Department of Health
and Human Services (HHS)
and Human Services (HHS)
EXPIRED
National Institutes of Health (NIH)
National Institute on Aging (NIA)
National Eye Institute (NEI)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
National Institute on Minority Health and Health Disparities (NIMHD)
National Institute of Nursing Research ( NINR )
All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.
Office of Behavioral and Social Sciences Research (OBSSR)
Office of Research on Women's Health (ORWH)
U01 Research Project Cooperative Agreements
The purpose of this FOA is to advance research on the impact of SARS-CoV-2 and associated mitigation efforts on individual, family, and community behavior and on how subsequent economic disruption affects health-related outcomes, with close attention to underserved and vulnerable populations.
To address these questions, this FOA aims to form a research consortium to access, extract, integrate, share, and analyze existing data from various sources with broad population coverage including underserved and vulnerable populations. Examples of existing data include public health data; personal digital data; economic, labor, and commerce data; electronic health records (EHRs); claims data; and ongoing health, demographic, and social surveys. This FOA solicits applications for individual population research projects that will be linked to a Social, Behavioral, and Economic Research on COVID-19 Consortium Coordination Center (SBECCC) to foster collaboration and synergies across consortium member projects. Investigators will work with the SBECCC to enhance as well as share data resources used in proposed research both within the consortium as well as with others for health research purposes. The SBECCC will organize annual meetings of the consortium investigators to share results, foster harmonization among measures collected, identify new opportunities for interaction/collaboration, and share results with NIH and the public. Further, the SBECCC will support the development of reports and analyses summarizing and integrating the findings/products of the consortium.
May 9, 2021; October 8, 2021
| Application Due Dates | Review and Award Cycles | ||||
|---|---|---|---|---|---|
| New | Renewal / Resubmission / Revision (as allowed) | AIDS | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
| June 09, 2021 | June 09, 2021 | Not Applicable | August 2021 | August 2021 | September 2021 |
| November 08, 2021 | November 08, 2021 | Not Applicable | December 2021 | January 2022 | April 2022 |
All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).
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.
Not Applicable
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.
Background
Pandemic mitigation and social distancing measures implemented across the United States in response to COVID-19 have had immediate effects on communities in terms of increased social isolation, reduced mobility and transportation, and historic levels of involuntary unemployment and resultant financial strain. The reallocation of healthcare system resources to expand access to COVID-19 testing and treatments may be crowding out access to medical care for other reasons, thereby producing secondary health effects. Reductions in earnings associated with job loss or reduction in hours worked could be lasting, particularly for underserved, vulnerable, and/or low-income workers. Reductions in income or lack of access to health insurance may influence adherence to drug regimens and other efficacious preventive services. These immediate impacts will have long-lasting downstream effects on socioeconomic status, attitudes, behaviors, health, and healthcare access that may influence the quality of life of people in the United States and around the world. However, reductions in economic activity associated with stay-at-home mitigation strategies may actually reduce some health problems and causes of death (e.g., fewer traffic accidents and fewer non-urgent elective surgeries). Research is needed to understand the net health and mortality impacts of mitigation strategies and their economic side effects.
Research to understand the health impacts of coronavirus mitigation strategies and the mechanisms that may convey risk and resilience, particularly in underserved and vulnerable populations, will help improve long-term responses to the pandemic and prepare more effectively for the next public health emergency. For example, the success of coronavirus mitigation strategies is contingent on adherence to preventive behaviors (e.g., staying at home, social distancing, hand washing, and mask wearing) as well as attitudes and behaviors related to vaccination. Research on adherence to these preventive behaviors and to understand how personal and social factors promote or impede adherence will be key for developing and communicating effective public health recommendations. As another example, in the United States there are substantial racial and ethnic disparities in COVID-19 incident infections and mortality. Understanding how individual-, family-, and community-level risk factors interact to produce these COVID-19 disparities will inform the development of more effective interventions for underserved populations.
Efforts to improve coronavirus mitigation practices and to understand and address associated economic and health impacts will be enhanced if researchers have access to integrated established behavioral, economic, and public health datasets. Existing datasets offer the advantage of continuous and historical data before and after the pandemic emerged, thereby facilitating analyses of the pandemic response and impacts. However, integrating diverse data sets also presents challenges, since many relevant datasets are discrete, not readily accessible or interoperable, and may lag in their data reporting. Additionally, there may be a need to improve the usefulness of existing data resources characterized by sparse data sampling by introducing novel data collection techniques to gather more temporally dense, real-time data.
This FOA solicits research that leverages existing data sets with wide population coverage to examine the efficacy of COVID-19 mitigation efforts and attendant influences, as well as the impact of these mitigation efforts on subsequent economic disruption and on multiple health-related outcomes, with particular attention to underserved and vulnerable populations. Applications should propose their own relevant research activities, which can include supplemental data collection, but also be prepared to share data with other researchers to answer a broad range of research questions related to social, behavioral and economic factors and COVID-19; a detailed data sharing plan is required.
Applications funded under this announcement will be cooperative awards and will be expected to coordinate data sharing, acquisition, discoverability, and use activities with the Social, Behavioral, and Economic Research on COVID-19 Consortium Coordination Center (SBECCC). A key role of the SBECCC is to facilitate harmonization and discoverability of data for health research on COVID-19. Applicants to this FOA will obtain data from various sources (federal, state, private, public sources) and at multiple levels (i.e., contextual, institutional, individual) to conduct proposed research aims. The SBECCC goal is to work with consortium investigators to apply recommended COVID-19 common data constructs or develop new ones as necessary to enhance comparability of data, promote collaboration among studies as appropriate, and help other researchers discover and use Consortium data to advance social, behavioral, and economic research on COVID-19. Coordination of data acquisition by the SBECCC is not for the purpose of having the SBECCC serve as a common hub for data storage/sharing, but to exploit any opportunities for more efficient data access and sharing across Consortium projects (e.g., cost savings from single purchase of similar data items, website information to improve discoverability of consortium data by the field, public sharing of protocols and programs used to access consortium data resources, etc.). Any proposed data collection efforts in applications to this FOA should include plans to coordinate with the SBECCC to enhance data harmonization efforts. This includes providing information on how data sources are acquired, programs used to produce research files, staff time/expertise to support the development of comparable data elements, etc. Further, the SBECCC will serve as a research dissemination and collaboration coordinator for the consortium projects. As such, all applications should include plans to interact with the SBECCC to meet the data, collaboration, and dissemination objectives of the consortium.
Definitions:
Underserved populations: NIH-designated health disparity populations and/or other groups known to experience barriers to needed health care services, or to have inadequate health care coverage. NIH-designated U.S. health disparity populations are defined as Blacks/African Americans, Hispanics/Latinos, American Indians/Alaska Natives, Asian Americans, Native Hawaiians and other Pacific Islanders, socioeconomically disadvantaged populations, underserved rural populations, and sexual and gender minorities (see https://www.nimhd.nih.gov/about/overview/).
COVID-19 medically and/or socially vulnerable populations: Residents of nursing homes and assisted living facilities; community-dwelling older adults; individuals with intellectual, developmental, sensory, or physical disabilities, cognitive impairment or dementia, or communication disorders; homeless populations; individuals involved with the criminal or juvenile justice systems (incarcerated or under community supervision); individuals with medical comorbidities known to increase risk of severe COVID-19, including heart failure and related cardiovascular conditions, diabetes mellitus, chronic lung disease, obesity, HIV/AIDS; pregnant and post-partum women; children and adolescents; individuals living in congregate housing such as shelters or residential treatment facilities; individuals in overcrowded or public housing; individuals with substance use disorders or serious mental illness; detainees in immigration detention centers; migrant and immigrant communities; residents of tribal lands or reservations; communities exposed to high rates of air pollution or other toxic exposures; and rural and remote communities.
Research Objectives
The purpose of this FOA is to advance research on the impact of COVID-19 and associated mitigation efforts on individual, family, and community behavior, as well as research on how subsequent economic disruption affects health-related outcomes. Emphasis should be placed on addressing these questions in underserved and vulnerable populations (see Definitions above). Health effects/outcomes studied are not limited to direct effects of infection and can/should consider indirect and secondary effects of the pandemic. Priority research questions include but are not limited to the following:
Relevant approaches may include but are not limited to:
Relevant data sets may include but are not limited to:
The National Institute of Mental Health (NIMH) will accept and consider support for applications that fall within the scope of this FOA and are relevant to the mission and strategic priorities of the NIMH. Applications to examine pandemic related changes in financing, delivery, receipt, and outcomes of mental health care will be seen as priorities. Applications with primary aims to describe the epidemiology of mental disorders and symptoms related to the COVID-19 pandemic are generally a lesser priority. Investigators interested in responding to this FOA with a focus on mental health are requested to consult with NIMH Scientific/Research Contact(s) prior to the application due date so that NIMH can can provide technical assistance on whether the proposed project meets the goals and mission of the Institute, and whether it addresses one or more high priority research areas, particularly in context of rapidly changing landscape of COVID-19 related research. NIMH Scientific/Research Contact(s) will not evaluate the technical and scientific merit of the proposed application.
Data Harmonization
The NIH 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 consistency of data collection. NIH 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. Recipients of awards under this FOA should plan to submit their COVID-19 specific instruments for inclusion into these resource sharing sites (see Data Collection Tools & Resources Form for DR2 and PhenX Repositories).
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.
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 its newly released social determinants of health collections. These protocols are suitable for inclusion in COVID-19-related studies, enabling data harmonization across studies.
Applicants capturing existing data should plan to develop research data files that apply common data constructs to facilitate comparisons. Applicants should plan to work with consortium investigators, led by the SBECCC, on enhancing the harmonization of data for their planned analyses.
Data Sharing
Identifying and sharing data to support innovative social, behavioral and economic research on COVID-19 with special emphasis on vulnerable populations is a key goal of this FOA. Applicants, whether collecting new data or using existing data as part of proposed research must submit a Data Sharing Plan. Projects collecting data should use best practices in data sharing to accelerate the scientific community’s ability to advance knowledge about the social, behavioral, economic and health impacts of COVID-19. As articulated in the NIH Strategic Plan for Data Science, NIH seeks to leverage its role as a funding agency to encourage rapid, open sharing of data, and greater harmonization of scientific efforts. Researchers are encouraged to ensure that the data resources that they produce meet the standard for being FAIR Findable, Accessible, Interoperable, and Reusable, and further elaborated upon by FORCE 11. Some tools to help researchers in the digital cloud environment have also been generated by the NIH Data Commons. NIH strongly encourages use of NIH-supported, domain-specific data repositories as a first choice for storing data and making it accessible (see NLM Data Sharing Resources). In instances where captured/re-used data is not directly sharable by the applicant, plans for providing access protocols and programs to allow third-party researchers to replicate proposed research data files is necessary to meet data sharing requirements. Specifically, this includes information describing the data source and how any investigator can apply for data access, computer code used to convert data from the capture source into research data files, explanations of any variables constructed by the investigators, and other relevant information required to assist the use of data from the source for replication studies. NIH requires researchers and publishers to make their COVID-19 publications immediately accessible in PubMed Central.
See Section VIII. Other Information for award authorities and regulations.
Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.
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.
Not Allowed: Only accepting applications that do not propose clinical trials.
Need help determining whether you are doing a clinical trial?
Applications will be assigned to participating ICs based on content. Each application will be considered for award based on the relevant FY 2021 funding policies of the assigned IC. NIH anticipates awarding 5-6 meritorious applications across participating ICs.
Application budgets are limited to less than $500,000 in direct costs in any year. All requested costs 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 5 years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Local Governments
Federal Governments
Other
Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Applicant organizations
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.
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.
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.
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. This means that the NIH will not accept:
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.
Letter of Intent
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:
The letter of intent should be sent to:
John W.R. Phillips, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-3136
Email: [email protected]
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
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.
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.
Additionally, the investigative team should cite appropriate expertise/experience in acquiring/developing the types of data proposed in the application.
R&R or Modular Budget
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.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Application should propose a project that includes obtaining and using data resources that cover large populations, including FOA-defined vulnerable populations. Further, the proposed research plan should include consideration of health disparities in the proposed areas of study.
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.
Data Sharing
Identifying and sharing data to support innovative social, behavioral and economic research on COVID-19 with special emphasis on vulnerable populations is a key goal of this FOA. Applicants, whether collecting new data or using existing data as part of proposed research must submit a Data Sharing Plan. Projects collecting data should use best practices in data sharing to accelerate the scientific community’s ability to advance knowledge about the social, behavioral, economic and health impacts of COVID-19. As articulated in the NIH Strategic Plan for Data Science, NIH seeks to leverage its role as a funding agency to encourage rapid, open sharing of data, and greater harmonization of scientific effort. Researchers are encouraged to ensure that the data resources that they produce meet the standard for being FAIR Findable, Accessible, Interoperable, and Reusable, and further elaborated upon by FORCE 11. Some tools to help researchers in the digital cloud environment have also been generated by the NIH Data Commons. NIH strongly encourages use of NIH-supported, domain-specific data repositories as a first choice for storing data and making it accessible (see NLM Data Sharing Resources). In instances where captured/re-used data is not directly sharable by the applicant, plans for providing access protocols and programs to allow third-party researchers to replicate proposed research data files is necessary to meet data sharing requirements. Specifically, information describing the data source and how any investigator can apply for data access, computer code used to convert data from the capture source into research data files, explanations of any variables constructed by the investigators, and other relevant information required to assist the use of data from the source for replication studies. NIH requires researchers and publishers to make their COVID-19 publications immediately accessible in PubMed Central.
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.
All instructions in the SF424 (R&R) Application Guide must be followed.
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
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 and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.
The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant will not be reviewed.
Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.
Only the review criteria described below will be considered in the review process.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Does the proposed project obtain and use data resources that cover large populations, including FOA-defined vulnerable populations? Does the proposed research plan include consideration of health disparities in the proposed areas of study?
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Does the investigative team include appropriate expertise/experience in acquiring/developing the types of data proposed in the application?
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Are data resources being used in the application novel or/and are the methods being employed innovative?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?
Does the application describe effective/efficient data collection/acquisition strategies? Does it provide adequate plans to share data, as per the FOA description? Specifically, does it address the following three issues: 1) for projects collecting data are best practices in data sharing proposed? 2) Do the data resources produced meet the standard for being FAIR Findable, Accessible, Interoperable, and Reusable? 3) In instances where captured/re-used data is not directly sharable by the applicant, are access protocols and programs to allow third-party researchers to replicate proposed research data files described? Does the approach include reasonable plans to interact/coordinate with the SBECCC on data and dissemination activities?
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
Protections for Human Subjects
For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
Inclusion of Women, Minorities, and Individuals Across the Lifespan
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
Vertebrate Animals
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Biohazards
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Resubmissions
For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
Renewals
Not Applicable
Revisions
Not Applicable
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
Applications from Foreign Organizations
Not Applicable.
Select Agent Research
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Sharing Model Organisms; and (2) Genomic Data Sharing Plan (GDS).
Authentication of Key Biological and/or Chemical Resources:
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by an appropriate objective review group, using objective review. Assignment to an objective review group will be shown in the eRA Commons.
Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial objective review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities. More information is provided at Award Conditions and Information for NIH Grants.
Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.
HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.
Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.
Cooperative Agreement Terms and Conditions of Award
The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 [Part 92 is applicable when State and local Governments are eligible to apply], and other HHS, PHS, and NIH grant administration policies.
The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and the NIH as defined below.
The PD(s) PI(s) will have the primary responsibility for:
The Principal Investigator(s) will have the primary responsibility for the design and details of the study/studies funded from this FOA and will retain primary responsibility for performance of the activities including analyzing and publishing results, negotiating required Data Use Agreements and other agreements to capture and share data, and maintaining ownership over data collected. The recipient(s) agree(s) to accept assistance from the designated NIH Program Official and Project Scientist(s) in aspects of the scientific and technical management of the study/studies and in coordinating with other Federal agencies.
After award, the PD/PI(s) should work with the consortium members, the SBECCC and NIH program staff as described in this FOA to achieve the dissemination and data acquisition, harmonization and sharing objectives of the Consortium as described in the FOA. NIH program staff will advise the PD/PI(s) on the overall scientific and financial management of the study/studies.
The recipient(s) will retain custody of and have primary rights to the data and software developed under this award, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.
NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
An NIH Project Scientist(s) will have substantial involvement that is above and beyond the normal stewardship role in awards. The NIH Project Scientist will assist in the following areas in collaboration with study investigators: refining study objectives and methodologies, coordinating/collaborating the study with other consortium studies and the SBECCC; providing additional guidance on NIH common data constructs with the SBECCC, and analyzing and publishing the results of the study.
Additionally, an NIH Program Official will be responsible for the normal scientific and programmatic stewardship of the award(s). The NIH Program Official will approve all major stages of the study/studies and all new major additions/changes to content and methods. In addition, this individual will assist in initiating and maintaining collaborative relationships with relevant federal agencies. Prior approval is required by the NIH Program Official for any replacements of key personnel or other changes in subawards. The NIH Program Official will also facilitate coordination between the SBECCC and the PD/PI to achieve Consortium dissemination and data coordination activities as described in this FOA.
Areas of Joint Responsibility include:
None; all responsibilities are divided between the recipient and NIH staff as described above.
Dispute Resolution:
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three academic members who are not involved in the study will be convened. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.
A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]
John W.R. Phillips, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-3136
Email: [email protected]
Erica Spotts, Ph.D.
Office of Behavioral and Social Sciences Research (OBSSR)
Telephone: 301-594-2105
Email: [email protected]
Partha Bhattacharyya, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-3136
Email: [email protected]
Susan Nicole Wright
National Institute On Drug Abuse (NIDA)
Phone: 301-402-6683
E-mail: [email protected]
Farris Tuma, Sc.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-9232
Email: [email protected]
Laura E. Kwako, Ph.D.
National Institute On Alcohol Abuse And Alcoholism (NIAAA)
Phone: 301-451-8507
E-mail: [email protected]
Nancy Lynne Jones
National Institute On Minority Health And Health Disparities (NIMHD)
Phone: 301-594-8945
E-mail: [email protected]
James Gao
National Eye Institute (NEI)
Phone: 301.594.6074
E-mail: [email protected]
Dionne Godette-Greer, Ph.D.
National Institute of Nursing Research (NINR)
Email: [email protected]
Ramesh Vemuri, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-9666
Email: [email protected]
E.C. Melvin
National Institute on Aging (NIA)
Telephone: 301- 480-8991
Email: [email protected]
Ericka Wells
National Institute On Drug Abuse (NIDA)
Phone: 3018276705
E-mail: [email protected]
Judy Fox
National Institute On Alcohol Abuse And Alcoholism (NIAAA)
Phone: 301-443-4704
E-mail: [email protected]
Priscilla Grant
National Institute On Minority Health And Health Disparities (NIMHD)
Phone: 301-594-8412
E-mail: [email protected]
Karen Robinson Smith
National Eye Institute (NEI)
Phone: (301) 451-2020
E-mail: [email protected]
Ron Wertz
National Institute of Nursing Research (NINR)
Telephone: 301-594-2807
Email: [email protected]
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.