: November 6, 2026
Purpose
The purpose of this Notice of Funding Opportunity (NOFO) is to support novel and innovative research that examines and/or intervenes on the underlying and multilevel causes, pathways, and factors adversely impacting the health and well-being of persons with disabilities at the intersections of race and ethnicity, and socioeconomic status.
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| 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 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
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| 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.
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Social and Behavioral Good Clinical Practice eCourse
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| 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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