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NOT-GM-21-050 - Notice of Special Interest (NOSI): Availability of Urgent Award for Competitive Revisions to IDeA-CTR Awards to Address the Continued Need for Documenting COVID-19-Related Patient Outcomes

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

Issued by

National Institute of General Medical Sciences (NIGMS)

Purpose

NIGMS is issuing this Notice of Special Interest (NOSI) to highlight the urgent need of documenting COVID-19-related patient outcomes among medically underserved populations.

Background

Coronaviruses are a diverse family of viruses that cause a range of disease in humans and animals. There are currently no approved coronavirus vaccines or therapeutics. In January 2020, a novel coronavirus, SARS-CoV-2, was identified as the causative agent of an outbreak of viral pneumonia centered around Wuhan, Hubei Province, China. Current information regarding confirmed cases is changing daily and can be found on the Centers for Disease Control and Prevention website and through other sources. Transmission characteristics and the associated morbidity and mortality are not completely understood, but there is clear evidence of human-to-human transmission. Fatality rates of COVID-19 patients among racial and ethical minorities, and residents of rural areas and underserved urban communities appear to be significantly higher than that of other populations. Documentation of COVID-19-related outcomes of patients from medically underserved populations is crucial to understanding the impact and to effectively combating the pandemic. The IDeA-Clinical Translational Research (IDeA-CTR) networks are uniquely positioned to address this need; they are located in IDeA states that typically have less access to medical research resources and are focused on addressing health challenges of medically underserved populations .

Research Objectives

NIGMS will accept applications for Competitive Revisions to active IDeA-CTR U54 awards to rapidly provide supplementary funds to create a registry of COVID-19 patients across IDeA states that includes a comprehensive set of deidentified clinical data elements. To reap the highest health benefit, the registry should be a secure clinical data portal that offers controlled access to clinicians providing care to patients and researchers studying the spread of SARS-CoV-2 and/or the pathology of COVID-19 for public health intervention measures.

One award is anticipated, and the awardee is expected to collaborate with other IDeA-CTR awardees to ensure broad coverage of the registry.

NIGMS strongly encourages applicants to make use of NIH Common Data Elements (CDEs) when developing their proposed registries: https://www.nlm.nih.gov/cde/index.html

NIGMS also encourages applicants to consider the use of cloud computing in order to minimize the need for researchers to download data from the registry. Applicants are encouraged to utilize the NIH STRIDES initiative and cloud-based solutions will need to be FISMA moderate, following NIST 800-53 security controls.

Wherever possible, applicants should leverage existing data resources and find ways to partner with other, related initiatives to find economies of scale and increase utility for researchers.

Eligibility

Eligible applicants are awardees with an active NIGMS IDeA-CTR U54 award. The parent award must be active when the competitive revision application is submitted (e.g., within the originally reviewed and approved project period), regardless of the time remaining on the current project.

Application and Submission Information

Applications in response to this NOSI must be submitted to PA-18-935 "Urgent Competitive Revision to Existing NIH Grants and Cooperative Agreements (Urgent Supplement - Clinical Trial Optional)", which is intended to provide funds for NIH awardees applying to expand the scope of their active U54 award. The activity code will be the same as that of the parent award.

Competitive revision applications to PA-18-935 must use the application form package with the Competition ID of NOT-GM-20-033-FORMS-F."

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

• Application Due Date(s) June 18, 2020 by 5:00 PM local time of applicant organization.
• For funding consideration, applicants must include NOT-GM-20-033 (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.
• Requests may be for one year of support only.
• Application budgets are limited to no more than $400,000 in direct costs, plus applicable F&A, and must reflect the actual needs of the proposed project.
• The Research Strategy section of the application is limited to 3 pages. This section should include a plan for partnering with other IDeA CTRs and for collaborating with the NIH-supported National COVID Cohort Collaborative.

Review Process

Applications will be evaluated for scientific and technical merit by an appropriate internal review panel convened by NIGMS staff, in accordance with the review criteria specified in the FOA as well as these additional review criteria:

• Are there specific, detailed, and attainable goals for the registry?
• Is the overall strategy well-designed to curate a sizable and deidentified database across IDeA states?
• Are there adequate plans in place for harmonizing data elements from multiple sources?
• Are there adequate plans to control access to the database and limit it to qualifying users?
• Are there adequate plans to provide rapid access to data by qualified users?

Applicants are strongly encouraged to notify the program contact listed below when a request has been submitted in response to this FOA in order to facilitate efficient processing of the request.

Inquiries

Please direct all inquiries to:

Ming Lei, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Email:leim@nih.gov