Key Dates

Related Announcements

None

Issued by

National Heart, Lung, and Blood Institute (NHLBI)

Purpose

THIS IS NOT A NOTICE OF FUNDING OPPORTUNITY (NOFO). NO SOLICITATION FOR GRANT APPLICATIONS WILL BE ISSUED FOR THIS PURPOSE. APPLICANTS MUST USE EXISTING FUNDING OPPORTUNITY ANNOUNCEMENTS AS APPROPRIATE.

1. PURPOSE
   
   This Notice invites investigators to submit proposals for ancillary studies related to the parent initiative: Researching COVID to Enhance Recovery (RECOVER). RECOVER is a multi-site observational cohort study conducted across adult (including pregnancy), pediatric, and deceased populations. Broadly speaking, the objectives of RECOVER are to characterize the prevalence, symptoms, natural history and distinct phenotypes of Long COVID; to identify risk factors for Long COVID; and to better understand the biologic mechanisms and pathophysiology underlying Long COVID in order to identify safe and effective strategies to treat and prevent Long COVID. Ancillary studies will build on RECOVER’s robust infrastructure while addressing gaps in knowledge regarding the natural history, pathophysiological mechanisms, and evaluate and validate potential diagnostics or interventions identified through utilization of existing RECOVER biospecimens, data and ongoing long-term follow-up of individuals living with Long-COVID participating in the RECOVER program.
    
2. BACKGROUND

In the context of this Notice, an ancillary study is an independent research project that uses samples or data from a parent study to extend knowledge in scientific areas beyond the original scope of the parent study. An ancillary study may require additional data or sample collection, but it must not overlap or interfere with the primary objectives of the parent study. A project that qualifies as a RECOVER ancillary study will be expected to collect/originate new information beyond that which the parent study has obtained, and/or investigate novel hypotheses, and/or derive new information from existing RECOVER data, biospecimens, images, other data types, etc. The intent is to build on RECOVER’s robust infrastructure while addressing critical knowledge gaps related to the study objectives described above. 

Proposals may include observational, pre-clinical, or mechanistic studies and should describe how the ancillary study will address RECOVER’s Research Questions all the while ensuring participant confidentiality and data security. 

This Notice allows interested researchers sufficient time to develop their research hypotheses and designs; comply with any applicable RECOVER cohort study-specific and NIH $500K requirements; submit and, if necessary, re-submit their research proposals.

3. ADDITIONAL INFORMATION

a. Proposals must describe the study hypothesis, specific aims, methodology, and proposed timeline.
b. Inclusion of detailed plans for the use of RECOVER data and biospecimens is required, along with any additional data collection approaches.
c. Applicants must demonstrate that all research activities will comply with current human subject protections policies and guidelines.
d. A feasibility assessment, including potential limitations and proposed strategies to mitigate them, must be provided.
e. Applicants are expected to describe processes for participant follow-up and plans for long-term outcome data collection, as appropriate.
f. Applicants should describe how data will be shared in accordance with NIH Scientific Data Sharing Policy and RECOVER Sharing Data for Broader Impact policies and processes.

4. SUBMISSION AND REVIEW PROCESS

Ancillary studies responsive to this Notice will need prior approval from RECOVER to utilize RECOVER resources. Interested investigators are referred to the Ancillary Studies page on the RECOVER website for eligibility criteria, application instructions, additional resource information and a link to the application portal. To propose studies to the RECOVER extension protocol, please refer to the Ancillary Studies Framework for Post?COVID Conditions under Longitudinal Follow?Up in RECOVER (RECOVER 2.0) on the RECOVER Ancillary Studies page for more information on what will be conducted under long-term follow-up to harmonize their proposals with the protocol.

Each proposal will undergo an expedited administrative review by the RECOVER Administrative Coordinating Center for responsiveness to the RECOVER Ancillary Studies policies. Review of proposals will occur under the RECOVER Governance structure which includes the RECOVER Ancillary Studies Oversight Committee (ASOC) and RECOVER Biospecimen Access Committee (BAC). Review under the ASOC and BAC includes a panel of experts in Long COVID research, including patient and community representatives. During the review process applicants may be asked to provide additional information or to revise their proposals to ensure alignment with RECOVER program priorities.

5. CONTACT AND ADDITIONAL INFORMATION

For questions regarding proposal scope and submission guidelines, please contact [email protected].

Interested investigators are referred to the Data Sharing page on the RECOVER website for detailed instructions on how to access RECOVER data and for a compilation of RECOVER resources, including study design and primary results publications, protocols, questionnaires and more.

6. EFFECTIVE DATE

This notice is effective immediately and remains open for proposal submission until the end of the RECOVER Program.

By fostering innovative ancillary studies that leverage the RECOVER Long COVID Program infrastructure, NIH strives to accelerate scientific discovery and inform long-term care strategies for those affected by COVID-19. We look forward to receiving high-quality proposals that will expand our collective understanding of the long-term impacts of this pandemic.

Inquiries

Please direct all inquiries to:

Marrah Lachowicz-Scroggins, Ph.D.
NHLBI/Division of Lung Disease
301-827-8229
[email protected]