Research on Informal and Formal Caregiving for Alzheimer's Disease (R01)

Research on Informal and Formal Caregiving for Alzheimer's Disease (R01) is sponsored by National Institutes of Health (NIH). This grant supports research on informal and formal caregiving for Alzheimer's Disease. Similar to other NIH opportunities, proposals incorporating arts-related elements to address mental health or well-being in caregiving contexts could be relevant.

Expired PAR-15-348: Research on Informal and Formal Caregiving for Alzheimer's Disease (R01) This notice has expired. Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) of Participating Organizations National Institute on Aging ( NIA ) National Institute of Nursing Research ( NINR ) Funding Opportunity Title Research on Informal and Formal Caregiving for Alzheimer's Disease (R01) R01 Research Project Grant November 6, 2017 - This PAR has been reissued as PAR-18-027 for due dates on or after January 25, 2018.

May 10, 2017 - New NIH "FORMS-E" Grant Application Forms and Instructions Coming for Due Dates On or After January 25, 2018. See NOT-OD-17-062 .

NOT-OD-16-004 - NIH & AHRQ Announce Upcoming Changes to Policies, Instructions and Forms for 2016 Grant Applications (November 18, 2015) NOT-OD-16-006 - Simplification of the Vertebrate Animals Section of NIH Grant Applications and Contract Proposals NOT-OD-16-011 - Implementing Rigor and Transparency in NIH & AHRQ Research Grant Applications October 8, 2015 - Notice of Correction for Foreign Institutions Eligibility for PAR-15-348.

See Notice NOT-AG-16-001 . Funding Opportunity Announcement (FOA) Number Companion Funding Opportunity PAR-15-351 , R21 Exploratory/Developmental Research Grant Additional Information on Eligibility .

Catalog of Federal Domestic Assistance (CFDA) Number(s) Funding Opportunity Purpose This Funding Opportunity Announcement (FOA) invites applications for basic and translational research on caregiving for individuals with Alzheimer’s disease (AD), at the individual, family, community, and population level.

The scope of this funding opportunity includes support for applications that propose the following: interventions to reduce caregiver burden and improve patient outcomes across various settings; population- and community-based research on the scope and impact of AD caregiving; improved characterization of informal and formal caregiving and the burden of caregiving across the full spectrum of the disease, including differences among socioeconomic, racial/ethnic and geographic sub-populations; and research addressing the unique challenges related to the provision of advanced AD care, including disparities in access to care.

Open Date (Earliest Submission Date) Letter of Intent Due Date(s) Any due dates on or after Jan 25, 2018 must use reissued FOA. December 11, 2015 (New, Revision, and Resubmission applications) followed by Standard dates , by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates.

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.

AIDS Application Due Date(s) New Date January 24, 2018 per reissuance of FOA (Original Expiration Date: September 8, 2018) Required Application Instructions It is critical that applicants follow the instructions in (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 I. Funding Opportunity Description Section II. Award Information Section III.

Eligibility Information Section IV. Application and Submission Section V. Application Review Information Section VI.

Award Administration Information Section VII. Agency Contacts Section VIII. Other Information Full Text of Announcement Section I.

Funding Opportunity Description Alzheimer’s disease directly affects as many as 5. 1 million people in the United States. The extensive care needs of individuals with AD are highly variable and care typically involves great demands on spouses and other family members, when they are available.

Family caregivers may experience both adverse health consequences (e.g., disrupted sleep, anxiety, depression, and compromised immune function) and economic hardship as a result of lost work and care expenditures. The challenges of caregiving may lead family members to seek institutional (nursing home) placement for demented elders in place of informal care.

For those families that either partially or fully use formal care options, the costs of such services are significant and often uninsured. How families organize resources to support formal care can affect the health and well-being of both the caregiver(s) and the care recipient with AD.

Alzheimer’s Project Act recognizes the need to enable family caregivers to continue to provide care while maintaining their own health and well-being and recommends the development and dissemination of evidence-based interventions for AD patients and their caregivers to reduce the burden of caregiving and delay nursing home placement.

An essential activity of this legislation is to support research that leads to the development of strategies to "identify high-quality dementia-care guidelines and measures across care settings" and to "explore the effectiveness of new models of care for people with (AD)."

Recommendations from the 2012 Alzheimer’s Disease Research Summit , and the 2015 Alzheimer’s Disease Research Summit highlighted the need for research to better understand and address the caregiving challenges across different settings and over the complete trajectory of AD. Such research should take into account the differing needs and capabilities of individuals with AD and other forms of dementia and their families.

Critical needs in caregiving research have been recently identified (see Next Steps for Research on Informal Caregiving at: https://www. nia. nih.

gov/research/dbsr/bsr-sponsored-publications ).

Specifically, these needs include: (1) improved definitions and characterization of caregiving throughout all of the progressive stages of AD , (2) deeper understanding of the health burden associated with caregiving, (3) assessment of how families support informal and formal care and the ramifications of these choices on their well-being, (4) identification of predictors of caregivers and care recipients at highest risk for poor outcomes, (5) development of novel interventions to meet the needs of caregivers and care recipients, and (6) development of novel approaches for integrating informal and formal care over the full trajectory of the disease.

In each of these areas, research is needed to understand and address the challenges faced by caregivers from diverse racial, ethnic, and socioeconomic backgrounds.

This Funding Opportunity Announcement encourages new research on informal and formal caregiving for individuals with AD in the randomized trials for comparative effectiveness research on Alzheimer’s disease caregiver interventions : There is an existing body of research on evidence-based interventions to relieve caregiver burden, and both NIA and NINR have supported the development of effective interventions, notably Resources for Enhancing Alzheimer’s Caregiver Health (REACH II), the NYU Caregiver Intervention, Care of Persons with Dementia in their Environments (COPE), and The Savvy Caregiver .

What is not known, however, is whether other programs demonstrated to be effective in the context of trials conducted in clinical settings would be effective if implemented in different settings.

Moreover, while many of these caregiving interventions have a positive impact on strain associated with caregiving, it is not known whether variable outcomes among them could indicate differential effectiveness in specific populations or geographic locations.

Further, most caregiving interventions are provided through community agencies or institutions and have not carefully measured important psychosocial variables, caregiver health, or care recipient transition This FOA encourages researchers to partner with insurers (including CMS) to conduct comparative effectiveness research to determine which existing evidence-based interventions to reduce burden in caregivers and improve care recipient outcomes are effective if implemented as an adjunct to primary care in non-research settings.

Interventions are needed across the full care continuum, including patients in a variety of settings (home, nursing home, assisted living, hospice), and for caregivers from diverse racial, ethnic, and socioeconomic backgrounds.

Cluster randomized trials are encouraged that will compare interventions stemming from contact with caregiver dyads in primary care, and where researchers can link the data obtained in the study with billing data. Such trials will allow researchers to follow longer range health effects of caregiving and assess the effectiveness of interventions.

community- and technology-based interventions for informal Alzheimer’s disease Many existing interventions to relieve caregiver burden require extensive time and personnel commitment.

There is a need for cost-effective, community-based, informal caregiving interventions and tools that address unmet psychological and physical health needs of caregivers; aid in assessment and management of AD symptoms; and ensure a safe home environment, where individuals with AD can remain for as long as possible.

Community based caregiving involves a care recipient who either ages in place or remains within a community, but requires additional support from various sources. The source of caregiving may be informal in that family or others are responsible for caregiving; formal through the provision of services provided in the home from various agencies; or through a hidden economy consisting of paid caregivers without agency affiliations.

Volunteer-initiated formalized programs to help older adults remain in their homes in the community are emerging in cities throughout the U.S. To date, however, there has been little dedicated research on their efficacy, nor any attempt to assess their impact on individuals suffering from AD and their family caregivers. Interventions that leverage technology to support caregivers in the community or in the home are also encouraged.

The recent 2015 Alzheimer’s Disease Summit highlighted the potential of technology for intervening in-home and in real time, and for monitoring adherence and other important intervention outcomes. This FOA also encourages research partnerships with community organizations, particularly those that have potential to deliver programs at regional or national scale.

Applications are encouraged that will lead to the development of effective in-home, in-community intervention programs and tools to support caregiver well-being and health, promote positive outcomes for care recipients, and aid in the integration of informal and formal care.

Research encouraged also includes financial planning interventions aimed at anticipating costs of long-term services and supports and palliative care to help mitigate the effects of such financial strain on caregiver and care recipient health and well-being.

This announcement supports all stages of caregiver intervention development research, with the expectation that basic science research will be infused throughout each of these stages. Applicants are referred to the Stage Model for Behavioral Intervention Development: https://www. nia.

nih. gov/research/dbsr/stage-model-behavioral-intervention-development .

the scope and impact of familial support and care for persons with AD: At the same time that population aging will put more individuals at risk for AD, demographic shifts in family composition (e.g., sequential marriages, rising levels of cohabitation and non-marital cohabitation, non-marital parenthood) could affect the availability of informal caregivers and increase the burden on those providing care.

Economic factors associated with providing formal or informal care may also impact familial burden. Nationally representative, population-based studies can lead to a better understanding of the availability of family caregivers, their variable roles and diverse needs, changes in economic circumstances, and the barriers to receiving services and support.

Multi-national studies can reveal how differences in policy and other factors affect care and outcomes. This initiative encourages projects that will enhance our understanding of the socio-demographic profile of the caregiving population, in order to form a coherent picture of how AD caregiving impacts society. To this end, both national and cross-national population-based research is encouraged.

Efforts supported under this initiative should enable researchers to identify predictors of high-risk caregivers; identify economic impact of informal caregiving on families and societies; and identify potential buffers and predictors of positive outcomes for caregivers and care recipients. For a further articulation of this need, see: Next Steps for Research on Informal Caregiving at: https://www. nia.

nih. gov/research/dbsr/bsr-sponsored-publications . Addressing these issues will require improved data infrastructure for the study of familial support for AD caregiving as well as projects that exploit new and existing data to address these issues.

This includes analysis of existing data from existing cohorts of nationally representative and cross-national samples and determination of the need for data collection in new cohorts. Projects are encouraged that propose to supplement existing national panel studies to collect data on informal and formal caregiving.

Projects are also encouraged that support the establishment of standard protocols for comparable data collection and data infrastructure on informal and formal caregiving. caregiving and assessing the impact of formal and informal care over the Research on familial caregiving (informal caregiving) and research on Long Term Services and Supports (formal caregiving) have traditionally been pursued independently.

There is a need for research to better define and assess the impact of informal and formal AD caregiving across a variety of settings (to include primary care, home health care, adult day care, nursing home, assisted living, hospice, etc.), in order to inform the design of new care delivery systems.

One of the major challenges faced by caregivers is navigating the interface of informal and formal care, including determining appropriate care transitions and securing adequate care Projects are encouraged that will lead to better definition and characterization of informal and formal caregiving, the domains of needs of caregivers and care recipients across the care continuum, the key social structural variables which contribute to variance in caregiving burden, and factors that characterize care delivery and care coordination models that reduce burden on caregivers and care recipients.

Caregiving definitions should take into account the role of the caregiver in a regional and racial/ethnic context, as well as the scope and breadth of caregiving, availability of social and economic resources to caregivers, and the inevitable changes in caregiving needs as the disease progresses.

Research is encouraged on disparities in the nature of informal caregiving, access to and utilization of long-term supports and services, including home and community-based services, such as adult day care, as well as residential care, for those with dementia. Research on disparities in quality of care received in different settings, its antecedents and consequences, is also encouraged.

Treatment of those with advanced dementia often includes inappropriate intensity and burdensome transitions; research is needed both to investigate reasons for disparities, which may include family preferences or lack of opportunities for informed choice. Interventions to address causes of disparities and improve access to high-quality care for disadvantaged populations is especially encouraged.

A deeper understanding of caregiving needs also requires improved assessments and characterization of the impact of caregiving on caregivers psychological and physical health, workforce participation and financial security. Assessments should be sensitive to both the potential benefits as well as burdens of the caregiving role.

There is particular need for identification and validation of assessments suitable for use in a range of research contexts including observational and interventional studies and large population-based surveys.

challenges in advanced Alzheimer’s disease care: Care for individuals with advanced AD poses particular challenges for caregivers, given the complexity of symptoms and the often protracted nature of decline in the last years of the disease.

These challenges include managing (and reducing) unnecessary transitions between care contexts, making decisions about treatment options for comorbid conditions, avoiding burdensome treatments, addressing the palliative care needs of care recipients at the end of life, and supporting caregivers in their role as surrogate decision-makers for care recipients who are unable to make decisions This initiative seeks to support research on the caregiving challenges associated with advanced AD.

Researchers are encouraged to develop interventions to aid caregivers in navigating the later stages of AD, in collaboration with health care professionals and other family members. There is potential to leverage existing palliative care research networks to develop and advance interventions for palliative and hospice care of persons with advanced AD and their families.

Observational studies and interventions addressing practices of health and long-term care systems that lead to burdensome transitions for persons with advanced AD are encouraged. Cross-disciplinary efforts to design and test clinical interventions and models of palliative and hospice care for persons with advanced AD and their families are particularly encouraged.

These programs should address needs across diverse subgroups, care settings, and rural/urban locales. Section II. Award Information Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed Glossary and the SF424 (R&R) Application Guide provide details on Funds Available and Anticipated Number of Awards NIH intends to fund an estimate of 12-16 awards, corresponding to a total of $10 million for fiscal year 2016. Future year amounts will depend on annual appropriations. Application budgets are not limited but need to reflect the actual needs of the proposed project.

The project period is limited to 5 years. 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 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 Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Nonprofits without 501(c)(3) IRS Status (Other than Institutions For-Profit Organizations (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Eligible Agencies of the Federal Government U.S. Territory or Possession Independent School Districts Public Housing Authorities/Indian Housing Authorities Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Non-domestic (non-U.S.) Entities (Foreign Institutions) are Non-domestic (non-U.S.) components of U.S. Organizations are not eligible Foreign components, as defined in the NIH Grants Policy Statement , are not 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 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 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. 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.

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 must have an active DUNS number and SAM registration in order to complete the Directors/Principal Investigators (PD(s)/PI(s)) All PD(s)/PI(s) must have an eRA Commons account.

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

Eligible Individuals (Program Director/Principal 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 This FOA does not require cost sharing as defined in the NIH Grants Policy Statement . 3.

Additional Information on Eligibility Applicant organizations may submit more than one application, provided that each application is scientifically distinct. The NIH will not accept duplicate or highly overlapping applications under review at the same time.

This means that the NIH will A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission 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 ). Section IV. Application and Submission Information Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.

gov . 2. Content and Form of Application Submission It is critical that applicants follow the instructions in (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 For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant All page limitations described in the SF424 Application Page Limits must be followed Instructions for Application Submission The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an All instructions in the SF424 (R&R) Application Guide SF424(R&R) Project/Performance Site Locations All instructions in the SF424 (R&R) Application Guide SF424(R&R) Other Project Information All instructions in the SF424 (R&R) Application Guide SF424(R&R) Senior/Key Person Profile All instructions in the SF424 (R&R) Application Guide All instructions in the SF424 (R&R) Application Guide All instructions in the SF424 (R&R) Application Guide PHS 398 Cover Page Supplement All instructions in the SF424 (R&R) Application Guide All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: Sharing Plan : Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Do not use the Appendix to circumvent page limits.

Follow all instructions for the Appendix as described in the SF424 (R&R) Application Planned Enrollment Report When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) PHS 398 Cumulative Inclusion Enrollment Report When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

See Part I. Section III. 1 for information regarding the requirements for obtaining a Dun and Bradstreet Universal Numbering System (DUNS) Number and for completing and maintaining an active System for Award Management (SAM) registration.

Part I. Overview Information contains information about Key Dates. 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.

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. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. 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. 4. Intergovernmental Review This initiative is not subject to intergovernmental 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 . Requirements and Information 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 Electronically . If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must for Applicants Experiencing System Issues .

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package . Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide. See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review, NIH.

Applications that are incomplete or non-compliant will Requests of $500,000 or more for direct costs in any year Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/ Research Contact at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 Post Submission Materials Applicants are required to follow our Post Submission Application Materials policy.

Section V. Application Review Information NOT-OD-16-006 and NOT-OD-16-011 for updated review language for applications for due dates on or after January 25, 2016. 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 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 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?

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 those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)?

If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Does the 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?

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?

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?

Additional Review Criteria As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Protections for Human Subjects For research that involves human subjects but does not involve one of the 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