NIH Research on the Long-Term Effects of COVID-19 (R01 Clinical Trial Optional)

NIH Research on the Long-Term Effects of COVID-19 (R01 Clinical Trial Optional) is sponsored by National Institutes of Health (NIH). Supports research on the long-term effects of COVID-19, including studies on post-acute sequelae of SARS-CoV-2 infection (PASC).

Expired PAR-22-113: Urgent Award: COVID-19 Mental Health Research (R01 Clinical Trial Optional) This notice has expired. Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations National Institute of Mental Health ( NIMH ) Funding Opportunity Title Urgent Award: COVID-19 Mental Health Research (R01 Clinical Trial Optional) R01 Research Project Grant NOT-OD-23-012 Reminder: FORMS-H Grant Application Forms and Instructions Must be Used for Due Dates On or After January 25, 2023 - New Grant Application Instructions Now Available NOT-OD-22-190 - Adjustments to NIH and AHRQ Grant Application Due Dates Between September 22 and September 30, 2022 August 31, 2022 - Notice of Change to PAR-22-113, Urgent Award: COVID-19 Mental Health Research (R01 Clinical Trial Optional) .

See Notice NOT-MH-22-301 Funding Opportunity Announcement (FOA) Number Companion Funding Opportunity See Section III. 3. Additional Information on Eligibility .

Assistance Listing Number(s) Funding Opportunity Purpose NIMH is issuing this FOA in response to the declared public health emergency issued by the Secretary, HHS, for 2019 Novel Coronavirus (COVID-19).

See " Determination that a Public Health Emergency Exists Nationwide as the Result of the 2019 Novel Coronavirus " as renewed in " Renewal of the Determination that a Public Health Emergency Exists Nationwide as the Result of the Continued Consequences of Coronavirus Disease 2019 (COVID-19) Pandemic ".

This Funding Opportunity Announcement (FOA) aims to address urgent, time-sensitive mental health research questions related to COVID-19, including broader secondary impacts of the pandemic as well as research on the intersection of mental health, COVID-19, and HIV.

Research supported will improve public health in the near term by informing responses to the current pandemic through 1) understanding mechanisms by which mental illness impacts SARS-CoV-2 morbidity and mortality, 2) exploring how COVID-19 contributes to incident mental illness or HIV-outcomes, 3) identifying modifiable targets uniquely or robustly implicated in the pandemic that are relevant to new and worsening mental illness, and 4) conducting mechanistic trials probing biological or behavioral processes of those targets that may be pursued in future mental health therapeutic development.

Research is anticipated to be informed by and directed towards vulnerable populations based on evidence of preexisting and worsened health disparities. Open Date (Earliest Submission Date) Letter of Intent Due Date(s) 30 days prior to the application due date(s) Renewal / Resubmission / Revision (as allowed) All applications are due by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date. No late applications will be accepted for this Funding Opportunity Announcement.

Required Application Instructions It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide ,except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts ). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced.

Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV . When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information Part 2. Full Text of Announcement Section I.

Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV.

Application and Submission Information Section V. Application Review Information Section VI. Award Administration Information Section VII.

Agency Contacts Section VIII. Other Information Part 2. Full Text of Announcement Section I.

Funding Opportunity Description NIMH is issuing this FOA in response to the declared public health emergency issued by the Secretary, HHS, for 2019 Novel Coronavirus (COVID-19).

This Funding Opportunity Announcement (FOA) aims to address urgent, time-sensitive mental health research questions related to COVID-19, including broader secondary impacts of the pandemic as well as research on the intersection of mental health, COVID-19, and HIV.

Research supported will improve public health in the near term by informing responses to the current pandemic through 1) understanding mechanisms by which mental illness impacts SARS-CoV-2 morbidity and mortality, 2) exploring how COVID-19 contributes to incident mental illness or HIV-outcomes, 3) identifying modifiable targets uniquely or robustly implicated in the pandemic and are relevant to new and worsening mental illness, and 4) conducting mechanistic trials probing the biological or behavioral processes of those targets that may be pursued in future mental health therapeutic development.

Research is anticipated to be informed by and directed towards vulnerable populations based on evidence of preexisting and worsened health disparities. The importance of expanding research on the impact of the COVID-19 pandemic on mental health is prioritized by the substantial funding proposed in the Fiscal Year 2022 budgets from both the House and Senate.

Although funds have not yet been appropriated and NIMH operates under a Continuing Resolution that maintains funding at the previous year's level, NIMH acknowledges the contribution that research could make to understand, prevent, and treat mental illness in the context of the pandemic. Mental illness is associated with increased morbidity and mortality from COVID-19, even after adjusting for other medical comorbidities.

Such elevated risks are particularly true for those with severe mental illness. In Fall 2021, the CDC added mood disorders and schizophrenia spectrum disorders to the list of medical conditions associated with higher risk for severe COVID-19.

There are shared risk factors in terms of socioeconomic status, disparities, and prevalence of mental health in congregate settings (e.g., inpatient treatment settings, homelessness shelters and community unhoused groups, jails and prisons) but it is also likely that mental illnesses makes compliance with preventative behaviors more challenging or physiologically leaves people with mental illness more susceptible to the virus.

Similarly, people infected with SARS-CoV-2 have higher incident mental illness relative to uninfected persons which may be related to acute social and economic consequences of testing positive for SARS-CoV-2, physiological processes of the immune response to the virus, or other aspects of post-acute sequelae of SARS-CoV-2 and recovery from COVID-19.

Full understanding of the direct impact of SARS-CoV-2 on brain cells and lymphatics is not yet known. However, there is some evidence to suggest that particularly among those patients who experience more severe reactions, including encephalopathy related to COVID-19, may have unique risk factors. Additional research indicates that mental illness may continue to emerge at elevated rates 6 months following COVID-19 diagnoses.

The NIH REsearching COVID to Enhance Recovery (RECOVER) initiative is a substantial commitment that includes neuropsychiatric and mental health conditions in the broad array of health conditions measured in adults and children; but further mental health focused research may allow deeper assessment and probing of mechanisms to yield modifiable targets to prevent or treat illness.

Beyond the direct role of the virus related to mental illness, broader population social, behavioral, and economic impacts are widespread. Across the lifespan and in several areas of illness, new and worsening mental health symptoms and diagnoses are widely reported.

Although depression and anxiety are most commonly studied, other illnesses including autism, eating disorders, and schizophrenia spectrum disorders have also been identified as adversely impacted by the pandemic. Mental health symptom complaints have risen and fallen with the rate of COVID-19 cases but remain elevated relative to similar periods prior to the pandemic. Preexisting mental health disparities are worsened by the pandemic.

Racial and ethnic minority populations have experienced higher rates of infection and loss of life, acute adverse employment and economic impacts, and disproportionate representation among essential workers experiencing increased risk of the virus and burden of stress to meet demands of workplaces.

The disproportionate mental health burden impacting these communities is consistent and evident in surveillance reports of mental health symptoms. Other groups including sexual and gender minorities have similarly reported disproportionate impacts of the COVID-19 pandemic on mental health as have socioeconomically disadvantaged and underserved rural populations.

Addressing mental health disparities, including those associated with the COVID-19 pandemic, is a priority of NIMH. Research Scope and Objectives This FOA uses the R01 mechanism to address research gaps related to COVID-19 and mental health.

Proposed studies should capitalize on a rapidly evolving understanding of virus impact and function in the brain, populations at risk, and mechanisms of illness uniquely or robustly impacted by the pandemic. Projects submitted under this FOA are limited to 3 years with the objective of timely results to impact understanding relevant to urgent public health needs.

Populations of interest include the full lifespan with an emphasis on addressing health disparities, including populations with or at risk for HIV. Basic, translational, and services intervention research are relevant but note this FOA only allows mechanistic clinical trials (see NOT-MH-20-105 Consolidated Notice on NIMH Clinical Trial Policies and related announcement for intervention development).

Areas of High Program Priority Research establishing experimental systems to model SARS-CoV-2 CNS infection. Studies of SARS-CoV-2 -specific maternal immune responses, e.g., TH17 signaling in CNS development and function in offspring.

Studies to clarify the role of SARS-CoV-2 infected brain endothelial cells and brain lymphatics responsible for triggering cognitive and emotional deficits, including the impact of stress, hormonal influences as well as sex effects in experimental systems. Studies to understand the impact of SARS-CoV-2 on the neuro-immune milieu and the resulting disruption of neuronal circuits, function, or behavior relevant to mental health.

Studies to identify mechanisms by which people with mental illness are at increased risk of SARS-CoV-2 infection and death. Mechanistic clinical trials to probe the relevance of therapeutic targets uniquely or robustly implicated specific to mental health complications of COVID-19.

Studies to develop scalable mental health interventions, particularly for populations who may have less familiarity with or access to technologically-mediated means of social connection (e.g., older adults, individuals in underserved rural communities).

Studies of existing mental health research data from multiple labs nationwide (e.g., see NIMH Data Archive ) to understand how the pandemic impacted the rigor of data collection and how adaptations to research in the pandemic may have impacted task reliability/validity or scientific rigor.

Services and Intervention Research Secondary data analyses to determine drivers of vaccine hesitancy, uptake, and implementation among mental health populations, especially using strategies that allow for causal inference. Secondary data analyses to evaluate whether evidence-based prevention interventions administered prior to or during the pandemic reduce risk for mental health difficulties across different stages of development.

Research to determine the impact of technology-enabled screening to identify/triage those in immediate need of in-patient behavioral health, medications, and opioid replacement therapy.

Higher priority research includes evaluation of participant follow through and outcomes related to point-of-care triage and referral to services (e.g., web-based or other self-care, and/or telephone counseling that supports individual brief cognitive behavioral therapy for distress, online group interventions, etc.).

Research to understand and improve engagement and continuity of care, including approaches to facilitate (re)connection to care for persons with serious mental disorders who experience disruption in services. Research to examine the impact of pandemic-related changes to the delivery of mental health care, including the emphasis on telehealth, and the impact on the quality of patient care and mental health outcomes and functioning.

This includes studies on the impact (e.g., access, quality, and clinical outcomes) of state, local, federal, and guild-specific guidelines and policies around telehealth services, and of changes in those policies, with specific attention on the risks and benefits of relaxing those guidelines or policies.

Research to examine the impact of pandemic-related changes in social determinants of health (e.g., school closures, employment loss, food insecurity, housing insecurity) on mental health outcomes and functioning.

Research accessing and leveraging public and/or commercial mental health claims data and/or private electronic health record data to identify populations at high risk for functional impairment and health service interruption and/or to target vulnerable populations for outreach and interventions.

Use of statistical, mathematical, or computational approaches to enhance understanding and identify modifiable targets of provider, clinic and systems-level factors that may impact capacity to implement integrated COVID-19 screening with evidence-based screening for mental health and provision of appropriate mental health services among persons at high risk for HIV or people living with HIV.

Use of modeling approaches to examine and predict the impact of mental health and mental health comorbidities, stigma, and other social determinants of health on HIV-related outcomes in the context of the COVID-19 pandemic and strategies to mitigate the negative effects.

Epidemiologic and clinical studies of the incidence and prevalence of Post-Acute Sequelae of COVID-19 (PASC) in people living with HIV compared to participants without HIV with a focus on mental health, neurologic, and behavioral sequelae and relating to potentially modifiable immunologic, viral and treatment factors as well as other factors both during the SARS-CoV-2 infection and post-acute stages.

Research to understand the pathophysiology of acute and post-acute SARS-CoV-2 CNS complications in people living with HIV, including the role of immune dysfunction on neuronal function and reactivation of HIV from latent reservoirs.

Research that leverages existing cohorts to examine CNS complications including mental illness risk, onset, course as well as behavioral consequences due to SARS-CoV-2 immune responses and impact of SARS-CoV-2 co-infection with HIV on the CNS.

Research to understand whether and how the COVID-19 pandemic and associated restrictions may have affected HIV care engagement, medication adherence, and viral suppression among people living with HIV in a manner that would directly inform future support interventions, care continuity, and pandemic preparedness.

Research to understand the intersection of the COVID-19 pandemic, violence, mental health, and HIV prevention and treatment outcomes. Global Mental Health Research Research to examine the impact of pandemic-related changes in social determinants of health (e.g., school closures, employment loss, food insecurity, housing insecurity) on mental health outcomes and functioning in low and middle income countries.

Additional areas of research relevant to COVID-19 and mental illness should be discussed with scientific program staff for technical assistance with NIMH priorities and potential overlap with existing research efforts. Applications Not Responsive to this FOA Applications that are not responsive to this FOA and will be withdrawn prior to review: Applications unrelated to changes in health due to the COVID-19 pandemic.

Projects that are exclusively qualitative. Purely descriptive research without prepandemic representative data from at a minimum cross jurisdictional regions. Applications that propose to test the safety or demonstrate pharmacodynamic or neurodynamic effects (to establish dosing), or demonstrate efficacy or effectiveness of an intervention.

Applicants are strongly encouraged to reach out to scientific contact to discuss. NIMH is dedicated to advancing science by improving the yield and impact of its research portfolio. One way to accomplish this is to encourage investigators to use a common set of tools and resources to facilitate collection of common data elements (CDEs) or, in the case of existing data/records apply common constructs.

NIH has worked with relevant communities to develop and provide access to tools and resources that can improve the consistency of data collection (e.g., mental health research collections). NIMH strongly encourages investigators collecting data to use these resources as they select COVID-related instruments for their proposed studies and devise programs to construct research data files.

This is particularly important for efforts to rapidly assess the needs and impact of COVID-19 across different population groups, particularly vulnerable populations.

The NIH Public Health Emergency and Disaster Research Response (DR2) includes COVID-19 related survey instruments and additional information such as the domains assessed, protocols, and a wide array of data collection tools and resources used in other public health emergencies and disasters (including in pediatric populations.

The PhenX Toolkit , hosts a collection of COVID-19 related item-module protocols drawn from the surveys listed in DR2. In addition, the PhenX Toolkit has a large collection of well-established and vetted phenotypic measurement protocols , including social determinants of health collections. These protocols are suitable for inclusion in COVID-19-related studies, enabling data harmonization across studies.

Recipients of awards under this FOA should plan to submit their COVID-19 specific instruments for inclusion into these resource sharing sites. Applicants are expected to abide by the data sharing expectations in NOT-MH-19-033 and the common data element expectations in NOT-MH-20-067 .

The NIMH has published updated policies and guidance for investigators regarding human research protection and clinical research data and safety monitoring ( NOT-MH-19-027 ). The application’s PHS Human Subjects and Clinical Trials Information, including the Data and Safety Monitoring Plan, should reflect the policies and guidance in this notice.

Plans for the protection of research participants and data and safety monitoring will be reviewed by the NIMH for consistency with NIMH and NIH policies and federal regulations. See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. Application Types Allowed The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Only those application types listed here are allowed for this FOA. Optional: Accepting applications that either propose or do not propose clinical trial(s). Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. Application budgets are limited to $750,000 direct costs per year and need to reflect the actual needs of the proposed project. The scope of the proposed project should determine the project period.

The maximum project period is 3 years. NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA. Section III.

Eligibility Information Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education: Hispanic-serving Institutions Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISIs) Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) For-Profit Organizations (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized) Eligible Agencies of the Federal Government U.S. Territory or Possession Independent School Districts Public Housing Authorities/Indian Housing Authorities Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Non-domestic (non-U.S.) Entities (Foreign Institutions) Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement , are allowed. Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award.

All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.

NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM. gov registration process.

SAM registrations prior to fall 2021 were updated to include a UEI. For applications due on or after January 25, 2022, the UEI must be provided on the application forms (e.g., FORMS-G); the same UEI must be used for all registrations, as well as on the grant application. Dun and Bradstreet Universal Numbering System (DUNS) Organization registrations prior to April 2022 require applicants to obtain a DUNS prior to registering in SAM.

By April 2022, the federal government will stop using the DUNS number as an entity identifier and will transition to the Unique Entity Identifier (UEI) issued by SAM. Prior to April 2022, after obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.

eRA Commons - Once the unique organization identifier (DUNS prior to April 2022; UEI after April 2022) is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants. gov registrations; all registrations must be in place by time of submission.

eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application. Grants. gov Applicants must have an active SAM registration in order to complete the Grants.

gov registration. Program Directors/Principal Investigators (PD(s)/PI(s)) All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons.

If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator) Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support.

Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement. 3. Additional Information on Eligibility Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 2. 3. 7.

4 Submission of Resubmission Application . This means that the NIH will not accept: A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application. A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.

An application that has substantial overlap with another application pending appeal of initial peer review (see 2. 3. 9.

4 Similar, Essentially Identical, or Identical Applications ) Section IV. Application and Submission Information 1. Requesting an Application Package The application forms package specific to this opportunity must be accessed through ASSIST, Grants.

gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants. gov Workspace are available in Part 1 of this FOA.

See your administrative office for instructions if you plan to use an institutional system-to-system solution. 2. Content and Form of Application Submission It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement to do otherwise.

Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1.

Overview Information , prospective applicants are asked to submit a letter of intent that includes the following information: Descriptive title of proposed activity Name(s), address(es), and telephone number(s) of the PD(s)/PI(s) Names of other key personnel Participating institution(s) Number and title of this funding opportunity The letter of intent should be sent to: All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA. All instructions in the SF424 (R&R) Application Guide must be followed. SF424(R&R) Project/Performance Site Locations All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Other Project Information All instructions in the SF424 (R&R) Application Guide must be followed. SF424(R&R) Senior/Key Person Profile All instructions in the SF424 (R&R) Application Guide must be followed. All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed. PHS 398 Cover Page Supplement All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: Resource Sharing Plan : Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

The following modifications also apply: All applications, regardless of the amount of direct costs requested for any one year, must address a Data Sharing Plan Sharing Data via the NIMH Data Archive: To advance research through widespread data sharing among researchers, investigators funded under this PAR are encouraged to share human subjects data via the NIMH Data Archive (NDA) (See ( NOT-MH-19-033 ) Notice of Data Sharing Policy for the National Institute of Mental Health).

Established by the NIMH, and supported by other NIH Institutes, the NDA is a secure informatics platform for scientific collaboration and data-sharing that enables the effective communication of detailed research data, results, tools, and supporting documentation.

Where possible, investigators funded under this FOA are expected to use NDA technologies to submit data in accordance with the NDA Data Sharing Terms and Conditions , incorporated by reference, which can be found at https://nda. nih. gov/contribute/sharing-regimen.

html. A resource sharing plan, formulated in accordance with these NDA Data Sharing Terms and Conditions, should be included in the supplement application. The NDA links data across research projects through its Global Unique Identifier (GUID) and Data Dictionary technologies.

Investigators funded under this FOA should use these technologies to submit and share their research data and results at the appropriate times. The NDA Cost Estimation Tool is a customizable Excel worksheet that can be used to calculate an estimate of the resources needed to submit and share data with the NDA. This resource estimate should be submitted as part of the application budget ( http://nda.

nih. gov/contribute_cost_estimation. html ).

To minimize the proliferation of one-off survey items, encourage comparisons across samples, and facilitate data integration and collaboration, a trans-NIH working group is making existing COVID-19 survey items and investigator contact information publicly available through two NIH-supported platforms: the NIH Public Health Emergency and Disaster Research Response (DR2) and the PhenX Toolkit .

Researchers addressing COVID-19 questions, whether population-based or for clinical research, are encouraged to consider these COVID-19 specific survey item repositories and select existing survey items or protocol modules currently being fielded if consensus measures are not available elsewhere. Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Human Subjects and Clinical Trials Information When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions: If you answered Yes to the question Are Human Subjects Involved?

on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record. Study Record: PHS Human Subjects and Clinical Trials Information All instructions in the SF424 (R&R) Application Guide must be followed.

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed. PHS Assignment Request Form All instructions in the SF424 (R&R) Application Guide must be followed.

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement , and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide. 3. Unique Entity Identifier and System for Award Management (SAM) See Part 1.

Section III. 1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants. gov 4.

Submission Dates and Times Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

When a submission date falls on a weekend or Federal holiday , the application deadline is automatically extended to the next business day. Organizations must submit applications to Grants. gov (the online portal to find and apply for grants across all Federal agencies).

Applicants must then complete the submission process by tracking the status of the application in the eRA Commons , NIH’s electronic system for grants administration. NIH and Grants. gov systems check the application against many of the application instructions upon submission.

Errors must be corrected and a changed/corrected application must be submitted to Grants. gov on or before the application due date