Notice of Special Interest regarding the Availability of Administrative Supplements and Urgent Competitive Revisions for the Establishment and Maintenance of a Research Database for Neurological Manifestations of the SARS-CoV-2
Release Date: April 14, 2020
First Available Due Date: April 06, 2020
Expiration Date: May 09, 2020
PA-18-935 Urgent Competitive Revision to Existing NIH Grants and Cooperative Agreements (Urgent Supplement - Clinical Trial Optional)
PA-18-591 Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
National Institute of Neurological Disorders and Stroke (NINDS)
NINDS is issuing this Notice of Special Interest (NOSI) to highlight the urgent need for research on the novel coronavirus SARS-CoV-2 (previously termed 2019-nCoV) and its associated illness, COVID-19. NINDS is especially interested in developing systems to collect data on the neurologic effects of COVID-19 infection in patients requiring intensive care and less severely affected individuals seen by health care practitioners
As people across the U.S. and the rest of the world confront the pandemic due to SARS-CoV-2, the research community should be alert to the possibility of COVID-19 neurologic complications in addition to non-specific symptoms such as headache and dizziness. In ICU patients, the neurologic symptoms of COVID-19 may be secondary to and overshadowed by the severe pulmonary, cardiovascular and hepatorenal dysfunction and associated change in level of consciousness. However, there are emerging reports of neurologic symptomatology ranging from the relatively mild (anosmia and dysgeusia) to the more extreme (encephalitis, ataxia, seizures, and cerebrovascular events). There are also concerns about possible post-viral complications like acute disseminated encephalomyelitis and Guillain-Barre syndrome, as seen in SARS and MERS. It is important to collect, aggregate and analyze data on neurologic signs and symptoms of COVID-19 in patients across the spectrum of disease severity and across life-span, from neonates/infants through the elderly. Such data will help us understand virus effects on the brain, spinal cord and nerves, including acute symptomatology and potential delayed effects in affected individuals.
In order to rapidly improve our understanding of the prevalence and symptomatology of SARS-CoV-2 neurologic involvement, NINDS is encouraging the submission of applications for Competitive Revisions and Administrative Supplements to active grants to establish and maintain a database that collects clinical information on the neurological manifestations of SARS-CoV-2 and addresses the following:
- Rapid establishment and deployment of a web-based portal for individual practitioners and institutions to enter de-identified data on neurological complications in COVID-19 patients. Data must be collected using established standards and Common Data Elements (CDEs).
- The protocol should include implementation of a set of CDEs related to neurologic disorders in patients infected with SARS-CoV-2 that incorporates and complements the current NINDS CDEs and other international standards. The core CDEs should incorporate data dictionaries using the NINDS CDE format (https://www.commondataelements.ninds.nih.gov/), additional relevant CDEs generated by a variety of neurospecialty organizations, and the ability to capture, additional relevant patient characteristics data not captured by the core CDEs, submitted in a computable format. In addition to study data (IPD=individual participant data), a data dictionary for the study must be provided. This data dictionary must be in a computable format (e.g., tab-separated-value file). The CONSIDER statement provides additional guidance for sharing data (see https://w3id.org/CONSIDER ).
- The portal should permit physicians to update information over the course of the illness.
- Establishment of a Global Unique Identifier (GUID) for patients entered into a COVID-19 NeuroDatabase to enable linkage to other GUID-enabled clinical research on the same individual.
- Establishment and maintenance of a COVID-19 NeuroDatabase to harmonize, aggregate and make the collected data widely available and useful for analysis, following the FAIR (Findable, Accessible, Interoperable, Reusable) Guiding Principles. To ensure maximal value of the project, applicants are expected to use open-source tools for harmonization and curation whenever possible.
Description of circumstances for which administrative supplements are available.
Application and Submission Information
Applications for this initiative must be submitted using one of the following opportunities:
- 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 grantees applying to expand the scope of their active grant.
- PA-18-591 Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional) This is intended to provide funds for NIH grantees where the work proposed in the supplement is fully within the scope of the ongoing grant.
The funding instrument, or activity code, will be the same as the parent award. All instructions in the SF424 (R&R) Application Guide and PA-18-935 or PA-18-591 must be followed, with the following additions:
- Applications are encouraged to be submitted as soon as possible and will be accepted on a rolling basis from April 6, 2020 until May 8, 2020 5:00 PM local time of applicant organization. This NOSI expires on May 9, 2020.
- For funding consideration, applicants must include “NOT-NS-20-046” (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.
- Applicants must hold an active U01 or U24NINDS data center award. Eligible Funding Opportunity Announcements include, but are not limited to:
- For supplements to awards that include multiple PDs/PIs, the supplement may be requested by any or all of the PDs/PIs (in accordance with the existing leadership plan) and must be submitted by the awardee institution of the original award.
- Applicants must have the resources and ability to do the work under this supplement without critically impacting other high-priority, on-going NINDS research programs.
- The project award and budget periods for this revision/supplement must be within the currently approved project period for the original/parent award (the original award must be active and not in a no cost extension for the entire extent of the supplement).
Administrative supplement applications to PA-18-591 must use the application form package with the Competition ID that contains “FORMS-E-ADMINSUPP”. In addition, the process for Streamlined Submissions using the eRA Commons cannot be used for this initiative.
Competitive revision applications to PA-18-935 must use the application form package with the Competition ID that contains “NOT-NS-20-046"
- The Research Strategy section of the application is limited to 6 pages.
- 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 original award.
Applications non-responsive to terms of this NOSI will be not be considered for the NOSI initiative.
Please direct all inquiries to:
Rebecca Hommer, MD
National Institute of Neurological Disorders & Stroke