Key Dates

Related Announcements

PA-18-935 - Urgent Competitive Revision to Existing NIH Grants and Cooperative Agreements (Urgent Supplement - Clinical Trial Optional)

NOT-OD-20-118 - Guide Notice of Information Highlighting Harmonization and Data Sharing Expectations for Supplement and Revision Projects Addressing Social, Behavioral, Economic and Health Impacts of the COVID-19 Public Health Emergency

Issued by

National Human Genome Research Institute (NHGRI)

Purpose

Purpose

This purpose of this Notice of Special Interest (NOSI) is to inform the extramural community about NHGRI’s interest in supporting research on pressing public health questions that can uniquely be addressed by collaborative efforts of large international cohort studies. Specifically, this call is limited to coordinated efforts focused on the collection and analysis of data or samples from ancestrally diverse cohorts of individuals participating in the International Hundred Thousand+ Cohort Consortium.

Background
Obesity is a major risk factor for leading causes of death including heart disease and stroke, diabetes, and some cancers, as well as disability due to osteoarthritis and other degenerative conditions. Worldwide, obesity has more than tripled since 1975, and most of the world’s population live in countries where more people die from obesity and being overweight than being underweight. Opioid use disorder has also become a public health crisis; globally, more than 100,000 people died of opioid overdose in 2017, while an estimated 1.7 million Americans suffered from opioid use disorders. Opioid use disorder, obesity, and numerous other risk factors are more prevalent in populations of lower socioeconomic status, including ethnic minorities and rural populations. Limited access to high-quality healthcare limits the potential to reduce these risk factors and ameliorate their adverse effects. Many of these factors are also associated with increased susceptibility to infection with the SARS-CoV2 virus and resultant morbidity and mortality from the illness it causes, COVID-19.

Applications in response to this NOSI are limited to active grants to network coordinating centers supported by the National Human Genome Research Institute (NHGRI).

Research Objectives
Large international cohort studies such as those collaborating in the International Hundred Thousand+ Cohorts Consortium (IHCC, https://ihccglobal.org/) are uniquely positioned to address pressing public health questions on a global scale that no cohort can answer alone. Such questions include, but are not limited to, the etiology and impact of critical risk factors for morbidity and mortality such as obesity, lower socioeconomic status, minority status, poor access to health care, and global pandemics. Research topics responsive to this NOSI include, but are not limited to:

• Genetic and environmental determinants of adverse mental health outcomes in the COVID-19 pandemic
• Role of genetically determined and environmentally mediated risk for obesity on morbidity and mortality in childhood and later life
• Genetic and environmental determinants of adverse outcomes from opioid use
• Identification of metabolomic or other biomarkers for poor health outcomes in persons of diverse genetic ancestries
• Role of genetic variation in susceptibility to and severe outcomes from SARS-CoV2 infection
• Use of polygenic risk scores in predicting susceptibility to or adverse outcomes from SARS-CoV2 infection, obesity, opioid use, and other serious threats to public health
• Improved harmonization and utilization of global data to address serious threats to public health such as SARS-CoV2 infection, obesity, opioid use, and health disparities

Funds may be used for the collection and analysis of data or samples from human cohorts of individuals participating in the IHCC. Expanding the representation of ancestrally and geographically diverse cohorts in these efforts, and improving methods for cost-efficient and secure analysis, are also strongly encouraged.

NHGRI strongly encourages investigators to promote the collection of comparable data across studies and to do so by incorporating measures from the PhenX Toolkit (www.phenxtoolkit.org) when applicable.

Eligibility

Eligible existing grants that can be revised in response to this NOSI are limited to network coordinating centers funded by NHGRI.

Application and Submission Information

Applications in response to this NOSI must be submitted using one of the following target opportunities or subsequently reissued equivalents.

• PA-18-935 "Urgent Competitive Revision to Existing NIH Grants and Cooperative Agreements (Urgent Supplement - Clinical Trial Optional)" is intended to provide funds for NIH grantees applying to expand the scope of their active grant.
• 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.

All instructions in the SF424 (R&R) Application Guide and in the target funding opportunity announcement PA-18-935 must be followed, with the following additions:

• The Research Strategy section of the application is limited to 6 pages.
• The project period will generally be limited to 2 years.
• Application budgets are limited to no more than $250,000 per year direct costs and must reflect the actual needs of the proposed project. Written requests for permission to exceed the $250,000 direct costs yearly cap for particularly meritorious work must be received by January 8, 2021, by the scientific contact listed below. These requests for permission to exceed $250,000 are limited to the amount of the current HG award and must include:
  • Name of PI
  • Title of Project
  • Name of Institution
  • Anticipated submission date
  • One page about the proposed project, including:
    • Goals and specific aims
    • Summary of the project’s significance, innovation, and generalizability
    • Summary of the approaches to be used
• No more than a one page budget justification including direct and total costs.

If approved, the document acknowledging that NHGRI will accept this greater than $250,000 direct costs per year application should be submitted in a cover letter along with the application.

• Applications will be accepted on a rolling basis from December 15 through January 15, 2021, by 5:00 PM local time of the applicant organization. This NOSI expires on January 16, 2021. An application submitted in response to this NOSI that is received on January 16, 2021 or later will be withdrawn.
• IMPORTANT: For funding consideration, all applicants must designate NOT-HG-21-020 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.
• Applications nonresponsive to the terms of this Notice will not be considered for this initiative.
• All applications (including those for multi-project activity codes) must be submitted electronically using a single-project application form package using the application form package with the Competition ID "NOT-HG-21-020-FORMS-F" for PA-18-935
• Applications must specifically address issues of potential biohazards, and all research must be conducted in compliance with the health and safety requirements found in the NIH Grants Policy Statement.

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 listed on this NOSI well in advance of the application receipt date to better determine appropriateness and interest of the NHGRI.

Inquiries

Please direct all inquiries to:

Rongling Li, M.D., Ph.D
National Human Genome Research Institute
Tel: 301-480-2487

E-Mail: [email protected]