Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Institute of Nursing Research (NINR)
Funding Opportunity Title	Acute Life Threatening Conditions and Opportunities for Palliative and End of Life Care Research (R01)
Activity Code	R01 Research Project Grant
Announcement Type	New
Related Notices	None
Funding Opportunity Announcement (FOA) Number	RFA-NR-11-008
Companion FOA	None
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.361
FOA Purpose	The purpose of this research initiative is to (a) Examine predictors of progression to life threatening illness, End of Life (EOL) issues, and death among individuals diagnosed with acute illnesses in the presence of underlying chronic diseases, adverse health risk factors, or other negative variables; (b) Develop algorithms for such adverse progressions to life limiting disease or EOL; (c) Examine the burden of illness imposed by acute illnesses when superimposed on individuals with underlying chronic diseases or other negative variables / adverse risk factors (such as age) that carry the potential to exacerbate and / or potentiate the impact of the acute illness and / or the severity or prognosis of the underlying chronic disease such that progression to End of Life can occur; (d) Explore the trajectories of disease in these individuals and their covariates, and issues and needs among such patients and their caregivers; (e) Identify the complex palliative and End of Life Care issues and needs arising as a result of the multi factorial etiology and co-occurrence of two (or more) co-existing diseases or negative variables; (f) Study the medical, physical and psychosocial inter-relationships between disease status, symptoms, psychosocial or functional status, spiritual concerns and the impact of such key variables on both length and / or QOL; (g) Develop and test appropriate palliative and End Of Life care interventions for individuals with acute illnesses occurring in the presence of underlying chronic diseases or adverse risk factors leading to severe illness requiring complex palliative care or End of Life care; (h) Assess similarities and differences in palliative and or EOL Care needs, issues, barriers, or success among those whose progression to the EOL phase is sudden compared to those progressing to this phase gradually or as a function of time; (i) Examine the impact on, needs of, and interventions for the caregivers of this population.

Posted Date	January 11, 2011
Open Date (Earliest Submission Date)	March 14, 2011
Letter of Intent Due Date	March 14, 2011
Application Due Date(s)	April 14, 2011, by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	June/July, 2011
Advisory Council Review	August, 2011
Earliest Start Date(s)	September, 2011
Expiration Date	April 15, 2011
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (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

Purpose:

Despite the improving outcomes in chronic and acute diseases, there continues to be a significant burden of illness associated with both, and characterized by symptom burden, diminished length and / or Quality of Life (QOL), and high costs to the health care system. The impact of the concomitant occurrence of both acute and chronic diseases is an under-researched area, especially in terms of the potentiating effect of an underlying chronic disease on the severity and impact of an acute illness, or the length or QOL. As a corollary to this, the potentiating effect of underlying adverse health risk factors (such as old age or belonging to ethno culturally diverse or medically underserved groups) on the prognosis and impact of either chronic or acute diseases, or their co-occurrence, also remains understudied, especially with respect to the imperative need for, and the content and intensity of, palliative and / or EOL care (inclusive of symptom management, palliation, referral to hospice, or end of life support), both for patients with advanced disease and their caregivers. In fact, little empirical evidence is available to guide palliative and EOL care (including hospice) for individuals with acute life limiting illness, let alone the identification of those at particularly high risk for (a) adverse progression of acute illness(es), or (b) the exacerbation of underlying chronic disease(s) to the point at which imminent or ultimate EOL is a realistic ultimate trajectory.

With the aging of the population and the concomitant increase in and growing numbers of adults with chronic diseases that may or may not be well managed or reversible, and the vast numbers of individuals in both developed and developing countries with adverse health risk factors, comes the need for more information regarding how individuals with such chronic conditions and / or adverse factors fare in the setting of an additional negative force of an acute illness, their experience with such an acute illness, it's impact on the underlying chronic diseases or risk factors, strategies for coping with this complex condition requiring varying management strategies, the similarities and differences by ethno cultural and medically underserved status, age, menopausal status and other effect modifying variables, and the undoubtedly complex and varying care needs ranging from acute care, to complex disease care, to palliation of either or both or all, to irreversible palliative care, and finally to end of life care and preparation for death. Undoubtedly, individuals with such complex health conditions and needs face many challenges, including those associated with the formal health care system, life disruption, social isolation, symptoms, and uncertainty about prognosis and symptoms. Coping strategies include management of either or both acute and chronic diseases or adverse risk factors, dealing with the dying process, and social support. There is an imperative need to address and strengthen issues faced by such individuals and their caregivers, and assessing the role of racial and ethnic diversity is particularly important. Of note, in addition to the multiple etiologies, individuals with these complex medical issues may also progress along various trajectories and may involve periods of chronicity before becoming refractory to treatment. Examinations of this complex nature may therefore play a unique role in enhancing our understanding of the inter-relationships between acute and chronic diseases and the co-existence of the two on the one hand, and of palliative and End of Life (EOL) care on the other, especially in terms of examining the transition points and the interface between palliative care and pre-emptive End of Life (EOL) care.

As a corollary to the above paragraph, we know far too little about the burden of illness associated with acute illnesses superimposed on underlying chronic diseases or adverse risk factors, and the complex palliative and EOL care needs brought about by the varying trajectories and the complex illnesses faced by individuals facing such adverse health challenges and their caregivers. Understanding the complex medical and psychosocial care needs of this population suffering from these condition conditions, and the impact on caregivers and family members, requires the conduct of palliative and end of life (EOL) care research that could ameliorate the negative health outcomes, enhance Health Related Quality of Life (HRQOL), QOL in general, and manage disease related symptoms that could affect these variables negatively.

Palliative care at the end of life involves meeting the physical, psychological, social, and practical needs of patients and caregivers. End of life is defined as a phase of life when a person is living with an illness that will worsen and eventually cause death. EOL is not limited to the short period of time when the person is moribund. Good clinical care can prevent or alleviate suffering for many patients at the end of life by assessing symptoms and providing psychological and social support to the patients and their families. End-of-life care has been identified by the Institute of Medicine as one of the priority areas to improve quality of health care. This IOM report identified specific gaps related to end-of-life care, such as pain control in advanced disease and the care needs for patients with advanced disease - these are germane to this Initiative as well. High-quality evidence on end-of-life care is limited and most of the evidence is derived from the literature that focused on patients with cancer; therefore, knowledge resulting from this Initiative, and based at least in part on a population of non-cancer patients and those with multiple diagnoses and a combination of acute and chronic diseases will fill these specific deficits in what we know to-date. Some important topics in end-of-life care, such as palliative or EOL care interventions in the setting of complex and/or multiple diseases and conditions, and interpersonal or social interventions, remain especially difficult to study. It is expected that this Initiative will stimulate work in this area. Further, to improve palliative care at the end of life is important for patients, caregivers, and all clinicians caring for patients needing pre-emptive palliative or end-of-life care. Anyone with seriously disabling or symptomatic chronic conditions and facing acute illnesses needs complex palliative care that takes into account the interface or nexus of such care with the advent of EOL care - this Initiative, by laying the groundwork for developing palliative and EOL care interventions that are particularly mindful of this interface and that support QOL, quality of care, and the range of issues and needs mentioned in this announcement will go far in stimulating this body of work. (Note: Resource: The American College of Physicians' End-of-Life Care Consensus Panel has a series of papers related to ethical issues around end-of-life care that can be accessed from its Web site (http://www.acponline.org/ethics/papers.htm).

Finally, we may significantly improve the quality or length of life of individuals suffering from the complex issues mentioned, and their significant others, by providing palliative and curative care concurrently. With few exceptions, it is the standard of care that persons with an acute illness receive curative care, including that which is aggressive, such as intubation and resuscitation. The risk of dying from the acute illness is considerably higher for individuals with serious chronic conditions such as heart failure, HIV, cancer, or multiple co-morbidities. In other words, address the possibility of, and initiate the provision of, complex palliative and EOL care in the setting of concurrent care for the acute condition through curative treatments. Among those with compromised health who acquire an acute illness, complex palliative or comfort measures and anticipatory preparation for potential end-of-life carries the potential to significantly improve the quality or length of life as well as the quality of impending death if curative care is not effective, for both the patients and their caregivers. While there has been a significant investment in understanding mechanisms of curing many acute conditions and research related to palliative / end of life care, few have considered their nexus; when is it appropriate to introduce palliative care, the content of such care, how is this best done, are what is the impact of such care? This initiative, by addressing these questions, can lead to improvements in the length or QOL, and preparation for potential death when this outcome is imminent, among persons with acute, life-threatening illness in the setting of chronic disease or other adverse risk factors.

The purpose of this research initiative is to (a) Examine predictors of progression to life threatening illness, End of Life (EOL) issues, and death among individuals diagnosed with acute illnesses in the presence of underlying chronic diseases, adverse health risk factors, or other negative variables; (b) Develop algorithms for such adverse progressions to life limiting disease or EOL; (c) Examine the burden of illness imposed by acute illnesses when superimposed on individuals with underlying chronic diseases or other negative variables / adverse risk factors (such as age) that carry the potential to exacerbate and / or potentiate the impact of the acute illness and / or the severity or prognosis of the underlying chronic disease such that progression to End of Life can occur; (d) Explore the trajectories of disease in these individuals and their covariates, and issues and needs among such patients and their caregivers; (e) Identify the complex palliative and End of Life Care issues and needs arising as a result of the multi factorial etiology and co-occurrence of two (or more) co-existing diseases or negative variables; (f) Study the medical, physical and psychosocial inter-relationships between disease status, symptoms, psychosocial or functional status, spiritual concerns and the impact of such key variables on both length and / or QOL; (g) Develop and test appropriate palliative and End Of Life care interventions for individuals with acute illnesses occurring in the presence of underlying chronic diseases or adverse risk factors leading to severe illness requiring complex palliative care or End of Life care; (h) Assess similarities and differences in palliative and or EOL Care needs, issues, barriers, or success among those whose progression to the EOL phase is sudden compared to those progressing to this phase gradually or as a function of time; and (i) Examine the impact on, needs of, and interventions for the caregivers of this population. The purpose of this research initiative is also to explore the complex needs of the population this Initiative focuses on, study the medical, physical and psychosocial relationships between disease status, symptoms, psychological, functional conditions, spiritual concerns and QOL, and develop and test appropriate palliative and EOL care interventions for those with advanced HF and their caregivers. This concept is consistent with the NINR Strategic Plan area of Quality of Life, Symptom Management, Palliative Care and End of Life.

In sum, specific research areas of interest responsive to this FOA include, but are not limited to, the following areas:

• Examine predictors of progression to life threatening illness, End of Life (EOL), and death among individuals diagnosed with acute illnesses in the presence of underlying chronic diseases, adverse health risk factors, or other negative variables.
• Examine the needs related to complex palliative and end-of-life care among persons facing an acute illness with a high risk of fatality due to underlying chronic diseases.
• Develop algorithms for such adverse progressions to life limiting disease or EOL.
• Examine the burden of illness imposed by acute illnesses when superimposed on individuals with underlying chronic diseases or other negative variables / adverse risk factors (such as age) that carry the potential to exacerbate and / or potentiate the impact of the acute illness and / or the severity or prognosis of the underlying chronic disease such that progression to End of Life can occur.
• Explore the trajectories of disease in these individuals and their covariates, and issues and needs among such patients and their caregivers.
• Identify the complex palliative and End of Life Care issues and needs arising as a result of the multi factorial etiology and co-occurrence of two (or more) co-existing diseases or negative variables.
• Examine and develop algorithms for the introduction of progressively intense palliative care interventions and the appropriate timing of such interventions.
• Assess varying needs by developmental stage or life course perspective.
• Identify biomarkers associated with increased risk of mortality among persons with concurrent acute and chronic illness.
• Develop strategies which help identify the circumstances, timing, and methods for transitioning from curative to comfort care.
• Assess ways to incorporate palliative and pre-emptive EOL care into aggressive curative care.
• Study the medical, physical and psychosocial inter-relationships between disease status, symptoms, psychosocial or functional status, spiritual concerns and the impact of such key variables on both length and / or QOL.
• Develop and test appropriate palliative and End Of Life care interventions for individuals with acute illnesses occurring in the presence of underlying chronic diseases or adverse risk factors leading to severe illness requiring complex palliative care or End of Life care.
• Develop and test interventions to increase anticipatory preparation for the potential lethality of acute conditions, including those superimposed on chronic disease and advanced age.
• Develop and test innovative models to provide palliative and end-of-life care to persons across the acute illness - chronic underlying chronic disease - life limiting illness trajectory and explore the nexus or interface between the palliative and EOL care phases, and predictors of the transition.
• Assess similarities and differences in palliative and or EOL Care needs, issues, barriers, or success among those whose progression to the EOL phase is sudden compared to those progressing to this phase gradually or as a function of time.
• Explore unique needs by ethno cultural background, age or medically underserved group status.
• Examine the impact on, needs of, and interventions for the caregivers of this population.
• Develop and assess components of Palliative and EOL care interventions for varying severities and trajectories of acute disease on chronic disease.
• Assess the impact of inter- disciplinary teams on outcomes among patients and their families .
• Examine EOL care needs among HF patients and care-givers.
• Study physical and psychosocial relationships between various trajectories and severities of disease.
• Assess whether and how the EOL care experiences of various ages (including older) patients and their caregivers can inform the development of new approaches to Advanced care planning (ACP).
• Assess barriers to care and examine similarities or differences in barriers by disease etiology and by ethno cultural diversity or medically underserved status.
• Examine the impact of interventions on symptom management with attention to symptom onset, duration, severity, and overall burden.

Funding Instrument	Grant
Application Types Allowed	New The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	National Institute of Nursing Research, $2 Million, up to 4-5 awards in FY 2011
Award Budget	Application budgets are limited to Direct Costs up to $300,000 and also need to reflect actual needs of the proposed project.
Award Project Period	The total project period for an application submitted in response to this funding opportunity may not exceed 4 years.

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

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)
• Eligible Agencies of the Federal Government
• 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 Organizations) are not eligible to apply.
Foreign (non-U.S.) components of U.S. Organizations are allowed.

Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

• Central Contractor Registration (CCR) must maintain an active registration, to be renewed at least annually
• Grants.gov
• eRA Commons

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) 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 SF 424 (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.

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed.

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.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, 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.

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 research
Name, address, and telephone number of the PD(s)/PI(s)
Names of other key personnel
Participating institutions
Number and title of this funding opportunity

The letter of intent should be sent to:

Dr. Yujing Liu
Chief, Office of Review
National Institute of Nursing Research, NIH
6701 Democracy Blvd., Rm. 710
One Democracy Plaza
Bethesda, MD 20892-4870
Telephone: (301) 451-5152
Fax: 301-480-8260
Email: yujing_liu@nih.gov

The forms package associated with this FOA includes all applicable components, mandatory and optional. Please note that some components marked optional in the application package are required for application submission. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS) as provided in the SF424 (R&R) Application Guide, with the following modifications:

• 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.

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via 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.

Applicants are responsible for viewing their application 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 SF 424 (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.

Important reminders:
All PD/PIs must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(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.

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 Central Contractor Registration (CCR). 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 by the Center for Scientific Review and responsiveness by the National Institute of Nursing Research, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

In order to expedite review, applicants are requested to notify the NINR Referral Office by email at yujing_liu@nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

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/priority 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.

Significance

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?

Investigator(s)

Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or 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?

Innovation

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?

Approach

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 clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Environment

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/priority 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 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 Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the National Institute of Nursing Research (assignments will be shown in the eRA Commons), in accordance with NIH peer review policy and procedures, using the stated review criteria.

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/priority score.
• Will receive a written critique.

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 Nursing Research . 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.

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 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 the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants 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.

Cooperative Agreement Terms and Conditions of Award

Not Applicable.

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

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.

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Noreen Aziz, MD, PhD, MPH
National Institute of Nursing Research (NINR)
Telephone: 301-594-2542
Email: azizn@mail.nih.gov

Yujing Liu, Ph.D., Chief, Office of Review
National Institute of Nursing Research (NINR)
Telephone: 301-451-5152
Email: yujing_liu@.nih.gov

Lawrence Haller, Grants Management Specialist
National Institute of Nursing Research(NINR)
Telephone: 301-402-1878
Email: hallerl@mail.nih.gov

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 Parts 74 and 92.