NIDA NEUROPROTEOMICS RESEARCH CENTERS (NIDA NPRCs)
RELEASE DATE: April 28, 2003 (see addendum NOT-DA-03-006)
RFA NUMBER: DA-04-004
National Institute on Drug Abuse (NIDA)
(http://www.nida.nih.gov)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.279
LETTER OF INTENT RECEIPT DATE: September 24, 2003
APPLICATION RECEIPT DATE: October 24, 2003
THIS REQUEST FOR APPLICATIONS (RFA) CONTAINS THE FOLLOWING INFORMATION
o Purpose of this RFA
o Research Objectives
o Mechanism of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS RFA
The National Institute on Drug Abuse is requesting applications for the
support of Neuroproteomics Research Centers (NPRCs). These Centers
should be built around scientific themes that address questions
relevant to the mission of the National Institute on Drug Abuse. The
Centers will support already existing neuroscience research, provide
training in proteomics technologies and develop new proteomics
technologies. The objective of this program is to provide technical
and administrative support for proteomics Centers in order to increase
the accessibility of the Centers to neuroscience researchers at
institutions with a demonstrated need for such a resource, to develop
new or improve existing proteomics technologies that would be applied
to the analysis of tissues of the nervous system and promote sharing of
information with the scientific community.
While Centers should be at institutions that have extensive ongoing
neurobiology research, they will not be restricted to working solely
with investigators from their own institution. The objectives in
establishing these Centers are to: (1) provide neurobiologists with the
ability to benefit from proteomics experiments, (2) build a cadre of
proteomics experts who will develop expertise in analyzing neural
tissues, and (3) develop new or improve existing proteomics
technologies as they relate to neurobiology or tissues of the nervous
system.
This announcement does not support the purchase of large pieces of
equipment ($100,000 +). Investigators may seek funding from the
National Center for Research Resources at the NIH for the purchase of
equipment. http://www.ncrr.nih.gov/rsrch_funding.asp
RESEARCH OBJECTIVES
Background:
Proteomics is generally defined as the study of the complement of
proteins produced by a given tissue, cell or subcellular organelle
under specific conditions. The proteome is not simply a catalog of
proteins, but also subsumes the post-translational modifications and
relative quantities of proteins. Ideally the entire proteome of a cell
or tissue would be examined, but in reality one is only able to look at
a subset of the proteome. That subset is defined by either the
investigator who selects a population of proteins based on some
intrinsic or extrinsic characteristic, or by limitations of the
technology or a combination of the two. In spite of these limitations,
proteomics is an extraordinarily powerful way to approach a scientific
question in that proteomics experiments presuppose very little about
the outcome of the experiment. As the hypotheses of proteomics
experiments are much broader than those of traditional experiments,
results from proteomics experiments can generate new hypotheses or help
guide current ideas. Furthermore, as a more global analysis of a
system, proteomics lends itself to the identification of multi-
component systems such as mechanistic pathways and signal transduction
cascades. By monitoring changes in the proteome that occur with a given
disease or treatment, one may gain insight into the mechanisms of
health and disease.
Current technology requires a significant financial and educational
investment to obtain, manage and interpret high quality data. Thus, it
is not feasible or practical for individual investigators to establish
such a resource for use by their laboratory alone. Furthermore,
information gathered from a single proteomics experiment provides a
wealth of information for subsequent hypothesis-driven experiments. By
providing a shared facility, a greater number of neuroscience
researchers will have the opportunity to benefit from these
information-rich experiments. Whenever possible, applicants are
encouraged to build the Center around a specific neuroscience theme
that will facilitate integration and synergy among the Center's
collaborators. In addition to the collaborative efforts of the Centers
with the neuroscience community, the scientific cores are expected to
develop new technology that will improve the analysis of samples
relevant to neuroscience research.
This announcement focuses on supporting Centers that will assist
neuroscientists in identifying additional targets and markers toward
which future research can be directed.
Areas of Scientific Interest -
A Center should be thematically integrated. Each project should
benefit from the other components of the Center. The Center components
may include, but are not limited to:
o Long-term changes in CNS associated with substance abuse to identify
proteins that may be involved in molecular mechanisms of relapse
o The use of proteomics to identify common cellular mechanisms
triggered by different substances of abuse
o Studies directed toward understanding signal transduction in cells
of the CNS and how the cascades differ with exposure to drugs of
abuse
o Studies designed to identify possible therapeutic target proteins
for the treatment of drug abuse
o Changes in CNS associated with HIV/AIDS and/or HCV infection and the
effects of drugs of abuse on disease progression, pathology and
treatment
o Studies directed toward understanding neural plasticity such as
proteomics on the post-synaptic density, dendrites and presynaptic
terminals of neurons from various states of drug exposure
o Proteomics of cytoskeletal proteins in neurons and glia involved in
mediating the addictive process
o Proteomics of the effect of drugs of abuse on regulating
extracellular matrix proteins and adhesion molecules
o Studies on the proteomics of drug-induced neurotoxicity or
neuroprotection
o Studies defining how drugs of abuse affect the processes of
exocytosis and endocytosis
o Studies directed toward understanding the effects of drugs of abuse
on development
o Proteomic approaches to identifying peptides and proteins secreted
by glia in response to drugs of abuse
o Studies to evaluate effects of therapeutics for substance abuse
o Proteomic analysis of the proteins involved in mRNA trafficking in
neurons and glia
o Proteomics of neuronal and glial transcription factors and chromatin
regulation
o Studies that identify molecular changes in the proteome that
correlate with changes in behavior
o Studies of genetic effects on the proteome of CNS cells or tissue
o Proteomics as a diagnostic or prognostic tool for CNS diseases
o Proteomics of membrane proteins
o Analysis of lipid raft and caveolae using proteomic approaches
Additionally, given the scientific evidence on sex differences in
genetic factors of drug abuse, NIDA encourages the evaluation of data
to determine if there are sex differences in the proteomes analyzed.
Areas of Interest in Technology Development -
It is recommended that a Center focus its technology development
efforts on select aspects of technology that capitalize on the
strengths of the research team. Areas of interest in proteomics
technology development include, but are not limited to:
o Methods to improve analysis of low copy number proteins
o Methods that improve the quality of absolute or relative
quantitative data
o Methods that increase dynamic range of analysis
o Methods that allow functional analysis of a proteome
o Methods that improve in situ proteomic analysis
o Development of new separations technology including isolation of
cellular or subcellular components from neural samples
o Development of new, high throughput technology for analyzing
protein-protein interactions
o Improved methods or software for the analysis of complex mixtures
o Development of technology for real time proteomics in culture
systems
o Development of "turn-key" technology such as protein chips for
neuroproteomics
o Improvements in the analysis of traditionally difficult proteins
such as very acidic, very alkaline or hydrophobic proteins
o Development of software or hardware that will increase efficiency
Evaluation Of Progress Following Grant Award -
Among the criteria used for evaluation of progress are the following:
o Number and quality of publications on which this grant is cited each
year, whether or not the Center PI is listed as a co-author
o New technology developed by the Center
o New technology implemented by the Center
o Overall benefit to the neuroscience community
o Sharing of data and resources with the neuroscience community
MECHANISM OF SUPPORT
This RFA will use NIH Center Core grant (P30) award mechanism. As an
applicant you will be solely responsible for planning, directing, and
executing the proposed project. This RFA is a one-time solicitation.
Future unsolicited, competing-continuation applications based on this
project will compete with all investigator-initiated applications and
will be reviewed according to the customary peer review procedures.
The anticipated award date is July 2004. Applications that are not
funded in the competition described in this RFA may be resubmitted as
NEW investigator-initiated applications using the standard receipt
dates for NEW applications described in the instructions to the PHS 398
application.
This RFA will support the establishment of Neuroproteomics Research
Centers (P30) at institutions with a demonstrated need for such a
Center. Each application at a minimum must contain the following: a
protein separations core, a protein identification core, a
bioinformatics core and an administrative core. Each core, except the
administrative core, will be required to devote no less than 20 percent
effort and no more than 40 percent effort to technology development for
the improvement of the analysis of samples relevant to neuroscience.
Technology development will be one of the criteria on which the
competitive and noncompetitive renewal will be assessed.
The Center must be able to demonstrate that it will collaborate with at
least two other funded projects (e.g. R01 grants) and these projects
must be described in summary form in the application. The projects need
not be limited to researchers at the applicants' institutions.
This RFA uses just-in-time concepts. This program does not require
cost sharing as defined in the current NIH Grants Policy Statement at
https://grants.nih.gov/archive/grants/policy/nihgps_2001/part_i_1.htm.
FUNDS AVAILABLE
NIDA intends to commit approximately $2.5 million in FY 2004 to fund 1
to 3 new and/or competitive continuation grants in response to this
RFA. An applicant may request a project period of up to five years.
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 NIDA provide support for this program, awards pursuant to this RFA
are contingent upon the availability of funds and the receipt of a
sufficient number of meritorious applications. At this time, it is not
known if this RFA will be reissued.
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
o Faith-based or community-based organizations
To be eligible, the application must list qualified personnel to
implement proteomics experiments. The institutions must have a
neuroscience constituency with substantial ongoing research in the
various subdisciplines of neuroscience. The Center must be able to
demonstrate that it will collaborate with at least two other funded
projects (e.g. R01 grants) and these projects must be described in
summary form in the application. The projects need not be limited to
researchers at the applicants' institutions, however large numbers of
collaborators from distant institutions are discouraged.
The applicant must clearly demonstrate how a proteomics research core
Center would enhance the individually funded projects and improve
programmatic coherence, synergy, and integration. Applicants must
demonstrate the potential for the continuation of funding of the
individual projects included in the Center application, and each
project must have at least two years of funding remaining at the time
of submission. Pilot projects will not be supported under the P30
mechanism.
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.
To be eligible, a PI must have the technical background and the
administrative skills needed to operate a proteomics Center. The
applicant must have substantial experience in the experimental design,
implementation and interpretation of proteomic data. The applicant
must be able to devote no less than a total of 25 percent effort to the
Center.
SPECIAL REQUIREMENTS
Key to a successful Center is the implementation of a well-designed
management plan. Internal and external advisory boards are
recommended for providing guidance regarding administrative issues that
arise when managing a Center with multiple users. It is also important
that at least one member of the Center work closely with the Center
project PIs after data is generated. While this requires more time on
the part of Center personnel, it ultimately lends itself to a more
productive environment. The complexity of proteomics data and the
statistical analysis needed for some experiments requires much more
interaction between the proteomics research team and the neuroscience
research team.
In addition to the science addressed in the application, the PI should
consider the following questions:
Communication:
How will Center project PIs interact with the individual cores, if at
all? At what stage of the experimental design will the Center director
or core directors work with the Center users? Who will be responsible
for various aspects of data analysis (e.g. interpretation of technical
data or statistical interpretation of large data sets)? What will the
format be for joint review of the data by the Center members and the
Center users? How will the efforts of the various core components be
coordinated? How will the cores and the core leaders interact and
communicate with one another? How will the PIs participating in the
Center be informed about guidelines and expectations? How will
summarizing progress and potential problems be communicated to P30
participants? Will the Center do anything to foster communication
and/or collaboration among Center users?
Administration:
How will the Center recruit users and prioritize projects? Who will
advise the Center regarding the merit of the biological questions being
asked by the various Center users? How will new administrative
functions be developed? How will progress be assessed? What are the
plans for regularly scheduled seminars/meetings/progress reports? How
will these meeting be used to train junior investigators? How will
ongoing strategic planning for the Center be conducted? How will the
director ensure proper budget management and necessary oversight? How
will the Center ensure proper regulatory guidelines are followed: Human
Subject/IRB approval if human subjects are used?
Data Sharing:
How will data be annotated, managed, archived and queried? How will
Center users access their own data (e.g. via intra- or internet
connection or through local computers)? Will the users be able to
manipulate the data and if so are there software licensing issues?
Will the format of the data be raw or summarized? How and when will
the data be shared with the scientific community? How will the Center
enforce data sharing obligations? NIDA strongly encourages full and
open access to well annotated data from control/normal samples.
Also see data sharing requirements under ADDITIONAL CONSIDERATIONS.
Advisory boards:
Are the administrative functions of the internal advisory and external
advisory boards well developed? What is the expertise of the external
advisory board? What are the functions of the external advisory board?
How will progress and problems be communicated by the director to
members of external advisory board before each meeting with the
external advisory board?
What will be the frequency and regularity of the meetings among core
heads and internal advisory board? What will be discussed? How will
conflicts be resolved within the Center? How will the core directors
work with the internal/external advisory boards to draft guidelines of
Center operations and oversight?
Technology:
Are the aims for technical development appropriate for nervous system
tissue samples? How will quality control be maintained? How many
proteomics experiments are anticipated per year? How will new issues in
neuroproteomics be identified? How frequently will the directors of the
Center interact with the office of technology transfer and their
institutions about issues surrounding intellectual property?
Scientific Cores:
How will technology developed in one core affect the other cores in the
Center? What are the qualifications of the core directors? Do any of
the core directors have a history of collaboration with one another?
Do any of the core directors have a history of collaboration with
prospective Center users and if so how will that affect prioritization
of projects?
WHERE TO SEND INQUIRIES
We encourage inquiries concerning this RFA 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:
Christine Colvis, 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
Rockville, MD 20852 (for express or courier service)
Telephone: (301) 435-1323
Fax: (301) 594-6043
Email: ccolvis@nida.nih.gov
o Direct your questions about 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
Rockville, MD 20852 (for express or courier service)
Telephone: (301) 443-2755
FAX: (301) 443-0538
Email: tl25u@nih.gov
o Direct your questions regarding financial 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
Email: gf6s@nih.gov
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that
includes the following information:
o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel
o Participating institutions
o Number and title of this RFA
Although a letter of intent is not required, is not binding, and does
not enter into the review of a subsequent application, the information
that it contains allows NIDA staff to estimate the potential review
workload and plan the review.
The letter of intent is to be sent by the date listed at the beginning
of this document. The letter of intent should be sent to:
Director
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Room 3158, MSC 9547
Bethesda, MD 20892-9547
Rockville, MD 20852 (for express or courier service)
Telephone: (301) 443-2755
FAX: (301) 443-0538
Email: tl25u@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 https://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
USING THE RFA LABEL: The RFA label available in the PHS 398 (rev.
5/2001) application form must be affixed to the bottom of the face page
of the application. Type the RFA number on the label. Failure to use
this label could result in delayed processing of the application such
that it may not reach the review committee in time for review. In
addition, the RFA title and number must be typed on line 2 of the face
page of the application form and the YES box must be marked. The RFA
label is also available at:
https://grants.nih.gov/grants/funding/phs398/label-bk.pdf.
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)
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/NIH/DHHS
6001 Executive Boulevard, Room 3158, MSC 9547
Bethesda, MD 20892-9547
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-2755
FAX: (301) 443-0538
Email: tl25u@nih.gov
APPLICATION PROCESSING: Applications must be received on or before the
application receipt date listed in the heading of this RFA. If an
application is received after that date, it will be returned to the
applicant without review.
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.
The Center for Scientific Review (CSR) will not accept any application
in response to this RFA that is essentially the same as one currently
pending initial review, unless the applicant withdraws the pending
application. However, when a previously unfunded application,
originally submitted as an investigator-initiated application, is to be
submitted in response to an RFA, it is to be prepared as a NEW
application. That is the application for the RFA must not include an
Introduction describing the changes and improvements made, and the text
must not be marked to indicate the changes. While the investigator may
still benefit from the previous review, the RFA application is not to
state explicitly how.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by the CSR
and responsiveness by NIDA. Incomplete and/or non-responsive
applications will be returned to the applicant without further
consideration.
Applications that are complete and responsive to the RFA will be
evaluated for scientific and technical merit by an appropriate peer
review group convened by NIDA in accordance with the review criteria
stated below. As part of the initial merit review, all applications
will:
o Receive a written critique
o Undergo a process in which only those applications deemed to have the
highest scientific merit, generally the top half of the 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 your 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 your 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,
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? 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? Is there evidence that the proposed
neuroproteomics Center is needed? If the aims in the technology
development are achieved, how will the neuroscience community benefit?
APPROACH: Are the conceptual framework, design, methods, and analyses
adequately developed, well integrated, and appropriate to the aims of
the project? Do you acknowledge potential problem areas and consider
alternative tactics? Are weaknesses acknowledged and alternative
approaches considered?
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? If other proteomics labs or facilities already exist at
the principal investigator's institution, how will this Center differ
and how will the facilities interact if at all? If other proteomics
labs or facilities already exist at the principal investigator's
institution, why is there a need for an additional proteomics resource?
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 core leaders?
ENVIRONMENT: Will the PI's institution cover the cost of equipment
maintenance? Does the scientific environment in which the work will be
conducted contribute to the probability of success? Do the proposed
experiments take advantage of unique features of the scientific
environment or employ useful collaborative arrangements? Do the
members of the external advisory committee seem appropriate? Is the
described role and extent of involvement of an external advisory
committee sufficient?
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. 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
DATA SHARING: The adequacy of the proposed plan to share data.
The NIH expects and supports the timely release and sharing of final
research data from NIH-supported studies for use by other researchers.
Starting with the October 1, 2003 receipt date, 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 data sharing is not possible. Applicants are encouraged to
discuss their data sharing plan with their program contact at the time
they negotiate an agreement with the Institute/Center (IC) staff to
accept assignment of their application as described at
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html.
Applicants are reminded that agreement to accept assignment of
applications over $500,000 must be obtained at least six weeks in
advance of the anticipated submission date. Reviewers will not factor
the proposed data-sharing plan into the determination of scientific
merit or priority score. Program staff will be responsible for
overseeing the data sharing policy and for assessing the
appropriateness and adequacy of the proposed data-sharing plan. Full
content of the final NIH statement on sharing of research data may be
found at https://grants.nih.gov/grants/guide/notice-files/
NOT-OD-03-032.html.
Also see Data Sharing under SPECIAL REQUIREMENTS
BUDGET: The reasonableness of the proposed budget and the requested
period of support in relation to the proposed research.
RECEIPT AND REVIEW SCHEDULE
Letter of Intent Receipt Date: September 24, 2003
Application Receipt Date: October 24, 2003
Peer Review Date: January/February 2004
Council Review: May 2004
Earliest Anticipated Start Date: July 2004
AWARD CRITERIA
Award criteria that will be used to make award decisions include:
o Scientific merit (as determined by peer review)
o Availability of funds
o Programmatic priorities.
o Geographic balance
REQUIRED FEDERAL CITATIONS
MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research
components involving Phases 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 Safety and Monitoring,
NIH Guide for Grants and Contracts, June 12, 1998:
https://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
(https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a
complete copy of the updated Guidelines are available at
https://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
https://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 https://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
https://grants.nih.gov/grants/stem_cells.htm and at
https://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.
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
https://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 https://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 RFA 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 https://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.