It is critical that applicants follow 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 the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Background

This FOA invites applications proposing multidisciplinary research to examine the complex causes and consequences of elder mistreatment to inform the future design of mechanistically focused interventions for individuals at risk of mistreatment and mistreating. The mistreatment of the elderly is a serious and widespread public health problem with far-reaching implications. Elder mistreatment is comprised of many subtypes, which generally include the following: emotional abuse, physical abuse, and sexual abuse; financial exploitation; abandonment; and neglect. While a single exposure to any one subtype may result in adverse effects, mistreatment is rarely an isolated incident. More typically, it escalates in severity and intensity over time. Elder mistreatment can result in long-lasting psychological and physical health problems for the individuals affected, the disruption of families and communities, and harmful consequences for society as a whole. In the United States, prevalence estimates of elder mistreatment in community settings range from 7.6% to 12.7%. These numbers likely underestimate the full scope of elder mistreatment. As the aging population grows, it is expected that the responsibilities of caring for impaired older adults will fall on family members even more. For family members who lack the resources and skills to cope with these challenges, the burden of care may further increase the potential for mistreatment. There is thus a compelling need for research to identify and develop effective strategies for prevention and eradication.

Knowledge of the causal pathways through which risk of elder mistreatment is increased and how factors are linked to adverse outcomes is critical for addressing the needs of both older adults at risk of maltreatment and those at risk of maltreating others. However, efforts to establish causal relationships remain a major challenge. Available evidence suggests that the etiology of elder mistreatment is complex and multifactorial, yet factors that account for differential exposure to and/or differential consequences of mistreatment remain little understood. Not all victims of elder mistreatment are subject to the same types of mistreatment or at the same frequency, and many older adults are exposed to multiple instances of different types of mistreatment, known as polyvictimization. At present, heterogeneity among this at-risk population in exposure to different subtypes of mistreatment and their different effects remains understudied. Moreover, while several factors are known to increase risk of mistreatment, involving personal characteristics of both the vulnerable elder and potential maltreater as well as the context in which they interact, at present, very few modifiable risk factors have been identified, which hinders efforts to design effective interventions. Causal knowledge of protective factors and protective processes is even more limited.

Health care practitioners are often the first and possibly even the last point of contact for a maltreated elder, which places them in a unique position to serve as gatekeepers to necessary resources and social welfare services in their communities and for combating elder mistreatment. However, clinicians face numerous challenges in identifying and treating older abuse victims. Tools to identify those who do not, will not, or cannot speak on their own behalf remain elusive, and distinguishing physical trauma caused by abuse from that resulting from accidental injury or illness remains a large clinical challenge. Maltreated older adults often remain silent due to feelings of shame or out of fear of retaliation both for self and possibly the maltreater especially when the perpetrator is a family member on whom they rely for support. Individuals with cognitive impairments, such as Alzheimer's disease and related dementias, are particularly vulnerable because omissions and errors in recall of the details and timing of events frequently cast doubt on their credibility. Victims of abuse often exhibit diffuse and unexplained somatic symptoms that fall within the spectrum of clinical characteristics of other serious but more readily diagnosable medical conditions, and therefore risk misdiagnosis and unremitting suffering. They may be released to the person who had harmed them. Too often, victims disappear from society, left alone and unable to fend for themselves against further abuse. Clinical approaches are needed to accurately distinguish different types of mistreatment from accidental injury or illness. Along with ascertainment challenges, ethical challenges also arise in the context of screening and research participation, especially for patients suffering from cognitive impairments, where obtaining informed consent is complicated. Moreover, there are often strict regulatory requirements for research in health care delivery settings with patients from these vulnerable populations.

In October of 2015, the National Institutes of Health convened experts in child abuse, intimate partner violence, emergency medicine, and elder mistreatment, as well as in the field of elder justice, for the NIH Workshop: Multiple Approaches to Understanding and Preventing Elder Abuse and Mistreatment to identify key barriers to progress and to consider the potential for the field of elder mistreatment to build on advances and experiences in these research areas. The meeting report summary is available here: https://www.nia.nih.gov/sites/default/files/nih_workshop_on_multiple_approaches_to_understanding_and_preventing_elder_abuse_-final.pdf.

This Funding Opportunity Announcement addresses three overarching recommendations from this meeting:

• To develop rapidly deployable approaches to improve screening and detection to identify who is at greatest risk of mistreatment or maltreating and to expand knowledge of the full magnitude of elder mistreatment.
• To develop a conceptual framework with objective measures to identify risk and protective factors for different types of elder mistreatment and to better assess and understand their cumulative risk or impact.
• To adopt novel approaches, extrapolated from tested and successful approaches in the fields of child abuse, intimate partner violence, and emergency medicine.

Research Objectives

This Funding Opportunity Announcement invites applications proposing multidisciplinary research that can advance our understanding of the complex causes and consequences of elder mistreatment and lay the foundation for the future design of mechanistically focused preventive and therapeutic interventions for individuals at risk of mistreatment and mistreating. Applications are solicited from multidisciplinary teams, including experts from the fields of elder mistreatment, child abuse and neglect, intimate partner violence, and/or emergency medicine, to pursue research in two priority areas: (1) the development of new and innovative tools and methods for the screening and detection of elder mistreatment; and (2) the identification of modifiable risk factors for elder mistreatment and modifiable protective factors, with potential to prevent mistreatment and/or enable the maltreated and the maltreaters to overcome adversity and thrive. To address ethical issues that are commonly raised about research in this area, all applications should address the unique ethical challenges posed by conducting research with vulnerable populations at risk for maltreatment and employ evidence-based practices for addressing those challenges (including practices from the fields of child abuse and neglect and/or intimate partner violence).

Methodological development: This FOA invites research that can lead to the establishment of well-validated research instruments and tools that can support data collection and analysis of robust measures of elder abuse, and improve identification of risk factors. The development of screening technology and methodological tools and analytic strategies for use in clinical settings and in the field is needed to support early detection of risk factors, warning signs, and indicators of elder mistreatment. NIA is also interested in supporting research that can lead to the development and refinement of standardized approaches. Several approaches from the fields of child abuse and neglect and intimate partner violence hold considerable promise for filling key knowledge gaps. Examples include, but are not limited to, the following:

• To improve screening efforts, the widespread use of smartphones and tablets offer opportunities to increase confidentiality and overcome health literacy, cultural, and communication barriers to disclosure.
• To improve detection, researchers could develop trigger tools for identifying and measuring adverse events with algorithms based on data extracted from electronic health records, electronic medical records, and CMS claims data.
• Research that integrates psychosocial measures with clinical biomarkers and injury patterns to identify pathognomonic symptoms and signs of physical abuse that can inform the development and validation of clinical decision rules and computer-aided decision support tools to facilitate diagnostic or therapeutic decision making and alert clinicians to patients and families possibly requiring intervention.
• Wearable technology that enables real-time passive monitoring and surveillance of behavior and health could also permit early detection of affective state and behavioral patterns and social interactions predictive of mistreatment for high-risk individuals. Analysis of geospatial data could hold promise for examining contextual influences.
• The analysis of informant reports and use of detailed naturalistic observational data of individuals, dyads, and families across a variety of contexts could reveal patterns of behavior and social dynamics and uncover sources of contextual influence.
• Methodological and technological development for the extraction and analysis of fine-grained measures of social interactions, including those involving visual, prosodic and syntactic cues, and use of lexical data.
• Development of financial technology tools that can facilitate passive and active monitoring and improve early detection of behavioral patterns and typologies that characterize individuals facing progressive cognitive decline.

Risk and protective factors

• Studies that examine associations between polyvictimization and psychological and physical health outcomes, and effects of repeated and cumulative exposure.
• Studies that can identify lifecourse predictors of and relationships among the different types of elder mistreatment and their consequences, in the context of polyvictimization and polyperpetration.
• Identification of modifiable risk and protective factors, which may include individual attributes, situational properties, and other aspects of the social ecology, could reveal malleable interpersonal strengths and factors that promote successful adaptation following exposure to and perpetration of maltreatment.
• Use-inspired basic science may reveal potentially modifiable intervention targets for prevention and treatment. Aligned with NIA's programmatic interest in supporting mechanistically informed interventions, NIA strongly encourages Stage 0 research based on the NIH Stage Model for Behavioral Intervention Development conceptual framework (https://www.nia.nih.gov/research/dbsr/stage-model-behavioral-intervention-development).
• Analysis of biomarkers and bio-behavioral measures could offer objective measures of risk and protective factors and outcomes.
• Use of datasets that combine elder mistreatment, child abuse, and IPV data for comparative analysis for identifying common features or patterns and point to potential strategies for addressing common problems and improve assessment of risk and needs.
• Leveraging existing elder mistreatment data, including from NIA-supported longitudinal cohort studies, such as the National Social Life, Health and Aging Project, as well as data from federal sources, including, but not limited to: The National Elder Mistreatment Study, the National Adult Maltreatment Reporting System, National Electronic Injury Surveillance System-All Injury Program, the National Violent Death Reporting System, and the Web-based Injury Statistics Query and Reporting System.

Responsiveness Criteria

• Applicants are strongly encouraged to pay close attention to the instructions in Section IV.2 of this FOA regarding multidisciplinary team composition and ethical considerations.
• Applications proposing to develop or conduct interventions will be deemed non-responsive to this FOA and will not be reviewed.
• While recognized as important, studies proposing research focused exclusively on ethical, legal, and social implications of elder mistreatment are considered outside of the scope of this FOA and will not be reviewed.

See Section VIII. Other Information for award authorities and regulations.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

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.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

Buttons to access the online ASSIST system or to download application forms 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.

It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Melissa S. Gerald, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-402-4156
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. Investigative teams should have requisite expertise in the field of elder mistreatment and must include at least one member in a significant role with expertise in the fields of child abuse and neglect, intimate partner violence, and/or emergency medicine. The investigative team should also possess relevant and appropriate multidisciplinary expertise, as demonstrated by academic work and publications in the respective fields of its members. NIA strongly encourages inclusion of an ethics consultant.

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:

Research Strategy, Approach: All applications are required to include a proposed plan for managing issues of confidentiality and compliance with mandated reporting requirements for both prospective and retrospective maltreatment ascertainment. Applications must also describe a plan for assessing how legal requirements for reporting maltreatment impact research participation.

Protection of Human Subjects: For research projects involving primary data collection, applications are required to provide detailed information on the following:

• Plan for ensuring adherence to the basic ethical principles of nonmaleficence, autonomy, beneficence, and justice, in the context of the proposed study
• Strategy for assessing decisional capacity and competency in the context of informed consent
• Specific ancillary considerations as appropriate for obtaining consent for subjects exhibiting signs of mild to severe cognitive impairments
• Provisions made for reporting suspected and confirmed maltreatment according to laws, local regulations, and statutory mandates, both federal and state.

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, with the following modification:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix:

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

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 Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. 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 and responsiveness by National Institute on Aging, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in the policy.

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research 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 there a strong scientific premise for the project? 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 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? Do members of the multidisciplinary team have the requisite expertise to undertake the project? Does the investigative team include at least one member in a significant role with expertise in the fields of child abuse and neglect, intimate partner violence, and/or emergency medicine?

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

• Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the 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? Does the application include an appropriate plan for managing issues of confidentiality and compliance with mandated reporting requirements?

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 children, 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.

Ethical Considerations

For research projects involving primary data collection, does the application provide sufficient information on the following:

1) plan for ensuring adherence to the basic ethical principles of nonmaleficence, autonomy, beneficence, and justice, in the context of the proposed study;

2) strategy for assessing decisional capacity and competency in the context of informed content;

3) specific ancillary considerations as appropriate for obtaining consent for subjects exhibiting signs of mild to severe cognitive impairments;

4) provisions made for reporting suspected and confirmed maltreatment according to laws, local regulations, and statutory mandates, both federal and state; and

5) plan for assessing how legal requirements for reporting maltreatment impact research participation?

For research that involves human subjects but does not involve one of the six 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 six 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 children 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.

Not Applicable

Not Applicable

Not Applicable

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Not Applicable

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).

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:

• 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.
• Will receive a written critique.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Council on Aging. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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 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.

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, Grantees, 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 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.

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 http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.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.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, 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 registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, 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)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

Melissa S. Gerald, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-402-4156
Email: [email protected]

Ramesh Vemuri, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-402-7700
Email: [email protected]

John Bladen
National Institute on Aging (NIA)
Telephone: 301-402-7730
Email: [email protected]

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.