INTERACTIONS BETWEEN STEM CELLS AND THE MICROENVIRONMENT IN VIVO
RELEASE DATE: September 16, 2003
PA NUMBER: PAS-03-172 (This PA has been reissued, see PAS-05-092)
EXPIRATION DATE: February 1, 2005
Department of Health and Human Services (DHHS)
PARTICIPATING ORGANIZATIONS:
National Institutes of Health (NIH)
(http://www.nih.gov)
COMPONENTS OF PARTICIPATING ORGANIZATIONS:
National Institute of Neurological Disorders and Stroke (NINDS)
(http://www.ninds.nih.gov)
National Institute on Drug Abuse (NIDA)
(http://www.nida.nih.gov)
National Institute of Deafness and Other Communication Disorders (NIDCD)
(http://www.nidcd.nih.gov)
National Institute of Alcohol Abuse and Alcoholism (NIAAA)
(http://www.niaaa.nih.gov)
National Institute on Aging (NIA)
(http://www.nia.nih.gov)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S):
93.853 (NINDS), 93.279 (NIDA), 93.173 (NIDCD), 93.273 (NIAAA), 93.866 (NIA)
THIS PA CONTAINS THE FOLLOWING INFORMATION
o Purpose of the PA
o Research Objectives
o Mechanism(s) of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Submitting an Application
o Supplementary Instructions
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS PA
National Institute of Neurological Disorders and Stroke (NINDS), the National
Institute on Drug Abuse (NIDA), the National Institute of Deafness and Other
Communication Disorders (NIDCD) the National Institute of Alcohol Abuse and
Alcoholism (NIAAA), and the National Institute on Aging (NIA) invite
applications for studies on the cellular and molecular signaling between the
local environment within organisms and stem and progenitor cells that are
either introduced as transplants or are normally resident within host tissues
and organs. The objective of this initiative is to promote a thorough
exploration and characterization of the bi-directional communication between
multipotent cells and the three-dimensional local milieu or niche that they
encounter in vivo under normal and compromised states, such as with aging or
following injury, disease or drug exposure. Of particular interest is the
rigorous characterization of how interactions with localized cues in space
and time regulate stem cell survival, migration, replication and 'plasticity'
in the nervous system and other parts of the body. Projects that address
comparisons between the responses of stem cells within niches in the
developing and mature or aging nervous system in vivo, or in host
microenvironments modified by injury, disease, or by exposure to drugs and
alcohol would also be directly relevant to this Program Announcement with
Set-aside (PAS), as are studies to compare different classes of stem cells or
progeny at progressively more advanced stages of differentiation when placed
in the same sites in vivo.
RESEARCH OBJECTIVES
Unlike organs such as the skin and the gut that self-renew throughout life,
the nervous system in adult mammals is restricted in its ability to replace
neurons and glia that have been lost through injury, disease, alcohol and
drug abuse or even advancing age. Stem cell research offers enormous
potential for treating many congenital, developmental, psychiatric or
degenerative diseases of the nervous system for which there are no treatments
or cures. Under the appropriate tissue culture conditions, a variety of
multipotent cells appear to acquire many properties of neurons and glia a
first step toward developing cell replacement therapies for neurological
dysfunction. The discovery of endogenous stem cells, residing either within
the nervous system or in other tissues raises the possibility that these
intrinsic systems may be harnessed to restore defective cells and functions.
In both cases the expectation is that, when exposed to the optimal
microenvironment in vivo, endogenous or transplanted stem cells will
differentiate in a manner appropriate to the local brain region, and
integrate with the existing circuits in the nervous system.
The past decade has seen enormous progress in our understanding of the
specific requirements of stem cells to proliferate and differentiate along
specified lineages. This progress has been made possible by the discovery of
myriad growth factors and substrate conditions followed by careful testing in
culture. Unfortunately, the behavior of cells in tissue culture does not
adequately predict how these same cells will behave when transplanted into
the living host where multiple known and unknown factors converge to
influence the biological process. We do not know the whole spectrum of
factors present in vivo that influence cell fate. Effective use of stem and
progenitor cells for therapeutic purposes hinges on their ability to thrive,
integrate, and function in a biologically meaningful manner in vivo without
causing adverse events. Therefore the next stage in developing cell
restoration therapy requires understanding how the newly generated cells will
behave within the host.
Recent reports indicate that the "niche" or local microenvironment that a
stem cell encounters governs its behavior and fate. For example, adult
neural stem cells produced neurons when transplanted into the neurogenic zone
of the hippocampus, but produced astrocytes in the environment of the spinal
cord. Further investigation showed that a specific component of the local
environment, the regional astrocytes from the hippocampus were capable of
instructing these stem cells to adopt a neuronal fate in vitro. In addition
to regional differences within the nervous system, the microenvironment
encountered by a stem cell may vary as a function of age of the host
organism. Similarly, alteration of the niche by injury, drugs or other
circumstances is likely to affect the ability of transplanted stem cells to
survive, differentiate and integrate into existing neural circuitry.
Understanding these changes will be important in making decisions about the
use of cell replacement therapies in very young or elderly patients, in
patients with a history of alcohol or drug usage, or suffering from injury or
other neurological conditions.
Transplanted cells can act to influence and change host cells in their
vicinity. Stem cells may release agents that alter the activity or resiliency
of damaged host cells. These dynamic interactions are inevitable as living
cells and tissue contact, react and respond to each other in time and space.
Teasing out and understanding these interactions poses a major challenge that
must be faced in order to develop realistic cell replacement therapies and
enhance normal tissue regeneration.
Objectives and Scope
This Program Announcement with Set-Aside is intended to promote studies that
establish and identify the nature and action of microenvironmental cues in
the nervous system that regulate stem cell fate. This Program Announcement
specifically targets cellular, molecular and genetic mechanisms that act in
vivo to influence stem cell survival, homing/migration, adhesion,
differentiation, plasticity and tumorigenicity in both the central and
peripheral nervous systems. Applications that only propose in vitro studies
will not be responsive to this initiative.
The following examples illustrate areas that are of high interest; other
innovative projects are also encouraged. These examples of research
approaches are not meant to be all-inclusive or restrictive. Plans for data
and/or reagent sharing and promulgation of results will be integral to the
applications.
o Identification, localization and comparison of known or novel cues within
the developing, adult and aging nervous system that influence the mitotic
potential, cell cycle and differentiation of stem and progenitor cells along
specific lineages.
o Characterization of the cell-extrinsic and cell-intrinsic signaling
pathways and components involved in transducing the action of local cues on
stem and progenitor cells in vivo.
o Investigation of the causal relationship between site-specific changes of
endogenous cues resulting from injury, disease, exposure to alcohol, drugs of
treatment or abuse, and any resulting alterations of stem cell activity.
o Evaluation of the effects of external factors such as stress, exercise, or
an enriched versus impoverished living conditions on the microenvironment
within the host organism, and how these changes in microenvironment influence
the behavior of stem cells at different periods throughout the life span of
the organism.
o Investigation of local cellular interactions that determine and maintain
the structural and functional integration of progenitor cells into the host
nervous system and existing circuitry.
o Development of assays facilitating the discovery of novel endogenous
signals that modulate stem cell behavior and fate, as well as signals
generated by stem cells that regulate components of the local host tissue.
These may include the development of measures (physiological, behavioral,
neurochemical, imaging) to evaluate the integration and function of
progenitor cells in the developing, adult and aging nervous system.
o Assessment of the short and long-term local effects of the interactions
between the immune system and glial reactions gendered in response to the
infiltration of stem cells and their progeny in the host.
The NIDA is interested in how drugs of abuse and factors such as stress and
environment affect the behavior of stem cells and the functional consequences
of such alterations, which might be related to the cognitive impairments,
developmental deficits, neuroadaption and addictive behaviors seen in drug
abuse. The NIDCD is particularly interested in stem cell research
targeting the various peripheral components of the auditory (hearing),
olfaction (smell) and gustatory (taste) systems. The NIAAA is interested in
how alcohol exposure alters the biochemical environment of tissues, thus
interfering with the capacity of stem cells to establish contact,
differentiate and function in target tissue. The NIA is interested in stem
cell research and neurogenesis in the aging nervous system with emphasis on
basic neurobiology, motor and sensory systems, integrative neurobiology,
cognition and the dementias of aging, particularly Alzheimer's disease.
MECHANISM(S) OF SUPPORT
This PAS will use the NIH Exploratory/Developmental Grant (R21) and the
Research Project Grant (R01) award mechanisms. As an applicant, you will be
solely responsible for planning, directing, and executing the proposed
project. The proposed project period during which the research will be
conducted should adequately reflect the time required to accomplish the
stated goals and should be no more than 5 years for R01 grants. The R21
grants are one-time awards to support innovative, high impact research
projects that would either 1) generate pilot data to assess the feasibility
of a novel avenue of investigation, 2) involve high risk experiments that
could lead to a breakthrough in a particular field, or 3) demonstrate the
feasibility of new technologies that could have major impact in a specific
area. Support for the R21 grants is limited to two years with a cumulative
maximum of $275,000 direct costs requested for both years. This program is
appropriate both for new investigators seeking to establish independent
research careers and for established investigators wishing to explore new
areas of neuroscience or develop novel technologies. For further information
on the R21 mechanism, including Institute-specific information, see
http://grants.nih.gov/grants/guide/pa-files/PA-03-107.html
This PAS 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.
FUNDS AVAILABLE
The participating ICs have set aside a total of $2 million dollars per year
to support this initiative. The amount and timing of awards paid from set
aside funds will depend on the overall scientific merit of the applications
and the availability of funds throughout the duration of this solicitation (2
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 IC(s) provide
support for this program, awards pursuant to this PAS are contingent upon the
availability of funds and the receipt of a sufficient number of meritorious
applications.
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
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.
SPECIAL REQUIREMENTS
Upon initiation of the program, the participating institutes will sponsor an
annual meeting to encourage the exchange of information among investigators
who participate in this program. In the preparation of the budget for the
grant application, applicants should REQUEST ADDITIONAL TRAVEL FUNDS for one
meeting each year to be held in Bethesda, Maryland. Applicants should also
include a statement in the applications indicating their willingness to
participate in such meetings. Applicants are also strongly encouraged to
include plans for data and/or reagent sharing and promulgation of results.
WHERE TO SEND INQUIRIES
We encourage your inquiries concerning this PAS 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:
Arlene Y. Chiu, Ph.D.
Program Director,
Repair and Plasticity Program
National Institute of Neurological Disorders and Stroke
Neuroscience Center, Room 2207, MSC 9525
Bethesda, MD 20892-9525
Telephone: (301) 496-1447
FAX: (301) 480-1080
Email: chiua@ninds.nih.gov
Geraline C. Lin, Ph.D.
Division of Neuroscience and Behavioral Research
National Institute on Drug Abuse
6001 Executive Boulevard
Room 4282, MSC 9555
Bethesda, MD 20892-9555
Telephone: (301) 435-1305
FAX: (301) 594-6043
Email: glin@nida.nih.gov
Barry Davis, Ph.D.
Director, Taste and Smell Program
National Institute of Deafness and Other Communication Disorders
6120 Executive Boulevard, Room 400-C, MSC-7180
Rockville, MD. 20892-7180
Telephone: (301) 402-3464
FAX: (301) 402-6251
Email: davisb1@nidcd.nih.gov
Sam Zakhari, Ph.D.
Director, Division of Basic Research
National Institute of Alcohol Abuse and Alcoholism
6000 Executive Boulevard, Suite 402, MSC 7003
Bethesda, MD 20892-7003
Telephone: (301) 443-0799
FAX: (301) 594-0673
Email: sz14w@nih.gov
Bradley C. Wise, Ph.D.
Program Director, Fundamental Neuroscience
Neuroscience and Neuropsychology of Aging Program
National Institute on Aging
7201 Wisconsin Avenue, Suite 350 MSC 9205
Bethesda, MD 20892-9205
Telephone: (301) 496-9350
FAX: (301) 496-1494
Email: wiseb@nia.nih.gov
o Direct your questions about financial or grants management matters to:
Michael J. Loewe
Chief, Grants Management Branch
National Institute of Neurological Disorders and Stroke
6001 Executive Blvd., Suite 3290, MSC 9537
Bethesda, MD 20892-9537
Telephone: (301) 496-9231
FAX: (301) 402-0219
Email: ml70m@nih.gov
Or to
Gavin Wilkom
Grants Management Specialist
Grants Management Branch, DER
National Institute of Neurological Disorders and Stroke
Neuroscience Center, 6001 Executive Blvd. Room 3250, MSC 9537
Bethesda MD, 20892
Telephone: (301) 496-7480
FAX: 301-402-0219
Email: gw62m@nih.gov
Michael Costa
Grants Management Specialist
Grants Management Branch
National Institute on Drug Abuse
6001 Executive Boulevard
Room 3131, MSC 9541
Bethesda, MD 20892-9541
Telephone: (301) 435-1354
Fax: (301) 594-6849
Email: mcosta@nida.nih.gov
Ms. Sara Stone
Chief, Grants Management Branch
Division of Extramural Research
National Institute of Deafness and Other Communication Disorders
Executive Plaza South 400C
6120 Executive Blvd. MSC-7180
Bethesda, MD 20892-7180
Telephone: (301) 402-0909
Fax: (301) 402-0219
Email: stones@nidcd.nih.gov
Judy Fox Simons
Chief, Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard, Suite 504
Bethesda, MD 20892-7003
Telephone: (301) 443-4704
Fax: (301) 443-3891
E-mail: jsimons@willco.niaaa.nih.gov
Linda Whipp
Grants and Contracts Management Office
National Institute on Aging
7201 Wisconsin Avenue, Suite 2N212 MSC 9205
Bethesda, MD 20892-9205
Telephone: (301) 496-1472
Fax: (301) 402-3672
E-mail: whippl@nia.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) 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 BUDGET GRANT APPLICATIONS: Applications
requesting up to $250,000 per year in direct costs must be submitted in a
modular budget grant format. The modular budget 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 the 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 the IC staff that the IC will accept your
application for consideration for award; and,
3) Identify, in a cover letter sent with the application, the staff member
and 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 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 PAS 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 unfunded version 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 PAS 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 the 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 evaluate 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 the following criteria in assigning
the 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, 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? 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?
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 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?
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
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 REVIEW CONSIDERATIONS
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.
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
DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for
all types of clinical trials, including physiologic, toxicity, and dose-
finding studies (phase I); efficacy studies (phase II), efficacy,
effectiveness and comparative trials (phase III). The establishment of data
and safety monitoring boards (DSMBs) is required for multi-site clinical
trials involving interventions that entail potential risk to the
participants. (NIH Policy for Data and Safety Monitoring, NIH Guide for
Grants and Contracts, June 12, 1998:
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
SHARING RESEARCH DATA: Starting with the October 1, 2003 receipt date,
investigators submitting an NIH application seeking more than $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 "NIH Guidelines
for Inclusion of Women and Minorities as Subjects in Clinical Research -
Amended, October, 2001," published in the NIH Guide for Grants and Contracts
on October 9, 2001
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines are available at
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the new PHS Form 398; and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that:
a) all applications or proposals and/or protocols must provide a description
of plans to conduct analyses, as appropriate, to address differences by
sex/gender and/or racial/ethnic groups, including subgroups if applicable;
and b) investigators must report annual accrual and progress in conducting
analyses, as appropriate, by sex/gender and/or racial/ethnic group
differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS:
The NIH maintains a policy that children (i.e., individuals under the age of
21) must be included in all human subjects research, conducted or supported
by the NIH, unless there are scientific and ethical reasons not to include
them. This policy applies to all initial (Type 1) applications submitted for
receipt dates after October 1, 1998.
All investigators proposing research involving human subjects should read the
"NIH Policy and Guidelines" on the inclusion of children as participants in
research involving human subjects that is available at
http://grants.nih.gov/grants/funding/children/children.htm.
REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH
policy requires education on the protection of human subject participants for
all investigators submitting NIH proposals for research involving human
subjects. You will find this policy announcement in the NIH Guide for Grants
and Contracts Announcement, dated June 5, 2000, at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research
on hESCs can be found at http://stemcells.nih.gov/index.asp and at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only
research using hESC lines that are registered in the NIH Human Embryonic Stem
Cell Registry will be eligible for Federal funding (see http://escr.nih.gov).
It is the responsibility of the applicant to provide, in the project
description and elsewhere in the application as appropriate, the official NIH
identifier(s)for the hESC line(s)to be used in the proposed research.
Applications that do not provide this information will be returned without
review.
PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The
Office of Management and Budget (OMB) Circular A-110 has been revised to
provide public access to research data through the Freedom of Information Act
(FOIA) under some circumstances. Data that are (1) first produced in a
project that is supported in whole or in part with Federal funds and (2)
cited publicly and officially by a Federal agency in support of an action
that has the force and effect of law (i.e., a regulation) may be accessed
through FOIA. It is important for applicants to understand the basic scope
of this amendment. NIH has provided guidance at
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this PA in a public
archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the
application. In addition, applicants should think about how to structure
informed consent statements and other human subjects procedures given the
potential for wider use of data collected under this award.
STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The
Department of Health and Human Services (DHHS) issued final 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 awards are
subject to the terms and conditions, cost principles, and other
considerations described in the NIH Grants Policy Statement. The NIH Grants
Policy Statement can be found at
http://grants.nih.gov/grants/policy/policy.htm.
The PHS strongly encourages all grant recipients to provide a smoke-free
workplace and discourage the use of all tobacco products. In addition,
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in
certain facilities (or in some cases, any portion of a facility) in which
regular or routine education, library, day care, health care, or early
childhood development services are provided to children. This is consistent
with the PHS mission to protect and advance the physical and mental health of
the American people.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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Department of Health and Human Services (HHS)
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NIH... Turning Discovery Into Health®
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