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: Centers in Symptom Management Research or Centers in
Health Promotion/Disease Prevention: Building Research Teams for the Future
(P20)
Announcement Type
New
Update: The following updates relating to this announcement have been issued:
Key Dates
Release Date: August 20, 2008
Letters of
Intent Receipt Date: November
15, 2008
Application Receipt Date: December 15, 2008
Peer
Review Date: February 2009
Council
Review Date: May 2009
Earliest Anticipated Start Date: July 2009
Additional Information To Be
Available Date (Url Activation Date): Not
Applicable
Expiration
Date: December 16, 2008
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: General
The
National Institute of Nursing Research (NINR) invites applications to establish
Centers in Symptom Management Research OR Centers in Health Promotion/Disease
Prevention: Building Research Teams for the Future (P20). The purpose of the
proposed grant program is to plan and develop sustainable interdisciplinary,
biobehavioral research capacity for scientists conducting Symptom Management
Research OR Health Promotion/Disease Prevention Research by enabling
development of research infrastructure and centralized resources in support of
these research programs.
The objectives of this program are to:
(1) facilitate the development of research infrastructure by establishing research resources to plan, promote and support Symptom Management Research OR Health Promotion/Disease Prevention Research;
(2) expand the number and quality of research projects aimed at improving (a) symptom management in persons of all ages with chronic and acute disorders, (b) the quality of life in persons with function-impairing symptoms and their caregivers, OR (c) expand the number and quality of research projects aimed at improving health and quality of life in both healthy and chronically ill persons of all ages;
(3) expand the number of Symptoms Management research investigators involved in interdisciplinary research;
(4) increase the quantity and quality of research projects utilizing biobehavioral methods;
(5) plan for and develop sustainability of research programs by building an active and growing research program with collaborations and partnerships both inside and outside of the applicant organization.
Research Objectives for 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 is 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 affected 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 Center 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 Center application around this symptom 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.
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.
Research Objectives for 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 RFA 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 Center 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 Center 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 departments 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.
NINR Centers
NINR currently supports a number of Exploratory/Developmental Center (P20s) and Centers of Excellence (P30s) grants. The purpose of an NINR P20 Center is to: (1) develop sustainable interdisciplinary, biobehavioral research capacity for scientists conducting nursing research by establishing centralized research resources and a research infrastructure; (2) advance the Center’s thematic science area through complementary, synergistic research activities; and (3) enable feasibility research that will develop into new programs of research and independent investigator research applications.
It is expected that new biomedical and behavioral knowledge will be discovered for improving symptom management of persons with acute and chronic disorders, and for improving the quality-of-life of all patients and their caregivers, across the NINR research mission areas and strategies presented in the 2006 NINR Mission and Strategic Plan (http://www.ninr.nih.gov/ AboutNINR/NINRMissionandStrategicPlan).
The Public Health Service (PHS) is committed to achieving the symptom management and health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This RFA 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/.
Interdisciplinary and biobehavioral approaches to improve symptom management or health promotion/disease prevention are needed. Attention to health disparities in symptom management or health promotion/disease prevention is encouraged. Applicant organizations should submit nursing research proposals in areas specific to the Symptom Management OR Health Promotion/Disease Prevention research areas in the NINR strategic plan priority areas. Applicants are to select one (not both) topical area for their application (i.e., Symptom Management OR Health Promotion/Disease Prevention) based on a conceptually sound integration of the currently funded projects that comprise the research base of the Center. Applications should propose innovative ideas consistent with NINR's mission. Although not inclusive of all topics that would be considered responsive to this RFA, applicants are encouraged to review the NINR’s Strategic Plan document (http://www.ninr.nih.gov/AboutNINR/NINRMissionandStrategicPlan/) that includes the following examples of Symptom Management areas of scientific opportunity at NINR:
OR the
following examples of Health Promotion/Disease Prevention areas of
scientific opportunity at NINR:
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 P20 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 are 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 $2.0 million/year for 5 years will be available to support scientifically
meritorious applications responding to this P20 FOA and the companion P20 and
P30 FOAs constituting the FY2009 NINR Centers initiative. It is anticipated
that support will be provided for up to 2-3 new P20 Centers for Building the
Research Teams of the Future. Individual P20 awards are expected to be $200,000
to $250,000 per year in direct cost; $300,000 is the maximum amount that may be
requested in total costs (i.e., direct plus F&A) per year.
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:
To be eligible, applicant organizations must operate within the United States or territories and must document at least two (2) peer reviewed research projects in the scientific topical area selected (i.e., Symptom Management OR Health Promotion/Disease Prevention)at the R01, R15, or R21 mechanism level that are active (not including periods of no cost extension ) at the time of P20 application submission. Peer-reviewed research projects supported by State governments or private foundations that are awarded for two (2) or more years duration may also be qualifying. If State government or foundation awards are used to demonstrate research focus in the scientific topical area selected (i.e., Symptom Management OR Health Promotion/Disease Prevention), at least one (1) award must be supported by DHHS. Awards from an applicant organization will not be considered as supporting evidence of a research focus. A description of the qualifying research activities must be included in the application.
Applicant organizations that have previously been or are currently the recipient of a P20 or P30 Center award funded by NINR are not eligible to apply to this FOA. However, applicant organizations that are Minority Serving Institutions (MSIs) that previously held an awarded NINR Partnership P20 Center are eligible to apply under this FOA.
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 (i.e., at the time of application receipt due date) NIH funding (not including no-cost extension periods) at the R01, R03, R15, or R21 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. Multi-PI applicants are also encouraged to contact the NINR Center Program Coordinator for additional detailed guidance on completing the PHS 398 application.
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. Successful
applicants should plan to participate in NINR-sponsored conferences to share
information, discuss problems, and collaborate with other awardees. It is
therefore strongly recommended that costs associated with attendance of the
principal investigator at one such conference per year be included as a part of
the budget proposal. Applicants are also encouraged to include funds to support
the creation and maintenance of a Center website, on which they can disseminate
their Center-related activities and research products.
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. Applicant organizations submitting more than one application will have all applications returned without review.
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.
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
Letter
of Intent Receipt Date: November 15,
2008
Application Receipt Date: December 15, 2008
Peer Review Date: February 2009
Council Review Date: May 2009
Earliest
Anticipated Start Date: July 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.)
Applicants should be aware that stipends and honoraria are prohibited
costs on a P20 grant. NINR will only consider administrative requests for
research supplements to support underrepresented minorities or persons with
disabilities on research components of a P20 grant.
6. Other Submission Requirements and Information
General Submission Requirements:
REQUIRED COMPONENTS OF THE APPLICATION: The Centers in Symptom Management Research OR Centers in Health Disparities/Disease Prevention Research: Building Research Teams for the Future (P20) must include the following:
Other cores, such as a Research Outreach/Dissemination Core, a Design/Methodology/ Statistics Core, or a Biobehavioral Tools Core, are optional, and may be added to help facilitate the achievement of goals and objectives outlined in the application. Each Core should be directed by an investigator/faculty with substantial expertise related to the Core. An important consideration is the degree to which core facilities (a) will be utilized by and benefit ongoing and/or proposed Projects and Center investigators and (b) will assist in the development of the activities related to Symptom Management OR Health Promotion/Disease Prevention Research.
It is not sufficient for the applicant to merely identify resources that will be shared by Center investigators. Rather, applicants must describe how each optional Core will augment or enhance the present capabilities of the investigators/faculty at the applicant organization, including both Project investigators within the Center, as well as investigators in the larger research community affiliated with the applicant organization. Likewise, proposed Project investigators must describe how they plan to utilize each Center Core. In the application, the description of each Core is limited to five (5) pages.
6.1 ADMINISTRATIVE CORE (MANDATORY), 5 PAGE LIMIT:
An Administrative Core is mandatory for all Centers. The Administrative Core should manage the overall activities of the Center, including developing, promoting, and managing use of Center resources. The Administrative Core should also actively develop means for and promote Center investigators networking and collaborating with the larger research community. The Administrative Core is responsible for the development and execution of an evaluation plan and a plan for sustainability. Active monitoring of all Center components for federal research guidelines (e.g., IRB and IACUC approvals) compliance is also the responsibility of the Administrative Core.
The Administrative Core must contain:
It is expected that the Center Administrative structure will accomplish the following:
An Evaluation Plan, developed, executed and tracked by the Administrative Core, is also required, but should be presented in a separate section from the Administrative Core (see 6.3 below).
While the final administrative structure of the Center will, for the most part, be left to the discretion of the applicant organizations, NIH's experience has demonstrated that the effective development of Center programs requires interaction among the Director(s), Core Leaders, directors of the research Projects, appropriate institutional administrative personnel, and the staff of the awarding agency. To facilitate communication among the Center staffs and the NINR, NINR expects that each Center application must include funds for the Center Director to travel to an annual meeting in Bethesda, Maryland.
An Executive Committee, consisting of the heads of all Cores and appropriate business official(s), should be established to assist the Director in the allocation of Center resources, the identification and selection of key personnel, and the planning and execution of Center activities. Other members can be added to the Executive Committee at the Director’s discretion.
The complex nature of administrative requirements of centers will necessitate the assistance of a person with business management expertise. It is important that such an official is identified and is directly involved with the fiscal aspects of the application and grant. An appropriate amount of this individual's time and effort should be committed for this purpose. The institutional business official should be a member the Executive Committee. While budget formulation and planning will undoubtedly begin with the Director in collaboration with the scientific staff, the business official should be involved in the process, provide consultation in matters of fiscal administration, and evaluate such issues as equipment on hand versus that requested for the core facilities. Additionally, this institutional official can assist the Director in determining the compliance with NIH research guidelines.
An External Advisory Committee of scientists and administrators should be established and composed of at least two (2) scientists from outside the applicant organization, with expertise and experiences relevant to the scientific program of the Center. This committee should be used in evaluating the overall research programs of the Center, the development and utilization of research resources, the effectiveness of communications within the Center, and any activities in which problems arise for which expertise is required or desirable. The External Advisory Committee should meet in person at least once annually. However, the nature of its responsibilities may require ad hoc meetings at more frequent intervals. A member of the NINR extramural program staff is to be invited to attend each meeting as an observer, and provided a copy of the meeting minutes within weeks of each meeting.
6.2 RESEARCH PROJECTS (THREE (3) MANDATORY), 5 PAGE LIMIT PER PROJECT WITHIN THE CENTER:
The Center application must include 3-6 research projects that will be undertaken during or dispersed throughout the period of Center support. All projects must come in with the application. Each research Project should be 2 to 3 years in duration and should include:
Three research Projects over the period of support for the Center are mandatory, additional Projects may be proposed up to a total of six (6) Projects. They are intended to enable eligible investigators to explore a scientific topic on Symptom Management OR Health Promotion/Disease Prevention, and to amass sufficient expertise and data to complete the study and develop an independent research track and applications (e.g., NIH R01). Research projects can not be used to supplement already-funded research at the applicant organization. The Center should have at least one ongoing research Project at all times during the period of support.
Eligible Project directors, co-investigators, and collaborators include:
Based on their own scientific merit, research projects will receive individual scores separate from the overall P20 Center score. Standard guidelines for IRB/IACUC approval, targeted enrollment table(s) for human research, and educational training for the protection of human subjects apply. The theoretical basis for the research projects must be clearly explicated, as well as a brief statement of fit within the Center as a whole. Each Project is limited to a total of 10 pages of description for the Research Plan, Sections a. through d., which should delineate the question being asked, detail the procedures to be followed, and discuss how the data will be analyzed. The application must indicate how the proposed study addresses a Symptom Management OR Health Promotion/Disease Prevention topic, and how the Project will utilize and interact with Center Core resources.
6.3 EVALUATION PLAN (MANDATORY), 10 PAGE LIMIT:
The National Advisory Council for Nursing Research (NACNR) reviewed and approved the NINR Centers Program concept. The need for collecting appropriate data (such as publications, presentations, grant awards, and other accomplishments that accrue as a result of the Center activity and presence) was emphasized. This will allow for annual planned evaluation of goals attainment and subsequent remedial action as needed. As a result of this guidance and the need of Centers to ensure their own success, a plan for ongoing evaluation of progress toward meeting the aims and goals of all Cores, Projects, and the overall Center is required. This plan should include the specific criteria and methods that will be used for the evaluation. The plan should specify the types of evaluation information that will be submitted in the Center's annual progress report.
After an award is made, the NINR will require detailed documentation (in the required annual PHS2590 Progress Report) of presentations, publications, resource sharing, collaborations, and grant submission activities (see NINR Guidance on Center Reporting http://www.ninr.nih.gov/ResearchAndFunding/GrantDevelopmentandManagementResources/CtrGrant% 20AdminReportingGuidance/NINRGuidanceonReporting.htm for details).
6.4 ADDITIONAL CORES (OPTIONAL), 5 PAGE LIMIT PER CORE:
Additional Cores may be proposed to support and enhance the activities of the Center, such as a Research Outreach/ Dissemination Core, a Design/Methodology/Statistics Core, or a Biobehavioral Tools Core, and may be added to help facilitate the achievement of goals and objectives outlined in the application. Each core should be directed by a doctorally prepared investigator with substantial expertise related to the Core activities. An important consideration is the degree to which a Core facility (a) will be utilized by and benefit ongoing and/or proposed Projects and Center investigators and (b) will assist in the development of the activities related to Symptom Management OR Health Promotion/Disease Prevention research, both within the Center and in the larger research community at the applicant organization. It is not sufficient for the applicant to merely identify resources that will be shared by Center investigators. Rather, applicants must describe how each Core will augment or enhance the present capabilities of the investigators/faculty at the applicant organization, including both Project investigators within the Center, as well as investigators in the larger research community affiliated with organization. Likewise, proposed Center Project investigators must describe how they plan to utilize each Center Core.
Each Core description must include:
Core investigators may collaborate and co-author research with other Center investigators, but Core budgets may not be used to supplement any research Project within or outside of the Center. Cores are not intended to function as independent research projects, however, they may investigate the benefit of the Core’s services/resources, or means of enhancing Core services/resource provision.
6.5 APPENDICES (OPTIONAL), MAXIMUM OF NINE (9) APPENDICES TOTAL:
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). The number of allowed appendices has been changed for this FOA only. Using the guidance in the above Notice, applicants may submit one (1) appendix per Center component (i.e., one per Core or Project), up to a maximum of nine (9) total appendices for any Center application. For example, if a Center application has two (2) Cores and three (3) Projects, the maximum number appendices is a total of five (5) appendices (i.e., 5 components).
Appendix Materials
All paper PHS 398 applications submitted must provide appendix material on CDs only. Include five 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 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 second level of review will be performed by the National Advisory Council for Nursing Research (NACNR). Applications recommended by the NACNR will be considered for funding on the basis of the overall scientific merit of the application as determined by peer review, as well as such considerations as program balance, relevance to the mission and goals of the NINR, geographic distribution, inclusion of health disparity populations, research program priorities, and availability of funds.
NIH considers the following in evaluating Center grant applications, per 42 CFR PART 52a.5 NATIONAL INSTITUTES OF HEALTH CENTER GRANTS:
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 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.
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? Does 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?
In addition to the above review criteria, the following criteria will be applied to applications in the determination of scientific merit and the priority score.
The initial review for scientific and technical merit of applications will emphasize three major aspects:
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.
CENTER AS AN INTEGRATED WHOLE will be evaluated with the following criteria:
Significance: Do the Center’s research goals address an important problem? Is there potential for favorable impacton the field of Symptom Management OR Health Promotion/Disease Prevention research, and the research capacity of the applicant organization?
Approach: Does the Center demonstrate a multi- and inter-disciplinary biobehavioral approach appropriate for its goals? Is the coordination among the Administrative Core, the optional Cores, and the research Projects adequately explained? Is there synergistic potential among the Center’s research components? Is the evaluation plan likely to ensure the advance of the Center research aims? Is there justification for each research and Core component in terms of the overall goals of the Center? Does the Center have the potential to achieve a whole greater than the sum of its parts? Is there evidence that Center activities and resources can be sustained beyond the period of funding?
Innovation: Will the Center make a unique contribution or fill a significant gap in the area of Symptom Management OR Health Promotion/Disease Prevention research? Will the Center resources provide a unique contribution to the research infrastructure at the applicant organization?
Investigators: Are the investigators appropriately trained and well suited to carry out this work? Do the investigators bring complementary and integrated expertise to the Center? Is the Center Director capable of providing the scientific leadership and administrative oversight required to lead a Center? Are the plans for External Advisory Committee input well integrated into the Center decision-making processes?
Environment: Is the academic and physical environment in which the research will be conducted, including availability of space, equipment, research subjects, and materials well defined? Is there evidence of long-term institutional commitment to the pursuit of Symptom Management OR Health Promotion/Disease Prevention research? Is the environment within and around the institution suitable for the advancement of Symptom Management OR Health Promotion/Disease Prevention research? Is there evidence of true collaboration with institutional partners and multidisciplinary research?
The ADMINISTRATIVE CORE will be evaluated with the following criteria:
Approach: Are the arrangements and organizational structure adequately developed, well reasoned and appropriate to the aims of the Center? Does the application describe how day-to-day management of the Center will be accomplished? Are the plans to facilitate and monitor attainment of Center objectives appropriate? Are contractual and consortium arrangements adequately described, if applicable? Are plans for sustainability and long-term management of the Center appropriate? Are plans for Center scientific growth and development over the Project period appropriate and adequately described?
Investigator: Are the qualifications, experience, commitment and administrative competence of the Administrative Core Director appropriate? Is there an appropriate time and effort commitment made by the Administrative Core Director? Is there evidence that the Administrative Core, other Cores, and research Projects staff have worked closely together in the preparation of the application and will continue to do so in meeting the proposed Center objectives?
Environment: Is institutional commitment to the pursuit of Symptom Management OR Health Promotion/Disease Prevention research and other proposed activities, including provision of resources, administrative authority and recognition, convincing? Is there evidence of institutional commitment to incorporate and highlight the Center and its activities at the institution level and beyond?
Each additional OPTIONAL CORE will be evaluated with the following criteria:
Approach: Are the arrangements and organizational structure adequately developed, well reasoned and appropriate to the aims of the Core? Does the application describe how day-to-day management of Core resources will be accomplished? Are there plans to identify emerging Core resource needs of the Center and applicant organization? Are Core plans appropriate to facilitate and monitor attainment of Center objectives? Does the Core enhance and complement the Center’s scientific goals (i.e., is there a good fit of the Core to the Center)?
Investigator: Are the qualifications, experience, commitment and competence of the Core Director appropriate? Is there an appropriate time and effort commitment made by the Core Director? Is there evidence that the researchers and faculty of the Core and the Projects and Administrative Core have worked closely together in the preparation of the application relative to the Core resources and will continue to do so in meeting the proposed Center objectives?
Environment: Is institutional commitment to the Core in its pursuit of resources to support Symptom Management OR Health Promotion/Disease Prevention research, including provision of resources and recognition, convincing?
The EVALUATION PLAN will be evaluated with the following criteria:
Approach: Is the evaluation plan adequately developed, well reasoned and appropriate to the aims of the Center? Does the application describe how monitoring, tracking, and corrective adjustments in activity will be determined or take place? Does this tracking accommodate the information required for annual progress reports to NINR? Does the evaluation plan include well-defined and quantifiable outcome measures? Are the overall plans to facilitate and monitor attainment of Center objectives appropriate? Does the evaluation plan include plans for sustainability of the Center?
Investigator: Has an investigator been named to head the evaluation effort? Does this individual have the qualifications, experience, commitment and competence to accomplish the task? Is there evidence that the researchers and faculty of the Center have worked closely together in the preparation of the evaluation and sustainability plan and will continue to do so in annually evaluating progress?
The RESEARCH PROJECTS will be evaluated with the following criteria:
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 Center goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each project. Note that a project 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. Reviewers will be asked to review each Project separately and assign it a score. These scores will be taken into account when assigning an overall score to the Center.
Significance: Does this study address an important problem? If the aims of the project 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? Does the proposed research address a significant problem and/or gap in Symptom Management OR Health Promotion/Disease Prevention research or care?
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? Are the proposed approaches appropriate for research in populations in need of symptom management OR Health Promotion/Disease Prevention strategies? Does the Project enhance and complement the Center’s scientific goals (i.e., is there a good fit of the Project to the Center)?
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? Are there plans to later develop this Project into an independent grant application? Is this Project likely to develop results worthy of publication?
Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the Project Director and other researchers? Does the investigative team bring complementary and integrated expertise to the Project (if applicable)?
Environment: Does the scientific environment in which
the work will be done contribute to the probability of success? Does the
proposed study benefit from unique features of the scientific environment, or
subject populations, or employ useful collaborative arrangements? Is there
evidence of institutional support? Does the proposed Project benefit from the
resources available at the Center? Does the application demonstrate the role of
the Center Cores in the accomplishment of this project?
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 rating:
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
P20 applications that propose or have the potential to support human subjects
research must obtain IRB approval for the Center 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 Center.
Evaluation and tracking reports as described in Sections IV.6.3 (Evaluation Plan) and IV.6.4 (Additional Cores) of this announcement should be included annually as part of the PHS2590 Progress Report. These reports must, at minimum, include Center progress tracking data (e.g., Core resources utilization data, collaborations established and their outcomes, developed products, new research applications spawned as a result of the Center), all new Center supported publications, and External Advisory Committee meeting minutes. The Center as a whole, as well as each Core and Project must provide a report of their progress and updated administrative approvals (e.g., IRB/IACUC approvals). See the website NINR Guidance on Center Reporting (http://www.ninr.nih.gov/ResearchAndFunding/ GrantDevelopmentandManagementResources/CtrGrant%20AdminReportingGuidance/NINRGuidanceonReporting.htm) for reporting guidance. The Center investigators and directors may chose to include additional information regarding progress and outcomes as appropriate.
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 encourages 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:
Paul Cotton, PhD, RD
Program Director
National Institute of Nursing Research/NIH
6701 Democracy Blvd, Suite 710
One Democracy Plaza
Bethesda, MD 20892-4870
Phone: 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) 594-5971
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.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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