and Human Services (HHS)
EXPIRED
Department
of Health and Human Services
Participating
Organizations
National Institutes of Health (NIH), (http://www.nih.gov/)
Components of Participating Organizations
Office of Behavioral and Social Sciences Research
(OBSSR), (http://obssr.od.nih.gov)
National Cancer Institute (NCI), (http://www.nci.nih.gov)
National Center for Complementary and
Alternative Medicine (NCCAM), (http://nccam.nih.gov)
National Heart, Lung, and Blood Institute
(NHLBI), (http://www.nhlbi.nih.gov)
National Institute of Dental and Craniofacial
Research (NIDCR), (http://www.nidr.nih.gov)
National Institute of Mental Health (NIMH), (http://www.nimh.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 on Drug Abuse (NIDA), (http://www.nida.nih.gov)
National Institute on Child Health and Human
Development (NICHD), (http://www.nichd.nih.gov)
Title: Research on
Mind-Body Interactions and Health (R01)
Announcement Type
This is a reissuance of PA-05-027,
for electronic submission, which was previously released on December 10, 2004.
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 (PA) Number: PA-07-046
Catalog of Federal Domestic Assistance Number(s)
93.213, 93.837, 93.866, 93.273, 93.279,
93.865, 93.399, 93.114, 93.121, 93.242
Key
Dates
Release/Posted
Date: November 21, 2006
Opening Date: January 5, 2007 (Earliest date an application may be submitted to
Grants.gov)
Letters of Intent Receipt Date(s): Not Applicable
NOTE: On time submission requires that
applications be successfully submitted to Grants.gov no later than 5:00 p.m.
local time (of the applicant institution/organization).
Application Submission/Receipt Date(s):
Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm
AIDS Application
Submission/Receipt Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS.
Peer Review Date(s): Standard dates apply,
please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review Date(s): Standard dates apply,
please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Additional Information To Be Available Date (URL
Activation Date): Not Applicable
Expiration Date: January 3, 2010 (now January 8, 2010 per NOT-OD-07-093)
Due Dates for E.O. 12372
Not Applicable
Additional
Overview Content
Executive Summary
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. Submitting an Application
Electronically 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 Contacts
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 Public Health Service has documented that many of the leading causes of
morbidity and mortality in the U.S. are attributable to social, behavioral, and
lifestyle factors (e.g., tobacco use, lack of exercise, poor diet, and drug and
alcohol abuse). Numerous studies have also documented that psychological stress
is linked to a variety of health outcomes, and researchers and public health
officials are becoming increasingly interested in understanding the nature of
this relationship. Research has shown, for example, that psychological stress
can contribute to increased heart disease, decreased immune system functioning,
and premature aging. Other research has demonstrated that cognitions
(attitudes, beliefs values), social support, prayer, and meditation can reduce
psychological stress and contribute to positive health outcomes. Consequently,
over the past decade the National Institutes of Health have increased efforts
to encourage and support health and behavior research (e.g., Innovative
Approaches to Disease Prevention through Behavior Change, NIH Guide to Grants
and Contracts, October 24, 1997; Maintenance of Behavioral Change, NIH Guide to
Grants and Contracts, January 15, 2003). Mind-body research is viewed as one
component of health and behavior research. In 1999, using funds especially
appropriated by Congress to the OBSSR, the NIH issued a Request for
Applications (RFA) for Centers for Mind-Body Interactions and Health
(OD-99-005) and subsequently awarded five P50 Center Grants (http://obssr.od.nih.gov/Content/Research/Request_for_Applications_(RFAs)/mbpage.htm).
On January 9 2003, NIH issued two related RFAs on Mind-Body Interactions and
Health: Research Infrastructure Program (OB-03-004; see http://grants.nih.gov/grants/guide/rfa-files/RFA-OB-03-004.html)
and Mind-Body Interactions and Health: Exploratory/developmental Research
Program (OB-03-005; http://grants.nih.gov/grants/guide/rfa-files/RFA-OB-03-005.html).
NIH issued a RFA on July 14, 2003 for research project grants (OD-03-008; http://grants.nih.gov/grants/guide/rfa-files/RFA-OD-03-008.html).
The current program announcement is based upon the July 2003 RFA.
During approximately the same time period, the NIH has commissioned a series of reports from the National Research Council and the Institute of Medicine, such as "New Horizons in Health: An Integrative Approach" (National Academy Press, 2001) and "Health and Behavior: The Interplay of Biological, Behavioral, and Societal Influences (National Academy Press, 2001). These reports include calls for expansion of interdisciplinary health research on mind-body topics. (See summary of recommendations at http://obssr.od.nih.gov/Content/Publications/Books_And_Reports/NRC-Reports.htm.)
Research Topics
Three areas of research are emphasized. In addition, special importance is given to mind-body research in diverse racial/ethnic and socioeconomic status populations (e.g., cultural beliefs regarding health and choice of treatments, such standard care vs. alternative or folk treatments; perceived racism and health; distrust of health care systems and health care utilization). The formation of multidisciplinary teams to perform the research of this initiative is viewed as essential.
1) The first area of emphasis is the effect of cognitions or personality (e.g., beliefs, attitudes, and values; modes of thinking) and of emotions on physical health. Included is research on social, psychological, behavioral, affective, and biological factors mediating these effects. What are the physiological, behavioral, and social pathways by which beliefs, attitudes, and values or particular stress- management interventions affect health? How do emotions, personality, and cognitions interact to affect health?
2) The second emphasis is on determinants or antecedents of health-related cognitions (beliefs, attitudes, or values; modes of thinking; decision-making styles). That is, given that some beliefs and attitudes have been shown to affect health, how are these beliefs, attitudes, and values developed, maintained, or changed?
Specifically, this program announcement encourages research that addresses issues such as: What contributes to individual differences in the beliefs, attitudes, and values that affect health and biological processes? How are health-related beliefs, attitudes, and values formed, maintained, and changed? How do social class, family, culture, disability, age, gender, or ethnicity influence health-related beliefs, attitudes, values, or cognitive styles?
3) The third is on how stress influences health, including: (a) basic research investigating how affect, attitudes, beliefs, and values influence perceived stress, individual differences in the biology of stress, and interactions between stress and behavioral risk factors for disease; (b) behavioral, affective, and biological mediators of the relationship between stress and health or disease, (c) the evaluation of mind-body interventions (e.g., relaxation-based, cognitive therapy, or support group) for physical illness and/or biological functioning, and (d) the translation of successful interventions into programs deliverable in clinical settings. These interventions may be examined alone or in conjunction with other stress management techniques.
Issues such as the following would be appropriate here: Through which psychological or physiological pathways do stress management approaches affect health? What are the effective components in successful stress- management practices? Does the combination of various stress management techniques improve outcome? Are particular stress- management interventions more effective for certain individuals, populations, or health outcomes? Can successful stress-management practices be effectively implemented in natural settings? What are the possible economic implications of utilizing stress management interventions? What are the factors that lead to individual differences in how stress is experienced and managed as well as in the health consequences of stress?
Examples of topics of interest specific to the Institutes that have joined with OBSSR in supporting this initiative are:
NCI is interested in research that examines how interactions among environmental, psychosocial, immune, neuroendocrine, genetic, and other biological factors affect the disease, its treatment and side- effects, and/or outcome. Research may involve cancer detection, prevention, treatment, or survivorship. Examples of relevant topics include host differences, sickness behaviors (e.g., nausea, fatigue, depression), and biological factors impacting tumor growth or metastasis (e.g., DNA damage and repair, apoptosis, angiogenesis). Interdisciplinary research and research that includes integrative conceptual models are encouraged.
Mind-body medicine represents one of the major domains of complementary and alternative medicine (CAM). This domain includes CAM practices that intend to facilitate the mind's capacity to affect bodily functions, lessen symptoms of disease, and impact disease processes. These diverse practices are of interest to NCCAM and include, but are not limited to, certain lifestyle behaviors, such as tai chi chaun exercise; meditative strategies such as yoga and mindfulness meditation; psychological strategies such as stress management approaches; and spiritual practices such as prayer and related practices. In addition, many traditional medical systems, such as Traditional Chinese, Native American, and Ayurvedic Medicine, utilize mind-body CAM techniques. NCCAM is also interested in research on the placebo effect, expectancy, resilience, coping, and studies on practitioner-patient interactions. Specifically related to this PA, NCCAM is interested in research involving various CAM mind-body strategies that can help elucidate the mechanisms by which personality, cognitions, behaviors, emotions, beliefs and attitudes can affect physical health; and how and whether CAM mind-body interventions can enhance healing and reduce the physical manifestations of illness. Investigations of certain mind-body interventions, such as cognitive behavioral therapy and stress management techniques, may be of interest to NCCAM when such investigations incorporate particularly innovative aspects or when applied to unique populations or questions. NCCAM encourages CAM-related mind-body research that draws upon contemporary tools of neurobiology, neuroimmunology, and neuroendocrinology using state-of-the-art imaging, cellular, biochemical and molecular approaches. Details of NCCAM's 5-year strategic plan can be found at http://nccam.nih.gov/about/plans/2005/index.htm.
The NHLBI supports behavioral research designed to investigate the relationship between psychosocial factors (e.g., depression, social support, hostility, stress, emotions) and diseases and disorders of the circulation, respiratory system, blood, and sleep, including the mechanisms that mediate these associations. Other areas include motivational, (e.g., beliefs, attitudes and values), emotional and cognitive processes involved in the formation, change, or maintenance of health related behaviors. The interactions of these processes with sociocultural and socioeconomic factors are also important. Finally, the study of gene /environment interactions is important. This includes not only the influence of genes on behavior, but also the neurohormonal pathways through which psychosocial factors influence gene expression. In all of these areas, translation of basic research into clinical applications is also encouraged.
The NIAAA is particularly interested in mind-body interactions as they may impact the prevalence and incidence of alcohol abuse and alcoholism; as they may be disrupted by alcohol use; and as they may play a critical role in recovery from alcoholism. Mind-body interactions of importance include, spirituality, motivation, and craving, as well as the effects of stress, alienation or stigmatization. For example, the role of spirituality in achieving and maintaining sobriety is widely acknowledged, but well-designed research is needed to determine the underlying mechanisms. Such studies may lead to new strategies to improve alcoholism treatment or enhance relapse prevention. We need to understand how mind-body interactions may influence the risk for harmful drinking or contribute to protective factors. Mind-body interactions may also influence progress through stages of change, help-seeking behavior, or readiness for cognitive- behavioral therapy. It is anticipated that such knowledge could be incorporated into more effective means of preventing and treating alcohol disorders among adolescents as well as adult populations. In addition, the NIAAA is committed to reducing alcohol-related health disparities in vulnerable populations. The mind-body interaction may enhance understanding of how reactions to stress, stigma, racism, and discrimination may influence the incidence of alcohol abuse and alcoholism.
NIDCR encourages studies that investigate mind-body interactions with regard to oral and craniofacial diseases and disorders or dental treatments. Examples include, but are not limited to, studies of the effects of beliefs, affective states, or stress on the immune system as related to the onset, progression, or treatment of oral diseases or conditions such as the periodontal diseases, caries, head and neck cancers, temporomandibular joint and/or muscle disorders, herpetic and apthous lesions, oral manifestations of HIV infection, or oral mucosal wound healing following oral surgery. Studies identifying linkages between changes in orofacial appearance or function and psychosocial outcomes are also of interest, as are studies of the psychosocial impacts of acquired or congenital craniofacial conditions (e.g., cleft lip/palate) or studies of the range of psychosocial impacts associated with head/neck cancers and ablative or other treatments. The NIDCR also encourages studies that integrate oral biomarkers into the evaluation of effects of stress-management or other therapeutic interventions. Changes in salivary composition and flow are examples of oral biomarkers shown to be relevant to stress and its physiological impact. The relative accessibility of the oral cavity provides unique opportunities for non-invasive studies of psychophysiological responses associated with positive or negative life events, acute or chronic stress-inducing conditions, and psychological characteristics or psychiatric conditions.
The NIMH supports mind-body research that has central and explicit relevance to mental disorders or related disability. Intervention studies--including prevention, treatment, and rehabilitation--submitted to the NIMH under this announcement should primarily target mental disorder outcomes that are co-morbid with other physical disorders (e.g., heart disease, diabetes, cancer, asthma, etc.). Examples include preventing or treating mood or anxiety disorders in people with another physical disorder. Interventions may be pharmacological, behavioral, psychosocial, environmental, or a combination of these approaches. The NIMH also supports mind-body research to improve function and reduce disability in people with mental disorders, especially research on health behavior change in people with mental disorders.
NICHD is particularly interested in interdisciplinary research projects examining mind/body interactions that influence child health and development, population processes and reproduction, and disability and rehabilitation in children and young adults. Studies are encouraged that: A) would focus on the interactions of the social context with family structure, relationships and support to influence the health, development and well-being of the population, especially children, adolescents and adults of reproductive age. Race, ethnicity, nativity, religious involvement, and socio-economic status are of particular interest as elements of the social context; B) would focus on the effects of mind/body interactions on male and female reproductive health in particular, menstrual cyclicity, ovulation, egg health and quality, semen quality, gonadal function, uterine environment, chronic pelvic pain, infertility and success of assisted reproduction; C) would focus on the influences on child health behavior and development such as: studies of stress, sleep, and pain in context of the immune system and illness; risk behaviors and health in terms of children's understanding of health, illness, religiosity, and spirituality; and childhood illnesses and complementary medicines; or D) would focus on the interactions of physical disability on the health of children and adults. Mind-body interactions such as: severity of disability and health status; severity of disability and family structure; beliefs and attitudes of health and physical disability; and, physical disability and stress in interacting with the environment.
The NIA’s mission is to improve the health and well-being of older Americans through research. The NIA takes a developmental life-course perspective on aging. With respect to the RFA, research areas of interest include: (1) Mind-body effects on acute and chronic health, quality of life, functional capacity, and life expectancy/mortality; (2) How diseases common in late-life (e.g. hypertension, Type II diabetes, osteoarthritis, Alzheimer’s disease) are modulated by the interaction of physiological and neurological mechanisms with cognitive, affective, perceptual, and psychosocial factors experienced by the older individual; and (3) Integrative approaches (e.g., social neuroscience, psychoneuroimmunology) to understanding the psychological and neurobiological mechanisms underlying the relations among social connectedness, social isolation, psychological well-being, self-regulation and the health and well-being of middle aged and older adults. Research on how mind-body processes affect health disparities is especially encouraged, as is multilevel/multi-system and interdisciplinary research. Illustrative examples include: mind-body effects on longevity; early life experiences mediated via mind-body interactions and their effects on late life health; the modulatory effects of age upon mind-body processes, especially in relation to stress and emotional or cognitive function; mind-body effects that are predictive of adherence to and benefit from an intervention; the cumulative effects of stress on the health of the elderly; the impact of optimism, happiness, or a positive attitude on well-being and health; the emotional and cognitive impact of social exclusion and disruptions to social functioning on health; the percepts and affective responses to one's socioeconomic and occupational environment and their effects on health; and the cumulative impact of extreme stress on health in low resource/low income and in-transition countries.
Behavioral and social sciences research plays an important role in the NIDA's search for solutions to the complex social and public health problems posed by drug abuse and addiction. These scientific disciplines provide NIDA with the knowledge necessary to better predict, prevent, and treat drug abuse and addiction problems. NIDA is interested in supporting research that investigates the role of cognitive and/or emotional variables mediating or moderating the development of drug abuse and addiction from the initiation of drug abuse ("chipping" or occasional drug use), the maintenance or continuation of drug taking behaviors (chronic abuse, including escalation to compulsive abuse and its associated negative consequences), relapse, and characteristics of sustained abstinence. The study of cognitive and/or emotional factors (e.g., self-regulation, beliefs, self-attributes, perceived risks or benefit), that influence vulnerability or resilience to drug abuse, is also of interest. Investigators may study responsivity to acute drug challenge, including the examination of how physiological, motivational or subjective responses to drugs of abuse are influenced by cognitive and emotional variables (e.g., expectancy, affective state, emotional context, etc.). Also appropriate would be studies examining cognitive and emotional variables (e.g., coping, emotional regulation, self-efficacy) in the context of treatment or preventive interventions (e.g., role in adherence or compliance). The study of decisions and other cognitive processes, and their associated neural substrates, which give rise to sexual risk behavior, is also an area of research interest. Studies on the influence of physiological indicators of stress, stress perception or stress reactivity on drug abuse vulnerability or clinical outcome, may be included in proposed investigations. NIDA has an interest in supporting research that investigates the epidemiology, prevention, and treatment of medical, behavioral, health, and other consequences of drug abuse, including but not limited to HIV/AIDS, hepatitis B, and STD's. Research of interest includes, for example, identifying how drug use affects the sensory perceptual system and cognitive abilities such as planning and organizing in terms of risk behaviors. Given that drug users and their sex partners account for a substantial proportion of new HIV infections in the US each year, studies to improve under- standing of the behavioral, social, and environmental mechanisms that facilitate HIV transmission and other infectious diseases among drug users are welcome. NIDA's focus on health promotion and disease prevention encourages researchers to investigate strategies for tailoring interventions to optimize their beneficial effects to determine which interventions work, for whom, and under what conditions.
See Section VIII, Other Information - Required Federal
Citations, for policies related to this
announcement.
Section
II. Award Information
1. Mechanism of Support
This Funding
Opportunity Announcement (FOA) will use the Research Project Grant (R01) award mechanism.
The applicant will be solely responsible for planning, directing, and executing the proposed project.
This FOA uses Just-in-Time information concepts. It also uses the modular as well as the non-modular budget formats (see http://grants.nih.gov/grants/funding/modular/modular.htm).
Specifically, if you are a U.S. organization and 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).
U.S. applicants requesting more than $250,000 in annual direct costs and all foreign applicants must complete and submit budget requests using the Research & Related Budget component found in the application package for this FOA. See NOT-OD-06-096.
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.
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.
F&A costs requested by
consortium participants are not included in the direct cost limitation. See NOT-OD-05-004,
November 2, 2004.
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:
1.B. Eligible Individuals
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
More than one PD/PI, or multiple PDs/PIs, may be designated on the application for projects that require a team science approach that clearly does not fit the single-PD/PI model. Additional information on the implementation plans and policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH eRA Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).
The decision of whether to apply for a single PD/PI or multiple PD/PI grant is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for multiple PD/PI grants will require additional information, as outlined in the instructions below. The NIH review criteria for approach, investigators, and environment have been modified to accommodate applications involving either a single PD/PI or multiple PDs/PIs. When considering multiple PDs/PIs, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PD/PIs will be factored into the assessment of the overall scientific merit of the application. Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.
2.
Cost Sharing or Matching
This program does not require cost
sharing as defined in the current NIH
Grants Policy Statement.
3. Other-Special Eligibility
Criteria
Applicants may submit more than one application, provided
each application is scientifically distinct.
Applications can be renewed by competing for additional project periods.
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/applicants/apply_for_grants.jsp and follow the directions provided on that Web site.
A one-time registration is required for institutions/organizations at both:
PDs/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 Registered
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.
Both the PD/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.
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 the 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 for this FOA through Grants.gov/Apply.
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 Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
The SF424 (R&R) application has several components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in 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 or Research & Related Budget,
as appropriate (See Section IV.6., Special Instructions,
regarding appropriate required budget component.)
Research
& Related Budget (required for foreign applications)
Optional Components:
PHS398 Cover Letter
File
Research & Related
Subaward Budget Attachment(s) Form
Foreign
Organizations (Non-domestic (non-U.S.) Entity)
NIH
policies concerning grants to foreign (non-U.S.) organizations can be found in
the NIH Grants Policy Statement at: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm#_Toc54600260.
Applications from foreign organizations must:
Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.
SPECIAL INSTRUCTIONS
Applications with Multiple PDs/PIs
When multiple PDs/PIs are proposed, NIH requires one PD/PI to be designated as the "Contact PI, who will be responsible for all communication between the PDs/PIs and the NIH, for assembling the application materials outlined below, and for coordinating progress reports for the project. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs, but has no other special roles or responsibilities within the project team beyond those mentioned above.
Information for the Contact PD/PI should be entered in item 15 of the SF424 (R&R) Cover component. All other PDs/PIs should be listed in the Research & Related Senior/Key Person component and assigned the project role of PD/PI. Please remember that all PDs/PIs must be registered in the eRA Commons prior to application submission. The Commons ID of each PD/PI must be included in the Credential field of the Research & Related Senior/Key Person component. Failure to include this data field will cause the application to be rejected.
All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership of the project.
Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the research plan, entitled Multiple PD/PI Leadership Plan (section 14 of the Research Plan Component in the SF424 (R&R) or Section I of the Research Plan in the PHS 398), must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, including communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.
If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.
Applications Involving a Single Institution
When all PDs/PIs are within a single institution, follow the instructions contained in the SF424 (R&R) Application Guide.
Applications Involving Multiple Institutions
When multiple institutions are involved, one institution must be designated as the prime institution and funding for the other institution(s) must be requested via a subcontract to be administered by the prime institution. When submitting a detailed budget, the prime institution should submit its budget using the Research & Related Budget component. All other institutions should have their individual budgets attached separately to the Research & Related Subaward Budget Attachment(s) Form. See Section 4.8 of the SF424 (R&R) Application Guide for further instruction regarding the use of the subaward budget form.
When submitting a modular budget, the prime institution completes the PHS398 Modular Budget component only. Information concerning the consortium/subcontract budget is provided in the budget justification. Separate budgets for each consortium/subcontract grantee are not required when using the Modular budget format. See Section 5.4 of the Application Guide for further instruction regarding the use of the PHS398 Modular Budget component.
3.
Submission Dates and Times
See Section
IV.3.A. for details.
3.A.
Submission, Review, and Anticipated Start Dates
Opening Date: January
5, 2007 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): Not applicable
Application Submission/Receipt Date(s): Standard dates
apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Submission/Receipt Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS
Peer Review
Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review
Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest
Anticipated Start Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
3.A.1. Letter of Intent
A letter of intent is not required for the funding opportunity.
3.B. Submitting an Application Electronically to the
NIH
To submit an application in response to this
FOA, applicants should access this FOA via http://www.grants.gov/applicants/apply_for_grants.jsp 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. The submitting AOR receives
the Grants.gov acknowledgments. The AOR and the PI receive Commons
acknowledgments. Information related to the assignment of an application to a
Scientific Review Group is also in the Commons.
Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on their application status 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 (3 pages maximum) 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.
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 or competing renewal (formerly
competing continuation ) 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 or competing renewal 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
PD/PI Credential (e.g., Agency Login)
The NIH requires the PD/PI(s) 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.
Organizational DUNS
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 Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
PHS398 Research Plan Component Sections
Items 2-5 of the PHS398 Research Plan component are limited to 25-pages. While each section of the Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component 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.
All application instructions outlined in the SF424 (R&R) Application Guide are to be followed, incorporating "Just-in-Time" information concepts, and with the following additional requirements:
Special Instructions for Modular Grant applications
R01 applications from U.S. institutions/organizations requesting up to $250,000 per year in direct costs (excluding consortium F&A costs) must be submitted in a modular budget format. Additional information on modular budgets is available at http://grants.nih.gov/grants/funding/modular/modular.htm. When submitting a modular budget, the applicant organization will include only the PHS398 Modular Budget component. See Section 5.4 of the SF424 (R&R) Application Guide for further instructions regarding the use of the PHS398 Modular Budget component.
Foreign organizations may not submit modular budgets. See NOT-OD-06-096.
Special Instructions for Applications Requesting $500,000 (direct costs) or More Per Year
Applicants
requesting $500,000 or more in direct costs for any year (excluding consortium
F&A costs) must carry out the following steps:
1) Contact the
IC program staff at least 6 weeks before submitting the application, i.e., as
you are developing plans for the study;
2)
Obtain agreement from the IC staff that the IC will accept your application for
consideration for award; and,
3)
Include the PHS398 Cover Letter component with the application to identify the
staff member and IC who agreed to accept assignment of the application.
This policy applies to all new applications, competing renewal (formerly competing continuation ) applications, resubmission (formerly revised/amended ) applications, and revision (formerly competing supplemental ) applications. See NOT-OD-02-004, October 16, 2001.
APPENDIX MATERIALS
IMPORTANT NOTE: NIH
has published new limitations on grant application appendix materials to
encourage applications to be as concise as possible while containing the
information needed for expert scientific review.
Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) Application Guide (See http://grants.nih.gov/grants/funding/424/index.htm).
Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.
Note: While each section of the PHS398 Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to monitor better 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.
Foreign Applications (Non-domestic (non-U.S.) Entity)
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 Web site, 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.
Applicants requesting more than $500,000 in direct
costs in any year of the proposed research must include a plan for sharing
research data in their application. The funding organization will be
responsible for monitoring the data sharing policy (http://grants.nih.gov/grants/policy/data_sharing).
The reasonableness of the data sharing plan or the
rationale for not sharing research data may 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.
NIH
policy expects that grant awardee recipients make unique research resources
readily available for research purposes to qualified individuals within the
scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a sharing
research resources plan addressing how unique research resources will be shared
or explain why sharing is not possible.
The adequacy of the resources sharing plan and any
related data sharing plans will be considered by Program staff of the funding
organization when making recommendations about funding applications. The
effectiveness of the resource sharing will be evaluated as part of the
administrative review of each Non-Competing Grant
Progress Report (PHS 2590). See Section VI.3.,
Reporting.
Section V. Application Review Information
1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).
Applications will be evaluated according to the standard criteria for scientific merit.
2. Review and Selection Process
Applications
submitted for this funding opportunity will be assigned to the ICs on the basis
of established PHS referral guidelines.
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.
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 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?
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 applications designating multiple PIs, does the Leadership Plan ensure that there will be sufficient coordination and communication among the PD/PIs? Are the administrative plans for the management of the research project appropriate, including plans for resolving conflicts?
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 or methodologies, tools, or technologies for this area?
Investigators: Are the PD/PIs and other key personnel appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level(s) of the principal investigator(s) and other researchers? Do the PD/PIs and investigative team bring complementary and integrated expertise to the project (if applicable)?
Environment: Do(es) the scientific environment(s) 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(s), or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?
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 the Human Subjects Sections of
the PHS398 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 the Human Subjects Sections of the PHS398 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 adequacy of the plans for their care and use will
be assessed. See the Other Research Plan Sections of the PHS398 Research Plan
component of the SF424 (R&R).
Biohazards: If materials or procedures are proposed that are potentially
hazardous to research personnel and/or the environment, determine if the
proposed protection is adequate.
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. The priority score should not be affected by the evaluation of the
budget.
Applications from Foreign Organizations: Does the project present special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources will be assessed.
Resubmission Applications (formerly revised/amended applications): Are the responses to comments from the previous scientific review group adequate? Are the improvements in the resubmission application appropriate?
2.C. Sharing Research Data
Data Sharing Plan: The reasonableness of the
data sharing plan or the rationale for not sharing research data may 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.
The funding organization will be responsible for monitoring the data sharing
policy. http://grants.nih.gov/grants/policy/data_sharing.
2.D. Sharing Research
Resources
NIH policy expects that grant
awardee recipients make unique research resources readily available for
research purposes to qualified individuals within the scientific community
after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a sharing
research resources plan addressing how unique research resources will be shared
or explain why sharing is not possible.
Program staff will be responsible for the administrative review of the plan for sharing research resources.
The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each Non-Competing Grant Progress Report (PHS 2590), See Section VI.3., Reporting.
3.
Anticipated Announcement and Award Dates
Announcements and awards will follow the standard schedule that is
posted at http://grants.nih.gov/grants/funding/submissionschedule.htm.
See Review and Award Schedule.
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.
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.
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:
Ronald P. Abeles, Ph.D.
Special Assistant to the Director
Office of Behavioral and Social Sciences Research
National Institutes of Health
Gateway Building, Room 2C234, MSC 9205
7201 Wisconsin Avenue
Bethesda, MD 20892-9205
Telephone: 301-496-7859
Fax: 301-435-8779
E-mail: [email protected]
Direct inquiries regarding research interests and topics of Specific Institutes and Centers to:
National Cancer Institute
Paige A. McDonald, Ph.D., MPH
Basic and Biobehavioral Research Branch
Behavioral Research Program
Division of Cancer Control and Population Sciences
National Cancer Institute
6130 Executive Boulevard, Room 4062, MSC 7363
Bethesda, MD 20892-7363
Phone: 301-496-8776
Fax: 301-435-7547
E-mail: [email protected]
National Center for Complementary and Alternative Medicine
Deborah Hayes, MS
Program Officer
Division of Extramural Research
National Center for Complementary & Alternative Medicine
National Institutes of Health (NCCAM/NIH)
6707 Democracy Boulevard, Suite 401
Bethesda, MD 20892-5475
Ph: (301) 496-2583
Fx: (301) 480-1587
www.nccam.nih.gov
National Heart, Lung and Blood Institute
Susan M. Czajkowski, Ph.D.
Clinical Applications and Prevention Branch
Division of Prevention and Population Sciences
6701 Rockledge Drive, Room 8114
Bethesda, MD 20892-7936
Telephone: 301-435-0406
Fax: 301- 480-1773
E-mail: [email protected]
National Institute of Dental and Craniofacial Research
Patricia S. Bryant, Ph.D.
Center for Health Promotion and Behavioral Research
National Institute of Dental and Craniofacial Research
45 Center Drive, Rm 4AS.43A
Bethesda, MD 20892-6402
Phone: 301-594-2095
Fax: 301-480-8322
E-mail [email protected]
National Institute of Mental Health
Donna Mayo, PhD
Program Chief
Functional Assessment in Mental Disorders
Assistant Director, Research Training and Career Development
Division of AIDS and Health and Behavior Research
6001 Executive Blvd., Rm. 6228, MSC 9621
Rockville, MD 20892-9621
Phone: 301-443-1829
Fax: 301-443-6000
E-mail: [email protected]
National Institute on Aging
Lis Nielsen, Ph.D.
Behavioral and Social Research Program
National Institute on Aging/National Institutes of Health
7201 Wisconsin Ave., #533
Bethesda, MD 20892-9205
Phone: 301-402-4156
Fax: 301-402-0051
Email: [email protected]
National Institute on Alcohol Abuse and Alcoholism
Peggy Murray, MSW
Chief, Health Sciences Education Branch
Office of Research Translation and Communications
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 3105, MSC 9304
Bethesda, MD 20892-9304
Phone: 301-443-2594
Fax: 301-480-1726
E-mail: [email protected]
National Institute on Drug Abuse
Ro Nemeth-Coslett, PhD
National Institute on Drug Abuse
Division of Treatment Research and Development
Clinical Neurobiology Branch
Neuroscience Center, Rm 4234 MSC 9551
6001 Executive Blvd,
Bethesda, MD 20892-9551
Phone: 301-402-1746
Fax: 301-443-6814
E-mail: [email protected]
National Institute of Child Health and Human Development
V. Jeffrey Evans, Ph.D., J.D.
Demographic and Behavioral Sciences Branch
National Institute of Child Health and Human Development
6100 Executive Blvd., Room 8B07
Bethesda, MD 20892
Phone: 301-496-1176
Fax: 301-496-0962
E-mail: [email protected]
2. Peer Review Contact(s):
Not applicable.
3. Financial or Grants Management Contacts:
National Cancer Institute
Crystal Wolfrey
Office of Grants Administration
Executive Plaza South, Room 243
Bethesda, Maryland 20892
Phone: 301-496-8634
E-mail: [email protected]
National Center for Complementary and Altnernative Medicine
George Tucker
Grants Management Officer
National Center for Complementary and Alternative Medicine
National Institutes of Health
6707 Democracy Blvd., Room 401, MSC 5475
Bethesda, MD 20892-5475
Phone: 301-594-9102
E-mail: [email protected]
National Heart Lung and Blood Institute
Ms. Teresa Farris Marquette
Section Chief
Office of Grants Management
6701 Rockledge Drive, Suite 700
Bethesda, Maryland 20892-7936
Telephone: 301-435-0171
Fax: 301-435-3310
Email: [email protected]
National Institute of Dental and Craniofacial Research
Mary E. Daley
45 Center Dr MSC 6402
Bethesda, MD 20892-6402
Phone: 301-594-4800
Fax: 301-480-8303
E-mail: [email protected]
National Institute of Mental Health
Rita V. Sisco
Division of Extramural Activities
6001 Executive Blvd., Room 6120, MSC 9537
Rockville, MD 20892-9537
Telephone: 301-443-2805
Fax: 301-443-6885
Email: [email protected]
National Institute on Aging
Richard Proper,
Grants Management Specialist
Grants and Contracts Management Office
National Institute on Aging
7201 Wisconsin Ave., #2N/212
Bethesda, MD 20892-N9205
Telephone: 301-402-7735
Fax: 301-402-3672
Email: [email protected]
National Institute on Alcohol Abuse and Alcoholism
Judy Fox
Chief, Grants Management Branch
Office of Planning and Resource Management
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Room 3023, MSC 9304
Bethesda, MD 20892-9304
Phone: 301-443-4704
Fax: 301-443-3891
E-mail: [email protected]
National Institute on Drug Abuse
Daisey Parker
Grants Management Specialist
Grants Management Branch
6101 Executive Boulevard
Suite 270 MSC 8403
Bethesda MD 20892-8403
Telephone: 301-443-6710
Fax: 301-594-6847
E-mail: [email protected]
National Institute of Child Health and Human Development
Cecilia E. Bruce
Grants Management Team Leader
National Institute of Child Health and Human Development
6100 Executive Blvd., Room 8A17L
Bethesda, MD 20892-7510
Phone: 301-496-1304
Fax: 301-480-4782
E-mail: [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 (HHS) 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 HHS
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. For publications listed in the appendix and/or
Progress report, Internet addresses (URLs) or PubMed Central (PMC) submission
identification numbers must be used for publicly accessible on-line journal articles. Publicly
accessible on-line journal articles or PMC articles/manuscripts accepted for
publication that are directly relevant to the project may be included only as URLs or PMC submission identification numbers accompanying the
full reference in either the Bibliography & References Cited section, the
Progress Report Publication List section, or the Biographical Sketch section of
the NIH grant application. A URL or PMC submission identification number
citation may be repeated in each of these sections as appropriate. There is no
limit to the number of URLs or PMC submission identification numbers that can
be cited.
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 PA 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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