Notice of Special Interest (NOSI): Addressing Evidence Gaps in Screening
Notice Number:
NOT-OD-22-107

Key Dates

Release Date:

May 13, 2022

First Available Due Date:
June 15, 2022
Expiration Date:
May 08, 2025

Related Announcements

NOT-OD-22-106 - Notice of Special Interest (NOSI): Increasing Uptake of Evidence-Based Screening in Diverse Populations Across the Lifespan

PAR-20-060 - NIDCR Prospective Observational or Biomarker Validation Study Cooperative Agreement (U01 Clinical Trial Not Allowed)

PAR-20-090 - NIAMS Clinical Trial Planning Grant (R34 Clinical Trial Not Allowed)

PAR-20-150 - NIMHD Exploratory/Developmental Research Grant Program (R21 - Clinical Trial Optional)

PA-20-183 - NIH Research Project Grant (Parent R01 Clinical Trial Required)

PA-20-184 - NIH Research Project Grant (Parent R01 Basic Experimental Studies with Humans Required)

PA-20-185 - NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed)

PA-20-194 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Required)

PA-20-195 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Not Allowed)

PA-20-196 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Basic Experimental Studies with Humans Required)

PA-20-227 - Administrative Supplements for Research on Dietary Supplements (Admin Supp Clinical Trial Not Allowed)

PAR-20-310 - Health Services Research on Minority Health and Health Disparities (R01- Clinical Trial Optional)

PAR-21-036 - NIAMS Clinical Trial Implementation Cooperative Agreement (U01 Clinical Trial Required)

PAR-21-045 - Exploratory Clinical Trial Grants in Arthritis and Musculoskeletal and Skin Diseases (R21 Clinical Trial Required)

PAR-21-063 - NIDCD Low Risk Clinical Trials in Communication Disorders (R01 Clinical Trial Required)

PAR-21-081 - Addressing Health Disparities Among Immigrant Populations through Effective Interventions (R01 Clinical Trial Optional)

PAR-21-097 - Prevention and Intervention Approaches for Fetal Alcohol Spectrum Disorders (R34 Clinical Trial Optional)

PAR-21-098 - Prevention and Intervention Approaches for Fetal Alcohol Spectrum Disorders (R61/R33 Clinical Trial Optional)

PA-21-110 - Pilot and Feasibility Studies in Preparation for Substance Use Prevention Trials (R34 Clinical Trial Optional)

PAR-21-129 - Clinical Trials to Test the Effectiveness of Treatment, Preventive, and Services Interventions (Collaborative R01 Clinical Trial Required)

PAR-21-130 - Clinical Trials to Test the Effectiveness of Treatment, Preventive, and Services Interventions (R01 Clinical Trial Required)

PAR-21-131 - Pilot Effectiveness Trials for Treatment, Preventive and Services Interventions (R34 Clinical Trial Required)

PAR-21-132 - Confirmatory Efficacy Clinical Trials of Non-Pharmacological Interventions for Mental Disorders (R01 Clinical Trial Required)

PAR-21-160 - NIDCR Clinical Trial Planning and Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required)

PA-21-180 - Pilot Health Services and Economic Research on the Treatment of Drug, Alcohol, and Tobacco Use Disorders (R34 - Clinical Trial Optional)

PAR-21-275 - The Role of Work in Health Disparities in the U.S. (R01 Clinical Trials Optional)

PAR-21-287 - Effectiveness of School-Based Health Centers to Advance Health Equity (R01 Clinical Trial Optional)

PAR-21-316 - Innovative Mental Health Services Research Not Involving Clinical Trials (R01 Clinical Trials Not Allowed)

PAR-21-317 - NIDCR Behavioral and Social Intervention Clinical Trial Planning and Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required)

PAR-21-358 - Risk and Protective Factors of Family Health and Family Level Interventions (R01 Clinical Trial Optional)

PAR-21-359 - Early- and Late-Stage Clinical Trials for the Spectrum of Alzheimer’s Disease/Alzheimer’s Related Dementias and Age-Related Cognitive Decline (R01 Clinical Trial Optional)

PAR-22-082 - Innovative Pilot Mental Health Services Research Not Involving Clinical Trials (R34 Clinical Trial Not Allowed)

Issued by

Division of Program Coordination, Planning and Strategic Initiatives, Office of Disease Prevention (ODP)

National Institute on Aging (NIA)

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

National Institute on Deafness and Other Communication Disorders (NIDCD)

National Institute of Dental and Craniofacial Research (NIDCR)

National Institute on Drug Abuse (NIDA)

National Institute of Mental Health (NIMH)

National Institute of Neurological Disorders and Stroke (NINDS)

National Institute of Nursing Research (NINR)

National Institute on Minority Health and Health Disparities (NIMHD)

All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.

Office of Dietary Supplements (ODS)

Office of Research on Women's Health (ORWH)

Sexual and Gender Minority Research Office (SGMRO)

Purpose

The Office of Disease Prevention (ODP) and participating National Institutes of Health (NIH) Institutes, Centers, and Offices (ICs) are issuing this Notice of Special Interest (NOSI) to solicit applications proposing to strengthen the evidence base for preventive screening services where the evidence is lacking, of poor quality, conflicting, or the balance of benefits and harms cannot be determined. This NOSI encourages the development and use of innovative and rigorous methods and approaches to close high priority evidence gaps to elevate screening services to a level suitable for a definitive grade or recommendation. The specific research interests of participating NIH ICs are detailed within.

Background:

Preventive screening is a critical strategy to prevent illness before it causes symptoms or problems, and as such, can play a key role in enhancing health, lengthening life, and reducing illness and disability. However, before a screening service for any condition or exposure can be broadly recommended, it must be grounded in evidence. Expert panels and committees, such as the U.S. Preventive Services Task Force (USPSTF), Community Preventive Services Task Force (CPSTF), American Academy of Pediatrics (AAP) Bright Futures Initiative, and the American College of Obstetricians and Gynecologists’ (ACOG) Women’s Preventive Services Initiative rely on such evidence when issuing their recommendations. For example, the USPSTF issues Grade A or B recommendations for screening services when the Task Force determines that the available evidence suggests that the net benefit is moderate or substantial. These recommendations have healthcare coverage implications as the Affordable Care Act requires that private insurers cover Grade A and B services without patient cost sharing. While the recommendations for or against a screening service receive a grade, the USPSTF issues an insufficient evidence (I) statement when the Task Force finds that the evidence is lacking, of poor quality, conflicting, or the balance of benefits and harms cannot be ascertained, thus precluding a recommendation for or against provision of the service. To address these shortcomings in evidence, the USPSTF identifies specific research needs and gaps for each I statement that, if addressed, may provide the basis for a definitive recommendation (See the USPSTF 11th Annual Report to Congress for examples of USPSTF-identified high priority screening research needs/gaps). Yet, inadequate research methods and approaches have been identified as a significant limitation to advancing screening I statements and their equivalent to definitive recommendations. To this end, a recent NIH workshop entitled “Methods for Assessing the Impact of Screening in Childhood on Health Outcomes” highlighted the pressing need to stimulate methodologic innovation to close screening-related evidence gaps.

Research Objectives:

This NOSI encourages translational research aimed at filling identified knowledge gaps to expand the evidence base for evaluating the balance of benefits and harms for proposed preventive screenings. This includes efficacy, effectiveness, mechanistic, and longitudinal studies, cost effectiveness analyses, as well as research on novel methods, measurements, study designs, analyses, theoretical frameworks, and tools that can generate the research needed to close screening-related evidence gaps. This also includes conceptualizing and validating measures for novel health outcomes to capture the impact of screening, encompassing not just reductions in disease and disability, but also effects on quality of life and subjective well-being. Applicants interested in research involving multilevel interventions to improve the uptake of recommended screening services and/or address barriers to screening are directed to the companion NOSI (NOT-OD-22-106).

At minimum, the proposed study must:

  • Focus on a screening service that has not received a definitive grade or recommendation from organizations issuing evidence-based recommendations (e.g., the USPSTF, CPSTF, AAP, ACOG); and
  • Include a measurable health outcome. Such outcomes may range from negative clinical outcomes, such as cardiovascular events, to positive health outcomes, such as school success or subjective well-being.

Research within scope of this opportunity includes, but is not limited to, studies of:

  • High quality randomized controlled trials to provide evidence of the benefits and harms of a screening service. For multi-level interventions, this would include group- or cluster-randomized trials and stepped wedge group- or cluster-randomized trials. For further information on these methods, see the Research Methods Resources website
  • Meta-analytic studies to synthesize available evidence on the benefits and harms of a screening service
  • Measures and methods appropriate for longitudinal studies that examine the impact of screening
  • Non-randomized methods that may include modeling, simulations, and econometric techniques
  • Studies that build the chain of evidence linking proximal/intermediate outcomes to more distal health outcomes of interest when direct linkage of screening to distal health outcomes is not feasible
  • Optimal screening strategies, including frequencies and settings in which screening occurs
  • Optimal management of screening results, such as referrals to clinical or community-based services, and their role on health outcomes
  • The balance of benefits and harms of screening for a particular condition or exposure
  • Screening measures and methods that are appropriate for various developmental abilities, stages of the life course, and/or are culturally relevant
  • Approaches to measuring screening events and outcomes that leverage electronic heath records or other big data systems

Populations of particular interest include, but are not limited to:

  • Persons or groups across the lifespan at increased risk for common physical and/or behavioral health conditions (e.g., alcohol misuse and alcohol use disorder, depression, frailty, oral disease, substance use disorder, suicidal thoughts and behaviors, undernutrition) or risk factors for these conditions (e.g., inadequate dietary intake) that might benefit from preventive screening
  • NIH-designated populations across the lifespan who experience health disparities in the United States, including (but not limited to) racial/ethnic minorities and other populations impacted by health disparities (refer to https://www.nimhd.nih.gov/about/strategic-plan/nih-strategic-plan-definitions-and-parameters.html and https://dpcpsi.nih.gov/sites/default/files/SGMStrategicPlan_2021_2025.pdf for definitions and additional information on sexual and gender minority populations)
  • Persons in state custody or involved with social service systems (e.g., child welfare or criminal justice)
  • Persons with developmental, intellectual, physical, or sensory disabilities
  • Populations that underutilize, do not have access to, and/or are underserved by preventive services
  • Other vulnerable populations, including high-risk pregnant women, homeless youth, immigrants, persons with limited English proficiency, older adults, persons who have experienced abuse, U.S. veterans, military members, and military families

Feasibility and pilot research studies are encouraged, as well as efficacy and effectiveness studies of new, adapted, or tailored interventions.

Researchers are highly encouraged to use the PhenX Toolkit to maximize comparisons across datasets or studies and facilitate data integration and collaboration.

Investigators should carefully review the specific research interests of NIH ICs that are participating in this NOSI.

IC Specific Application and Submission Information:

NIH ICs have separately advanced funding opportunity announcements (FOAs) relevant to this NOSI. These FOAs might be specific to each IC mission area. Applicants must select the IC and associated FOA to use for submission of an application in response to the NOSI. The selection must align with the IC requirements listed in order to be considered responsive to that FOA. Non-responsive applications will be withdrawn from consideration for this initiative.


National Institute on Aging (NIA)

The National Institute on Aging encourages experimental, observational, or interventional studies focused on screening adults in midlife and at older ages where current evidence is insufficient for broad recommendations. Interventions may be focused on individuals, dyads, families, communities, organizations, and/or systems. NIA is especially interested in intervention research that aligns with the Alzheimer's Disease-Related Dementias (AD/ADRD) Research Implementation Milestones (https://www.nia.nih.gov/research/milestones).

Areas of interest include, but are not limited to:

  • Evaluate the benefits and harms of screening for cognitive impairment in community-dwelling older adults in primary care–relevant settings, and effect on decision-making, patient, family, or caregiver, and/or societal outcomes.
  • Evaluate how screening and early recognition of cognitive impairment can help clinicians and families make better health care decisions, anticipate problems, and plan for the future
  • Evaluate interventions that could help family members and others who have responsibility of caring for a person with cognitive impairment.
  • Develop/evaluate the implementation of screening procedures and follow up for cognitive impairment within under-resourced areas or among health disparity populations
  • Application of artificial intelligence/machine learning approaches for integration of disparate data sources and screening for cognitive impairment
  • Evaluate approaches for including patient and caregiver preferences and values in post-screening clinical decision-making and how to improve shared decision-making, especially for caregivers and patients with cognitive impairment.
  • Evaluate benefits and harms of screening in health care settings for those at current, past, or increased risk for elder abuse and neglect in older and vulnerable adults
  • Evaluate the impact of a personalized preventive care program on screening and health care utilization. Determine how linkages and more coordinated screening activities targeting multiple conditions across various healthcare and community settings could result in improved health outcomes

Measures and methods appropriate for longitudinal studies that examine the impact of screening

NIA is especially interested in receiving applications for preliminary (Stage I, II, and III) behavioral intervention development in the NIH Stage Model for Behavioral Intervention Development for mid-life and older individuals that capitalizes on and integrates basic research to inform the development of efficacious interventions, in accordance with the NIH Stage Model. Information about the NIH Stage Model and behavioral intervention development can be found at: https://www.nia.nih.gov/research/dbsr/stage-model-behavioral-intervention-development.


National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIAAA supports alcohol-related biomedical and behavioral research in a wide range of scientific areas to generate and disseminate fundamental knowledge about the effects of alcohol on health and well-being, and apply that knowledge to improve diagnosis, prevention, and treatment of alcohol-related problems across the lifespan.

For this NOSI, NIAAA is interested in innovative and rigorous research that addresses screening-related evidence gaps relevant to the NIAAA mission and research priorities outlined in the NIAAA Strategic Plan.

Increasing rates of alcohol misuse and alcohol use disorder (AUD) among some population groups, including women, older adults, and sexual and gender minority populations, along with limited utilization of alcohol screening, brief intervention, and referral to treatment (SBI/SBIRT) draw attention to the need to develop tools for improving and expanding the delivery of SBI/SBIRT for these populations. In addition, the U.S. Preventive Services Task Force (USPSTF) has indicated that more evidence is needed to determine whether screening for unhealthy alcohol use is beneficial for adolescents.

Areas of interest include, but are not limited to:

  • Determine the effectiveness of alcohol screening and SBI/SBIRT for adolescents
  • Design and test preventive alcohol screening tools and strategies for underreported, understudied, and underrepresented US population groups and cultures where alcohol misuse is prevalent and/or increasing
  • Develop and evaluate alcohol screening (SBI/SBIRT) models to reach diverse, underserved, and hard to reach US populations (e.g., rural populations, individuals with disabilities, and minority groups)
  • Determine the effectiveness of alcohol screening methods in real-world settings for vulnerable population groups (e.g., pregnant women, individuals involved in the criminal or juvenile justice systems) in which alcohol use might be stigmatized or/and associated with legal or other consequences
  • Evaluate feasibility and outcomes of alcohol screening (SBI/SBIRT) combined with screening for co-occurring mental health conditions and substance use (e.g., post-traumatic stress disorder, depression, tobacco, cannabis, and other drug use)
  • Develop and evaluate cost-effective approaches and screening tools for alcohol-related conditions in which the evidence-based screening and early identification practice is limited, such as for fetal alcohol spectrum disorders
  • Determine the effectiveness of alcohol screening methods in real-world settings in hepatology and gastroenterology clinics
  • Following SBIRT in hepatology and gastroenterology clinics, evaluate acceptance of treatment for alcohol misuse and health outcomes following referral and acceptance to treatment
  • Develop psychosocial and physical assessment tools to help determine suitability for behavioral interventions vs suitability for medication treatment
  • Design and validate screening tools for monitoring and quantifying alcohol use for clinical research protocols for alcohol-associated organ diseases as well as integrated care of AUD patients with alcohol-associated organ diseases
  • Develop screening tools for monitoring adherence to the intervention for AUD patients enrolled in clinical trials for alcohol-associated organ diseases
  • Design and evaluate novel methods to increase uptake and/or delivery of alcohol SBI/SBIRT (e.g., novel technology-based assessments, use of electronic medical records)


National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

The mission of the National Institute of Arthritis and Musculoskeletal and Skin Diseases is to support research into the causes, treatment, and prevention of arthritis and musculoskeletal and skin diseases. Clinical research areas include rheumatology, orthopaedics, dermatology, metabolic bone diseases, heritable disorders of bone and cartilage, inherited and inflammatory muscle diseases, and sports and rehabilitation medicine. In the context of this NOSI, the NIAMS is interested in research related to strengthening the evidence base for preventive screening services where the evidence is lacking, of poor quality, conflicting, or the balance of benefits and harms cannot be determined. This includes screening recommendations with an I for Insufficient in areas of arthritis, skin, and musculoskeletal disorders defined by USPSTF specific categories (see Osteoporosis and Adolescent Idiopathic Scoliosis). NIAMS only accepts mechanistic clinical trials through the parent R01/R21 FOAs listed below (see NOT-AR-21-009). All other clinical trials must be submitted through one of the listed NIAMS clinical trials FOAs. More information related to those can be found at https://www.niams.nih.gov/grants-funding/conducting-clinical-research/grants. Applicants are encouraged to discuss potential applications with the appropriate NIAMS program director.


Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NICHD supports research to understand human development, improve reproductive health, enhance the lives of children and adolescents, and optimize abilities for all. The institute provides an articulation of priority areas in the NICHD Strategic Plan 2020. For this funding opportunity, NICHD is interested in projects to address evidence gaps for screening recommendations relevant to its priority populations, which include:

  • Infants, children, and adolescents
  • Individuals with intellectual and developmental disabilities
  • Individuals with specific learning disorders
  • Individuals with physical disabilities
  • Pregnant, lactating, and postpartum women
  • Young adult and midlife (up to age 50) outcomes of childhood screening

NICHD is particularly interested in projects that consider context and the multiple levels of the socioecological model, including family and community. NICHD’s STRIVE initiative aims to improve equity, diversity, inclusion, and accessibility (EDIA) in all aspects of supported research, which includes encouragement to leverage unique insights from members of the populations of interest as research team members or in paid advisory roles.


National Institute on Drug Abuse (NIDA)

The United States Preventive Services Task Force (USPSTF) has concluded that the current evidence for screening adolescents for unhealthy drug use is insufficient and does not recommend screening in primary care for individuals under 18 years of age. There is a need for research to contribute to the evidence base on screening for unhealthy drug use and substance use disorder, prescription drug and opioid misuse, and opioid use disorder in adolescents in primary and other healthcare settings. In addition, there is a need for research on screening of adolescents in settings beyond primary care, including schools, juvenile justice, and child welfare settings, where adolescents engage in social and recreational activities, and particularly in settings that are utilized by vulnerable and at-risk populations.

The USPSTF identified gap areas in need of well-designed studies, includes research to evaluate:

  • The effectiveness of screening and interventions for drug use in adolescents;
  • The optimal screening interval for detecting unhealthy drug use;
  • The accuracy of screening tools for detecting nonmedical use of prescription drugs, including opioids;
  • Strategies to improve access to pharmacotherapy and psychosocial interventions for persons with various types of substance use disorders;
  • The harms that occur when the result of screening is punitive; and
  • The benefits and harms of providing prophylactic prescriptions for naloxone “rescue therapy” to patients in whom opioid misuse or opioid use disorders are detected after primary care screening.

NIDA also encourages research to validate existing or new instruments for unhealthy drug use and substance use disorder, prescription drug and opioid misuse, and opioid use disorder in healthcare and non-healthcare settings.


National Institute on Deafness and Other Communication Disorders (NIDCD)

The National Institute on Deafness and Other Communication Disorders (NIDCD) welcomes applications focused on normal and disordered communication processes, including diseases or conditions affecting hearing, balance, taste, smell, voice, speech, and language. Populations of interest include both pediatric and adult. For this initiative, applications focused on screening and early identification of differences and disorders related to NIDCD mission areas are highly desirable. Applicants are strongly encouraged to learn more about NIDCD research areas at https://www.nidcd.nih.gov/research/extramural.

Ares of interest include, but are not limited to:

  • Intervention work (including screening) that evaluates the effect, feasibility, and accessibility of screening and interventions to improve health care and outcomes
  • Evaluation of the effectiveness of the provision of preventive screening services and outcomes for populations that experience health disparities
  • Development and evaluation of screening tools integrated into primary care settings
  • Studies involving diverse, underserved, and vulnerable populations that address appropriate screening and assessment measures
  • Identification of effective screening practices that address special health care needs for populations that experience health disparities
  • Research that addresses disparities and inequities in minority health and health disparity populations related to?identification of a disorder, access to care, or quality of care
  • Novel mechanisms or technology to address screening gaps in underserved populations with health disparities
  • Development of innovative and new technologies to enhance implementation of screening and linkage to prevention and treatment services in healthcare and other settings
  • Study designs that examine aspects of screening across the care continuum from risk assessment to detection, through initial referral, and seeking care with medical or clinical providers


National Institute of Dental and Craniofacial Research (NIDCR)

The dental office is a primary care setting that provides an opportunity for oral health practitioners to conduct preventive general and oral health services, such as evidence-based screenings. ?Many individuals in the U.S. may have a dental visit in a given year, but not a routine medical visit, or they may not be aware of the need to be screened for certain medical conditions throughout the lifespan. Health screenings in dental offices provide opportunities to identify individuals with undiagnosed or progressing medical conditions, beyond those conditions specific to the head and neck region. Previous research indicates acceptability of screening for medical conditions in a dental setting by both dental professionals and patients. Additionally, several studies have demonstrated the feasibility of conducting evidence-based screenings in the dental setting for certain medical conditions occurring throughout the lifespan.

Preventive oral health services delivered in settings outside the dental office (medical settings, community, etc.) may improve health equity and reduce the prevalence and incidence of oral conditions, such as dental caries.

NIDCR encourages research focused on strengthening the evidence that supports sustainable screening by oral health professionals in a dental setting and appropriate follow-up (treatment or referral) for medical conditions and risk behaviors that have yet to receive a definitive grade or recommendation from organizations issuing evidence-based recommendations and include a measurable health outcome. Examples of conditions suitable for screening include, but are not limited to oral cancer, prediabetes, Type 2 diabetes or high blood pressure in children and adolescents, depression in children and adolescents, tobacco cessation, unhealthy drug use in adolescents, child maltreatment, intimate partner violence/elder abuse/abuse of vulnerable adults, suicide risk, cognitive impairment, eating disorders, celiac disease, obstructive sleep apnea.

Further, NIDCR encourages research focused on strengthening the evidence on preventive oral health services in settings outside the dental office, such as screening for dental caries in children younger than 5 years by primary care physicians. The complete list of conditions with USPSTF evidence grade I is updated periodically, and investigators are encouraged to review the most up-to-date listing. Investigators may also consider interventions that are related to screening activities recommended in the American Academy of Pediatrics (AAP) Bright Futures Guidelines, or by the Community Preventive Services Task Force (CPSTF), which are relevant to NIDCR’s mission.

Examples of relevant study designs would include efficacy, effectiveness, validation, and longitudinal studies, cost-effectiveness analyses or novel approaches to screening. Areas of interest include, but are not limited to, studies that:

  • Seek to improve the evidence of medical and/or risk behavior screening in diverse dental settings, including those settings that target underserved or special needs populations;
  • Assess feasibility of and test screening tools/activities in dental care settings, to facilitate appropriate referral to treatment;
  • Compare the effectiveness of different screening approaches in dental care settings;
  • Assess the effectiveness, including risk assessment, of oral screening performed by non-dental professionals;
  • Evaluate the effectiveness of coordinated screening efforts among healthcare professionals, with participation of dental care providers;
  • Evaluate the effectiveness of screening for dental, oral, or craniofacial diseases/conditions in non-healthcare settings;
  • Assess the balance of physical and psychological benefits and harms of screening tools/activities in diverse population subgroups;
  • Assess novel screening approaches using new instruments, algorithms, or technologies; and
  • Improve rates of referral following screening


National Institute on Mental Health (NIMH)

The National Institute of Mental Health (NIMH) is interested in research that addresses evidence gaps in screening for mental health conditions and autism spectrum disorder (ASD) that have received an Insufficient (I) Statement from the USPSTF, topics that are under review by the USPSTF or in the process of being updated, and gap areas identified by other professional organizations (e.g., American College of Surgeons Committee on Trauma or American Academy of Pediatrics).

Research is needed to strengthen the evidence-base for screening where evidence is lacking, and where the balance of benefits and harms of screening cannot be determined. For mental health conditions and autism screening, studies are needed to bridge these gaps, including potential harms described in the USPSTF (2015) Procedures Manual: psychological harms (i.e., invasiveness of a diagnostic screening), false-positive or false-negative results, opportunity costs (increased demand on healthcare services), and overdiagnosis (diagnosis that is correct yet confers no benefit). NIMH also encourages investigators to develop and leverage strong research-practice partnerships with public and private stakeholders, so that the research follows a deployment-focused model.

Areas of interest include research aimed at filling the knowledge gaps that expand the evidence base for evaluating the balance of benefits and harms of screening for any of these topics: (1) major depressive disorders in children aged 11 years or younger; (2) screening for depression, anxiety, and suicide risk in children, adolescents and adults, including pregnant and postpartum women; (3) suicide risk in adolescents, adults, and older adults in primary care; (4) eating disorders in adolescents and adults; and (5) autism spectrum disorder (ASD) in young children for whom no concerns of ASD have been raised by their parents or a clinician.

Examples of research encouraged by this NOSI include, but are not limited to, studies that focus on:

  • Examining the benefits and harms of screening for asymptomatic individuals and explore how universal screening impacts psychological harms, classification errors, opportunity costs and overdiagnosis within service systems
  • Building the existing evidence base on the balance of benefits and harms by comparing clinical outcomes/treatment effects among individuals who were diagnosed through universal screening compared to those of individuals who screened positive through standard surveillance systems
  • Exploring and addressing social determinants of health that contribute to health inequities – including how social determinants of health impact the benefits and harms of screening and treatment outcomes among underserved populations impacted by mental health disparities
  • Testing clinical care enhancement approaches (e.g., provider training, medical records prompts or other infrastructure support) that can be used to facilitate screening and subsequent steps in the chain of care (e.g., assessment, referral, engagement in evidence-based care) and inform USPSTF reviews on suicide screening and other mental health conditions

For clinical trial research on the effectiveness of implementation strategies, NIMH requires a study design using an experimental therapeutics approach, in which clinical trials test intervention effects on mental health outcomes as well as elucidate the intervention’s mechanism(s) of action. In the case of implementation studies, targets/mechanisms might involve change in organizational/system-level factors to improve the adoption and sustained implementation of screening, and the fidelity and equity with which screening and related services are implemented. See the Support for Clinical Trials at NIMH web page for additional information and contact NIMH Program Staff in advance of applying for information about NIMH clinical trials practices and priorities.

NIMH does not accept clinical trials in response to the Clinical Trial Parent Announcements (PA-20-183; PA-20-184; PA-20-194; PA-20-195; or PA-20-196).

National Institute on Minority Health and Health Disparities (NIMHD)

NIMHD is interested in projects that address screening disparities for conditions that are more prevalent in populations experiencing health disparities. Populations with health disparities include African Americans/Blacks, Hispanics/Latinos, American Indians/Alaska Natives, Asians, Native Hawaiians and Pacific Islanders, socioeconomically disadvantaged populations, underserved rural populations, and sexual and gender minorities. Projects are encouraged that encompass innovative methods and approaches in multiple domains (e.g., biological, behavioral, socio-cultural, environmental, physical environment, healthcare system) and multiple levels (e.g., individual, interpersonal, community, societal) to evaluate potential impact and effectiveness of screening practices in these populations (see the NIMHD Research Framework, https://www.nimhd.nih.gov/about/overview/research-framework.html).

Examples of potential topic areas include but are not limited to:

  • Develop and test measures and methods that reflect a complex interplay of cultural, social, and environmental factors that influence screening behavior in populations experiencing health disparities
  • Studies that assess benefits and harms for proposed preventive screenings and their implementation in populations experiencing health disparities
  • Clinical and pragmatic trials of efficacy and effectiveness of innovative screening methods and disease outcomes in populations experiencing health disparities
  • Novel mechanisms or technology to address screening gaps in underserved populations and populations impacted by health disparities
  • Develop measures for novel health outcomes to capture the impact of screening
  • Comparative effectiveness of different interventions to increase screening rates among populations experiencing health disparities
  • Development and testing of new screening methods, outcomes, or guidelines that better capture disease risk for populations that experience health disparities
  • Methodological approaches to best assess social determinants of screening behavior among populations experiencing health disparities beyond the individual level, such as those at community and societal levels
  • Innovative screening uptake methods and approaches that integrate health determinants across levels and consider experiences of populations with intersectional identities that experience compounding barriers to screening (i.e., subpopulations characterized by two or more of the following: racial and ethnic minority populations, less privileged socioeconomic status populations, underserved rural populations, and sexual and gender minorities)
  • Development of approaches in collaboration with community-based organizations for culturally appropriate strategies to improve screening uptake in populations experiencing health disparities


National Institute of Neurological Disorders and Stroke (NINDS)

The NINDS is interested in mission relevant applications. The NINDS supports basic, clinical, translational, and implementation research focused on identifying, monitoring, and targeting biological, environmental, social, community, structural, and healthcare system factors that lead to or are associated disparities (or inequities) in neurological diseases and care across the lifespan. Some priority disease areas include stroke and other cerebrovascular diseases, Alzheimer’s disease-related dementias (including frontotemporal neurodegeneration, Lewy body dementias, vascular contributions to cognitive impairment and dementia and mixed etiology dementia), epilepsy, migraine, nervous system infections, spinal cord injury, headache, Parkinson's disease, and other neurodegenerative disorders, brain trauma, neurodevelopmental disorders, and the neurological consequences of HIV/AIDS. Applicants are encouraged to incorporate community engagement strategies into their study designs. A letter of intent and communication with NINDS program staff prior to submission of an application is strongly encouraged.

National Institute of Nursing Research (NINR)

The National Institute of Nursing Research (NINR) supports research that advances the prevention, detection, and management of disease and disability for individuals and populations and informs practice and policy across clinical and community settings. Drawing on nursing’s holistic, contextualized perspective, NINR funds observational, intervention, and implementation research that integrates factors at multiple levels, including social determinants of health, to identify their role in health, health improvement, and health equity across many settings, including homes, schools, workplaces, clinics, justice settings, and the community.

Office of Disease Prevention (ODP)

The ODP is interested in research that close screening-related evidence gaps using (but not limited to) innovative methods and approaches that are relevant to the mission and research priorities outlined in the ODP Strategic Plan. Studies that involve the development of innovative methods and measures to close evidence gaps in screening are also encouraged. Furthermore, the ODP encourages applications that include projects seeking to develop and/or test preventive interventions. The ODP offers co-funding support for research that has strong implications for disease and injury prevention, advances health equity, and that includes innovative and appropriate research design, measurement, and analysis methods. Information on resources for designing studies using the best available methods is available at: https://researchmethodsresources.nih.gov/. ODP does not award grants. Please contact one of the IC program contacts listed for questions related to funding.

Office of Dietary Supplements (ODS)

The ODS supports research that strengthens the knowledge and understanding of dietary supplement use in the U.S. population. The ODS is interested in providing co-funding support for research on the role of dietary supplements in the prevention of disease and the maintenance of health. Dietary supplement ingredients are defined as including vitamins, minerals, herbs and other botanicals, amino acids, and other dietary or bioactive substances, consumed as dietary supplements to promote health and prevent disease. For this NOSI, ODS is interested in research that addresses the evidence gaps in the balance of benefits and harms of screening for vitamin and mineral deficiencies among vulnerable groups, such as pregnant women, children, older adults, and asymptomatic adults at risk. This research should include the use of data-driven screening tools, including nutritional status, diet, and dietary supplement assessment tools, to identify risk factors for disease, disability, reduced quality of life, and subjective well-being. ODS does not award grants. Please contact one of the IC program contacts listed for questions related to funding.

Application and Submission Information

This NOSI applies to due dates on or after June 15, 2022, and subsequent receipt dates through May 8, 2025.

Submit applications for this initiative using one of the following funding opportunity announcements (FOAs) or any reissues of these announcement through the expiration date of this notice.

Activity Code

FOA

First Available Due Date

Participating ICs

U01

PAR-20-060 - NIDCR Prospective Observational or Biomarker Validation Study Cooperative Agreement (U01 Clinical Trial Not Allowed)

October 5, 2022

NIDCR

R34

PAR-20-090 - NIAMS Clinical Trial Planning Grant (R34 Clinical Trial Not Allowed)

July 1, 2022

NIAMS

R21

PAR-20-150 - NIMHD Exploratory/Developmental Research Grant Program (R21 - Clinical Trial Optional)

June 16, 2022 NIMHD

R01

PA-20-183 - NIH Research Project Grant (Parent R01 Clinical Trial Required)

October 5, 2022

NIA, NIAAA, NIAMS, NICHD, NIDA, NIMHD, NINR

R01

PA-20-184 - NIH Research Project Grant (Parent R01 Basic Experimental Studies with Humans Required)

October 5, 2022

NIA, NIAAA, NICHD, NIDA, NIDCR, NIMHD, NINDS, NINR

R01

PA-20-185 - NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed)

October 5, 2022

NIA, NIAAA, NIAMS, NICHD, NIDA, NIDCD, NIDCR, NIMH, NIMHD, NINDS, NINR

R21

PA-20-194 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Required)

June 16, 2022

NIA, NIAAA, NIAMS, NICHD, NIDA, NIDCD, NINR

R21

PA-20-195 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Not Allowed)

June 16, 2022

NIA, NIAAA, NIAMS, NICHD, NIDA, NIDCD, NIDCR, NIMHD, NINR

R21

PA-20-196 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Basic Experimental Studies with Humans Required)

June 16, 2022

NIA, NIAAA, NICHD, NIDA, NIDCD, NIDCR, NIMHD, NINR

 

PA-20-227 - Administrative Supplements for Research on Dietary Supplements (Admin Supp Clinical Trial Not Allowed)

October 15, 2022

ODS

R01

PAR-20-310 - Health Services Research on Minority Health and Health Disparities (R01- Clinical Trial Optional)

November 17, 2022

NIMHD, NIDA

U01

PAR-21-036 - NIAMS Clinical Trial Implementation Cooperative Agreement (U01 Clinical Trial Required)

July 1, 2022

NIAMS

R21

PAR-21-045 - Exploratory Clinical Trial Grants in Arthritis and Musculoskeletal and Skin Diseases (R21 Clinical Trial Required)

July 1, 2022

NIAMS

R01

PAR-21-063 - NIDCD Low Risk Clinical Trials in Communication Disorders (R01 Clinical Trial Required)

October 5, 2022

NIDCD

R01 PAR-21-081 - Addressing Health Disparities Among Immigrant Populations through Effective Interventions (R01 Clinical Trial Optional) October 5, 2022 NIMHD

R34

PAR-21-097 - Prevention and Intervention Approaches for Fetal Alcohol Spectrum Disorders (R34 Clinical Trial Optional)

June 17, 2022

NIAAA

R61/R33

PAR-21-098 - Prevention and Intervention Approaches for Fetal Alcohol Spectrum Disorders (R61/R33 Clinical Trial Optional)

June 17, 2022

NIAAA

R34

PA-21-110 - Pilot and Feasibility Studies in Preparation for Substance Use Prevention Trials (R34 Clinical Trial Optional)

June 16, 2022

NIDA

R01

PAR-21-129 - Clinical Trials to Test the Effectiveness of Treatment, Preventive, and Services Interventions (Collaborative R01 Clinical Trial Required)

June 15, 2022

NIMH

R01

PAR-21-130 - Clinical Trials to Test the Effectiveness of Treatment, Preventive, and Services Interventions (R01 Clinical Trial Required)

June 15, 2022

NIMH

R34

PAR-21-131 - Pilot Effectiveness Trials for Treatment, Preventive and Services Interventions (R34 Clinical Trial Required)

June 15, 2022

NIMH

R01

PAR-21-132 - Confirmatory Efficacy Clinical Trials of Non-Pharmacological Interventions for Mental Disorders (R01 Clinical Trial Required)

June 15, 2022

NIMH

UG3/UH3

PAR-21-160 - NIDCR Clinical Trial Planning and Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required)

October 4, 2022

NIDCR

R34

PA-21-180 - Pilot Health Services and Economic Research on the Treatment of Drug, Alcohol, and Tobacco Use Disorders (R34 - Clinical Trial Optional)

June 16, 2022

NIAAA

R01

PAR-21-275 - The Role of Work in Health Disparities in the U.S. (R01 Clinical Trials Optional)

October 5, 2022 NIMHD

R01

PAR-21-287 - Effectiveness of School-Based Health Centers to Advance Health Equity (R01 Clinical Trial Optional)

October 5, 2022

NIDA, NINR

R01

PAR-21-316 - Innovative Mental Health Services Research Not Involving Clinical Trials (R01 Clinical Trials Not Allowed)

October 5, 2022

NIMH

UG3/UH3

PAR-21-317- NIDCR Behavioral and Social Intervention Clinical Trial Planning and Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required)

October 4, 2022

NIDCR

R01

PAR-21-358 - Risk and Protective Factors of Family Health and Family Level Interventions (R01 Clinical Trial Optional)

October 5, 2022

NIMHD, NINR

R01

PAR-21-359 - Early and Late Stage Clinical Trials for the Spectrum of Alzheimer’s Disease/Alzheimer’s Related Dementias and Age-Related Cognitive Decline (R01 Clinical Trial Optional)

October 5, 2022

NIA

R34 PAR-22-082 - Innovative Pilot Mental Health Services Research Not Involving Clinical Trials (R34 Clinical Trial Not Allowed) June 16, 2022 NIMH


All instructions in the SF424 (R&R) Application Guide and the funding opportunity announcement used for submission must be followed, with the following additions:

  • For funding consideration, applicants must include “NOT-OD-22-107” (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.

Investigators planning to submit an application in response to this NOSI are strongly encouraged to contact and discuss their proposed research/aims with Program staff/Scientific Contacts listed on this NOSI well in advance of the application receipt date to better determine appropriateness and interest of the relevant Institute.

Applications nonresponsive to terms of this NOSI will not be considered for the NOSI initiative.

Inquiries

Please direct all inquiries to the contacts in Section VII of the listed funding opportunity announcements with the following additions/substitutions:


Melissa C. Green Parker, PhD
Office of Disease Prevention (ODP)
Telephone: 301-480-1161
Email: melissa.greenparker@nih.gov

Marcel E. Salive, MD, MPH
National Institute on Aging (NIA)
Telephone: 301-496-5278
Email: marcel.salive@nih.gov

Tatiana Balachova, PhD
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-5726
Email: tatiana.balachova@nih.gov

Kristy M. Nicks, PhD
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-594-5055
Email: kristy.nicks@nih.gov

Tracy King, MD, MPH
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-402-1822
Email: tracy.king@nih.gov

Sarah M. Steverman, PhD, MSW
National Institute on Drug Abuse (NIDA)
Telephone: 301-827-5435
Email: sarah.steverman@nih.gov

Judith A. Cooper, PhD
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-496-5061
Email: cooperj@nidcd.nih.gov

Lorena Baccaglini, DDS, MS, PhD, NE-CPhT
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-435-7908
Email: lorena.baccaglini@nih.gov

Dena Fischer, DDS, MSD, MS
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-4876
Email: dena.fischer@nih.gov

Denise Pintello, Ph.D., M.S.W.
National Institute of Mental Health (NIMH)
Telephone: 301-451-1481
E-mail: denise.pintello@nih.gov

Olga M. Herren, PhD
National Institute of Minority Health and Health Disparities (NIMHD)
Telephone: 301-402-4492
E-mail: olga.herren@nih.gov

Erica Littlejohn, PhD
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: (301) 496-9135
E-mail: erica.littlejohn@nih.gov

Dionne Godette-Greer, PhD
National Institute of Nursing Research (NINR)
Telephone: 301-827-0095
Email: dionne.godette@nih.gov

Patricia Haggerty, PhD
Office of Dietary Supplements (ODS)
Telephone: 301-529-4884
Email: patricia.haggerty@nih.gov

Elizabeth Anne Barr, PhD
Office of Research on Women's Health (ORWH)
Telephone: 301-402-7895
Email: elizabeth.barr@nih.gov

Christopher Barnhart, PhD
Sexual & Gender Minority Research Office (SGMRO)
Telephone: 301-594-8983
Email: christopher.barnhart@nih.gov