Director’s Voice Blog

NIH Research to Prevent Firearm Injury and Mortality. Firearms deaths constitute an urgent and significant public health crisis. In 2020, 79% of all homicides and 53% of all suicides involved firearms. From 2019 to 2020, the firearm homicide rate increased about 35%, to its highest recorded rate in over 25 years. In addition, the firearm suicide rate remained consistently high from 2019 to 2020 with increases in some populations. As such, in 2020, firearm-related injuries became the leading cause of death for children and youth ages 1-19. The increase in firearm-related deaths from 2019-2020 further widened disparities by race, ethnicity and poverty. For example, firearm homicides among Black individuals increased by 39% and firearm suicide rate increased by 42% among American Indian and Alaska Native persons. Read full blog.

Behavioral and Social Sciences Research Spotlights

 

Risk of “long COVID” and connection with psychological distress prior to SARS-CoV-2 infection

Symptoms of COVID-19 that extend beyond four weeks from onset of SARS-CoV-2 infection are often referred to as “long COVID” and have been identified as an emerging and important health concern. Long COVID is characterized by a host of symptoms including fatigue; shortness of breath or difficulty breathing; persistent cough; muscle, joint, or chest pain; smell or taste problems; confusion, disorientation, and brain fog; memory issues; depression, anxiety, and changes in mood; headache; and heart palpitation. Relatively little is known about the psychological factors associated with increased risk of long COVID symptoms. Recently published research supported by the NICHD, NHLBI, NIEHS, NCI, Veteran’s Association, and others examined whether pre-infection psychological distress, early in the pandemic, including depression, anxiety, loneliness, perceived stress, and worry were associated with an increased likelihood of developing post-COVID-19 conditions among individuals who were infected with SARS-CoV-2 after the baseline measures of psychological distress.

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New frontier in music-based interventions: Measuring music exposure dosage to decrease delirium in older, mechanically ventilated patients in intensive care units

Mechanical ventilation for acute respiratory failure is used in intensive care units (ICUs) for one million adult patients annually. While in the ICU, up to 80% of those patients develop delirium, a syndrome of acute brain dysfunction resulting in a severe state of confusion, during their hospital stay. Older ventilated adults with delirium are at increased risk of longer hospital stays, in-hospital complications, elevated costs of care, and risk of death. Long-term post-ICU complications associated with delirium include cognitive impairment and dementia. Despite the high prevalence of delirium in ICUs, there are no effective pharmacological agents available for treatment, indicating the need for non-pharmacological therapies to prevent and/or manage delirium. In a recent study supported by the NIA, researchers investigate the use of music to reduce delirium and coma duration and severity in mechanically ventilated ICU patients and improve their post-ICU brain health.

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[Register for 9/27 Webinar] Webs of Wellness: Connections Between Mind, Body, and Community for Making Change

Join NIH OBSSR for a director’s webinar titled “Webs of Wellness: Connections Between Mind, Body, and Community for Making Change” on September 27, 2022, from 2:00 – 3:00 p.m. EDT, featuring guest presenter Dr. Emily Falk, University of Pennsylvania.

Presentation Overview: We are facing global challenges including intertwined mental health crises, the ongoing COVID-19 pandemic, spikes in our collective blood pressure, more frequent and severe climate disasters, and the anxiety that comes with all of this. How do we maintain wellness and a sense of well-being in the face of all of these challenges? Dr. Falk will present findings from her recent interdisciplinary work in neuroscience, psychology, and communication science, aimed at understanding pieces of this question. She will highlight purpose in life as one psychological resource linked to wellness behaviors and describe how sharing with other people can serve as a vehicle to shift norms related to wellness.

Presenter Biography: Dr. Emily Falk studies behavior change, persuasion, and how ideas and behaviors spread. Emily 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. Her research has been recognized by numerous awards, including early career awards from the International Communication Association, the Society for Personality and Social Psychology Attitudes Division, a Fulbright grant, the Social and Affective Neuroscience Society, a DARPA Young Faculty Award, and the NIH Director’s New Innovator Award. She was named a Rising Star by the Association for Psychological Science. Dr. Falk received her bachelor’s degree in neuroscience from Brown University and her Ph.D. in psychology from the University of California, Los Angeles.

REGISTER NOW
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Individuals with disabilities who need reasonable accommodation to participate in this event should contact Erica Moore at erica.moore2@nih.gov or 301-594-4392, and/or the Federal Relay at 1-800-877-8339.

Research Opportunity Alert: The NIH Common Fund’s Community Partnerships to Advance Science for Society (ComPASS) OTA-22-007

The NIH Common Fund’s Community Partnerships to Advance Science for Society (ComPASS) Program published a new Research Opportunity Announcement (ROA): Community-Led, Health Equity Structural Intervention Initiative (OTA-22-007) to support the development, implementation, assessment, and dissemination of community-led, health equity structural interventions, co-created in partnership with research organizations, that intervene upon structural factors that produce and perpetuate health disparities.

ComPASS is focused on community-led research that will intervene on structural factors that limit the optimization of health. The program aims to develop structural interventions that leverage multi-sectoral partnerships to improve health outcomes of communities, reduce health disparities, and to change systems, policies and practices to achieve optimal health for all.

For more details on how to apply read the full ROA at: https://bit.ly/compassROA

Additionally, NIH staff will hold technical assistance webinars for the required letter of intent (LOI) for all interested applicants on October 4th and October 11th at 2pm-3pm ET.

Registration is required. Register here: bit.ly/compass-roa-webinar

Visit https://commonfund.nih.gov/compass for more information about the Common Fund’s ComPASS program, and please sign up for the ComPASS listserv to receive announcements about upcoming funding opportunities and additional program information.

REGISTER NOW

[10/6 Webinar Registration] Technical Assistance Webinar for PAR-22-233: Time-Sensitive Opportunities for Health Research (R61/R33 Clinical Trial Not Allowed)

Technical Assistance Webinar for PAR-22-233: Time-Sensitive Opportunities for Health Research (R61/R33 Clinical Trial Not Allowed)

Date: October 6, 2022
Time: 3:00 p.m. EDT
Register: https://scgcorp.zoom.us/webinar/register/WN_A-eRLDrbTPinDM5i-70bLA 

The NIH Office of Behavioral and Social Sciences Research (OBSSR) is holding a technical assistance webinar related to the recently released funding opportunity announcement (FOA) PAR-22-233: Time-Sensitive Opportunities for Health Research (R61/R33 Clinical Trial Not Allowed).

This FOA establishes an accelerated review/award process to support research to understand health outcomes related to an unexpected and/or time-sensitive event (e.g., emergent environmental threat; pandemic; change in local, state, or national policy; natural disaster). Applications in response to this FOA must demonstrate that the research proposed is time-sensitive and must be initiated with minimum delay due to a limited window of opportunity to collect baseline data, answer key research questions, and/or prospectively evaluate a new policy or program. This FOA is intended to support opportunities in which empirical study could only be available through expedited review and funding, necessitating a substantially shorter process than the typical NIH grant review/award cycle. The time from submission to award is expected to occur within 4-5 months. However, administrative requirements and other unforeseen circumstances may delay issuance dates beyond that timeline.

The webinar will provide an overview of the FOA (PAR-22-233) and provide an opportunity to address participant questions. NIH staff will discuss the purpose and scope of this funding opportunity, go over the scientific review process, and review criteria and other logistical information. Participants should submit their questions in advance of the webinar to Dr. Sarika Parasuraman (sarika.parasuraman@nih.gov) by COB on Tuesday, October 4th. An effort will be made to include all questions in the live discussion, but it is possible that not all will be addressed due to time constraints. Participation in the webinar is recommended but not required in order to apply to this funding announcement.

Register: https://scgcorp.zoom.us/webinar/register/WN_A-eRLDrbTPinDM5i-70bLA
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This webinar will include live captioning and will also be recorded and posted with captions on the OBSSR website.

Individuals with disabilities who need reasonable accommodation to participate in this event should contact Erica Moore at erica.moore2@nih.gov or 301-594-4392, and/or the Federal Relay at 1-800-877-8339.

Presentation at NIH BSSR-CC Meeting on 10/7 at 9:00 a.m. ET

The NIH Behavioral and Social Sciences Research Coordinating Committee (BSSR-CC) meeting on Friday, October 7 at 9:00 a.m. ET will feature a presentation from the NIH Center for Scientific Review (CSR)’s Valerie Durrant, Ph.D. As the Director of CSR’s Division of AIDS, Behavioral, and Population Sciences, Dr. Durrant will speak to recent updates and changes at CSR and review study sections, as well as integration of behavioral and social sciences research in the science, review process, and among review panels.

Registration is not required. Join via:
Web: https://nih.zoomgov.com/s/1619847996

Phone: +1 669 254 5252 or +1 646 828 7666 or +1 551 285 1373 or +1 669 216 1590; Meeting ID: 161 984 7996

An H.323/SIP room system: H.323: 161.199.138.10 (US West); 161.199.136.10 (US East); Meeting ID: 161 984 7996
SIP: 1619847996@sip.zoomgov.com

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Registration Now Open: Gender and Health Scientific Workshop on 10/26

You are invited to register and attend a scientific workshop on Gender and Health hosted by the NIH Office of Research on Women’s Health (ORWH) on October 26, 2022. The virtual workshop titled “Gender and Health: Impacts of Structural Sexism, Gender Norms, Relational Power Dynamics, and Gender Inequities” is being offered in partnership with NICHD, NIA, NIAID, NCI, NHLBI, NINDS, NIMH, NIDA, and OBSSR.

This virtual scientific workshop will convene the extramural community, NIH scientific and program staff, and other stakeholders to discuss methods and best practices in biomedical and sociobehavioral research on gender roles, gender norms, gender inequity, and structural sexism. The plenary speakers include:

  • Nancy Krieger, Ph.D., Professor of Social Epidemiology and American Cancer Society Clinical Research Professor at Harvard T.H. Chan School of Public Health (HSPH) and Director of the HSPH Interdisciplinary Concentration on Women, Gender, and Health
  • Patricia Homan, Ph.D., M.A., Assistant Professor and Associate Director of the Public Health Program at Florida State University
  • Typhanye Vielka Dyer, Ph.D., M.P.H., Associate Professor of Epidemiology and Biostatistics at the University of Maryland School of Public Health

REGISTER TODAY

Input requested on scientific priorities and cross-cutting themes for OBSSR Strategic Plan 2023-2028 (Respond by 11/14)

OBSSR recently released a Request for Information (RFI) (NOT-OD-22-211) to obtain input on cross-cutting themes and scientific priorities that will help inform OBSSR’s Strategic Plan 2023-2028. You can view the most recent strategic plan (2017-2021) here: https://obssr.od.nih.gov/about/strategic-plan/. The proposed scientific priorities and themes for the OBSSR Strategic Plan 2023-2028 include:

Three scientific priorities:

  1. Improve the synergy between basic behavioral and social sciences research and research testing approaches to improve health outcomes
  2. Enhance and promote research measures, methods, and infrastructure needed to support an integrated and more cumulative approach to behavioral and social sciences research
  3. Accelerate sustained adoption of behavioral and social sciences research findings in practice

Four cross-cutting themes:

  1. Integration of BSSR across NIH research
  2. Science of science
  3. Diversity, Equity, Inclusion and Accessibility (DEIA)
  4. Training and capacity building

Review the new RFI [https://grants.nih.gov/grants/guide/notice-files/NOT-OD-22-211.html] and respond by November 14, 2022, 11:59:59 PM EST: https://rfi.grants.nih.gov/?s=6318d59514480000ab000fa2

New Dates for the NIH Behavioral and Social Sciences Research Festival: 12/8-12/9

The 2022 NIH Behavioral and Social Sciences Research Festival will be held on December 8-9, 2022, from 1:00 to 5:00 p.m. EST each day. Registration information will be available soon.

Festival Overview: This annual meeting, organized by the Office of Behavioral and Social Sciences Research (OBSSR) and the NIH Behavioral and Social Sciences Research Coordinating Committee (BSSR-CC), informs the wider BSSR community, interested parties, and NIH Institutes and Centers (ICs) about the latest BSSR funded by the NIH and its overall impact and importance across the entire field of biomedical research. Additional goals are to assist the ICs with the establishment of research priorities and the coordination of their programmatic efforts, thus minimizing redundancy and maximizing returns on NIH investments in BSSR.

The festival highlights exciting research results, emerging areas, and innovations in health related BSSR. This NIH-wide event enables efficient leveraging of NIH resources and expertise. The BSSR-CC members contribute diverse and comprehensive perspectives on the NIH BSSR portfolio, thus facilitating the selection of an outstanding array of research results that are highlighted at the festival.

 

Now Open: Registration for the 15th Annual Science of D&I Conference (12/11-14)

Register for the in-person 15th Annual Conference on the Science of Dissemination and Implementation (D&I) in Health, to be held December 11-14 at the Walter E. Washington Convention Center, Washington, DC:
https://academyhealth.org/page/2022-di-registration

This December, individuals on the frontlines of dissemination and implementation (D&I) science will convene in-person for the first time in two years to ensure that evidence is used to inform decisions that will improve the health of individuals and communities.

Through a combination of plenaries, workshops, breakout, and poster sessions, the 15th Annual Conference on the Science of Dissemination and Implementation in Health, co-hosted by the National Institutes of Health (NIH) and AcademyHealth, supports the collective understanding of the research agenda, puts forth new findings, and identifies research priorities to set the field up for the next decade.

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Notice of Special Interest (NOSI): Development and Preliminary Testing of Health-related Behavioral Interventions

Notice Number
NOT-OD-22-203

Key Dates
First Available Due Date: October 3, 2022
Expiration Date: September 27, 2024

Purpose
To achieve more potent strategies to promote sustained health-related behavior change, there is a need for intentional and methodical translation of foundational behavioral and social science discoveries into new or improved interventions. The Office of Behavioral and Social Sciences Research (OBSSR) and participating ICOs are issuing this Notice to highlight interest in the systematic development of original health-related behavioral interventions that test hypotheses that draw on basic behavioral and social sciences research (bBSSR) findings that posit causal or processual mechanisms of action of healthier behavior change. This includes research that focuses on use-inspired bBSSR, understanding of mechanisms of action underlying initial and sustained behavior change, and systematic development and testing of health-related behavioral interventions and their components.

View NOT-OD-22-203

Time-Sensitive Opportunities for Health Research (R61/R33 Clinical Trial Not Allowed)

FOA Number
PAR-22-233

Key Dates
Open Date (Earliest Submission Date): November 1, 2022
Expiration Date: November 2, 2023

Purpose
This FOA establishes an accelerated review/award process to support research to understand health outcomes related to an unexpected and/or time-sensitive event (e.g., emergent environmental threat; pandemic; change in local, state, or national policy; natural disaster). Applications in response to this FOA must demonstrate that the research proposed is time-sensitive and must be initiated with minimum delay due to a limited window of opportunity to collect baseline data, answer key research questions, and/or prospectively evaluate a new policy or program. This FOA is intended to support opportunities in which empirical study could only be available through expedited review and funding, necessitating a substantially shorter process than the typical NIH grant review/award cycle. The time from submission to award is expected to occur within 4-5 months. However, administrative requirements and other unforeseen circumstances may delay issuance dates beyond that timeline.

View PAR-22-233

NIH Blueprint for Neuroscience Research: Computational Training in Neuroscience and Behavior (T90/R90 – Clinical Trial Not Allowed)

FOA Number
RFA-DA-23-037

Key Dates
Open Date (Earliest Submission Date): October 29, 2022
Expiration Date: November 30, 2022

Purpose
On behalf of the NIH Blueprint for Neuroscience Research, the National Institute on Drug Abuse seeks grant applications that will establish research training programs in computational neuroscience and behavior for undergraduate and predoctoral level students. The training program should expose undergraduate and graduate students to a wide range of neuroscience and behavioral questions, quantitative methods, and experimental systems to ensure a strong dual foundation in clinical and quantitative science. This foundation is expected to give trainees the ability to adopt new computational theory and methodology and apply these methods to relevant questions in health and disease

View RFA-DA-23-037

Expanding Collaborative Implementation Science to Address Social and Structural Determinants of Health and Improve HIV Outcomes (R01 Clinical Trial Required)

FOA Number
RFA-MH-22-190

Key Dates
Open Date (Earliest Submission Date): October 18, 2022
Expiration Date: November 19, 2022

Purpose
Through this FOA, the National Institute of Mental Health, in partnership with other NIH Institutes, Centers, and Offices, aims to support implementation science research to strengthen the evidence for effective interventions and implementation strategies that target Social and Structural Determinants of Health (SSDoH) and ultimately improve HIV outcomes and reduce inequities. This initiative will support applications that propose hybrid implementation-effectiveness studies that simultaneously test the effectiveness of interventions addressing SSDoH and implementation strategies to facilitate their uptake or adaptation. This initiative is closely aligned with the goals of the Ending the HIV Epidemic (EHE) in the U.S. initiative, coordinated by the Health and Human Services Office of the Assistant Secretary of Health.

View RFA-MH-22-190

Expanding Collaborative Implementation Science to Address Social and Structural Determinants of Health and Improve HIV Outcomes (R24 Clinical Trial Not Allowed)

FOA Number
RFA-MH-22-191

Key Dates
Open Date (Earliest Submission Date): October 18, 2022
Expiration Date: November 19, 2022

Purpose
Through this FOA, the National Institute of Mental Health in partnership with the National Institute on Drug Abuse, and the Office of Research on Women’s Health aims to support implementation science research to strengthen the evidence for effective interventions and implementation strategies that target Social and Structural Determinants of Health (SSDoH) and ultimately improve HIV outcomes and reduce inequities. This R24 will support the activities of a Data Coordination and Consultative Hub to provide scientific leadership across a set of funded R01 project teams supported by its companion RFA (RFA-MH-22-190). The companion R01 RFA will support applications that propose hybrid implementation-effectiveness studies that simultaneously test the effectiveness of interventions addressing SSDoH and implementation strategies to facilitate their uptake or adaptation. This initiative is closely aligned with the goals of the Ending the HIV Epidemic (EHE) in the U.S. initiative, coordinated by the Health and Human Services Office of the Assistant Secretary of Health.

View RFA-MH-22-191

Continued Extension of Certain Flexibilities for Prospective Basic Experimental Studies With Human Participants

Notice Number
NOT-OD-22-205

Purpose
This notice replaces NOT-OD-21-088. The purpose of this notice is to further extend interim policy flexibilities regarding registration and results reporting for a subset of NIH-funded research whose primary purpose is basic experimental studies with humans (BESH) submitted in response to BESH Funding Opportunity Announcements (FOAs). These studies, referred to in NOT-OD-18-212 as “prospective basic science studies involving human participants,” meet both the NIH definition of a “clinical trial” and also the definition of basic research.

This additional extension will last through September 24, 2024. During this extension period, NIH will continue to work with the BESH community to achieve effective and efficient dissemination of information that is useful to other researchers and members of the public, while also maintaining the NIH commitment to stewardship and increasing transparency.

View NOT-OD-22-205

NIH Blueprint for Neuroscience Research: Computational Training in Neuroscience and Behavior (T90/R90 – Clinical Trial Not Allowed)

FOA Number
RFA-DA-23-037

Key Dates
Open Date (Earliest Submission Date): October 29, 2022
Expiration Date: November 30, 2022

Purpose
On behalf of the NIH Blueprint for Neuroscience Research, the National Institute on Drug Abuse seeks grant applications that will establish research training programs in computational neuroscience and behavior for undergraduate and predoctoral level students. The training program should expose undergraduate and graduate students to a wide range of neuroscience and behavioral questions, quantitative methods, and experimental systems to ensure a strong dual foundation in clinical and quantitative science. This foundation is expected to give trainees the ability to adopt new computational theory and methodology and apply these methods to relevant questions in health and disease.

View RFA-DA-23-037

Environmental influences on Child Health Outcomes (ECHO) Data Analysis Center (U24) Clinical Trial Not Allowed

FOA Number
RFA-OD-22-022

Key Dates
Open Date (Earliest Submission Date): October 21, 2022
Expiration Date: November 22, 2022

Purpose
This FOA invites applications for a Data Analysis Center for the NIH Environmental influences on Child Health Outcomes (ECHO) program. The Data Analysis Center’s main roles are to 1) lead, standardize, and integrate ECHO Cohort Protocol data capture, management, and storage through a central data system; 2) provide analytic support and expertise to analysis proposals approved by the ECHO Cohort consortium; and 3) enrich research infrastructure and data science to facilitate broader sharing of ECHO Cohort data and resources with the scientific community.

View RFA-OD-22-022

Environmental influences on Child Health Outcomes (ECHO) Coordinating Center (U2C) (Clinical Trial Not Allowed)

FOA Number
RFA-OD-22-021

Key Dates
Open Date (Earliest Submission Date): October 21, 2022
Expiration Date: November 22, 2022

Purpose
The purpose of this FOA is to invite applications for a Coordinating Center for the Environmental influences on Child Health Outcomes (ECHO) program. The ECHO Coordinating Center will provide comprehensive operational leadership and an organizational infrastructure to manage and coordinate all ECHO Cohort activities. The Coordinating Center’s main roles are to: 1) Provide oversight and effective project management for all aspects of the ECHO Cohort consortium; 2) Support multiple ECHO Cohort committees and serve as the centralized ECHO Cohort communications center; and 3) Administer the Opportunities and Innovation Fund.

View RFA-OD-22-021

Environmental influences on Child Health Outcomes (ECHO) Measurement Core (U24) Clinical Trial Not Allowed

FOA Number
RFA-OD-22-020

Key Dates
Open Date (Earliest Submission Date): October 21, 2022
Expiration Date: November 22, 2022

Purpose
This FOA invites applications for a Measurement Core for the Environmental influences on Child Health Outcomes (ECHO) program. Working collaboratively with the other members of the ECHO Cohort consortium, the ECHO Measurement Core will: 1) develop and refine measures for the ECHO Cohort Protocol, including methods to implement the measures; 2) assist all ECHO Cohort Study Sites, Cores, and Centers in implementing and evaluating the ECHO Cohort Protocol which comprises standardized measures at specified study visits; and 3) lead strategic decision-making to incorporate new and revised measures to advance ECHO Cohort science while moderating participant and staff burden.

View RFA-OD-22-020

Limited Competition: Environmental influences on Child Health Outcomes (ECHO) Cohort Study Sites for Pediatric Follow Up. Clinical Trial Not Allowed (UG3/UH3)

FOA Number
RFA-OD-22-019

Key Dates
Open Date (Earliest Submission Date): October 21, 2022
Expiration Date: November 22, 2022November 10, 2021

Purpose
This FOA invites applications to renew current ECHO Cohort Study Sites to extend the capacity of the ECHO Cohort to further investigate the roles of a broad range of early exposures from society to biology on ECHO’s five key child health outcome areas—pre-, peri- and postnatal, upper and lower airways, obesity, neurodevelopment, and positive health—among diverse populations. The objectives of this FOA are to solicit applications to 1) lead collaborative ECHO Cohort science, 2) follow up existing ECHO Cohort participants, and 3) implement the ECHO Cohort Data and Biospecimen Collection Protocol using the ECHO Cohort consortium’s central data capture system, e.g., REDCap Central. This FOA does not support site-specific analyses and science. Only current ECHO Cohort awardees are eligible to apply. This new funding period will be 7 years in duration provided successful performance in the UG3 phase and the UH3 phase.

View RFA-OD-22-019

Limited Competition: Environmental influences on Child Health Outcomes (ECHO) Pregnancy and Pediatric Cohort Study Sites. Clinical Trial Not Allowed (UG3/UH3)

FOA Number
RFA-OD-22-018

Key Dates
Open Date (Earliest Submission Date): October 21, 2022
Expiration Date: November 22, 2022

Purpose
This FOA invites applications to renew current ECHO Cohort Study Sites to extend and expand the capacity of the ECHO Cohort to further investigate the roles of a broad range of early exposures from society to biology, including the preconception period, on ECHO’s five key child health outcome areas—pre-, peri- and postnatal, upper and lower airways, obesity, neurodevelopment, and positive health—among diverse populations. The objectives of this FOA are to solicit applications to 1) lead collaborative ECHO Cohort science 2) follow up existing ECHO Cohort participants, 3) recruit new pregnant participants from diverse populations, their resulting offspring, and, if available, the conceiving partner, 4) develop and implement the ECHO Cohort Preconception Pilot Study, and 5) implement the ECHO Cohort Data and Biospecimen Collection Protocol using the ECHO Cohort consortium’s central data capture system, e.g., REDCap Central. This FOA does not support site-specific analyses and science. Only current ECHO Cohort awardees are eligible to apply. This new funding period will be 7 years in duration provided successful performance in the UG3 phase and the UH3 phase.

View RFA-OD-22-018

Open Competition: Environmental influences on Child Health Outcomes (ECHO) Pregnancy Cohort Study Sites. Clinical Trial Not Allowed (UG3/UH3)

FOA Number
RFA-OD-22-017

Key Dates
Open Date (Earliest Submission Date): October 21, 2022
Expiration Date: November 22, 2022

Purpose
This FOA invites applications for new ECHO Cohort Study Sites to extend and expand the capacity of the ECHO Cohort to further investigate the roles of a broad range of early exposures from society to biology, including the preconception period, on ECHO’s five key child health outcome areas—pre-, peri- and postnatal, upper and lower airways, obesity, neurodevelopment, and positive health—among diverse populations. The objectives of this FOA are to solicit applications to 1) lead collaborative ECHO Cohort science, 2) recruit new pregnant participants from diverse populations, their resulting offspring, and, if available, the conceiving partner, 3) develop and implement the ECHO Cohort Preconception Pilot Study, and 4) implement the ECHO Cohort Data and Biospecimen Collection Protocol using the ECHO Cohort consortium’s central data capture system, e.g., REDCap Central. This FOA does not support site-specific analyses and science. This new funding period will be 7 years in duration provided successful performance in the UG3 phase and the UH3 phase.

View RFA-OD-22-017

Environmental influences on Child Health Outcomes (ECHO) Laboratory Core (U24) Clinical Trial Not Allowed

FOA Number
RFA-OD-22-016

Key Dates
Open Date (Earliest Submission Date): October 21, 2022
Expiration Date: November 22, 2022

Purpose
The purpose of this FOA is to invite applications for a Laboratory Core for the Environmental influences on Child Health Outcomes (ECHO) program.The ECHO Laboratory Core will provide leadership, project management, and infrastructure for all activities related to ECHO Cohort biospecimens and data generated from biospecimen assays. The main roles of the ECHO Laboratory Core are to: (1) facilitate ECHO Cohort biospecimen collection and processing; (2) manage the ECHO Cohort Biorepository; (3) perform or facilitate a wide range of biospecimen assays to support ECHO Cohort analyses; and (4) coordinate biospecimen information and assay results.

View RFA-OD-22-016

 

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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