IMPORTANT NOTE: NIH
has published new limitations on grant application appendix materials to
encourage applications to be as concise as possible while containing the
information needed for expert scientific review.EXPIRED
Department of Health and Human Services
Participating Organizations
National Institutes of Health (NIH),
(http://www.nih.gov/)
Components of Participating
Organizations
National Institute on Drug Abuse
(NIDA), (http://www.nida.nih.gov/)
Title: Drug Abuse Prevention Intervention Research (R01)
Announcement Type
This is a reissue of PA-05-118,
which was previously released June 9, 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-07-110
Catalog of Federal Domestic
Assistance Number(s)
93.279
Key Dates
Release/Posted Date: December 6, 2006
Opening Date: January 5, 2007
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: May 8, 2008
Due Dates for E.O. 12372
Not Applicable
Additional Overview Content
Executive Summary
Part II Full Text of Announcement
Section
I. Funding Opportunity Description
1. Research Objectives
Section
II. Award Information
1. Mechanism(s) of Support
2. Funds Available
Section
III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility
Criteria
Section
IV. Application and Submission Information
1. Address to Request Application
Information
2. Content and Form of Application
Submission
3. Submission Dates and Times
A. Receipt and 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
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
Purpose
The purpose of the National Institute on Drug Abuse's (NIDA) Prevention Research Branch (PRB) is to support a developmentally grounded program of research on the prevention of the initiation of drug use, progression to abuse and dependence, and transmission of drug-related HIV infection. This research involves the use of rigorous scientific methods to test theoretically derived hypotheses to advance our understanding of the science of prevention within diverse populations and settings. Studies that support this purpose include investigations of cognitive, behavioral, and social processes as they relate to 1) the development of novel prevention approaches, 2) the efficacy and effectiveness of newly developed and/or modified prevention programs, 3) the processes associated with the selection, adoption, adaptation, implementation, sustainability, and cost effectiveness of science-based interventions, and 4) methodologies appropriate for studying complex aspects of prevention science.
Background and Significance
Drug abuse and dependence are disorders that interfere with the normal, healthy functioning of persons across the lifespan, and are preventable causes of health problems, injuries, lost income and productivity, and family dysfunction. While the initiation of licit and illicit drug use, a necessary precursor to abuse and dependence, grows dramatically during the adolescent years, this behavior is preceded by proximal and distal biological, psychological, social, and environmental precursors originating as early as the prenatal period. Furthermore, the misuse and illicit use of drugs extends well beyond adolescence and, for some, begins in adulthood, even in late adulthood.
The life course developmental perspective suggests that individual and environmental factors interact to increase or reduce vulnerability to drug use, abuse and dependence. Vulnerability can occur at many points along the life course but peaks at critical life transitions. Thus, prevention researchers should recognize the significance of timing interventions to coincide with important biological transitions, such as puberty; normative transitions, such as moving from elementary to middle school; social transitions, such as dating; and traumatic transitions, such as the death of a parent. In addition, because vulnerability to drug abuse involves dynamic intrapersonal (e.g., temperament), interpersonal (e.g., family and peer interactions) and environmental (e.g., school environment) influences, prevention intervention research must target interactions between individuals and social systems across the life span. To address this complexity, intervention research needs to test strategies designed to alter specified modifiable mediators to determine which are most related to and effective in reducing drug use initiation and escalation, with what audiences, and under what conditions. Drug use, abuse, and dependence often co-occur with delinquency and criminal behavior, violence, mental health problems and HIV, therefore understanding the prevention of co-occurring problems and their contribution to elevated levels of risk is important to NIDA's mission.
Successful drug abuse and drug-related HIV prevention programs have utilized a number of theoretical perspectives for predicting differential drug use trajectories and elucidating developmentally grounded mediators, or risk and protective factors, amenable to change. Notable among these theories are Problem Behavior Theory, Social Cognitive Theory, and the Social Development Model. Resulting research has focused on prevention approaches involving positive modification of various precursors of substance use, such as aggressive behavior, academic problems and failure, poor social skills, misperceptions of social norms, poor parent-child attachment, and inappropriate parental expectations and responses. Successful programs have also intervened in multiple contexts, such as schools, health care settings, community service organizations, and workplaces. Drug abuse and related HIV prevention research is most successful when the intervention delivery contexts provide ready access to the target population. That is, the more central the delivery context is to the target audience's existing life routines, the more likely the intervention and associated research will be able to recruit and retain members of the target population.
Audiences or targets for prevention interventions are generally classified into one of three categories depending on level of risk: universal, selective, or indicated. Universal prevention interventions are targeted to the general public or to a whole population group, such as all children in a school. Selective prevention interventions are targeted to individuals or subgroups of the population with defined risk factors for the development of substance abuse, such as children of drug abusers. Indicated prevention interventions are targeted to individuals or subgroups that are identified as having non-clinical but detectable signs or symptoms foreshadowing drug abuse, dependence, and addiction. A Tiered approach to prevention interventions incorporates two or more of these levels of intervention with increasing sensitivity to individuals with greater problem severity.
To advance the field, novel interventions must build on basic science findings from diverse fields such as neuroscience, epidemiology, human development, psychology, sociology, anthropology, and communications. Many factors that may hold promise for informing the development and testing of prevention interventions have received little if any attentions, for example, individual learning styles and cognitive processing, intergenerational family communication patterns, quality of family child peer interactions, neighborhood cohesiveness and legislation on drug abuse. Work with children who have shown early aggressive behavior is an example of how the identification and targeting of etiological processes may hold promise for prevention. Early aggressive behavior was linked to subsequent interpersonal and academic problems, social alienation, association with deviant peers and eventual substance abuse. Thus, effective prevention strategies were developed, such as helping children to identify their behaviors and practice self-control, good classroom management practices that reinforce pro-social behaviors, and parental involvement in positive child activities. These strategies have been shown to have long-term impact on drug use and antisocial behavior.
The study of interactions between domains of variables (e.g., biological and social) may be a promising route of inquiry as the science of prevention progresses because interactions between risk factors in multiple domains can result in elevation of risk or protection. For example, early pubertal maturation in girls places them at risk for drug abuse and precocious sexual activity because they are perceived and treated, by both adults and peers, as older than their years and they tend to become involved with older male partners and as a result increase their opportunities for drug exposure and risky sexual behaviors. However, parental awareness, involvement and monitoring can be protective factors for this subpopulation of girls. Research that considers the potential for such interactions in the prevention process will better define the complex relationships that necessarily pervade investigations on drug abuse prevention.
Among the many underdeveloped areas of drug abuse prevention research, three will be discussed briefly here: developmental transitions, differential effectiveness and fidelity of implementation, and emerging technologies. Characteristics and differences that contribute to drug abuse risk during late adolescence and emerging adulthood have not been well studied. This is a particularly important area of research because late adolescence is a significant transition point in human development, and the initiation of use of so-called hard drugs often takes place during this period. Other transitions during this life course stage, such as learning to drive, entering college or the first job, courtship and marriage, and victimization have not been seriously considered as targets for drug abuse prevention interventions. Moreover, no prevention interventions for later stages of adulthood have been developed despite the fact that individuals who have used licit, prescription and illicit drugs for long periods of time without developing dependency can move toward abuse and dependence as the result of biological (e.g., lower tolerance with aging), normative (e.g., retirement), social (e.g., making new friends in retirement) or traumatic (e.g., lose of a spouse) transitions. Thus, greater attention to a wide variety of transitions and the risk and protective factors related to them is needed for the development and testing of innovative interventions that target high-risk periods across the life course.
Some effective prevention interventions show differential effectiveness by gender, ethnicity, and other factors. Research is needed to understand underlying biological, psychological and social processes and mechanisms that account for these differences so that interventions can be adapted for specific sub-groups while maintaining the integrity of the intervention core components. The importance of fidelity of implementation is well established, yet there are situations where strict adherence is not possible. Developing a better understanding of what constitutes the effective ingredients of an intervention and how modification can be made while maintaining or boosting effect sizes may be a superior approach to developing a wholly new intervention.
Emerging technologies, such as the Internet and wireless communication, may have application to both intervention design and prevention methodology. While the full impact of such changes on prevention programming and research is unknown, possible new improvements to intervention processes and data collection methodology should be explored. Technology-assisted interventions have the potential to be both more personalized, through the use of individualized programs, and more confidential, as they involve less face-to-face contact than more traditional methods. In addition, integrating media or other high-tech intervention components into existing interventions may potentiate effectiveness. Technology based innovations in data collection, such as using hand held devices to collect moment to moment data are already in use, but other methodological innovations are likely.
Specific Areas of Research Interest
NIDA's drug abuse prevention research program is comprehensive in nature and fully reflects the prevention research mission, objectives, and study areas advanced by the Department of Health and Human Services and the National Institutes of Health. The following sections address drug abuse prevention research areas of specific interest to NIDA. Under each research section, examples of topics requiring further study are given. However, many areas for future research are not addressed, and investigators should not view the examples provided as limiting the areas of research of interest to NIDA.
1. Basic Prevention Research
A priority of NIDA is to stimulate the translation of emerging scientific discoveries to the design and testing of innovative prevention intervention approaches. Previous research from the basic biological (e.g., neurobiological), psychological (e.g., emotional, behavioral, cognitive, communication, and developmental) and social (e.g., social learning, peer network, and communications) sciences and drug abuse epidemiology and etiology and have elucidated individual and group vulnerabilities and pathways to drug use initiation and escalation. Based on these findings and their underlying theoretical frameworks, prevention research has produced programs with proven efficacy and effectiveness. However, much existing research on biological, psychological and social processes and mechanisms has not been fully utilized for the purposes of developing and testing novel drug abuse prevention interventions. Basic prevention research uses empirically- and theoretically-derived hypotheses regarding malleable biological, psychological and social mediators of behavior to develop and test new prevention paradigms. Attention to specific patterns of interactions between individual, developmental and environmental factors that influence vulnerability to drug abuse and associated problems and health risking behaviors can be important elements of this research. In addition, drug abuse prevention research findings have the potential to inform epidemiology, etiology and basic science hypotheses with implications for the further development of new intervention paradigms or refinement/improvement of existing programs and strategies. Most basic prevention science investigations are expected to be human laboratory studies or small-scale field randomized controlled trial (RCT) studies of well-defined hypotheses derived from prior research. Possible research foci include:
Studies that use findings on learning styles and cognitive strategies and functioning to improve or develop targeted prevention strategies.
Examination of interaction between emotional and cognitive responses to prevention messages to construct messages more likely to elicit appropriate responses (e.g., triggering refusal behaviors when confronted with potential drug use situations).
Qualitative studies of ethnic or culturally defined sub-groups with low incidence and prevalence of substance abuse to determine what naturally occurring protective factors are operating for the purpose of testing those factors for possible inclusion in prevention interventions.
Examination of influences on program effectiveness when emerging knowledge about sub-population specific biological vulnerability to HIV, HCV, and other STDs is integrated into existing drug abuse prevention programs.
Construction and decomposition studies that systematically examine the impact of program components, alone and together, to determine mechanisms of effectiveness.
2. Prevention Intervention Research
Research on prevention intervention programs and strategies should focus on the manipulation of presumed causal factors derived from basic prevention and other studies on the origins, pathways and mechanism of vulnerability to drug abuse and addiction. Prevention intervention research includes efficacy, effectiveness, and systems research. Efficacy trials are generally the first step in testing innovative prevention strategies and interventions and utilize small RCTs. The theoretical or empirical basis of the intervention defines the role of modifiable mediating variables, how various programmatic components have been designed to address those elements and the hypothesized outcomes. An important aspect of efficacy studies is determining the relevance and acceptability of the program for translation to real world settings.
Effectiveness trials replicate efficacious strategies and interventions in less controlled real-world settings with larger more diverse samples, and generally employ a RCT or equivalent research design (such as, multiple baseline, cross over, etc.). In addition to determining effectiveness, these studies usually incorporate prevention services research questions related to factors such as participant recruitment and retention, dosage, cost, fidelity of implementation, and implementer training (for further discussion see below). That is, they examine issues that affect the transportability of programs to real world settings, facilitators and barriers to implementation, and generalizability to diverse populations and geographic settings.
Systems research takes prevention programs or strategies with demonstrated efficacy and effectiveness to scale. Systems trials are implemented through existing (e.g., schools, primary care settings, workplaces) or newly created delivery systems with large samples. Random assignment to intervention and control conditions remains the ideal study design. A major emphasis of systems trials is identifying and understanding how factors that affect the sustainability of programming operate. Thus, addressing prevention services research questions is a core goal of this type of study. All three intervention study types, efficacy, effectiveness, and systems, generally incorporate a longitudinal design to allow for the examination of the role of moderators, mediators and a variety of proximal and distal outcomes over time.
An important emphasis of NIDA's prevention research program is on prevention services research questions. Prevention services research involves identifying and determining how features internal and external to interventions contribute to efficacy and effectiveness. Examples of internal features are: content, implementation strategies, fidelity, dosage, delivery setting and implementer training. Examples of external features are: exposure to other programs, media, enforcement of regulations and laws related to substance use and community norms around substance abuse. A clear understanding these features is essential to adapting programs to meet the needs of specific groups and, when appropriate, to generalizing strategies to other settings. Prior research suggests that features such as program duration, reinforcement of prevention messages over time, consistency of messages across settings, use of developmentally appropriate content and materials, use of interactive teaching techniques, use of intermittent reinforcement, client-facilitator fit, grouping of clients, and interactions between these features need further investigation to improve the quality of programming and increase the potential for translation into real-world settings. Questions around these and other features that concentrate on the availability, organization, management and financing of prevention interventions fall into the broad category of prevention services research. Prevention services research is integral to intervention research and forms the link between research and practice. Examples of topics requiring further research include:
Efficacy
Developing and testing strategies to strengthen existing group and environmental anti-drug norms and characteristics that have been show to be protective against drug abuse and addiction.
Studies on the efficacy of drug abuse prevention program and strategies that are untested but widely used such as: case management, mentoring, job training, and challenge activities.
Testing the efficacy of drug use and/or HIV/STI screening tests for their potential effects in reducing or preventing drug abuse and dependence and/or HIV/STI infection.
Developing and testing the efficacy of brief HIV and drug abuse prevention interventions for specific contexts such as primary care settings and college/workplace health programs.
Effectiveness
Independent replication studies of efficacious drug abuse and drug abuse-related HIV prevention programs in multiple sites to determine cross-site and cross-population generalizability.
Tests for the effectiveness of proven prevention interventions for individuals at-risk for the combined problems of drug abuse, HIV/AIDS, anti-social behavior, high-risk health behaviors, and co-morbid psychiatric disorders.
Analyzing longitudinal data to determine the long-term and potential cross-over effects of drug abuse prevention programs on associated health problem behaviors such as unsafe sexual practices leading to HIV infection.
Adapting and assessing the effectiveness of proven drug abuse prevention strategies for use in contexts with the potential to maximize access to hard to reach populations, such as accessing parents through the workplace or racial/ethnic minority populations in places of worship.
Systems
Examining how differences in school environments, including drug abuse rules, influence mediators of drug abuse--such as attitudes, norms and intentions --and eventually substance abuse behaviors with particular attention to the pattern and duration of the environmental change processes.
Comparisons of effective HIV prevention programs across sites such as health clinics, primary care settings, school health programs, and faith-based programs to determine equivalent or differential effectiveness by setting, delivery characteristics and financial and human resources.
Studies of the initiation, development, and continuity of community coalitions to prevent drug abuse and their impact on selection and implementation of effective drug abuse prevention strategies.
Determining the extent to which research-based strategies for training high-risk parents -- such as those who abuse drugs and those for which abusive child-rearing practices have been documented -- are available through existing service delivery systems.
Determination of the cost and cost-effectiveness of short-term drug abuse and HIV prevention programs that have been integrated into standard health, mental health and community settings.
3. Methodological Research
Methodological research is needed in the field of drug abuse prevention on promising data collection, data management, analysis, and reporting techniques. Special attention should be given to: the hierarchical nature of most prevention data; the adaptation of measures for intervention cohorts over the course of time and development; the measurement and analysis of complex theoretical process models including moderating and mediating variables; the problems of missing data and attrition when following intervention and control subjects over time; and the development of statistical strategies that can assist in identifying the most salient features of interventions. NIDA supports the adaptation and assessment of proven scientific procedures from other disciplines to determine their applicability to drug abuse prevention research. Specific areas of research include:
The development of more powerful designs for detecting differences in program effectiveness by attributes such as subgroup membership, content delivered, content exposure, and so forth.
The development and assessment of physiological and biochemical measures that may elucidate cognitive and affective factors associated with individual responsiveness to particular prevention interventions.
The development and trial use of real-time data collection strategies or other methods to strengthen, validate, or corroborate self-reported behaviors.
Special Considerations:
HIV/AIDS Counseling and Testing Policy for the National Institute on Drug Abuse: Researchers funded by NIDA who are conducting research in community outreach settings, clinical, hospital settings, or clinical laboratories and have ongoing contact with clients at risk for HIV infection, are strongly encouraged to provide HIV risk reduction education and counseling. HIV counseling should include offering HIV testing available on-site or by referral to other HIV testing service for persons at risk for HIV infection including injecting drug users, crack cocaine users, and sexually active drug users and their sexual partners. For more information see http://grants.nih.gov/grants/guide/notice-files/NOT-DA-01-001.html.
National Advisory Council on Drug Abuse Recommended Guidelines for the Administration of Drugs to Human Subjects: The National Advisory Council on Drug Abuse recognizes the importance of research involving the administration of drugs to human subjects and has developed guidelines relevant to such research. Potential applicants are encouraged to obtain and review these recommendations of Council before submitting an application that will administer compounds to human subjects. The guidelines are available on NIDA's Home Page at www.nida.nih.gov under the Funding, or may be obtained by calling (301) 443-2755.
See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.
Section II. Award Information1. Mechanism of Support
This Funding Opportunity Announcement (FOA) will use the NIH Research Project Grant (R01) award mechanism.
The applicant will be solely responsible for planning, directing, and executing the proposed project.
This FOA uses Just-in-Time information concepts. It also uses the modular as well as the non-modular budget formats (see http://grants.nih.gov/grants/funding/modular/modular.htm).
Specifically, if you are a U.S. organization and 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).
U.S. applicants requesting more than $250,000 in annual direct costs and all foreign applicants must complete and submit budget requests using the Research & Related Budget component found in the application package for this FOA. See NOT-OD-06-096, August 23, 2006.
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.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
F&A costs requested by consortium participants are not included in the direct cost limitation. See NOT-OD-05-004, November 2, 2004.1. Eligible Applicants
1.A. Eligible Institutions
You may submit an application(s) if your institution/organization has any of the following characteristics:
1.B. Eligible Individuals
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the 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.
More than one PD/PI, or multiple PDs/PIs, may be designated on the application for projects that require a team science approach that clearly does not fit the single-PD/PI model. Additional information on the implementation plans and policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH eRA Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).
The decision of whether to apply for a single PD/PI or multiple PD/PI grant is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for multiple PD/PI grants will require additional information, as outlined in the instructions below. The NIH review criteria for approach, investigators, and environment have been modified to accommodate applications involving either a single PD/PI or multiple PDs/PIs. When considering multiple PDs/PIs, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PD/PIs will be factored into the assessment of the overall scientific merit of the application. Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.
2. Cost Sharing or Matching
This
program does not require cost sharing as defined in the current NIH
Grants Policy Statement.
3. Other-Special Eligibility Criteria
Applicants may submit more than one application, provided each application is scientifically distinct.
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/applicants/apply_for_grants.jsp 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 Registered
2) Organizational/Institutional Registration in the eRA Commons
3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.
Both the PD/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.
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 the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.
Note: Only the forms
package directly attached to a specific FOA can be used. You will not be able
to use any other SF424 (R&R) forms (e.g., sample forms, forms from another
FOA), although some of the "Attachment" files may be useable for more
than one FOA.
For further assistance, contact GrantsInfo: Telephone 301-710-0267, Email: [email protected].
Telecommunications for the hearing impaired: TTY 301-451-5936.
2. Content and Form of Application Submission
Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.
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 has several components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in 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 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
PHS398 Modular Budget or Research & Related
Budget, as appropriate (See Section IV.6., Special Instructions,
regarding appropriate required budget component.)
Research
& Related Budget (required for foreign applications)
Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s) Form
Foreign Organizations Non-domestic (non-U.S.) Entity)
NIH
policies concerning grants to foreign (non-U.S.) organizations can be found in
the NIH Grants Policy Statement at: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm#_Toc54600260.
Applications from foreign organizations must:
Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.
SPECIAL INSTRUCTIONS
Applications with Multiple PDs/PIs
When multiple PDs/PIs are proposed, NIH requires one PD/PI to be designated as the "Contact PI, who will be responsible for all communication between the PDs/PIs and the NIH, for assembling the application materials outlined below, and for coordinating progress reports for the project. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs, but has no other special roles or responsibilities within the project team beyond those mentioned above.
Information for the Contact PD/PI should be entered in item 15 of the SF424(R&R) Cover component. All other PDs/PIs should be listed in the Research & Related Senior/Key Person component and assigned the project role of PD/PI. Please remember that all PDs/PIs must be registered in the eRA Commons prior to application submission. The Commons ID of each PD/PI must be included in the Credential field of the Research & Related Senior/Key Person component. Failure to include this data field will cause the application to be rejected.
All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership of the project.
Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the research plan, entitled Multiple PD/PI Leadership Plan (Section 14 of the Research Plan Component in the SF424 (R&R)), must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, including communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.
If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.
Applications Involving a Single Institution
When all PDs/PIs are within a single institution, follow the instructions contained in the SF424 (R&R) Application Guide.
Applications Involving Multiple Institutions
When multiple institutions are involved, one institution must be designated as the prime institution and funding for the other institution(s) must be requested via a subcontract to be administered by the prime institution. When submitting a detailed budget, the prime institution should submit its budget using the Research & Related Budget component. All other institutions should have their individual budgets attached separately to the Research & Related Subaward Budget Attachment(s) Form. See Section 4.8 of the SF424 (R&R) Application Guide for further instruction regarding the use of the subaward budget form.
When submitting a modular budget, the prime institution completes the PHS398 Modular Budget component only. Information concerning the consortium/subcontract budget is provided in the budget justification. Separate budgets for each consortium/subcontract grantee are not required when using the Modular budget format. See Section 5.4 of the Application Guide for further instruction regarding the use of the PHS398 Modular Budget component.
3. Submission Dates and Times
3.A. Submission,
Review and Anticipated Start Dates
Opening Date: January 5, 2007
Application Submission/Receipt
Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Submission/Receipt Date(s): Standard
dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS
Peer Review Date(s): Standard dates apply,
please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review Date(s): Standard dates
apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
3.A.1. Letter of Intent
A letter of intent is not required for the funding opportunity.
3.B. Sending an Application 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.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. The submitting AOR receives
the Grants.gov acknowledgments. The AOR and the PI receive Commons
acknowledgments. Information related to the assignment of an application to a
Scientific Review Group is also in the Commons.
Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on their application status in the Commons.
The NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of an application already reviewed with substantial changes, but such application must include an Introduction addressing the previous critique. Note 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 or competing renewal (formerly 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 renewal award.
The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See the NIH Grants Policy Statement.
6. Other Submission Requirements
PD/PI Credential (e.g., Agency Login)
The NIH requires the PD/PI(s) 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.
Organizational DUNS
The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
PHS398 Research Plan Component Sections
Items 2-5 of the PHS398 Research Plan component are limited to 25 pages. 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.
All application instructions outlined in the SF424 (R&R) Application Guide are to be followed, incorporating "Just-in-Time" information concepts, and with the following additional requirements:
Special Instructions for Modular Grant applications
R01 applications from U.S. institutions/organizations requesting up to $250,000 per year in direct costs (excluding consortium F&A costs) must be submitted in a modular budget format. Additional information on modular budgets is available at http://grants.nih.gov/grants/funding/modular/modular.htm. When submitting a modular budget, the applicant organization will include only the PHS398 Modular Budget component. See Section 5.4 of the SF424 (R&R) Application Guide for further instructions regarding the use of the PHS398 Modular Budget component.
Foreign organizations may not submit modular budgets. See NOT-OD-06-096.
Special Instructions for Applications Requesting $500,000 (direct costs) or More Per Year
Applicants
requesting $500,000 or more in direct costs for any year (excluding consortium
F&A costs) 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 the PHS398 Cover
Letter component with the application to identify the staff member and IC who
agreed to accept assignment of the application.
This policy applies to all new applications, competing renewal (formerly competing continuation ) applications, resubmission (formerly revised/amended ) applications, and revision (formerly competing supplemental ) applications. See NOT-OD-02-004, October 16, 2001.
APPENDIX MATERIALS
IMPORTANT NOTE: NIH
has published new limitations on grant application appendix materials to
encourage applications to be as concise as possible while containing the
information needed for expert scientific review.
Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) Application Guide (See http://grants.nih.gov/grants/funding/424/index.htm).
Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.
Note: While each section of the PHS398 Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to monitor better formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.
Foreign Applications (Non-domestic (non-U.S.) Entity)
Plan for Sharing Research Data
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 expects that
grant recipients make unique research resources readily available for research
purposes to qualified individuals within the scientific community after
publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a sharing
research resources plan addressing how unique research resources will be shared
or explain why sharing is not possible.
The adequacy of the resources sharing plan and any related data sharing plans
will be considered by Program staff of the funding organization when making
recommendations about funding applications. The effectiveness of the resource
sharing will be evaluated as part of the administrative review of each Non-Competing Grant
Progress Report (PHS 2590). See Section VI.3.,
Reporting.
Section V. Application Review Information
1. Criteria
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:
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 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? For applications
designating multiple PDs/PIs, is the leadership approach, including the
designated roles and responsibilities, governance, and organizational structure,
consistent with and justified by the aims of the project and the expertise of
each of the PDs/PIs?
Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?
Investigators: Are the PD/PIs and other key personnel appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level(s) of the principal investigator(s) and other researchers? Do the PD/PIs and investigative team bring complementary and integrated expertise to the project (if applicable)?
Environment: Do(es) the scientific environment(s) in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?
2.A. Additional Review Criteria:
In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:
Resubmission Applications (formerly revised/amended applications): Are the responses to comments from the previous scientific review group adequate? Are the improvements in the resubmission application appropriate?
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
Human Subjects Sections of the PHS398 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 the Human Subjects Sections of the PHS398 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
adequacy of the plans for their care and use will be assessed. See the Other
Research Plan Sections of the PHS398 Research Plan component of the SF424
(R&R).
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. The priority score should not be affected by the evaluation of the budget.
Applications from Foreign Organizations: Whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources will be assessed.
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 expects that grant
recipients make unique research resources readily available for research
purposes to qualified individuals within the scientific community after
publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a sharing
research resources plan addressing how unique research resources will be shared
or explain why sharing is not possible.
Program staff will be responsible for the administrative review of the plan for
sharing research resources.
The adequacy of the resources
sharing plan 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.
3. Anticipated Announcement and Award Dates
Not Applicable
Section VI. Award Administration Information
1. Award Notices
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the 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:
Elizabeth B. Robertson, Ph.D.
Chief
Prevention Research Branch
Division of Epidemiology, Services
and Prevention Research
National Institute on Drug Abuse
6001 Executive Boulevard, Room 5160
Bethesda, MD 20892-9589
Telephone: (301) 443-6504
FAX: (301) 480-2542
Email: [email protected]
2. Peer Review Contacts:
Not Applicable
3. Financial or Grants Management Contacts:
Chris Kidd
Grants Management Branch
National Institute on Drug Abuse
6101 Executive Boulevard, Room 270
Bethesda, MD 20892-8403
Telephone: (301) 443-6710
FAX: (301) 594-6849
Email: [email protected]
Section VIII. Other Information
Required Federal Citations
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, 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. Beginning
October 1, 2004, all investigators submitting an NIH application or contract
proposal are expected to include in the application/proposal a description of a
specific plan for sharing and distributing unique model organism research
resources generated using NIH funding or state why such sharing is restricted
or not possible. This will permit other researchers to benefit from the
resources developed with public funding. The inclusion of a model organism
sharing plan is not subject to a cost threshold in any year and is expected to
be included in all applications where the development of model organisms is
anticipated.
Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their
sub-populations must be included in all NIH-supported clinical research
projects unless a clear and compelling justification is provided indicating
that inclusion is inappropriate with respect to the health of the subjects or
the purpose of the research. This policy results from the NIH Revitalization
Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing
clinical research should read the "NIH Guidelines for Inclusion of Women
and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the SF424 (R&R) application; and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a) all
applications or proposals and/or protocols must provide a description of plans
to conduct analyses, as appropriate, to address differences by sex/gender
and/or racial/ethnic groups, including subgroups if applicable; and b)
investigators must report annual accrual and progress in conducting analyses,
as appropriate, by sex/gender and/or racial/ethnic group differences.
Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of
21) must be included in all clinical research, conducted or supported by the
NIH, unless there are scientific and ethical reasons not to include them.
All investigators proposing research involving human subjects should read the
"NIH Policy and Guidelines" on the inclusion of children as participants
in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).
Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants
for all investigators submitting NIH applications for research involving human
subjects and individuals designated as key personnel. The policy is available
at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.
Only research using hESC lines that are registered in the NIH Human Embryonic
Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/).
It is the responsibility of the applicant to provide in the project description
and elsewhere in the application as appropriate, the official NIH identifier(s)
for the hESC line(s) to be used in the proposed research. Applications that do
not provide this information will be returned without review.
NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript
submission (NIHMS) system (http://www.nihms.nih.gov/) at PubMed
Central (PMC) an electronic version of the author's final manuscript upon
acceptance for publication, resulting from research supported in whole or in
part with direct costs from NIH. The author's final manuscript is defined as
the final version accepted for journal publication, and includes all
modifications from the publishing peer review process.
NIH is requesting that authors submit manuscripts resulting from 1) currently
funded NIH research projects or 2) previously supported NIH research projects
if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms,
cooperative agreements, contracts, Institutional and Individual Ruth L.
Kirschstein National Research Service Awards, as well as NIH intramural
research studies. The Policy applies to peer-reviewed, original research
publications that have been supported in whole or in part with direct costs
from NIH, but it does not apply to book chapters, editorials, reviews, or
conference proceedings. Publications resulting from non-NIH-supported research
projects should not be submitted.
For more information about the Policy or the submission process, please visit
the NIH Public Access Policy Web site at http://publicaccess.nih.gov// and view the
Policy or other Resources and Tools, including the Authors' Manual.
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 http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs in NIH Grant Applications or Appendices:
All applications and
proposals for NIH funding must be self-contained within specified page
limitations. For publications listed in the appendix and/or Progress report,
Internet addresses (URLs) or PubMed Central (PMC) submission identification
numbers must be used for publicly accessible on-line journal
articles. Publicly accessible on-line journal articles or PMC
articles/manuscripts accepted for publication that are directly relevant to the
project may be included only as URLs or PMC submission
identification numbers accompanying the full reference in either the
Bibliography & References Cited section, the Progress Report Publication
List section, or the Biographical Sketch section of the NIH grant application.
A URL or PMC submission identification number citation may be repeated in each
of these sections as appropriate. There is no limit to the number of URLs or
PMC submission identification numbers that can be cited.
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 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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