Key Dates

Related Announcements

PA-20-272 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)

Issued by

National Institute on Minority Health and Health Disparities (NIMHD)

Purpose

Purpose

This Notice of Special Interest (NOSI) invites applications for administrative supplements to NIMHD Research Centers in Minority Institutions (RCMI) U54 awards to support pilot research projects led by post-doctoral fellows, junior faculty, or other early-stage investigators (ESIs) that utilize the NIH’s All of Us Research Program dataset. NIMHD is particularly interested in health equity studies that explore the role of social determinants in health outcomes or clinical care for populations that experience health disparities.

Background

The All of Us Research Program is part of an effort to advance individualized health care by enrolling one million or more participants to contribute their health data over many years. The program aims to reflect the diversity of the United States and to include participants from groups that have been historically not been invited to participate  in biomedical research or they were invited but were not told what was involved. To date, All of Us has enrolled more than 330,000 participants who have completed initial steps of the program, with approximately 50% from racial or ethnic minority populations as defined by the U.S. Census and approximately 80% from individuals who have been less represented in biomedical research. Data collected includes physical measurements, lifestyle questions, electronic health records, and social determinants of health. The All of Us Research Program provides custom tools and software to approved researchers to analyze participant data while keeping information secure.

NIMHD’s RCMI program expands the national capacity for research in the health sciences by providing cooperative agreement support to minority institutions that offer doctorate degrees in the health professions or in a health-related science and have a documented historical and current commitment to educating underrepresented students, and for institutions that provide clinical services to the medically underserved. Each RCMI U54 Center includes an Investigator Development Core to support post-doctoral fellows, junior faculty, and other early-stage investigators (ESIs) in basic biomedical, behavioral, and/or clinical sciences through a Pilot Project Program. Centers are expected to provide ongoing support to these scholars as they conduct their research projects, submit publications based on their work, and apply for external funding such as Mentored Career Development (K-awards) or equivalent and ultimately an R01 grant as appropriate to their career level.

Research Objectives

The All of Us Research Program is partnering with the NIMHD RCMIs to support pilot projects led by ESIs who utilize the All of Us Research Program datasets. Of priority are research questions that address minority health or health disparities for NIH-designated United States populations with 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/)].

Pilot project investigations of multiple levels of influence (i.e., community, individual) with one or more domains of influence (i.e., biological, behavioral, environmental) to understand the underlying etiologic factors and mechanisms that contribute to minority health or health disparities that align with the NIMHD Research Framework) are a priority. In addition, the All of Us Research Program and NIMHD are interested in supporting integrative research that encourages cross-discipline collaborations that characterize mechanisms by which social experiences at various stages of the life course affect biological or gene function, thereby influencing health trajectories or modifying disease risk in racial/ethnic minority and other populations with health disparities.

Research topics of interest may include but are not limited to health outcomes from:

• Cancer
• Heart disease
• COVID-19
• Diabetes
• Stroke
• Mental health
• Unintentional injuries
• Suicide
• Chronic lower respiratory disease
• Kidney disease
• Hypertension
• Sleep
• Chronic liver disease and cirrhosis
• Multiple coexisting chronic health conditions
• Substance use and geographic variations within the US as well as rural or urban residence
• Social determinants affecting access to and quality of clinical care

The All of Us Research Hub includes the Researcher Workbench, which houses the data along with tools and personalized support resources such as an integrated help desk, regular office hours, sample datasets, and more. This centralized, secure, cloud-based platform combines biological, electronic health record (EHR), wearable, and participant survey data on a large, inclusive scale. Access is available to researchers whose institutions have Data Use and Registration Agreements in place with the program.

The currently available participant data on the Researcher Workbench include:

• Physical measures including blood pressure, heart rate, body mass index (BMI), and more from over 267,000 participants.
• Survey responses from over 329,000 participants that include lifestyle, access to care, and medical history. There are also survey data from nearly 100,000 participants on their experiences with COVID-19 during the pandemic (see https://www.researchallofus.org/data-tools/survey-explorer/).
• Electronic Health Records (EHRs) from 214,000+ participants which have been standardized to the Observational Medical Outcomes Partnership (OMOP) Common Data Model.
• Wearable data from 11,600+ participants with Fitbit data including physical activity and heart rate.
• Genomic data available through the “Controlled Tier,” with large sample sizes that are appropriate for precision medicine research. The Controlled Tier dataset includes:
  • Nearly 100,000 whole genome sequences and more than 165,000 genotyping arrays
  • More granular survey data, including on self-reported race and ethnicity, Tribal affiliation, education, sex assigned at birth, gender identity, and more.
  • More detailed EHR data, including additional International Classification of Diseases ( ICD) codes, event dates, and previously generalized or suppressed demographic information.
  • All COVID-19 data in EHRs except for data pertaining to vaccines.
• (Slated for release in Summer 2022) Data from a Social Determinants of Health survey with the following 12 domains: neighborhood safety, built environment walkability, social support, loneliness, everyday life discrimination, health care discrimination, food security, housing security, perceived stress, daily spiritual experiences, religious service attendance, and English proficiency.

Accessing and Using Data in the Researcher Workbench

Funded applicants, like all Researcher Workbench users, will be provided technical support through video tutorials, sample workspaces, frequently asked questions (FAQs), an online community forum, regular office hours with Research Workbench support staff, and a dedicated support center to help researchers access and use the data. To learn more about data access and use, visit https://www.researchallofus.org/data-tools/data-access/.

The Research Hub has a Research Projects Directory to explore research underway through the All of Us Research Program, available at https://www.researchallofus.org/research-projects-directory/.

Application and Submission Information

Applications for this initiative must be submitted using the following opportunity or its subsequent reissued equivalent.

• PA-20-272 Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)

Administrative supplements proposed through PA-20-272 must be within the scope of the peer reviewed and approved parent RCMI U54 award. For the purposes of this NOSI, proposed pilot research projects must be administered by the parent RCMI U54 Center's Investigator Development Core.

To be eligible for an Administrative Supplement under this NOSI, the parent RCMI U54 award must:

• be awarded under either RFA-MD-17-003, RFA-MD-17-006, RFA-MD-18-012, or RFA-MD-20-006,
• be an active NIH award at the time of application (i.e., within five years of the start date of the originally reviewed and approved project period of the existing parent RCMI U54’s competitive segment; or if applicable, within the originally reviewed and approved project period of a competitive revision), and
• have sufficient time left to complete the studies proposed within the parent award's current project period.

All instructions in the SF424 (R&R) Application Guide and PA-20-272 must be followed, with the following additions:

• Budget: An eligible applicant institution may propose one pilot research project, with a maximum direct cost budget of $200,000 for one year.
• Project Period: The pilot project and budget periods must be within five years of the start date of the originally reviewed and approved project period of the existing parent U54 award’s competitive segment; or if applicable, within the originally reviewed and approved project period of a funded competitive revision.
• Application Due Date: June 27, 2022, by 5:00 PM local time of the applicant organization. For funding consideration applicants must include “NOT-MD-22-015” 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.
• Institutional Commitment: The applicant institution should convincingly demonstrate the availability of adequate resources, appropriate and dedicated mentoring support, and commitment to the success of the early stage investigators (ESI) and new investigators (NI).
• Research Strategy: This section of the application is limited to 6 pages per pilot project and at minimum should include a summary of the funded parent award including support provided by the pilot project program, significance of the supplement project, innovation, and approach.

Inquiries

Please direct all inquiries to:

Scientific/Research Contacts

Gniesha Y. Dinwiddie, PhD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-827-2784
Email: gniesha.dinwiddie@nih.gov

Nancy Jones, PhD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8945
Email: nancy.jones@nih.gov

Karriem S. Watson, DHS, MS, MPH
All of Us Research Program
Telephone: 301-451-4333
Email: Karriem.Watson@nih.gov

Fiscal/Grants Management Contact

Priscilla Grant, JD
National Institute on Minority Health and Health Disparities (NIMHD)
Email: pg38h@nih.gov