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

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

BACKGROUND

This Funding Opportunity Announcement (FOA) establishes an accelerated review/award process to support novel behavioral and social science research (BSSR) to understand health outcomes related to an unexpected and/or time-sensitive event. Applications in response to this FOA must demonstrate that the research proposed is time-sensitive and must be initiated with minimum delay due to a limited window of opportunity to collect baseline data, answer key research questions, and/or prospectively evaluate a new policy or program that will likely impact health-related behavior or health outcomes in a given population. In other words, the urgency of the public health problem being studied will not, on its own, be sufficient justification for time sensitivity.

RESEARCH SCOPE

This FOA is intended to support research and data collection for unanticipated real-world events (i.e., those that occur outside of a laboratory or other controlled setting for research purposes). These events inherently have limited windows of opportunity for planning and conducting rigorous research and data collection. It is critical that researchers maximize these learning opportunities to better inform health care and public health efforts, as well as policymakers.

Key Definitions for this FOA:

An event is a unique and often unanticipated issue that arises in a particular community/population, due to emerging environmental threats, other public health threats, disaster events, or policy changes.
Policy is broadly defined to include both formal public policies at local, state, and federal levels of government, and organizational level policies, such as those implemented by large organizations, worksites, or school districts.
Program is defined as a set of activities such as implementation of system-level interventions, tools, or guidelines initiated by governmental or other organizational bodies, within public or private entities in local, state, or federal jurisdictions.
Infrastructure changes are alterations to the built environment such as housing, roads and other aspects of transportation systems, retail environments, and building of parks or green spaces.
This FOA encourages partnerships and collaboration between researchers and the impacted community, which may include the following types of entities (as appropriate): community-based organizations, local and state governments, private or non-profit organizations, behavioral health or health care systems, individual health care providers, departments of health, community health clinics, juvenile or criminal justice settings, schools, child welfare systems, etc.

The distinguishing features of a responsive study are:

(1) The unpredictable and unanticipated nature of the research opportunity.

(2) The clear scientific value and feasibility of the study.

(3) A feasible plan for collection of baseline data and primary data collection (although use of existing data is allowed, a plan for collecting important and new data rapidly should be provided).

(4) A justification for why an expedited review and funding (substantially shorter than the typical NIH grant review/award cycle) are required in order for the scientific question(s) to be addressed and the research design to be implemented. Expected study methodologies may include, but are not limited to, interrupted time-series, difference-in-difference designs, regression discontinuity, or propensity scoring.

In situations where applications under this FOA focus on a particular locality (region, community, or other defined geographic area), note that findings should have the potential to be generalizable beyond the particular locality or population. Proposed studies should demonstrate the ability to inform the understanding of the impact of the event, policy, program or infrastructure change in the near-term. Applicants are encouraged to include secondary implementation related outcomes that could inform interpretation of outcomes for future researchers and decision-makers, such as unintended consequences or barriers and facilitators associated with implementation.

Applicants are also encouraged to review the NIH-led efforts that recommend research strategies for ensuring study rigor and reducing bias, such as including an appropriate comparison group where possible: NIH Pathways to Prevention (P2P) Workshop: Method for Evaluating Natural Experiments in Obesity. Furthermore, attention should be paid to ongoing developments in strengthening causal inference from evaluation of these natural experiments or observational study designs. Considerable progress has been made on this topic in public health, econometrics, and diverse aspects of policy research.

STRUCTURE

This FOA will utilize a bi-phasic, milestone-driven R61/R33 mechanism, consisting of a R61 phase with developmental activities and a R33 phase with expanded activities designed to achieve the full research aims. The R61 phase will be up to one year, and will support developmental, exploratory research, Institutional Review Board approval for human subjects protection, further development of study partnerships, and the collection of baseline data. The R33 phase will build on this initial work for up to four years to include further development, application, follow-up data collection, or implementation as appropriate and relevant to the proposed research questions.

The application should articulate clear aims and objectives for each phase of the proposed research, with specific discussion of how results from the R61 phase will inform the R33 phase. In addition, applications must delineate explicit milestones for the R61 and R33 phases. A milestone is defined as a scheduled event in the project timeline that indicates completion of a project stage or activity. It is expected that baseline data collection will be conducted within six months of award, which should be included in the applicant’s submission of a project timeline and milestones. At the completion of the R61 phase, the Program Director (PD)/Principal Investigator (PI) will submit a report that includes the progress on each of the milestones and a clear description of how research during the R33 phase will be impacted by attainment of the R61 milestones. The IC program and other relevant staff will review the report and make recommendations on funding of the R33 grant based on two independent factors: 1) the preliminary research results and achievement of the milestones and 2) availability of funds and program priorities, irrespective of milestone achievements. Transition to the R33 phase is neither automatic nor guaranteed. Funding for the R33 phase is subject to availability of funds and program priorities, independent of milestone achievement. In addition, given the possibility for changes in policy or program implementation that are beyond the control of the grantee, grant awards may be terminated early if these changes limit the possibility to collect meaningful outcome data.

ADDITIONAL GUIDANCE

While applicants may propose to investigate time-sensitive opportunities outside the U.S., they must demonstrate within the application that all the proper logistics, human subjects concerns, and approvals, both domestic and international, can be addressed within the limited time frame outlined in this announcement. In addition, the applicant must demonstrate how information obtained from this study will have direct implications for US practice or policy.

Applicants are strongly encouraged to contact the relevant scientific contact(s) listed below to discuss whether their application would likely be responsive based on time-sensitivity four (4) weeks in advance of planned application.

Applications Not Responsive to this FOA

The following types of applications are not responsive to this FOA. Applications not responsive to this FOA will not be reviewed.

Applications that do not explicitly justify the time sensitivity of the proposed work, the urgent need for data collection, and the need for an expedited review timeline. Include this explanation in the Significance section of the application.
Applications that propose to use qualitative data exclusively (though mixed method approaches are encouraged).
Applications that propose to conduct analyses of existing data exclusively (unless allowed in IC-specific interests).
Applications aimed at addressing unanticipated needs or additional aims for an existing study (i.e., expansion of an existing study).
Applications proposing to use animals (e.g., pets, laboratory animals, or wildlife) as surrogates for human health or exposure.
Applications where the PD/PI of the evaluation study application is the Director and/or initiator of the policy, program, or infrastructure change that will be evaluated.
Applications that independently propose initiation and/or delivery of new policies or programs.
All responsive applications to this FOA will be subject to an accelerated review and award process. It is intended that eligible applications selected for funding will be awarded within 4-5 months of the application due date. However, administrative requirements and other unforeseen circumstances may delay issuance dates beyond that timeline.

SPECIFIC AREAS OF RESEARCH INTEREST

National Cancer Institute (NCI)

NCI supports time-sensitive evaluation of programs, policies, and major events that concern aspects of cancer prevention and control including, but not limited to:

Evaluation of the effects of:

Laws, regulations, or policies that may influence cancer risk factors including use of tobacco, alcohol, and other substances, sun safety and indoor tanning, diet, physical activity, and sleep.
Changes to the built and natural environment involving factors such as housing, transportation infrastructure, food environment, parks and other green and blue spaces and the potential effect on cancer risk factors, exposure to environmental carcinogens, access to care, or other cancer-related health outcomes.
Emerging programs and policies related to cancer screening, diagnosis, vaccination (e.g., HPV), treatment, and survivorship.
New policies, programs, and practices in cancer care delivery related to standards of care, health insurance coverage, access to services, reimbursement, and other factors that influence delivery of cancer care services and its outcomes
The impact and response to public health emergencies or disasters (natural or man-made) on acute stress, allostatic load or other aspects of accumulated stress, or cancer-related care, including preventative, diagnostic, treatment, and survivorship care.
Natural and man-made disasters (e.g., chemical spills, fumes, weather events, and fires), and resulting environmental exposures on biomarkers, etiology, and healthcare delivery across the cancer control continuum.
Natural and man-made disasters (e.g., chemical spills, fumes, weather events, and fires), and resulting environmental exposures on biomarkers, etiology, and healthcare delivery across the cancer control continuum.
Proposals evaluating policy and program efforts and responses to major events from diverse sectors, including government, educational, non-profit, and commercial sectors are of interest.

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

NICHD has particular interest in research on time-sensitive events, policies, programs, or infrastructure changes on vulnerable populations falling within the NICHD scientific mission area, including infants, children, and adolescents and pregnant and post-partum people; individuals with physical and/or intellectual disabilities; and children who are unhoused or in foster care. The NICHD Strategic Plan outlines high priority areas for the Institute.

Examples of research questions include but are not limited to the following:

Understanding the short- and long-term impact of the time-sensitive event on child development outcomes, as well as family functioning.
The impact of climate/environmental changes on dietary patterns, food choices, and eating behaviors.
How changes in access to school lunch programs affect dietary patterns, food choices, and eating behaviors in children and their families.
The impact of the event and the concomitant public health response on the management of complex medical conditions, critical illness, and severe, life-threatening injuries in children.
The impact of the event on emergency medical services to children (EMSC) and the availability of these services during and after the event to affected children in low- to moderate- resourced communities.
Studies identifying and developing data sources, tools and resources needed to strengthen tracking, reporting and communication among systems of care for traumatized, injured and affected children during and after the unexpected event.
The impact of the event and the concomitant public health response on children and adults with physical and/or intellectual disabilities, and disparities in outcomes experienced by persons with disabilities compared to persons without disabilities.
Studies that examine how unexpected disruptions in access to therapies and special education services affect developmental, behavioral and functional outcomes in children and adults with disabilities.
National Institute on Drug Abuse (NIDA)

This notice of funding opportunity (NOFO) will support pilot, feasibility or exploratory research in priority areas in substance use epidemiology, prevention, and health services, including: 1) responses to sudden and severe emerging drug issues (e.g. the ability to look into a large and sudden spike in opioid or synthetic cannabinoid use/overdoses in a particular community); 2) responses to emerging marijuana trends and topics related to the shifting policy landscape, related to imminent policy change; 3) responses to unexpected and time-sensitive prescription drug abuse research opportunities (e.g., new state or local efforts); 4) responses to unexpected and time-sensitive medical system issues (e.g. opportunities to understand addiction services in the evolving health care system); 5) responses to unexpected and time-sensitive criminal or juvenile justice opportunities (e.g. new system and/or structural level changes) that relate to drug abuse and access and provision of health care service; 6) partnerships between researchers and state or local organizations to support the evaluation of new local policies, programs, or practices in response to public health emergencies (e.g., the opioid crisis); 7) research examining how the COVID-19 pandemic has impacted drug markets and overdose risk; 8) research examining health outcomes associated with telehealth compared to in-person psychiatric care (e.g. risk of diversion/misuse, reduced treatment gap); 9) research examining the impact of the discontinuation of the Medicaid continuous enrollment provision that was enacted during the COVID-19 pandemic on populations with substance use disorders, and 10) research to understand outcomes related to states receiving and implementing Centers for Medicare and Medicaid Services (CMS) 1115 waivers that allow Medicaid to pay for health care services in carceral settings.

National Institute on Minority Health and Health Disparities (NIMHD)

The mission of NIMHD is to lead scientific research to improve minority health and reduce health disparities. NIMHD focuses on all aspects of health and health care for racial and ethnic minority populations in the U.S. and the full continuum of health disparity causes as well as the interrelation of these causes. NIMHD projects should include a focus on racial and ethnic minority populations (African Americans/Blacks, Latinos/Hispanics, American Indians and Alaska Natives, Asian Americans, Native Hawaiians and Pacific Islanders) and or less privileged socioeconomic groups, Projects may also examine intersectionality of race or ethnic minority identity and/or low socioeconomic status with rurality and/or sexual and gender minority identity and/or disability condition. Comparison groups/populations may also be included as appropriate for the research questions posed. NIMHD encourages research projects that use approaches encompassing multiple domains of influence (e.g., biological, behavioral, sociocultural, environmental, physical environment, health system) and multiple levels of influence (e.g., individual, interpersonal, family, peer group, community, societal) to understand and address health disparities (see the NIMHD Research Framework, https://www.nimhd.nih.gov/about/overview/research-framework.html, for more information). Studies based outside the U.S. or its territories will not be supported by NIMHD under this FOA. Time-sensitive research that NIMHD is interested in supporting includes:

The effects of policy changes on health outcomes, and mechanisms of those health outcomes, in populations that experience health disparities, including: immigration policy, health care coverage, gun policy, police use-of-force policy, environmental regulations, prescribing practices, and vaccination requirements
The immediate and longer-term impact of natural disasters on the health of populations that experience health disparities (particularly through the lens of understanding how climate change is impacting health disparities)
Effects of changes to the built environment (e.g., greenspace, pedestrian walkways, bike paths) on health and health behaviors for populations that experience health disparities
National Institute of Nursing Research (NINR)

NINR supports research to solve pressing health challenges and inform practice and policy - optimizing health and advancing health equity into the future. NINR discovers solutions to health challenges through the lenses of health equity, social determinants of health, population and community health, prevention and health promotion, and systems and models of care. Drawing on the strengths of nursing’s holistic, contextualized perspective, core values, and broad reach, NINR funds multilevel and cross-sectoral research that examines the factors that impact health across the many settings in which nurses work, including homes, schools, workplaces, clinics, justice settings, and the community. Observational, intervention, and implementation research are of interest to NINR.

Research is encouraged in the following areas:

Factors involved in a response to a time-sensitive event that affect health equity, including mechanisms involved.
Effects of social determinants of health on the response to and health effects resulting from a time-sensitive event.
Prevention and early detection of health effects of a time-sensitive event, including plans for health promotion during and following the event.
Examining clinical, organizational and/or policy changes to address health related needs during and following a time-sensitive event.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIAAA will support time-sensitive research in public health priority areas in alcohol and related substance use epidemiology, prevention, and health services, including but not necessarily limited to:

time-sensitive research opportunities to study the effects of changes in alcohol-related policies, including effects on combined use of alcohol and other substances and evaluation of the implementation or effectiveness of policies, programs, or practices affecting alcohol-related behaviors and outcomes;
time-sensitive research opportunities to study changes in factors affecting access, delivery, or financing of health care services for alcohol use disorder and alcohol-related conditions;
time-sensitive research opportunities to study alcohol-related effects associated with sudden and severe events, such as natural disasters, acts of war, or epidemics;
time-sensitive research opportunities to study the effects on diversity, health equity, inclusion, or access of unanticipated events affecting alcohol-related behaviors and outcomes; and
time-sensitive research opportunities to inform state or local organizations of the alcohol-related consequences of new or changing policies, programs, or practices.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIAMS is interested in applications focused on evaluating time-sensitive natural experiments that concern populations with or at risk for development of NIAMS core-mission diseases (arthritic and other rheumatic, musculoskeletal, and skin disorders. Examples include, but are not limited to, time-sensitive natural experiments of changes to the neighborhood food and physical activity environments on the health of populations experiencing or at risk for NIAMS core-mission diseases. Studies among underserved, vulnerable, diverse and health disparities populations are encouraged.

Office of Disease Prevention (ODP)

The ODP is the lead office at the NIH responsible for assessing, facilitating, and stimulating research in disease prevention. In partnership with the 27 NIH Institutes and Centers, the ODP strives to increase the scope, quality, dissemination, and impact of NIH-supported prevention research. The ODP co-funds research that has strong implications for disease and injury prevention and health equity and that includes innovative and appropriate research design, measurement, and analysis methods. The ODP has a specific interest in projects that develop and/or test preventive interventions. Of particular interest is prevention research addressing leading causes and risk factors for premature morbidity and mortality, dissemination and implementation, and health disparities. The ODP does not award grants; therefore, applications must be relevant to the objectives of at least one of the participating NIH Institutes and Centers (IC) listed in this announcement. Please contact the relevant IC Scientific/Research Contact(s) listed for questions regarding IC research priorities and funding. ODP only accepts co-funding requests from NIH Institutes and Centers (ICs). For additional information about ODP, please refer to the ODP Strategic Plan for Fiscal Years 2019 2023.

Office of Research on Women's Health (ORWH)

ORWH works with the 27 NIH Institutes and Centers to advance rigorous research of relevance to women and individuals assigned female at birth. For this funding opportunity, ORWH is particularly interested in intersectional research into the health impacts of time-sensitive events, policies, programs, or infrastructure changes on women, including:

Impacts of policy changes on the health of women and people who can become pregnant (e.g., state abortion regulations, extensions to postpartum insurance coverage)
Impacts of policy changes that influence access to women's preventative health services (e.g., contraception, HPV vaccination, pre-exposure prophylaxis (PrEP))
Gender-based violence following time-sensitive events (e.g., natural disasters; pandemics)