and Human Services
9000 Rockville Pike
Bethesda, Maryland 20892
BEHAVIORAL SCIENCE TRACK AWARD FOR RAPID TRANSITION (B/START) – NIDA
RELEASE DATE: July 7, 2003
PA: PAR-03-146
National Institute on Drug Abuse (NIDA)
(http://www.nida.nih.gov)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.279
THIS PROGRAM ANNOUNCEMENT (PA) CONTAINS THE FOLLOWING INFORMATION
o Purpose of the PA
o Research Objectives
o Mechanism 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 is a reissuance of PAR-01-014, which was issued November 8, 2000 in
the NIH Guide, and is hereby withdrawn. This reissuance will become
effective as of the October 1, 2003, receipt date. The National Institute on
Drug Abuse (NIDA), through the issuance of this PA seeks to facilitate the
entry of beginning investigators into the field of behavioral science
research. NIDA invites newly independent investigators to submit applications
for small-scale, exploratory, or pilot research projects related to NIDA's
behavioral sciences mission. Funding of B/START awards is relatively rapid,
i.e., within approximately six months of the date of receipt of the
application.
RESEARCH OBJECTIVES
NIDA, through the issuance of this PA, seeks to facilitate the entry of
beginning investigators into the field of behavioral science research. It is
well documented that the number of investigators entering behavioral sciences
research is declining. This is of special concern to NIDA because
understanding behavioral processes is fundamental to understanding drug abuse
and addiction.
To be appropriate for a B/START award, research must be primarily focused on
behavioral processes and research questions. Thus, research on neural,
genetic, or other biological processes would be appropriate for a B/START
award only if its overall emphasis were on understanding behavioral processes
or outcomes.
Behavioral research proposed under B/START need not be conducted in drug-
abusing populations or involve administration of drugs; however, the
relevance of the research to drug abuse or drug addiction must be clearly
established in the application.
In all proposed research, investigators are encouraged to consider designing
the research to permit an analysis of data by gender.
All areas of behavioral research related to drug abuse are sought under this
announcement including (a) animal and human basic behavioral research aimed
at elucidating underlying behavioral mechanisms, determinants and correlates
of drug abuse and characterizing the harmful sequelae of drug abuse and
addiction; (b) research incorporating neural and other biological approaches
if the research has a primary focus on behavior; (c) drug abuse
epidemiology, risk and protective factors, treatment, prevention, and drug
abuse services; and (d) behavioral research on the intersection of drug abuse
and HIV/AIDS and other infectious diseases. These areas of interest
include, but are not limited to:
o Measurement of the incidence, prevalence, and patterns and trends of drug
abuse (in various stages) and its adverse effects.
o Identification of risk, vulnerability, protective, and resiliency factors
for drug use and dependence.
o Studies of behavioral mechanisms that may underlie drug dependence, e.g.,
learning and conditioning processes, cognitive processes tolerance,
habituation, and sensitization.
o Studies of learning, motivational, cognitive, and emotional factors
contributing to the acquisition of drug taking, maintenance, withdrawal, and
relapse.
o Characterization of the effects of abused drugs on diverse behavioral
domains including sensory-perceptual, psychomotor, learning, motivation,
cognitive, social, and cultural as well as the reciprocal role of adverse
outcomes on further drug involvement.
o Development of new animal behavioral models that correlate well with the
human abuse and addiction, including an examination of underlying neural
processes.
o Development of new animal behavioral models to serve as screening
procedures in the search for pharmacotherapies to treat drug dependence.
o Development of mathematical or computational models of learning,
conditioning, or cognitive processes relevant to drug abuse.
o Studies of the behavioral factors involved in the transition from drug use
to drug dependence.
o Behavioral genetic approaches either in animal models (e.g., transgenic
animals, development of simple high-input behavioral screens) or human
subject studies (e.g., establishment of pedigrees, twin studies).
o Studies of innovative theory-based prevention approaches including
interventions to mitigate or ameliorate adverse consequences associated with
drug abuse.
o Studies of behavioral treatments of drug dependence, including animal
models.
o Identification of factors affecting treatment access, entry, readiness,
retention, and compliance.
o Studies of the effects of organization, financing, and management of
services on treatment outcomes.
o Studies of risk reduction strategies to reduce HIV and other infectious
diseases among drug abusers.
o Studies of drug abuse treatment services for HIV seropositive patients and
for those at risk for HIV infection.
MECHANISM OF SUPPORT
This PA will use the NIH small grant (R03) award mechanism. An award is not
to exceed $50,000 in direct costs and is for a period of one year only. The
award is not renewable. Responsibility for the planning, direction, and
execution of the proposed project will be solely that of the applicant.
This PA uses just-in-time concepts. It also uses the modular as well as the
non-modular budgeting formats (see
http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if
you are submitting an application with direct costs in each year of $250,000
or less, use the modular format. Otherwise follow the instructions for non-
modular research grant applications. 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.
Because this announcement targets newly independent investigators, this
mechanism is ideal for obtaining pilot data that could serve as the basis for
a subsequent grant application using other mechanisms of support. Therefore,
under this program announcement, inclusion of pilot data is not a
requirement.
As an alternative mechanism of support to the B/START, investigators
interested in pursuing periods of supervised training and career development
are encouraged to consider NIDA's career development award mechanisms.
Information on these mechanisms is provided at
http://www.nida.nih.gov/ResFundslist.html.
Resubmission of a B/START application is not permitted.
The principal investigator on a B/START award may not be replaced. Transfer
of a B/START award with the principal investigator to another institution may
be requested.
ELIGIBILITY REQUIREMENTS
You may submit (an) 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
o Faith-based or community-based organizations
Foreign institutions are not eligible for a B/START award. Racial/ethnic
minority individuals, women, and persons with disabilities are encouraged to
apply as principal investigators.
To be eligible for a B/START-NIDA award, the proposed principal investigator
must be independent of a mentor at the time of award, but be at the beginning
stages of her/his research career. No B/START award will be made to
individuals in training status. Thus, applicants may submit applications
only after their training is complete. The proposed principal investigator
may not have been designated previously as principal investigator on a
National Institutes of Health (NIH) or federally-supported research project
or component (except a dissertation research grant) or have received similar
support from another federal agency, e.g., the National Science Foundation.
Previous receipt of National Research Service Award is permissible.
Recipients of mentored K-awards are not eligible.
Because this program is targeted at newly independent investigators,
individuals who are more than five years beyond a training status should
consider other mechanisms of support.
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
Any individual with the skills, knowledge, and resources necessary to carry
out the proposed research is 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 programs.
WHERE TO SEND INQUIRIES
We encourage your 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:
Paul Schnur, Ph.D.
Division of Neuroscience and Behavioral Research
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Room 4282, MSC 9555
Bethesda, MD 20892-9555
Telephone: 301-435-1887
FAX : 301-594-6043
E-mail: pschnur@nida.nih.gov
o Direct inquiries regarding peer review issues to:
Teresa Levitin, Ph.D.
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Room 3158, MSC 9547
Bethesda, MD 20892-9547
Telephone: (301) 443-2755
FAX: (301) 443-0538
E-mail: tl25u@nih.gov
o Direct inquiries regarding fiscal or grants management matters to:
Gary Fleming, J.D., M.A.
Grants Management Branch
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Room 3131, MSC 9541
Bethesda, MD 20892-9541
Telephone: (301) 443-6710
FAX : (301) 594-6847
E-mail: gf6s@nih.gov
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant application
instructions and forms (rev. 5/2001). 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) 435-0714,
Email: GrantsInfo@nih.gov.
APPLICATION RECEIPT DATES: Applications submitted in response to this program
announcement will be accepted at the standard application deadlines, which
are available at http://grants.nih.gov/grants/dates.htm. Application
deadlines are also indicated in the PHS 398 application kit.
SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting
up to $250,000 per year in direct costs must be submitted in a modular grant
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 grants. Additional information on modular
grants is available at
http://grants.nih.gov/grants/funding/modular/modular.htm.
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of
the application, including the checklist, and threesigned 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)
At the time of submission, two additional copies of the application must be
sent to:
Director, Office of Extramural Affairs
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3158, MSC 9547
Bethesda, MD 20892-9547
Rockville, MD 20852 (for express/courier service)
APPLICATION PROCESSING: Applications must be mailed on or before the receipt
dates described at
http://grants.nih.gov/grants/funding/submissionschedule.htm. The 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.
Prior to submitting an application, investigators are strongly encouraged to
contact the program contact listed under INQUIRIES in order to assess the
responsiveness of their proposed project to the mission of NIDA and to the
goals of this PA.
Sections a-d of the Research Plan must not exceed ten pages in total.
No appendix materials are to be submitted.
PEER REVIEW PROCESS
Applications submitted for this PA will be assigned 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:
o Receive a written critique
o 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
o Receive a second level review by the National Advisory Council on Drug
Abuse
REVIEW CRITERIA
The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health. In
the written comments, reviewers will be asked to discuss the following
aspects of the application in order to judge the likelihood that the proposed
research will have a substantial impact on the pursuit of these goals:
o Significance
o Approach
o Innovation
o Investigator
o Environment
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. The application does not need to be strong in all
categories to be judged likely to have major scientific impact and thus
deserve a high priority score. For example, an investigator may propose to
carry out important work that by its nature is not innovative but is
essential to move a field forward.
SIGNIFICANCE: Does this study address an important problem?
APPROACH: Are the conceptual framework, design, methods, and analyses
adequately developed, well integrated, and appropriate to the aims of the
project?
INNOVATION: Does the project employ novel concepts, approaches, or methods?
INVESTIGATOR: Is the investigator appropriately trained and well suited to
carry out this work?
ENVIRONMENT: Does the scientific environment in which the work will be done
contribute to the probability of success?
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following
items 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
Applications submitted in response to a PA will compete for available funds
with all other recommended applications. The following will be considered in
making funding decisions:
o Scientific merit of the proposed project as determined by peer review
o Availability of funds
o Relevance to program priorities
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
MONITORING PLAN AND DATA AND SAFETY MONITORING BOARD: Research components
involving Phase I and II clinical trials must include provisions for
assessment of patient eligibility and status, rigorous data management,
quality assurance, and auditing procedures. In addition, it is NIH policy
that all clinical trials require data and safety monitoring, with the method
and degree of monitoring being commensurate with the risks (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 clinical research 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 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.
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.
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 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). 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://grants1.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.
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