and Human Services (HHS)
EXPIRED
Department of Health and Human Services
Participating Organizations
National Institutes of Health (NIH) (http://www.nih.gov)
Canadian Institutes of Health Research (CIHR) (http://www.cihr.ca/)
National Alliance for Autism Research (NAAR) (http://www.naar.org)
Components of Participating Organizations
Fogarty International Center (FIC) (http://www.fic.nih.gov)
National Eye Institute (NEI) (http://www.nei.nih.gov)
National Institute on Aging (NIA) (http://www.nia.nih.gov)
National Institute on Alcohol Abuse and Alcoholism (NIAAA) (http://www.niaaa.nih.gov)
National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov)
National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov)
National Institute of Environmental Health Sciences (NIEHS) (http://www.niehs.nih.gov)
National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov)
National Institute of Neurological Disorders and Stroke (NINDS) (http://www.ninds.nih.gov)
Office of Dietary Supplements, Office of the Director (ODS) (http://dietary-supplements.info.nih.gov)
Institute of Neuroscience, Mental Health and Addiction (INMHA/CIHR) (http://www.cihr-irsc.gc.ca/e/8602.html)
Title: Brain Disorders in the Developing World: Research Across the Lifespan (R21)
Announcement Type
This is a modification of PAR-05-100, which was previously released on May 3, 2005.
Update: The following update relating to this announcement has been issued:
NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.
APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.
This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).
A registration process is necessary before submission and applicants are highly encouraged to start the process at least four weeks prior to the grant submission date. See Section IV.
Program Announcement Number: PAR-06-420
Catalog of Federal Domestic Assistance Number(s)
93.989, 93.866, 93.273, 93.173, 93.279, 93.113, 93.114, 93.115, 93.242, 93.853, 93.867, 93.209, 93.865
Key Dates
Release/Posted Date: May 17, 2006
Opening Date: May 17, 2006 (Earliest date an application may be submitted to Grants.gov)
NOTE: On time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of applicant institution/organization).
Letters of Intent Receipt Date(s): Applications not related to HIV/AIDS: April 16, 2007. HIV/AIDS-related applications only: July 23, 2007
Application Submission/Receipt Date(s): Applications not related to HIV/AIDS: May 16, 2007; HIV/AIDS-related applications only: August 23, 2006; August 23, 2007
Peer Review Date(s): October/November 2006 and October/November 2007
Council Review Date(s): January/February 2007 and January/February 2008
Earliest Anticipated Start Date(s): April 1, 2007 and April 1, 2008
Additional Information To Be Available Date (Activation Date): http://www.fic.nih.gov/programs/BrainDisorders.html
Expiration Date: August 24, 2007
Due Dates for E.O. 12372
Not Applicable
Additional Overview Content
Executive Summary
A concise description of the funding opportunity.
Table of Contents
Part I Overview Information
Part II Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
Section II. Award Information
1. Mechanism of Support
2. Funds Available
Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2. Cost Sharing or Matching
3. Other - Special Eligibility Criteria
Section IV. Application and Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Submission, Review, and Anticipated Start Dates
1. Letter of Intent
B. Sending an Application to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award Dates
Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting
Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/Grants Management Contact(s)
Section VIII. Other Information - Required Federal Citations
Part II - Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
The purpose of the Brain Disorders in the Developing World: Research Across the Lifespan FOA is to support the development and conduct of innovative, collaborative research and research training projects, between developed and developing country scientists, on brain disorders throughout life, relevant to low- and middle-income nations. The collaborative research programs are expected to 1) involve research on neurological/neurodevelopmental (including sensory, motor, cognitive and behavioral) function and impairment throughout life, and 2) contribute to the long-term goal of building sustainable research capacity in developing countries to initiate and conduct such research.
All projects should: 1) involve a partnership between developed and developing country individuals or research teams; 2) lead to pursuit of basic, epidemiological, clinical, prevention, intervention or health services research in the area of brain disorders of relevance to developing countries; and 3) build capacity, as necessary, in the proposed research area to enable further research to take place.
The R21 grant will provide support to assess needs, to initiate preliminary studies and training, and to organize, plan, prepare, and assemble the information and data for an application for a more comprehensive R01 application involving collaboration between the developed and developing country investigators.
Research Objectives
The overall intent of the program is three-fold: 1) to encourage multidisciplinary collaborative approaches to identify and address brain disorders of particular importance to low- and middle-income countries; 2) to address brain disorders of significance to developing nations by promoting international cooperation between scientists and institutions in these countries and investigators in the U.S. and other developed nations who are pursuing relevant research programs; and 3) to build and enhance the research capacity of developing nations to identify and address relevant brain/neurodevelopmental disorders across the lifespan.
Relevant research may range from basic science to epidemiological, translational (e.g. translation of basic research to therapy and of clinical research to applications in the field), clinical, operational and health services research.
The main goals of the application should be to: 1) assess research needs (define the problem and determine the magnitude of and factors involved in the problem to be addressed in the countries in question) and training needs for conduct of a follow-up R01 submission; 2) develop collaborations and needed resources; 3) show feasibility and generate preliminary data for the collaborative research to be proposed in a follow-up R01 submission; and 4) integrate capacity building/collaborator training into the proposed research program.
Applicants should propose specific milestones and a timeline to meet these goals. During the R21 award period, the applicant should:
Pilot research projects should demonstrate feasibility of certain aspects of the research approaches and develop further research directions. Training, informal meetings, workshops and small conferences may be conducted as necessary to develop the research and collaboration and for assessment of needs. New analyses of extant data sets and development or use of new methodologies or approaches may also be proposed. These activities may also serve to identify which specific research questions show the greatest promise for advancement in specific countries and settings. Travel among sites for these purposes may be proposed.
Each exploratory/planning grant should also present a description of the anticipated longer-term goals of the collaboration as it develops into an application for an R01 grant. As one outcome of the work under the R21, grantees will be expected to provide a detailed assessment of the specific research issues and capacity building/training needs in the developing country that the proposed follow-up R01 will address. The relevance of the focus of the proposed research to the health of the host endemic country should be justified. The assessment may include, but is not limited to, needed skills and expertise in laboratory, clinical, epidemiological and social science research.
In addition, the involvement, if any, of the developing country institution and faculty in formulating treatment and prevention policies locally, nationally, regionally or internationally should be noted.
Collaboration:
The purpose of the R21 mechanism is to foster initial development of collaborative work focused on brain disorders across the lifespan and relevant to developing countries; accordingly, investigators need not demonstrate any history of prior collaboration in the R21. However, those factors in the investigators' background and/or institutional circumstances that would facilitate success in such collaboration should be clearly delineated.
Plans for coordination of research and associated collaborator training between the partner country institutions should be described and should include regular meetings (virtual and/or physical).
Research Capacity Building Activities:
The proposed program should contain explicit strategies or plans to assess the research capacity needs and to strengthen this capacity through research training, career development, mentoring and/or other models. Research training for the developing country collaborators and their staff, in the context of the proposed R21 and subsequent R01 research, may take place at any of the collaborating sites and may vary, depending on the strengths of the particular investigators and institutions that apply and the need to build capacity to support research and future interventions. The major portion of the proposed research must be conducted at the developing country site or sites and the majority of the funds must be used for research and research-related costs at the developing country site (including collaborator training at the foreign site). Any research at the developed (high-income) country site must also involve training for participating developing country collaborators.
Background:
During the past several decades, improvements in health care have led to a decrease in infant mortality in the developing world. The continuing burden of infectious disease and malnutrition, along with a growing burden of chronic disease associated with aging populations, has resulted in a complex epidemiological situation. Developed nations have relatively high proportions of people aged 65 and over, but the most rapid increases in elderly populations are in the developing world. The current aggregate growth rate of the elderly population in developing countries is more than double that in developed countries, and also double that of the total world population. This increase in life expectancy is further complicated by the widespread incidence of neurological, psychiatric, and developmental disorders. With the exception of sub-Saharan Africa, brain disorders are the leading contributor to years lived with a disability in all regions of the world.
Policy makers began to recognize the social and economic impact of brain disorders, in part as a result of the 1996 publication of the global burden of disease study (Murray CJL, Lopez AD, Eds. The Global Burden of Disease And Injury Series, Volume 1: A Comprehensive Assessment Of Mortality And Disability From Diseases, Injuries, And Risk Factors In 1990 And Projected To 2020). This report compared the total cost of various diseases on the basis of disability-adjusted life years (DALYs), a measure that accounts for the overall burden of disease by combining years of potential life lost as a result of premature death with years of productive life lost because of disability.
Measures of mortality and disability do not include the social isolation and stigma experienced by individuals affected with brain disorders, as well as the financial hardship borne by affected individuals, their families, and the communities in which they live. As a result of negative attitudes, prejudice, and stigma, many affected with brain disorders remain undiagnosed and untreated. In addition to poverty and gender inequality that underlie many of the key risk factors for brain disorders, available care is frequently inadequate. In some countries, the overall physician-patient ratio can be low as 1:20,000, with even fewer psychiatrists and neurologists.
Despite the enormous burden of disease, brain disorders have been largely absent from the international health research agenda. Responding to the growing awareness of brain disorders in the developing world, in 1999 the U.S. Institute of Medicine was charged to prepare a study that would define the increasing burden, identify opportunities for effectively reducing the burden, and identify areas for intervention, research, and capacity building. The results were compiled in a report entitled "Neurological, Psychiatric, and Developmental Disorders: Meeting the Challenges in the Developing World" (2001, available at http://books.nap.edu/books/0309071925/html/). Study sponsors included the National Institutes of Health (Fogarty International Center, the National Institute of Child Health and Human Development, the National Institute of Neurological Disorders and Stroke, and the National Institute of Mental Health), the U.S. Centers for Disease Control and Prevention, and the Global Forum for Health Research.
The report brings together a growing body of evidence indicating that the social and economic impact of neurological, psychiatric, and developmental disorders is large and increasing. Present figures almost certainly underestimate the impact of brain disorders, particularly in the developing world. A sustained, comprehensive, and integrated research effort is the key to reducing the burden of brain disorders in the developing world. Among the main recommendations of the report was the need to create both national centers for training and research, as well as programs to facilitate competitive funding for research on developmental disabilities and epilepsy in resource-poor nations. The WHO 2001 World Health Report documented and contributed to the data on the burden of brain disorders in the developed and developing world alike ( WHO World Health Report 2001: Mental Health: New Understanding, New Hope ).
This FOA focuses on conditions and influences on the nervous system that affect cognition, learning and memory across the lifespan. Examples of specific conditions that affect brain function across the lifespan include, but are not limited to, neurodevelopmental disorders, neurodegenerative diseases (such as Alzheimer's and Parkinson's Diseases), neurotoxic insults, infection of the nervous system by viral and parasitic diseases (such as HIV/AIDS and malaria), pre- and post-natal environmental insults and physical trauma (e.g., fetal alcohol syndrome, drug abuse/exposure, child abuse and neglect, shaken baby syndrome and traumatic nervous system injury due to accidents).
Neurodevelopmental disabilities include conditions such as mental retardation, behavioral disorders, learning disabilities and cerebral palsy that result from abnormal prenatal development, influences during the prenatal period, or from injury or insult to the brain and central nervous system during infancy or childhood. In the U.S., approximately 12 to 18 percent of children are disabled. Many of the causes of developmental disabilities including genetic and nutritional factors, infectious diseases, environmental toxins, and traumatic events are particularly common in resource-poor countries, suggesting that the prevalence is expected to be even higher.
Some disabling brain disorders are readily treatable at low cost, and yet many in developing countries suffer untreated with detrimental individual, family and societal consequences. As an example, epilepsy is a treatable brain disorder that affects an estimated 40 million people in developing countries, roughly 85 percent of the total number affected worldwide. Epilepsy commonly affects young adults in the most productive years of their lives and frequently leads to their being unemployed. Although inexpensive and effective treatments are available, epilepsy is frequently untreated and even unrecognized in the developing world often because of stigmatization and lack of knowledge. In such disorders, research into interventions taking social and cultural factors into account and involving education, media, policy and behavior are especially appropriate.
Prevention of disability due to neurological impairment is also possible in many situations with appropriate research leading to knowledge and interventions. For example, research to identify neurotoxins and their mechanisms can be combined with interventions to minimize human exposure to known neurotoxins by reduction in use or release to the environment and by appropriate safeguards in occupational settings.
Infectious diseases can also have significant neurological consequences. HIV infection is an example. Estimates from UNAIDS and WHO state that 36 to 44 million people were HIV-infected worldwide at the end of 2004. Importantly, 23 to 28 million reside in sub-Saharan Africa while nearly 7.1 million are in south and south-east Asia. Extensive research carried out in the developed countries has demonstrated that neurological complications, such as HIV-1-associated dementia, occurred in 20-30 percent of symptomatic individuals prior to the introduction of anti-retroviral therapy. Symptoms of HIV-associated dementia include slowing of motor and mental function with memory loss and language difficulty. Other neurological complications such as peripheral neuropathy and HIV-associated myelopathy also occur following HIV infection. In addition, opportunistic infections such as cryptococcal meningitis, bacterial meningitis, toxoplasmosis and neurosyphilis frequently cause neurological problems. Although a large number of individuals are HIV-infected in developing countries, very limited data are available on the epidemiology, natural history and pathogenesis of neurological disease caused by HIV and associated opportunistic infections in these settings.
This FOA attempts to address, on a sustained basis, these and other health research issues relevant to brain disorders in developing countries. Applicants may propose a research and capacity building program on brain disorders with a focus on neurological (including sensory, motor, cognitive and behavioral) function and impairment throughout life.
Research Topics:
Relevant research topics should be related to neurodevelopmental disabilities and neurological disorders, including cognitive, motor, sensory and behavioral impairment from birth to advanced age. Research findings must be relevant to the collaborating developing nation(s). Some examples are: mental retardation, seizure disorders such as epilepsy, movement disorders such as Parkinson's and dementias - including those related to age and those caused by HIV, malaria or other infections.
Research relevant to this announcement includes basic research and epidemiology, as well as research on early interventions, clinical treatment, prevention, and health services that are culturally appropriate, feasible, and acceptable for implementation within the foreign country. This FOA encourages development of multidisciplinary research, whenever relevant to the research question. Expertise may involve, but is not limited to, fields such as neurology, cognitive neuroscience, developmental neurobiology, neurotoxicology, neuroendocrinology, pharmacology, psychiatry, neuro-immunology, neuro-virology, and biotechnology (e.g., for development of diagnostic tools), as well as the behavioral and social sciences.
Examples of some cross-cutting areas for research incorporating social sciences are:
Suggested areas of research include, but are not limited to:
1. Epidemiological studies
3. Research on potential interventions and how the success or failure of interventions may be modulated by sociocultural and gender variables. Primary outcomes of the proposed R21 activities should be specification of a further research agenda with needed capacity building. The activities proposed should include design and execution of small, preliminary studies to demonstrate feasibility and obtain pilot data.
Activities undertaken under the planning grant may include, but are not limited to:
Specific Research Interests of the FOA Sponsors:
Applicants can obtain information and research interests for each of the sponsoring Institutes and Centers (ICs) and organizations listed on the first page of this announcement at their respective web sites and by contacting the appropriate program contact listed in this announcement (Section VII. Agency Contacts). Some of the participating ICs and organizations have provided additional statements of interest. Only applications within these stated interests will be considered by that IC or organization, and potential applicants are strongly encouraged to contact the relevant IC or organization prior to submitting a letter of intent):
NIH:
The Fogarty International Center (FIC) is interested in all eligible applications that are responsive to this FOA.
The National Eye Institute (NEI) conducts and supports research that helps prevent and treat eye diseases and other disorders of vision, and which leads to sight-saving treatments, reduces visual impairment and blindness, and improves the quality of life for people of all ages. In the context of this announcement, NEI would particularly like to encourage research on eye diseases relevant to developing countries and involving neuronal cell dysfunction and degeneration (such as, but not restricted to, retinitis pigmentosa, age-related macular degeneration, cataracts and glaucoma).
The National Institute on Aging (NIA) is interested in applications relevant to Alzheimer's disease and other degenerative diseases of the nervous system, and age-related changes in cognition and memory. Of interest also are studies on reducing disability and/or preventing or slowing additional decline among persons with neurological disabilities as they continue to age.
The National Institute on Alcohol Abuse and Alcoholism (NIAAA) is interested in applications that address alcohol-related birth defects (such as Fetal Alcohol Syndrome).
The National Institute of Child Health and Human Development (NICHD) is particularly interested in encouraging studies in response to this announcement, which propose to address problems in child health and development, such as mental retardation, cognitive and behavioral disorders, neurodevelopmental disabilities and learning disabilities. Relevant research includes etiology, pathophysiology, screening, prevention, treatment, and epidemiology. Also of interest are studies on cognitive, social, and affective development, including studies in high-risk settings (e.g., in violent or abusive environments, or families experiencing stressors such as poverty, unemployment or parental depression). Biomedical, behavioral, and biobehavioral research in these areas is encouraged along with investigations of socio- and ethno-cultural, familial, individual, and biological influences. Also of interest are studies investigating the roles played by nutritional and hormonal factors in nervous system development and function.
The National Institute on Drug Abuse (NIDA) is interested in applications which focus on behavioral, cognitive and neurobiological factors as antecedents to, or impacting on, consequences of drug abuse. Of particular interest are studies aimed at reducing drug abuse and addiction and its associated adverse social, behavioral, and health consequences (e.g., violence and infectious diseases transmission and including research related to the interaction between HIV/AIDS and abuse). NIDA especially encourages research capitalizing on unique opportunities to study adverse environmental and socio-cultural effects on drug abuse patterns and behaviors in populations of developing countries (e.g., caregiver neglect or abandonment, large orphan populations or street children at risk for both drug abuse and HIV or HCV). In countries where abuse of high doses of individual drugs is more common than in the U.S. and Europe, NIDA is interested in supporting studies on prenatal effects, cognitive consequences, epidemiological patterns, and associations with HIV/AIDS and other transmitted diseases. NIDA will give priority to meritorious research that builds upon existing NIDA-funded collaborations between developed and developing country colleagues.
The National Institute of Environmental Health Sciences (NIEHS) is interested in supporting research in the developing world to identify the causes of, and opportunities to prevent or ameliorate the consequences of, neurotoxic insult to the nervous system throughout life (pesticides, heavy metals etc.).
The National Institute of Mental Health (NIMH) is interested in research limited to areas relating to epidemiology, natural history, and pathogenesis of HIV-associated disease of the nervous system.
The National Institute of Neurological Disorders and Stroke (NINDS) encourages research across the spectrum of neurological disorders to reduce the burden of neurological disease borne by every age group and segment of society all over the world.
Canada:
The Institute of Neurosciences, Mental Health and Addiction (INMHA) of the Canadian Institutes of Health Research (CIHR) is interested in co-sponsoring collaborative proposals between Canadian and low- to middle-income country investigators. Eligible applications include those dealing with the spectrum of research related to neurological disorders, mental illnesses and addictions. CIHR will provide direct funding to meritorious Canadian applicants.
Other Participating Organizations:
The National Alliance for Autism Research (NAAR) will consider support for scientifically meritorious autism-related research proposals and will provide direct funding to meritorious applicants
See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.
Section II. Award Information
1. Mechanism of Support
This FOA will use the NIH Exploratory/Developmental Research Grant (R21) award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.
This FOA uses just-in-time concepts. It also uses the modular budget formats (see the Modular Applications and Awards section of the NIH Grants Policy Statement. Specifically, if you are submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs), use the PHS398 Modular Budget component provided in the SF424 (R&R) Application Package and SF424 (R&R) Application Guide (see specifically Section 5.4, Modular Budget Component, of the Application Guide).
Exploratory/developmental grant support is for new projects only; competing renewal (formerly competing continuation ) applications will not be accepted. Up to two resubmissions (formerly revisions/amendments") of a previously reviewed exploratory/developmental grant application may be submitted. See NOT-OD-03-041, May 7, 2003.
If a consortium is involved, please see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-004.html for information on the relationship of F&A costs on subcontracts to the direct costs requested.
2. Funds Available
Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the ICs provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.
Consortium/Contractual Facilities and Administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004. Foreign applicant organizations may now request up to 8% administrative costs (excluding equipment) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-028.html).
The participating organizations, the Fogarty International Center (FIC), the National Eye Institute (NEI), the National Institute on Aging (NIA), the National Institute on Alcohol Abuse and Alcoholism (NIAAA), the National Institute of Child Health and Human Development (NICHD), the National Institute on Drug Abuse (NIDA), the National Institute of Environmental Health Sciences (NIEHS), the National Institute of Mental Health (NIMH), the National Institute of Neurological Disorders and Stroke (NINDS), and the Office of Dietary Supplements of the Office of the Director (ODS/OD), all of the National Institutes of Health (NIH), along with the Institute of Neuroscience, Mental Health and Addiction (INMHA) of the Canadian Institutes of Health Research (CIHR), and the National Alliance for Autism Research (NAAR), intend to commit approximately $2,000,000 in FYs 2007 and 2008 to fund five to 15 applications. At this time, it is not known if this FOA will be reissued.
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.
Facilities and Administrative (F&A) costs requested by consortium participants are not included in the direct cost limitation. See NOT-OD-05-004.
Section III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
You may submit an application(s) if your organization has any of the following characteristics:
EXCEPTIONS: Financial institutions and international intergovernmental organizations are not eligible to apply for FIC research or training programs. However, staff of such institutions, if invited by eligible applicants, may serve as unpaid collaborators or consultants on such projects.
At least two institutions, one in a developed (high-income) country and one in a developing (low- to middle-income) country, will be involved as partners in the grant application.
See http://www.worldbank.org/data/countryclass.html for World Bank country classification tables to identify those countries considered low- or middle-income. Hong Kong-based institutions are not eligible as the primary low- to middle-income country partner institution. A second institution in mainland China must be involved as the primary collaborating foreign institution if an institution in Hong Kong is included as a partner institution. Taiwan is not listed in the World Bank income classification list but is considered high-income.
1.B. Eligible Individuals
Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI), and whose institution meets the institutional eligibility criteria, 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.
This announcement provides an avenue for investigators in developed countries and those in developing countries, with shared interests in brain disorders, to explore, initiate and implement research collaborations between themselves and their institutions. Therefore, at least two investigators, one from an institution in a developed (high-income) country and one from an institution in a developing country (low- to middle-income) (see definitions above, under Eligible Institutions ) must collaborate on the application as Principal Investigator (PI) and Co-Investigator. The PI may be from the developing country institution or from the developed country institution, but the collaborators must prepare the proposal jointly. While there is no cap on the maximum number of investigators or institutions involved, the applicant must discuss how the contributions of each member will be integrated in the proposed activities.
2. Cost Sharing or Matching
Not applicable. This program does not require cost sharing as defined in the current NIH Grants Policy Statement.
3. Other-Special Eligibility Criteria
An individual investigator may only be involved as PI or primary collaborator on one application per round.
Applicant organizations may submit more than one application, provided each application is scientifically distinct. However, the NIH will not accept similar grant applications with essentially the same research focus from the same applicant organization.
Section IV. Application and Submission Information
To download a SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.
A one-time registration is required for institutions/organizations at both:
PD/PIs should work with their institutions/organizations to make sure they are registered in the eRA Commons.
Several additional separate actions are required before an applicant institution/organization can submit an electronic application, as follows:
1) Organizational/Institutional Registration in Grants.gov/Get Started
2) Organizational/Institutional Registration in the eRA Commons
3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.
Note that if a PD/PI is also an NIH peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.
Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.
1. Request Application Information
Applicants must download the SF424 (R&R) application forms and SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.
Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the "Attachment" files may be useable for more than one FOA.
For further assistance, contact GrantsInfo: Telephone 301-710-0267, Email: [email protected].
Telecommunications for the hearing impaired: TTY 301-451-5936.
2. Content and Form of Application Submission
Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide (MS Word or PDF).
The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by NIH (e.g., the Credential log-in field of the Research & Related Senior/Key Person Profile component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see Tips and Tools for Navigating Electronic Submission on the front page of Electronic Submission of Grant Applications.
The SF424 (R&R) application is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY will include all applicable components, required and optional. A completed application in response to this FOA will include the following components:
Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
PHS398 Modular Budget
Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s) Form
Note: While both budget components are included in the SF424 (R&R) forms package, the NIH R21 uses ONLY the PHS 398 Modular Budget. (Do not use the detailed Research & Related Budget.)
Foreign Organizations
Several special provisions apply to applications submitted by foreign organizations:
3.A.1. Letter of Intent
Prospective applicants are asked to submit a letter of intent that includes the following information:
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.
The letter of intent is to be sent by the date listed in Section IV.3.A.
The letter of intent should be sent to:
Dr. Kathleen Michels
Program Director
Division of International Training and Research
Fogarty International Center
Building 31, Room B2C39
31 Center Drive, MSC 2220
Bethesda, MD 20892-2220
Telephone: (301) 496-1653
Fax: (301) 402-0779
Email: [email protected]
3.B. Sending an Application to the NIH
To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/Apply and follow steps 1-4. Note: Applications must only be submitted electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED.
3.C. Application Processing
Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the application submission/receipt date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the receipt date(s) and time, the application may be delayed in the review process or not reviewed.
Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two business days to view the application image.
Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Incomplete applications will not be reviewed.
There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. Information related to the assignment of an application to a Scientific Review Group is also in the Commons.
The NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of an application already reviewed with substantial changes, but such application must include an Introduction addressing the previous critique. Note such an application is considered a "resubmission" for the SF424 (R&R).
4. Intergovernmental Review
This initiative is not subject to intergovernmental review.
5. Funding Restrictions
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
It is expected that the majority of the funds awarded will be used for supplies, equipment, services, travel and personnel at the developing country site, and that any funds spent at the developed country site will involve the developing country collaborators and will be directly related to the collaborative research or training under the R21 award.
Pre-Award Costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new award.
The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See the NIH Grants Policy Statement.
6. Other Submission Requirements
The NIH requires the PD/PI to fill in his/her Commons User ID in the PROFILE Project Director/Principal Investigator section, Credential log-in field of the Research & Related Senior/Key Person Profile component. The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see Tips and Tools for Navigating Electronic Submission on the front page of Electronic Submission of Grant Applications.
Note: While each section of the Research Plan needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.
Supplemental Instructions:
Applications need not include preliminary data although it is recommended that relevant data be included if it supports the proposed research.
Applications should include a plan for assessment of needs for resources and capacity building to enable the proposed research to be carried out (including training in research, research ethics, and human and animal subjects guidelines, as appropriate).
Because the applications may be funded or co-funded by the NIH, CIHR or NAAR, all applicants should submit a brief letter to the NIH indicating that the application and the Summary Statements for such applications, and the Progress Reports of funded grants can be shared with CIHR and NAAR. Letters of authorization should be prepared by the Principal Investigator and co-signed by the official signing for the applicant organization. This letter may be submitted as a cover letter accompanying the application.
Since foreign sites are involved and are the main focus of the grant, applicants should include a description of the items, services and personnel for which the requested funds will be used and where they will be used, subject to the Funding Restrictions described above.
A network meeting involving grantees of these awards will be held in the Washington, D.C. area in FY s2007, 2008 and 2009 to share information and discuss new insights, and will include grants-writing and other workshops according to the needs of the awardees and program. Each R21 applicant should budget for one such meeting. Funds should be budgeted for travel by the PIs, collaborators and/or other relevant individuals with significant day-to-day involvement in the activities performed under this award. Involvement of the collaborating investigators from the low-to middle country institution is especially encouraged.
The following materials may be included in the Appendix:
Up to five publications, manuscripts (accepted for publication), abstracts, patents, or other printed materials directly relevant to the proposed project. Do not include manuscripts submitted for publication. Applicants should refer to instruction guides and specific Funding Opportunity Announcements (FOAs) to determine the appropriate limit on the number of publications that may be submitted for a particular program. Note that not all grant mechanisms allow the inclusion of publications.
Applicants are cautioned not to use the Appendix to circumvent the page limitations of the Research Plan. An application that does not observe the relevant policies and procedures may be delayed in the review process.
Applicants are reminded to review specific FOAs for any additional program-specific guidance on Appendix material and other application requirements.
Plan for Sharing Research Data
All applicants must include a plan for sharing research data in their application. The data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing. All investigators responding to this funding opportunity should include a description of how final research data will be shared, or explain why data sharing is not possible.
The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.
The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.
Sharing Research Resources
N/A
Section V. Application Review Information
1. Criteria
Only the review criteria described below will be considered in the review process.
2. Review and Selection Process
Applications submitted for this funding opportunity will initially be assigned to FIC.
Appropriate scientific review groups convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit.
Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the Center for Scientific Review in accordance with the review criteria stated below.
As part of the initial merit review, all applications will:
Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:
The NIH R21 exploratory/developmental grant is a mechanism for supporting novel scientific ideas or new model systems, tools, or technologies that have the potential to significantly advance our knowledge or the status of health-related research. Because the Research Plan is limited to 15 pages, an exploratory/developmental grant application need not have extensive background material or preliminary information as one might normally expect in an R01 application. Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Reviewers will place less emphasis on methodological details and certain indicators traditionally used in evaluating the scientific merit of R01 applications, including supportive preliminary data. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R21 applications; however, they may be included if available.
The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application.
Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.
Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Is the research on a problem of particular relevance for the foreign country involved?
Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? For projects with multiple sites and/or multidisciplinary components, is there an adequate plan to coordinate and integrate the research among the sites/components?
In conducting an evaluation of the scientific assessment of Approach criteria, SRGs will also evaluate the involvement of human/animal subjects, the proposed plans for inclusion of minorities and members of both sexes/genders. The evaluation will be factored into the overall score for scientific and technical merit of the application.
Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area? Does the project make use of unique or special expertise, resources, circumstances or environment of the foreign site to frame or address the research question? Does the project propose innovative or special ways to incorporate capacity building or training into the research program at the foreign site?
Investigators: The collaborators may each be at various stages in their respective careers. Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the PD/PI and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?
Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support? Are the resources necessary to perform the research available or obtainable at the foreign site? Has the primary Foreign Collaborator’s home institution made a convincing commitment (e.g., provided a research/academic appointment and salary support)? Does the R21 proposal include a plan to assess what specific resource and training needs to conduct the proposed research exist at the foreign site and a proposal to begin to meet those needs?
International Research Collaboration: In the course of the research, what is the potential for sustainable collaborations between the developed and developing country scientists to be established? Does the research constitute a substantial scientific endeavor for the Foreign Collaborator, including creative and scientific input to the research proposal? The foreign site and investigators should not be used merely to gather biological samples (clinical, plants, etc.) or behavioral data (interviews, surveys, etc.). In all cases, the Foreign Collaborators should be actively involved in analyzing and interpreting the data.
Research Capacity Building: What is the potential for the developing country institutions to improve their capacity and ability to address important issues in brain disorders research, develop independently-supported research programs and obtain financial support nationally and internationally? How will this occur? Does the proposed program contain explicit strategies or plans to assess the research capacity needs and to strengthen this capacity through research training, career development, mentoring and other models? Will the proposed research and collaboration lead to enhancement of specific departments in foreign institutions and contribute to overall institutional excellence? Does the proposed project describe a plan to assess research and capacity building needs and ways to address those needs?
The potential of the R21 planning grant to lay the foundation for future collaborative research grant applications and the potential significance of the proposed research and capacity building will be major considerations in the evaluation of the R21 exploratory/developmental grant mechanism. Because the R21 is designed to support planning, development and initiation of innovative collaborative research and ideas, preliminary data as evidence of feasibility of the project are not required to apply, although it is useful to include or cite pilot data where relevant and available. The applicant is, however, responsible for presenting the background literature that provides sound basis for the approach and for developing a rigorous research plan.
2.A. Additional Review Criteria:
In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:
Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. See item 6 of the Research Plan component of the SF424 (R&R).
Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. See item 7 of the Research Plan component of the SF424 (R&R).
Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under item 11 of the Research Plan component of the SF424 (R&R) will be assessed.
2.B. Additional Review Considerations
Budget and Period of Support: The reasonableness of the proposed budget and the appropriateness of the requested period of support in relation to the proposed research may be assessed by the reviewers. Is the percent effort listed for the PD/PI appropriate for the work proposed? Is each budget category realistic and justified in terms of the aims and methods?
2.C. Sharing Research Data
Not applicable.
2.D. Sharing Research Resources
Not applicable.
3. Anticipated Announcement and Award Dates
Not applicable.
Section VI. Award Administration Information
1. Award Notices
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 NIH eRA Commons.
If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official.
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. See Section IV.5., Funding Restrictions.
2. Administrative and National Policy Requirements
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.
3. Reporting
When multiple years are involved, awardees will be required to submit the Non-Competing Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.
In the performance site block on the PHS2590, Grantees must list BOTH the developed and developing country sites at which the work is being carried out and the primary collaborator contact at the foreign site.
Section VII. Agency Contacts
We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:
1. Scientific/Research Contacts:
General Inquiries regarding the scope and content of this Program Announcement should be directed to:
Dr. Kathleen Michels
Program Director
Division of International Training and Research
Fogarty International Center
Building 31, Room B2C39
31 Center Drive, MSC 2220
Bethesda, MD 20892-2220
Telephone: (301) 496-1653
Fax: (301) 402-0779
Email: [email protected]
Direct your questions about Scientific/Research Issues to the contacts below:
Canada:
Canadian Institutes of Health Research:
Astrid Eberhart
Institute Liaison
Institute of Neurosciences, Mental Health and Addiction
Canadian Institutes of Health Research
410 Laurier Avenue W., 9th Floor
Address Locator 4209A
Ottowa, ON K1A 0W9
Telephone: (613) 941-4643
Fax: (613) 941-1040
Email: [email protected]
United States:
FIC/NIH:
Kathleen Michels, Ph.D.
Program Director
Division of International Training and Research
Fogarty International Center
National Institutes of Health
Building 31, Room B2C39, MSC 2220
Bethesda, MD 20892-2220
Telephone: (301) 435-6031
Fax: (301) 402-0779
Email: [email protected]
NEI/NIH
Michael D. Oberdorfer, Ph.D.
Director, Strabismus, Amblyopia, and Visual Processing Program
Division of Extramural Research
National Eye Institute
Executive Plaza South, Suite 350
6120 Executive Blvd, MSC 7164
Bethesda MD 20892-7164
Telephone: (301) 451-2020
Fax: (301) 402-0528
Email: [email protected]
NIA/NIH:
Andrew A. Monjan, Ph.D., M.P.H.
Chief, Neurobiology of Aging Branch
Neuroscience and Neuropsychology of Aging Program
National Institute on Aging
Gateway Building, Suite 350
7201 Wisconsin Avenue, MSC 9205
Bethesda, MD 20892-9205 (use 20814 for express mail)
Telephone: (301) 496-9350
Fax: (301) 496-1494
Email: [email protected]
NIAAA/NIH:
Margaret M. Murray, M.S.W.
Chief, Health Sciences Education Branch
Office of Research Translation and Communications
National Institute of Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 3105, MSC 9304
Bethesda, MD 20892-9304
Telephone: (301) 443-2594
Fax: (301) 480-1726
Email: [email protected]
NICHD/NIH:
Mary Lou Oster-Granite, Ph. D.
Health Scientist Administrator
Acting Chief
Mental Retardation and Developmental Disabilities Branch
Center for Developmental Biology and Perinatal Medicine
National Institute of Child Health and Human Development
National Institutes of Health
Room 4B09G, MSC 7510
6100 Executive Boulevard
Bethesda, MD 20892-7510 (for express mail, use Rockville, MD 20592)
Telephone: (301) 435-6866
Fax: (301) 496-3791
E-mail: [email protected]
NIDA/NIH:
L. R. Stanford, Ph.D.
Developmental Neurobiology Program
Behavioral and Brain Development Branch
Division of Clinical Neuroscience, Development, and Behavioral Treatment
National Institute on Drug Abuse
National Institutes of Health
6001 Executive Boulevard, Room 4232, MSC 9593
Bethesda, MD 20892-9593
Telephone: (301) 402-3869
Fax: (301) 443-6814
Email: [email protected]
NIEHS/NIH:
Annette Kirshner, Ph.D.
NIEHS-DERT
Box 12233, MD EC-23
Research Triangle Park, NC 27709
Telephone: (919) 541-0488
Fax: (919) 541-5064
Email: [email protected]
NIMH/NIH:
Jeymohan Joseph, Ph.D.
Chief, HIV NeuroVirology, Genetics and Molecular Therapeutics Program
Center for Mental Health Research on AIDS
National Institute of Mental Health
National Institutes of Health
Room 6202, MSC 9619
6001 Executive Blvd
Bethesda, MD 20892-9619 (FedEx: Rockville, MD 20852)
Telephone: (301) 443-3012
Fax: (301) 443-9719
Email: [email protected]
NINDS/NIH:
Yuan Liu, Ph.D.
Program Director
National Institute on Neurological Disorders and Stroke
National Institutes of Health
NSC/2110B, 6001 Executive Blvd, MSC 9529
Bethesda, MD 20892-9529
Telephone: (301) 496-1917
Fax: (301) 402-0182
Email: [email protected]
ODS/OD/NIH:
Mary Frances Picciano, Ph.D.
Senior Nutrition Research Scientist
Office of Dietary Supplements
National Institutes of Health
6100 Executive Boulevard, Suite 3B01
Bethesda, MD 20892-7517
Telephone: (301) 435-3608
Fax: (301) 480-1845
Email: [email protected]
Other Participating Organizations:
National Alliance for Autism Research (NAAR):
Andy Shih
Chief Science Officer
99 Wall Street
Princeton, NJ 08540
Telephone: (609) 430-9160
Fax: (609) 430-9163
Email: [email protected]
2. Peer Review Contacts:
Sherry L. Dupere, Ph.D.
Chief, Biology of Development and Aging IRG
Center for Scientific Review
6701 Rockledge Drive, Room 5136, MSC 7840
Bethesda, MD 20892-7840 (FedEx: 20817)
Telephone: (301) 435-1021
Fax: (301) 480-3567
Email: [email protected]
3. Financial or Grants Management Contacts:
FIC/NIH:
Bruce Butrum
Grants Management Officer
Fogarty International Center
National Institutes of Health
Building 31, Room B2C29
Bethesda, MD 20892-2220
Telephone: (301) 496-1670
Fax: (301) 594-1211
Email: [email protected]
NEI/NIH:
William W. Darby
Grants Management Officer
Division of Extramural Research
National Eye Institute
National Institutes of Health
Executive Plaza South, Suite 350
6120 Executive Boulevard, MSC 7164
Bethesda, MD 20892-7164
Telephone: (301) 451-2020
Fax: (301) 496-9997
Email: [email protected]
NIA/NIH:
Deborah Stauffer
Lead Grants Management Specialist
National Institute on Aging
Gateway Building, Suite 2N212
7201 Wisconsin Avenue
Bethesda, MD 20892-9205
Telephone: (301) 496-1472
Fax: (301) 402-3672
Email: [email protected]
NIMH/NIH:
Rebecca Claycamp
Chief Grants Management Officer
Grants Management Branch
National Institute of Mental Health
National Institutes of Health
6001 Executive Boulevard, Room 6122, MSC 9605
Bethesda, MD 20892-9605
Telephone: (301) 443-2811
Fax: (301) 443-6885
Email: [email protected]
Section VIII. Other Information
Required Federal Citations
Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.
Human Subjects Protection:
Federal regulations (45 CFR 46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants ( NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).
Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.
Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.
Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement. Beginning October 1, 2004, all investigators submitting an NIH application or contract proposal are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.
Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the SF424 (R&R) application; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.
Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.
All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).
Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research. Applications that do not provide this information will be returned without review.
NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.
NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.
For more information about the Policy or the submission process, please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view the Policy or other Resources and Tools, including the Authors' Manual.
Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).
Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.
Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.
Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. 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. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.
Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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