EXPIRED
May 20, 2022
PA-20-272 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
All of Us Research Program (All of Us)
Office of The Director, National Institutes of Health (OD)
Office of AIDS Research (OAR)
National Eye Institute (NEI)
National Heart, Lung, and Blood Institute (NHLBI)
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 Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
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 Environmental Health Sciences (NIEHS)
National Institute of General Medical Sciences (NIGMS)
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)
National Library of Medicine (NLM)
National Center for Complementary and Integrative Health (NCCIH)
National Center for Advancing Translational Sciences (NCATS)
Office of Strategic Coordination (Common Fund)
Sexual and Gender Minority Research Office (SGMRO)
National Cancer Institute (NCI)
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 Behavioral and Social Sciences Research (OBSSR)
Office of Research on Women's Health (ORWH)
The All of Us Research Program (All of Us) within the Office of the Director (OD) encourages eligible grantees of the participating Institutes, Centers, and Offices (ICOs) to apply for administrative supplements to support analysis of currently available data within the All of Us Research Program’s Researcher Workbench or to develop analysis tools for the available data within the general scope of the parent award.
Background
The All of Us Research Program is building a database to help transform the future of health research by equipping researchers nationwide with expansive health data from diverse populations, especially those underrepresented in biomedical research. It is built in partnership with participants spanning different ages, races and ethnicities, and regions of the country. New data are added twice a year. Available to registered researchers includes:
The All of Us dataset, available to scientists across the United States, provides unprecedented opportunities for a wide range of studies to understand how biological, behavioral, and environmental factors influence health and a broad range of diseases and conditions. The All of Us data are housed on the Researcher Workbench, which also includes tools, along with personalized support resources, such as an integrated help desk, regular office hours, sample datasets and more.
Researchers must register and apply for access to the All of Us Researcher Workbench to analyze data (https://www.researchallofus.org/apply/). Once registered, researchers can create research projects using collaborative workspaces, cohort-building tools, interactive notebooks, and more. Currently, researchers must complete the All of Us Research Program data access process to access the Researcher Workbench and Registered Tier data. Additional training is required to access the controlled tier, which includes more granular data on participants as well as whole genome sequence and genotyping data, as described above. The All of Us Research Hub (https://www.researchallofus.org/) is a good place to start to learn more about data access and use, as well and to explore research underway. The Researcher Workbench (link at the beginning of this paragraph) also provides information on computing costs (this NOSI will not be using STRIDES; https://cloud.nih.gov/about-strides/).
Specific Areas of Research Interest
Research is encouraged that can help advance precision medicine in high priority areas of the participating NIH ICOs and the All of Us Research Program. Additionally, proposals are encouraged that leverage All of Us electronic health records (EHR) data on COVID-19 exposure, treatment and Post-Acute Sequelae of SARS CoV-2 (long COVID) in conjunction with other All of Us data types (please see section on RECOVER).
Applications must make direct use of All of Us data that is available through the Researcher Workbench. Applicants may analyze the All of Us data in combination with other existing data sets, but for the purpose of this administrative supplement program, they should not propose ancillary studies that would require the collection of additional data beyond what is already available in the Researcher Workbench or studies that would require a linkage of All of Us data to other datasets at the level of the individual.
Because information regarding the user experience could help NIH improve its data resources, it is expected that NIH will receive feedback from awardees on usability and utility of data sets and public data portals, which the awardees can provide in their progress reports to ICO Program Officers.
Applicants will be expected to make their workspace, and any tools they develop, available to other registered users of the All of Us Research Workbench.
Applicants may request funds, in addition to research costs, to present their work using All of Us data at a national meeting and/or All of Us Researchers Convention.
RECOVER
The goal of the NIH RECOVER (Researching COVID to Enhance Recovery) Initiative is to accelerate the understanding, treatment, and prevention of the post-acute sequelae of SARS-CoV-2 infection (PASC). RECOVER seeks to advance knowledge of virtually every aspect of PASC, including but not limited to incidence and prevalence, natural history, clinical spectrum, risk and resilience factors, how complex interactions (e.g., person x virus x environment x time) influence PASC, the influence of social determinants of health, the underlying biology of PASC, and the safety and efficacy of proposed treatment and preventive strategies. Applicants have the opportunity to undertake creative analyses of the multimodal data available through the All of Us Researcher Workbench to further our understanding of PASC and guide prevention and treatment of PASC. More information on RECOVER is available at https://recovercovid.org/.
Scope of Support
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious supplement requests.
The All of Us Research Program intends to commit up to $2,000,000 in Fiscal Year (FY) 22 to fund 12-20 awards, subject to availability of funds. ICOs may use their own funds to make additional awards.
Supplement budget requests cannot exceed $75,000 in direct costs. Budgets may not exceed the total costs of the current parent award. Requests must reflect the actual needs of the proposed project. Requests may be only for one year of support.
ICO-Specific Considerations
The work proposed in the supplement requests needs to be within the scope of the research in the awarded parent grant that is already supported. Applicants are strongly encouraged to discuss their proposed supplement project with the ICO Program Officer of the funded parent award prior to submission of a supplement application, to ensure that the proposed activity aligns with the scientific priorities of the ICO and is within the scope of the parent award. Scientific inquiries may also be addressed to the contacts listed in the Inquiries section below.
NHGRI
NHGRI supports the development of resources, approaches, and technologies that accelerate and support studies focused on the structure and biology of genomes; the genomics of disease; the implementation and effectiveness of genomic medicine; genomic data science and bioinformatics; training, developing, and expanding the diversity of the genomics workforce; and ethical, legal, and social issues related to genomic advances. More details about the institute’s vision and priority areas can be found in the 2020 NHGRI Strategic Vision (https://www.genome.gov/2020SV).
NCI
The National Cancer Institute is interested in research across the cancer continuum including: assessment of cancer risk and related risk factors, early detection and prevention; diagnosis and treatment; and cancer control and epidemiology including: assessing cancer incidence, prevalence, prognosis, survival, health outcomes, and health disparities across the lifespan.
NIDCR
NIDCR supports research and research training for advancing fundamental knowledge about dental, oral, and craniofacial health and disease, and translating these findings into prevention, early detection, and treatment strategies that improve overall health for all individuals and communities across the lifespan. Details on specific Strategic Priorities are described in NIDCR Strategic Plan 2021-2026.
NIDCD
NIDCD is interested in those administrative supplement applications that address mission specific sensory and communication disorders. The application must be related to NIDCD’s specific programs of hearing, balance, taste, smell, voice, speech and language.
OBSSR
OBSSR does not administer or manage grants, but can provide funding support to the ICO that manages the grant. Applicants responding to OBSSR interests are encouraged to contact their ICO Program Officer to be sure their proposal also meets the priorities of the ICO. OBSSR is particularly interested in supporting research that leverages the multiple levels of influence available within the All of Us data set to help advance understanding of the interplay between genetic factors, behaviors and other individual factors, interpersonal and relationship factors, and social determinants of health.
Topics of interest to OBSSR include, but are not limited to:
NCCIH
The mission of NCCIH is to determine, through rigorous scientific investigation, the fundamental science, usefulness, and safety of complementary and integrative health approaches and their roles in improving health and health care. NCCIH seeks to expand the knowledge base about how multifaceted complementary health approaches exert their effects, and describe how these approaches improve resilience, restore health, and manage symptoms in a whole person health framework. Examples of complementary approaches include therapies or interventions with nutritional (e.g., special diets, dietary supplements, herbs, probiotics, and microbial-based therapies), psychological (e.g., meditation, hypnosis, music-based interventions, relaxation therapies), physical (e.g., acupuncture, massage, chiropractic manipulation, devices related to these approaches), and/or a combination of psychological and physical (e.g., yoga, tai chi, music or dance therapies, some forms of art therapies) input. In the context of this NOSI, NCCIH is particularly interested in encouraging supplement applications from currently funded NCCIH investigators who desire to augment ongoing studies by using All of Us Research Program data. Supplement applications could support analyses to describe the utilization and integration of complementary and conventional care, associations of complementary health approaches with health outcomes, and when possible, use analytic methods that could attempt to account for bias in the data.
NIAAA
NIAAA is particularly interested in supplements making use of the All of Us dataset’s unique variables: electronic health records (EHR), whole genome sequencing, surveys, including the AUDIT-C, and physical activity tracker data. Specific topics of interest include but are not limited to: comorbidities between alcohol use disorder (AUD) and other health diagnoses, EHR and alcohol health services, pharmacoepidemiological approaches relevant for AUD and drinking outcomes, and alcohol use and AUD across the lifespan. Given the diversity of the sample, supplement applications should include a consideration of how they will incorporate NIH-defined minority populations in their analysis.
NCATS
NCATS encourages investigators supported by NCATS awards to consider submission of applications for in-scope projects that can utilize the data and tools available through the NIH All of Us Researcher Workbench. Meritorious applications that propose to use both the All of Us Researcher Workbench and the National COVID Cohort Collaborative (N3C) resource to address important scientific questions related to the SARS-CoV-2/COVID-19 pandemic or long-term sequelae of SARS-CoV-2 infection will be given highest priority. Supplement project and budget periods must be consistent with the parent award. NCATS award recipients applying for this opportunity that require 12 months of time and funding to complete the activity but do not have the needed time remaining in the current Fiscal Year 2022 budget period should split the activity and funding to the appropriate budget period. Note - The total period of support cannot exceed one year (12 months) and the total funding requested cannot exceed $75,000 in direct costs.
NIEHS
NIEHS is interested in administrative supplement applications that address the impact of the environment on human health and/or develop methods for understanding the influence of environmental factors for disease risk. Environmental factors are broadly defined including chemical, biological, lifestyle and behavioral factors, social determinants of health, the natural and built environment, and climate factors. Applicants are encouraged to leverage the available All of Us data set and publicly available environmental data sets to explore opportunities at the interface of gene environment interactions or integration of environmental data with other complex data types for mechanistic or etiologic understanding of disease.
OAR
OAR encourages applications for administrative supplements to active awards administered by the NIH ICOs that are supported with HIV-appropriated funds. OAR is particularly interested in analysis of HIV data in the All of Us Research Workbench database that will help inform and advance the specific objectives of the parent awards. The current research priorities of OAR can be found at https://www.oar.nih.gov/hiv-policy-and-research/research-priorities.
OSC
OSC manages the NIH Common Fund programs which address emerging scientific opportunities, pressing challenges, and innovative endeavors across biomedical research. Common Fund programs are short-term, goal-driven, strategic investments, with deliverables intended to catalyze research across multiple biomedical research disciplines. OSC encourages applications from any Common Fund awardee who proposes new uses of All of Us data. However, OSC is particularly interested in applicants with proposals that combine All of Us data with Common Fund data resources (such as 4D Nucleome, Extracellular RNA Communication, Gabriella Miller Kids First, Genotype-Tissue Expression, Glycosciences, Human BioMolecular Atlas Program, Illuminating the Druggable Genome, Integrated Human Microbiome Project, Knockout Mouse Phenotyping Program, Library of Integrated network-based Cellular Signatures, Metabolomics Workbench, Molecular Transducers of Physical Activity in Humans, or Stimulating Peripheral Activity to Relieve Conditions).
NINDS
NINDS welcomes applications from investigators supported by NINDS awards for in-scope projects that utilize the data and tools available through the All of Us Researcher Workbench to support the NINDS mission to seek fundamental knowledge about the brain and nervous system and to use that knowledge to reduce the burden of neurological disease for all people.
NIMH
The NIMH mission is to transform the understanding and treatment of mental illnesses through basic and clinical research, paving the way for prevention, recovery, and cure. Applications considered for funding by the NIMH must fall within the areas of research priority detailed in the NIMH Strategic Plan. Applicants are strongly encouraged to contact Scientific/Research Contact(s) prior to submission.
NIAID
NIAID conducts and supports basic and applied research to better understand, treat, and ultimately prevent infectious, immunologic, and allergic diseases. NIAID’s Division of AIDS is working to better understand HIV and how it causes disease, find new tools to prevent HIV infection, develop new and more effective treatments for HIV-infected people, and find a cure. NIAID’s Division of Microbiology and Infectious Diseases conducts and supports research on nearly 300 infectious agents and investigates the biological properties of these pathogens and the immune system’s responses to them. Findings from this research are vital to NIAID efforts to create vaccines, drugs, and diagnostic tools to better diagnose, prevent, and treat infectious diseases. NIAID’s Division of Allergy, Immunology and Transplant supports basic and clinical research to increase our understanding of the causes and mechanisms that lead to the development of allergic and immunologic diseases and to expand knowledge that can be applied to improving techniques of diagnosis, treatment, and prevention.
NHLBI
The National Heart, Lung, and Blood Institute (NHLBI) supports basic, preclinical, translational, and clinical research that leads to improvement of heart, lung, blood, and sleep (HLBS) health outcomes. More details about the NHLBI mission, strategic vision, and research priorities can be found in the NHLBI Strategic Vision.
NIMHD
Of priority are research questions to address minority health or health disparities for NIH-designated United States populations affected by health disparities [e.g., racial and ethnic minority populations, sexual and gender minority groups, underserved rural populations, and socioeconomically disadvantaged populations (https://www.nimhd.nih.gov/about/overview/)] that align with the NIMHD research framework (https://www.nimhd.nih.gov/about/overview/research-framework/nimhd-framework.html). Multi-level approaches and studies that address social determinants affecting health and access to and quality of clinical care are encouraged. Also of priority are studies that prioritize investigations of multiple levels of influence (e.g., community, individual) with one or more domains of influence (e.g., biological, social, environmental, health care system) to understand the underlying etiologic factors and mechanisms that contribute to minority health or health disparities. These may include both risk and protective factors (e.g., tobacco use, alcohol/drug use, poor quantity/quality of sleep, vaccination, exercise, social support) and the interplay of multiple factors that result in health advantages and health disparities. Health outcomes of interest may include but are not limited to: Cancer, Cardiovascular Disease, COVID-19, Diabetes, Stroke, Unintentional Injuries, Suicide, Chronic Lower Respiratory disease, Chronic Kidney Disease, Hypertension, Assault and Homicide, Chronic Liver disease and Cirrhosis, and Mental Health and Substance Abuse conditions.
NIGMS
NIGMS supports basic research that increases our understanding of biological processes and lays the foundation for advances in disease diagnosis, treatment, and prevention. NIGMS' research mission is aimed at understanding the principles, mechanisms, and processes that underlie living organisms, often using research models. NIGMS does not support research that is relevant to the diseases, organ systems, stages of life, or populations within the mission areas of other NIH Institutes and Centers.
Supplement awards may provide support above the established program budget limits only for the NIH Research Enhancement Award (R15), the Support for Research Excellence (SuRE) Program (R16), and for the Competitive Research (SCORE) Program (SC1, SC2, SC3).
All requests for administrative supplements must fall within the scientific scope of the original grant awards. Advance discussion of research plans with the relevant program director at NIGMS is strongly encouraged.
NIDA
NIDA is interested in research that leverages All of Us data to better understand causal and risk factors for substance use disorders (SUD); the relationship between SUD, pain, and other common comorbidities; and the clinical consequences of substance use and misuse. This research includes but is not limited to:
Other Information
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Eligibility
This announcement is for supplements to existing projects. To be eligible, the parent award must be active when the supplemental application is submitted (i.e., within the originally reviewed and approved project period). The parent award must be able to receive funds in FY22. The research proposed in the supplement must be accomplished within the competitive segment. Awards in a No-Cost Extension (NCE) or going into a no-cost extension in FY22 are not eligible.
NIH institutional training grants (Ts), research career development awards (Ks), fellowships (Fs), and other non-traditional research awards [Research Education Program (R25)] are not eligible to apply.
Application and Submission Information
Applications for this initiative must be submitted using the following opportunity or its subsequent reissued equivalent.
All instructions in the SF424 (R&R) Application Guide and PA-20-272 must be followed, with the following additions:
Supplement requests that do not comply with these instructions or are deemed otherwise non-responsive to the terms of this NOSI will not be accepted for review
Scientific Review Process
The NIH program staff will conduct administrative reviews of submitted applications and will support the most meritorious applications, pending the availability of funds.
Criteria
NIH staff will consider the ability of the proposed supplement activities to increase or preserve the parent award’s overall impact within the original scope of award as appropriate. All criteria for review in Section V. Application Review Criteria in PA-20-272 will be followed.
Please direct all inquiries to the Program Officer associated with the parent award and/or the designated contact at the ICO supporting the parent award listed below:
All of Us Research Program
Sheri Schully, Ph.D.
Telephone: 240-827-1691
Email: schullys@mail.nih.gov
National Human Genome Research Institute (NHGRI)
Rongling Li, M.D., Ph.D., M.P.H.
Telephone: 301-480-2487
Email: rongling.li@nih.gov
National Cancer Institute (NCI)
Dana Wolff-Hughes, Ph.D.
Telephone: 240-620-0673
Email: dana.wolff@nih.gov
National Institute of Mental Health (NIMH)
Jenni Pacheco, Ph.D.
Telephone: 301-443-3645
Email: jenni.pacheco@nih.gov
NIH Office of Strategic Coordination (OSC)
Christopher Kinsinger
Telephone: 301-640-1855
Email: Christopher.Kinsinger@nih.gov
National Institute of Minority and Disparities (NIMHD)
Rada Dagher, Ph.D., M.P.H.
Telephone: 301-451-2817
Email: rada.dagher@nih.gov
Office of AIDS Research (OAR)
J. Rafael Gorospe, M.D., Ph.D.
Telephone: 240-292-4824
Email: gorospejr@mail.nih.gov
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Stephanie George, Ph.D., M.P.H., M.A.
Telephone: 301-594-4974
Email: stephanie.george@nih.gov
National Center for Complementary and Integrative Health (NCCIH)
Sekai Chideya, M.D., M.P.H.
Telephone: 301-827-1916
Email: sekai.chideya@nih.gov
National Library of Medicine (NLM)
Lisa Lang, M.P.P.
Telephone: 301-827-4293
Email: langl@mail.nlm.nih.gov
National Center for Advancing Translational Sciences (NCATS)
Eric Sid, M.D., M.H.A. or Josh Fessel, M.D., Ph.D.
Telephone: 301-827-3073 or 301-402-7734
Email: eric.sid@nih.gov
Email: josh.fessel@nih.gov
National Eye Institute (NEI)
James Gao, Ph.D.
Telephone: 301-594-6074
Email: james.gao@nih.gov
National Heart, Lung, and Blood Institute (NHLBI)
Nicole Redmond, M.D., Ph.D., M.P.H.
Telephone: 301-435-0379
Email: nicole.redmond@nih.gov
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Laura E. Kwako, Ph.D.
Telephone: 301-451-857
Email: laura.kwako@nih.gov
National Institute of Child Health and Human Development (NICHD)
Caroline Signore, M.D., Ph.D.
Telephone: 301-496-5577
Email: signorec@mail.nih.gov
National Institute on Drug Abuse (NIDA)
Daniel Stimson, J.D., Ph.D.
Telephone: none
Email: stimsond@mail.nih.gov
National Institute on Deafness and Other Communication Disorders (NIDCD)
Bracie Watson, Jr., Ph.D.
Telephone: 301-402-3458
Email: bracie.watson@nih.gov
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
(Division of Diabetes, Endocrinology and Metabolic Diseases)
Jean M. Lawrence, Sc.D., M.P.H., M.S.S.A.
Telephone: 301-435-6243
Email: jean.lawrence@nih.gov
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
(Division of Kidney, Urologic and Hematologic Diseases)
Afshin Parsa, M.D., M.P.H.
Telephone: 301-827-1375
Email: afshin.parsa@nih.gov
National Institute of Dental and Craniofacial Research (NIDCR)
Lillian Shum, Ph.D.
Telephone: 301-594-0618
Email: Lillian.Shum@nih.gov
National Institute of Aging (NIA)
Winnie Rossi, M.A.
Telephone: 301-496-3836
Email: rossiw@nia.nih.gov
National Institute of Neurological Disorders and Stroke (NINDS)
Rebecca Hommer, M.D.
Telephone: 301-827-2257
Email: Rebecca.hommer@nih.gov
Office of Behavioral and Social Sciences Research (OBSSR)
Beth Jaworski, Ph.D.
Telephone: 301-496-0979
Email: beth.jaworski@nih.gov
Office of Research on Women’s Health (ORWH)
Jamie White, M.S.
Telephone: 301-496-9200
Email: jamie.white@nih.gov
National Institute of Environmental Health Sciences (NIEHS)
Yuxia Cui, Ph.D.
Telephone: 984-287-3251
Email: yuxia.cui@nih.gov
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Andrew Weitz, Ph.D.
Telephone: 301-451-7813
Email: andrew.weitz@nih.gov
Sexual and Gender Minority Research Office (SGMRO)
Christopher Barnhart, Ph.D.
Telephone: 301-594-8983
Email: christopher.barnhart@nih.gov
National Institute of General Medical Sciences (NIGMS)
Baishali Maskeri, PhD
Email: maskerib@mail.nih.gov
National Institute of Nursing Research (NINR)
Liz Perruccio, M.S., Ph.D.
Telephone: 301-402-8084
Email: liz.perruccio@nih.gov
National Institute of Allergy and Infectious Diseases (NIAID)
Carolyn Williams, Ph.D., M.P.H.
Telephone: 301-402-2305
Email: cwilliams@niaid.nih.gov