Director’s Voice

Continuing to Work with the Community on Registration and Results Reporting for Basic Experimental Studies involving Humans. The research that NIH funds doesn’t always fall neatly into a single category. Basic research involving humans that seeks to understand the fundamental aspects of phenomena also may meet the NIH-definition of a clinical trial. We refer to these studies as BESH—Basic Experimental Studies involving Humans (see our previous blog). Since this type of research meets the NIH definition of a clinical trial, these trials must register and report summary results information for transparency and other purposes outlined in the NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information. However, some researchers have faced challenges in fitting these studies into the data fields for submission in ClinicalTrials.gov.

This blog was co-authored by Drs. Michael Lauer, Deputy Director for Extramural Research, and Carrie Wolinetz, Associate Director for Science Policy.

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Research Spotlights Findings from Recently Published Research

Seeing is feeling—How Artificial Intelligence is helping us understand emotions

Recently published research supported by NIMH and NIDA sheds light on how our brains process visual information with emotional features by incorporating machine-learning innovations and human brain-imaging. The researchers started with an existing neural network, AlexNet, which enables computers to recognize objects and adapted it using prior research that identified stereotypical emotional responses to images.
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Why give up now? Scientists gain new insights into motivation and reward seeking

Researchers funded by NIDA, NIMH, NIGMS, NCI, and the Brain and Behavior Research Foundation just published findings that add insight into motivation and reward research by elucidating the neural pathways involved in giving up. Nociceptin, an opioid-like peptide, and its receptors are widely distributed throughout the brain in regions associated with reward behavior.
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Stress during pregnancy is linked with long-term effects on mother’s health

Recently, research supported by NICHD, NHLBI, NICHD, and OBSSR was published that investigated the associations of prenatal stress and adverse pregnancy outcomes on maternal mental health 2 to 7 years after pregnancy. Stress has been shown to be a risk factor for adverse pregnancy outcomes such as gestational diabetes, hypertensive disorders of pregnancy, preeclampsia, and medically indicated or spontaneous preterm birth.
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In the Know Events and Announcements

Dr. Felicia Hill-Briggs "Advancing BSSR to Address National Priorities for Health Care and Population Health Improvement" Webinar

On Tuesday, September 24, 2019 at 2 p.m. ET, Felicia Hill-Briggs, Ph.D., ABPP, Professor of Medicine and Core Faculty of the Welch Center for Prevention, Epidemiology, and Clinical Research at Johns Hopkins University School of Medicine, will present "Advancing BSSR to Address National Priorities for Health Care and Population Health Improvement." The recording of this webinar will be available with closed captioning on OBSSR’s website approximately one month after the event: http://bit.ly/2TOdYqr.

If you have questions about the webinar or require reasonable accommodations, please contact Erica Moore at 301-594-4392 or erica.moore2@nih.gov, and/or the Federal Relay at 1-800-877-8339.
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Digital Clinical Trials Workshop Executive Summary: Creating a Vision for the Future

The National Heart, Lung, and Blood Institute (NHLBI), in partnership with the National Science Foundation (NSF) and OBSSR, hosted a workshop April 1–2, 2019, to discuss the potential transformation of NIH-funded clinical trial research by leveraging digital technologies, including data analytics. Development of diverse digital technologies and analytics has impelled a paradigm shift in how clinical trials can be conducted. This development points to opportunities to advance the clinical trial process on both scientific and cost effective grounds while moving toward a more patient-centered trial experience. This workshop convened experts in the field of clinical trials and digital health technology to identify best practices, gaps, barriers, and future priorities for leveraging digital technologies for clinical trials.
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Workshop Executive Summary: Identifying Research Priorities in Child Suicide Risk

According to the Centers for Disease Control and Prevention (CDC), rates of suicide attempts and deaths—including among children—have been increasing in the United States over the past decade. However, very little research has been conducted on suicide risk in children relative to adolescents and adults. The NIH National Institute of Mental Health (NIMH) and OBSSR held a workshop May 9-10, 2019, to foster discussion among experts in the field with the goal of identifying future research priorities in the area of child suicide risk.
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New Video on the “NIH Story”

NIH has produced a new video that captures the spirit, mission, community, and the lifesaving work we do at NIH and the more than 2,500 universities, medical schools, and other research institutions in every state and around the world. For many, we are considered the National Institutes of Hope. This video tells the story of NIH and our community, and represents the thousands of people who dedicate their lives to improving health and fighting disease, and operating the biomedical research enterprise that enables this important work. We consider this video as much your video as it is ours and we encourage you to share it with your constituents. For questions, please contact the NIH Office of the Director Office of Communications: OCPLPressTeam@od.nih.gov.
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Registration Is Now Open for HIV-associated Comorbidities Workshop: September 19–20, 2019

The NIH Office of AIDS Research (OAR) funds research on HIV-associated comorbidities, co-infections, and complications through multiple Institutes and Centers (ICs), with a focus on diseases that fall within each IC’s mission and HIV/AIDS related funding priorities. This workshop will foster discussion among experts from different fields and disciplines to share their perspectives and explore interrelationships among multiple comorbidities, in an effort to refine research priorities that aim to improve the health and well-being of people with HIV. This workshop is free and open to the public on a first-come, first-served basis. If you cannot attend in person, please consider participating by webcast (link will be provided closer to the date of the meeting). The plenary sessions of the workshop (not breakout sessions) will be videocasted, recorded, and archived.
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Registration for the Mental Health and SUD Forum's First Workshop Is Now Open

The NASEM Forum on Mental Health and Substance Use Disorders is hosting its first public workshop October 15–16, 2019. This first workshop will provide an overview of five key policy challenges to improve care for people with mental health and substance use disorders. The workshop will explore issues related to:

• Promoting person-centered care, patient and family member engagement, and shared decision-making
• Defining what constitutes minimally adequate care for mental health and substance use disorders for different types of providers and in different care settings
• Identifying promising strategies to translate knowledge to practice and to monitor implementation
• Highlighting innovative practices to facilitate and optimize data collection, integration, and use
• Improving care spanning the medical, mental health, and substance use disorder workforce and care delivery systems

It is expected that subsequent workshops will continue to build on this foundational work, examining key issues in greater detail.
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Save the Date: November 3, 2019, APHA-LI 2002.0 Introduction to Implementation Science

The purpose of this course is to provide participants with an orientation to implementation science, which addresses the gap between research evidence and routine practice. This course is targeted to public health practitioners, researchers and community health workers at all stages in their careers, who are interested in understanding the rationale for and application of implementation science and its importance to public health.

This course will address:

• Strategies to advance implementation of effective interventions in community and clinical settings
• Barriers that prevent interventions from reaching diverse and at-risk populations
• How evidence is used to inform local, state, and national policy
• Major components of an implementation study and examples of research designs

Faculty
Jennifer Leeman, Dr.P.H., M.Div., Associate Professor, University of North Carolina at Chapel Hill, School of Nursing

Jonathan Purtle, Dr.P.H., M.P.H., M.Sc., Assistant Professor, Drexel University School of Public Health, Department of Health Management & Policy

Antoinette L. Percy-Laurry, Dr.P.H., M.S.P.H., Health Scientist, National Cancer Institute, Implementation Science

Organized by: National Institutes of Health, National Cancer Institute, Implementation Science Contact: percyl@mail.nih.gov

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NIH Behavioral and Social Sciences Research Festival Save the Date: December 6, 2019

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. Location: NIH Campus, Natcher Conference Center (Bldg. 45).

Funding Announcements Environmental Influences on Aging: Effects of Extreme Weather and Disaster Events on Aging Processes

The purpose of this funding opportunity announcement (FOA) is to support research to explore the impacts of extreme weather and disaster events on the basic biology of aging. Together with the companion FOA (PAR-19-250) that focuses on how extreme weather and disaster events impact older adults, these complementary FOAs will help to explicate the behavioral, biological, epigenetic, genetic, neurological, and socioecological processes that affect the aging process. Through integration of this and the companion population studies FOA, the ultimate goal is to improve the health and well-being of older adults via increased knowledge about extreme weather and disaster preparedness, response, and recovery.

PAR-19-249 (R01 Clinical Trial Not Allowed)

Protocol Template for Behavioral and Social Sciences Research

Resource for Communicating the Science, Methods, and Operations of a Clinical Trial

This Protocol Template for Behavioral and Social Sciences Research is a suggested format for clinical trials that are testing a behavioral or social intervention or experimental manipulation. 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 delays down the road. Use of the protocol template is encouraged but not required.
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Social and Behavioral Research eLearning Course

Good Clinical Practice in Social and Behavioral Research

Complete the free NIH Good Clinical Practice (GCP) Training through the Society of Behavioral Medicine. In September 2016, the NIH issued a Policy on Good Clinical Practice Training for NIH awardees involved in NIH-funded clinical trials. The principles of GCP help assure the safety, integrity, and quality of clinical trials. Certificates will be given upon completion of the training.
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