IMPORTANT NOTE: NIH
has published new limitations on grant application appendix materials to
encourage applications to be as concise as possible while containing the
information needed for expert scientific review.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)
National Institute of Child
Health and Human Development
(NICHD), (http://www.nichd.nih.gov)
National Cancer Institute (NCI), (http://www.nci.nih.gov)
National Heart, Lung, and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov/)
Office of Dietary Supplements (ODS), (http://dietary-supplements.info.nih.gov/)
Title: Chronic Illness Self-Management in Children and Adolescents (R03)
Announcement
Type
This
is a reissue of PA-03-159, which was previously released on August 6, 2003, and
now is divided into separate FOAs for R21, R01 and R03 funding mechanisms.
Update: The following update relating to this announcement has been issued:
NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.
APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.
This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).
A registration process is necessary before submission and applicants are highly encouraged to start the process at least four weeks prior to the grant submission date. See Section IV.
Program Announcement (PA) Number: PA-07-098
Catalog
of Federal Domestic Assistance Number(s)
93.361,
93.865, 93.849, 93.395
Key Dates
Release/Posted Date: November 29, 2006
Opening Date: January 5, 2007 (Earliest date an application may be
submitted to Grants.gov)
Letters
of Intent Receipt Date(s): Not
Applicable.
NOTE: On time submission requires that applications be successfully
submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant
institution/organization).
Application Submission/Receipt
Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Submission/Receipt Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS.
Peer Review Date(s): Standard dates apply,
please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review Date(s): Standard dates apply,
please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date(s): Standard dates
apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Additional Information To Be Available Date (URL
Activation Date): Not Applicable
Expiration Date: January 3, 2010 (now January 8, 2010 per NOT-OD-07-093)
Due
Dates for E.O. 12372
Not
Applicable
Additional Overview Content
Executive
Summary
Table of Contents
Part I Overview Information
Part II Full Text of Announcement
Section I. Funding Opportunity
Description
1. Research Objectives
Section II. Award Information
1. Mechanism of Support
2. Funds Available
Section III. Eligibility
Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2. Cost Sharing or Matching
3. Other - Special Eligibility Criteria
Section IV. Application and
Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Submission, Review, and Anticipated Start Dates
1. Letter of Intent
B. Submitting an Application Electronically to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
Section V. Application Review
Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review
Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award Dates
Section VI. Award Administration
Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting
Section VII. Agency 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
SCOPE: The common characteristic of the small grant is provision of
limited funding for
a short period of time to conduct:
The purpose of this Funding Opportunity Announcement (FOA) issued by the NINR, NICHD, NIDDK, NCI, and ODS is to solicit research to improve self-management and quality of life in children and adolescents with chronic illnesses. Biobehavioral studies of children within the context of family and family-community dynamics are encouraged. Children with a chronic disease and their families have a long-term responsibility for self-management. The child with the illness will have a life-long responsibility to maintain and promote health and prevent complications. Research related to sociocultural, environmental, and behavioral mechanisms as well as biological/ technological factors that contribute to successful and ongoing self-management of particular chronic illnesses in children is encouraged.
This FOA is restricted to studies of chronic illnesses in children and adolescents ages 8 to 21 grouped by developmental stages according to the discretion of the investigator. Studies of chronic mental illness or serious cognitive disability are beyond the scope of this FOA.
Research Objectives
Management of chronic illness is one of the main challenges facing our health care system. Diseases that were once acute and life-threatening, such as heart disease, diabetes, end-stage renal disease, HIV and some cancers are now long-term, chronic conditions. Emerging global health threats may have chronic sequelae.
Increasing self-management is a desirable goal for the 15% to 20% of children and adolescents who have significant ongoing health care needs related to a chronic illness [CDC, NVSS, 4/2006]. Promoting self-management in young people with chronic illness can be difficult for parents and children. Most of the self-management research has focused on older populations in which the burden and costs of chronic illness and disability are increasingly evident. However, the economic and the quality of life costs of chronic illness, disability, developmental delay and behavior problems are also prevalent in children and adolescents are equally devastating and are predicted to be even more enduring.
The term self-management means different things to different people. It can mean simply living with a chronic illness in ways that allow a person to get on with life as best as possible. It can also refer to adherence to treatment regimens. Self-management is intended to improve well-being and strengthen self-determination and participation in health care, while reducing inappropriate health care utilization and health care costs.
Children with chronic illnesses must live with their condition even when the condition is in remission. Some examples of chronic conditions include but are not limited to: asthma, diabetes, cystic fibrosis, end-stage renal disease, cerebral palsy, migraine, epilepsy, heart disease, obesity, sickle cell disease, hemophilia, HIV and some forms of cancer. The discussion below is meant to assist the applicant and is not exhaustive.
Asthma is the most common chronic disorder in childhood, currently affecting an estimated 6.2 million children under 18 years; of which 4 million suffered from an asthma attack or episode in 2003. Asthma morbidity continues to pose a significant personal and societal burden despite the availability of effective medications to manage the disease. Many children in the United States who should receive preventive medications do not receive them. Minority children and children living in poverty have a greater burden from asthma compared with white non-poor children and the same children are less likely to receive adequate treatment and are less likely to have family or community support for their asthma management. In addition, the incidence of allergy in children is on the rise. The biggest increases are being seen in heavily populated areas. The rise is due to a composite of factors that are associated with the way children and adolescents live in homes and their exposure to inhalant allergens. Lower prevalence rates of allergic illnesses in rural as compared with urban populations have been interpreted as indicating an effect of air pollution. However, little is known about other factors of the rural environment which may determine the development of atopic sensitization and related illnesses.
According to the Centers for Disease Control and Prevention (CDC), (2005), almost 21 million Americans, or 7 percent of the population, have diabetes. Among young people aged 20 or younger, the prevalence of Type 1 diabetes is 176,500 which translates as one in every 400 to 600 children and adolescents. Furthermore, clinical evidence points to an increase in Type 2 diabetes in youth, particularly among American Indians, African Americans, and Hispanic/Latino Americans. Finally, when considering that obesity is a major risk factor for diabetes later in life as well as many other adult onset chronic diseases the need for self-management of chronic illness in children is apparent.
Cystic fibrosis is a genetic disease that frequently has its first health impact in infancy often progressing through childhood into young adulthood, with death usually occurring as a result of pulmonary complications. Cystic fibrosis is one of the most common fatal inherited diseases. It is most prevalent among Caucasians and Ashkenazi Jews: one in 25 people of European descent carries one gene for cystic fibrosis, making it the most common genetic disease among them. Individuals with cystic fibrosis can be diagnosed prior to birth by genetic testing or in early childhood by a sweat test. There is no cure for cystic fibrosis, and the current median age of survival for people living in the U.S. is 36.6 years. Ultimately, lung transplantation is often necessary as cystic fibrosis worsens.
The incidence of end-stage renal disease (ESRD) in patient’s age 0 19 years in the United States is 15 per million people, according to the 2005 USRDS Annual Data Report. Exact numbers for patients who have chronic kidney disease, but do not yet require dialysis, are not available, but are certainly higher than for those with ESRD. There are now data emerging on the detrimental impact of the lack of self-care ability as this patient population reaches adolescence and have their ESRD care transferred from pediatric nephrologists to internist nephrologists.
Migraine headaches most often begin in childhood. About half of all school-aged children have some type of headache. Estimates indicate that five percent of school age children suffer from migraine headaches, and the frequency of headache increases as children go through puberty. Although prepubescent boys and girls suffer from migraine at approximately the same rate, more girls are affected post-menarche. Like the onset of migraine episodes in adulthood, childhood migraines are difficult to predict or to prevent, and often to treat. Frequently migraines result in significant disability, lost time in school, reduced socialization, increased depression, and impaired quality of life. Self-monitoring and self-management are essential to migraine management as there are currently no biologic measures to predict headache onset or to assure accurate diagnosis.
Although epilepsy represents one of the most frequently occurring neurological problems in children, the incidence and prevalence of the epileptic syndromes are largely unknown. The yearly incidence of epilepsy (recurrent unprovoked seizures) in children and adolescents ranges from 50 to 100/100,000 with the highest incidence in the first year of life. Epilepsy manifested by generalized onset seizures accounts for most of the newly diagnosed cases in the first 5 years of life. Temporal lobe epilepsy, the most common form of epilepsy that affects approximately one percent of the adult population, begins in late childhood and adolescence. However there is an association between temporal lobe epilepsy and febrile seizures in childhood, Children and adolescents with epilepsy must adhere to daily prescriptions, manage drug side effects such as lethargy, increased clumsiness and confusion, and cope with the social stigma of their condition and the potential of reduced autonomy (such as the inability to drive) in their teens.
Because risk factors for adult cardiovascular disease are elevated early in life, studying them in the young should increase our understanding of their influence in the development of left ventricular mass. Questions about the independent effects of body composition and insulin resistance are of particular relevance. Left ventricular mass in normotensive children has been related to lean body mass and measures of visceral fat. Little is known about the progression of left ventricular mass from childhood to adulthood. More research is needed to address this issue, as well as, biobehavioral issues associated with cardiovascular illness in children and adolescents.
HIV/AIDS is now treated in children who were infected at birth, in the US, and increasingly so in other parts of the world. As these children mature, they need to manage a regimen of medication that requires strict (95%) adherence. They also need to manage associated side-effects, and psychosocial issues related to stigma, and avoiding risk behaviors that can lead to transmission of the virus. Some of these issues may be even more complex among those young people who first become infected as adolescents since it can be assumed that these teenagers engage in high risk behaviors. In all situations, the relationship between the young person responsible for self-management and the caretakers must be considered.
Childhood cancer is a treatable condition resulting in long-term survival or cure in upwards of 75 percent of cases. However, treatment is often a lengthy process meaning that the cancer must be managed as a chronic condition. Furthermore, treatment often leads to ongoing effects, or even late effects that must be monitored throughout the life of the survivor. For example, acute lymphocytic leukemia, the most common form of cancer in young children requires a maintenance phase of treatment following the more intensive induction treatment. Although children return to the community during maintenance treatment, they must deal with a wide range of concerns. These range from avoiding infection to dealing with cognitive issues, such as difficulties in learning mathematical skills. Other common forms of childhood cancer may result in the need to cope with loss of a limb, other permanent changes in body image, later concerns about fertility, or the need to avoid behaviors that will increase risk for heart disease or a second cancer as adults. In addition to childhood cancers, hematological disorders, such as sickle cell disease or hemophilia also require biobehavioral research on self-management.
Even though these are very different illnesses, children and families dealing with any chronic illness have a lot in common. Learning to live with a chronic condition can be very challenging for a child, for parents, and for siblings and friends.
The development of self-management practices for children and adolescents with chronic illness requires active engagement of both young people and their parents, with attention to the psychosocial world of the young person. Poor family relationships and low levels of parental support are associated with poorer adherence with treatment regimens, while high levels of family functioning and family support are associated with better treatment adherence, even in the 18 21 years age bracket. While engagement in self-management will not necessarily result in good adherence (which is known to reflect many different variables), it is a good start, as poor understanding and poor commitment to treatment regimens are known barriers to adherence.
There are, however, several areas that require further exploration. First, we know surprisingly little about what constitutes good self-management in children with chronic illness, and what is developmentally appropriate as children mature into adolescents and young adults. For example, we do not know at what age young people generally take on more responsibility for the different components of self-management, such as taking medication, making health care appointments or seeking health care when they become acutely unwell. Furthermore, we do not know how the type or severity of the chronic illness or the nature of the treatment regimen alters the age of acquisition of various self-management practices.
Little is known about rates of participation in health-risk behaviors in this group. While we might intuitively believe that young people will be less likely to engage in behaviors that have a greater attributable risk (e.g., smoking in young people who have diabetes), there is little evidence that this is so, and there are few models about how best to intervene.
Little is also known about the health-risk behaviors of children and youth consuming dietary supplements. Use of supplements in healthy youth and adolescent populations is approximately 24% and 29%, respectively. Among chronically ill children that number rises to 62% with vitamin and mineral supplements being the most commonly consumed. Significant differences have been noted among diagnosis groups with the highest use reported for children with cystic fibrosis. Reported reasons for use include to enhance general health, improve dietary intake, and for the prevention of disease. Few health care providers are aware of their patient’s use of non-prescribed dietary supplements. What remains a concern is whether supplements affect the course of chronic illness, what effects supplements may have on growth and development, if they are being used in place of conventional medications, and their potential for adverse drug interactions.
We also need more information to guide parents. Some styles of parental interaction are perceived as unhelpful by adolescents with chronic illness (such as parents being overly strict or controlling or giving a lot of negative feedback), while others (such as parents trying to work in partnership with their child and giving positive feedback) are viewed more positively. However, there is little research about how parent behavior can either facilitate or hinder the emerging capacity for self-care in adolescents with chronic illness, and thus, whether more effective parenting styles can be learned.
We do know that styles of health care provider patient interaction can influence how adults engage with medical knowledge. Recognizing this fact has made health care providers more aware of the effectiveness of patient-centered practice as a means of improving health outcomes for patients with chronic illness. A critical tenet of such patient-centered practice is the partnering between health care providers and patients. However, a key question for adolescent health is how partnerships are formed between adolescents with chronic illness, parents and health care providers and whether these partnerships can improve health outcomes by improving self-management practices in adolescents with chronic illness.
Implementing evidence-based approaches is possible, but there are no formulas for how best to achieve this in practice. At times, immediate health priorities will need to be balanced against the need to support young people’s emerging autonomy and growing capacity to manage their chronic illness. Intervention research with both behavioral and biological outcomes would assist in developing an evidence base for balancing children’s need for autonomy and demands of their chronic illnesses.
Participation in community-based support groups is a common strategy for promoting self-management in adults with chronic illness. Peer support groups are also highly rated by young people with chronic illness, who particularly value the social support of other young people in the group and the opportunities for wider participation. Despite the prevalence of chronic illness and disability in young people, relatively few peer support groups have been specifically developed for them. In some instances, such as when the number of young people diagnosed with certain chronic diseases is relatively small, it would be beneficial to promote peer support groups that are not disease specific . Rather, the core premise underpinning such peer support groups is that young people with chronic illnesses share many problems in common. Models for such groups have been developed and successfully put into practice. In addition to face-to-face support, young people may also benefit from virtual groups, such as online chat rooms or more formal programs for young people with chronic illness. Schools are a suitable site for health promotion around self-management practices, and school-based programs have been shown to improve health and life outcomes in young people with chronic illness. As with clinical interventions, successful programs are based on a strong understanding of adolescent development, youth participation and promotion of self-management practices.
NIH brings a unique perspective to the interactions between healthy persons, patients, and their families, and health practitioners. Science explores self-management of health because it is closely linked to disease prevention, health promotion, and in particular symptom management.
As self-management includes sensitivity to cultural norms, values and practices, it informs the emerging science of research on health disparities. Also technology is becoming an increasing part of day-to-day patient care, presenting new challenges and driving new areas of research in self-management. NIH seeks to support research that will, but are not limited to:
1. Mechanism(s) of Support
This Funding Opportunity Announcement (FOA) will use the NIH Small Research
Grant (R03) award mechanism. The applicant will be solely responsible for
planning, directing, and executing the proposed project.
This FOA uses Just-in-Time information concepts. It also uses the modular as well as non-modular budget formats (see the Modular Applications and Awards section of the NIH Grants Policy Statement. All applications submitted in response to this FOA must use the modular budget format. Specifically, if you are submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs), use the PHS398 Modular Budget component provided in the SF424 (R&R) Application Package and SF424 (R&R) Application Guide (see specifically Section 5.4, Modular Budget Component, of the Application Guide).
All foreign applicants must complete and submit budget requests using the Research & Related Budget component found in the application package for this FOA. See NOT-OD-06-096.
Competing renewal (formerly competing continuation ) applications will not be accepted for the R03 grant mechanism. Small grant support may not be used for thesis or dissertation research. Up to two resubmissions (formerly revisions/amendments") of a previously reviewed small grant application may be submitted. See NOT-OD-05-046, April 29, 2005.
For specific information about the R03 programs, see: http://grants.nih.gov/grants/funding/r03.htm.
2. Funds Available
Because the nature and scope of the proposed
research will vary from application to application, it is anticipated that the
size and duration of each award will also vary. Although the financial plans of
the NIH Institutes and Centers (ICs) 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.
A project period of up to two years and a budget for direct costs of up to two $25,000 modules, or $50,000 per year, may be requested (i.e., a maximum of $100,000 over two years in four modules of $25,000 each). Commensurate Facilities and Administrative (F&A) costs are allowed.
F&A costs requested by consortium participants are not included in
the direct cost limitation. See NOT-OD-05-004, November 2, 2004.
Section III. Eligibility Information
1. Eligible Applicants
1.A. Eligible
Institutions
You may submit an application(s) if your organization
has any of the following characteristics:
1.B. Eligible Individuals
Any individual with the skills, knowledge, and
resources necessary to carry out the proposed research as the Project
Director/Principal Investigator (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.
R03 eligibility is limited to new investigators
2. Cost Sharing or Matching
This program does not require cost sharing as defined in the current NIH Grants Policy Statement.
3.
Other-Special Eligibility Criteria
Applicants may submit more than one application, provided each application is
scientifically distinct.
Section IV. Application and Submission Information
To download an
Application Package and SF424 (R&R) Application Guide for completing the
SF424 (R&R) forms for this FOA, link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.
A one-time registration is required for institutions/organizations at both:
PDs/PIs should work with their institutions/organizations to make sure they are registered in the NIH eRA Commons.
Several additional separate actions are required before an applicant institution/organization can submit an electronic application, as follows:
1) Organizational/Institutional Registration in Grants.gov/Get Started
Grants.gov
Customer Support
Contact Center Phone: 800-518-4726
Business Hours: M-F 7:00 a.m. - 9:00 p.m. Eastern Time
Email [email protected]
2) Organizational/Institutional Registration in the eRA Commons
eRA
Commons Help Desk
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Business hours M-F 7:00 a.m. 8:00 p.m. Eastern Time
Email [email protected]
3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.
Note that if a PD/PI is also an NIH peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.
Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.
1. Request Application
Information
Applicants must download the SF424 (R&R)
application forms and SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.
Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the Attachment files may be useable for more than one FOA.
For further assistance contact GrantsInfo, Telephone 301-710-0267, Email: [email protected].
Telecommunications for the hearing impaired: TTY 301-451-5936.
2.
Content and Form of Application Submission
Prepare all applications using the SF424
(R&R) application forms and in accordance with the SF424 (R&R)
Application Guide.
The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by NIH (e.g., the Credential log-in field of the Research & Related Senior/Key Person Profile component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
The SF424 (R&R) application is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY will include all applicable components, required and optional. A completed application in response to this FOA will include the following components:
Required
Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site
Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
PHS398 Modular Budget
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s)
Form
Note: While both budget components are included in the SF424 (R&R) forms package, the NIH R03 uses ONLY the PHS398 Modular Budget. (Do not use the detailed Research & Related Budget.)
Foreign Organizations (Non-domestic (non-U.S.) Entity)
NIH policies concerning grants to foreign (non-U.S.)
organizations can be found in the NIH Grants Policy Statement at: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm#_Toc54600260.
Applications from foreign organizations must:
Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.
3. Submission Dates and Times
See Section IV.3.A. for
details
3.A.
Submission, Review, and Anticipated Start Dates
Opening Date: January 5, 2007(Earliest date an application may be
submitted to Grants.gov)
Letters
of Intent Receipt Date(s): Not
Applicable.
Application
Submission/Receipt Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Submission/Receipt Date(s): Standard
dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS
Peer Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review Date(s): Standard dates apply, please
see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
3.A.1.
Letter of Intent
A letter of intent is not required for the funding
opportunity.
3.B.
Submitting an Application Electronically to the NIH
To submit an application in response to this FOA, applicants should
access this FOA via http://www.grants.gov/Apply and follow steps 1-4. Note: Applications must only be submitted
electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED.
3.C. Application Processing
Applications may be submitted on or
after the opening date and must be successfully received by Grants.gov
no later than 5:00 p.m. local time (of the
applicant institution/organization) on the
application submission/receipt date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the receipt
date(s) and time, the application may be delayed in the review process or not
reviewed.
Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two business days to view the application image.
Upon receipt, applications will be evaluated for completeness by the
Center for Scientific Review, NIH. Incomplete applications will not be
reviewed.
There
will be an acknowledgement of receipt of applications from Grants.gov and the Commons. Information related to the
assignment of an application to a Scientific Review Group is also in the Commons.
Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on their application status in the Commons.
The NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of an application already reviewed with substantial changes, but such application must include an Introduction addressing the previous critique. Note that such an application is considered a "resubmission" for the SF424 (R&R).
4. Intergovernmental Review
This initiative is not subject to intergovernmental
review.
5. Funding Restrictions
All NIH awards are subject to the terms and
conditions, cost principles, and other considerations described in the NIH Grants
Policy Statement.
Pre-Award Costs are allowable. A grantee may, at its
own risk and without NIH prior approval, incur obligations and expenditures to
cover costs up to 90 days before the beginning date of the initial budget
period of a new award if such costs: are necessary to conduct the project and
would be allowable under the grant, if awarded, without NIH prior approval. If
specific expenditures would otherwise require prior approval, the grantee must
obtain NIH approval before incurring the cost. NIH prior approval is required
for any costs to be incurred more than 90 days before the beginning date of the
initial budget period of a new award.
The incurrence of pre-award costs in anticipation of a
competing or non-competing award imposes no obligation on NIH either to make
the award or to increase the amount of the approved budget if an award is made
for less than the amount anticipated and is inadequate to cover the pre-award
costs incurred. NIH expects the grantee to be fully aware that pre-award costs
result in borrowing against future support and that such borrowing must not
impair the grantee's ability to accomplish the project objectives in the
approved time frame or in any way adversely affect the conduct of the project.
See the NIH
Grants Policy Statement.
6.
Other Submission Requirements
PD/PI Credential (e.g., Agency Login)
The NIH requires the PD/PI to fill in his/her Commons User ID in the PROFILE Project Director/Principal Investigator section, Credential log-in field of the Research & Related Senior/Key Person Profile component. The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see Registration FAQs Important Tips -- Electronic Submission of Grant Applications.
Organizational DUNS
The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
Renewal (formerly competing continuation or Type 2 ) applications are not permitted.
All application instructions outlined in the SF424 (R&R) Application Guide are to be followed, with the following requirements for R03 applications:
R03 applications will use the modular as well as non-modular budget format and Just-in-Time information concepts, with direct costs requested in up to two $25,000 modules, or $50,000 per year, for up to two years (i.e., a maximum of $100,000 over two years in four modules of $25,000 each). All foreign applicants must complete and submit budget requests using the Research & Related Budget component found in the application package for this FOA. See NOT-OD-06-096.
APPENDIX MATERIALS
IMPORTANT NOTE: NIH
has published new limitations on grant application appendix materials to
encourage applications to be as concise as possible while containing the
information needed for expert scientific review.
Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) Application Guide (See http://grants.nih.gov/grants/funding/424/index.htm).
Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.
Note: While each section of the PHS398 Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to monitor better formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.
Foreign Applications (Non-domestic (non-U.S.) Entity)
Plan
for Sharing Research Data
All applicants must include a plan for sharing research data in their
application. The data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing.
All investigators responding to this funding opportunity should include a
description of how final research data will be shared, or explain why data
sharing is not possible.
The reasonableness of the data sharing plan or the rationale for not sharing
research data will be assessed by the reviewers. However, reviewers will not
factor the proposed data sharing plan into the determination of scientific
merit or the priority score.
Sharing Research Resources
NIH policy expects that grant award recipients
make unique research resources readily available for research purposes to
qualified individuals within the scientific community after publication (See
the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a sharing
research resources plan addressing how unique research resources will be shared
or explain why sharing is not possible.
The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each Non-Competing Grant Progress Report (PHS 2590). See Section VI.3., Reporting.
Section V. Application Review Information
1.
Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).
Only the review criteria described below will be
considered in the review process.
2.
Review and Selection Process
Applications submitted for this funding opportunity
will be assigned to the ICs on the basis of established Public Health Service
(PHS) referral guidelines.
Appropriate scientific review groups convened in
accordance with the standard NIH peer review procedures (http://cms.csr.nih.gov/ResourcesforApplicants/)
will evaluate applications for scientific and technical merit.
As part of the initial merit review, all applications
will:
Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:
The NIH R03 small grant is a mechanism for supporting discrete, well-defined projects that realistically can be completed in two years and that require limited levels of funding. Because the Research Plan component is restricted to 10 pages, a small grant application will not have the same level of detail or extensive discussion found in an R01 application. Accordingly, reviewers should evaluate the conceptual framework and general approach to the problem, placing less emphasis on methodological details and certain indicators traditionally used in evaluating the scientific merit of R01 applications, including supportive preliminary data. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or from investigator-generated data. Preliminary data are not required, particularly in applications proposing pilot or feasibility studies.
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 comments, 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. The scientific review group will address and consider each of these criteria in assigning the application's overall score, weighting them as appropriate for each application.
Note
that an application does not need to be strong in all categories to be judged
likely to have major scientific impact and thus deserve a high priority score.
For example, an investigator may propose to carry out important work that by
its nature is not innovative but is essential to move a field forward.
Significance: Does this study address
an important problem? If the aims of the application are achieved, how will
scientific knowledge or clinical practice be advanced? What will be the effect
of these studies on the concepts, methods, technologies, treatments, services,
or preventative interventions that drive this field?
Approach: Are
the conceptual or clinical framework, design, methods, and analyses adequately
developed, well integrated, well reasoned, and appropriate to the aims of the
project? Does the applicant acknowledge potential problem areas and consider
alternative tactics?
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 investigators 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
investigative team bring complementary and integrated expertise to the project
(if applicable)?
Environment: Does the scientific environment in which the work
will be done contribute to the probability of success? Do the proposed studies
benefit from unique features of the scientific environment, or subject
populations, or employ useful collaborative arrangements? Is there evidence of
institutional support?
2.A.
Additional Review Criteria
In addition
to the above criteria, the following items will continue to be considered in
the determination of scientific merit and the priority score:
Protection of Human Subjects from Research Risk: The involvement of human subjects and protections
from research risk relating to their participation in the proposed research
will be assessed. See item 6 of the Research Plan component of the SF424
(R&R).
Inclusion of Women, Minorities and Children in Research: The adequacy of
plans to include subjects from both genders, all racial and ethnic groups (and
subgroups), and children as appropriate for the scientific goals of the
research will be assessed. Plans for the recruitment and retention of subjects
will also be evaluated. See item 7 of the Research Plan component of the SF424 (R&R).
Care and Use of Vertebrate Animals in Research: If vertebrate animals
are to be used in the project, the five items described under item 11 of the Research Plan
component of the SF424 (R&R) will be assessed.
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.
Applications from Foreign Organizations: Does the project present special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources will be assessed.
Resubmission Applications (formerly revised/amended applications): Are the responses to comments from the previous scientific review group adequate? Are the improvements in the resubmission application appropriate?
2.C. Sharing Research Data
Data Sharing Plan: The reasonableness of the
data sharing plan or the rationale for not sharing research data will be
assessed by the reviewers. However, reviewers will not factor the proposed data
sharing plan into the determination of scientific merit or the priority score.
The presence of a data sharing plan will be part of the terms and conditions of
the award. The funding organization will be responsible for monitoring the data
sharing policy.
2.D. Sharing Research Resources
NIH policy expects that grant award recipients make
unique research resources readily available for research purposes to qualified
individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a sharing
research resources plan addressing how unique research resources will be shared
or explain why sharing is not possible.
Program staff will be responsible for the
administrative review of the plan for sharing research resources.
The adequacy of the resources sharing plan will be
considered by Program staff of the funding organization when making
recommendations about funding applications. Program staff may negotiate
modifications of the data and resource sharing plans with the awardee before
recommending funding of an application. The final version of the data and
resource sharing plans negotiated by both will become a condition of the award
of the grant. The effectiveness of the resource sharing will be evaluated as
part of the administrative review of each Non-Competing Grant
Progress Report (PHS 2590). See Section VI.3., Reporting.
Model Organism Sharing Plan: Reviewers are asked to assess the sharing plan in an administrative note. The sharing plan itself should be discussed after the application is scored. Whether a sharing plan is reasonable can be determined by the reviewers on a case-by-case basis, taking into consideration the organism, the timeline, the applicant's decision to distribute the resource or deposit it in a repository, and other relevant considerations. For the R03 mechanism, the presence or adequacy of a plan should not enter into the scoring of the application.
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/her Summary Statement (written critique)
via the NIH eRA Commons.
If the application is under consideration for funding, NIH will request
"just-in-time" information from the applicant. For details,
applicants may refer to the NIH
Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards,
Subpart A: General.
A formal notification in the form of a Notice
of Award (NoA) will be provided to the applicant organization. The NoA
signed by the grants management officer is the authorizing document. Once all
administrative and programmatic issues have been resolved, the NoA will be
generated via email notification from the awarding component to the grantee
business official.
Selection of an application for award is not an
authorization to begin performance. Any costs incurred before receipt of the
NoA are at the recipient's risk. These costs may be reimbursed only to the
extent considered allowable pre-award costs. See Section IV.5.,
Funding Restrictions.
2. Administrative and National Policy Requirements
All NIH grant and cooperative agreement awards include
the NIH Grants Policy Statement as part of the NoA. For these terms of award,
see the NIH
Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards,
Subpart A: General and Part
II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions
for Specific Types of Grants, Grantees, and Activities.
3. Reporting
When multiple years are involved, awardees will be required to submit the Non-Competing Grant
Progress Report (PHS 2590) annually and financial statements as required in
the NIH
Grants Policy Statement.
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: Lynne M. Haverkos, MD, MPH Marva Moxey-Mims, MD Ann O Mara,
PhD, RN Rebecca B. Costello, PhD, FACN 2. Peer Review Contacts: Section VIII. Other Information Required Federal Citations Sharing Research
Data: Access to
Research Data through the Freedom of Information Act: Standards
for Privacy of Individually Identifiable Health Information: Healthy
People 2010: 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.
Weekly TOC for this Announcement
1.
Scientific/Research Contacts:
Dr. Linda S. Weglicki, PhD, RN, MSN
Program Director, Office of Extramural Activities
National Institute of Nursing Research, NIH
6701 Democracy Blvd., Suite 710
One Democracy Plaza
Bethesda, MD 20892-4870
Telephone: (301) 594-6908
Fax: (301) 480-8260
Email: [email protected]
Behavioral Pediatrics and Health Promotion Research
Program
National Institute of Child Health and Human Development
6100 Executive Blvd., Rm.
4B05, MSC 7510
Bethesda, MD 20892-7510
(Rockville, MD 20852 for Fed Ex or UPS)
Phone: (301) 435-6881
Fax: (301) 480-0230
E-mail: [email protected]
Division of Kidney, Urologic and Hematologic Diseases
National Institute of Diabetes and Digestive and Kidney
Diseases
6707 Democracy Blvd., Room
639, MSC 5458
Bethesda, MD 20892-5458
Phone: (301) 594-7717
Fax: (301) 480-3510
E-mail: [email protected]
Program
Director
Research
Areas: Symptom Management/End of Life
Community
Clinical Oncology Program (CCOP)
National
Cancer Institute
6130 Executive
Blvd.,
EPN 2010
Bethesda, MD 20892
Phone:
(301) 496-8541
Fax: (301)
496-8667
E-mail: [email protected]
Director of
Grants and Extramural Activities
Office of Dietary Supplements
Office of
the Director
National
Institutes of Health
6100 Executive
Blvd.,
Room 3B01, MSC 7517
Bethesda, MD 20892-7517
Phone: (301) 435-2920
Fax: (301) 480-1845
E-mail: [email protected]
Not
Applicable
3. Financial or Grants
Management Contacts:
Mr. Brian Albertini
Office of Grants and Contracts Management
National Institute of Nursing Research
6701 Democracy Blvd, Room
710, MSC 4870
Bethesda, MD 20892-4870
Telephone: (301) 594-6869
Fax: (301) 451-5651
Email: [email protected]
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).
Investigators
submitting an NIH application seeking $500,000 or more in direct costs in any
single year are expected to include a plan for data sharing or state why this
is not possible ( http://grants.nih.gov/grants/policy/data_sharing).
Investigators should seek guidance from their
institutions, on issues related to institutional policies and local IRB rules,
as well as local, State and Federal laws and regulations, including the Privacy
Rule. Reviewers will consider the data sharing plan but will not factor the
plan into the determination of the scientific merit or the priority score.
The Office of Management and Budget (OMB) Circular A-110 has been revised to
provide access to research data through the Freedom of Information Act (FOIA)
under some circumstances. Data that are (1) first produced in a project that is
supported in whole or in part with Federal funds and (2) cited publicly and
officially by a Federal agency in support of an action that has the force and
effect of law (i.e., a regulation) may be accessed through FOIA. It is important
for applicants to understand the basic scope of this amendment. NIH has
provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this funding opportunity in a
public archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the application.
In addition, applicants should think about how to structure informed consent
statements and other human subjects procedures given the potential for wider
use of data collected under this award.
Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important
research resources including the sharing of model organisms for biomedical
research (see http://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time the NIH recognizes the rights of grantees and contractors to
elect and retain title to subject inventions developed with Federal funding
pursuant to the Bayh Dole Act (see the NIH
Grants Policy Statement).
Beginning October 1, 2004, all investigators submitting an NIH application or
contract proposal are expected to include in the application/proposal a
description of a specific plan for sharing and distributing unique model
organism research resources generated using NIH funding or state why such
sharing is restricted or not possible. This will permit other researchers to
benefit from the resources developed with public funding. The inclusion of a
model organism sharing plan is not subject to a cost threshold in any year and
is expected to be included in all applications where the development of model
organisms is anticipated.
Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their
sub-populations must be included in all NIH-supported clinical research
projects unless a clear and compelling justification is provided indicating
that inclusion is inappropriate with respect to the health of the subjects or
the purpose of the research. This policy results from the NIH Revitalization Act
of 1993 (Section 492B of Public Law 103-43). All investigators proposing
clinical research should read the "NIH Guidelines for Inclusion of Women
and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the SF424 (R&R) application; and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a) all
applications or proposals and/or protocols must provide a description of plans
to conduct analyses, as appropriate, to address differences by sex/gender
and/or racial/ethnic groups, including subgroups if applicable; and b)
investigators must report annual accrual and progress in conducting analyses,
as appropriate, by sex/gender and/or racial/ethnic group differences.
Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of
21) must be included in all clinical research, conducted or supported by the
NIH, unless there are scientific and ethical reasons not to include them.
All investigators proposing research involving human subjects should read the
"NIH Policy and Guidelines" on the inclusion of children as
participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).
Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants
for all investigators submitting NIH applications for research involving human
subjects and individuals designated as key personnel. The policy is available
at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
Human Embryonic Stem Cells (hESC):
Criteria for Federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.
Only research using hESC lines that are registered in the NIH Human Embryonic
Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility
of the applicant to provide in the project description and elsewhere in the
application as appropriate, the official NIH identifier(s) for the hESC line(s)
to be used in the proposed research. Applications that do not provide this
information will be returned without review.
NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript
submission (NIHMS) system (http://www.nihms.nih.gov)
at PubMed Central (PMC) an electronic version of the author's final manuscript
upon acceptance for publication, resulting from research supported in whole or
in part with direct costs from NIH. The author's final manuscript is defined as
the final version accepted for journal publication, and includes all modifications
from the publishing peer review process.
NIH is requesting that authors submit manuscripts resulting from 1) currently
funded NIH research projects or 2) previously supported NIH research projects
if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award
mechanisms, cooperative agreements, contracts, Institutional and Individual
Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural
research studies. The Policy applies to peer-reviewed, original research
publications that have been supported in whole or in part with direct costs
from NIH, but it does not apply to book chapters, editorials, reviews, or
conference proceedings. Publications resulting from non-NIH-supported research
projects should not be submitted.
For more information about the Policy or the
submission process, please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view the Policy or other Resources and Tools, including the Authors' Manual.
The Department of Health and Human Services (HHS) issued final modification to
the "Standards for Privacy of Individually Identifiable Health
Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a Federal regulation under the Health Insurance Portability and
Accountability Act (HIPAA) of 1996 that governs the protection of individually
identifiable health information, and is administered and enforced by the HHS
Office for Civil Rights (OCR).
Decisions about applicability and implementation of the Privacy Rule reside
with the researcher and his/her institution. The OCR Website (http://www.hhs.gov/ocr/) provides
information on the Privacy Rule, including a complete Regulation Text and a set
of decision tools on "Am I a covered entity?" Information on the
impact of the HIPAA Privacy Rule on NIH processes involving the review,
funding, and progress monitoring of grants, cooperative agreements, and
research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html
URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH
funding must be self-contained within specified page limitations. For
publications listed in the appendix and/or Progress report, internet addresses
(URLs) 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.
The Public Health Service (PHS) is committed to achieving the health promotion
and disease prevention objectives of "Healthy People 2010," a PHS-led
national activity for setting priority areas. This PA is related to one or more
of the priority areas. Potential applicants may obtain a copy of "Healthy
People 2010" at http://www.health.gov/healthypeople.
Authority and Regulations:
This program is described in the Catalog
of Federal Domestic Assistance and is not subject to the intergovernmental
review requirements of Executive Order 12372 or Health Systems Agency review.
Awards are made under the authorization of Sections 301 and 405 of the Public
Health Service Act as amended (42 USC 241 and 284) and under Federal
Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92. All awards are subject
to the terms and conditions, cost principles, and other considerations
described in the NIH Grants
Policy Statement.
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.
NIH Funding Opportunities and Notices
Department of Health
and Human Services (HHS)
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