CROSS-DISCIPLINARY TRANSLATIONAL RESEARCH AT NIH
RELEASE DATE: June 9, 2004
PA NUMBER: PA-04-109
Update: The following update relating to this announcement has been issued:
December 7, 2006 - The R01 portion of this funding opportunity has been
replaced by PA-07-109, which now uses the electronic SF424 (R&R)
application for February 5, 2007 submission dates and beyond.
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. This announcement will stay active for
only the May 1, 2006 AIDS and AIDS-related application submission date for these
mechanisms. The non-AIDS portion of this funding opportunity for these mechanisms
expires on the date indicated below. Other mechanisms relating to this announcement
will continue to be accepted using paper PHS 398 applications until the stated
expiration date below, or transition to electronic application submission.
Replacement R03 (PA-06-322) and R21 (PA-06-321) funding opportunity announcements
have been issued for the submission date of June 1, 2006 and submission dates for
AIDS and non-AIDS applications thereafter.
EXPIRATION DATE for R03 and R21 Non-AIDS Applications: March 2, 2006
EXPIRATION DATE for R03 and R21 AIDS and AIDS-Related Applications: May 2, 2006
EXPIRATION DATE for R01 Non-AIDS Applications: November 2, 2006
EXPIRATION DATE for R01 AIDS and AIDS-Related Applications: January 3, 2007
Department of Health and Human Services (DHHS)
PARTICIPATING ORGANIZATION:
National Institutes of Health (NIH)
(http://www.nih.gov)
COMPONENTS OF PARTICIPATING ORGANIZATION:
National Institute on Drug Abuse (NIDA)
(http://www.nida.nih.gov)
National Cancer Institute (NCI)
(http://www.nci.nih.gov)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.279 (NIDA), 93.399 (NCI)
THIS PROGRAM ANNOUNCEMENT (PA) CONTAINS THE FOLLOWING INFORMATION
o Purpose of the PA
o Research Objectives
o Mechanisms 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
The National Institute on Drug Abuse (NIDA) is committed to
translating research findings into practice. As part of its
mission, NIDA facilitates the translation of basic or clinical
research discoveries in the field of drug abuse research into new
clinical and research tools, medications, and behavioral
therapies. The purpose of this PA is to foster research that will
have a practical impact on the treatment and prevention of drug
abuse through the development of new research technologies that
are based on existing basic and/or clinical research knowledge,
and technology transfer knowledge.
RESEARCH OBJECTIVES
The scope of this program announcement includes a range of
activities designed to extend basic or clinical research findings
to yield a knowledge base for the development of novel,
efficacious drug abuse prevention or treatment interventions. It
is envisioned that the research conducted under this PA will
primarily use laboratory studies with human volunteers. However,
it is possible that preclinical research studies may be relevant
to the objective of this PA and, as such, may be a logical
component of the work plan of an application. For example,
studies with animal models might be relevant to the discovery of
more details regarding the mode of action of a clinically used
medication, knowledge that, in turn, would allow development of
more specific medications. Medications development research, per
se, is not the focus of this PA.
Background:
Significant progress has been made in the development of drug
abuse prevention and treatment interventions. Nonetheless, many
youth continue to experiment with and become addicted to drugs
such as marijuana, cocaine, heroin, nicotine and amphetamine.
Drug abuse public health concerns tend to be of a persistent
nature. Part of the persistence of drug abuse is the result of
social barriers to treatment, such as the stigma attached to
replacement therapies (e.g., methadone) that inhibit treatment-
seeking behavior. For others, current prevention or treatment
options are ineffective: drug dependence occurs among
experimental drug abusers as their drug abuse behaviors escalate,
or abstinence is short-lived as drug abusers relapse to drug
abuse. A key requirement for the development of successful
prevention or treatment strategies is the characterization of new
assays, models, tools, and technologies. Basic behavioral and
cognitive research may also guide the development of new treatment
and prevention interventions. A great deal of basic science
knowledge exists, but has not yet been fully exploited in
prevention or treatment strategies. For example, many science-
based prevention programs have proven efficacious for significant
numbers of youth, yet more research is needed to elucidate reasons
why some individuals are non-responsive to such programs.
Differences in neurocognitive processes may contribute to
differential ability to process prevention related information,
and this needs to be explored.
As recent years have seen an explosion of fundamental insights in
the basic sciences, translating this knowledge into practical
advances has become a priority for NIDA. As such, the purpose of
this announcement is to foster research that furthers the
translation of existing knowledge into treatment and treatment
practice, or research that, in and of itself, will readily
translate to clinical research or practice. This PA is intended
to encourage projects that provide tools and resources that serve
as platforms for the development of effective prevention and
treatment strategies.
Collaboration of basic and applied investigators or between
clinical and health services investigators working towards a
common goal may produce new perspectives, insights and approaches
to improving drug abuse prevention and treatment. Behavioral
research, for example, has demonstrated the profound role that
conditioned cues play in drug addiction, and has shown that drug-
taking behavior is modified by environmental and situational
factors. The neurochemical systems mediating some of these
effects have been identified. As a second example, cognitive
science suggests an influence of higher-order mental processes in
decision-making expectancies and memories of drug use. Research
on neurocognitive processing and decision-making, particularly
among adolescents and young adults who may be at high risk for
drug use onset or drug dependency may contribute to the
development or refinement of intervention material. Outcomes from
treatment and basic research also suggest that there may be gender
differences in responses to interventions that could be examined
from a neuroscience perspective. As a third example, health
services research on technology transfer suggests that there are
financial, organizational, and management factors that may help to
explain differences in the rates and processes of uptake (i.e.,
exposure, adoption, implementation, sustained use) of new,
efficacious drug abuse prevention and treatment technologies among
community-based programs. Collaborations between basic and
applied researchers with diverse fields of interest, or between
clinical and health services researchers (e.g., health economists,
industrial/organizational psychologists, public health experts),
may aid in the development of innovative approaches to drug abuse
treatment or prevention and to the delivery of services to those
individuals who need them. Applications responsive to this PA
will include such collaborations.
Goals of such projects include, but are not limited to:
o Laboratory studies with human volunteers that are designed to
discover whether neurochemical or related mechanisms observed in
preclinical science can serve as important targets for the
treatment of drug addiction are needed. Agents to be tested might
interact with the primary drug effects (e.g., reinforcement,
craving, tolerance, withdrawal, etc.) and/or secondary drug
effects (e.g., conditioned reinforcement, cue-induced craving,
decision-making, etc.). Demographic factors, such as gender and
age, could be examined as moderators of identified effects.
o Laboratory studies, especially phase I clinical studies, with
human volunteers that evaluate drugs that are currently being used
to treat non-addiction disorders, but whose preclinical effects
indicate possible utility for treating drug abuse are needed.
Demographic factors, such as gender and age, could be examined as
moderators of identified effects.
o Studies that develop and evaluate new assessment or measurement
tools designed to measure various aspects of the addictive state,
including initiation, the transition from use to addiction,
dependency, craving, withdrawal or relapse are needed. These
tools will be important for further characterizing this disorder
and evaluating treatment outcomes.
o Discovery and evaluation of animal models that permit further
evaluation of candidate therapeutics, such as using animals that
have been modified genetically, chemically, or through any
intervention, that captures critical features of drug abuse are
needed. This may include individual vulnerability to drugs of
abuse, development of addiction, withdrawal, or relapse.
o Research that focuses on non-drug interventions that
specifically address the role of conditioned reinforcement,
craving, and relapse, as well as consciousness and higher-order
mental processes (e.g., decision-making) are needed. This
approach is envisioned to go beyond the contingency management and
cognitive behavioral treatments that have already been translated
and are currently used in clinical setting. It is anticipated
that these types of interventions will be used in combination with
existing addiction treatments to improve clinical outcomes.
Demographic factors, such as gender and age, could be examined as
moderators of identified effects.
o Studies that assess the effectiveness and utility of using
established basic behavioral and cognitive assessment paradigms
(e.g., measures of implicit cognition, inter-temporal choice,
semantic networks) in treatment intervention and in predicting
treatment outcomes and relapse are needed. This is envisioned to
go beyond cognitive assessments that have already been translated
and are currently used in clinical setting. For more extensive
development of behavioral therapies, please see PA-03-126
(http://grants.nih.gov/grants/guide/pa-files/PA-03-126.html )
o Development and testing of clinical tools for screening,
assessment, diagnosis, and treatment matching to improve the
targeting of treatment services, based on human laboratory studies
of individual, social, and environmental factors, as well as
studies of services characteristics.
o Development and testing of innovative prevention and treatment
services that can be used in a wide variety of non-specialty
health care settings to address drug abuse using untapped findings
on cognitive factors such as decision-making, automatic vs.
controlled thinking, affective mediators and modulators of
cognition.
o Development of models of longitudinal care including
medications, behavioral therapies, social services, and education
for defined populations, based on clinical research of long-term
patterns of drug use (e.g., cycles involving experimental use,
escalation, abuse, dependence, withdrawal, abstinence, relapse)
and long-term patterns of response to prevention and treatment
(e.g., time to relapse, triggers for relapse, response to social
support for abstinence) for these defined populations.
o Studies looking at the utility in the prevention and treatment
of drug abuse of approaches, technologies and strategies that have
been developed for other clinical conditions. For example,
virtual reality technologies are being used with success for some
clinical conditions (e.g. phobias, eating disorders), but not for
drug abuse prevention or treatment. Research examining how these
types of treatments might be used to prevent or treat drug abuse
is sought.
o Using discoveries from the basic biological (e.g.
neurobiological), psychological (e.g. emotional, behavioral,
cognitive, and developmental) and social (e.g. social learning,
peer network, and communications) sciences for developing and
testing innovative drug abuse prevention interventions.
o Development and testing of innovative methods for studying
adolescent decision-making related to drug use and sexual risk
behaviors that will apply more readily to real world settings.
MECHANISMS OF SUPPORT
This PA will use the National Institutes of Health (NIH) research
project grant (R01), small grant (R03) (PA-03-108: NIH SMALL RESEARCH
GRANT PROGRAM (R03)), and exploratory/developmental (R21) (PA-03-107:
NIH EXPLORATORY/DEVELOPMENTAL RESEARCH GRANT AWARD (R21)) award
mechanisms. As an applicant, you will be solely responsible for
planning, directing, and executing the proposed project.
Collaborations within and between research institutions are encouraged.
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, 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.
ELIGIBLE INSTITUTIONS
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 or foreign institutions/organizations
o Faith-based or community-based organizations
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 two areas: scientific/research and financial or grants
management issues:
o Direct your questions about scientific/research issues to:
Dr. Allison L. Chausmer
Division of Basic Neuroscience and Behavioral Research
National Institute on Drug Abuse, NIH, DHHS
6001 Executive Boulevard, Room 4282, MSC 9555
Bethesda, MD 20892-9555
Rockville, MD 20852 (for express/courier service)
Telephone: 301-402-5088
FAX: 301-594-6043
Email: achausme@nida.nih.gov
Dr. Jacqueline Stoddard
Tobacco Control Research Branch
National Cancer Institute, NIH, DHHS
6130 Executive Boulevard, Suite 440
Bethesda, Maryland 20892-7337
Rockville, Maryland 20852 (for express/courier service)
Telephone: 301-496-0274
FAX: 301-496-8675
Email: stoddaja@mail.nih.gov
o Direct your questions about financial or grants management matters
to:
Dr. Gary Fleming
Chief, Grants Management Branch
National Institute on Drug Abuse, NIH, DHHS
6101 Executive Boulevard, Room 270, MSC 8403
Bethesda, Maryland 20892-8403
Rockville, MD 20852 (for express/courier service)
Telephone: 301-443-6710
Fax: 301-594-6849
E-mail: GF6S@NIH.GOV
Ms. Crystal Wolfrey
Grants Administration Branch
National Cancer Institute, NIH, DHHS
6120 Executive Boulevard, Suite 243
Bethesda, MD 20892-7340
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496-8634
Fax: (301) 496-8601
E-mail: crystal.wolfrey@nih.gov
SUBMITTING AN APPLICATION
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: GrantsInfo@nih.gov.
The title and number of this program announcement must be typed on line
2 of the face page of the application form and the YES box must be
checked.
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.
SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER
YEAR: Applications requesting $500,000 or more in direct costs for any
year must include a cover letter identifying the NIH staff member
within one of NIH institutes or centers who has agreed to accept
assignment of the application.
Applicants requesting more than $500,000 must carry out the following
steps:
1) Contact IC program staff at least 6 weeks before submitting the
application, i.e., as you are developing plans for the study;
2) Obtain agreement from IC staff that IC will accept your application
for consideration for award; and,
3) Identify, in a cover letter sent with the application, the staff
member in IC who agreed to accept assignment of the application.
This policy applies to all investigator-initiated new (type 1),
competing continuation (type 2), competing supplement, or any amended
or revised version of these grant application types. Additional
information on this policy is available in the NIH Guide for Grants and
Contracts, October 19, 2001 at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html.
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten
original of the application, including the checklist, and five 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)
APPLICATION PROCESSING: Applications must be received by or 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.
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 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 written critique
o Receive a second level review by an appropriate national advisory
council or board.
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 your application 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 your application's overall
score, weighting them as appropriate for each application.
o Significance
o Approach
o Innovation
o Investigator
o Environment
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, you 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? If the
aims of your 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?
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?
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?
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 to that of other
researchers (if any)?
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 items will be considered in the determination of scientific
merit and 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)
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm.
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.
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).
ADDITIONAL REVIEW CONSIDERATIONS
BUDGET: The reasonableness of the proposed budget and the requested
period of support in relation to the proposed research.
Sharing Research Data
Applicants requesting more than $500,000 in direct costs in any year of
the proposed research are expected to include a data sharing plan in
their application. The reasonableness of the data sharing plan or the
rationale for not sharing research data will be assessed by the
reviewers. However, reviewers will not factor the proposed data sharing
plan into the determination of scientific merit or priority score.
(http://grants.nih.gov/grants/policy/data_sharing )
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.
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 (DSMB) 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).
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, 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.
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 AMENDMENT
"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.
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.
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.
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
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.
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 No. 93.279, and is not subject to the
intergovernmental review requirements of Executive Order 12372 or
Health Systems Agency review. Awards are made under authorization of
Sections 301 and 405 of the Public Health Service Act as amended (42
USC 241 and 284)(or other authorizations) and administered under NIH
grants policies described at
http://grants.nih.gov/grants/policy/policy.htm and under Federal
Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.
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
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