and Human Services (HHS)
EXPIRED
Participating Organization(s) |
National Institutes of Health (NIH) |
National Institute on Aging (NIA) |
|
Funding Opportunity Title |
Multidisciplinary Studies of HIV/AIDS and Aging (R03) |
Activity Code |
R03 Small Grant Program |
Announcement Type |
New |
Related Notices
|
|
Funding Opportunity Announcement (FOA) Number |
PAR-12-176 |
Companion Funding Opportunity |
PAR-12-174, R21 Exploratory/Developmental Grant |
Catalog of Federal Domestic Assistance (CFDA) Number(s) |
93.866, 93.393, 93.394, 93.395, 93.396, 93.399, 93.856, 93.865, 93.279, 93.242, 93.273 |
Funding Opportunity Purpose |
This FOA invites applications proposing to study HIV infection, HIV-associated conditions, HIV treatment, and/or biobehavioral or social factors associated with HIV/AIDS in the context of aging and/or in older adults. Research approaches of interest include clinical translational, observational, and intervention studies in domestic and international settings. |
Posted Date |
April 24, 2012 |
Open Date (Earliest Submission Date) |
July 7, 2012 |
Letter of Intent Due Date |
Not applicable. |
Application Due Date(s) |
August 7, 2012; December 7, 2012; April 9, 2013; August 7, 2013;(Extended to December 10, 2013 per NOT-OD-14-022) December 6, 2013; April 9, 2014; August 7, 2014; December 9, 2014; April 7, 2015, by 5:00 PM local time of applicant organization. |
AIDS Application Due Date(s) |
Not applicable |
Scientific Merit Review |
Standard dates apply |
Advisory Council Review |
Standard dates apply |
Earliest Start Date(s) |
Standard dates apply |
Expiration Date |
April 8, 2015 |
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
The number of older individuals living with HIV/AIDS has risen dramatically over the last decade. From 2001-2008, the proportion of Americans living with HIV who were aged 50 years or older rose from 17% to nearly 31% (1). By 2015, more than half of all HIV-infected Americans are projected to be over the age of 50 (2).
The rise in HIV prevalence among older Americans is attributed primarily to two factors. First, effective treatment with highly active antiretroviral therapy (HAART) has led to a marked increase in survival among individuals who were infected in their younger years and are now living into older age. Second, new infections have increased among older adults: in 2001, Americans aged 50 and older accounted for 13% of new HIV diagnoses, and in 2008, the rate was over 16% (1).
While HAART has led to a marked reduction in the incidence of AIDS-defining illnesses, a variety of HIV-Associated Non-AIDS (HANA) conditions are becoming increasingly commonplace in individuals with long-standing HIV infection. These conditions include cardiovascular disease, lung disease, infection-related and non-infection-related cancers, HIV-Associated Neurocognitive Disorders (HAND), neuropsychiatric disorders, osteopenia/osteoporosis, liver cirrhosis, and renal disease. It is unclear whether HIV infection and/or its treatment lead directly to these conditions, which might suggest an "acceleration of aging," or whether HIV infection and/or treatment confer additive risk of developing HANA conditions in aging individuals. Nevertheless, it is clear that individuals living with prolonged HIV infection exhibit many of the clinical characteristics commonly observed in aging, such as multiple co-morbidities, polypharmacy, physical and cognitive impairment, functional decline, alterations in body composition, and increased vulnerability to stressors. Moreover, the clinical picture of HIV in older adults may be complicated by many other risk factors, including infections with oncogenic viruses (e.g., Human papillomavirus [HPV], Kaposi-sarcoma Associated Herpesvirus [KSHV/HHV-8], Epstein-Barr virus [EBV], hepatitis B Virus [HBV], and hepatitis C virus [HCV]), obesity, and licit and illicit substance abuse including nicotine, alcohol, marijuana, and prescription drugs. As such, improved management of older individuals with HIV will require a much deeper understanding of the interface between aging, HIV, associated co-morbid conditions, and concurrent treatment. In addition, research is needed to address the unique psychosocial challenges faced by this growing population.
Recent activities within and outside the NIH have highlighted the importance of enhanced research on HIV in aging populations. In October, 2007, the Association of Specialty Professors, along with NIA, NIAID, the Infectious Diseases Society of America, and the HIV Medical Association, organized a workshop on HIV and aging, whose proceedings were published in Effros et al. Clinical Infectious Diseases 2008; 47:542-553). In 2011, the NIH Office of AIDS Research (OAR) established the Working Group on HIV and Aging, a panel of academic and community experts charged with identifying current and high priority research opportunities in HIV and aging. A report from this Working Group is currently in press in the Journal of Acquired Immune Deficiency Syndromes (JAIDS). This FOA builds on the recommendations that have emerged from these efforts.
SCOPE
The goal of this announcement is to invite research grant applications studying HIV infection, HIV-associated conditions, HIV treatment, and/or biobehavioral or social factors associated with HIV/AIDS in the context of aging and/or in older adults. Research approaches of interest include clinical translational, observational, and intervention studies in domestic and international settings. General topic areas appropriate for this FOA include, but are not limited to the following:
Cellular and molecular mechanisms of HIV in aging
It is now recognized that innate and adaptive immune cells play an important physiological role in eliminating senescent cells and maintaining normal tissue architecture across the lifespan. Many, though not all, changes typical of the aging immune system are also observed in individuals with HIV. Some studies have characterized changes in the adaptive immune system with HIV infection, but knowledge gaps still exist in our understanding of long-term changes with treated infection or in the setting of chronic substance use and abuse. In addition, less is understood about changes in the innate immune system associated with HIV over time. Moreover, most studies evaluate immune function through assays of peripheral blood, which contains only a fraction of the body's immune cells. Investigators are encouraged to expand studies to include other tissues including brain, bone marrow, gut mucosa, skin, lymph nodes, and other lymphoid tissues. Studies should also relate cellular, molecular, or genetic measures to clinical outcomes. Finally, insights into immune system pathophysiology gleaned from other immune-mediated diseases, such as rheumatoid arthritis, may provide useful research directions for applications responsive to this FOA. Examples of relevant topics at the intersection of HIV, aging, and the immune system may include, but are not limited to:
HANA Conditions / Co-morbidities
A variety of co-morbid diseases and conditions may arise in the setting of long-standing treated HIV infection. These include insulin resistance, dyslipidemia, cardiovascular disease, cancers (infection- and non-infection-related), renal impairment, metabolic bone disease, liver disease, neurological diseases, and neuropsychiatric disorders. All of these conditions may develop in aging individuals without HIV infection, but the additive effects of HIV infection and/or its treatment on development or progression of these conditions is not well understood. Investigators have proposed that such comorbidities not directly referable to HIV infection may be the consequence of chronic HIV infection, long-term ART toxicities, or a state of chronic inflammation, but further research is needed to disentangle whether these factors are causal, concurrent, or sequential to HIV infection.
Further studies are needed to refine our understanding of the complex relationships among HIV infection, HIV treatment, aging physiology, and other biological and psychosocial co-occurring conditions. Finally, a variety of prevention guidelines are available for HANA conditions, based largely on evidence from non-HIV populations. It is unclear whether adherence to such guidelines in multiply-morbid individuals with HIV results in improved health, increased survival, or cost-effective care comparable to those in age-matched populations without HIV. Studies on HANA conditions may include, but are not limited to:
Biomarkers or clinical indices of HIV-associated pathology
Development and validation of biomarkers for development or progression of HIV/AIDS disease status or HANA conditions may produce useful surrogate measures of important clinical outcomes. Such biomarkers may be used to measure comorbid disease status and response to therapy, as well as point to potential underlying mechanisms that may be amenable to intervention; however, relationships between biomarkers and the outcomes they may be associated with may be impacted significantly by ART effects, co-infections, or other comorbidities. Pro-inflammatory cytokines, such as IL-6, and markers of declining renal function, such as cystatin C, have proven to be valid indicators in HIV-infected adults. Other biomarkers deserving further study, individually or as part of combined indices, include, but are not limited to:
HIV-Associated Neurocognitive Disorders (HAND)
It is estimated that over 50% of HIV-infected individuals in the US have HAND, a significant cause of interference with activities of daily living and reduced quality of life. Age is a significant risk modifier for HAND, and there is a growing body of evidence indicating overlapping neuropathology between aging-associated neurodegenerative diseases and HAND. Although brain pathology differs between HAND and Alzheimer’s disease, brains from patients with HAND often show accumulation of abnormal protein such as amyloid-beta. A variety of biological or environmental factors, including genetic factors and chronic substance abuse, may contribute to neurodegenerative processes in aging HIV-positive individuals. Examples of studies on neurologic and neuropsychiatric complications in older HIV-infected individuals include, but are not limited to:
In addition, several existing resources related to Alzheimer's Disease and dementia may be useful in pursuing studies related to HAND; for example, the Alzheimer's Disease Neurological Initiative (ADNI) can provide normative data for brain imaging and neurocognitive function in age-matched non-HIV-infected controls
Interventions
Evidence-based treatment for HIV in older individuals has been extrapolated largely from studies in younger individuals. While HIV-specific indicators of disease status may respond to such treatment, non-HIV-related indicators may respond less well or not at all. Innovative treatment approaches are also needed that target aging-related outcomes, such as maintaining physical and cognitive function, reducing polypharmacy, and managing multiple competing disease processes and their individual treatments. The risks and benefits of treating age-related comorbidities are particularly warranted. Preventative interventions, including primary prevention of HIV infections in older adults and prevention of development or progression of HANA conditions are also needed. Intervention studies may include, but are not limited to, the following:
Frailty / Vulnerability
Frailty has been defined as a multi-system syndrome of diminished physiologic reserve associated with increased vulnerability to stressors. Advancing age is a significant risk factor for developing frailty, though the mechanisms leading to it are complex, interrelated, and not well understood. Like individuals with other chronic diseases, those with long-standing HIV infection are at higher risk of developing frailty than newly-infected or non-infected age-matched controls. Studies are needed to improve our understanding of the relationship between HIV and development or progression of specific contributors to frailty in older HIV-infected individuals. Relevant studies may include, but are not limited to:
Social, behavioral, and mental health studies
The burgeoning population of older adults with HIV faces considerable challenges with regard to social engagement and interaction, adequacy of informal social supports and caregiving resources, and utilization of community-based services to meet growing needs. Individuals aging with HIV tend to have limited or inadequate social networks, particularly within traditional family structures. As a result, older individuals with HIV will need to rely more heavily on community-based services in the future; however, such resources may be ill-equipped to handle the complex psychosocial issues with which aging individuals with HIV frequently present. Moreover, older individuals infected with HIV earlier in life may be quite different from those who contracted HIV later in life. Understanding not only the variety of psychosocial co-morbidities in the aging HIV population, but also the positive psychology and related constructs of individuals who are aging successfully with HIV (e.g., mindfulness, hardiness, resilience, self-efficacy, spirituality) may lead to greater insights into management strategies for older adults living with HIV/AIDS. Examples of social and behavioral research studies include, but are not limited to:
General Considerations
In general this FOA encourages applications with the following characteristics:
The following describes the scientific interests of specific Institutes and Centers in more detail.
National Cancer Institute (NCI)
NCI as a participating institute seeks to foster research studies to help understand how aging in the presence of chronic HIV infection affects the risk, spectrum and biology of cancer (AIDS-defining and non-AIDS-defining cancers). Recent data indicates an increase in the non-AIDS-defining cancers that is driven to a large extent by the growth and aging of the HIV/AIDS population. Aging is by itself a key factor promoting the development of many cancers, and there is a lack of data on the interplay between aging, HIV, long-term exposure to antiretroviral drugs, and other factors promoting cancer development in the aging population. In addition, there is little understanding of the interplay between host factors and immune perturbations that occur in aging and how these interactions affect cancers that are mostly seen in older people (e.g., Kaposi’s sarcoma and Merkel cell carcinoma).
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Of particular interest to NICHD are studies of reproductive aging among HIV-infected women, the interaction of reproductive aging and menopause with other HIV-associated complications such as neurocognitive decline and bone changes, behavioral aspects of aging with HIV, impact of stigma, and HIV prevention for aging women. The reproductive tract changes (immunologic, microbiologic, epithelial, etc.) and behavioral changes during and after menopause may increase susceptibility to HIV infection, and older women may not be aware of HIV risk. Novel prevention strategies may be required for older women. In addition, systemic changes with loss of reproductive hormones may alter immune responses and increase development of complications such as osteoporosis which are more common among persons with HIV infection.
National Institute on Drug Abuse (NIDA)
For this initiative, NIDA is interested in understanding the intersection of aging, HIV/AIDS, and the chronic use and abuse of addictive substances, including nicotine, marijuana, narcotics, psychostimulants, prescription drugs, and polysubstance use. Topics relevant to NIDA include but are not limited to:
National Institute of Mental Health (NIMH)
The NIMH Division of AIDS Research (DAR) supports research in HIV and aging with special focus on behavioral/psychosocial studies and on basic and clinical NeuroAIDS studies. NIMH is interested in research studies in HIV/aging in the following areas: (1) prevention research in HIV-at risk; (2) optimal treatment of HIV-infected individuals; (3) HIV CNS pathophysiological mechanisms; (4) neuropsychiatric comorbidities. With the successes of effective antiretroviral treatment, HIV-positive patients are living longer, but are at greater risk of developing previously unrecognized long-term complications of HIV infection. Comorbidities are now common in persons on antiretroviral therapy, and as the HIV+ population ages, a greater understanding is needed about the causes and effective management for these comorbidities. Neuropsychiatric comorbidities and others not directly referable to HIV have attracted increased importance for the behavioral and NeuroAIDS research agendas of DAR because they constitute a disease burden equivalent to or greater than HIV-related co-morbidities. Knowledge is critical in the areas enumerated above and in a number of other related areas (e.g., normal aging processes; diseases associated with aging; relevant moderators and mediators; methodologic improvements in subpopulation sampling and behavioral phenotypes). This will provide the foundation for a program of intervention research for HIV/aging which can identify effective prevention or treatment strategies. We encourage longitudinal strategies to help differentiate between the subpopulations of aging, assess developmental trajectories and provide causal explanations. Research designs should go beyond using chronological age alone because HIV, like the process of aging, is shaped more by the individual’s social, physical, cultural, and economic setting than by biological senescence. Examples of relevant research include, but are not limited to:
(1) Centers for Disease Control and Prevention, HIV Surveillance Reports, Volumes 17 and 21 (2005 and 2009). http://www.cdc.gov/hiv/surveillance/resources/reports/2005report/ and http://www.cdc.gov/hiv/surveillance/resources/reports/2009report/
(2) CDC Fact Sheet: HIV/AIDS among Persons Aged 50 and Older. http://www.cdc.gov/hiv/topics/over50/resources/factsheets/over50.htm
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 |
The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications. |
Award Budget |
The combined budget for direct costs for the two year project period may not exceed $100,000. No more than $50,000 in direct costs may be requested in any single year. |
Award Project Period |
The maximum project period is 2 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
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Governments
Other
Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, 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.
All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s))
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 4-6 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 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 PD(s)/PI(s), visit the Multiple
Program Director(s)/Principal Investigator(s) 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. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.
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.
For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
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 submission of applications for this FOA. 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 modification:.
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.
Foreign (non-US) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout 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(s)/PI(s) 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, NIH. Applications that are incomplete will not be reviewed.
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.
For this particular announcement, note the following:
The R03 small grant supports discrete, well-defined projects that realistically can be completed in two years and that require limited levels of funding. Because the research project usually is limited, an R03 grant application may not contain extensive detail or discussion. Accordingly, reviewers should evaluate the conceptual framework and general approach to the problem. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or from investigator-generated data. Preliminary data are not required, particularly in applications proposing pilot or feasibility studies.
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(s)/PI(s), 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(s)/PI(s), 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
For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
Renewals
Not Applicable.
Revisions
For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact/priority score.
Applications from Foreign Organizations
Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.
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 Center for Scientific Review, in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.
As part of the scientific peer review, all applications:
Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:
After the peer review of the application is completed, the PD(s)/PI(s) 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’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 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 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.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
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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
Basil A. Eldadah, MD, PhD
National Institute on Aging (NIA)
Telephone: 301-496-6761
Email: basil.eldadah@nih.gov
Kendall J. Bryant, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-402-9389
Email: kbryant@mail.nih.gov
Geraldina Dominguez, PhD
National Cancer Institute (NCI)
Telephone: 301-496-3204
Email: domingug@mail.nih.gov
Robin Huebner, PhD, MPH
National Institute of Allergy and Infectious Diseases
(NIAID)
Telephone: 240-627-3216
Email: rhuebner@niaid.nih.gov
D. Heather Watts, MD
Eunice Kennedy Shriver National Institute of Child Health
and Human Development (NICHD)
Telephone: 301-435-6874
Email: wattsh@mail.nih.gov
Jag Khalsa, Ph.D.
Chief, Medical Consequences of Drug Abuse and Co-occurring Infections Branch
Division of Pharmacotherapies and Medical Consequences of Drug Abuse
National Institute on Drug Abuse, NIH, DHHS
Telephone: 301-443-2159
Fax: 301-443-2599
Email: jkhalsa@nida.nih.gov
David M. Stoff, PhD
National Institute of Mental Health (NIMH)
Telephone: 301-443-4625
Email: dstoff@mail.nih.gov
Robert Freund, PhD
Center for Scientific Review (CSR)
Telephone: 301-435-1050
Email: freundr@csr.nih.gov
Robin Laney
National Institute on Aging (NIA)
Telephone: 301-496-1473
Email: laneyr@mail.nih.gov
Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4704
Email: jfox@mail.nih.gov
Shane Woodward
National Cancer Institute (NCI)
Telephone: 301-496-8791
Email: woodwars@mail.nih.gov
Ann Devine
National Institute of Allergy and Infectious Diseases
(NIAID)
Telephone: (240) 669-2988
Email: adevine@niaid.nih.gov
Bryan Clark
Eunice Kennedy Shriver National Institute of Child Health
and Human Development (NICHD)
Telephone: 301-435-6975
Email: clarkb1@mail.nih.gov
Carol Alderson
National Institute on Drug Abuse (NIDA)
Telephone: 301-933-6196
Email: aldersoc@nida.nih.gov
Rita Sisco
National Institute of Mental Health (NIMH)
Telephone: 301-443-2805
Email: siscor@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.
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