Neuropsychological Effects of COVID-19 in Older Adults from Health Disparity Populations (NeuroCOVID)

ACCEPTING APPLICATIONS

Purpose

Alzheimer's Association & National Academy of NeuropsychologyThe purpose of this notice is to announce that the National Academy of Neuropsychology (NAN) and Alzheimer’s Association are partnering to launch a targeted request for applications focused on research on the neuropsychological impact of COVID-19 in older adults from health disparity populations (see National Institute on Minority Health and Health Disparities for NIH operationalization). Two awards, each having a maximum budget of $100,000 (including indirect costs), are available for this up to two-year award.

Background

The COVID-19 pandemic, caused by the Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2), spread rapidly around the world. A wide spectrum of clinical manifestations and outcomes have been documented, ranging from asymptomatic disease to death. A myriad of persistent symptoms (post-acute sequelae) has been reported following COVID-19, even among those who experienced a mild acute illness. This has commonly included fatigue, cognitive changes such as “brain fog,” change in mental status, reduced sense of smell, muscle and joint pain, weakness or wasting, among other symptoms. [1, 2, 3, 4, 5]

As the long-term clinical consequences of COVID-19 are better understood, it is becoming apparent that neurological manifestations are common in those who contract the disease. [6, 7, 8] However, although neurological complications arising from stroke, encephalopathies, inflammatory syndrome, microbleeds and autoimmune responses have been noted, [8, 9, 10, 11] there are very few empirical investigations into the cognitive correlates of COVID-19 infection. Thus, it remains unknown if cognitive features of COVID-19 are affected by psychosocial factors, symptom severity and hospitalization status.

Older adults, especially those with medical comorbidities (e.g., cardiovascular, metabolic and pulmonary comorbidities), appear to be more susceptible to SARS-CoV-2 infection than those from younger age groups. The infection is also associated with more severe symptoms and worse outcomes, including higher death rate, in older individuals. [12, 13] Notably, older adults with Alzheimer’s disease and other dementias appear to be especially vulnerable to the infection and its consequences. [14]

Similarly, COVID-19 has had a profound impact on health disparities populations, as well as other health disparity populations in the United States, with growing evidence of poorer outcomes than for white individuals including disproportionate infection, hospitalization, intensive care unit admission and death rates. [15, 16, 17] Although the reasons for these disparities are unclear, several potential explanations have been put forth including differences in health care access and delivery of care, psychosocial factors, working environments that limit ability to physically distance and elevated rates of underlying health conditions associated with increased risk of acquiring and having adverse outcomes from COVID-19 infection. [15, 18, 19]

In order to address highlighted disparities brought on by COVID-19, NAN and the Alzheimer’s Association are partnering to offer this targeted request for applications to fund up to two research proposals addressing the effects of COVID-19 on brain functioning related to post-acute sequelae in older adults from health disparity populations. Some examples of topics of interest include:

  • Health disparities, including environmental, sociocultural, behavioral and psychosocial factors (e.g., racism, xenophobia) that may be contributing to cognitive outcomes. [see NIA Health Disparities Research Framework to be consistent with the levels of analyses and relevant determinants].
  • Longitudinal studies of cognitive outcomes (within the 2-year funding timeline).
  • Factors that impede and/or facilitate cognitive recovery (e.g., medical comorbidities, personality, community).
  • Biomarkers of cognitive outcome (e.g., viral load, immunity status, genetics, neuroimaging).
  • Neuropsychiatric symptoms and their relationship to cognition.
  • Treatment effects on COVID-19 related cognitive dysfunction.
  • Factors that promote recovery (e.g., cognitive reserve, personality characteristics, community resources).

Health disparities populations groups, as well as other populations (e.g., rural), continue to be under-represented in health research, including research on COVID-19. Investigators should include within their proposal an explicit plan for overcoming barriers to the enrollment of individuals from health disparity populations in their study. Investigators with established community partnerships/collaborations are encouraged to consider responding to this call for proposals.

Those invited to submit a full application are encouraged to include with their submission letters of support (no more than three) that demonstrate strong community support for the project.

Funding and award period

NAN and the Alzheimer’s Association anticipates funding up to two proposals. Each award is limited to $100,000 total funding (direct and indirect costs) over a period of up to two years. Requests in any given year may not exceed $100,000 (direct and indirect costs). Additional details on allowable costs are outlined in the budget section.

Key dates

  • Letter of Intent Launch – Sept. 1, 2021
  • Letter of Intent Deadline – Oct. 7, 2021
  • Application Deadline – Dec. 9, 2021
  • Application Review – Dec. 16-Jan. 27, 2022
  • Award Notifications – Feb. 15, 2022

The Letter of Intent and application must be received by 5 p.m. Eastern Time on their respective deadlines via ProposalCentral (instructions below). They will not be accepted after these dates – no exceptions will be made. Hard copies or emails will not be accepted.

Eligibility requirements

  • Early Stage Investigators are preferred, defined as individuals who have completed postdoctoral training within the past 15 years.
  • Mid-Career Investigators (typically at Associate Professor level), 15 years or more from terminal degree completion at the time of application, and senior investigators may serve as co-Investigators on the project to strengthen the team and future funding success, but cannot be the principal investigator. Students or postdoctoral fellows may be included in the proposal as members of the study team, but cannot be the principal investigator.

In general, scientists and clinicians from public, private, domestic and foreign research laboratories, medical centers, hospitals and universities are eligible to apply. State and federal government-appropriated laboratories in the U.S. and abroad and for-profit organizations are prohibited from serving as the applicant institution. For U.S. VA-based investigators, please work with your affiliated non-profit organization to apply. In other circumstances, state and federal government scientists can participate as collaborating scientists with research teams from other eligible applicant institutions.

For U.S. entities, the Letter of Intent (LOI) materials will include proof of your organization’s not-for-profit status and a W-9 signed and dated by the signing official. Non-U.S. entities must provide a W-8 BEN-E signed and dated by the signing official. Your LOI will not be accepted without these documents. Current awardees of NAN or the Alzheimer’s Association are eligible provided current funded grant does not overlap with this proposal.

Letter of intent (LOI) submission

The first step in applying is to create and submit a Letter of Intent (LOI) through the online application system. Applications will not be accepted without an approved LOI.

First-time users must register and fill out a Professional Profile to begin the LOI/application process. The LOI and completed application must be submitted by a single Principal Investigator (PI). Hard copies or emails of the LOI will not be accepted.

The purpose of the LOI is to ensure that all applicants are eligible for the competition they are applying to and to assist Association staff in planning for peer reviews.

LOIs will not be accepted after the deadline date. No exceptions will be made. The applicant is responsible for adhering to the space limitations (described below) and any decision regarding moving an LOI forward will be evaluated based on the submitted information.

The Letter of Intent (LOI) is completed through the online interactive system; it is not a letter but rather specific fields in the online system for the applicant to complete. Applicants must complete the required tabs and upload any required documents.

The LOI should include the following information:

  • Descriptive title of proposed research.
  • Name, physical address, email address and telephone number of the principal investigator(s).
  • Names of other key personnel.
  • Name of participating institution(s).
  • Include a concise description of your proposed project, including methodology (1,000 characters).
  • Specific aims, including a description of how your project addresses this specific RFA (1,000 characters).
  • Include your plan for overcoming barriers to the enrollment of individuals from health disparity populations in the project; including name(s) any established community partnerships/collaborations that will facilitate recruitment (1,000 characters)

Investigators planning to submit a LOI can contact and discuss their proposed research/aims with the NAN Clinical Research Grants committee or the Alzheimer’s Association by contacting either Robert.M.Roth@Hitchcock.org or grantsapp@alz.org. Please provide sufficient time in advance of the deadline for any discussion.

Full application submission

If you are invited by NAN and the Alzheimer’s Association to submit a full application, the required materials including the application format, templates and instructions, will be available online at ProposalCentral after your LOI has been approved in the system. The full application must consist of the following documents and must not exceed the maximum page limit allowed for each section:

  • Problem Statement (1 page).
  • Work Plan (5 pages).
  • Recruitment Plan (1 page).
  • Available Resources & Budget Justification (2 pages).
  • Up to three letters of support (no more than 2 pages each) highlighting the community support and/or partnerships of applicable organizations.
  • Biosketch(es) – PI/Co-PI/Key personnel – limited to 4-5 pages each (the new NIH format is acceptable).
  • W-9 signed and dated by the signing official for U.S. entities. For non-U.S. entities, a W-8 signed and dated by the signing official.
  • Plan for Data Sharing (1 page).
  • References (1 page) – use the reference style that is most common in the major journal(s) for your discipline, specialty, or sub-specialty.

Applications will be reviewed by NAN and the Alzheimer’s Association and a select panel of experts with special attention to:

  • Significance of the question being studied.
  • Applicant information.
  • Quality of the work plan.
  • Quality and adequacy of available resources and budget.
  • Impact-risk of the proposal and how it will add to overall knowledge and advancement.

The PI who submits the application must be the same PI who submitted the approved LOI. An LOI submitted on behalf of another applicant or by an administrator will result in a rejected LOI. Once the applicant enters the application system, on-screen instructions will be provided to complete the application process. The application does not need to be completed in one session; a partially completed application can be saved and completed at any time before the deadline.

It is imperative that you proofread your application before submission; you will not be allowed to make any changes to the application after the deadline or once applications are under review.

It is the responsibility of the applicant to ensure and verify that:

  • The application is submitted by the receipt date/time deadline. Once submitted, you will receive a confirmation email from ProposalCentral that your application was successfully submitted. If you do not receive a confirmation, click the Proposals tab and under the “Status” column, make sure it says Submitted and not In Progress, which indicates you have not yet submitted your application.
  • The application is complete and accurate before submission. Only a single copy of an application will be accepted. We do not require signatures at the time of submission. The signature page provided is for use should your institution/organization require signatures; we do not override any institutional policies and/or procedures. Please do not submit the signature page with your application.
  • Revisions, additional materials and/or reference, manuscripts, appendices, etc., are not allowed and, if attached, will be removed from your application. Up to three letters of support (no more than two pages each) are allowed. Additional letters will be removed.

Full Applications must be submitted no later than 5 p.m. EST on Dec. 9, 2021.

Multiple and overlapping submissions

Multiple submissions from one applicant are not permitted. This includes multiple submissions from the same group and/or collaborators.

Review process overview

LOI

LOI are subject to a peer-review process carried out through an online system. LOIs are reviewed and rated by a minimum of three peer scientists with expertise in the proposed area of research.

Full applications

All full proposals are subject to a multistage peer-review process carried out through an online system. In the first stage, applications are reviewed and rated by a minimum of three peer scientists with expertise in the proposed area of research. Applicants may include recommended reviewers and also have the option to exclude specific reviewers from evaluating their application if a conflict of interest exists. Conflicts of interest include, but are not limited to:

  • The Applicant trained with or by the reviewer.
  • The Reviewer published with the Applicant in the last four years. This excludes workshops or large consortia (e.g., ADNI, IGAP).
  • The Reviewer has been a co-investigator on a grant application or award with the Applicant in the last four years.
  • Reviewer has a conceptual difference of opinion with the Applicant that will prevent a fair review.
  • Reviewer will receive financial benefit from the Applicant receiving an award.

The second stage includes further review and discussion of the scores and comments resulting from the initial review process. This second review is carried out by a NAN and the Alzheimer’s Association identified committee of experts to ensure fairness and equity in the initial review procedures and to make funding recommendations to the funding partners. This multistage process is central to our award decisions and is designed to ensure both scientific rigor and fairness in the review of all submitted applications.

Budget

A “budget summary” for the proposed research project is required and must be submitted with the application and within the allowable two-page limit. However, if the application is to be awarded, a more detailed budget will be required and must be approved before the disbursement of funds. Your budget must not exceed the maximum amount of the award of $100,000 in total. Award can be requested for up to two years, and it is required that most of the funds awarded under this program be used for direct research support. No more than 10% of budget may be included as indirect costs; this is inclusive of indirect costs for the implementing institution as well as any to subcontracts.

Allowable costs under this award include:

  • Small pieces of laboratory equipment and laboratory supplies (purchases over $10,000 require prior approval, even if included in the project proposal budget).
  • Computer software if used strictly for data collection and/or analysis.
  • Salary for the principal investigator, scientific (including postdoctoral fellows) and technical staff (including modest administrative support).
  • Research supplies needed for the proposed studies.
  • Support for travel to scientific and professional meetings, not to exceed $1,000 in any given year.

Not allowable as direct costs under this award include:

Additional information

Ethical/regulatory approvals and reporting requirements

If awarded for funding, NAN and the Alzheimer’s Association require that any necessary ethical and/or regulatory approvals are kept current, and may also require specific reporting throughout the lifetime of the award. This includes, but is not limited to, the following:

Human Subject Assurances

Human subject assurances are not required at the time of application. Investigators have up to 90 days after receipt of their award notification to submit these documents. However, the NAN and the Alzheimer’s Association encourage investigators to initiate their certification applications on a schedule that recognizes that approvals at many institutions can take more than 90 days. We will accept only certifications that apply specifically to the funded project and must include the name of the awardee. An award letter will not be issued unless the appropriate certifications are in place and include the name of the awardee within the 90 days from award notification. The same applies for animal ethical approvals, if applicable.

Annual Scientific and Financial Reports

Interim Scientific and Financial Reports must be submitted at the end of each reporting period as long as the grant remains active. Final Scientific and Financial Reports must be filed within 90 days of the grant's end date. All reports must be submitted electronically via proposalcentral.com. The Financial Report must be approved and signed by someone with financial authority in the Office of Research and Sponsored Programs at the recipient‘s institution.

Publications, Presentations and Abstracts

Electronic copies of publications, presentations and abstracts that report research supported by funds from the “National Academy of Neuropsychology & Alzheimer’s Association NeuroCOVID Program” should acknowledge that support and must be submitted electronically at the time of publication to office@NANonline.org and grantsapp@alz.org.

Recruitment Efforts for Clinical Studies

Projects involving human participants must address the appropriate inclusion or exclusion of individuals in the proposed research project and describe recruitment efforts to represent the community in which the study is planned or being conducted. Prior to distribution of funding, the researcher must provide a description of their recruitment plan, including an outline describing how their recruitment efforts will ensure diversity in their participants (see National Institute on Minority Health and Health Disparities for NIH operationalization). Recruitment efforts should focus on diversity within key target groups, including a diverse representation of, but not limited to: sex, gender identity, sexual orientation, socioeconomic status, race and ethnicity. This will be tracked throughout the duration of the grant and continued funding is contingent on applications addressing these goals.

Financial Responsibility

Funding is awarded to the institution, not to the individual principal investigator. The principal investigator or a first-degree relative cannot be listed as the signing official or financial officer, or have checks sent to their attention if awarded.

Multiple and Overlapping Submissions

Multiple submissions from one applicant is not permitted. This includes multiple submissions from the same group and/or collaborators.

Appeals of Scientific Peer Review

To maintain a fair and rigorous review system, NAN and the Alzheimer’s Association have a process for appeal of funding decisions. There is no appeal accepted for the letter of intent stage. Regarding applications, an appeal is intended to address extraordinary circumstances. Appropriate reasons for initiating an appeal might include:

  • Evidence that a reviewer has an undeclared conflict of interest.

  • An egregious error or misunderstanding in the review process.

  • Active malfeasance or demonstrable lack of due diligence.

The appeal process is not intended to provide a mechanism for routine protest of failure to receive a grant. It is anticipated that funding through NeuroCOVID will be extremely competitive and is limited by availability of funds. If an applicant believes an extraordinary circumstance has contributed to failure to receive funding, the principal investigator may send a two-page, double-spaced formal letter of appeal (Word document) to grantsappeals@alz.org. Any supporting documents included must be submitted as a PDF. Appeals must be submitted within two weeks from the date your application outcome notification is sent. Notification of action on the appeal will be made via email, usually within 90 days of the appeal deadline.

Nondiscrimination and Harassment Statement

NAN and the Alzheimer’s Association are committed to providing an environment free from harassment and discrimination. NAN and the Alzheimer’s Association strictly prohibits harassment and discrimination based on race; creed; color; religion; sex; sexual orientation; national origin; ancestry; age; veteran status; citizenship status; marital status; physical or mental disabilities; pregnancy, gender identity or expression (including transgender status); genetic information; and any other characteristic protected by federal, state or local law.

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