Director's Voice
New Guidance for Basic Experimental Studies Involving Humans. On April 28, the Office of Extramural Research (OER) released a new webpage that provides additional guidance to investigators conducting Basic Experimental Studies with Humans (BESH). The NIH definition of a clinical trial includes basic research manipulating an independent variable, resulting in some basic research studies being subject to NIH clinical trials policies.
Based on prior feedback from the research community, NIH provided temporary leniency to basic research applications subject to the clinical trials policies to allow flexibility on the platform used for registration and results reporting and on applications submitted to an incorrect FOA based on the study-type designation (NOT-OD-18-212). Soon after this notice, the NIH issued parent FOAs on Basic Experimental Studies With Humans (e.g., PA-19-091), and only submissions to these BESH FOAs have the continued registration and reporting leniency that now extends through September 24, 2023 (NOT-OD-21-088).
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Cognitive impairment has been separately linked to traffic-related air pollution and noise exposure, as well as to metabolic syndromes, but the interaction of these two vulnerabilities is not well understood. In a study funded by the NIEHS, NIA, and NIDDK, researchers used 10-year longitudinal data from Mexican American participants to examine whether the presence of metabolic dysfunction modifies associations between air pollution or noise exposures and cognitive impairment, with or without dementia.
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An important concern during the COVID-19 pandemic has been whether reopening schools for in-person visits would increase the risk of COVID-19 infections, leading to a resurgence. Recently published research funded by the NIA and the Conrad N. Hilton Foundation sought to answer this question because children across the nation have been impacted by COVID-19 through altered access to education, food, social services, and their peers. To address this question, the researchers leveraged two large sources of national data: mobile phone tracking data and medical insurance claims data from the first 46 weeks of 2020.
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Depression is a common disease with limited effective treatments for the greater population with therapeutics being effective in only small groups of individuals. In a study funded by the NIA, NINDS, NIMH, Veterans Affairs, and others, researchers hypothesized that specific genetic variants influence depression by altering brain protein expression levels. The researchers used a study design which combined genome-wide association studies (GWAS) and human brain proteomic data to determine if variations in genes altered brain protein levels and could explain some of the inherited risk for depression.
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NIH Resources for Basic Experimental Studies Involving Humans (BESH)
Working on a study that might meet both the definition of basic research and the NIH definition of a clinical trial? Check out NIH’s new webpage on Basic Experimental Studies involving Humans (BESH). This webpage contains new resources to help investigators:
- understand the definition of BESH,
- differentiate between a measurement and an intervention,
- answer the four key questions that determine if a study meets the NIH definition of a clinical trial—from a BESH perspective,
- and more!
NIH also updated the library of clinical trial case studies, designed to help you identify whether your study would be considered by NIH to be a clinical trial.
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Scientific Review Officer (SRO) Position Openings at the Center for Scientific Review (CSR)
The Center for Scientific Review (CSR) at NIH will soon recruit for several Scientific Review Officer (SRO) positions and are looking to hire social and behavioral scientists.
The successful candidate will be a respected, accomplished scientist with maturity, integrity and outstanding communication skills. Requirements include a Ph.D., M.D., Dr.P.H., Sc.D. or other doctoral degree in the behavioral sciences; American citizenship; and a record of independent research accomplishments, documented by a publication record and administrative background.
Interested? Please send a brief paragraph that includes the below information to [email protected]. CSR can answer your questions and give you more information about how to successfully apply.
- Your academic discipline (e.g., behavioral science, psychology, anthropology, medicine, etc.)
- Current position/career stage (e.g., assistant professor, associate professor, research scientist)
- Degree (e.g., Ph.D., M.D., Ed.D., Psy.D.—note you should have a doctoral level degree)
- Describe your research experience, publications, funding etc.
In addition, CSR is hosting an informational session for interested applicants on Thursday, May 13 at 12 p.m. EDT. Link to join: https://csrnih.zoomgov.com/j/1604018917?pwd=RFlQc3lOZVRWUEV5VHBOa0QwOHNUZz09
To learn more about working as an SRO at CSR see: https://public.csr.nih.gov/AboutCSR/Employment
Register for Telehealth in Cancer Care Webinar on May 18
The National Cancer Institute (NCI) recently released a Notice of Special Interest (NOSI) on Telehealth in Cancer Care (NOT-CA-21-043). During this May 18 webinar, co-hosted by the NCI Behavioral Research Program and Healthcare Delivery Research Program, speakers will describe the NOSI mechanism and introduce NCI’s research priorities and relevant Funding Opportunity Announcements. Speakers include Kelly Blake, Sc.D., NCI Behavioral Research Program, and Gurvaneet Randhawa, M.D., M.P.H., NCI Healthcare Delivery Research Program.
Please submit questions in advance to [email protected]. Questions about individual projects will not be addressed during the webinar.
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Training in Advanced Data Analytics for Behavioral and Social Sciences (TADA-BSSR) Webinar on May 20 at 12 p.m. EDT
Join the upcoming TADA-BSSR Webinar “Integrating Data Analytics into the Social and Behavioral Science Research Lifecycle” on May 20, 2021, 12–1 p.m. EDT/9–10 a.m. PDT via Zoom. This webinar will explore the ways that elements of Cook and Campbell’s validity framework can strengthen analyses of “big data” that are designed to study, monitor, and intervene in drug-related harms. Speakers, Hannah L. F. Cooper, Sc.D., and Lance Waller, Ph.D., Rollins School of Public Health at Emory University, will discuss the relevance of specific threats to internal validity, external validity, and statistical conclusion validity to these analyses, and strategies to minimize these threats. Free registration is required: https://www.scgcorp.com/BehavioralSocialSci/.
View archived TADA-BSSR Webinars at: https://www.scgcorp.com/BehavioralSocialSci/
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Environmental influences on Child Health Outcomes (ECHO) Program Request for Information (RFI)
The NIH Environmental influences on Child Health Outcomes (ECHO) Program recently released a Request for Information (RFI) to seek input from the scientific community and the general public about enhancing ECHO science. This RFI seeks input from stakeholders throughout the extramural scientific community and the public regarding enhancing the science of ECHO.
In 2016 NIH launched the nationwide ECHO Program. Its mission is to enhance the health of children for generations to come. The impact of ECHO’s observational research rests on availability of combined data from multiple diverse pre-existing and ongoing maternal-child cohort studies, driven by the ECHO-wide Cohort data collection protocol. To date the ECHO-wide Cohort data platform contains data on over 50,000 children and their families.
Please provide comments by May 25, 2021, to [email protected].
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Technical Assistance Webinar for RFA-MD-21-004, Understanding and Addressing the Impact of Structural Racism and Discrimination on Minority Health and Health Disparities
The NIMHD will host a pre-application technical assistance webinar (via Webex) to provide information and respond to questions from prospective applicants who plan to submit applications to RFA-MD-21-004 on May 26, 2021, 1–2:30 p.m. EDT. NIH program and review staff will provide an overview of the RFA, including objectives, application instructions, and review criteria and will be available to answer questions. Pre-registration is required: https://nih.webex.com/nih/onstage/g.php?MTID=ed390dddb36143ab829d5482b9aa7f0ba.
Please direct all inquiries to: [email protected].
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RFI on Proposed NIH Sleep Disorders Research Plan: Critical Opportunities and Strategic Goals
This is a time-sensitive Request for Information (RFI) to solicit input regarding revisions to the NIH Sleep Research Plan. It is issued by the NHLBI, the National Center on Sleep Disorders Research (NCSDR), on behalf of the NIH-wide Sleep Research Coordinating Committee (SRCC). This RFI has been issued to seek input from the research community, stakeholders, and interested members of the public. The information collected from this RFI will be used to refine the research plan. Specifically, the NIH requests feedback on strategic goals, critical opportunities, and emerging opportunities.
All responses to this RFI must be submitted electronically to the following webpage at https://rfi.grants.nih.gov/?s=607dc60e763e00005d0059923 by May 31, 2021.
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HIV-Related Stigma Research as a Priority at the National Institutes of Health
The NIH recognizes that, despite HIV scientific advances, stigma and discrimination continue to be critical barriers to the uptake of evidence-based HIV interventions. Achieving the Ending the HIV Epidemic: A Plan for America (EHE) goals will require eliminating HIV-related stigma. NIH has a significant history of supporting HIV stigma research across its Institutes, Centers, and Offices (ICOs) as a research priority. This article provides an overview of NIH HIV stigma research efforts. Each ICO articulates how their mission shapes their interest in HIV stigma research and provides a summary of ICO-relevant scientific findings. Research gaps and/or future opportunities are identified throughout, with key research themes and approaches noted. Taken together, the collective actions on the part of the NIH, in tandem with a whole of government and whole of society approach, will contribute to achieving EHE’s milestones.
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NIH Reviewer Recommendations Portal for Scientific Societies
The NIH Scientific Society Reviewer Recommendations Portal is for scientific societies that would like to recommend reviewers. When first visiting the portal, a representative from the society should create a user account. After an account is created, we will confirm that you are acting on the society’s behalf. After confirmation, you will receive an email inviting you to submit recommendations.
Please carefully vet all recommended reviewers. They should be scientists who are generally willing to serve as reviewers and are experts, with integrity, in their field. They should have an active research program, extramural funding, and not currently be a standing member of an NIH study section or advisory council. We strongly encourage societies to recommend productive scientists from diverse backgrounds and career stages (e.g., assistant, associate, and full professors). Contact Kristin Kramer with any questions at [email protected].
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Recording and Slides Available: Common Fund Health Disparity Webinar
On April 27, 2021, the NIH Common Fund hosted a pre-application webinar for Transformative Research to Address Health Disparities and Advance Health Equity (RFA-RM-21-021 and RFA-RM-21-022). NIH program, grants management, and review staff discussed the overall scope and intent of these funding opportunities, the review process, and the use of the cooperative agreement (U01) mechanism. The webinar recording and slides are available to view.
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2021 NIH Behavioral and Social Sciences Research Festival
SAVE THE DATE: Friday, November 19, 2021
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.
View Past Research Festival Materials
Addressing Social Determinants of Health to Eliminate Oral Health Disparities (UG3/UH3 Clinical Trials Optional)
Notice Number
RFA-DE-22-002
Key Dates
Open Date (Earliest Submission Date): June 8, 2021
Expiration Date: July 27, 2021
Purpose
The purpose of this Funding Opportunity Announcement (FOA) is to support research on how to effectively identify and optimally address upstream social determinants of health that can often present as a barrier to optimal oral health, impede the effectiveness of interventions, and contribute to oral health disparities in vulnerable and underserved groups.
View RFA-DE-22-002
Notice of Special Interest (NOSI): COVID-19 Related School Disruptions Impact on Mental Health, Cognitive, Social, and Emotional Development of Children
Notice Number
NOT-MH-21-225
Key Dates
First Available Due Date: June 5, 2021
Expiration Date: September 8, 2022
Purpose
The NIMH is issuing this Notice of Special Interest (NOSI) to highlight interest in research to understand the mental health impact of the Coronavirus Disease 2019 (COVID-19) pandemic on school-aged children, specifically ages 3 to 12. Particularly, we are interested in the potential impact of primary instruction settings disruptions (e.g., pre-school, elementary school) on the mental health, cognitive, social, and emotional development of children. Empirical data would aid in balancing health risks for various public health mitigation strategies affecting children in the current pandemic as well as inform how to both be prepared and respond to future public health emergencies, including pandemics and disaster scenarios.
View NOT-MH-21-225
Emergency Award: Social, Behavioral, and Economic Research on COVID-19 Consortium (U01 Clinical Trial Not Allowed)
FOA Number
PAR-21-213
Key Dates
Open Date (Earliest Submission Date): May 9, 2021
Expiration Date: November 9, 2021
Purpose
The purpose of this FOA is to advance research on the impact of SARS-CoV-2 and associated mitigation efforts on individual, family, and community behavior and on how subsequent economic disruption affects health-related outcomes, with close attention to underserved and vulnerable populations.
View PAR-21-213
BRAIN Initiative: Development and Validation of Novel Tools to Probe Cell-Specific and Circuit-Specific Processes in the Brain (R01 Clinical Trial Not Allowed)
FOA Number
RFA-MH-21-175
Key Dates
Open Date (Earliest Submission Date): September 8, 2021
Expiration Date: October 7, 2023
Purpose
The purpose of this Brain Research through Advancing Innovative Neurotechnologies® (BRAIN) Initiative is to encourage research that will develop and validate novel tools to facilitate the detailed analysis of complex circuits and provide insights into cellular interactions that underlie brain function. The new tools and technologies should inform and/or exploit cell-type and/or circuit-level specificity. Plans for validating the utility of the tool/technology will be an essential feature of a successful application.
View RFA-MH-21-175
NIH Blueprint and BRAIN Initiative Diversity Specialized Predoctoral to Postdoctoral Advancement in Neuroscience (D-SPAN) Award (F99/K00 Clinical Trial Not Allowed)
FOA Number
RFA-NS-21-012
Key Dates
Open Date (Earliest Submission Date): November 15, 2021
Expiration Date: December 16, 2023
Purpose
The purpose of the NIH Blueprint and BRAIN Initiative Diversity Specialized Predoctoral to Postdoctoral Advancement in Neuroscience (D-SPAN) Award is to support a defined pathway across career stages for outstanding graduate students from diverse backgrounds, including those from groups underrepresented in biomedical and behavioral sciences.
View RFA-NS-21-012
Blueprint Neurotherapeutics Network (BPN): Biologic-based Drug Discovery and Development for Disorders of the Nervous System (U44 Clinical Trial Optional)
FOA Number
PAR-21-233
Key Dates
Open Date (Earliest Submission Date): July 10, 2021
Expiration Date: April 6, 2024
Purpose
The Blueprint Neurotherapeutics Network for Biologics (BPN-Biologics) provides support for biologic-based therapeutic discovery and development, from lead optimization through Phase I clinical testing. This Funding Opportunity Announcement (FOA) supports preclinical discovery and development of potential therapeutic Biotechnology Products and Biologics including, but not limited to, large biologic macromolecules, (e.g., proteins, antibodies, and peptides), gene-based therapies (i.e., oligonucleotide- and viral-based), cell therapies, and novel emerging therapies (e.g., microbial and microbiome therapies).
View PAR-21-233
