and Human Services (HHS)
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)
National Institute on Alcoholism and Alcohol
Abuse (NIAAA) (http://www.niaaa.nih.gov)
Title: Behavioral & Integrative Treatment Development Program (R34)
Announcement
Type
This is a new
companion FOA to the reissue of PA-06-486 and PA-06-488.
Program Announcement (PA) Number:
PA-10-013
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 (4) weeks prior to the grant submission date. See Section IV.
Catalog of Federal Domestic Assistance Number(s)
93.279, 93.272
Key Dates
Release/Posted
Date: October 14, 2009
Opening Date: January 16, 2010 (Earliest date an application may be
submitted to Grants.gov)
Letters
of Intent Receipt Date(s): Not required
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 Due Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Due Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS.
Peer Review
Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review
Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest
Anticipated Start Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Additional
Information To Be Available Date (URL Activation Date): Not Applicable
Expiration Date: January 8, 2013
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. Resource Sharing Plan(s)
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
Contacts
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
The National Institute on Drug Abuse (NIDA) and the National Institute on Alcohol Abuse and Alcoholism (NIAAA) are seeking research grant applications on the development and testing of behavioral and integrative treatments for drug and alcohol abuse and dependence. This Funding Opportunity Announcement (FOA) reaffirms NIDA's and NIAAA's continued commitment to major programs of research on behavioral and integrative treatments. The term "behavioral treatments" is used here in a broad sense and includes but is not limited to psychotherapies, cognitive, relapse prevention, remediative, rehabilitative, skills training, counseling, family, and exercise therapies and includes screening, brief, computerized, adherence, therapist training and HIV prevention interventions. Integrative refers to combinations with other treatments, including medications or complementary and alternative treatments. Mechanisms of behavior change, and the use and/or development of valid and reliable assessment tools, is relevant to all three Stages of treatment research supported under this initiative:
Stage I involves research on the development, manualization, refinement, improvement, adaptation, and pilot testing of behavioral and integrative treatment, HIV prevention, and therapist training interventions. Stage I may include translational studies involving research from other disciplines (e.g. basic science or neuroscience) conducted or utilized to gain information about mechanisms of behavior change and ultimately to develop new or improved interventions. Stage I may also include community-friendly research to adapt interventions that retain or increase their potency when modified for use in real-world settings.
Stage II includes larger-scale clinical trials or dose-response studies of piloted interventions that show promise. Of particular interest are studies that examine mechanisms of behavior change within the context of treatment research..
Stage III encompasses research aimed at ensuring that evidence-based interventions retain their effects in community settings (e.g., ERs, primary care, criminal justice settings, etc.). Stage III includes studies that examine whether interventions retain their efficacy when administered by community therapists.. Stage III may also include studies that test training methods for community providers to administer evidence-based interventions. (The initial development of these methods, although crucial to Stage III, is considered to be Stage I research).
Significance
Behavioral treatments play a critical role in most evidence-based drug abuse treatments, and often constitute the entire treatment. This funding opportunity announcement (FOA) is intended to promote Stage I treatment and intervention development research. This FOA (in conjunction with the parallel FOAs using the R01 and R03 mechanisms) will support all of the necessary Stages of behavioral and integrative treatment and intervention research so that better treatments and interventions are developed as advancements in science are made, and so that these treatments and interventions are tailored so that they can be readily transported to the community. Over the past two decades, numerous evidence-based behavioral and integrative treatments for drug abuse and addiction have been created. With recent advances in science, particularly in neuroscience, it is evident that more can be done to incorporate new scientific discoveries into behavioral treatment and intervention development, in order to improve clinical outcome. In addition, as more is known about mechanism of action of treatment, and as new technologies are developed, it is clear that more can be done to make treatments and interventions more easily transportable to community settings. To achieve these goals, the Behavioral Therapies Development Program, renamed the Behavioral and Integrative Treatment Development Program, is continued.
For alcohol abuse and dependence, most of the treatments available in the U.S. also have been behavioral in nature. A large number of clinical trials have demonstrated effectiveness for several types of behavioral therapies, including cognitive behavioral therapy, motivational enhancement therapy, marital family therapy, brief interventions, and the community reinforcement approach. Although progress has been made in a broad range of behavioral interventions to treat alcohol abuse and dependence, many alcoholics do not respond adequately to currently available behavioral therapies. For alcohol abuse and dependence, this FOA supports research to develop new innovative behavioral therapies or modify existing treatments to improve their effectiveness and devise ways to improve the engagement, retention, adherence, and outcome of alcoholism treatment across various populations of alcohol dependent and abuse subjects.
Behavioral and integrative treatment and intervention research has been conceptualized within a Stage Model having three Stages.
Stage I. This is the first Stage of behavioral and integrative treatment (and treatment adherence and HIV prevention intervention) development. Stage I is an iterative process that may involve some or all of the following: (1) identifying promising basic or clinical scientific findings relevant to behavioral and integrative treatments or interventions; (2) translating basic science findings into intervention development research (3) generating/ formulating theories relevant to intervention development; (4) producing, operationally defining, and standardizing new or modified principle-driven treatments and interventions based upon these findings and/or theories; (5) pilot testing the treatment, and testing the theory upon which the intervention is based to understand the mechanisms and principles of behavior change; and (6) if necessary, further refining the treatment.
One goal of a Stage I project is to provide necessary materials and information to proceed to a later phase Stage I, Stage II or Stage III project. An equally important goal is to obtain scientific knowledge of the behavioral, biological and/or social processes that lead to behavior change (i.e., mechanism of behavior change). Early Stage I, or "Stage Ia" can be viewed as the most exploratory part of the treatment or intervention development process, in which the critical intervention development groundwork is laid. During Stage Ia, based on new findings or theories of behavior change, the intervention is conceptualized, operationally defined, standardized and tested for feasibility. The incorporation of basic science findings into new or improved interventions may occur during Stage Ia. "Stage Ib," although still exploratory, can be viewed as the phase of Stage I in which the treatment undergoes pilot testing, typically in the form of a pilot clinical trial. However, type of methodology is not mandated, and quasi-experimental studies or single-case designs may be warranted in some circumstances. In addition to information to help estimate effect sizes on the primary outcome measure, information may be collected from Stage Ib studies on other relevant variables, such as rate of attrition, or other relevant and important outcomes measures.
Although testing of treatments in community settings is generally considered to be a Stage III activity, research to adapt, modify, or refine treatment to be delivered by community treatment providers (development of community-friendly treatment) is a Stage I activity, even when conducted with community treatment providers in real-world settings. Pilot tests of treatments with community treatment providers, and in community settings is also considered to be Stage I. If Stage I research is conducted in this way with promising results there may be immediate progression to Stage III.
Treatment development is incomplete if there are no clinical training materials for community treatment providers to administer the treatment. Research on the development or modification, and pilot-testing of clinical training procedures for treatment providers are considered Stage Ia and Ib activities. Stage I clinical training projects generally examine therapist related outcomes (e.g., acceptability, knowledge, and adherence/competence). Stage III training studies are concerned with both how well community providers learn and perform the treatment and how this changes patient outcomes. Full-scale testing of clinical training procedures is considered to be a Stage III activity.
Stage II. Stage II research consists of testing of promising behavioral and integrative treatments (and adherence and HIV prevention interventions) and examining mechanisms of behavior change. Stage II does not specify a particular research design. Testing of treatments may be done in randomized clinical trials, but also use other methodologies (e.g., adaptive designs, single-case designs, A-B-A designs, etc.). Stage II studies may include examinations of the components of treatments, dose-response, and individual differences in treatment response. Stage II provides unique opportunities to further test the principles and mechanisms underlying behavioral change associated with treatment.
Proceeding to Stage II (or Stage III in the case of a treatment developed in a community treatment setting) presumes that promising pilot data exist. If sufficiently strong evidence of promise does not exist, but if there is a good rationale for additional modification of the treatment, applicants may consider a new Stage I application.
Information obtained from Stage II studies may be used to inform future Stage I studies. For example, if it is shown that a treatment works for some people, but not for others, a Stage II study may lay the groundwork for a Stage I proposal aimed at developing a treatment (or modifying the treatment) for patients who were unresponsive to the initial treatment.
Stage III. Stage III research examines behavioral and integrative treatments (and adherence and HIV prevention interventions) and clinical training procedures in community settings. As is the case in all of the Stages, examination of the mechanism of action of treatments and/or training procedures is considered to be an integral part of Stage III. Stage III research may be used to determine if and how a treatment works when administered by community treatment providers in community settings. Stage III research also may be used to determine if and how a clinical training procedure for a treatment is effective for community treatment providers. In addition, Stage III research may be used to determine how to facilitate the effectiveness, efficiency, or ease of administration of a treatment.
Stage III research does not require a particular research methodology, but could involve randomized clinical trials or adaptive trials of evidence-based treatments and/or clinical training procedures. Applicants are encouraged to utilize research designs that are systematic and facilitate knowledge about principles and mechanisms of behavior change.
Pilot studies comparing the effects of different treatments to one another when delivered by community treatment providers (e.g. comparative effectiveness research or CER) are Stage I research. Fully powered comparative effectiveness studies are Stage III research.
Although research on the development or modification of a treatment for use in a community setting is consistent with Stage III goals, such research is considered to be Stage I. All treatment, intervention, and training development and modification activities are Stage I activities, even when the purpose is creating or modifying treatment, intervention or training method to be community-friendly. As is the case for Stage II, information obtained from Stage III studies may be used to inform future Stage I studies. For example, if it is shown in Stage III that a treatment works for some people, but not for others, a Stage III study may lay the groundwork for a Stage I proposal aimed at developing a treatment (or modifying the treatment) for patients who were unresponsive to the initial treatment.
The objective of this and the accompanying two other announcements is to ensure sufficient emphasis and support for all Stages of behavioral and integrative treatment research, so that scientific knowledge can be incorporated into newer and better behavioral, combined behavioral and pharmacological, integrative and CAM treatments, and so that treatments can be effectively transported from research to the community.
Specific Areas of Research Interest
This FOA encourages Stage I research on behavioral and integrative treatments or any medication/treatment adherence interventions for any substance abusing population or populations with pain. Included is Stage I research on behavioral, combined, or integrated treatment interventions, adherence interventions, and HIV prevention interventions. This may involve creating novel treatment interventions, modifying or adapting existing interventions, and incorporating novel intervention components into existing treatments or interventions. This may also include the development, modification, adaptation or improvement of integrated or sequential treatments for populations with substance use disorder(s) and co-occurring medical and/or psychiatric condition(s). This research may be conducted for any drug of abuse, including illicit drugs, prescription medications, nicotine, alcohol and multiple drugs. Of particular interest are interdisciplinary combined basic and clinical studies that seek to determine, within the context of treatment, adherence, and/or HIV prevention research, determinants of basic mechanisms of behavior change. Therefore, applicants are strongly encouraged to include (and if necessary develop) measures of proposed mediators, moderators, and mechanisms of behavior change relevant to their intervention. This may include, for example, behavioral, cognitive, social, affective, and/or neurobiological measures. It is expected that research conducted via this R34 mechanism will consist of Stage I treatment development research that will provide feasibility, tolerability, and acceptability information and/or pilot data for later phase Stage I or for Stage II or Stage III behavioral and integrative treatment studies.
Also included is research on the development of methods and technologies relevant to treatment, adherence, and HIV prevention within the context of drug abuse treatment.
Specific areas of interest include, but are not limited to:
1) Translational Research:
Translational research that incorporates basic science and/or neuroscience into behavioral and integrative treatment, HIV prevention, and/or adherence intervention development is encouraged.
Examples include, but are not limited to:
Stage I research aimed at identifying possible mechanisms of behavior change for a behavioral treatment under development.
Stage I research that links behavioral constructs (e.g., affect regulation, self-monitoring, craving, impulsivity, etc.) with neurobiological underpinnings and/or brain development to develop new or improved behavioral treatment/interventions, and to understand behavior change mechanisms.
Stage I research that utilizes genetic, neuropsychological, behavioral, or other diagnostic data to tailor treatment to specific subgroups.
Treatment development research utilizing relevant research from the animal model literature (e.g., avoidance and impulsivity paradigms) to develop or improve treatments/interventions.
Stage I treatment development research utilizing relevant research from the social psychology literature (e.g., basic research on stereotyping) to develop or improve treatments/interventions.
2) Technologically-Enhanced Behavioral Treatments and Training Procedures Research:
Stage I research involving the development or adaptation of evidence-based treatment interventions that utilize various technologies in order to increase efficacy and/or increase community-friendliness (i.e., increase treatment accessibility, decrease cost, facilitate ease of administration while maintaining or increasing efficacy) is encouraged.
Examples include, but are not limited to:
Stage I research developing computer-assisted interventions to increase community-friendliness and enhance intervention potency
Stage I studies utilizing web-based technology, virtual reality software or hand-held computers and mobile devices to improve or extend treatments/interventions and training procedures
3) Combined Behavioral and Medication Treatment Research:
The development and evaluation of behavioral treatments that complement and/or potentiate the effects of medications is encouraged.
Examples include, but are not limited to:
Stage I research to develop or adapt interventions that promote adherence to drug and alcohol abuse pharmacotherapy.
Stage I studies to modify stepped care approaches that integrate both behavioral and pharmacological interventions.
4) Setting-Specific and Delivery Mode Treatment Research
The development or modification of evidence-based treatments to make them more community-friendly, for use in varied traditional and non-traditional as well as community settings is encouraged.
Examples include, but are not limited to:
Stage I studies to develop, determine feasibility and pilot test treatment interventions that are delivered in mental health settings, medical and dental settings (primary care, emergency room, dental clinics), criminal and juvenile justice systems, workplace settings, and school systems. Adapting/modifying evidence-based treatments into community-friendly formats (e.g., individual to group, briefer formats, less intensive delivery, computer-assisted delivery, etc.), and examining their resulting potency.
Stage I studies to examine the relative efficacy of various forms of treatment delivery (e.g., episodic vs. continuous/extended care for drug abuse) to determine when intensity of treatment delivery should be increased or decreased.
5) Comorbidity Research:
The development and modification for improvement of treatment interventions for psychiatric and medicals conditions that are co-occurring with substance abuse is encouraged. Comorbid psychiatric and medical illnesses may be related to the onset and/or maintenance of drug abuse and thus may affect treatment. In addition, the neurobiology of comorbid disorders may be related to the neurobiology of the addictive disorder which consequently informs treatment development. Examples include:
Stage I studies developing treatment interventions for individuals with Axis I (e.g., Posttrauamtic Stress Disorder, Major Depression, etc.) and Axis II (e.g., Borderline Personality Disorder) disorders that often co-occur with substance abuse.
Stage I studies to develop sleep hygiene modules for incorporation into drug abuse treatment protocols for drug abusers with insomnia
Stage I research developing and piloting treatment protocols that target substance abuse as well as constructs that cut across various psychiatric disorders (e.g., suicide, affect regulation, expressed emotion, distress tolerance) and mechanisms of treatment.
Stage I studies to develop interventions that promote the prevention of HIV/AIDS, hepatitis, or other infectious diseases (e.g., risk reduction, decreased sexual and other risk behavior) within the context of substance abuse treatment.
6) Treatment Training Procedures Research
Examples include, but are not limited to:
Developing and assessing treatment provider training procedures for evidence-based treatments (e.g., computerizing training procedures). This can include initial training as well as supervision requirements.
7) HIV Prevention
Examples include:
Stage I studies to develop interventions to promote adherence to medical treatment regimens in HIV+ drug users
Stage I research developing or modifying (to improve effect size) HIV prevention interventions for people in methadone maintenance treatment programs.
Research aimed at computerizing, or partially computerizing evidence-based HIV prevention interventions for indivudals in treatment for stimulant addiction
Stage I research adapt or modify to enhance HIV prevention interventions for adolescents in treatment for marijuana dependence
8) Pain Treatment Research
Examples include, but are not limited to:
Stage I research developing interventions to reduce pain in various populations, including drug abusing and non-drug abusing populations and/or individuals with chronic pain
Complementary and alternative medicine treatment: To treat drug abuse, behavioral treatments are sometimes combined with complementary and alternative treatments. Research on complementary and alternative treatments is included under this program announcement, as sole treatments or as adjunctive strategies to enhance the therapeutic potency of existing drug and alcohol abuse treatments. For a detailed description of complementary and alternative treatments for alcohol and drug abuse, see Program Announcement: http://grants.nih.gov/grants/guide/pa-files/PA-07-120.html.
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.
Networking Website for Consultation and Collaboration
NIDA has established a web-based Networking Project (NNP) to encourage investigators to collaborate with other scientists to gain access to specialized expertise, unique research resources, diverse populations, or geographic locations not otherwise available. For applicants interested in identifying potential collaborators, the NNP website is available at http://nnp.drugabuse.gov, as a source of information on the mission, focus, and leadership of NIDAs research networks. The website features an interactive map with more than 300 local network sites, a directory of close to 400 addiction researchers and practitioners, and the extensive resources of 14 NIDA-supported research networks located across the country. If appropriate for the proposed research, NIDA encourages grant applicants to use the resources of the NNP and make reference in the grant application when they are utilized.
See Section VIII, Other
Information - Required Federal Citations, for policies related to this announcement.
Section
II. Award Information
1. Mechanism of
Support
This
FOA will use the
R34
award mechanism. The
Project Director/Principal Investigator (PD/PI) will be solely responsible for
planning, directing, and executing the proposed project.
This FOA uses Just-in-Time information concepts (see SF424 (R&R) Application Guide). It also uses the modular as well as the non-modular budget formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, a U.S. organization submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs) should use the PHS398 Modular Budget component.
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.
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
IC(s) provide support for this program, awards pursuant to this funding
opportunity are contingent upon the availability of funds.
Facilities and Administrative (F&A) costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.
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.
Section III. Eligibility Information
1. Eligible Applicants
1.A.
Eligible Institutions
The following organizations/institutions are eligible
to apply:
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 (i.e., multiple PDs/PIs), may be designated on the application for projects that require a team science approach and therefore clearly do 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 electronic Research Administration (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 grant with a single PD/PI or multiple PDs/PIs grant is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. When considering the multiple PD/PI option, 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 PDs/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
Number of Applications. Applicants may submit more than one application, provided that each application is scientifically distinct.
Resubmissions. Applicants may submit a resubmission application, but such application must include an Introduction. Beginning with applications intended for the January 25, 2009 official submission due date, all original new applications (i.e., never submitted) and competing renewal applications are permitted addressing the previous peer review critique (Summary Statement) only a single amendment (A1). See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-003.html and NOT-OD-09-016. Original new and competing renewal applications that were submitted prior to January 25, 2009 will be permitted two amendments (A1 and A2). For these grandfathered applications, NIH expects that any A2 will be submitted no later than January 7, 2011, and NIH will not accept A2 applications after that date.
Renewals. Renewals are not allowed.
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, use the Apply for
Grant Electronically button in this FOA or link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.
Registration:
Appropriate registrations with Grants.gov and eRA Commons must be completed on or before the due date in order to successfully submit an application. 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 with both Grants.gov and the Commons. All registrations must be complete by the submission deadline for the application to be considered on-time (see 3.C.1 for more information about on-time submission).
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 can submit an electronic application, as follows:
1) Organizational/Institutional Registration in Grants.gov/Get Registered http://www.grants.gov/applicants/get_registered.jsp
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(s)/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.
Note: The registration process is not sequential. Applicants should begin the registration processes for both Grants.gov and eRA Commons as soon as their organization has obtained a DUNS number. Only one DUNS number is required and the same DUNS number must be referenced when completing Grants.gov registration, eRA Commons registration and the SF424 (R&R) forms.
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. Some fields within the SF424 (R&R) application components, 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 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.)
Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s)
Form
Foreign
Organizations (Non-domestic [non-U.S.] Entities)
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 (U.S.) 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 plan approach for the proposed 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, and should include 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 (NoA).
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
See Section IV.3.A. for details.
3.A. Submission, Review, and Anticipated Start Dates
Opening Date: January 16, 2010 (Earliest
date an application may be submitted to Grants.gov)
Letter of Intent Receipt Date(s): Not Applicable
Application Due Date(s): Standard dates apply, please
see http://grants.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Due 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/applicants/apply_for_grants.jsp and follow Steps
1-4. Note: Applications must only be submitted electronically.
PAPER APPLICATIONS WILL NOT BE ACCEPTED.
3.C.1 Submitting On-Time
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.
Please 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.
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 Commonshttps://commons.era.nih.gov/commons/. The submitting AOR/SO
receives the Grants.gov acknowledgments. The AOR/SO 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. However, the NIH will accept a resubmission application, but such application must include an Introduction addressing the critique from the previous review.
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 renewal
award if such costs: 1) are necessary to conduct the project, and 2) 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 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 NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.
6. Other
Submission Requirements
PD/PI Credential (e.g., Agency Login)
The NIH requires the PD(s)/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
The Research Strategy section of the R34 application may not exceed 12 pages, including tables, graphs, figures, diagrams, and charts. See Table of Page Limits
All application instructions outlined in the SF424 (R&R) Application Guide are to be followed, incorporating "Just-in-Time" information concepts,
Appendix Materials
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 comply with the required page limitations may be delayed in the review process.
Resource Sharing Plan(s)NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value and further the advancement of the research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in the Resource Sharing section of the application (see http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm).
(a) Data Sharing Plan: Not Applicable
(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.
(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (e.g., blood pressure or weight) or the presence or absence of a disease or condition. For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (go to NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.)
Foreign Applications (Non-domestic [non-U.S.] Entities)
Indicate how the proposed project has specific relevance to the mission and objectives of the NIH/IC and has the potential for significantly advancing the health sciences in the United States
Section V. Application Review Information
1. Criteria
Only the review criteria described below will be considered in the review process.
2. Review Process
Applications
submitted for this funding opportunity will be assigned on the basis of
established PHS referral guidelines to the ICs for funding consideration.
Applications that are complete will be evaluated for scientific and technical merit by (an) appropriate scientific review group(s) in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/) using the review criteria stated below.
As part of the scientific peer review, all applications will:
The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability. As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
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 PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
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 overall strategy, methodology, and analyses well-reasoned
and appropriate to accomplish the specific aims of the project? Are potential
problems, alternative strategies, and benchmarks for success
presented? If the project is in the early stages of development,
will the strategy establish feasibility and will particularly risky aspects be
managed?
If the project involves clinical research, are the plans for 1) protection of
human subjects from research risks, and 2) inclusion of minorities and members
of both sexes/genders, as well as the inclusion of children, justified in terms
of the scientific goals and research strategy proposed?
Environment. Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
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.
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.
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 (Not Applicable); 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).
Selection Process
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:
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 Continuation Grant Progress Report (PHS
2590)
annually and financial statements as required in the NIH Grants Policy Statement.
A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.
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 (program), peer review, and financial or grants management issues:
1. Scientific/Research Contact(s):
Lisa
Onken, Ph.D.
Chief,
Behavioral and Integrative Treatment Branch
Associate
Director for Treatment
Division
of Clinical Neuroscience and Behavioral Research
National
Institute on Drug Abuse
National
Institutes of Health
6001
Executive Boulevard,
Room 3172 MSC 9593
Bethesda, MD 20892-9593
(301)
443-2235
E-mail: [email protected]
Daniel
E. Falk, Ph.D.
Health
Scientist Administrator
Division
of Treatment and Recovery Research
National
Institute on Alcohol Abuse and Alcoholism
NIH/DHHS
5635
Fishers Lane,
Rm 2040, Rockville, MD 20892-9304
Voice:
301-443-0788
Fax:
301-480-8774
Email:
[email protected]
2. Peer Review Contact(s):
Not applicable
3. Financial/Grants Management Contact(s):
Debra
Dudley
Grants Management Branch
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Blvd., Room 270
Bethesda, MD 20892
Telephone: (301) 443-6710
FAX: (301) 594-6849
E-mail: [email protected]
Section VIII. Other Information
Required Federal Citations
Use of Animals
in Research:
Recipients of PHS support for activities involving
live, vertebrate animals must comply with PHS Policy on Humane Care and Use of
Laboratory Animals (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 (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 institutional review board (IRB) rules, as well as local, State and
Federal laws and regulations, including the Privacy Rule.
Policy for Genome-Wide
Association Studies (GWAS):
NIH is interested in advancing genome-wide association
studies (GWAS) to identify common genetic factors that influence health and
disease through a centralized GWAS data repository. For the purposes of this
policy, a genome-wide association study is defined as any study of genetic
variation across the entire human genome that is designed to identify genetic
associations with observable traits (such as blood pressure or weight), or the
presence or absence of a disease or condition. All applications, regardless of
the amount requested, proposing a genome-wide association study are expected to
provide a plan for submission of GWAS data to the NIH-designated GWAS data
repository, or provide an appropriate explanation why submission to the
repository is not possible. Data repository management (submission and access)
is governed by the Policy for Sharing of Data Obtained in NIH Supported or
Conducted Genome-Wide Association Studies, NIH
Guide NOT-OD-07-088. For additional information,
see http://grants.nih.gov/grants/gwas/
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.
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.
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-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 Requirement:
In accordance with the NIH Public Access Policy, investigators
funded by the NIH must submit or have submitted for them to the
National Library of Medicines PubMed Central (see http://www.pubmedcentral.nih.gov/), an electronic version of their final, peer-reviewed
manuscripts upon acceptance for publication, to be made publicly available no
later than 12 months after the official date of publication. The
NIH Public Access Policy is available at (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html).
For more information, see the Public
Access webpage at http://publicaccess.nih.gov/.
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 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 at http://www.cfda.gov/
and is not subject to the intergovernmental review requirements of Executive
Order 12372. 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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