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 Heart, Lung, and Blood
Institute (NHLBI), (http://www.nhlbi.nih.gov/)
National Institute on Alcohol,
Alcoholism, and Alcohol Abuse (NIAAA), (http://www.niaaa.nih.gov/)
National Institute on Drug Abuse
(NIDA), (http://www.nida.nih.gov/)
Title: Parenting
Capacities and Health Outcomes in Youths and Adolescents (R21)
Announcement Type
This is a reissue of PA-06-098, which was previously released on December 15, 2005
Update: The following update relating to this announcement has been issued:
NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.
APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.
This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).
A registration process is necessary before submission and applicants are highly encouraged to start the process at least four weeks prior to the grant submission date. See Section IV.
Program Announcement (PA) Number: PA-06-530
Catalog of Federal Domestic Assistance Number(s)
93.361, 93.865, 93.837, 93.273, 93.279
Key Dates
Release/Posted Date: August 22, 2006
Opening Date: August 22, 2006 (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, 2009 (now January 8, 2009 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
This
Funding Opportunity
Announcement (FOA) solicits research aimed at increasing parenting capacities
while simultaneously focusing on the reduction, elimination or prevention
of one or more high-risk health behaviors or poor health habits in youth and
adolescent children. Investigators responding to this announcement are required
to target two or more ineffective parenting practices or behaviors (e.g.,
lack of appropriate parental monitoring, supervision, and communication, high
family conflict and disorganization, parental stress and depression, lack
of parent-child bonding and negative discipline methods), and two or more
youth/adolescent high-risk behaviors (e.g., unhealthy dietary behaviors, inadequate
physical activity, tobacco use, alcohol and other drug use, sexual behaviors,
and unintentional (accidents) and intentional behaviors (firearm related injuries).
These behaviors are frequently established during childhood and adolescent
years and continue on to the adult years. These behaviors are potentially
amenable to a variety of health promotion and prevention efforts. As part
of the national efforts to eliminate health disparities, proposals specifically
targeting racial/ethnic minority populations are strongly encouraged. Strategic
Plans on Reducing Health Disparities are located at http://www.ninr.nih.gov, http://www.nhlbi.nih.gov/resources/docs/plandisp.htm, http://www.niaaa.nih.gov/, http://www.nichd.nih.gov/, and http://www.nida.nih.gov/.
Research targeting other diverse groups of parents and their youths/adolescents is also encouraged (e.g., sexual orientation, religious background, single parent families). For purposes of this announcement, children age 10-18 can be targeted.
Background
It is well documented that the probability of children and adolescents acquiring non-optimal health behaviors and developmental problems increases substantially in the presence of ineffective parenting practices. Specifically, there is empirical support for the notion that many early precursors of serious middle childhood and adolescent problems can be significantly reduced or thwarted through effective early interventions aimed at improving parenting practices and family dynamics. While it would be gross over simplification to equate child and adolescent developmental, behavioral and health outcomes to products of child rearing practices, parental and caregiver behaviors and practices do have a large impact and exert, perhaps, the most significant and pervasive influence over the health risk behaviors and health habits of their adolescent children.
Undoubtedly, genes, peers, the mass media, school, neighborhood and other societal and cultural influences do play a role in shaping child and adolescent developmental, behavioral and health outcomes. Nevertheless, the critical roles of parenting and the family dynamics cannot be minimized. There is convincing evidence that parenting behaviors impact, profoundly, the development of positive behaviors and outcomes in youths and adolescents. Parental behaviors implicated include: appropriate parental monitoring, supervision, and communication, low family conflict and disorganization, low parental stress and depression, healthy parent-child bonding and positive discipline methods (evidenced by interactional behaviors associated with warmth, patterns of punishment and reward, verbal techniques, appropriate direction and control). For example, although evidence suggests that peer influence is pivotal in the initiation of negative behaviors in youths and adolescents, parental disapproval has been shown to have a major suppressive effect for alcohol and drug use. Other recent evidence also suggests that a positive family environment, inclusive of positive parent-child relationships, consistent supervision and communication of pro social and healthy values and expectations, act as major deterrents for youths and adolescents to engage in negative and unhealthy behaviors and are associated with better school performance and psychosocial development.
In a 2003 report from the National Academy of Sciences it was revealed that between 1970 and 2000 the maternal labor force rose from 38 to 68 percent. Moreover, this trend reflects a broad range of demographics and circumstances including: first-time and never married mothers, mothers of all income brackets, education levels, race, ethnicity or place of residence. With parents spending substantial amounts of their daily lives at the workplace, and with fewer supports from a second parent or extended family members, coupled with high adolescent and youth involvement in negative and unhealthy behaviors, parents need to know how to parent effectively. Parenting effectively includes, in addition to the aforementioned factors, an understanding of the concept of healthy adolescence and normative development, how to assess the status of their adolescent child in terms of his or her health trajectory, how to facilitate healthy development and foster the adoption of positive health behaviors, how to access resources and support for themselves and their adolescent when there is a problem. Adolescent health behaviors include, but are not limited to, nutrition/dietary practices, physical activity, weight control, drug, alcohol, and tobacco use, injuries and violence, and sexual activity.
Public Health Need
In 2004, in excess of 40 million US residents were classified as adolescents ranging in age from 10–19 years. This represents 14% of the US population. Among these, approximately 2/3 of the adolescent population was non-Hispanic and 1/3 of other racial ethnic identity. Projections indicate that by year 2050, the nation's racial ethnic minority groups (Black, Hispanic, American Indian, Asian) will constitute approximately 56% of the adolescent population. While the health status of adolescents differs according to age, gender, race, and ethnic origin, there is ample documentation suggesting that adolescents, regardless of background, engage in high-risk behavior.
Today, tobacco use constitutes the single leading cause of preventable death in the United States. Epidemiologists estimate that tobacco related illnesses will be responsible for over 5 million premature deaths among persons age 17 and under who begin to use tobacco products in 1995. Data from the Youth Risk Behavior Surveillance System (YRBS) noted that 80% of individuals who use tobacco began before age 18. Further, data from the 2004 Monitoring the Future (MTF) Survey of 50,000 students show that 9% of 8th graders reported smoking in the prior 30 days, along with 16% of 10th graders and 25% of 12th graders. Some important subgroup differences have been observed, particularly for smoking. Students who plan to complete a four-year college education are much less likely to smoke than those who do not have such plans. Youth living in rural areas and small town areas are considerably more likely to smoke than those living in metropolitan areas. Students with more educated parents are less likely to smoke, particularly at young ages.
Poor dietary habits or improper eating habits have been linked to the development of coronary heart disease, cancer, diabetes, osteoporosis, hypertension, and obesity. Although childhood obesity has been a longstanding public health problem, recent increases have raised the level to epidemic proportions among US children. In a 2005 IOM report, it was estimated that approximately nine million children over six years of age were overweight. Among children 6 through 19 years, 31% were at risk for overweight or overweight, and 16% were overweight (BMI > 95th percentile for age growth charts). These findings, based upon measured weight and height, reflect a substantial and alarming increase in childhood obesity over the past two decades. Further, the current increase is most prominent among non-Hispanic black and Mexican American children, with the increase in these groups at more than 10 % over the last two decades. For example, for non-Hispanic black and Mexican-American adolescents, overweight prevalence increased from 13.4% to 23.6% and from 13.8% to 23.4%, respectively. Despite recommendations for a healthier diet, recent data show that the usual diet of today's adolescents includes foods high in saturated fat, high in calorie dense foods, and low in fruit and vegetable consumption.
Similarly, inadequate physical activity contributes to a variety of adverse health conditions and consequences. In contrast, regular physical activity has been associated with increased psychological and mental well-being, improved cardiovascular health, and proper weight maintenance. Physical activity declines during the transition from childhood through adolescence. The National Growth and Health Studies found 34% decline in physical activity in youth during this transitional period from 10-18 years of age. The decline is more dramatic in girls and in African American youth. Data from the Youth Risk Behavior Surveillance Survey (YRBS) found that vigorous physical activity declines about 30% between grade 9 and grade 12. Thus, the decline in physical activity begins early, about the time of entry into middle school, and continues throughout adolescence.
This decline in physical activity may contribute to the recent increases in obesity among adolescents. Physical inactivity during adolescence may later result in obesity during adulthood. Healthy People 2010 and the Dietary Guidelines for America recommends that adolescents engage in physical activity that promotes cardiovascular fitness most days of the week for a minimum of 60 minutes or more per occasion.
With respect to substance abuse, the use of alcohol and other drugs was among the 4 risk behaviors of concern among adolescents during the 1990’s and continue to be major public health concerns today. Underage drinking, in particular, is a major public health problem. Alcohol is the drug of choice for youth, and, on average, adolescents tend to drink more per occasion than adult drinkers, with binge drinking (4 or more drinks for women, 5 or more for men) especially problematic. In a 2003 IOM and NRC report, it was revealed that nearly half of high school seniors reported using alcohol 30 days prior to being surveyed; this compares to 27% for tobacco and 22% for marijuana. Most adolescents being surveyed reported starting using alcohol or other drugs before entering high school. An additional troubling finding is that the proportion of underage drinkers has remained virtually unchanged from 2002. The use of alcohol and other drugs is associated with a variety of adverse consequences such as violence, injuries in car crashes, and premature death. In addition, national survey data show that early initiation of alcohol use is associated with elevated risk for later alcohol dependency. As such, the IOM and NRC concluded new interventions such as those targeting parents and other adults are warranted. Finally, according to the 2004 MTF survey, several illicit drugs (such as marijuana, ecstasy, and amphetamines) have shown modest declines, while other drugs have been showing signs of increasing use. The main areas of concern that are raised by the 2004 MTF findings are the increasing use of inhalants by 8th graders, and the continued high rates of abuse of prescription pain killers in each grade.
Responsible sexual behavior has been identified as a leading health indicator in Healthy People 2010 with specific behavior objectives aimed at increasing the proportion of adolescents who abstain from sexual intercourse or use condoms if sexually active. Adolescents who engage in early sexual behaviors are at an increased risk of sexually transmitted diseases including HIV infection as well as unintended pregnancy, and, for drinking teens, possibly conceiving a child afflicted with Fetal Alcohol Spectrum Disorder (FASD). Recent estimates (2005) are that over half of all high school students engage in some form of sexual activity. However, national trends have also showed that the prevalence of sexual experience among adolescents decreased 8% while the prevalence of multiple partners decreased 13%.
Currently, motor vehicle and firearm related injuries are the leading cause of death for adolescents. The high death rates from motor vehicle injuries are in part due to high-risk behaviors among adolescents (e.g., drunken driving, the non-use of seat belts). Motor vehicle death rates were higher for male adolescents, non-Hispanic white, American Indian and Alaskan Native adolescents and lower among non-Hispanic black, Hispanic, Asian and Pacific Islander adolescents. Death rates from firearm injuries increase with age with highest rates for males 19 years of age or older. Similarly, death rates from firearm injuries for females 19 years of age or older are 10 times higher when compared with firearm death injuries for females age 11-18. Nevertheless, firearm-related death rates are strikingly higher for Black adolescents when compared to adolescents from other racial/ethnic minority groups. These two leading causes of death are identified as high priority areas in Healthy People 2010.
Summary of research needs
In summary, scientific evidence suggests that interventions targeting parents and families can exert powerful influence and are cost-effective in reducing or eliminating health risk behaviors among adolescent children. Continued research is needed to decrease the numbers of adolescents engaging in high-risk behaviors, thus reducing and ameliorating the short and long-term consequences associated with these behaviors. Further, many of these behaviors are interrelated and thus may be amenable to interventions that address multiple risk behaviors simultaneously. For example, research has shown that youths and adolescents who engage in heavy drinking may also engage in high-risk sexual behaviors. Thus, targeting both ineffective parenting practices and high-risk behaviors in one application may be more successful in improving the overall health profile of youths and adolescents. Research has shown that interventions that target combinations of risk factors may result in more successful and long-term behavioral changes. Similarly, more research is needed that takes into consideration parental characteristics (e.g., age, gender, and socio-economic status), family dynamics, geographic location, and other special needs that may impact the promotion of adolescent behavior and health outcomes. Psychosocial mediators of health behavior such as parental cultural beliefs and values, and parental self efficacy must also be considered. Applications in response to this announcement should be grounded in theory and should reflect the current literature on parenting and its effects on adolescent risk behaviors. Applications should identify constructs to be measured, review the relevant theoretical literature, and clearly identify research aims and design, along with the strengths and limitations of the proposal. Outcome measures should have sound psychometric properties and should be age and language appropriate. The cultural and socioeconomic status of participants should also be considered.
The following are potential areas of research related to this program announcement. These examples are not listed in any priority order and are not to be viewed as exhaustive or an exclusive listing of potential areas. Suitable topics for research include, but are not limited to, the following:
1. Interventions that incorporate protective factors that aid in improving parenting practices and preventing youth and adolescents from engaging in multiple risky behaviors.
2. Interventions that focus on modifying parental practices to improve diet and physical activity and prevent excessive weight gain in normal weight youth and/or reduce rate of weight gain in overweight youth.
3. Interventions testing the effects of modifying parental psychosocial factors (e.g., parental self-efficacy) on diet and physical activity behaviors with the goal of controlling childhood obesity.
4. Biobehavioral descriptive or intervention studies that elucidate and incorporate the physiological, psychological, socioeconomic, emotional, environmental, cultural, and genetic factors that influence parenting practices and health compromising and or health promoting behaviors among youths and adolescents.
5. Innovative intervention studies devoted to enhancing parent self-efficacy, competence, and skill development to support the initiation and or maintenance of youth and adolescent health promoting behaviors.
6. Intervention studies using community-based approaches to facilitate improved parenting practices and health promotion/risk reduction behaviors in youth and adolescents in rural and urban settings. Community interventions using indigenous community infrastructures are relevant, as is the fostering of partnerships between academic researchers and community health care providers. Reaching populations outside of traditional channels, (such as families involved with social service agencies, the juvenile justice or foster care systems), may identify parents and children with clusters of risk factors.
7. Prevention/intervention strategies that target parents or caregivers of youth and adolescents with HIV/AIDS.
8. Prevention/intervention strategies that target families with special needs, such as parents or caregivers of youths and adolescents with chronic illness or developmental disabilities.
9. Studies investigating the effects and interrelationships among psychosocial and environmental factors (e.g., single parenting, gender, age, poverty, geographic location), and the adoption of high-risk behaviors or health-promoting behaviors among youth and adolescents.
10. Intervention studies that facilitate parent/child communication and bonding in situations where child/parent temperaments conflict leading to difficulties with discipline and subsequent risk behaviors.
11. Prevention studies that incorporate motivational strategies for behavior change and skills development for behavioral control for children (and parents).
12. Culturally and linguistically appropriate intervention studies that incorporate the stages of cognitive and normative development in families having diverse backgrounds.
13. Unique and culturally sensitive interventions to promote healthier dietary intake and adequate activity in minority parents and their youth and adolescents.
14. Interventions to reduce the risk of poor outcomes for children in families affected by alcohol use disorders. This can include intervening with parents whose alcohol use is impeding effective caregiving; youth with experimental or established alcohol use patterns who need improved parental attention; parents or youth with neurological damage and/or behavioral and cognitive deficits resulting from prenatal alcohol exposure who are at high risk for future social, psychological and psychiatric problems.
15. Prevention strategies targeting a broad range of parenting factors, focusing on family system changes during late childhood and adolescence.
16. Intervention strategies focusing on multiple risk or protective parenting and caregiver practices in vulnerable families (such as single mothers and fathers, grandparent[s] as parents/caregivers, low-income, migrant, parents with chronic illnesses such as depression or HIV/AIDS, parents with a history of substance use or abuse, etc.] that contribute to or protect against negative youth and adolescent and health behavior outcomes.
17. Testing of prevention strategies, known to be effective with early and middle-childhood, adapted for use with older youth and adolescents.
18. Work-site based intervention studies to facilitate improved parenting practices and health promotion/risk reduction behaviors in youths and adolescents in rural and urban settings.
19. Biobehavioral or intervention strategies that represent improved or new methods (e.g., adaptation of or novel technology) and or measures that are culturally appropriate.
20. Prevention interventions that target parenting practices and training in drug education in combination with youth and adolescent drug abuse prevention strategies, during key transition points, such as the transition to middle school or high school.
21. Novel or adapted drug abuse prevention programs that are tailored to racial and ethnic minority groups, and are culturally appropriate and theoretically based.
See Section VIII, Other Information
- Required Federal Citations, for policies related
to this announcement.
Section II. Award Information
1. Mechanism of Support
This FOA will use the NIH Exploratory/Developmental
Research Grant (R21) award mechanism. As
an applicant, you will be solely responsible for planning, directing, and
executing the proposed project.
This FOA uses “Just-in-Time” information concepts. It also uses the modular budget formats (see the “Modular Applications and Awards” section of the NIH Grants Policy Statement. Specifically, if you are submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs), use the PHS398 Modular Budget component provided in the SF424 (R&R) Application Package and SF424 (R&R) Application Guide (see specifically Section 5.4, “Modular Budget Component,” of the Application Guide).
Exploratory/developmental grant support is for new projects only; competing renewal (formerly “competing continuation”) applications will not be accepted. Up to two resubmissions (formerly “revisions/amendments") of a previously reviewed exploratory/developmental grant application may be submitted. See NOT-OD-03-041, May 7, 2003.
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 Institutes and Centers
(ICs) provide support for this program, awards pursuant to this funding opportunity
are contingent upon the availability of funds and the submission of a sufficient
number of meritorious applications.
The total project period for an application
submitted in response to this funding opportunity may not exceed 2 years.
Although the size of award may vary with the scope of research proposed, it
is expected that applications will stay within the budgetary guidelines for
an exploratory/developmental project; direct costs are limited to $275,000
over an R21 two-year period, with no more than $200,000 in direct costs allowed
in any single year. Applicants may request direct costs in $25,000 modules,
up to the total direct costs limitation of $275,000 for the combined two-year
award period. NIH grants policies as described in the 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
organization to develop an application for support. Individuals from underrepresented
racial and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH support.
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.
This is no limit on the number of applications that may be submitted.
Section IV. Application and Submission Information
To download a SF424 (R&R) Application Package and SF424
(R&R) Application Guide for completing the SF424 (R&R) forms for this
FOA, link to http://www.grants.gov/Apply/
and follow the directions provided on that Web site.
A one-time registration is required for institutions/organizations at both:
PDs/PIs should work with their institutions/organizations to make sure they are registered in the eRA Commons.
Several additional separate actions are required before an applicant institution/organization can submit an electronic application, as follows:
1) Organizational/Institutional Registration in Grants.gov/Get Started
3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.
Note that if a PD/PI is also an NIH peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.
Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.
1. Request
Application Information
Applicants must download the SF424 (R&R) application
forms and SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.
Note: Only the forms package directly
attached to a specific FOA can be used. You will not be able to use any other
SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although
some of the "Attachment" files may be useable for more than one
FOA.
For further assistance, contact GrantsInfo: Telephone
301-710-0267, Email: GrantsInfo@nih.gov.
Telecommunications for the hearing impaired: TTY 301-451-5936.
2. Content and Form of Application Submission
Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide (MS Word or PDF).
The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by NIH (e.g., the “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see “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 R21 uses ONLY the PHS398 Modular Budget. (Do not use the detailed Research & Related Budget.)
Foreign Organizations
Several special provisions apply to applications submitted
by foreign organizations:
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: August 22, 2006 (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 https://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.
The NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of an application already reviewed with substantial changes, but such application must include an “Introduction” addressing the previous critique. Note such an application is considered a "resubmission" for the SF424 (R&R).
4. Intergovernmental
Review
This initiative is not subject to intergovernmental
review.
5. Funding Restrictions
All NIH awards are subject to the terms and conditions,
cost principles, and other considerations described in the NIH Grants Policy
Statement.
Pre-Award Costs are allowable. A grantee may, at its
own risk and without NIH prior approval, incur obligations and expenditures
to cover costs up to 90 days before the beginning date of the initial budget
period of a new award if such costs: are necessary to conduct the project,
and would be allowable under the grant, if awarded, without NIH prior approval.
If specific expenditures would otherwise require prior approval, the grantee
must obtain NIH approval before incurring the cost. NIH prior approval is
required for any costs to be incurred more than 90 days before the beginning
date of the initial budget period of a new award.
The incurrence of pre-award costs in anticipation
of a competing or non-competing award imposes no obligation on NIH either
to make the award or to increase the amount of the approved budget if an award
is made for less than the amount anticipated and is inadequate to cover the
pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award
costs result in borrowing against future support and that such borrowing must
not impair the grantee's ability to accomplish the project objectives in the
approved time frame or in any way adversely affect the conduct of the project.
See the NIH Grants
Policy Statement.
6. Other Submission Requirements
The NIH requires the PD/PI to fill in his/her Commons
User ID in the “PROFILE – Project Director/Principal Investigator” section,
“Credential” log-in field of the “Research & Related Senior/Key Person
Profile” component. The applicant organization must include its DUNS number
in its Organization Profile in the eRA Commons. This DUNS number must match
the DUNS number provided at CCR registration with Grants.gov. For additional
information, see “Registration FAQs – Important Tips -- 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 (MS Word or PDF) are to be followed, with the following requirements for R21 applications:
Note: While each section of the Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.
Plan for Sharing Research Data
The precise content of the data-sharing plan will vary, depending on the data
being collected and how the investigator is planning to share the data. Applicants
who are planning to share data may wish to describe briefly the expected schedule
for data sharing, the format of the final dataset, the documentation to be
provided, whether or not any analytic tools also will be provided, whether
or not a data-sharing agreement will be required and, if so, a brief description
of such an agreement (including the criteria for deciding who can receive
the data and whether or not any conditions will be placed on their use), and
the mode of data sharing (e.g., under their own auspices by mailing a disk
or posting data on their institutional or personal website, through a data
archive or enclave). Investigators choosing to share under their own auspices
may wish to enter into a data-sharing agreement. References to data sharing
may also be appropriate in other sections of the application.
The reasonableness of the data sharing plan or the rationale for not sharing
research data may be assessed by the reviewers. However, reviewers will not
factor the proposed data sharing plan into the determination of scientific
merit or the priority score.
Sharing Research Resources
NIH policy requires that grant
awardee recipients make unique research resources readily available for research
purposes to qualified individuals within the scientific community after publication
(See the NIH Grants Policy Statement https://grants.nih.gov/archive/grants/policy/nihgps_2003/index.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 R21 exploratory/developmental grant is a mechanism for supporting novel scientific ideas or new model systems, tools, or technologies that have the potential to significantly advance our knowledge or the status of health-related research. Because the Research Plan component is limited to 15 pages, an exploratory/developmental grant application need not have extensive background material or preliminary information as one might normally expect in an R01 application. Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Reviewers will place less emphasis on methodological details and certain indicators traditionally used in evaluating the scientific merit of R01 applications, including supportive preliminary data. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R21 applications; however, they may be included if available.
The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application.
Note that an application does not
need to be strong in all categories to be judged likely to have major scientific
impact and thus deserve a high priority score. For example, an investigator
may propose to carry out important work that by its nature is not innovative
but is essential to move a field forward.
Significance: Does this study address an important scientific health 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 PD/PI and other researchers? Does the investigative team bring
complementary and integrated expertise to the project (if applicable)?
Environment: Does the scientific environment in which the work will be done
contribute to the probability of success? Do the proposed studies benefit
from unique features of the scientific environment, or subject populations,
or employ useful collaborative arrangements? Is there evidence of institutional
support?
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 and Period of Support: The reasonableness of the proposed budget
and the appropriateness of the requested period of support in relation to
the proposed research may be assessed by the reviewers. Is the number of person
months listed for the effort of the PD/PI appropriate for the work proposed?
Is each budget category realistic and justified in terms of the aims and methods?
2.C. Sharing Research Data
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 requires that grant awardee recipients
make unique research resources readily available for research purposes to
qualified individuals within the scientific community after publication (See
the NIH Grants Policy Statement https://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a sharing
research resources plan addressing how unique research resources will be shared
or explain why sharing is not possible.
Program staff will be responsible for the administrative
review of the plan for sharing research resources.
The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each Non-Competing Grant Progress Report (PHS 2590), See Section VI.3., “Reporting.”
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 R21 mechanism, the presence or adequacy of a plan should not enter into the scoring of the application.
3. Anticipated Announcement and Award
Dates
Applications will be reviewed and awards will be made
according to the standard schedule described at https://grants.nih.gov/grants/funding/submissionschedule.htm
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:
1. Scientific/Research Contacts:
NINR
Yvonne Bryan, PhD, RN
Division of Extramural Activities
National Institute of Nursing Research
6701 Democracy Blvd., Suite 710
Bethesda, MD 20892
Telephone: (301) 594-6908
Fax: (301) 480-8260
Email: bryany@mail.nih.gov
NICHD
Lynne M. Haverkos, MD, MPH
Program Director
Behavioral Pediatrics and Health Promotion Research
National Institute of Child Health and Human Development
6100 Executive Blvd.,
Rm. 4B05
Bethesda, MD
20892
Telephone: (301) 435-6881
Fax: (301) 480-0230
Email: haverkol@mail.nih.gov
NHLBI
Charlotte Pratt, PhD, MS, RD
Program Officer
National Heart, Lung, and Blood Institute
Division of Epidemiology and Clinical Applications
6701 Rockledge Drive,
Rm. 8134
Bethesda, MD
20892
Telephone: (301) 435-0382
Fax: (301) 480-1669
Email: prattc@nhlbi.nih.gov
NIAAA
Margaret E. Mattson, Ph.D.
National Institute on Alcohol Abuse and Alcoholism
Division of Treatment and Recovery Research
5635 Fishers Lane (NIH Mail Stop 9304)
Bethesda MD 20892-9304
Telephone: (301) 443-0638
Fax: (301) 443-8774
Email: mmattson@mail.nih.gov
NIDA
Belinda E. Sims, Ph.D.
Division of Epidemiology, Services and Prevention Research
Prevention Research Branch
National Institute on Drug Abuse
6001 Executive Blvd, Rm. 5185, MSC 9589
Bethesda, MD 20892-9589
Phone: 301-402-1533
Fax: 301-443-2636
Email: bsims@nida.nih.gov
2. Peer Review Contacts:
Not Applicable.
3. Financial or Grants Management Contacts:
Brian Albertini
Chief, Office of Grants and Contract Management
National Institute of Nursing Research
6701 Democracy Blvd., Suite 710
Bethesda, MD 20892
Telephone: (301) 594-6869
Fax: (301) 451-5648
Email: Albertib@mail.nih.gov
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 (https://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf)
as mandated by the Health Research Extension Act of 1985 (https://grants.nih.gov/grants/olaw/references/hrea1985.htm),
and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm)
as applicable.
Human Subjects Protection:
Federal regulations (45 CFR 46) require that applications
and proposals involving human subjects must be evaluated with reference to
the risks to the subjects, the adequacy of protection against these risks,
the potential benefits of the research to the subjects and others, and the
importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types
of clinical trials, including physiologic toxicity and dose-finding studies
(phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative
trials (Phase III). Monitoring should be commensurate with risk. The establishment
of data and safety monitoring boards (DSMBs) is required for multi-site clinical
trials involving interventions that entail potential risks to the participants
(“NIH Policy for Data and Safety Monitoring,” NIH Guide for Grants and
Contracts, https://grants.nih.gov/grants/guide/notice-files/not98-084.html).
Sharing Research Data:
Investigators submitting an NIH application seeking
$500,000 or more in direct costs in any single year are expected to include
a plan for data sharing or state why this is not possible (https://grants.nih.gov/grants/policy/data_sharing).
Investigators should seek guidance from their institutions,
on issues related to institutional policies and local IRB rules, as well as
local, State and Federal laws and regulations, including the Privacy Rule.
Reviewers will consider the data sharing plan but will not factor the plan
into the determination of the scientific merit or the priority score.
Access to Research Data through
the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular
A-110 has been revised to provide access to research data through the Freedom
of Information Act (FOIA) under some circumstances. Data that are (1) first
produced in a project that is supported in whole or in part with Federal funds
and (2) cited publicly and officially by a Federal agency in support of an
action that has the force and effect of law (i.e., a regulation) may be accessed
through FOIA. It is important for applicants to understand the basic scope
of this amendment. NIH has provided guidance at https://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 https://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” (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is available at https://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 (https://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 https://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 https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.
Only research using hESC lines that are registered in the NIH Human Embryonic
Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility
of the applicant to provide in the project description and elsewhere in the
application as appropriate, the official NIH identifier(s) for the hESC line(s)
to be used in the proposed research. Applications that do not provide this
information will be returned without review.
NIH Public Access Policy:
NIH-funded investigators are requested to submit to
the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov)
at PubMed Central (PMC) an electronic version of the author's final manuscript
upon acceptance for publication, resulting from research supported in whole
or in part with direct costs from NIH. The author's final manuscript is defined
as the final version accepted for journal publication, and includes all modifications
from the publishing peer review process.
NIH is requesting that authors submit manuscripts
resulting from 1) currently funded NIH research projects or 2) previously
supported NIH research projects if they are accepted for publication on or
after May 2, 2005. The NIH Public Access Policy applies to all research grant
and career development award mechanisms, cooperative agreements, contracts,
Institutional and Individual Ruth L. Kirschstein National Research Service
Awards, as well as NIH intramural research studies. The Policy applies to
peer-reviewed, original research publications that have been supported in
whole or in part with direct costs from NIH, but it does not apply to book
chapters, editorials, reviews, or conference proceedings. Publications resulting
from non-NIH-supported research projects should not be submitted.
For more information about the Policy or the submission
process, please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view
the Policy or other Resources and Tools, including the Authors' Manual.
Standards for Privacy of Individually Identifiable
Health Information:
The Department of Health and Human Services (HHS)
issued final modification to the "Standards for Privacy of Individually
Identifiable Health Information", the "Privacy Rule", on August
14, 2002. The Privacy Rule is a federal regulation under the Health Insurance
Portability and Accountability Act (HIPAA) of 1996 that governs the protection
of individually identifiable health information, and is administered and enforced
by the HHS Office for Civil Rights (OCR).
Decisions about applicability and implementation of
the Privacy Rule reside with the researcher and his/her institution. The OCR
website (http://www.hhs.gov/ocr/) provides
information on the Privacy Rule, including a complete Regulation Text and
a set of decision tools on "Am I a covered entity?" Information
on the impact of the HIPAA Privacy Rule on NIH processes involving the review,
funding, and progress monitoring of grants, cooperative agreements, and research
contracts can be found at https://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 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.
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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