Department of Health and Human Services
National Institutes of Health (NIH), (http://www.nih.gov/)
Components of Participating Organizations
National Institute of Nursing Research (NINR/NIH), (http://www.ninr.nih.gov/)
National Institute of Child Health and Human Development (NICHD/NIH), (http://www.nichd.nih.gov)
National Heart, Lung, and Blood Institute (NHLBI/NIH), (http://www.nhlbi.nih.gov)
National Institute on Alcohol, Alcoholism, and Alcohol Abuse (NIAAA/NIH), (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 (R01)
Update: The following update relating to this announcement has been issued:
Looking Ahead: As part of the Department of Health and Human Services' implementation of e-Government, during FY 2006 the NIH will gradually transition each research grant mechanism to electronic submission through Grants.gov and the use of the SF 424 Research and Related (R&R) forms. Therefore, once the transition is made for a specific grant mechanism, investigators and institutions will be required to submit applications electronically using Grants.gov.. For more information and an initial timeline, see http://era.nih.gov/ElectronicReceipt/. NIH will announce each grant mechanism change in the NIH Guide to Grants and Contracts (http://grants.nih.gov/grants/guide/index.html). Specific funding opportunity announcements will also clearly indicate if Grants.gov submission and the use of the SF424 (R&R) is required. Investigators should consult the NIH Forms and Applications Web site (http://grants.nih.gov/grants/forms.htm) for the most current information when preparing a grant application.
Program Announcement (PA) Number: PA-06-097
Catalog of Federal Domestic Assistance Number(s)
93.361, 93.865, 93.837, 93.273, 93.279
Release Date: December 15, 2006
Letters of Intent Receipt Date(s): Not Applicable
Application Submission Dates(s): Standard dates apply, see http://grants.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Receipt Date: See http://grants.nih.gov/grants/funding/submissionschedule.htm#AIDS
Peer Review Date(s): Standard dates apply, see http://grants.nih.gov/grants/funding/submissionschedule.htm
Council Review Date(s): Standard dates apply, see http://grants.nih.gov/grants/funding/submissionschedule.htm
Earliest Anticipated Start Date: Standard dates apply, see http://grants.nih.gov/grants/funding/submissionschedule.htm
Expiration Date for R01 Non-AIDS Applications: November 2, 2006
Expiration Date for R01 AIDS and AIDS-Related Applications: January 3, 2007
Due Dates for E.O. 12372
Additional Overview Content
Part II Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available
Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria
Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Submission, Review and Anticipated Start Dates
1. Letter of Intent
B. Sending an Application to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
Section V. Application Review Information
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
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
1. Research Objectives
This program announcement 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.
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(s) of Support
This funding opportunity will use the NIH Research Project Grant (R01) award mechanism(s). As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.
This funding opportunity uses just-in-time concepts. It also uses the modular as well as the non-modular budget formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular budget format described in the PHS 398 application instructions. Otherwise follow the instructions for non-modular research grant applications.
2. Funds Available
Applications received in response to this program announcement will compete for funds in the general funding pool of the participating NIH ICs. No specific funds have been set aside for this announcement. The number and size of the awards will depend on the number of applications received, their relative scientific merit, and the general availability of funds for investigator-initiated research at the participating ICs.
For the R01 award mechanism, the applicant may request a project period of up to 5 years. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.
Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.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 is invited to work with their 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 programs.
2. Cost Sharing or Matching
The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing
3. Other-Special Eligibility Criteria
1. Address to Request Application Information
The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.
Telecommunications for the hearing impaired: TTY 301-451-5936.
2. Content and Form of Application Submission
Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.
The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.
Several special provisions apply to applications submitted by foreign organizations:
research should provide a unique research opportunity not available in the U.S.
3. Submission Dates and Times
See Section IV.3.A for details.
3.A. Submission, Review and Anticipated Start Dates
Letter of Intent Submission Date: Not Applicable.
Application Submission Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
Peer Review Date: http://grants.nih.gov/grants/funding/submissionschedule.htm
Council Review Date: http://grants.nih.gov/grants/funding/submissionschedule.htm
Earliest Anticipated Start Date: http://grants.nih.gov/grants/funding/submissionschedule.htm
3.A.1. Letter of Intent
A letter of intent is not required for the funding opportunity.
3.B. Sending an Application to the NIH
Applications must be prepared using the research grant application forms found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and five signed photocopies in one package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)
Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).
3.C. Application Processing
Applications must be submitted on or before the application receipt/submission dates described above (Section IV.3.A.) and at http://grants.nih.gov/grants/dates.htm. Upon receipt applications will be evaluated for completeness by CSR. Incomplete applications will not be reviewed.
The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial 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 a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique.
Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.
4. Intergovernmental Review
This initiative is not subject to intergovernmental review.
5. Funding Restrictions
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.
Pre-Award Costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or competing continuation award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or competing continuation award.
The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.
6. Other Submission Requirements
Specific Instructions for Modular Grant applications.
Applications requesting up to $250,000 per year in direct costs must be submitted in a modular budget format. The modular budget format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular budgets. Applicants must use the currently approved version of the PHS 398. Additional information on modular budgets is available at http://grants.nih.gov/grants/funding/modular/modular.htm.
Instructions for Applications Requesting $500,000 (direct costs) or More per
Applicants requesting $500,000 or more in direct costs for any year must carry out the following steps:
1) Contact the IC program staff at least 6 weeks before submitting the application, i.e., as you are developing plans for the study;
2) Obtain agreement
from the IC staff that the IC will accept your application for consideration
for award; and,
3) Include a cover letter with the application that identifies the staff member and IC who agreed to accept assignment of the application.
This policy applies to all
investigator-initiated new (type 1), competing continuation (type 2), competing
supplement, or any amended or revised version of these grant application types.
Additional information on this policy is available in the NIH Guide for Grants
and Contracts, October 19, 2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html.
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.
Applicants requesting more than $500,000 in direct costs in any year of the proposed research must include a plan for sharing research data in their application. The funding organization will be responsible for monitoring the data sharing policy (http://grants.nih.gov/grants/policy/data_sharing).
The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.
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 (NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a plan for sharing research resources 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, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.
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 PHS referral guidelines.
Appropriate scientific review groups convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit.
As part of the initial merit review, all applications will:
goals of NIH supported research are to advance our understanding of biological
systems, to improve the control of disease, and to enhance health. In their
written critiques, reviewers will be asked to comment on each of the following
criteria in order to judge the likelihood that the proposed research will have
a substantial impact on the pursuit of these goals. Each of these criteria will
be addressed and considered in assigning the overall score, weighting them as
appropriate for each application. Note that an application does not need to be
strong in all categories to be judged likely to have major scientific impact
and thus deserve a high priority score. For example, an investigator may
propose to carry out important work that by its nature is not innovative but is
essential to move a field forward.
Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?
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
In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:
Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. See the Research Plan, Section E on Human Subjects in the PHS Form 398).
Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. See the Research Plan, Section E on Human Subjects in the PHS Form 398).
Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions will be assessed.
Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.
2.B. Additional Review Considerations
Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.
2.C. Sharing Research Data
Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The funding organization will be responsible for monitoring the data sharing policy. http://grants.nih.gov/grants/policy/data_sharing.
2.D. Sharing Research Resources
NIH policy 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 http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). 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.
3. Anticipated Announcement and Award Dates
Applications will be reviewed and awards will be made according to the standard schedule described at http://grants.nih.gov/grants/funding/submissionschedule.htm.Section VI. Award Administration Information
1. Award Notices
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 (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 14 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.
Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Also Section IV.5. Funding Restrictions.
2. Administrative and National Policy Requirements
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the Notice of Award. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).
Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement.
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
1. Scientific/Research Contacts:
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
Lynne M. Haverkos, MD, MPH
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
Charlotte Pratt, PhD, MS, RD
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
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
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
2. Peer Review Contacts:
3. Financial or Grants Management Contacts:
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
Required Federal Citations
Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.
Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).
Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.
Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.
Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.
Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.
Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.
All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).
Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review.
NIH Public Access Policy:
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://www.nih.gov/about/publicaccess/ and view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/publicaccess_manual.htm).
Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002 . The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).
Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to 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 at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.
The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.
Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
Office of Extramural
National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
Department of Health
and Human Services (HHS)