and Human Services (HHS)
EXPIRED
Part I Overview Information
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)
National Institute on Alcohol Abuse and Alcoholism (NIAAA),
(http://www.niaaa.nih.gov/)
Title: Genetic
Epidemiology of Substance Use Disorders (R03)
Announcement
Type
This is
a reissue of PA-02-112,
which was previously released May 30, 2002.
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-07-414
Catalog of Federal Domestic Assistance Number(s)
93.279, 93.273
Key Dates
Release/Posted Date: July 24, 2007
Opening Date: July 25, 2007(Earliest date an application may be submitted
to Grants.gov)
Letters
of Intent Receipt Date(s): Not
applicable.
NOTE: On time submission requires that applications be successfully
submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant
institution/organization).
Application Submission/Receipt Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Submission/Receipt Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS.
Peer Review Date(s): Standard dates apply,
please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review Date(s): Standard dates apply,
please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date(s): Standard dates
apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Additional Information To Be Available Date (URL
Activation Date): Not Applicable
Expiration Date: September 8, 2010
Due
Dates for E.O. 12372
Not Applicable
Additional Overview Content
Executive
Summary
Table of Contents
Part I Overview Information
Part II Full Text of Announcement
Section I. Funding Opportunity
Description
1. Research Objectives
Section II. Award Information
1. Mechanism of Support
2. Funds Available
Section III. Eligibility
Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2. Cost Sharing or Matching
3. Other - Special Eligibility Criteria
Section IV. Application and
Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Submission, Review, and Anticipated Start Dates
1. Letter of Intent
B. Submitting an Application Electronically to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
Section V. Application Review
Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review
Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award Dates
Section VI. Award Administration
Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting
Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/Grants Management Contact(s)
Section VIII. Other Information
- Required Federal Citations
Part II - Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
Purpose
This announcement replaces PA-02-112, Genetic Epidemiology of Substance Use Disorders,.
The National Institute on Drug Abuse and the National Institute on Alcohol Abuse and Alcoholism seek to stimulate small research projects applying genetic epidemiologic methods to studies of substance and alcohol use disorders (SUDs/AUD, drug or alcohol abuse and dependence). Previous studies using twin, adoption, and family approaches indicate that genetic factors substantially contribute to the vulnerability to SUDs/AUD. Shared environmental factors have also been shown strongly to influence risk, particularly for the onset of substance and alcohol use, while heritability estimates generally rise with age and with progression from substance use to disorder. Significant advances have been made in our understanding of the developmental nature of the onset and progression of SUDs/AUD and in defining a disinhibited phenotype. Building on these findings, new studies are needed to apply genetic epidemiologic approaches to advance our understanding of a variety of developmental trajectories of SUD/AUD, integrate as well as differentiate genetic, environmental, and developmental factors in the onset and maintenance of SUD/AUD, broaden and refine phenotypic definitions of SUDs/AUD, guide the translation of etiologic findings to treatment, prevention, gene-finding and molecular studies, and meet the methodologic challenges of the field. Secondary analyses, pilot and feasibility studies, and small methodologic studies are encouraged under this R03 mechanism.
Research Objectives
Background
A variety of research approaches have established that SUDs/AUD are heritable complex disorders, and that family history of SUD/AUD is probably the most potent risk factor for these disorders. Heritability estimates have been high, and shared environmental effects appear to be strong, particularly early in adolescence and at the points of drug use initiation. Genetic epidemiologic studies have highlighted the nature of SUD/AUD as a developmental disorder, particularly as part of a general vulnerability to problem behavior associated with disinhibition. A surprising degree of non-specificity has been found in regard to choice of drug and to gender; that is, many risk factors appear to operate similarly in the vulnerability to abuse and dependence for a variety of drugs in both men and women. Increasingly sophisticated approaches have been applied to understand the high prevalence of psychiatric comorbidity with SUDs/AUD. Important findings are emerging on the roles of gene-environment correlation and gene-environment interaction in elucidating the development of substance and alcohol use and SUDs/AUD. A review of NIDAs portfolio of funded research using genetic epidemiologic methods was conducted in February, 2005, and is summarized at http://www.nida.nih.gov/whatsnew/meetings/geneticepidemiology/Index.html. NIAAAs portfolio of grants involving genetic studies was reviewed by its National Advisory Council Subcommittee External Advisory Board (EAB) in August, 2004. The NIAAA EAB recommendations for Gene by Environment Interactions may be found at http://www.niaaa.nih.gov/NR/rdonlyres/75A42848-D013-48F5-94A4-326FDCCE7BEC/0/GenexEnvironment2004.pdf . In addition, NIAAAs Five-Year Strategic Plan summarizing priorities for research on genetic risks for alcohol use disorders and alcohol related problems across the lifespan can be found at http://pubs.niaaa.nih.gov/publications/StrategicPlan/NIAAASTRATEGICPLAN.htm ; and priorities outlined for genetic epidemiology of alcohol use in the Division of Epidemiology and Prevention Research Strategic Plan can be found at http://pubs.niaaa.nih.gov/publications/DEPRStrategicPlan/BriefingBook2.htm#C._GENETIC_EPIDEMIOLOGY_AND_ALCOHOL.
New studies using genetically-informative approaches are now needed to build on these findings by enhancing our understanding of developmental trajectories of SUD/AUD and the true roles of genetic, social/environmental, and developmental factors in the development and maintenance of SUD/AUD; expanding phenotypic definitions; guiding gene-finding, molecular studies, treatment and preventive interventions; and meeting the methodologic challenges of the field. In regard to developmental trajectories, gaps remain in our ability to distinguish genetic, environmental, and developmental factors in transitions among stages of, and alternative pathways into and out of, drug use, abuse, dependence, persistence, and relapse. Genetically informative approaches to understanding gender differences in trajectories, the relative roles of environmental, genetic, and developmental or physiological factors (such as early puberty), and the role of early use as a marker or causal risk factor all merit further attention and carry important implications for developing targeted preventive interventions. Further work is needed on the developmental and cognitive consequences of SUDs/AUD, to define who is at risk for adverse sequellae and who is more resilient, and the genetic or environmental nature of those risk and protective factors. Much more research is needed to explicate the role of gene-environment interactions, from in utero exposure through all stages of development, in order to help identify both genetic and environmental factors in SUD/AUD vulnerability as well as risk for neurobehavioral deficits in fetal alcohol spectrum disorders. In cases where a genotype has been identified as conferring risk, stratification by genotype while studying environmental variables can enhance understanding of the role of the environment. Emerging evidence indicates that passive and evocative gene-environment correlations play a role in parenting behaviors, and active and evocative processes influence how individuals select their peer groups, drug exposures, and social environments; improved understanding of such gene-environment correlations can help target preventive interventions appropriately. Moreover, gene-environment correlations need to be clarified in order to accurately identify gene-environment interactions. Other environmental factors that merit study with genetic epidemiologic approaches are outlined in the bullets below and include trauma, ethnic and cultural influences, and the acquisition and transmission of HIV and other infectious diseases.
Genetic epidemiologic research has begun to make important contributions to the understanding of underlying phenotypes and endophenotypes for SUDs/AUD. More research is needed to move beyond empirical identification of endophenotypes, to delineate the brain mechanisms underlying these behaviors and ultimately help identify genes that are linked to the specific brain processes that convey risk. Other topics that can benefit from the application of genetic epidemiologic approaches include affective neuroscience; endophenotypes that extend beyond electrophysiology; startle modulation endophenotypes; behavioral inhibition and possible internalizing (affective) phenotypes; and sleep (circadian rhythm) endophenotypes. Phenotypes that differ in the pharmacogenetic responses to drugs, and those that are particularly sensitive to environmental influences, also merit further study.
In addition to clarifying the etiology of SUDs/AUD, genetic epidemiologic approaches hold important translational implications for nosology, prevention, treatment, gene-finding and other molecular research. Potential contributions of genetic epidemiology to molecular and gene-finding approaches include: refining phenotypes and definitions of drug use disorders that merit molecular study, quantifying the range of effect of genes for study, improving sample collection, informing design of studies on gene expression (including development and timing), and helping to refine the definition of control subjects. Studies of gene-environment interaction can help refine the search for genes for drug use disorders, with potential for clarifying exposure status, improving replication, and enhancing effect sizes. Etiologic studies of gene-environment-development interplay can make significant contributions to targeting preventive interventions, by distinguishing causal from correlational associations and clarifying mechanisms and direction of risk processes, which in turn help in identifying which environmental factors are useful targets for intervention and when during development such interventions are likely to be most effective. Treatment research can benefit from genetically informed studies of relapse and desistance. Long-term studies of genetic and environmental factors associated with risks for HIV/AIDS are can help identify potential opportunities for targeted behavioral interventions to avert HIV infection and progression to disease. Given the increasing importance of translational research, genetic epidemiologic researchers should clearly articulate the translational applications of their findings to public health.
Further studies are needed to address the numerous methodological challenges that affect research on the genetic epidemiology of SUDs/AUD. The conditionality of drug and alcohol use disorders (that development of drug or alcohol abuse and dependence, unlike other disorders, depends on exposure to drugs or alcohol, and on initiation) is a key issue that impacts other aspects of this work, including the definition of an unaffected individual (those who have never used vs. those who used without progressing to dependence), or missing data on etiology due to those at risk for dependence who never initiated use. Another issue is testing alternative causal models; this approach can help move the field forward, and applicants are encouraged to consider this method in their proposals. More studies that focus on methodologic issues specific to drug abuse and AUD (phenotype definitions and nosology, causal modeling, quantitative approaches) continue to be needed. Along with developing these sophisticated methodologic approaches, more biostatisticians and methodologists need to be attracted to and retained in applying their skills to existing questions and databases in drug abuse and AUD research; information on mechanisms of support for training and career awards with NIDA can be found at http://www.nida.nih.gov/researchtraining/traininghome.html; and for NIAAA at: http://www.niaaa.nih.gov/ResearchInformation/ExtramuralResearch/PAs/researchtraining.htm; and http://www.niaaa.nih.gov/ResearchInformation/ExtramuralResearch/PAs/career.htm.
The R03 mechanism is suited to cost-effective or exploratory approaches to genetic epidemiologic research. A variety of genetic epidemiologic databases already exist, and studies applying secondary analyses to these data are very welcomed. Other approaches include the addition of appropriate measures and data analysis to ongoing studies, gathering retrospective data on established samples, combining data across studies to increase power for research on understudied subsamples and on outcomes characterized by small effects, and innovative forms of data collection such as web-based methods. Each of these approaches poses challenges to the field, and appropriately sophisticated methodology needs to be proposed and developed. General guidance for human genetics applications to NIDA can be found at http://www.nida.nih.gov/about/organization/Genetics/humanapp/index.html; genetic epidemiologic proposals should respond to those bullets that are relevant. These include clarifying sample selection; research design; statistical power for main effects, correlations, and interactions; procedures for pooling data when appropriate; generalizability; phenotype selection; choice of instruments for assessing SUDs/AUD and comorbid conditions where appropriate.
Proposals responding to this Program Announcement are expected to focus on genetic epidemiologic techniques and designs. Applicants seeking support for studies that focus primarily on the molecular genetics of drug abuse vulnerability are referred to the NIDA Program Announcement: Molecular Genetics of Drug Addiction and Related Co-morbidities (http://grants.nih.gov/grants/guide/pa-files/PA-07-073.html). Any molecular genetic component included in applications under this Genetic Epidemiology Program Announcement needs to be fully developed, with appropriate hypotheses and gene-identifying techniques. Further guidance, announcements and resources regarding NIDAs program on the molecular genetics of drug abuse can be found at http://www.drugabuse.gov/Genetics/GeneticsHome.html.
Areas of interest
The following points represent areas and issues of interest to NIDA and NIAAA; applicants are not limited to these ideas:
Special Considerations
HIV/AIDS Counseling and Testing Policy for the National Institute on Drug Abuse: In light of recent significant advances in rapid testing for HIV and in effective treatments for HIV, NIDA has revised its 2001 policy on HIV counseling and testing. NIDA-funded researchers are strongly encouraged to provide and/or refer research subjects to HIV risk reduction education and education about the benefits of HIV treatment, counseling and testing, referral to treatment, and other appropriate interventions to prevent acquisition and transmission of HIV. This policy applies to all NIDA funded research conducted domestically or internationally. For more information see http://grants.nih.gov/grants/guide/notice-files/NOT-DA-07-013.html.
National Advisory Council on Drug Abuse Recommended Guidelines for the Administration of Drugs to Human Subjects: The National Advisory Council on Drug Abuse (NACDA) recognizes the importance of research involving the administration of drugs with abuse potential, and dependence or addiction liability, to human subjects. 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 Web site at http://www.nida.nih.gov/about/organization/nacda/CouncilStatement.html.
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 Announcement (FOA) will use the NIH Small Research Grant (R03) award mechanism. The applicant will be solely responsible for planning, directing, and executing the proposed project.
This FOA uses Just-in-Time information concepts. It also uses the modular as well as the non-modular budget formats (see the Modular Applications and Awards section of the NIH Grants Policy Statement. All applications submitted in response to this FOA must use the modular budget format. Specifically, if you are submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs), use the PHS398 Modular Budget component provided in the SF424 (R&R) Application Package and SF424 (R&R) Application Guide (see specifically Section 3.4, Modular Budget Component, of the Application Guide).
All foreign applicants must complete and submit budget requests using the Research & Related Budget component found in the application package for this FOA. See NOT-OD-06-096, August 23, 2006.
Competing renewal (formerly competing continuation) applications will not be accepted for the R03 grant mechanism. Small grant support may not be used for thesis or dissertation research. Applicants may submit a resubmission, but such applications must include an Introduction addressing issues raised in the previous critique (Summary Statement).
For specific information about the R03 programs, see: http://grants.nih.gov/grants/funding/r03.htm.
2. Funds Available
Because the nature and scope of the proposed
research will vary from application to application, it is anticipated that the
size and duration of each award will also vary. Although the financial plans of
the NIH Institutes and Centers (ICs) provide support for this program, awards
pursuant to this funding opportunity are contingent upon the availability of
funds and the receipt of a sufficient number of meritorious applications.
A project period of up to two years and a budget for direct costs of up to two $25,000 modules, or $50,000 per year, may be requested (i.e., a maximum of $100,000 over two years in four modules of $25,000 each). Commensurate Facilities and Administrative (F&A) costs are allowed.
F&A costs requested by consortium participants are not included in
the direct cost limitation. See NOT-OD-05-004, November 2, 2004.
Section III. Eligibility Information
1.
Eligible Applicants
1.A.
Eligible Institutions
You may submit an application(s) if your organization
has any of the following characteristics:
1.B. Eligible Individuals
Any individual with the skills, knowledge, and
resources necessary to carry out the proposed research as the Project
Director/Principal Investigator (PD/PI) is invited to work with his/her
institution to develop an application for support. Individuals from
underrepresented racial and ethnic groups as well as individuals with
disabilities are always encouraged to apply for NIH support.
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. 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 an
Application Package and SF424 (R&R) Application Guide for completing the
SF424 (R&R) forms for this FOA, link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.
A one-time registration is required for institutions/organizations at both:
PDs/PIs should work with their institutions/organizations to make sure they are registered in the NIH eRA Commons.
Several additional separate actions are required before an applicant institution/organization can submit an electronic application, as follows:
1) Organizational/Institutional Registration in Grants.gov/Get Started
Grants.gov
Customer Support
Contact Center Phone: 800-518-4726
Business Hours: M-F 7:00 a.m. - 9:00 p.m. Eastern Time
Email [email protected]
2) Organizational/Institutional Registration in the eRA Commons
eRA
Commons Help Desk
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Business hours M-F 7:00 a.m. 8:00 p.m. Eastern Time
Email [email protected]
3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.
This registration/affiliation must be done by the AOR/SO or their designee who is already registered in the Commons.
Both the PD/PI 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 institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.
1. Request Application Information
Applicants must download the SF424 (R&R) application forms and SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.
Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the Attachment files may be useable for more than one FOA.
For further assistance contact GrantsInfo, Telephone 301-710-0267, Email: [email protected].
Telecommunications for the hearing impaired: TTY 301-451-5936.
2.
Content and Form of Application Submission
Prepare all applications using the SF424
(R&R) application forms and in accordance with the SF424 (R&R)
Application Guide.
The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by NIH (e.g., the Credential log-in field of the Research & Related Senior/Key Person Profile component must contain the PD/PIs assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
The SF424 (R&R) application is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY will include all applicable components, required and optional. A completed application in response to this FOA will include the following components:
Required
Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site
Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
PHS398 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 13 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, 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 3.4 of the Application Guide for further instruction regarding the use of the PHS398 Modular Budget component.
3. Submission Dates and Times
See Section IV.3.A. for
details.
3.A.
Submission, Review, and Anticipated Start Dates
Opening Date: July 25, 2007 (Earliest date an application may be
submitted to Grants.gov)
Letters
of Intent Receipt Date(s): Not
applicable.
Application
Submission/Receipt Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Submission/Receipt Date(s): Standard
dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS
Peer Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review Date(s): Standard dates apply, please
see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
3.A.1.
Letter of Intent
A letter of intent is not required for the funding
opportunity.
3.B.
Submitting an Application Electronically to the NIH
To submit an application in response to this FOA, applicants should
access this FOA via http://www.grants.gov/Apply and follow steps 1-4. Note: Applications must only be submitted
electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED.
3.C. Application Processing
Applications may be submitted on or after the opening date and must be successfully
received by Grants.gov no later than 5:00 p.m. local
time(of the applicant
institution/organization) on the application due date(s). (See Section
IV.3.A. for
all dates.) If
an application is not submitted by the due date(s) and time, the application
may be delayed in the review process or not reviewed. All applications must meet the following criteria to be considered on-time:
Please visit http://era.nih.gov/electronicReceipt/app_help.htm for detailed information on what to do if Grants.gov or eRA system issues threaten your ability to submit on time.
Submission to Grants.gov is not the last step - applicants must follow their application through to the eRA Commons to check for errors and warnings and view their assembled application!
3.C.2 Two Day Window to Correct eRA Identified Errors/Warnings
IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123.
Once an application package has been successfully submitted through Grants.gov NIH provides applicants a two day error correction window to correct any eRA identified errors or warnings before a final assembled application is created in the eRA Commons. The standard error correction window is two (2) business days, beginning the day after the submission deadline and excluding weekends and standard federal holidays. All errors must be corrected to successfully complete the submission process. Warnings will not prevent the application from completing the submission process.
Note that the following caveats apply:
3.C.3 Viewing an Application in the eRA Commons
Once any eRA identified 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 weekdays (Monday Friday, excluding Federal holidays) to view the assembled application before it automatically moves forward to NIH for further processing.
Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on their application status in the Commons.
The NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of an application already reviewed with substantial changes, but such application must include an Introduction addressing the previous critique. Note that such an application is considered a "resubmission" for the SF424 (R&R).
4. Intergovernmental Review
This initiative is not subject to intergovernmental
review.
5. Funding Restrictions
All NIH awards are subject to the terms and
conditions, cost principles, and other considerations described in the NIH Grants
Policy Statement.
Pre-award costs are allowable. A grantee may, at its
own risk and without NIH prior approval, incur obligations and expenditures to
cover costs up to 90 days before the beginning date of the initial budget
period of a new award if such costs: are necessary to conduct the project and would
be allowable under the grant, if awarded, without NIH prior approval. If
specific expenditures would otherwise require prior approval, the grantee must
obtain NIH approval before incurring the cost. NIH prior approval is required
for any costs to be incurred more than 90 days before the beginning date of the
initial budget period of a new award.
The incurrence of pre-award costs in anticipation of a
competing or non-competing award imposes no obligation on NIH either to make
the award or to increase the amount of the approved budget if an award is made
for less than the amount anticipated and is inadequate to cover the pre-award
costs incurred. NIH expects the grantee to be fully aware that pre-award costs
result in borrowing against future support and that such borrowing must not
impair the grantee's ability to accomplish the project objectives in the
approved time frame or in any way adversely affect the conduct of the project.
See the NIH
Grants Policy Statement.
6.
Other Submission Requirements
PD/PI Credential (e.g., Agency Login)
The NIH requires the PD/PI to fill in his/her Commons User ID in the PROFILE Project Director/Principal Investigator section, Credential log-in field of the Research & Related Senior/Key Person Profile component. The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see Registration FAQs Important Tips -- Electronic Submission of Grant Applications.
Organizational DUNS
The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
Renewal (formerly competing continuation or Type 2) applications are not permitted.
All application instructions outlined in the SF424 (R&R) Application Guide are to be followed, with the following requirements for R03 applications:
APPENDIX MATERIALS
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. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-018.html
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. An application that does not observe the required page limitations may be delayed in the review process.
Warning: Please be sure that you observe the direct cost, project period, and page number limitations specified above for this FOA. Application processing may be delayed or the application may be rejected if it does not comply with these requirements.
Note: While each section of the Research Plan 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.
Foreign Applications (Non-domestic (non-U.S.) Entity)
Plan
for Sharing Research Data
Not Applicable.
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 (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).
Only the review criteria described below will be
considered in the review process.
2.
Review and Selection Process
Applications submitted for this funding opportunity
will be assigned to the ICs on the basis of established Public Health Service (PHS)
referral guidelines.
Appropriate scientific review groups convened in
accordance with the standard NIH peer review procedures (http://cms.csr.nih.gov/ResourcesforApplicants/)
will evaluate applications for scientific and technical merit.
As part of the initial merit review, all applications
will:
Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:
The NIH R03 small grant is a mechanism for supporting discrete, well-defined projects that realistically can be completed in two years and that require limited levels of funding. Because the Research Strategy component is restricted to 6 pages, a small grant application will not have the same level of detail or extensive discussion found in an R01 application. Accordingly, reviewers should evaluate the conceptual framework and general approach to the problem, placing less emphasis on methodological details and certain indicators traditionally used in evaluating the scientific merit of R01 applications, including supportive preliminary data. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or from investigator-generated data. Preliminary data are not required, particularly in applications proposing pilot or feasibility studies.
The goals of NIH-supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written comments, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of these criteria in assigning the application's overall score, weighting them as appropriate for each application.
Note
that an application does not need to be strong in all categories to be judged
likely to have major scientific impact and thus deserve a high impact/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.
Overall Impact. Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five core review criteria, and additional review criteria (as applicable for the project proposed).
Core Review Criteria. Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Significance: Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Investigator(s): 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)?
Innovation: Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
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.
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?
Additional Review Criteria
As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.
Protections for Human Subjects. For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.
Inclusion of Women, Minorities, and Children. When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.
Vertebrate Animals. The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia.
Resubmission Applications. When reviewing a Resubmission application (formerly called an amended application), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
Renewal Applications. When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period.
Revision Applications. When reviewing a Revision application (formerly called a competing supplement application), the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.
Biohazards. Reviewers will assess
whether materials or procedures proposed are potentially hazardous to research
personnel and/or the environment, and if needed, determine whether adequate
protection is proposed.
2.B.
Additional Review Considerations
As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact/priority score.
Budget and Period Support. Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Select Agents Research. Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Applications from Foreign Organizations. Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.
Resource Sharing Plans.
Reviewers will comment on whether the following Resource Sharing Plans, or the
rationale for not sharing the following types of resources, are reasonable: 1)
Data Sharing Plan (http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm);
2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html);
and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).
2.C. Sharing Research Data
Not Applicable.
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 will be
considered by Program staff of the funding organization when making
recommendations about funding applications. Program staff may negotiate
modifications of the data and resource sharing plans with the awardee before
recommending funding of an application. The final version of the data and resource
sharing plans negotiated by both will become a condition of the award of the
grant. The effectiveness of the resource sharing will be evaluated as part of
the administrative review of each Non-Competing Grant
Progress Report (PHS 2590). See Section VI.3., Reporting.
Model Organism Sharing Plan: Reviewers are asked to assess the sharing plan in an administrative note. The sharing plan itself should be discussed after the application is scored. Whether a sharing plan is reasonable can be determined by the reviewers on a case-by-case basis, taking into consideration the organism, the timeline, the applicant's decision to distribute the resource or deposit it in a repository, and other relevant considerations. For the R03 mechanism, the presence or adequacy of a plan should not enter into the scoring of the application.
3. Anticipated Announcement and Award Dates
Not
Applicable.
Section VI. Award Administration Information
1. Award Notices
After the peer review of the application is completed,
the PD/PI will be able to access his/her Summary Statement (written critique)
via the NIH eRA Commons.
If the application is under consideration for funding, NIH will request
"just-in-time" information from the applicant. For details,
applicants may refer to the NIH
Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards,
Subpart A: General.
A formal notification in the form of a Notice
of Award (NoA) will be provided to the applicant organization. The NoA
signed by the grants management officer is the authorizing document. Once all
administrative and programmatic issues have been resolved, the NoA will be
generated via email notification from the awarding component to the grantee
business official.
Selection of an application for award is not an
authorization to begin performance. Any costs incurred before receipt of the
NoA are at the recipient's risk. These costs may be reimbursed only to the
extent considered allowable pre-award costs. See Section IV.5.,
Funding Restrictions.
2. Administrative and National Policy Requirements
All NIH grant and cooperative agreement awards include
the NIH Grants Policy Statement as part of the NoA. For these terms of award,
see the NIH
Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards,
Subpart A: General and Part
II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions
for Specific Types of Grants, Grantees, and Activities.
3. Reporting
When multiple years are involved, awardees will be required to submit the Non-Competing Grant
Progress Report (PHS 2590) annually and financial statements as required in
the NIH
Grants Policy Statement.
We encourage your inquiries concerning this
funding opportunity and welcome the opportunity to answer questions from
potential applicants. Inquiries may fall into three areas: scientific/research,
peer review, and financial or grants management issues:
1.
Scientific/Research Contacts:
For genetic epidemiologic studies
of any substances other than those focused on
alcohol:
Naimah Weinberg, M.D.
Division
of Epidemiology, Services, and Prevention Research
National
Institute on Drug Abuse
6001
Executive Boulevard, Room 5185
Bethesda, MD 20892-9589
Telephone:
(301) 402-1908
Fax: (301) 443-2636
Email: [email protected]
For alcohol-related genetic epidemiology research:
Marcia
S. Scott, Ph.D.
Division
of Epidemiology and Prevention Research
National
Institute on Alcohol Abuse and Alcoholism
5635
Fishers Lane
Room
2085 MSC 9304
Bethesda, MD 20892-9304
Tel:
(301) 402-6328
Fax:
(301) 443-8614
Email: [email protected]
2. Peer Review Contacts:
Not applicable.
3. Financial or Grants
Management Contacts:
Maryellen M. Connell
Grants Management Specialist
National Institute on Drug
Abuse
National Institutes of
Health
6101 Executive Blvd
Suite 270, MSC
8403
Bethesda, MD 20892-8403
Phone: (301) 435-1354
FAX: (301) 594-6849
Section VIII. Other Information
Required Federal Citations
Vertebrate Animals:
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 impact/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, Minorities, and Children:
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-09-116.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.
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) must be used for publicly accessible on-line journal
articles. Unless otherwise specified in this solicitation, Internet
addresses (URLs) should not be used to provide any other information necessary for the review because reviewers are under no obligation
to view the Internet sites. Furthermore, we caution reviewers that their
anonymity may be compromised when they directly access an Internet site.
Healthy
People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion
and disease prevention objectives of "Healthy People 2010," a PHS-led
national activity for setting priority areas. This FOA is related to one or
more of the priority areas. Potential applicants may obtain a copy of
"Healthy People 2010" at http://www.health.gov/healthypeople.
Authority and Regulations:
This program is described in the Catalog
of Federal Domestic Assistance 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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