National Institute on Aging (NIA)
August 23, 2019- Clarifying Competing Application Instructions and Notice of Publication of Frequently Asked Questions (FAQs) Regarding Proposed Human Fetal Tissue Research. See Notice NOT-OD-19-137
This Funding Opportunity Announcement (FOA) invites applications to pursue development and validation studies of cognitive screening instruments or assessments in clinical settings and to translate these screening and assessment tools into electronic health record (EHR) systems that can assist physicians in making clinically meaningful care recommendations for patients experiencing cognitive decline. This FOA will support an R61 pilot phase (Stage I) which will allow researchers to develop and validate tools for cognitive assessment and then create scalable, tailored interventions for patients experiencing cognitive decline to help overcome barriers to uptake. If successful, researchers may transition to an R33 phase (Stage IV) for implementation of pragmatic trials. All applicants are required to address health disparities. This FOA does not require preliminary data.
The transition from the R61 to the R33 phase of the award will be administratively reviewed for successful completion of the go/no-go criteria specified for the R61 phase.
September 27, 2019
December 30, 2019
January 30, 2020
No late applications will be accepted for this funding opportunity announcement.
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.
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.
Early detection of cognitive decline may be critical to the efforts to stop dementia progression, including Alzheimer’s disease (AD) and AD-related dementias (ADRD). Dementia and mild cognitive impairment (MCI) are under-diagnosed, and analyses using claims data, as well as other methods, indicate that clinical diagnoses occur late in the process of cognitive decline. As noted by the United States Preventive Service Task Force (USPSTF), fewer than 50% of persons with dementia are diagnosed, and rates are even lower for persons with MCI. Furthermore, detection and diagnosis rates are worse in minority populations. The inability to diagnose and treat cognitive impairment results in prolonged and expensive medical care. Early detection could help persons with dementia and their care partners plan for the future. Additionally, early detection will become increasingly important both for recruitment of individuals for clinical trials and, as effective treatments become available, for assuring that people receive early treatment. In October 2017, NIA supported a meeting titled “Cost-Effective Early Detection of Cognitive Decline,” which highlighted the need for development, validation, and translation of screening and assessment tools for measuring cognitive decline. This FOA seeks applications which will develop (Stage I creation, adaptation, and piloting of an intervention), validate (Stage I ), and translate (State IV pragmatic trial) cognitive assessment tools in clinical settings.
Validation Work: Validation research is needed to assess computerized or digital screening tools, automated EHR tools, and/or machine learning approaches used to develop risk indices of early cognitive decline against gold standard measures. Validation work under this FOA may include the following:
Translation Work: Assessment and screening tools, administrative data analysis methods, and risk indices to detect early signs of cognitive decline are often developed in research contexts. More research is needed to adapt, test, and implement such tools in clinical settings and to link them to clinically meaningful care. Researchers are expected to incorporate cognitive assessment into EHRs for patients' Medicare Annual Wellness Visit. Translation work under this FOA may include the following:
This FOA requires all applicants to create tools and develop interventions for both providers and patients which will address health disparities in diagnosis of cognitive impairment.
The tools and interventions developed must be simple, inexpensive, and powerful enough to move directly from Stage I (creation, adaptation, and piloting of an intervention) to Stage IV pragmatic trials testing the effectiveness of the intervention (please see the NIH Stage Model). More complex interventions that require additional Stage I work, such as the development and testing of physician/provider training materials or other materials to ensure fidelity, may be included only if such Stage I testing may be conducted within the R61 phase (see below); if a compelling case can be made that traditional Stage III testing (highly-controlled, high internal validity real-world clinical) is not needed before proceeding to Stage IV (high external validity pragmatic trials); and if validation is completed during the R61 phase.
The ultimate goals of this initiative are two-fold: 1) to create tools and assessments—including both adapting existing instruments and developing and validating new ones that can feasibly be integrated into the EHR systems—and 2) to facilitate their integration into existing healthcare settings.
The R61 Phase (Planning/Pilot/Validation Phase, including Stage I research)
During the R61 pilot phase, researchers can conduct development of instruments and validations of such instruments in EHR systems to establish their feasibility. They will conduct Stage I research to create tailored interventions within the EHR system. Interventions, if successful, can then transition to the R33 phase for implementation of Stage IV pragmatic trials. The specific activities and milestones appropriate for the R61 phase will depend on the individual application and its stage of development. The applicant must include the following activities and milestones for the R61 phase:
The R33 Phase (Implementation Phase, including Stage IV pragmatic trial)
During the R33 phase, the PD(s)/PI(s) will implement the intervention in a clinical setting. General activities for this phase include:
Milestones and R61/R33 Transition
The application must propose a well-defined set of milestones (see required milestones above) for the planning phase (R61) and annual milestones for the implementation phase (R33). Specifically, the transition from the R61 to the R33 phase of the award will be administratively reviewed for successful completion of the go/no-go criteria that will be clearly specified in the R61 phase. Generally, the application could include the following activities and milestones for the R61 phase:
(1) Establishment of partnerships with healthcare providers and documentation of the commitment of the organization(s) to the project
(2) Ability to obtain access to EHRs and modify and implement pilot interventions
(3) Operationalization of definitions and objective measures of the intervention (i.e., the hypothesized mechanism of action)
(4) Provision of preliminary evidence that the mechanism of action can be manipulated reliably and validly through the EHR-linked process
(5) Assessment and justification of adequacy and finalization of clinically-relevant outcome measures
(6) Results of the pilot test intervention(s) and preliminary data for R33 administrative review showing feasibility of the intervention and completion of pragmatic trial protocol
At the completion of the R61 planning phase, the applicant will be required to submit a detailed transition request for the R33 implementation phase. R33 transition requests will undergo an administrative review to determine whether the milestones have been met. Unless the R61 meets go/no-go criteria, the R61 may not transition to the R33 phase.
Prospective applicants should note that funding of the R61 phase of a grant application does not guarantee support of the R33 phase. Transition to the R33 phase of the project will occur only if an administrative review process recommends that the R61 planning activities have been successful, the implementation phase of the project can proceed with confidence of success, and funds are available.
Partnerships and Access to EHRs
Partnerships with healthcare delivery organizations will be critical to implementing this FOA. It is anticipated that interventions will generally be performed with electronically-supported, integrated healthcare delivery organizations to establish efficiencies. The partnership must facilitate access to all EHR data sources relevant to the project (modifying the system when necessary). Further, we encourage collaborations with retail EHR vendors (EPIC, eClinical, MedSeek, etc.) to scale the adoption of successful interventions to solo and small-group practices.
Duration of R61/R33 Phases
It is expected that during the first 1-3 years the PD(s)/PI(s) will conduct development and validation work to test the feasibility of predicting cognitive decline (R61). Researchers who complete development work are encouraged to apply to R61 transition to the implementation phase (R33) in large clinical settings and encourage subsequent adoption across multiple EHR systems for the remaining 2-4 years of the grant.
The following types of applications will not be considered nonresponsive and will not be reviewed:
Additionally, extensive data collection (i.e. direct cost exceeding $200,000 for the full R61 phase or direct cost exceeding $300,000 for the full R33 phase) is not permissible for this announcement. Researchers are encouraged to use administrative data sources, such as EHRs; Centers for Medicare and Medicaid Services claims data; other nursing home, federal, or state administrative data; and low- to no-cost smartphone or web-based interventions. It is expected that PD(s)/PI(s) will highlight data collection cost in their budget justification.See Section VIII. Other Information for award authorities and regulations.
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
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.
NIA intends to commit $4M in FY 2020 to fund 3-4 awards..
For the R33 implementation phase, the combined budget for direct costs may not exceed $3M.
Applicant's budgets need to reflect the actual needs of the proposed project.
The maximum project period for the R61 planning phase is 2 years.
The maximum project period for the R33 phase is 3 years.
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
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 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.
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.
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:
Partha Bhattacharyya, Ph.D.
National Institute on Aging (NIA)
All instructions in the SF424 (R&R) Application Guide must be followed.
Applicants should budget for travel to an annual investigators meeting to be held in the Washington, D.C. area.
Specific Aims: Specific aims should be presented in one page and must separate the specific aims for R61 and R33 phase.
Research Strategy: The Research Strategy should contain separate sections for development, validation, and translation phases. It is not necessary to repeat shared information or details across both sections.
Preliminary data are NOT required. Any preliminary data that will support or justify the proposed hypothesis, including literature from prior development in areas such as applications of machine learning algorithms to predict and/or measure cognitive decline or analyze EHR data, may be included.
PDs/PIs should propose to follow best practices for the conduct of their randomized trial and, in particular, clearly state how randomization will be performed. For example, if randomization is performed at the hospital level, the applicant should describe the number of effective observations after accounting for intra-cluster correlation. If the randomization is at a lower level than the hospital (e.g., memory clinic or primary care practice), PDs/PIs should address potential threats to validity that could occur due to contamination across treatment groups. PDs/PIs must clearly present power calculations that reflect a range of effect sizes of clinical significance. Specifically, it is recommended that PDs/PIs provide beta ranges to assess the sample size and effect size across multiple sites.
Applicants should provide a description of how the study designs, methods, and assessments are complementary such that outcomes from the development/validation phase will enhance the interpretation of outcomes during the translation phase across multiple sites.
Rigor and Reproducibility: For replication purposes, applicants must identify additional implementation sites for translation work (R33 phase).
Since the intent of this FOA is to leverage findings from planning phase to implementation phase and to increase the potential for translation research, PDs/PIs are encouraged to collaborate with EHR vendors to maximize translation potential.
Milestones and the R61/R33 Transition
The application must include milestones the researchers expect to achieve by the end of the R61 phase, as well as milestones for the R33 phase. Milestones should be specific, quantifiable, and scientifically justified; they should not be simply a restatement of the specific aims for the R61 phase. It is recommended that PD(s)/PI(s) include a section labeled "milestones" describing milestones to be achieved during the R61 phase to qualify for the transition to the R33.
It is understood that the proposed milestones for the R33 phase may be revised based on activities during the R61 phase. In the event of an award, the PD(s)/PI(s) and NIH staff will negotiate a list of milestones for each year of support.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:
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.Delayed Onset Study
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.
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.
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 and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant, and/or nonresponsive will not be reviewed.
In order to expedite review, applicants are requested to notify the NIA Referral Office by email at firstname.lastname@example.org when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.
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.
For this particular announcement, note the following:
A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.
The initiative will support interventions integrated with EHRs for early detection of cognitive decline without overruling physicians’ autonomy to exercise clinical judgment. Preliminary data are not required; however, any preliminary data that will support or justify the proposed hypothesis, rationale, or development plan may be included. Since implementation of cognitive decline evaluation through EHRs is an emerging research area, investigators may not have experience working together as a team, as expertise may be necessary from multiple disciplines (e.g. medicine, biostatistics, neurology, data science, machine learning expertise, psychology, etc.).
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?
Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy?
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?
With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?
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 design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?
Does the design/research plan include the integration of data science (e.g., machine learning or predictive modeling) and/or integrative of developed instruments to measure cognitive decline?
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?
Is there a unifying and testable hypothesis that transcends the validation and translation phases? Are the aims described for development and validation work conducive to accomplishing the study aims in the translation phase? Are the goals of the translation phase based, in part, on findings from the development/validation phase? Did the PDs/PIs establish an appropriate partnership with health care providers (e.g., primary care physicians, specialists, HMOs, etc.) and document the commitment of the organization(s) to the project? Will the PDs/PIs be able to access an EHR system to modify and implement interventions during the validation phase? Did the PDs/PIs provide adequate power calculations and adequate justification?
Did the PDs/PIs operationalize definitions and clinically relevant cognitive outcomes to measure cognitive decline across the intervention timeline? Did the applicant assess and justify adequacy and finalize clinically relevant outcome measures?
Did the PDs/PIs propose plans for validating cognitive decline? How reasonable are the proposed plans? Note: For this FOA, PDs/PIs do not need to validate their findings with emerging biomarkers.
Are the endpoints/outcomes described in the application meaningful to healthcare providers and patients with cognitive decline?
Does the application adequately address the following, if applicable:
Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?
Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?
Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?
Data Management and Statistical Analysis
Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?
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?
If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?
Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?
If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?
If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?
Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?
Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?
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.
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.
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.
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.
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).
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).
Additionally, reviewers will comment on Sharing of Resources such as statistical codes for analyses, machine learning algorithms, digital instruments for detecting cognitive decline, or codes associated with development of prompts for EHR.
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.
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 the National Institute on Aging, 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:
Information regarding the disposition of applications is available 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 grantee’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.
Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.
ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm
Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that all 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. Data and Safety
Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).
Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).
Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. 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.
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.
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. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.htmlhttps://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. 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. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
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.
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Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Partha Bhattacharyya, Ph.D.
National Institute on Aging (NIA)
Ramesh Vemuri, Ph.D.
National Institute on Aging (NIA)
National Institute on Aging (NIA)
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