June 5, 2020
PA-18-591 Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
PA-18-935 Urgent Competitive Revision to Existing NIH Grants and Cooperative Agreements (Urgent Supplement -Clinical Trial Optional)
National Institute of Mental Health (NIMH)
National Eye Institute (NEI)
National Heart, Lung, and Blood Institute (NHLBI)
National Institute on Aging (NIA)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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 of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute on Drug Abuse (NIDA)
National Institute of Nursing Research (NINR)
National Institute on Minority Health and Health Disparities (NIMHD)
National Center for Complementary and Integrative Health (NCCIH)
National Center for Advancing Translational Sciences (NCATS)
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.
Sexual and Gender Minority Research Office (SGMRO)
Division of Program Coordination, Planning and Strategic Initiatives, Office of Disease Prevention (ODP)
Office of Behavioral and Social Sciences Research (OBSSR)
Office of Research on Women's Health (ORWH)
This Notice of Special Interest (NOSI) highlights interest in research to strengthen the healthcare response to Coronavirus Disease 2019 (COVID-19) caused by the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and to future public health emergencies, including pandemics. While the direct clinical effects of COVID-19 are supported by other funding opportunities, the purpose of this NOSI is to support research to address secondary health effects of the social, behavioral, and economic changes, particularly among populations who experience health disparities and vulnerable populations through the use of digital health assessments and interventions to yield measurable near-term impact.
Across the life span, the COVID-19 pandemic will result in social, behavioral, and economic changes that impact health. These adverse effects are compounded by disruptions in the provision and access to healthcare including access to allied health providers, such as therapists and visiting nurses.In response, the healthcare landscape in the United States and around the world has shifted dramatically to a rapid uptake of digital health technologies delivered online across a variety of platforms for addressing health and disease management.
Existing digital health interventions [e.g., mobile health (mhealth), telemedicine and telehealth, health information technology (IT), wearable devices, and personalized medicine] provide opportunities to help consumers and clinicians manage and improve health during and following population level healthcare and other critical disruptions. Most importantly, digital health interventions offer the potential to increase access to screening, self-management and prevention services for individuals at risk or who currently need but are unable to access treatment and other services, particularly populations who experience health disparities, to bridge the treatment gap and provide evidence-based interventions.
This notice is not intended to support the development of novel digital health interventions. Interventions may utilize phone delivery, app-based approaches, video delivery, web-based platforms, wearable devices, and/or new technologies.
In order to significantly improve near term impact of treatment and identification of individuals at risk for, or experiencing worsening health secondary to the COVID-19 pandemic across the full lifespan, supplements will focus particularly on NIH-designated health disparity (racial/ethnic minorities, less privileged socioeconomic status, rural residents and sexual and gender minorities) and other populations with medical or social vulnerabilities. The latter include residents of chronic care facilities, community-dwelling older adults, pregnant women, children, individuals with cognitive impairment or dementia, homeless, and those incarcerated or involved with the criminal justice system, individuals with substance use disorder or severe mental illness, those who are deaf or with visual, hearing, communication, or mobility impairment, and uninsured individuals. Those on the frontlines of healthcare during the COVID-19 pandemic also are vulnerable populations. Research may evaluate the effects of the pandemic on vulnerable frontline health care workers and first responders, including physicians in direct patient care, nurses, dentists, respiratory therapists, mental health therapists, other support staff, home health aides, police officers, fire fighters, emergency medical technicians, and all workers with direct patient contact, as well as family or informal caregivers. Research on frontline vulnerable populations also extends to those working in essential business operations (e.g., grocery, pharmacy, and transit workers, postal and other delivery service workers, sanitation workers) who may be disproportionately impacted by the pandemic and its social, behavioral, and economic impacts on health.
Applications are expected to describe how research outcomes will lead to a tangible difference within 6 months to a year of completing the supplement work, with respect to improving how we identify, treat, or provide services for health conditions secondary to the COVID-19 pandemic for health disparate and vulnerable populations. Submission of applications to address the following areas of scientific interest are encouraged:
Applicants proposing supplements to study the following research areas will not be supported:
Design, Analysis, and Sample Size for Studies to Evaluate Group-Based Interventions:
Investigators who wish to evaluate the effect of a digital health intervention on a health-related biomedical or behavioral outcome may propose a study in which (1) groups or clusters are assigned to study arms and individual observations are analyzed to evaluate the effect of the intervention, or (2) participants are assigned individually to study arms but receive at least some of their intervention in a real or virtual group or through a shared facilitator. Such studies may propose a parallel group- or cluster-randomized trial, an individually randomized group-treatment trial, a stepped-wedge design, or a quasi-experimental version of one of these designs. In these studies, special methods are required for analysis and sample size estimation. Applicants will need to show that their methods are appropriate given their plans for assignment of participants and delivery of interventions. Additional information is available at https://researchmethodsresources.nih.gov/.
Applications for this initiative must be submitted using the following opportunity or its subsequent reissued equivalent.
The funding instrument, or activity code, will be the same as the parent award. The parent award must be active when the supplement application is submitted (e.g. within the originally reviewed and approved project period), regardless of the time remaining on the current project. Only active awards from the Institutes listed in the ISSUED BY section are eligible to submit for this NOSI.
Applicants are reminded that the appropriate consideration of sex and gender as described in NOT-15-102 is NIH policy and a consideration for NIH support.
When developing applications in response to this NOSI, all instructions in the SF424 (R&R) Application Guide must be followed, with the following additions:
The project period will generally be limited to one year but two years are allowed with strong justification.
Application budgets are limited to no more than $200,000 direct costs and should reflect the actual needs of the proposed project.
Pre-award costs may be incurred from January 20, 2020 through the public health emergency period and prior to the date of the federal award
IMPORTANT: For funding consideration, applicants must include “NOT-MH-20-053” (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 the NOSI are strongly encouraged to contact the program officers listed below to discuss the proposed project in the context of the parent award. All applications (including those for multi-project activity codes) must be submitted electronically using a single-project application form package:
Applications nonresponsive to terms of this NOSI will be not be considered for the NOSI initiative.
Adam Haim, Ph.D.
National Institute of Mental Health (NIMH)