and Human Services (HHS)
EXPIRED
BEHAVIORAL SCIENCE TRACK AWARD FOR RAPID TRANSITION (B/START)
RELEASE DATE: October 20, 2003
PA NUMBER: PAR-04-010 (Announcement being discontinued
after expiration, see NOT-MH-05-015)
March 2, 2006 (NOT-OD-06-046) Effective with the June 1, 2006 submission date,
all R03, R21, R33 and R34 applications must be submitted through Grants.gov using
the electronic SF424 (R&R) application. Accordingly, this funding opportunity
expires on the date indicated below. A replacement R03 (PAR-06-141) funding
opportunity announcements have been issued for the submission date of June 1, 2006
and submission dates thereafter.
See NOT-OD-06-048 for information on May 1, 2006 Submission Date for AIDS and
AIDS-related R03 and R21 Applications.
EXPIRATION DATE: March 2, 2006
Department of Health and Human Services (DHHS)
PARTICIPATING ORGANIZATIONS:
National Institutes of Health (NIH)
(http://www.nih.gov)
COMPONENTS OF PARTICIPATING ORGANIZATIONS:
National Institute of Mental Health (NIMH)
(http://www.nimh.nih.gov)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.242
THIS PA CONTAINS THE FOLLOWING INFORMATION
o Purpose of the PA
o Research Objectives
o Mechanism(s) of Support
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Where to Send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS PA
This PA replaces PAR-00-119.
The National Institute of Mental Health (NIMH), through the issuance of this
Program Announcement (PA), intends to facilitate the entry of new investigators
into the field of behavioral science research to advance the mission of reducing
mental illness and behavioral disorders through research. NIMH invites newly
independent investigators to submit applications for small-scale exploratory or
pilot research projects related to the behavioral science mission of the NIMH.
This includes basic research on psychological and behavioral processes (e.g.,
cognition, emotion, personality, social cognition), research incorporating neural
and other biological approaches if the research has a primary focus on behavior,
research on mental illness (risk factors, diagnosis, treatment, and prevention),
and research on mental health services (e.g., organization, financing, delivery,
and effectiveness; psychosocial rehabilitation, adherence). Funding of B/START
awards is relatively rapid, i.e., within approximately six months of the date of
receipt of the application.
RESEARCH OBJECTIVES
Research areas relevant for support by NIMH can be found at the following URL:
http://www.nimh.nih.gov/grants/program_contact.cfm. To be appropriate for a
B/START award, research in these areas must, in addition, be primarily focused on
behavioral science research questions. That is, research on neural, genetic, or
other biological processes would be appropriate for a B/START award only if
incorporated within a project whose overall emphasis is on understanding behavioral
processes or outcomes. Examples of the latter include individual mental function
(e.g., cognition, emotion, personality); mental health disparities; developmental
and environmental influences on behavior; behavioral or psychosocial factors in
risk, treatment, and prevention of mental disorder; psychosocial rehabilitation;
adherence; and behavioral factors in mental health service delivery.
MECHANISM OF SUPPORT
This PA will use the NIH Small Grant (R03) award mechanism. As an applicant you
will be solely responsible for planning, directing, and executing the proposed
project. The total project period for a B/START application may not exceed one
year. The total direct costs for the project may not exceed $50,000. Grant funds
may be used for expenses clearly related and necessary to conduct the research
project, including both direct costs that can be specifically identified with the
project plus allowable facilities and administrative (F&A) costs of the
institution. Replacement of the Principal Investigator on a B/START award is not
permitted. Transfer of a B/START award with the Principal Investigator to another
institution for the remainder of the grant period may be requested. B/START awards
are not renewable. If a B/START application is unsuccessful in obtaining funding
on the first submission, it may be revised (amended) and resubmitted one time.
Additional revision and resubmission of a B/START application is not permitted.
This PA uses just-in-time concepts. It also uses the modular budgeting format.
(see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically,
B/START applications may request up to two modules of $25,000 direct costs each.
Because B/START grants have special eligibility requirements, application formats,
and review criteria, applicants are strongly encouraged to consult with program
staff (listed under WHERE TO SEND INQUIRIES) prior to submitting an application.
There are alternative mechanisms of support for individuals interested in pursuing
periods of supervised training and career development activities. Such individuals
are encouraged to consider applying for NIMH individual postdoctoral fellowships or
NIMH mentored career development awards. Additional information regarding
Institute-wide training initiatives and support mechanisms can be found at
http://www.nimh.nih.gov/grants/training.cfm.
This program does not require cost sharing as defined in the current NIH Grants
Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm.
ELIGIBLE INSTITUTIONS
You may submit application(s) if your institution has any of the following
characteristics:
o For-profit or non-profit organizations
o Public or private institutions, such as universities, colleges, hospitals, and
laboratories
o Units of State and local governments
o Eligible agencies of the Federal government
o Domestic or foreign institutions/organizations
o Faith-based or community-based organizations
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
To be eligible for a B/START award, the proposed Principal Investigator must be
independent of a mentor at the time of award, but be in the beginning stages of
his/her research career (typically not more than five years from receipt of the
doctorate or, if applicable, from the end of postdoctoral training). If the
applicant is in the final stages of training, s/he may apply, but no B/START award
will be made to individuals still in training status. The proposed Principal
Investigator may not have been designated previously as Principal Investigator on
any PHS-supported research or career grant (except a dissertation research grant)
or have received similar support from another federal agency, e.g., the National
Science Foundation. However, previous funding as a trainee through the National
Research Service Award (NRSA) program (i.e., Institutional Training Grant or
Individual Fellowship), or through training support from another agency, is
permissible.
Individuals from underrepresented racial and ethnic groups as well as individuals
with disabilities are always encouraged to apply for NIH programs.
WHERE TO SEND INQUIRIES
We encourage inquiries concerning this PA 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:
o Direct your questions about scientific/research issues to:
Mary Ellen Oliveri, Ph.D.
Division of Neuroscience and Basic Behavioral Science
National Institute of Mental Health
6001 Executive Boulevard, Room 7220, MSC 9651
Bethesda, MD 20892-9651
Telephone: (301) 443-3942
FAX: (301) 443-9876
Email: [email protected]
Emeline M. Otey, Ph.D.
Division of Mental Disorders, Behavioral Research and AIDS
National Institute of Mental Health
6001 Executive Boulevard, Room 6186, MSC 9624
Bethesda, MD 20892-9625
Telephone: (301) 443-3728
FAX: (301) 443-4611
Email: [email protected]
Enid Light, Ph.D.
Division of Services and Intervention Research
National Institute of Mental Health
6001 Executive Boulevard, Room 7160, MSC 9635
Bethesda, MD 20892-9635
Telephone: (301) 443-1185
FAX: (301) 594-6784
Email: [email protected]
o Direct your questions about peer review issues to:
Michael Kozak, Ph.D.
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6138, MSC 9608
Bethesda, MD 20892-9608
Telephone: (301) 443-1340
FAX: (301) 594-0702
Email: [email protected]
o Direct your questions about financial or grants management matters to:
Ms. Carol J. Robinson
Grants Management Branch
National Institute of Mental Health
6001 Executive Boulevard, Room 6118, MSC 9605
Bethesda, MD 20892-9605
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-3858
FAX: (301) 443-6885
Email: [email protected]
SUBMITTING AN APPLICATION
Prior to submitting an application, investigators are strongly encouraged to
contact the program contacts listed under WHERE TO SEND INQUIRIES in order to
assess the responsiveness of their proposed project to the mission of NIMH and to
the goals of this PA. Applications judged not to be responsive or not
appropriately focused on mental-health-relevant behavioral processes and research
questions (as addressed in PURPOSE and RESEARCH OBJECTIVES) may be returned to the
applicant without review.
Applications must be prepared using the PHS 398 research grant application
instructions and forms (rev. 5/2001). Applications must have a Dun and Bradstreet
(D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier
when applying for Federal grants or cooperative agreements. The DUNS number can be
obtained by calling (866) 705-5711 or through the web site at
http://www.dunandbradstreet.com/. The DUNS number should be entered on line 11 of
the face page of the PHS 398 form. The PHS 398 is available at
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format.
For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email:
[email protected].
APPLICATION RECEIPT DATES: For B/STARTs, there is an exception to the standard
deadlines as noted at: http://grants.nih.gov/grants/dates.htm. In order to permit
expedited funding, revised (amended) applications are due on the same dates as new
applications (February 1, June 1, and October 1). (As noted in MECHANISM OF
SUPPORT, B/STARTs are allowed one revision only.)
SPECIAL INSTRUCTIONS FOR A B/START APPLICATION: All instructions for the PHS 398
(rev. 5/2001) must be followed, with these exceptions:
o The title, Behavioral Science Track Award for Rapid Transition (B/START), and
number of the program announcement (PAR-04-010) must be typed on line 2 of the face
page of the application form and the YES box must be marked.
o For revised (amended) applications, the Introduction to Revised Application must
not exceed one page.
o Sections a-d of the Research Plan must not exceed seven pages in total.
o Appendix. The appendix may include original, glossy photographs or color images
provided that a photocopy (may be reduced in size) is also included within the page
limits of the research plan. No publications or other printed material, with the
exception of pre-printed questionnaires or surveys, may be included in the
appendix.
SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: B/START applications must be
submitted in modular format. The modular grant format simplifies the preparation
of the budget in these applications by limiting the level of budgetary detail.
Applicants request direct costs in $25,000 modules. Section C of the research
grant application instructions for the PHS 398 (rev. 5/2001) at
http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step
guidance for preparing modular budgets. Additional information on modular grants
is available at http://grants.nih.gov/grants/funding/modular/modular.htm.
For the B/START, applicants may request up to two modules (maximum of $50,000
direct costs) for a period of one year.
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the
application, including the checklist, and three signed photocopies in one package
to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710
Bethesda, MD 20817 (for express/courier service)
To permit an expedited review of the application applicants must simultaneously
send two complete copies to:
Jean G. Noronha, Ph.D.
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6154, MSC 9609
Bethesda, MD 20892-9609
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-3367
FAX: (301) 443-4720
Email: [email protected]
APPLICATION PROCESSING: Applications must be mailed on or before the applicable
receipt date (see APPLICATION RECEIPT DATES). The Center for Scientific Review
(CSR) will not accept any application in response to this PA that is essentially
the same as one currently pending initial review unless the applicant withdraws the
pending application. The CSR will not accept any application that is essentially
the same as one already reviewed. This does not preclude the submission of a
substantial revision of an application already reviewed, but such application must
include an Introduction addressing the previous critique.
Although there is no immediate acknowledgement of the receipt of an application,
applicants are generally notified of the review and funding assignment within 8
weeks.
PEER REVIEW PROCESS
B/START applications are evaluated for scientific and technical merit by
appropriate reviewers selected by NIMH in accordance with NIH peer review
procedures.
REVIEW CRITERIA
The B/START award is a mechanism for pilot or preliminary research conducted by
investigators new to the grant process. Because of the restricted length of the
research plan, a B/START application will not have the same level of detail or
extensive discussion found in R01 applications. Accordingly, reviewers should
evaluate the overall conceptual framework, general approach to the problem, and
promise of the application, placing less emphasis on methodological details and
other indicators traditionally used in evaluating scientific merit. Supportive
preliminary data are not required.
Reviewers will evaluate the following aspects of B/START applications:
o Significance
o Approach
o Innovation
o Investigator
o Environment
Reviewers will address and consider each of these criteria in assigning an
application’s overall score, weighting them as appropriate for each application.
An application does not need to be strong in all categories to be judged worthy of
a high priority score.
(1) SIGNIFICANCE: Does this study address an important problem? If the aims of
the application are achieved, how will scientific knowledge be advanced? What will
be the effect of these studies on the concepts or methods that drive this field?
(2) APPROACH: Are the conceptual framework, design, methods, and analyses
adequately developed, well-integrated, and appropriate to the aims of the project?
Does the applicant acknowledge potential problem areas and consider alternative
tactics?
(3) INNOVATION: Does the project employ novel concepts, approaches or methods?
Are the aims original and innovative? Does the project challenge existing
paradigms or develop new methodologies or technologies?
(4) INVESTIGATOR: Is the investigator appropriately trained and well suited to
carry out this work? Is the work proposed appropriate to the experience level of
the principal investigator and other researchers (if any)?
(5) ENVIRONMENT: Does the scientific environment in which the work will be done
contribute to the probability of success? Do the proposed experiments take
advantage of unique features of the scientific environment or employ useful
collaborative arrangements? Is there evidence of institutional support?
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following will
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 criteria included in the section on Federal
Citations, below).
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 Inclusion Criteria in the sections on Federal Citations, below).
CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be
used in the project, the five items described under Section f of the PHS 398
research grant application instructions (rev. 5/2001) will be assessed.
ADDITIONAL CONSIDERATIONS
BUDGET: The reasonableness of the proposed budget and the requested period of
support in relation to the proposed research.
AWARD CRITERIA
The following will be considered in making funding decisions:
o Quality of the proposed project as determined by peer review
o Appropriateness to the goals of the B/START program
o Availability of funds
o Program priority
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). The establishment of data and safety monitoring boards (DSMBs)
is required for multi-site clinical trials involving interventions that entail
potential risk to the participants (NIH Policy for Data and Safety Monitoring, NIH
Guide for Grants and Contracts, June 12, 1998:
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
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 research involving human subjects should read the "NIH
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research -
Amended, October, 2001," published in the NIH Guide for Grants and Contracts on
October 9, 2001
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines are available at
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical research;
updated racial and ethnic categories in compliance with the new OMB standards;
clarification of language governing NIH-defined Phase III clinical trials
consistent with the new PHS Form 398; and updated roles and responsibilities of NIH
staff and the extramural community. The policy continues to require for all NIH-
defined Phase III clinical trials that: a) all applications or proposals and/or
protocols must provide a description of plans to conduct analyses, as appropriate,
to address differences by sex/gender and/or racial/ethnic groups, including
subgroups if applicable; and b) investigators must report annual accrual and
progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic
group differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The
NIH maintains a policy that children (i.e., individuals under the age of 21) must
be included in all human subjects research, conducted or supported by the NIH,
unless there are scientific and ethical reasons not to include them. This policy
applies to all initial (Type 1) applications submitted for receipt dates after
October 1, 1998.
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 that is available at
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 proposals for research involving human subjects.
You will find this policy announcement in the NIH Guide for Grants and Contracts
Announcement, dated June 5, 2000, 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 (see 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.
PUBLIC 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 public
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 PA 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.
STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The
Department of Health and Human Services (DHHS) issued final modifications 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). Those who
must comply with the Privacy Rule (classified under the Rule as covered entities )
must do so by April 14, 2003 (with the exception of small health plans which have
an extra year to comply).
Decisions about applicability and implementation of the Privacy Rule reside with
the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr)
provides information on the Privacy Rule, including a complete Regulation Text and
a set of decision tools on Am I a covered entity? Information on the impact of
the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress
monitoring of grants, cooperative agreements, and research contracts can be found
at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for
NIH funding must be self-contained within specified page limitations. Unless
otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be
used to provide information necessary to the review because reviewers are under no
obligation to view the Internet sites. Furthermore, we caution reviewers that
their anonymity may be compromised when they directly access an Internet site.
HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the
health promotion and disease prevention objectives of "Healthy People 2010," a PHS-
led national activity for setting priority areas. This PA is related to one or
more of the priority areas. Potential applicants may obtain a copy of "Healthy
People 2010" at http://www.health.gov/healthypeople.
AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal
Domestic Assistance at http://www.cfda.gov/ and is not subject to the
intergovernmental review requirements of Executive Order 12372 or Health Systems
Agency review. Awards are made under the authorization of Sections 301 and 405 of
the Public Health Service Act as amended (42 USC 241 and 284) and under Federal
Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the
terms and conditions, cost principles, and other considerations described in the
NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at
http://grants.nih.gov/grants/policy/policy.htm.
The PHS strongly encourages all grant recipients to provide a smoke-free workplace
and discourage the use of all tobacco products. In addition, Public Law 103-227,
the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some
cases, any portion of a facility) in which regular or routine education, library,
day care, health care, or early childhood development services are provided to
children. This is consistent with the PHS mission to protect and advance the
physical and mental health of the American people.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
|
| ||||||
|
|
|
Department of Health and Human Services (HHS) |
|
|||
|
NIH... Turning Discovery Into Health® |
||||||