This notice has expired. Check the NIH Guide for active opportunities and notices.
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 Alcoholism and Alcohol Abuse (NIAAA), (http://www.niaaa.nih.gov)
National Center for Complementary and Alternative Medicine (NCCAM), (http://www.nccam.nih.gov)
Title: Behavioral & Integrative Treatment
Development Program (R03)
Announcement Type This is a reissue of PA-03-126,
which was previously released May 19, 2003.
Update: The following update relating to this announcement has been issued:
October 14, 2009 - This PA has been reissued as (PA-10-011) R03 and (PA-10-013) R34.
June 3, 2009 - See Notice NOT-DA-09-008 Notice to Extend the Expiration Date .
September 17, 2007 - Expiration Date adjusted to accommodate recent changes to standing submission deadlines, per NOT-OD-07-093.
NOTICE: Applications submitted in response to this Funding Opportunity
Announcement (FOA) for Federal assistance must be submitted electronically
through Grants.gov (http://www.grants.gov)
using the SF424 Research and Related (R&R) forms and the SF424 (R&R)
Application Guide.
Applications may not be submitted in paper format.
This FOA must be read in conjunction with the application guidelines included
with this announcement in Grants.gov/Apply
for Grants (hereafter called Grants.gov/Apply).
A registration process is necessary before submission and applicants are
highly encouraged to start the process at least four weeks prior to the grant
submission date. See Section IV.
Program Announcement (PA) Number: PA-06-488
Catalog of Federal Domestic Assistance Number(s) 93.279, 93.213, 93.272
This funding opportunity announcement (FOA) issued
by the National Institute on Drug Abuse invites applications for grant funding
to support behavioral and integrative treatment research that will have
a meaningful impact on improving treatment for drug and alcohol abuse and
dependence.
This FOA will use the NIH Small Research
Grant (R03) award mechanism and runs in parallel with an FOA of identical
scientific scope, PA-06-486,
that solicits applications under the traditional research project grant (R01),
and PA-06-487,
that solicits applications under the exploratory/developmental (R21) mechanism.
The R03 grant mechanism supports different types of projects including pilot
and feasibility studies; secondary analysis of existing data; small, self-contained research projects; development of research methodology;
and development of new research technology.
The R03 is intended to support small research projects that can be carried
out in a short period of time with limited resources. The R03 is not renewable.
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. The total amount awarded and the number of awards will depend
upon the mechanism numbers, quality, duration, and costs of the applications
received.
Budget and Project Period: Budgets for direct costs of up to $50,000 per year and a project duration
of up to two years may be requested for a maximum of $100,000 direct costs
over a two-year project period.
Eligible organizations: For-profit organizations; non-profit organizations; public or private institutions,
such as universities, colleges, hospitals, and laboratories; units of State
and local governments; eligible agencies of the Federal government; domestic or foreign institutions/organizations; faith-based or community-based organizations; Indian/Native American Tribal Government (Federally Recognized); Indian/Native
American Tribal Government (Other than Federally Recognized); and Indian/Native
American Tribally Designated Organization.
Eligible Project Directors/Principal Investigators (PDs/PIs): Individuals with the skills, knowledge, and resources necessary to carry
out the proposed research are invited to work with their institution to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always encouraged
to apply for NIH support.
Applicants may submit more than one application,
provided each application is scientifically distinct.
See Section IV.1 for application
materials. The SF424 (R&R) Application Guide for this FOA is located
at these Web sites:
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
The National Institute on Drug Abuse (NIDA),
the National Institute on Alcohol Abuse and Alcoholism (NIAAA), and the National Center for Complementary and Alternative Medicine (NCCAM) are seeking
research grant applications on the development and testing of behavioral and
integrative treatments for drug and alcohol abuse and dependence. This Funding
OpportunityAnnouncement
(FOA) reaffirms NIDA's, NIAAA's, and NCCAM’s continued and
ongoing commitment to major programs of research on behavioral and integrative
treatments. The term "behavioral treatments" is used here in a broad
sense and includes various forms of psychotherapy, behavior therapy, cognitive
therapy, family therapy, couples and marital therapy, group therapy, skills
training, meditation, yoga, tai chi (taiji), guided imagery, counseling, and
rehabilitative therapies. The term, Integrative treatments refers to treatments
that combine behavioral interventions with other treatments, including other
behavioral therapies, medications, and/or complementary/alternative therapies.
Behavioral and integrative treatment research has been conceptualized, for
the purpose of this initiative, to consist of three stages. Stage I, or early
treatment development, involves research on the development, refinement, and
pilot testing of behavioral and integrative interventions. Stage I may include
translational research that incorporates concepts, methods or findings from
other disciplines (e.g., neuroscience, cognitive science, etc.) into the development
of behavioral and integrative treatments. Stage I may also include research
to develop or adapt treatments to become more community-friendly. Stage
II includes testing treatments that show promise and testing the dose-response
of treatments. Stage III is research aimed at determining if and how efficacious
behavioral treatments may be transported to community settings. Stage III
may include studies that test treatments in community settings, with community
therapists. Stage III may also include studies that develop or test methods
of training treatment providers to administer treatments. Determination of
mechanism of action of treatment is relevant to all three stages. This FOA replaces
in its entirety PA-03-126, published in the NIH Guide, May 19, 2003 at http://grants.nih.gov/grants/guide/pa-files/PA-03-126.html.
Applicants interested in the organization,
management, and economics of drug abuse treatment services, and the effects
of these factors on the quality, cost, access to, effectiveness, and outcomes
of care for drug abuse and addictive disorders are referred to the program
announcement "Drug Abuse Health Services Research" http://grants.nih.gov/grants/guide/pa-files/PA-05-139.html.
NIMH also encourages research examining innovative
approaches to behavioral and integrative treatment aimed at combining and
sequencing Mental Health treatment (to individualize and and optimize care).
NIMH supports pilot interventions research via the R34 mechanism (http://grants2.nih.gov/grants/guide/pa-files/PAR-06-248.html). This NIMH
announcement encourages research in what is described in this announcement
as Stage Ia and Ib (but uses different designations of these Stages).
RESEARCH OBJECTIVES
Background and Rationale
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 all of the necessary stages of behavioral and integrative
treatment research so that better treatments are developed as advancements
in science are made, and so that evidence-based treatments may 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 development, in order to improve treatment effects.
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 more easily transportable to community settings. To achieve these
goals, NIDA, in partnership with NIAAA and NCCAM, is continuing the Behavioral
Therapies Development Program with the release of this announcement, renamed
the Behavioral and Integrative Treatment Development Program.
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 conducted over the past 15 years 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 research
has been conceptualized within a Stage Model having three stages.
Stage I. Stage I, early treatment development,
is viewed as an iterative process involving: (1) identifying promising basic
or clinical concepts, methods or findings relevant to treatment; (2) generating
and formulating new behavioral and integrative treatments or modifying existing
treatments; (3) operationally defining and standardizing principles and techniques
of the treatments; and (4) pilot testing and, if necessary, refining the treatments.
Stage I also involves testing the theory upon which a treatment is based to
understand the mechanisms and principles of behavior change.
Although one goal of a Stage I project is to
proceed to Stage II, another goal is to obtain scientific knowledge of behavioral
processes that lead to behavior change. Early Stage I, or "Stage Ia"
can be viewed as the most exploratory part of the treatment development process,
in which theories of behavior change are tested, and the critical therapy
development groundwork is laid. Late Stage I or "Stage Ib," although
still exploratory, can be viewed as the phase of Stage I in which theory-relevant
data continues to be obtained, and the treatment undergoes pilot testing (type
of methodology is not mandated) to determine whether or not a Stage II (or
Stage III) study is warranted.
When evidence-based treatments need to be adapted
to be delivered by community treatment providers, that adaptation is considered
to be early treatment development, a Stage I activity. Such Stage I research
may be conducted with research therapists or community treatment providers.
If Stage I research is conducted in this way, there may be immediate progression
to Stage III.
Research on the development or modification,
and pilot-testing of training procedures for treatment providers is considered
a Stage I activity. After pilot testing, research on the full-scale testing
of these procedures is considered to be a Stage III activity.
Stage II. Stage II research consists of testing
of promising treatments. Stage II does not specify a particular research design.
Testing treatments may refer to randomized clinical trials, but also may refer
to other methodologies (e.g., 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 presumes that promising
pilot data exist. If evidence of promise does not exist, or such evidence
is not strong enough to warrant progression to Stage II, applicants are encouraged
to reconsider a Stage II submission.
If results are robust, Stage II studies may
progress to Stage III. However, information obtained from Stage II studies
may also 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) so that it works on the patients who were unresponsive
to the initial treatment
Stage III. The ultimate goal of treatment development
is to produce treatments that work, and continue to work when used in the
community. Stage III research is aimed at obtaining knowledge and methods
to ensure that an evidence-based treatment will retain its potency when delivered
by community treatment providers. One question relevant to Stage III research
is, Does this treatment work when administered by community treatment providers?
Another question relevant to Stage III research is, How can this treatment
be made to work when administered by community treatment providers? Stage
III research does not require a particular research methodology, and may involve
randomized clinical trials (of evidence-based treatments or of clinical training
procedures), or a variety of other methodologies. Examination of the mechanism
of action of treatments and/or training procedures is considered to be an
integral part of Stage III.
Research on the development or modification
of a treatment for use in a community setting is considered to be Stage I
research, as is research on the development or modification of a training
procedure for treatment providers.
As is the case for Stage II, information obtained
from Stage III studies may also 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) so that
it works on the patients who were unresponsive to the initial treatment.
It is NIDA's, NIAAA's, and NCCAM’s objective
to ensure sufficient emphasis and support for all stages of behavioral and
integrative treatment research, so that scientific knowledge can readily be
incorporated into newer and better behavioral and CAM interventions and treatments,
and so that treatments can be effectively transported from research to the
community. This FOA is intended
to promote this objective by encouraging research grant applications in any
one of the three Stages of behavioral or integrative treatment research.
AREAS OF INTEREST
This announcement solicits research targeting
Stage I, II, and III behavioral and integrative treatment of any drug- or
alcohol-abusing population, including but not limited to women, minorities,
families, couples, specific cultural groups, adolescents, the elderly, and
persons with disabilities, such as the deaf. This includes research targeting
the behavioral and integrative treatment of any drug of abuse, including marijuana,
methamphetamine, MDMA and other club drugs, prescription drugs, inhalants,
sedative-hypnotics, hallucinogens, appetite suppressants and other supplements,
heroin, cocaine, nicotine, and alcohol.
It should be noted that if a subject is identified
as being at risk for HIV acquisition and/or transmission, HIV testing and
counseling should be offered to the subject in accordance with current guidelines.
Wherever possible and appropriate, investigators are encouraged to collect
data on the effect of treatment on AIDS risk behaviors, including data on
the route of drug administration and sexual behaviors that may place individuals
at risk for HIV transmission. Also, as appropriate, investigators should offer
risk-reduction counseling and collect data on the effect of treatment on the
acquisition/transmission of HIV/AIDS and other infectious diseases, such as
Hepatitis C, associated with drug use.
Applicants are encouraged to include, and if
necessary develop, measures of mediators of behavior change and mechanism
of action of behavioral and integrative treatment in all three Stages. This
may include research on the neurobiological, behavioral, cognitive, social,
affective, etc. mechanism of action, and may involve any number of methodologies.
If focus on mechanisms of action is not appropriate for a particular application,
applicants are encouraged to address and justify why this will not be done.
Specific areas of interest include, but are
not limited to:
Translational Research:
Major advances have been made in understanding
how drugs of abuse alter various brain processes and systems, both structurally
and functionally. Further advances in understanding the neurobiology of drug
abuse, neurobiological and genetic predictors of response to behavioral treatment,
and the neurobiology of the effects of behavioral treatment are imminent.
Translational research linking neuroscience and/or genetics to behavioral
treatment development is encouraged. Examples include, but are
not limited to:
Stage I studies developing or improving behavioral
treatments and/or HIV risk reduction interventions by incorporating findings,
methods, or principles from basic, clinical, cognitive, affective or social
neuroscience (e.g., exercises to improve brain function).
Stage I, II, or III translational research
to develop and test components to boost treatment effects (e.g., sleep hygiene
modules).
Stage I, II, or III research linking behavioral
constructs (e.g., affect regulation, attention, learning, memory, self-monitoring,
craving, delay discounting, impulsivity, etc.) associated with drug abuse
with their neurobiological underpinnings and behavioral treatment development.
Stage I, II, or III research identifying neurobiological
or genetic predictors of behavioral treatment response and/or developing methods
for assessing these predictors.
Community-friendly treatment: For treatments
to be used in community settings, they must not only work, but also must be
workable in those settings. For instance, one setting may necessitate group
treatment (e.g., community mental health settings with limited resources),
but another setting may call for an individual-based, brief screening and
treatment (e.g., in a primary care or dental office). The complexity and/or
intensity of the treatment, training or additional staff requirements, fit
with existing treatment programs, and of course cost can all be factors determining
whether a treatment is community friendly.
Where appropriate and potentially feasible,
Stage I research is needed to modify evidence-based treatments into community-friendly
formats (e.g., individual to group, briefer formats, computer-assisted delivery,
etc.), and to test these community-friendly treatments to determine if potency
is diminished, retained, or improved. In addition, promising existing treatments,
already being utilized in the community, may be the basis for a Stage I proposal,
and such treatments may be operationally defined, modified, pilot tested (in
Stage I), and ultimately tested in Stage III (possibly but not necessarily
by-passing Stage II).
Understanding how and why a treatment works
and for whom a treatment works may be critical to paring it down to its most
essential elements, ultimately making it not only more streamlined and less
costly, but also easier to administer and more principle-driven. Therefore,
most community-friendly behavioral treatment research is inextricably linked
to understanding mechanism of action. Behavioral and integrative treatment
research, particularly in Stage I and Stage III, is encouraged that is aimed
at determining mechanism of action while developing or adapting treatments
to be community-friendly, including, but are not limited
to, the following:
Group therapy Evidence-based individual treatments sometimes
cannot be readily incorporated into community treatment programs. Where
appropriate and potentially feasible, research is needed to modify evidence-based
individual treatments into group formats, and to test these group treatments
to determine if potency is diminished, retained, or improved. In addition,
promising existing community-based group treatments may form the basis for
a Stage I proposal, and such treatments may be operationally defined, modified,
pilot tested, and ultimately tested. Research aimed at understanding the
mechanism(s) of action of group treatment, e.g., research that links group
treatment development to social neuroscience, basic social science, clinical
science, etc., is particularly encouraged.
Setting-specific treatment: Research is sought for behavioral
and integrative treatments for use in medical and dental settings, mental
health settings, the criminal and juvenile justice systems, the welfare system,
workplace settings, school settings, faith-based settings, etc.
Technology-assisted treatment and training: Research is
sought at all three Stages on treatments, treatment add-ons or components,
and therapist training modules, administered or assisted by technological
devices and software applications such as computers, virtual reality software,
the Internet, expert systems models, telephone, pagers, or hand-held computers.
More brief, less complex, and/or less intensive treatment.
Research that attempts to gain and use knowledge about how and why a treatment
exerts its effects, to make that treatment briefer, less complex and/or less
intensive while retaining its effectiveness-is encouraged.
Extended behavioral and integrative treatment. It is understood
that drug addiction is a chronic, relapsing disorder, and that treatment and
continuing care may be required over an extended period of time. Research
is needed to determine when continued treatment is necessary, how to administer
extended behavioral and integrative treatments in the most community-friendly
ways.
Therapist training research. Research on how to best train
treatment providers to administer specific interventions is sought.
Combined behavioral and
medication treatment research: Stage I - III studies are solicited in areas such as:
Behavioral treatment to complement and/or potentiate the
effects of medications. Therapies to be utilized in conjunction with medications,
to optimize the efficacy of drug/alcohol addiction treatment.
Behavioral treatment integrated with medications for drug
abusers with comorbid disorders.
Optimal combinations and sequencing of behavioral and
pharmacological treatments.
Adherence to drug and alcohol abuse treatment medications.
Adherence to HIV and other infectious disease
treatment: Stage I, II, and III studies on adherence to treatment regimens
for drug abusers with infectious disease, such as HIV, Hepatitis C, etc. are
needed. This includes research on drug abusers with comorbid psychiatric disorders.
HIV prevention in drug abuse treatment: Many
types of drug abuse are associated with increased HIV risk. Although drug
abuse treatment in and of itself may reduce HIV risk, behavioral interventions
to specifically reduce HIV risk may decrease risk further. Examples of research
are supported under this PA include, but are
not limited to:
Stage I projects to develop and pilot test HIV risk reduction
modules to be used in conjunction with evidence-based behavioral and integrative
treatments, and Stage II or Stage III projects on these modules.
Research aimed at decreasing sexual risk behavior in drug
abuse treatment populations.
Research aimed at decreasing HIV risk behavior in HIV+
drug abuse treatment populations.
Behavioral and brain development:
As the brain develops, different treatment approaches may be necessary.
Understanding the developing brain and the mechanism of action of behavioral
treatments in the developing brain is critical to producing the best treatment.
Behavioral and integrative treatment research is needed in, but are
not limited to the following areas:
Stage I projects linking brain development to behavioral
and integrative treatment research
Stage I research linking adolescent social behavior, family
process, social neuroscience, and behavioral treatment approaches
Stage II and III projects testing the efficacy/effectiveness
of promising treatments for adolescents alone or in combination with pharmacotherapies.
Comorbidity: Substance abusers often have psychiatric
and medical problems. These problems may be related to the onset and/or maintenance
of drug abuse, and may affect treatment. In addition, the neurobiology of
comorbid disorders may be related to the neurobiology of the addictive disorder,
and may help inform treatment development. Examples of Stage I, II and III
comorbidity-related behavioral and integrative research areas included in
this FOA are:
Borderline personality disorder, suicide, affect regulation,
neurobiology, and treatment mechanisms.
Anxiety disorders, distress tolerance, and mechanisms
of treatment.
Translational research linking behavioral and integrative
treatment development to serious mental illness, drug abuse, family and group
dynamics (e.g., expressed emotion) and neurobiology.
Obesity (or other eating disorders) and behavioral treatment
development and mechanisms.
Behavioral and integrative treatment of substance abusing
patients with HIV/AIDS, hepatitis, or other infectious diseases.
Therapies to manage precipitants of relapse:
Relapse to drinking or drug use is common after treatment. Patients have identified
multiple precipitants of relapse including negative affect, stress, insomnia,
anger, depression, anxiety, and social and environmental cues associated with
prior drinking or substance use experiences. Behavioral and integrative treatments
to enable patients to manage these precipitants without resorting to drinking
or drug use are needed. Research on the long term maintenance of behavior
change is encouraged.
Treatment engagement and retention: Stage I,
II and III research is needed on behavioral interventions to enhance motivation,
and to facilitate treatment engagement and retention, including outreach and
engagement approaches in community and specialty clinic settings. For example,
engagement and retention strategies may be informed by advances in neuroscience
relating brain systems associated with trust, cooperation, empathy, and other
social behaviors.
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-05-097.html.
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 concepts. It also uses the 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 5.4, Modular
Budget Component, of the Application Guide).
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. Up to two resubmissions (formerly
revisions/amendments") of a previously reviewed small grant application
may be submitted. See NOT-OD-05-046,
April 29, 2005.
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.
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:
For-profit organizations
Non-profit organizations
Public or private institutions, such as universities, colleges, hospitals,
and laboratories
Units of State government
Units of local government
Eligible agencies of the Federal government
Domestic institutions/organizations
Foreign institutions/organizations
Faith-based or community-based organizations
Indian/Native American Tribal Government (Federally Recognized)
Indian/Native American Tribal Government (Other than Federally Recognized)
Indian/Native American Tribally Designated Organizations
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.
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:
If your organization does not have a Taxpayer Identification Number (TIN)
or Employer Identification Number (EIN), allow for extra time. A valid TIN
or EIN is necessary for CCR registration.
The CCR also validates the EIN against Internal Revenue Service records,
a step that will take an additional one to two business days.
Direct questions regarding Grants.gov registration to:
Direct questions regarding the Commons registration
to:
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]
The individual designated as the PD/PI on the application must also be registered
in the NIH eRA Commons. It is not necessary for PDs/PIs to register with
Grants.gov.
The PD/PI must hold a PD/PI account in the Commons and must be affiliated
with the applicant organization. This account cannot have any other role
attached to it other than the PD/PI.
This registration/affiliation must be done by the Authorized Organization
Representative/Signing Official (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
(MS
Word or PDF).
The SF424 (R&R) Application Guide is critical to submitting a complete
and accurate application to NIH. There are fields within the SF424 (R&R)
application components that, although not marked as mandatory, are required
by NIH (e.g., the Credential log-in field of the Research & Related
Senior/Key Person Profile component must contain the PD/PI’s assigned eRA
Commons User ID). Agency-specific instructions for such fields are clearly
identified in the Application Guide. For additional information, see Tips
and Tools for Navigating Electronic Submission on the front page of 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/APPLYwill include all applicable
components, required and optional. A completed application in response to
this FOA will include the following components:
Required Components: SF424 (R&R) (Cover component) Research & Related Project/Performance Site Locations Research & Related Other Project Information Research & Related Senior/Key Person PHS398 Modular Budget PHS398 Cover Page Supplement
PHS398 Research Plan PHS398 Checklist
Optional Components: PHS398 Cover Letter File Research & Related Subaward Budget Attachment(s)
Form
Note: While both budget components are included
in the SF424 (R&R) forms package, the NIH R03 uses ONLY the PHS 398 Modular
Budget. (Do not use the detailed Research & Related Budget.)
Foreign Organizations
Several special provisions apply to applications submitted
by foreign organizations:
Charge back of customs and import fees is not allowed.
Format: Every effort should be made to comply with the format specifications
which are based upon a standard U.S. paper size of 8.5 x 11 within each
PDF.
Funds for up to 8% administrative costs (excluding equipment) may be requested.
See NOT-OD-01-028,
March 29, 2001.
Organizations must comply with Federal/NIH policies on human subjects, animals,
and biohazards.
Organizations must comply with Federal/NIH biosafety and biosecurity regulations.
See Section VI.2., Administrative and National Policy
Requirements.
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.
A letter of intent is not required for the funding
opportunity.
3.B. Submitting an Application Electronically to the
NIH
To submit an application in response to this FOA, applicants should access
this FOA via http://www.grants.gov/Apply
and follow steps 1-4. Note: Applications must only be submitted electronically. PAPER
APPLICATIONS WILL NOT BE ACCEPTED.
3.C. Application Processing
Applications may be submitted on or after the
opening date and must be successfully received by Grants.gov no later
than 5:00 p.m. local time (of the applicant
institution/organization) on the application
submission/receipt date(s). (See Section IV.3.A.
for all dates.) If an application is not submitted by the receipt date(s)
and time, the application may be delayed in the review process or not reviewed.
Once an application package has been successfully
submitted through Grants.gov, any errors have been addressed, and the assembled
application has been created in the eRA Commons, the PD/PI and the Authorized
Organization Representative/Signing Official (AOR/SO) have two business days
to view the application image.
If
everything is acceptable, no further action is necessary. The application
will automatically move forward for processing by the Division of Receipt
and Referral, Center for Scientific Review, NIH, after two business days.
Prior to the submission deadline, the AOR/SO can
Reject the assembled application and submit a changed/corrected application
within the two day viewing window. This option should be used if the AOR/SO
determines that warnings should be addressed. Reminder: warnings do not stop
further application processing. If an application submission results in warnings
(but no errors) it will automatically move forward after two business days
if no action is taken. Please remember that some warnings may not be applicable
or may need to be addressed after application submission.
If the two day window falls after the submission
deadline, the AOR/SO will have the option to Reject the application if,
due to an eRA Commons or Grants.gov system issue, the application does not
correctly reflect the submitted application package (e.g., some part of the
application was lost or didn t transfer correctly during the submission process).
The AOR/SO should first contact the eRA Commons Helpdesk to confirm the
system error, document the issue, and determine the best course of action.
NIH will not penalize the applicant for an eRA Commons or Grants.gov system
issue.
If the AOR/SO chooses
to Reject the image after the submission deadline for a reason other than
an eRA Commons or Grants.gov system failure, a changed/corrected application
still can be submitted but it will be subject to the NIH
late policy guidelines and may not be accepted. The reason for this delay
should be explained in the cover letter attachment.
Both the AOR/SO and PD/PI will receive e-mail notifications
when the application is rejected or the application automatically moves forward
in the process after two days.
Upon receipt, applications will be evaluated for
completeness by the Center for Scientific Review, NIH. Incomplete applications
will not be reviewed.
There will be an acknowledgement of receipt of
applications from Grants.gov and the Commons. Information related to the assignment
of an application to a Scientific Review Group is also in the Commons.
The NIH will not accept any application in response
to this FOA that is essentially the same as one currently pending initial
merit review unless the applicant withdraws the pending application. The NIH
will not accept any application that is essentially the same as one already
reviewed. This does not preclude the submission of an application already
reviewed with substantial changes, but such application must include an Introduction
addressing the previous critique. Note that such an application is considered
a "resubmission" for the SF424 (R&R).
All NIH awards are subject to the terms and conditions,
cost principles, and other considerations described in the NIH Grants Policy
Statement.
Pre-Award Costs are allowable. A grantee may, at its
own risk and without NIH prior approval, incur obligations and expenditures
to cover costs up to 90 days before the beginning date of the initial budget
period of a new award if such costs: are necessary to conduct the project
and would be allowable under the grant, if awarded, without NIH prior approval.
If specific expenditures would otherwise require prior approval, the grantee
must obtain NIH approval before incurring the cost. NIH prior approval is
required for any costs to be incurred more than 90 days before the beginning
date of the initial budget period of a new award.
The incurrence of pre-award costs in anticipation
of a competing or non-competing award imposes no obligation on NIH either
to make the award or to increase the amount of the approved budget if an award
is made for less than the amount anticipated and is inadequate to cover the
pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award
costs result in borrowing against future support and that such borrowing must
not impair the grantee's ability to accomplish the project objectives in the
approved time frame or in any way adversely affect the conduct of the project.
See the NIH Grants
Policy Statement.
6. Other Submission Requirements
The NIH requires the PD/PI to fill in his/her Commons
User ID in the PROFILE Project Director/Principal Investigator section,
Credential log-in field of the Research & Related Senior/Key Person
Profile component. The applicant organization must include its DUNS number
in its Organization Profile in the eRA Commons. This DUNS number must match
the DUNS number provided at CCR registration with Grants.gov. For additional
information, see Tips and Tools for Navigating Electronic Submission on
the front page of Electronic Submission of Grant Applications.
Renewal (formerly competing continuation or Type 2 ) applications are
not permitted.
All application instructions outlined in the SF424 (R&R)
Application Guide (MS
Word or PDF)
are to be followed, with the following requirements for R03 applications:
R03 applications will use the modular budget format and Just-in-Time concepts,
with direct costs of up to two $25,000 modules, or $50,000
per year, may be requested for up to two years (i.e., a maximum of $100,000
over two years in four modules of $25,000 each).
Items 2-5 of the PHS398 Research Plan component of the R03 application may
not exceed 10 pages, including tables, graphs, figures, diagrams, and charts.
"Introduction (required for a resubmission application) is limited
to one page.
Preliminary data are not required but may be included
if available.
R03 Appendix materials may include graphic images of gels, micrographs, etc.
provided that the image (may be reduced in size) is contained within the
10-page limit of Items 2-5 of the Research Plan. No images may be included
in the Appendix that are not also represented within the Research Plan.
No publications or other printed material, with the exception of pre-printed
questionnaires or surveys, may be included in the Appendix.
Do not use the Appendix to circumvent the page limitations
of the Research Plan. An application that does not observe these limitations
may be delayed in the review process.
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 as a single document, separating sections into
distinct PDF attachments just before uploading the files. This approach will
enable applicants to better monitor formatting requirements such as page limits.
All attachments must be provided to NIH in PDF format, filenames must be included
with no spaces or special characters, and a .pdf extension must be used.
Plan for Sharing Research Data
Not applicable.
Sharing Research Resources
NIH policy requires that grant awardee recipients make unique research resources
readily available for research purposes to qualified individuals within the
scientific community after publication (See the NIH Grants Policy Statementhttp://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 PHS referral guidelines.
Appropriate scientific review groups convened in accordance
with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm)
will evaluate applications for scientific and technical merit. As part of the initial merit review, all applications
will:
Undergo a selection process in which only those applications deemed to have
the highest scientific merit, generally the top half of applications under
review, will be discussed and assigned a priority score.
Receive a written critique.
Receive a second level of review by the
appropriate national advisory council or board.
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:
Scientific merit of the proposed project as determined by peer review.
Availability of funds.
Relevance of program priorities.
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 plan is restricted to
10 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 priority score. For example, an investigator may propose
to carry out important work that by its nature is not innovative but is essential
to move a field forward.
Significance: Does this study address an important scientific health problem?
If the aims of the application are achieved, how will scientific knowledge
or clinical practice be advanced? What will be the effect of these studies
on the concepts, methods, technologies, treatments, services, or preventative
interventions that drive this field?
Approach: Are the conceptual or
clinical framework, design, methods, and analyses adequately developed, well
integrated, well reasoned, and appropriate to the aims of the project? Does
the applicant acknowledge potential problem areas and consider alternative
tactics?
Innovation: Is the project original
and innovative? For example: Does the project challenge existing paradigms
or clinical practice; address an innovative hypothesis or critical barrier
to progress in the field? Does the project develop or employ novel concepts,
approaches, methodologies, tools, or technologies for this area?
Investigators: Are the investigators appropriately trained and well suited
to carry out this work? Is the work proposed appropriate to the experience
level of the PD/PI and other researchers? Does the investigative team bring
complementary and integrated expertise to the project (if applicable)?
Environment: Does the scientific environment in which the work will be done
contribute to the probability of success? Do the proposed studies benefit
from unique features of the scientific environment, or subject populations,
or employ useful collaborative arrangements? Is there evidence of institutional
support?
2.A. Additional Review Criteria
In addition to the above criteria, the following items
will continue to be considered in the determination of scientific merit and
the priority score:
Protection of Human Subjects from Research Risk:
The involvement of human subjects and protections from research risk relating
to their participation in the proposed research will be assessed. See item
6 of the Research Plan component of the SF424 (R&R).
Inclusion of Women, Minorities and Children in Research: The
adequacy of plans to include subjects from both genders, all racial and ethnic
groups (and subgroups), and children as appropriate for the scientific goals
of the research will be assessed. Plans for the recruitment and retention
of subjects will also be evaluated. See item 7 of the Research Plan component
of the SF424 (R&R).
Care and Use of Vertebrate Animals in Research: If
vertebrate animals are to be used in the project, the five items described
under item 11 of the Research Plan component of the SF424 (R&R) will be
assessed.
Biohazards: If materials or procedures are proposed that are potentially
hazardous to research personnel and/or the environment, determine if the proposed
protection is adequate.
2.B. Additional Review Considerations
Budget and Period of Support: The reasonableness of the proposed budget
and the appropriateness of the requested period of support in relation to
the proposed research may be assessed by the reviewers. Is the percent effort
listed for the PD/PI appropriate for the work proposed? Is each budget category
realistic and justified in terms of the aims and methods?
2.C. Sharing Research Data
Not applicable.
2.D. Sharing Research Resources
NIH policy requires that grant awardee recipients
make unique research resources readily available for research purposes to
qualified individuals within the scientific community after publication (See
the NIH Grants Policy Statementhttp://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: Reviewersare 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 or her Summary Statement (written critique)
via the NIH eRA Commons.
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
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:
Lisa Onken, Ph.D.
Division of Clinical Neuroscience and Behavioral Research
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Blvd., MSC 9593
Bethesda, Maryland 20892-9593
Telephone: (301) 443-2235
Fax: (301) 443-6814
E-mail: [email protected]
Robert B. Huebner, Ph.D.
Deputy Director
Division of Treatment and Recovery Research
National Institute on Alcohol Abuse and Alcoholism
National Institutes of Health
5635 Fishers Lane, MSC 9304
Room 2049
Bethesda, MD 20892-9304* Telephone: (301) 443-4344 Fax: (301) 443-8774 - fax [email protected]
For overnight delivery, please use Rockville, MD 20852
Catherine M. Stoney, Ph.D.
Division of Extramural Research and Training National Center for Complementary and Alternative Medicine 6707 Democracy Blvd., Suite 401 Bethesda, MD 20892 Telephone: (301) 402-1272 Fax: (301) 480-3621 Email: [email protected]
2. Peer Review Contacts:
Not applicable.
3. Financial or Grants Management Contacts:
Edith Davis
Grants Management Branch
National Institute on Drug Abuse/NIH/DHSS
6001 Executive Blvd., MSC 9541 Rockville, MD 20892-9541 Telephone: 301-443-6710 Fax: 301-594-6849 E-mail: [email protected]
Judy Fox
Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism/NIH/DHHS
6000 Executive Blvd., MSC 7003
Bethesda, MD 20892-7003
Telephone: 301-443-4704
Email: [email protected]
Mr. George Tucker
Grants Management Branch
National Center for Complementary and Alternative Medicine
6707 Democracy Boulevard, Suite 401 Bethesda, MD 20892 (for express/courier service use 20817)
Telephone: (301) 594-9102
FAX: (301) 480-2419
Email: [email protected]
Section VIII. Other Information
Required Federal Citations
Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving
human subjects must be evaluated with reference to the risks to the subjects,
the adequacy of protection against these risks, the potential benefits of
the research to the subjects and others, and the importance of the knowledge
gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including
physiologic toxicity and dose-finding studies (Phase I); efficacy studies
(Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring
should be commensurate with risk. The establishment of data and safety monitoring
boards (DSMBs) is required for multi-site clinical trials involving interventions
that entail potential risks to the participants (NIH Policy for Data and Safety
Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct
costs in any single year are expected to include a plan for data sharing or
state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).
Investigators should seek guidance from their institutions, on issues related
to institutional policies and local IRB rules, as well as local, State and
Federal laws and regulations, including the Privacy Rule. Reviewers will consider
the data sharing plan but will not factor the plan into the determination
of the scientific merit or the priority score.
Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised
to provide access to research data through the Freedom of Information Act
(FOIA) under some circumstances. Data that are (1) first produced in a project
that is supported in whole or in part with Federal funds and (2) cited publicly
and officially by a Federal agency in support of an action that has the force
and effect of law (i.e., a regulation) may be accessed through FOIA. It is
important for applicants to understand the basic scope of this amendment.
NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this funding opportunity
in a public archive, which can provide protections for the data and manage
the distribution for an indefinite period of time. If so, the application
should include a description of the archiving plan in the study design and
include information about this in the budget justification section of the
application. In addition, applicants should think about how to structure informed
consent statements and other human subjects procedures given the potential
for wider use of data collected under this award.
Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research
resources including the sharing of model organisms for biomedical research
(see http://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time the NIH recognizes the rights of grantees and contractors
to elect and retain title to subject inventions developed with Federal funding
pursuant to the Bayh Dole Act (see the NIH Grants Policy
Statement). Beginning October 1, 2004, all investigators submitting
an NIH application or contract proposal are expected to include in the application/proposal
a description of a specific plan for sharing and distributing unique model
organism research resources generated using NIH funding or state why such
sharing is restricted or not possible. This will permit other researchers
to benefit from the resources developed with public funding. The inclusion
of a model organism sharing plan is not subject to a cost threshold in any
year and is expected to be included in all applications where the development
of model organisms is anticipated.
Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and
their sub-populations must be included in all NIH-supported clinical research
projects unless a clear and compelling justification is provided indicating
that inclusion is inappropriate with respect to the health of the subjects
or the purpose of the research. This policy results from the NIH Revitalization
Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing
clinical research should read the "NIH Guidelines for Inclusion of Women
and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new
OMB standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the SF424 (R&R) application; and updated roles
and responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a)
all applications or proposals and/or protocols must provide a description
of plans to conduct analyses, as appropriate, to address differences by sex/gender
and/or racial/ethnic groups, including subgroups if applicable; and b) investigators
must report annual accrual and progress in conducting analyses, as appropriate,
by sex/gender and/or racial/ethnic group differences.
Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age
of 21) must be included in all clinical research, conducted or supported by
the NIH, unless there are scientific and ethical reasons not to include them.
All investigators proposing research involving human subjects should read
the "NIH Policy and Guidelines" on the inclusion of children as
participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).
Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants
for all investigators submitting NIH applications for research involving human
subjects and individuals designated as key personnel. The policy is available
at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
Human Embryonic Stem Cells (hESC):
Criteria for Federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp
and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.
Only research using hESC lines that are registered in the NIH Human Embryonic
Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility
of the applicant to provide in the project description and elsewhere in the
application as appropriate, the official NIH identifier(s) for the hESC line(s)
to be used in the proposed research. Applications that do not provide this
information will be returned without review.
NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission
(NIHMS) system (http://www.nihms.nih.gov)
at PubMed Central (PMC) an electronic version of the author's final manuscript
upon acceptance for publication, resulting from research supported in whole
or in part with direct costs from NIH. The author's final manuscript is defined
as the final version accepted for journal publication, and includes all modifications
from the publishing peer review process.
NIH is requesting that authors submit manuscripts resulting from 1) currently
funded NIH research projects or 2) previously supported NIH research projects
if they are accepted for publication on or after May 2, 2005. The NIH Public
Access Policy applies to all research grant and career development award mechanisms,
cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein
National Research Service Awards, as well as NIH intramural research studies.
The Policy applies to peer-reviewed, original research publications that have
been supported in whole or in part with direct costs from NIH, but it does
not apply to book chapters, editorials, reviews, or conference proceedings.
Publications resulting from non-NIH-supported research projects should not
be submitted.
For more information about the Policy or the submission
process, please visit the NIH Public Access Policy Web site athttp://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 (DHHS) issued final modification
to the "Standards for Privacy of Individually Identifiable Health Information",
the "Privacy Rule", on August 14, 2002. The Privacy Rule is a Federal
regulation under the Health Insurance Portability and Accountability Act (HIPAA)
of 1996 that governs the protection of individually identifiable health information,
and is administered and enforced by the DHHS Office for Civil Rights (OCR).
Decisions about applicability and implementation of the Privacy Rule reside
with the researcher and his/her institution. The OCR Website (http://www.hhs.gov/ocr/) provides information
on the Privacy Rule, including a complete Regulation Text and a set of decision
tools on "Am I a covered entity?" Information on the impact of the
HIPAA Privacy Rule on NIH processes involving the review, funding, and progress
monitoring of grants, cooperative agreements, and research contracts can be
found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
HIV/AIDS Counseling and Testing Policy for the National Institute on Drug
Abuse: Researchers funded by NIDA who are conducting research in community
outreach settings, clinical, hospital settings, or clinical laboratories and
have ongoing contact with clients at risk for HIV infection, are strongly
encouraged to provide HIV risk reduction education and counseling. HIV counseling
should include offering HIV testing available on-site or by referral to other
HIV testing service for persons at risk for HIV infection including injecting
drug users, crack cocaine users, and sexually active drug users and their
sexual partners. For more information see http://grants.nih.gov/grants/guide/notice-files/NOT-DA-01-001.html.
National Advisory Council on Drug Abuse Recommended
Guidelines for the Administration of Drugs to Human Subjects: The National
Advisory Council on Drug Abuse recognizes the importance of research involving
the administration of drugs to human subjects and has developed guidelines
relevant to such research. Potential applicants are encouraged to obtain and
review these recommendations of Council before submitting an application that
will administer compounds to human subjects. The guidelines are available
on NIDA's Home Page at www.nida.nih.gov
under the Funding, or may be obtained by calling (301) 443-2755.
URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within
specified page limitations. For publications listed in the appendix and/or
Progress report, internet addresses (URLs) must be used for publicly accessible
on-line journal articles. Unless otherwise specified in this solicitation,
Internet addresses (URLs) should not be used to provide any other information
necessary for the review because reviewers are under no obligation to view
the Internet sites. Furthermore, we caution reviewers that their anonymity
may be compromised when they directly access an Internet site.
Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion
and disease prevention objectives of "Healthy People 2010," a PHS-led
national activity for setting priority areas. This PA is related to one or
more of the priority areas. Potential applicants may obtain a copy of "Healthy
People 2010" at http://www.health.gov/healthypeople.
Authority and Regulations: .
This program is described in the Catalog
of Federal Domestic Assistance and is not subject to the intergovernmental
review requirements of Executive Order 12372 or Health Systems Agency review.
Awards are made under the authorization of Sections 301 and 405 of the Public
Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations
42 CFR Part 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms
and conditions, cost principles, and other considerations described in the
NIH Grants Policy
Statement.
The PHS strongly encourages all grant recipients to provide a smoke-free
workplace and discourage the use of all tobacco products. In addition, Public
Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities
(or in some cases, any portion of a facility) in which regular or routine
education, library, day care, health care, or early childhood development
services are provided to children. This is consistent with the PHS mission
to protect and advance the physical and mental health of the American people.
Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified
health professionals who have made a commitment to pursue a research career
involving clinical, pediatric, contraception, infertility, and health disparities
related areas. The LRP is an important component of NIH's efforts to recruit
and retain the next generation of researchers by providing the means for developing
a research career unfettered by the burden of student loan debt. Note that
an NIH grant is not required for eligibility and concurrent career award and
LRP applications are encouraged. The periods of career award and LRP award
may overlap providing the LRP recipient with the required commitment of time
and effort, as LRP awardees must commit at least 50% of their time (at least
20 hours per week based on a 40 hour week) for two years to the research.
For further information, please see: http://www.lrp.nih.gov.
