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
National Institute of Nursing Research (NINR),
( http://www.ninr.nih.gov)
Title: NINR Program Projects in Symptom Management
Research and Program Projects in Health Promotion/Disease Prevention Research
(P01)
Announcement Type
New
Request For Applications
(RFA) Number: RFA-NR-09-003
Catalog of Federal
Domestic Assistance Number(s)
93.361
Key Dates:
Release Date: October 7, 2008
Letters of
Intent Receipt Date: March
16, 2009
Application Receipt Date: April 16, 2009
Peer Review
Date: July 2009
Council Review
Date: October 2009
Earliest
Anticipated Start Date: September/October
2009
Additional Information To Be Available Date (Url
Activation Date): Not Applicable
Expiration Date: April 17, 2009
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(s) 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. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Receipt, Review and
Anticipated Start Dates
1.
Letter of Intent
B. Sending an Application to
the NIH
C. Application Processing
D. Application Assignment
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements and Information
Section
V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review
Considerations
C. Resource Sharing Plan(s)
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 National Institute of Nursing Research
(NINR) invites applications for Program Projects
in Symptom Management Research and Program Projects in Health Promotion/Disease
Prevention Research (P01). The purpose of the proposed grant
program is to significantly advance the science of an interdisciplinary,
biobehavioral research program focused in Symptom Management Research OR Health
Promotion/Disease Prevention Research.
1.A. Program Projects
The program project mechanism is designed to support research in which the funding of several interdependent, but conceptually related or synergistic projects offers significant scientific advantages over support of these same projects as individual regular research grants (e.g., R01s).
Potential applicants are strongly encouraged to contact the NINR Extramural staff listed at the end of this announcement for guidance about the areas appropriate for program project grant applications.
Successful program projects are designed to bring together scientists in diverse fields, who would not otherwise collaborate, to apply interdisciplinary approaches to work on an important well-defined problem. The principal investigator, and each individual project leader need to describe how the program is more effective as a whole, rather than as a series of independent research grants. In addition, the program project can facilitate the support of essential shared core facilities, e.g., major equipment, although the need of a group of investigators for a major piece of equipment or a core facility does not in itself justify a program project grant. Small, well justified administrative cores will be considered, but are not encouraged. It is expected that successful program projects will establish effective collaborations that extend beyond the life of the program project grant. Applicants should consider engaging the resources and expertise of nearby or otherwise available Clinical and Translational Science Award grant sites (CTSAs) and/or federally funded research centers where possible.
Generally, a program project consists of three to five individual interdependent components from different investigators. The scientist(s) designated by the applicant institution as the principal investigator(s) bear responsibility for the overall scientific leadership and fiscal management of the program project grant. It is expected that each of the collaborating scientists responsible for the individual projects will be independent investigators. The program project grant is not intended to be a vehicle for school/college/department/division support, nor is the research support of a single senior investigator and several postdoctoral and research associate-level scientists appropriate under this mechanism.
In addition, the program project and each individual project must represent a significant effort on the part of the participating scientists and be distinct from their other funded efforts. If individuals have substantial support in areas closely related to the program project, their support should be subsumed under the program project. If their support cannot be subsumed, they may participate as associate members. Associate members have full use of, for example, core facilities, and contribute to the overall collegiality of the project, but derive no financial support from it.
1.B. Science Areas of Opportunity
It is expected that new biomedical and behavioral knowledge will be discovered for improving the quality-of-life of persons at all ages by promoting healthy behaviors, across the NINR research mission areas and strategies presented in the 2006 NINR Mission and Strategic Plan (http://www.ninr.nih.gov/AboutNINR/NINRMissionandStrategicPlan). This P01 program is principally designed to support the development of biobehavioral interventions including cost-effectiveness analyses for (1) symptom management OR (2) health promotion/disease prevention.
1.B.1. Symptom Management
Chronic diseases and their symptoms disrupt the quality of life of 90 million Americans (CDC Chronic Disease Prevention Program). Symptom management is an urgent public health concern. Each year chronic pain alone is responsible for more than $150 billion spent on healthcare and disability-related costs in the U.S. (American Pain Society APS Bulletin, Winter 2006, Vol. 16 (1)), affecting more than 50 million Americans. Fifty to 70 million Americans chronically suffer from sleep difficulties, hindering daily functioning and adversely affecting health and longevity (Report Brief: Sleep Disorders and Sleep Depravation: An Unmet Public Health Problem. 2006, April. National Academy of Sciences). Depressive symptomatology and depression significantly affect approximately 7 - 25 percent of the US population and are associated with increased medical illness, higher rates of comorbid conditions such as obesity and cardiovascular disease, and increased mortality.
Symptoms are the result of a complex interaction of biological, cognitive, behavioral, sociocultural, spiritual, and environmental factors. The responses to symptom treatment and management are equally complex. Managing recurring or chronic symptoms is often challenging as symptoms rarely remain static. Some patients may experience isolated symptoms (e.g., headache pain); however, many conditions result in characteristic symptom clusters (e.g., pain, sleep difficulties, and mood changes). Symptom management research seeks to identify and test interventions that will reduce the burden of symptoms on effected persons and improve their quality of life.
Begun in 2004 as part of the NIH Roadmap for Medical Research, the PROMIS (Patient-Reported Outcomes Measurement Information System) initiative is developing new ways to measure symptoms or patient-reported outcomes (PROs), such as pain, fatigue, physical functioning, emotional distress, and social role participation that have a major impact on quality-of-life across a variety of chronic diseases (http://nihroadmap.nih.gov/clinicalresearch/overview-dynamicoutcomes.asp). In addition, it is developing a web-based system to give clinical researchers access to the item banks and the computer adaptive testing (CAT) system.
NINR seeks to support research that will leverage the successes of initiatives like PROMIS to:
This call for Program Project applications focuses on the most frequently reported symptoms already being studied by PROMIS: pain, sleep disturbances, fatigue, and cognitive/affect changes, as well as their interactions. Applicants must select one of these symptoms and build their program project application around this symptom, the organizing central theme of the application, so as to develop strong expertise in this research domain and move the field of science forward significantly.
Sleep
An estimated 70 million people in the United States suffer from sleep problems, and more than 50% of them have a chronic sleep disorder. About 30 million American adults have frequent or chronic insomnia. Approximately 18 million have sleep apnea (sleep disordered breathing), but fewer than 50% are presently being treated. An estimated 250,000 people have narcolepsy, and 10 to 20% of adults are affected by restless legs syndrome. According to the National Highway Traffic and Safety Administration (NHTSA), 100,000 accidents and 1,500 traffic fatalities per year are related to drowsy driving. More than 50% of Americans over age 65 have sleep difficulties, and prevalence of sleep problems will therefore increase as the over-65 population increases. Each year, sleep disorders, sleep deprivation, and excessive daytime sleepiness add approximately $16 billion annually to the cost of health care in the U.S., and result in $50 billion annually in lost productivity. Sleep problems and disorders have major societal impacts but have not received sufficient attention in basic and clinical research.
Fatigue
In this announcement fatigue is defined as a subjective lack of physical and/or mental energy, despite adequate access to sleep or rest periods, that is perceived by the individual or caregiver to interfere with usual and desired activities. In a study of non-disabled community-dwelling subjects, fatigue was reported as the most common cause for restricting activity. Older adults are especially vulnerable to fatigue; it is a strong predictor of adverse outcomes, including mortality, in this population. Fatigue is a prominent symptom in a wide array of disorders, including such disorders as Chronic Fatigue Syndrome, neurologic diseases, cardiac disorders, pulmonary dysfunction, hemolytic disorders, infectious diseases including HIV/AIDS, metabolic disorders, as well as in response to many potent treatments for illnesses such as cancer. It is often the cause of persons with chronic illness leaving the workforce, resulting in substantial public health costs.
Pain
More than 30 million Americans suffer from unrelieved chronic pain; 42% of adults in the United States experience pain daily and 89% monthly. Pain is the most common reason for medical appointments in the United States, amounting to 140 million visits and $100 billion each year in health care costs and lost productivity. Although all groups of persons regardless of age, gender, ethnicity, or cultural background experience unrelieved pain, women are significantly more likely to develop chronic pain disorders. Despite having made significant strides in understanding acute pain and in developing effective treatments for these, chronic pain, as well as the transition from acute to chronic pain, are still poorly understood and the treatment for chronic pain remains inadequate.
Cognitive Function
It is estimated that over 95 million Americans live with a central nervous system (CNS) disorder. The burden of these diseases, including their effect on cognition, is substantial; worldwide, brain disorders are the leading contributor to years lived with disability (YLDs). Disorders of the CNS, and their consequent impact on cognition, have the potential to profoundly impact the subsequent health of persons with these diseases. Across illness groups, Health-Related Quality-of-Life is strongly associated with cognitive function. In 2004, mental disorders alone were responsible for 48 million office-based physician visits. Negative affect and depressive symptomatology are significantly associated with poorer health outcomes, poor quality of life, reduced productivity, and reduced life expectancy. Mental illness ranks second in the burden of disease (Disability Adjusted Life Years or DALYs) in established market economies, such as the United States. Alterations in thinking, mood, or behavior contribute to a host of problems patient distress, impaired functioning, or heightened risk of death, pain, disability, or loss of freedom (American Psychiatric Association, 1994). More than one in four American adults suffer from mild but clinically diagnosable mental disorders in a given year; these disorders are the leading cause of disability among U.S. workers under age 45 and significantly contribute to declines in overall health and quality of life.
1.B.2. Health Promotion and Disease Prevention
The interplay of biology and behavior is especially apparent in health promotion and disease prevention. As our understanding of the role that lifestyle plays in disease increases, so does the need for predictors and strategies that target long term behavior change. The development of interventions based on well-defined underlying mechanisms is critical to advancing health promotion and disease prevention. Environmental and genetic factors, as well as emerging diseases, interact with behavior to create new challenges. Socioeconomic factors influencing health include housing, population density, and other factors related to geographic location. Many potential interventions must be studied, and perhaps modified, to take into account differences among urban, suburban, rural, and remote environments. NINR seeks to support research that will:
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/ .
This call for Program Project applications focuses on the four high priority areas for Health Promotion and Disease Prevention research in both healthy and chronically ill persons across the life span: obesity, premature birth/low birth weight infants, HIV/AIDS, and cardiopulmonary disease. Applicants must select one of these conditions and build their Program Project application around the prevention of this condition as the organizing central theme of the application, so as to develop strong expertise in this research domain and move the field of science forward significantly.
Overweight and Obesity
Obesity across the lifespan has been dubbed the US epidemic of the decade. Over the last two decades, the prevalence of overweight and obesity has increased sharply for both adults and children. According to the NHANES data, among adults aged 20 74 years the prevalence of obesity increased from 15.0% (in the 1976 1980 survey) to 32.9% (in the 2003 2004 survey). For children aged 2 5 years, the prevalence of overweight increased from 5.0% to 13.9%; for those aged 6 11 years, prevalence increased from 6.5% to 18.8%; and for those aged 12 19 years, prevalence increased from 5.0% to 17.4%. Obesity contributes to significant morbidities including hypertension, stroke, sleep disorders, osteoarthritis, diabetes, coronary heart disease, metabolic syndrome, and some cancers, and is associated with increases in all-cause mortality. It has been identified as a risk factor for Alzheimer disease, depression, reductions in fertility, and significant reductions in health and social quality-of-life. It also significantly exacerbates many conditions, such as asthma, multiple sclerosis, and most musculoskeletal disorders. According to a study of national costs attributed to both overweight (BMI 25 29.9) and obesity (BMI greater than 30), medical expenses accounted for 9.1 percent of total U.S. medical expenditures in 1998 and may have reached as high as $78.5 billion ($92.6 billion in 2002 dollars). Despite major prevention initiatives, the CDC reports that obesity levels remain staggeringly high, with at least 34% of adults (20 yrs and older) continuing to be obese.
Preterm Delivery and Low Birth-Weight Births
Preterm delivery (PTD) or short gestation (birth occurring before 37 weeks of pregnancy), low birth weight (LBW, less than 2,500 grams) and very low birth weight (VLBW; less than 1,500 grams), consequences of which can be profound, continue to be major public health concerns. Despite tremendous advances in medicine and a growing body of research on explanatory risk factors for adverse pregnancy outcomes, the gap between whites and nonwhites in pregnancy outcomes has widened. Black infants are more than twice as likely to die as White infants. For example, low birth weight and very low birth weight percent of live births are 13.1 and 3.1 percent, respectively, for Blacks or African Americans, compared to 6.5 and 1.1 percent, respectively, for Whites (Healthy People, 2010). Similarly, rates for American Indians and Alaska natives are approximately 50% higher than rates for White women. Rates for Hispanic women approximate or are slightly higher than rates for White women except for Puerto Ricans whose rates are 50% higher than Whites (Healthy People, 2010). PTD and LBW contribute substantially to both infant mortality and to childhood physical impairment. Recent evidence suggests that these impairments persist well into adulthood. LBW children experience more health problems, such as asthma, upper and lower respiratory infections and ear infections. Although infant mortality in the United States has declined steadily over the past several decades and is at a record low of 7.2 per 1,000 live births, the United States still ranks 25th in infant mortality compared with other industrialized nations, largely due to its high PTD and LBW rates. The strong association between LBW and preterm delivery places LBW children at risk for neurosensory, developmental, physical, and psychological problems.
HIV/AIDS
Well into the third decade of the human immunodeficiency virus (HIV) epidemic, rates of HIV infection remain high, especially among minority populations. HIV incidence in the U.S. "flattened" in 2004, falling from 22.8 new cases per 100,000 people in 2001 to 20.7 per 100,000 in 2004. Of newly diagnosed HIV infections in the United States during 2003, CDC estimated that approximately 63% were among men who were infected through sexual contact with other men, 50% were among blacks, 32% were among whites, and 16% were among Hispanics. In addition to the spread of HIV/AIDS, comorbid infections, such as hepatitis B and C viruses significantly reduce the health and quality of life of persons living with HIV. Further, despite the advent of effective antiretroviral therapy (ART) for HIV/AIDS and the concomitant reductions in HIV/AIDS mortality, the spread of HIV remains at unacceptably high rates. Although a significant minority, many persons with HIV/AIDS still report unprotected behaviors and need additional help to sustain risk reduction over their lifetime. There are numerous primary and secondary HIV prevention interventions available for implementation by clinical and community agencies (for examples, see http://www.effectiveinterventions.org), many are being distributed through the CDC Disseminating Evidence Based Interventions (DEBI) project. Efficacious intervention modalities include individual and group format, and have been designed to be appropriate for many different subpopulations at risk for HIV in the United States. Despite the efficacy of these interventions, the effectiveness continues to be suboptimal.
Cardiopulmonary Disease
Heart disease is the leading cause of death in the United States for both men and women, and is a major cause of disability. Almost 700,000 people die of heart disease in the U.S. each year. That is about 29% of all U.S. deaths. Coronary heart disease is the principal type of heart disease, accounting for 71% of all heart disease deaths. Congestive heart failure (CHF), the most severe clinical manifestation of HF, poses an enormous national public health burden. 4.9 million Americans live with CHF. 550,000 new cases are diagnosed yearly, and the average duration of disease is ~9 years. In 2002 CHF accounted for 56,000 deaths, $15 billion in hospital costs, and $28 billion in total costs attributable to health care expenditures and lost productivity. Elderly individuals are at particularly high risk of developing CHF; indeed, CHF is the leading hospital discharge diagnosis from medical wards among this age group. Systolic HF is the most common form found in the elderly. Diastolic HF also occurs frequently in the aged, presenting with dyspnea and decreased exercise tolerance. Elderly women are the individuals who are most at risk of developing diastolic HF. The risk of coronary heart disease can be reduced by taking steps to prevent and control those adverse factors that put people at greater risk for heart disease and heart attack. Lifestyle actions such as healthy diet, regular physical activity, not smoking, and maintaining healthy weight are all known efficacious intervention points to maintain heart health. Additionally, knowing the signs and symptoms of heart attack, calling 911 right away, and getting to a hospital are crucial to the most positive outcomes after having a heart attack. People who have had a heart attack can also work to reduce their risk of future events.
Chronic obstructive pulmonary disease (COPD) is the fourth leading cause of death, illness, and disability in the United States. As many as 24 million Americans are affected by COPD, with the rate of COPD growing much faster in women than men. In 2000, 119,000 deaths, 726,000 hospitalizations, and 1.5 million hospital emergency department visits were caused by COPD. An additional 8 million cases of hospital outpatient treatment or treatment by personal physicians were linked to COPD in 2000. U.S. women also had more COPD hospitalizations than men and more emergency department visits, as well as more deaths.
Many other pulmonary diseases appear to be induced by or exacerbated by environmental exposures and life style behaviors. All of these significantly impair function and quality of life.
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 will use the P01 award mechanism(s).
The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.
This FOA uses Just-in-Time information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).
A detailed categorical budget for the Initial Budget Period and the Entire Budget Period of support is to be submitted with the application.
This FOA is a one time research opportunity. Successful applications are not renewable. There are no plans to reissue this FOA. Support will be available for up to 5 years only.
2. Funds Available
It is anticipated that $1.4
million/year for 5 years will be available to support scientifically
meritorious applications responding to this FOA. It is anticipated that support
will be provided for up to 2 new program projects (P01). Individual P01 awards
are limited to $700,000 in total costs (i.e., direct plus F&A, inclusive of
consortium and contractual costs) per year. A minimum of 3 components, of
which two must be independent research projects are required.
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 IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.
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.
Section III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
The following
organizations/institutions are eligible to apply:
1.B. Eligible Individuals
Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her institution 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. Principal investigators must have current NIH funding (i.e. active on published receipt date and excluding any period of no-cost extension) at the R01 or Center (P20/P30/P50/P60) level.
More than one PD/PI, or multiple PDs/PIs, may be designated on the application for projects that require a team science approach and therefore clearly do not fit the single-PD/PI model. Additional information on the implementation plans, 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 grant with a single PD/PI or multiple PDs/PIs is the responsibility of the investigators and applicant organizations, and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs 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 PDs/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 are not permitted to submit a resubmission application in
response to this FOA.
Renewal applications are not permitted in response to this FOA
Only one application per applicant organization in response to this FOA will be accepted for consideration.
Section IV. Application and Submission Information
1. Address to Request Application Information
The PHS 398
application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of
the PHS 398. 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
Applications
must be prepared using the most current PHS 398 research grant application
instructions and forms. Applications must have a D&B Data Universal
Numbering System (DUNS) number as the universal identifier when applying for
Federal grants or cooperative agreements. The D&B number can be obtained by
calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be
entered on line 11 of the face page of the PHS 398 form.
The title and
number of this funding opportunity must be typed in item (box) 2 only of the
face page of the application form and the YES box must be checked.
The program project grant application should be
structured as a series of separate but interrelated project proposals (minimum
of three (3) components, of which no less than two (2) must be individual
research projects).
The following format should be used:
Overall Proposal
An overview section must contain justification for the program project grant mechanism and describe those goals that are not readily attainable through individual research project grants. This section should include: the face page, an abstract; a description of the objectives of the program as a whole that describes the relationship of the individual research projects, and core(s) if applicable, to the entire program project and the special benefits to be achieved by funding as a program project grant rather than as a series of individual research grants; a list of participating personnel; the consolidated budget for the program project grant (summarizing budgets for the component parts and core); a description of facilities available including major instruments and special program resources; administrative arrangements for overall scientific leadership, quality control, and management of the program project grant; and a separate overall listing of the proposed person months on the program project grant and actual and pending research support from all sources for each project leader (including percent effort devoted to each project). This section must also detail the relationship of existing support to the proposed program project and describe planned modifications to that support in the event of funding, for example, folding in support for related funded research. The length of this section should be no more than twenty-five (25) pages, exclusive of budget and biosketches.
Components (minimum of three (3) components, of which no less than two (2) must be individual research projects)
Each individual project of a program project grant should represent both an independent and an interdependent research effort, and should be prepared in the format of an individual research grant (i.e., R01) application. The cover page, description, budget pages, biographical information, a detailed description of the research to be conducted, and any justification for human and animal experimentation, if applicable, should be included as noted below. The special benefits associated with being part of the program project must also be addressed.
If support for core resources is requested, a separate component describing and justifying these should be included.
The page limits for individual R01 research grant applications apply to both individual projects and cores. A brief Project/Core Overview section may be included at the beginning of each component to provide background on how the projects/components inter-relate and how the science of the component is benefited from the program project above and beyond the individual component science had it been funded separately. The Project/Core Overview is limited to one (1) page.
Guidance on appendix
materials can be found in NOT-OD-07-018 ( http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07 018.html).
SPECIAL INSTRUCTIONS
Applications with Multiple PDs/PIs
When multiple PD/PIs are proposed, use the Face Page-Continued page to provide items 3a 3h for all PD/PIs. NIH requires one PD/PI be designated as the contact PD/PI for all communications between the PD/PIs and the agency. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PD/PIs, but has no special roles or responsibilities within the project team beyond those mentioned above. The contact PD/PI may be changed during the project period. The contact PD/PI should be listed in block 3 of Form Page 1 (the Face Page), with all additional PD/PIs listed on Form Page 1-Continued. When inserting the name of the PD/PI in the header of each application page, use the name of the Contact PD/PI, et. al. The contact PD/PI must be from the applicant organization if PD/PIs are from more than one institution.
All individuals designated as PD/PI must be registered in the eRA Commons and must be assigned the PD/PI role in that system (other roles such as SO or IAR will not give the PD/PI the appropriate access to the application records). Each PD/PI must include their respective eRA Commons ID in the eRA Commons User Name field.
All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership plan approach for the proposed 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 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, and should include 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.
Additional information is available in the PHS 398 grant application instructions.
3. Submission Dates and Times
Applications must be
received on or before the receipt date described below (Section IV.3.A). Submission times N/A.
3.A. Receipt, Review and Anticipated Start Dates
Letters
of Intent Receipt Date: March 16, 2009
Application Receipt Date: April 16, 2009
Peer Review Date: July 2009
Council Review Date: October 2009
Earliest Anticipated Start Date: September/October 2009
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. Yujing Liu, Chief
Office of Review
National Institute of Nursing Research
6701 Democracy Plaza; Suite 710
Bethesda, MD 20892-4870
Telephone: (301) 594-5971
FAX: 301-480-8260
Email: [email protected]
3.B.
Sending an Application to the NIH
Applications
must be prepared using the forms found in the PHS 398 instructions for
preparing a research grant application. Submit a signed, typewritten original
of the application, including the checklist, and three
(3) signed photocopies in one package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express
or regular mail)
Bethesda, MD 20817 (for express/courier service;
non-USPS service)
Personal deliveries
of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).
At
the time of submission, two additional copies of the application and all
copies of the appendix material (including CD, if applicable) must be sent to:
Dr. Yujing Liu, Chief
Office of Review
National Institute of Nursing Research
6701 Democracy Plaza; Suite 710
Bethesda, MD 20892-4870
Telephone: (301) 594-5971
FAX: 301-480-8260
Email: [email protected]
3.C.
Application Processing
Applications
must be received
on or before the application receipt date) described above (Section IV.3.A.). If
an application is received after that date, the application may be delayed in
the review process or not reviewed. Upon receipt, applications will be
evaluated for completeness by the CSR and for responsiveness by the reviewing
Institute Incomplete and/or non-responsive applications will not be reviewed.
The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.
Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.
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. The Grants Policy Statement can be found at 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 award if such costs: 1)
are necessary to conduct the project, and 2) 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 NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.)
A maximum limit for requested award under this
FOA is $700,000 (in total costs, i.e., direct plus F&A, inclusive of
consortium and contractual costs) over a five (5) year period. If fewer than
five (5) years are requested, the limit will be prorated accordingly.
Applications that exceed this limit will not be reviewed. .
Applicants
should be aware that stipends and honoraria are prohibited costs on a program
project (P01) grant. After P01 award, NINR will only consider administrative
requests for research supplements to support underrepresented minorities or
persons with disabilities on research components of a P01 grant.
6. Other Submission
Requirements and Information
General Submission Requirements:
The program project grant application should be structured as a series of separate but interrelated project proposals (minimum of three (3) components, of which no less than two must be individual research projects).
The following format should be used:
Overall Proposal Summary
A summary section for the overall proposal must contain justification for the program project grant mechanism and describe those goals that are not readily attainable through individual research project grants. This section should include (in this order; maximum of twenty-five (25) pages, exclusive of budget, biosketch, and person month/other support pages):
1. the face page,
2. an abstract description of the overall program project;
3. a list of key personnel (including any key consultants);
4. the consolidated budget for the program project grant (summarizing budgets for the component parts);
5. a description of resources and environment/facilities available including major instruments and special program resources;
6. administrative arrangements for overall scientific leadership, quality control, and management of the program project grant; and
7. a separate overall listing of the proposed person months on the program project grant and actual/current and pending research support from all sources for each key personnel (including percent effort devoted to each component).
8. an Overview narrative including a description of the objectives of the program as a whole that describes the relationship of the individual research projects, and core(s) if applicable, to the entire program project and the special benefits to be achieved by funding as a program project grant rather than as a series of individual research grants. This section must also detail the relationship of existing support to the proposed program project and describe planned modifications to that support in the event of funding, for example, folding in support for related funded research.
Components (minimum of three (3) components, no less than two (2) of which must be individual research projects):
Each individual project of a program project grant should represent both an independent and an interdependent research effort, and should be prepared in the format of an individual research grant (i.e., R01) application. The cover page, description (abstract), budget and justification pages, biographical and other support information of the Project Leader(s), a detailed description of the research to be conducted, and any justification for human and animal experimentation, if applicable, should be included as noted below. The special benefits associated with being part of the program project must also be addressed.
If support for core resources is requested, a separate component describing and justifying these should be included. The page limits for individual R01 research grant applications apply to both individual projects and cores.
A Project/Core Overview section may be included to provide background on how the projects/components inter-relate and how the science is benefited from the program project above and beyond had each project been separately funded. The Project/Core Overview is limited to one (1) page and should be placed immediately before the Project Specific Aims and Background sections.
Applicants are encouraged to send Appendix materials on a CD in PDF format in lieu of the five collated sets. See PHS 398 paper application instructions for details on preparing CDs. Only a single CD need be sent.
Appendix Materials
All paper PHS 398 applications submitted must provide appendix material on CDs only. Include five (5) identical CDs in the same package with the application. (See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.)
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.
Resource Sharing Plan(s)NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.
(a) Data Sharing Plan: Not Applicable
(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.
(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition. For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.
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).
Only the review
criteria described below will be considered in the review process.
2. Review
and Selection Process
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 NINR Office of Scientific Review and in accordance with NIH
peer review procedures (http://grants1.nih.gov/grants/peer/),
using the review criteria stated below.
As part of the scientific peer review, all applications will:
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, and weighted 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 meritorious 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.
The scientific merit of the entire program project grant application, as well as its coherence as a program, will be assessed on the basis of the criteria outlined below. In addition, the scientific merit of each individual project will be assessed and a priority score assigned. This assessment of the individual project will be based on the scientific merit, based on the published criteria for regular research grants, taking into account the additional strength the project gains from interactions with other components of the proposed program project grant and its potential importance to the success of the total effort. In this context, it may be the case that an individual project may be highly meritorious in the context of the entire program project, but not make sense as a stand-alone research grant.
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 PDs/PIs, is the leadership approach,
including the designated roles and responsibilities, governance, and
organizational structure, consistent with and justified by the aims of the
project and the expertise of each of the PDs/PIs?
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?
Investigators: Are the
PD/PI(s) and other key personnel appropriately trained and well suited to carry
out this work? Is the work proposed appropriate to the experience level of the
principal investigator and other researchers? Do the PD/PI(s) 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, 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 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 Research Plan section on Human
Subjects in the PHS 398 instructions).
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 Research Plan section on Human Subjects in the
PHS 398 instructions).
Care and Use of Vertebrate Animals in Research: If vertebrate animals are to
be used in the project, the five points described in the Vertebrate Animals
section of the Research Plan will be assessed.
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: The reasonableness of the
proposed budget and the requested period of support in relation to the proposed
research. The priority score should not be affected by the evaluation of the
budget.
2.C. Resource Sharing Plan(s)
When relevant, reviewers will be instructed to comment on the reasonableness of the following Resource Sharing Plans, or the rationale for not sharing the following types of resources. However, reviewers will not factor the proposed resource sharing plan(s) into the determination of scientific merit or priority score, unless noted otherwise in the FOA. Program staff within the IC will be responsible for monitoring the resource sharing.
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 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 (designated in item 12 on
the Application Face Page). If a grantee is not email enabled, a hard copy of
the NoA will be mailed to the 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 Also Section IV.5. Funding
Restrictions.
2.
Administrative and National Policy Requirements
All P01 applications that propose or have the
potential to support human subjects research must obtain IRB approval for the
program project as a whole prior to funding. Individual Projects that
include human or animal subjects must also obtain the appropriate institutional
protocol approval (i.e., IRB or IACUC approval) prior to commencing research
activities.
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 (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm)
and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and
Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).
3.
Reporting
Awardees will be
required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement, including
a detailed budget for each component of the program project.
Copies (paper or electronic) of publications (in press or in print) that are developed as a result of this support must be provided to NINR. NINR must be acknowledged by the awardee (via inclusion of grant number) as the source of support for the work in all publications and presentations.
NIH requires all grantees to submit to the NIH National Library of Medicine's (NLM) 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, 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 (http://grants2.nih.gov/grants/guide/notice-files/NOT-OD-05-022.html). The Public Access website (http://publicaccess.nih.gov/) provides instructions on submitting manuscripts.
A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.
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:
Dr. Paul Cotton
Office of Extramural Programs
National Institute of Nursing Research
6701 Democracy Plaza; Suite 710
Bethesda, MD 20892-4870
Telephone: (301) 402-6423
FAX: 301-480-8260
Email: [email protected]
2. Peer Review Contacts:
Dr. Yujing Liu, Chief
Office of Review
National Institute of Nursing Research
6701 Democracy Plaza; Suite 710
Bethesda, MD 20892-4870
Telephone: (301) 451-5152
FAX: 301-480-8260
Email: [email protected]
3. Financial or Grants
Management Contacts:
Brian Albertini, Chief
Office of Grants and Contract Management
National Institute of Nursing Research
6701 Democracy Plaza; Suite 710
Bethesda, MD 20892-4870
Telephone: (301) 594-6869
FAX: 301-480-8260
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 (45CFR46) 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).
Policy
for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association
studies (GWAS) to identify common genetic factors that influence health and
disease through a centralized GWAS data repository. For the purposes of this
policy, a genome-wide association study is defined as any study of genetic
variation across the entire human genome that is designed to identify genetic
associations with observable traits (such as blood pressure or weight), or the
presence or absence of a disease or condition. All applications, regardless of
the amount requested, proposing a genome-wide association study are expected to
provide a plan for submission of GWAS data to the NIH-designated GWAS data
repository, or provide an appropriate explanation why submission to the
repository is not possible. Data repository management (submission and access)
is governed by the Policy for Sharing of Data Obtained in NIH Supported or
Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas/
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 http://grants.nih.gov/grants/policy/nihgps_2003/index.htm).
All investigators submitting an NIH application or contract proposal, beginning
with the October 1, 2004 receipt date, 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 new PHS Form 398; 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 Requirement:
In accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html)
investigators must submit or have submitted for them their final, peer-reviewed
manuscripts that arise from NIH funds and are accepted for publication as of
April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly
available no later than 12 months after publication. As of May 27, 2008,
investigators must include the PubMed Central reference number when citing an
article in NIH applications, proposals, and progress reports that fall under
the policy, and was authored or co-authored by the investigator or arose from
the investigator’s NIH award. For more information, see the Public
Access webpage at http://publicaccess.nih.gov/.
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. For publications listed in the
appendix and/or Progress report, internet addresses (URLs) must be used
for publicly accessible on-line journal articles. Unless otherwise
specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for 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. 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 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
NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.
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.
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NIH Funding Opportunities and Notices
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