Notice of NIMH Participation in PA-18-488 "NIH Small Research Grant Program (Parent R03 Clinical Trial Not Allowed)"

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Notice Number: NOT-MH-18-025

Key Dates
Release Date: March 19, 2018

Related Announcements
PA-18-488

Issued by
National Institute of Mental Health (NIMH)

Purpose

The purpose of this Notice is to inform potential applicants that the National Institute of Mental Health (NIMH) is participating, effective April 1, 2018, in PA-18-488 "NIH Small Research Grant Program (Parent R03 Clinical Trial Not Allowed)"

NIMH is interested in applications in areas of NIMH priority as detailed in the NIMH Strategic Plan and the NIMH Strategic Research Priorities.

Specific research priorities are listed as follows.

Division of Translational Research (DTR): Supports research that translates knowledge from basic science to discover the etiology, pathophysiology, and trajectory of mental disorders and develops effective interventions for children and adults.

DTR high priority research areas appropriate for the R03 mechanism include but are not limited to the following topics (note that clinical trials are not supported):

• Delineate specific neural circuits contributing to one or more major mental disorders or subtypes of mental disorders.
• Using previously acquired data and novel data analytic approaches, develop, test, validate, and refine markers (e.g., genetic, proteomic, imaging, quantified behaviors measured with passive sensing devices, thought markers derived from natural language processing, subjective state markers derived from facial dynamics, etc.) for use in translational research. Uses of such markers might include diagnosing or detecting risk or resilience, onset, progression, and/or severity of mental disorders, evaluating treatment response, and serving as predictive criteria to personalize treatment.
• Identify mechanisms (e.g., biological, behavioral, environmental) that confer risk for and resilience to mental disorders.
• Discover novel targets for future therapeutic intervention by identifying causal relationships between neural circuits and symptom expression.
• Develop, test, and validate methods to assess domains of psychopathology for use in future studies or clinical trials.
• Delineate neurobehavioral mechanisms responsible for the development of psychopathology, including critical and sensitive periods in brain development and the effects of sex, behavior, and experience on the brain.
• Utilize behavioral phenotypes reflecting dimensional processes (e.g., attention, mood regulation) to maximize discovery of underlying neural systems and refine behavioral assessment tools so that they are comparable across age, species, and social experience (e.g., SES, culture).
• Develop novel computational approaches to reliably infer subjective state from naturalistic behaviors passively assessed and quantified outside of the laboratory.
• Based on expanded knowledge of neurobehavioral trajectories, identify early signs of risk that could represent targets for future studies that may employ preventive and treatment interventions.
• Assess the mechanisms of action of efficacious interventions in the brain in bench, pre-clinical context, or computational models.
• Development of novel analytical, statistical or computational approaches that can be used to integrate multiple types of data relevant for understanding the pathophysiology of mental illness.
• Use of existing data sets (e.g., NIMH Data Archive, other public data bases) to probe novel hypothesis-driven questions of high priority to DTR and NIMH.

Division of AIDS Research (DAR): Supports research on behavioral and social science strategies to stop the spread of HIV, basic and clinical neuroscience of HIV infection, and the mental health effects of living with HIV.

DAR high priority research areas include but are not limited to the following topics:

• Expand approaches to integrate behavioral and social science with effective biomedical strategies for HIV prevention.
• Advance developmental research to inform potential interventions delivered beyond the individual level, by incorporating appropriate context into intervention development.
• Increase intervention potency and long-term maintenance of effects, with an emphasis on targeting key populations.
• Develop strategies to increase HIV testing and improve linkage to care and timely treatment initiation.
• Develop and advance developmental research to inform potential interventions to improve HIV treatment outcomes through optimal treatment adherence and sustained engagement in care.
• Support implementation science and operations research to enhance dissemination strategies and public health impact of effective interventions.
• Examine evolving pathophysiologic mechanisms of HIV-induced CNS dysfunction in the setting of long-term antiretroviral therapy and viral suppression, and development of novel therapeutic approaches to mitigate CNS complications of HIV infection.
• Support the use of state-of-the-art (epi)genetic approaches to identify and validate viral and host genetic factors that influence the pathophysiology and manifestations of HIV-induced CNS dysfunction.
• Define and characterize HIV persistence in the CNS in the context of suppressive highly active antiretroviral therapy, and foster translational research to enable eradication of HIV from the brain.
• Use of existing data sets (e.g. the NNTC including the CHARTER Study, ACTG, MACS, WIHS IeDEA, IMPAACT, HPTN, PHACS public data sets and other public data bases) to conduct exploratory research and to probe novel hypothesis-driven questions of high priority to DAR and NIMH.

Division of Services and Intervention Research (DSIR): Supports innovative research aimed at testing and optimizing the effectiveness of therapeutic and preventive interventions, improving access to and delivery and quality of evidence-based services, and research to accelerate the dissemination, implementation, and continuous improvement of new practices in diverse settings.

DSIR encourages R03 applications with research consistent with Objectives 3 and 4 of the NIMH Strategic Research Priorities, including but not limited to the following:

• Secondary analysis to inform the refinement and optimization of therapeutic and preventive interventions (for more potent, efficient, and personalized interventions), including:
  • Analyses of moderators and biomarkers of treatment response from large and/or combined existing clinical trials datasets;
  • Computational approaches that utilize electronic health record data or data from existing clinical trials to identify and evaluate treatment matching strategies; and
  • Computational approaches using existing data (EHR; trials) that enhance early treatment response prediction and/or rapidly identify patients who would benefit from augmented or alternative treatments.
• Innovative exploratory/developmental services research to improve access to and delivery, quality, and reach of evidence-based services, including:
  • Studies to identify mutable factors that may serve as targets for future services interventions aimed at improving access, continuity, equity, engagement, adoption, sustainment, scalability, utilization, quality, financing, and clinical outcomes;
  • Studies to develop and test new research measures, methods, or novel analytic approaches (e.g., machine learning and big data analytics leveraging data from health care systems, decision analysis, predictive analytics), to enable early detection of mental disorders, to improve clinical and financial decision making within delivery systems (e.g., schools, workplace, primary and specialty care settings, criminal justice, virtual communities), etc.;
  • Studies utilizing innovative technologies (e.g., mobile devices, health information systems, social networking platforms) to identify strategies for improving early detection of mental illnesses, for engaging and connecting service users to evidence-based care, and for increasing the reach, clinical impact, and scalability of services for un- and under-served populations; and
  • Research to inform and improve innovative service delivery models to identify approaches for improving coordination between inpatient, outpatient and pharmaceutical services, for continuous quality improvement strategies, and for de-implementing low value service and expanding the use of high value services.

Applicants pursuing pilot services research studies that do not involve development and testing of services interventions, such as (1) studies to identify mutable factors that impact access, utilization, quality, financing, outcomes including disparities in outcomes, or scalability of mental health services, which may serve as targets in future intervention development; 2) development and testing of new research tools, measures, or methods; or 3) testing the feasibility of integrating existing data sets to understand factors affecting access, quality or outcomes of care are also encouraged to consider PAR-15-323 (Pilot Services Research Grants Not Involving Interventions (R34)). PD(s)/PI(s)s interesting in submitting clinical trials applications focused on the development and testing of therapeutic-, preventive- and services- interventions should see the NIMH Clinical Trials Funding Opportunity Announcements web page for a list of clinical trials FOAs and consult with Scientific/Research Staff regarding FOAs that are appropriately matched to the study scope and stage of intervention development and testing.

Office of Technology Development and Coordination (OTDC): Supports basic and applied research related to the development of scientific tools, technologies, and approaches related to brain and behavioral research.

OTDC high priority research areas include but are not limited to the following topics:

• The development or enhancement of relevant software tools.
• The secondary analysis of data in existing publicly available data archives.
• Development of novel statistical and analytic approaches for handling large datasets.
• Software tools for enhancing and scaling automated image processing, connectivity analysis, and data interpretation, including algorithms, information extraction routines, and user interfaces.
• Novel approaches to increase availability and utility of public resources such as atlases and databases.

Office for Research on Disparities and Global Mental Health (ORDGMH): ORDGMH encourages research on mental health disparities, women's mental health, and rural mental health and supports global mental health research.

• Mental health disparities, women's mental health, and rural mental health: Given differences in illness prevalence and mental health outcomes based on sex, gender, age, race, ethnicity, and geography, NIMH-supported research should include adequate numbers of men and women and members of diverse racial/ethnic groups in studies from genomics to services research in order to detect, understand, and mitigate these disparities. In addition, studies of diverse populations can contribute to understanding of risks for mental illness, responsiveness to prevention and treatment interventions, and access to and engagement in care. Specifically, research on sex, gender, age, racial, and ethnic differences related to mental disorders will provide information essential to the development of precision medicine and personalized interventions.
• Global mental health: ORDGMH supports global mental health research with a focus on testing and optimizing the effectiveness of treatment and preventive interventions; improving the accessibility, delivery, and quality of evidence-based services; and accelerating the implementation, scale up, and continuous improvement of evidence-based mental health care in low- and middle-income countries.

Office of Genomics Research Coordination (OGRC): Supports research to elucidate genomic risk factors that underlie mental disorders.

OGRC high priority areas include, but are not limited to, projects that will enhance the value of the resources being generated by NIMH such as:

• Computational methods development for analysis of large scale genomic or multi-scale molecular data.
• Innovative methods development for genomics, proteomic, etc. exploration of post-mortem human samples, especially single cell analysis.
• Projects making innovative use of genomics resources (e.g., NIMH Repository and Genomics Resource; SYNAPSE).

Division of Neuroscience and Basic Behavioral Science (DNBBS): Supports research programs in basic neuroscience, genetics, resource and technology development, and drug discovery.

DNBBS high priority research areas include but are not limited to the following topics:

• Discover novel mechanisms of nervous system development (across genes, proteins, cells and circuitry) and signaling properties that underlie the emergence of cognition, emotion, and social behavior.
• Develop and use innovative strategies, including genome-wide and comparative approaches, to discover genes and gene regulatory mechanisms underlying brain function, cognition, emotion, and social behavior.
• Develop and apply innovative biological, biophysical or cell-based assays for interrogating novel biological targets or processes relevant to mental disorders.
• Discover cellular and molecular mechanisms whereby hormones and immune molecules modulate signaling in brain circuits relevant to emotion regulation, cognition, and social behavior.
• Identify novel therapeutic targets, ligands to modify targets, and neuroimaging tools to advance innovative treatment development for mental illnesses.
• Develop innovative preclinical assays and neurobiological measures of fundamental processes relevant to emotional and cognitive disorders.
• Develop new and use existing physiological and computational models to understand the biological functions of genes, gene products, cells, and brain circuits in health and atypical mental function.
• Develop and empirically evaluate computational and theoretical models that address plasticity of brain circuits during development impacting cognitive, affective, and social behaviors.
• Extend analyses of key determinants of cognitive, affective, and social processes across levels of analysis between genomic, molecular, cellular, circuits to behavior.
• Apply biologically-grounded theory- and data-driven computational models to understand the functions of genes, gene products, cells, and brain circuits in mental functions and complex behaviors.
• Identify, at a genome-wide level, genetic variants that increase risk for mental disorders and related traits in diverse populations from the US and around the world.
• Develop integrative and comparative approaches for understanding the biology of molecular and cellular networks implicated in mental disorders by genome-scale human genetics.
• Identify biological markers (e.g., genetic, proteomic, imaging) in experimental (model) systems and in humans that could be further validated as methods for diagnosing and/or detecting risk/vulnerability, onset, progress, and/or severity of mental disorders.

This FOA will not support applications proposing:

• Basic neuroscience studies of motor systems and motor function
• Sensory representation and/or multi-sensory integration without connection to mental health relevant functions
• Basic neuroscience studies of neural circuits underlying homeostatic feeding where the stated goal is to understand eating disorders
• Homeostatic behavioral responses (e.g., thirst, hunger etc)
• Basic molecular circadian biology including molecular circadian mechanisms, behavioral circadian phenomenon, shift work, jet lag, and biological clocks
• Basic sleep studies lacking connection to neural mechanisms that underlie mental health relevant functions and behavior
• Studies using classical conditioning tasks as outcome measure (e.g., eye blink conditioning)
• Single brain region-based or static conceptual models of brain function and behavior
• Studies of sexual behaviors, prejudice, stereotyping, in-group/out-group relationships
• Behavioral studies that lack neurobiological measures
• Studies of fear learning that do not advance the knowledge of the neural bases of fear learning toward prevention and treatment of fear and anxiety disorders
• Computational projects that model a single level of analysis and/or are not experimentally testable and validated
• Computational projects where the primary focus is not to classify, predict, explain, and/or modify brain and behavior activity
• Evaluation of animal models of DSM syndromes including eating disorder models and comorbid syndromes.
• Studies focused predominantly on behavioral effects of environmental or dietary manipulations in animals.
• Studies to determine the mechanism of action of drugs commonly used in the treatment of mental disorders

Updated priorities for NIMH research are detailed on NIMH research priorities website.

The following Sections of PA-18-488 have been updated to reflect the participation of NIMH in this Funding Opportunity Announcement.

National Human Genome Research Institute (NHGRI)
National Institute on Aging (NIA)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Drug Abuse (NIDA)
National Institute of Environmental Health Sciences (NIEHS)
National Institute of Mental Health (NIMH)
National Institute on Minority Health and Health Disparities (NIMHD)
National Institute of Neurological Disorders and Stroke (NINDS)

Note: Not all NIH Institutes and Centers (ICs) participate in Parent Announcements. Applicants should carefully note which ICs participate in this announcement and view their respective areas of research interest at the R03 IC-Specific Scientific Interests and Contact website. ICs that do not participate in this announcement will not consider applications for funding.

93.273, 93.866,93.855, 93.279, 93.286, 93.113, 93.865, 93.172, 93.307, 93.853, 93.242

All other Aspects of this FOA remain unchanged.

Inquiries

Please direct all inquiries to:

Aileen Schulte, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-1225
Email: aschulte@mail.nih.gov

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Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

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