Department of Health
and Human Services (HHS)
and Human Services (HHS)
EXPIRED
National Institutes of Health (NIH)
National Institute on Aging (NIA)
U01 Research Project Cooperative Agreements
The purpose of this Funding Opportunity Announcement (FOA) is to solicit an Alzheimer's disease and Alzheimer's disease related dementias (AD/ADRD)-focused U01 that is ancillary to, but integrated with, the Midlife in the United States Study (MIDUS) U19 (see PAR-21-156) to provide in-depth information to elucidate behavioral, social, psychological and biological pathways of risk and resilience to cognitive decline and AD/ADRD. In addition to capitalizing on already-collected data, new measures should be included to test hypotheses regarding development of AD/ADRD via cumulative stress exposures over 30 prior years of data collection. As well, the research should examine the protective influence of psychosocial resources, affective style, and lifestyle factors assessed over multiple prior waves of MIDUS. The new assessments on two national samples with many years of information on potential influences on AD/ADRD hold potential for yielding invaluable insights relevant for preventative interventions and treatments in future studies.
Dates in bold italics in the following table were modified per issuance of NOT-AG-21-025
| Application Due Dates | Review and Award Cycles | ||||
|---|---|---|---|---|---|
| New | Renewal / Resubmission / Revision (as allowed) | AIDS | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
| April 26, 2021 | April 26, 2021 | Not Applicable | July 2021 | August 2021 | September 2021 |
| August 16, 2021 | August 16, 2021 | Not Applicable | October 2021 | January 2022 | April 2022 |
| February 1, 2022 | February 1, 2022 | Not Applicable | July 2022 | August 2022 | September 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.
New Date February 2, 2022 per issuance of NOT-AG-21-025. (Original Expiration Date: November 19, 2021)
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
The Midlife in the United States (MIDUS) Study was initiated in 1995 with a national sample of more than 7,000 adults aged 25 to 74. The central objective was to bring to population health research a rich array of psychosocial and behavioral factors that had previously been studied only with small select samples. In addition to a national probability sample (N = 3,487), the study included over-samples in select metropolitan areas (N = 757), a sample of siblings (N = 950) of the main respondents, and a national sample of twin pairs (N=1,914). In 2003, the National Institute on Aging funded a longitudinal follow-up of MIDUS, which added new biological and neurological assessments onto the original assessment battery. In 2011, a Refresher cohort was added to strengthen cross-project analyses by increasing the sample sizes available for testing hypotheses dealing with the interplay of key factors in mid- and later-life health. The unique multi-project design of the MIDUS study enables, broadly, (a) the investigation of the role of long-term, cumulative psychosocial factors on mid- and later-life health; (b) the identification of the biological mechanisms and pathways through which psychosocial factors influence health; and (c) the discovery of protective psychosocial factors (those that promote positive health and resilience).
Purpose
The purpose of this FOA is to solicit an Alzheimer's disease and Alzheimer's disease related dementias (AD/ADRD)-focused U01 ancillary to, but integrated with, the Midlife in the United States Study (MIDUS) U19 (see PAR-21-156) to provide in-depth information to elucidate behavioral, social, psychological and biological pathways involved in cognitive decline and AD/ADRD. In addition to capitalizing on already-collected data, new measures should be included to test hypotheses regarding development of AD/ADRD via cumulative stress exposures over 30 prior years of data collection. As well, the research should examine the protective influence of psychosocial resources, affective style, and lifestyle factors assessed over multiple prior waves of MIDUS. The new assessments on two national samples with many years of information on potential influences on AD/ADRD hold potential for yielding invaluable insights relevant for preventative interventions and treatments in future studies.
The current announcement targets subprojects from the original MIDUS study that are directly relevant to AD/ADRD (i.e., the cognitive and neuroscience subprojects, and inclusion of additional measures/subprojects and analyses to advance knowledge of risk and protective factors specifically related to AD/ADRD outcomes). As outlined in a companion announcement, PAR-21-156, this AD/ADRD project is linked to the core MIDUS study’s biopsychosocial integration using select subprojects that collect data on sociodemographic and psychosocial factors, daily experience, biomarkers, and gene expression and connecting these content areas through innovative analyses. As with the original MIDUS study, a central goal is to support data dissemination, provide user support of public use files, and encourage data use broadly by the scientific community.
Research Objectives
Harnessing the data potential in MIDUS for research that contributes in novel ways to the field of aging is critical to the continuation of the MIDUS study. NIA is particularly interested in promoting areas of science prioritized by the NIA Division of Behavioral and Social Research described here: http://www.nia.nih.gov/research/dbsr. Such areas include, but are not limited to: (1) improved understanding of health disparities in aging, (2) increased understanding of how macro-social trends influence aging, (3) use of a range of approaches to better understand behavioral, psychological, social, and geroscience explanations of aging, and (4) incorporation of a life course perspective to examine integrative pathways linking behavioral and psychosocial factors with biological mechanisms of health and illness.
A required component of the next project period is to enhance retention of at-risk and minority participants in MIDUS, including prior respondents lost to follow-up, to promote the potential for studying risk and resiliency among individuals in the most vulnerable segments of society.
With its decades of longitudinal data, the MIDUS study has potential for yielding important new information concerning the early detection of modifiable risk and protective factors that can inform interventions and treatments to prevent or reduce cognitive declines and dementia. MIDUS is unique for its emphasis on the interplay of cognitive, emotional, and brain health as well as its capacity to illuminate how racial and socioeconomic disparities contribute to AD/ADRD risk. That said, the next project period should minimize the lag between survey, biomarkers, and other measures, and the lag between the survey and an individual’s participation in the various projects should be shortened and clarified. To enhance informed comparisons among participants on the various measures collected - across both the AD/ADRD-focused study and the MIDUS continuation - the lag between different assessments for a given participant must be explicitly reported. Although it is understood that the same sequencing of projects cannot be done for all participants, it is nonetheless worthwhile to attain closer temporal alignment between the survey and project-specific measures. The temporal tightening of multi-project data collection will reduce the time lag between projects and waves and help mitigate the problem of time decay in what might otherwise be stronger cross-sectional associations between survey constructs and sub-project constructs, and more cleanly establish the nature of the associations as longitudinal vs. cross-sectional. This is particularly important in older participants for whom considerable change can occur over time gaps.
Objectives for applications submitted to this FOA are listed below. Applicants are not expected to address all the research objectives; if all research objectives are addressed, applicants are not expected to address them evenly. Applicants are encouraged to balance among these and justify their priorities and focus.
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?
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. NIA intends to make one award pending the availability of funds.
The scope of the proposed project should determine the project period. The maximum project period is 6 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 not 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.
Number of Applications
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:
Dana Jeffrey Plude, 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.
The application should demonstrate sufficient diversity of interdisciplinary representation among U01 PD/PI(s) and Senior/Key Personnel, including representation from the behavioral and social sciences, neuroscience, and AD/ADRD biomedical sciences. In conjunction with the parent MIDUS U19 PD/PI(s), the U01 PD/PI(s) should have substantial background in a range of fields relevant to the content domains of the MIDUS study, including: psychology, epidemiology, affective neuroscience, biostatistics, psychoneuroimmunology, life-span development, medicine, geriatrics, sociology, and economics to allow for multidisciplinary organization and management structure appropriate for a mature yet constantly innovating study. In addition, the Project and Core Leaders from the parent U19 and associated Senior/Key Personnel of the proposed study should have substantial background in the range of fields relevant to the aims of those components to assure ongoing innovation and promotion of cross-project integration.
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:
Specific Aims: Describe how the project will promote advances in either: (a) investigating the role of long-term, cumulative psychosocial factors on AD/ADRD outcomes in later life; (b) identifying the neurobiological mechanisms and pathways through which psychosocial factors contribute to AD/ADRD progression; and/or (c) advancing knowledge of protective psychosocial factors (those that protect against and/or slow the progression of AD/ADRD. Describe how the project will make major scientific contributions to the field of aging research, in areas such as, but not limited to: (1) improved understanding of health disparities in AD/ADRD, (2) increased understanding of how macro-social trends influence AD/ADRD outcomes, (3) use of a range of approaches to better understand behavioral, psychological, social, and geroscience explanations of AD/ADRD, and (4) incorporation of a life course perspective to examine integrative pathways linking behavioral and psychosocial factors with biological mechanisms of AD/ADRD.
Research Strategy: Focusing on the MIDUS study as a whole, address: (1) the potential of the project to yield early markers of modifiable risk and protective factors that can inform interventions and treatments to prevent or reduce cognitive declines and dementia; (2) how the proposed study will promote a deeper understanding of the interplay of cognitive, emotional, and brain health as related to AD/ADRD; and (3) the capacity of the research for illuminating how racial and socioeconomic disparities contribute to AD/ADRD risk.
Describe innovations in measures development and analytic approaches that will advance mechanistic understanding of links between behavioral, social, and biological factors in shaping life course trajectories of health and illness, including AD/ADRD.
Describe how the study will enhance retention of at-risk and minority participants; minimize the lag between survey, biomarkers, and other measures; and shorten and clarify the lag between the survey and an individual’s participation in the various projects.
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:
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.
In order to expedite review, applicants are requested to notify the NIA Referral Office by email at [email protected] when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.
Requests of $500,000 or more for direct costs in any year
Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/ Research Contact at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.
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. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
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 project promote advances in either: (a) investigating the role of long-term, cumulative psychosocial factors on AD/ADRD outcomes in later life; (b) identifying the neurobiological mechanisms and pathways through which psychosocial factors contribute to AD/ADRD progression; and/or (c) advancing knowledge of protective psychosocial factors (those that protect against and/or slow the progression of AD/ADRD)? Is the study poised to make major scientific contributions to the field of aging research, in areas such as, but not limited to: (1) improved understanding of health disparities in AD/ADRD, (2) increased understanding of how macro-social trends influence AD/ADRD outcomes, (3) use of a range of approaches to better understand behavioral, psychological, social, and geroscience explanations of AD/ADRD, and (4) incorporation of a life course perspective to examine integrative pathways linking behavioral and psychosocial factors with biological mechanisms of AD/ADRD?
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?
Is there sufficient diversity of interdisciplinary representation among Senior/Key Personnel, including representation from the behavioral, social, and biomedical sciences? Do the investigators have substantial background in a range of fields relevant to the content domains of the MIDUS study, including: psychology, epidemiology, affective neuroscience, biostatistics, psychoneuroimmunology, life-span development, medicine, geriatrics, sociology, and economics, to allow for multidisciplinary organization and management structure appropriate for a mature yet constantly innovating study? Do the investigators and Senior/Key Personnel of the proposed study have substantial background in the range of fields relevant to the aims of the project, to assure ongoing innovation and promotion of cross-project integration with the 'parent' MIDUS U19? Is there adequate expertise in AD/ADRD to support the proposed research?
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?
Does the study offer innovation in measures development and analytic approaches that will advance mechanistic understanding of links between behavioral, social, and biological factors in shaping life course trajectories of health and illness, including AD/ADRD?
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?
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
For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.
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) Data Sharing Plan; (2) Sharing Model Organisms; and (3) 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 Scientific Review Group(s) convened by NIA, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications will receive a written critique.
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 peer review, recommended applications will receive a second level of review by the National Advisory Council on Aging (NACA). 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.
The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, 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 recipientsis 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 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 recipientsfor the project as a whole, although specific tasks and activities may be shared among the recipientsand the NIH as defined below.
The PD(s)/PI(s) will have the primary responsibility for
NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below
NIH/NIA Project Scientist
An NIH/NIA Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards. The NIH/NIA Project Scientist will participate as an active voting member of the Executive Steering Committee, and as such, will assist in activities including refining study objectives, methodologies, and aims; setting priorities in the content of data collection; exploring the use of alternative strategies for incorporating new measurement approaches and instruments; facilitating cross-project coordination and cross-project analyses; and analyzing and publishing results of the study. Given the function of the MIDUS Study as a resource for the larger aging research community, the NIH/NIA Project Scientist will facilitate coordinating the study with other surveys (nationally and internationally) of the midlife and older adult population in order to enhance the capacity for comparative and integrative analyses. This will include facilitating efforts to harmonize data with other NIH and NIA-supported projects, engaging study investigators in formal harmonization activities supported by the NIA, promoting efforts to enhance the accessibility of study data to a wider range of scientists, and offering advice on how to enhance the value of the study for addressing scientific questions of priority to the NIH/NIA.
NIA Program Official
Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The NIA Program Official will approve all major stages of the study 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 NIA Program Official for any replacements of key personnel or other changes in subcontracts.
Areas of Joint Responsibility include
Executive Steering Committee:
To enable this complex project to continue to serve as a catalyst for innovative, multidisciplinary aging research and to permit incorporation of new ideas and input from the scientific community, an Executive Steering Committee will function as the governing board of this collaborative research study. This Executive Steering Committee will serve as the project's central point of communication; exchange of ideas; development, review, and management of common protocols; research and training activities; and problem resolution. Its actions and decisions will be determined by majority vote. The Executive Steering Committee is composed of the U19 and U01 PD/PI(s), Senior/Key Personnel who serve in joint scientific leadership roles on each Core or Project (NIA encourages no more than 3-4 individuals per Core/Project), and the NIA Project Scientist, each of whom has one vote, regardless of the number of roles they play in the study. In the case of a tie, the vote of the NIA Project Scientist will not count. In the event of co-funding, representatives of other NIH and co-sponsoring Institutes and Centers (ICs) may participate as non-voting members.
The Executive Steering Committee will meet twice yearly in person and will participate in telephone or video conferences on a monthly basis. During these meetings, the Executive Steering Committee will discuss the impact of any NIA mandated or potential budget cuts, discuss research progress and problems for each project and core, refine common theoretical and analytic approaches, and discuss emerging findings and pending publications. Subcommittees may be established as needed, and subcommittee chairs will be chosen by the Executive Steering Committee. Subcommittee members and other project personnel may participate in face-to-face meetings and conference calls as needed.
The Executive Steering Committee will be responsible for all major decisions regarding implementation and completion of study aims. This includes refining study objectives, methodologies, and aims; setting priorities in the content of data collection; exploring the use of alternative strategies for incorporating new measurement approaches and instruments; facilitating cross-project coordination and cross-project analyses; setting conventions for how data files should be structured and organized; establishing timelines for delivering datasets to the Administrative Core; and analyzing and publishing results of the study.
The Executive Steering Committee members will, in carrying out the above roles:
Data Monitoring Committee
MIDUS is a complex award of significance to the National Institute on Aging. In order to ensure that MIDUS achieves NIA assistance objectives under the cooperative agreement, the NIA will establish and appoint members to a Data Monitoring Committee (DMC), comprised of independent scientific experts in areas appropriate to the multidisciplinary content areas of MIDUS. The DMC will be supported by the project to attend all in-person meetings of the Executive Steering Committee; the project will also provide support for maintaining minutes and recording decisions at all DMC meetings. The purpose of the DMC is to provide expert independent guidance to NIA, the MIDUS U19 and U01 Principal Investigator(s), and Executive Steering Committee on the successful implementation of the study, including on how to best utilize the comprehensive data already collected, promote cooperative efforts with other large studies involving relevant comparative samples, evaluate security procedures for public data release, and identify new scientific directions. Experts, including, but not limited to, the Principal Investigator(s), co-investigators, NIA Project Scientist, NIA Program Official, and invited independent experts, will make presentations to the DMC on scientific and administrative issues regarding the development and implementation of study aims.?Both the NIA Program Official and the PI may request the DMC’s guidance on specific issues.?The DMC will report to the NIA and it will communicate specific guidance regarding funding priorities for MIDUS via executive sessions of DMC meetings.?The DMC will also, where appropriate, provide guidance to the study’s PI(s) and Executive Steering Committee regarding implementation of study aims as well as additions or changes to content and methods during the execution of the cooperative agreement.?The NIA Program Official and the MIDUS investigators will consider the guidance of the DMC regarding implementation of study aims as well as additions or changes to content and methods during the execution of the cooperative agreement. This guidance is not binding on the PI(s) who retain(s) primary responsibility for the scientific direction and implementation of the study. New DMC Chair and members will be appointed by NIA when necessary.
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 members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual recipient. 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 1.
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]
Dana Jeffrey Plude, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-3136
Email: [email protected]
Ramesh Vemuri, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-402-7700
Email: [email protected]
Terry Pham
National Institute on Aging (NIA)
Telephone: 301-402-6982
Email: terry.[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.