NEUROBIOLOGY OF PERSISTENT PAIN MEDIATED BY THE TRIGEMINAL NERVE
RELEASE DATE: September 16, 2003
PA NUMBER: PAS-03-173
March 2, 2006 (NOT-OD-06-046) Effective with the June 1, 2006 submission date,
all R03, R21, R33 and R34 applications must be submitted through Grants.gov using
the electronic SF424 (R&R) application. Accordingly, this funding opportunity
expires on the date indicated below. A replacement R21 (PAS-06-199)
funding opportunity announcement has been issued for the submission date
of June 1, 2006 and submission dates thereafter.
EXPIRATION DATE:
Expiration Date for R21 Applications: July 02, 2006
Expiration Date for R01 Applications: July 01, 2006, unless reissued.
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 of Dental and Craniofacial Research (NIDCR)
(http://www.nidcr.nih.gov)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): No. 93.853 (NINDS); 93.121
(NIDCR)
THIS PAS CONTAINS THE FOLLOWING INFORMATION
o Purpose of the PA
o Research Objectives
o Mechanism(s) of Support
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
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 of Neurological Disorders and Stroke (NINDS), along
with the National Institute of Dental and Craniofacial Research (NIDCR),
invite applications to advance our understanding of the neurobiology of
persistent pain mediated by the trigeminal nerve and to develop effective
therapeutic strategies to alleviate pain associated with disorders of
myofascial, nervous, or skeletal tissues of the head and face, which are
innervated by this nerve. The purpose of this initiative is to foster
research that addresses the mechanisms of pain onset, chronic pain
conditions, and responsiveness to pain therapy through novel basic and
clinical research. Current knowledge of the neurobiology and neurochemistry
of nociception, pain modulation and pain perception needs to be further
developed and correlated with clinical manifestations of craniofacial pain to
improve therapeutic strategies. This Program Announcement with Set-Aside
funds (PAS) contributes to the goals of the NIH Pain Consortium, which is co-
chaired by NINDS, NIDCR, and the National Institute of Nursing Research
(NINR).
RESEARCH OBJECTIVES
Chronic pain is a debilitating condition that adversely affects the lives of
millions of people. A diverse group of disorders arises from trauma,
pathology, structural or degenerative changes, and sometimes unknown causes
that affect the deep tissues of the head and face and often lead to severe,
chronic pain. The trigeminal brainstem complex, which processes nociceptive
input from craniofacial structures differs notably from spinal pain systems.
The unique nature of nociceptive processing and varied etiology of pain
conditions mediated by the trigeminal nerve contribute to the lack of
understanding of the basic mechanisms of pain onset, and the development of
chronic pain and abnormal pain responses (allodynia, hyperalgesia). These
conditions hinder the development of effective treatment strategies to
alleviate chronic pain in structures served by this nerve. Pain disorders
mediated by the trigeminal nerve are often associated with severe and
persistent pain of deep tissues, which may be of neuronal, muscular, joint,
or vascular origin. Chronic pain mediated by the trigeminal nerve complex is
a predominant feature of conditions such as migraine disorder, trigeminal
neuralgia (TN), temporomandibular disorders (TMD), and dry eye syndrome.
This diverse group of disorders involves neurochemical, physiological and
molecular changes associated with deep tissue and nerve injury, which are
signaled by the peripheral and central nervous system components of the
trigeminal nerve. This nerve conveys afferent signals of tactile, thermal,
and nociceptive stimuli from numerous structures of the head, including
facial skin, jaw musculature, temporomandibular joints, ears, cornea, dura,
and cranial vasculature. It also sends efferent signals that control the
muscles of mastication. Nociceptive processing by the trigeminal complex
differs from that by the spinal system serving the trunk and extremities:
Specialized structures of the head are innervated by unique fiber
contributions and nociceptive afferents are uniquely distributed and
connected within the trigeminal spinal nucleus. Currently, the pain
syndromes that involve the deep tissues of the head and face are categorized
primarily on symptomatic, rather than on pathophysiologic grounds.
Migraine is a disabling disorder, of which headache is one of several
components. Studies suggest that the trigeminal nerve complex provides the
signaling pathway for generation of pain associated with migraine. Pain
often manifests in the periorbital facial area, the somatic territory
innervated by the ophthalmic division of the trigeminal nerve. Afferents
arising from this division of the nerve also innervate proximal regions of
the cerebral blood vessels and meningeal vasculature and sinuses.
Stimulation of perivascular trigeminal sensory afferent fibers releases
vasoactive neuropeptides, which elicits dilation of the innervated vessels
and transduction of central nociceptive information. It has been suggested
that the pain experience may be generated by neurogenic inflammation of the
meninges or sensitization of central trigeminal neurons. Although the
chemical activation of these perivascular nerve fibers originates in deep
tissues, it is referred to the periorbital area by convergence of trigeminal
visceral and somatic fibers in the brainstem. The pain of migraine is
perceived in the somatic territory of the nerve.
Trigeminal neuralgia is characterized by intense pain arising from abnormal
processing of signals from one or more of the peripheral branches of the
trigeminal nerve. Innocuous stimuli to the territory innervated by the
trigeminal nerve, such as a light breeze or movement, may trigger sudden,
severe, electric shock-like or stabbing pain. Most often, the pain presents
intermittently, affecting one side of the jaw or cheek. The etiology of TN
remains uncertain, but one postulate is that vascular compression may occur
at the point of entry of the nerve into the brainstem. The compression is
thought to cause myelin damage leading to generation of abnormal impulses.
The pain is perceived as arising from tactile stimuli to the face, but may
actually be referred to the unaffected skin region from afferent signals
arising from nociceptive stimuli to deep muscular or vascular tissues.
Temporomandibular disorders encompass a group of conditions characterized by
orofacial pain and tenderness of the masticatory muscles, the
temporomandibular joint and associated structures, or both. Pain and
dysfunction most commonly are of myofascial origin, but may also arise from
intra-articular derangements, such as dislocation of the jaw, damage of the
condyle, or arthritic changes. Localization, duration and temporal patterns
of pain vary, but typically it is described as aching pain in the
temporomandibular region that persists beyond the duration of the
precipitating cause. The pain may be debilitating and may last for months or
even years.
Dry eye syndrome is a painful condition characterized by a chronic lack of
sufficient lubrication and moisture of the cornea. It may be associated with
damage to the trigeminal nerve and is often a symptom of systemic diseases
such as lupus and rheumatoid arthritis.
Craniofacial/deep tissue persistent pain conditions are diverse, but shared
objectives for future research directions on these disorders can be defined.
Appropriate mechanism-based models are needed to optimize basic and clinical
research. The factors that influence the age-at-onset and gender selectivity
associated with these conditions need to be identified and considered when
developing treatment strategies. Inadequate diagnostic criteria that often
lead to inappropriate or untimely treatment of these conditions need to be
better defined and used. A better understanding of the basic mechanisms
underlying the onset of pain, the shift to a chronic pain state and the
development of abnormal pain responses must be gained in order to develop
effective pain therapies. Progress towards effective pain management of
these disorders lags behind that for other pain conditions.
GOALS
The current PAS encourages the integration of basic research on the
neurobiology of persistent pain mediated by the trigeminal nerve with
clinical observations in humans suffering from these pain conditions. This
PAS encourages the translation of relevant research using animal models into
clinical trials aimed at improving pain treatment in humans. Carefully
designed studies that cut across scientific disciplines will be necessary to
accomplish these goals. Experts from many clinical and basic research arenas
will be needed to establish correlations between clinical manifestations and
underlying mechanisms that are crucial to development and assessment of
effective therapeutic interventions. Investigators in the fields of
neurobiology, genetics, immunology, endocrinology, anesthesiology, neurology,
and epidemiology are encouraged to submit proposals that will contribute to
the successful achievement of the goals of this PAS. Potential research
questions include, but are not limited to the following issues:
o Development of model systems that appropriately mimic the clinical features
of syndromes associated with deep tissue pain in the head and neck region, in
order to provide optimal tools for basic and clinical studies;
o Effective application of research paradigms in animal models and in human
studies of persistent trigeminal nerve mediated pain into clinical research
on human subjects in order to develop mechanistically derived pain therapies
(development and application of clinically relevant assays of pain in human
studies);
o Characterization of the immune and inflammatory mechanisms in the
pathophysiology of craniofacial/deep tissue persistent pain through
determination of the role of glial cells and cytokine release in central and
peripheral pain pathways, and clinical assessment of relevant findings;
o Discovery of mechanisms of plasticity at the neurochemical, molecular and
cellular level, which contribute to abnormal pain responses (hyperalgesia,
allodynia) and persistent pain associated with disorders of tissues
innvervated by the trigeminal nerve;
o Neuroimaging of pain signaling pathways to elucidate the roles of central
(including descending modulation) and peripheral plasticity in mediating the
onset, persistence, and management of chronic pain associated with migraine
and other pain disorders of the head and neck;
o Characterization of changes in gene and protein expression along the
components of the trigeminal nerve complex in response to nociceptive stimuli
using gene chip technology, and determination of how these changes contribute
to development of chronic pain and abnormal pain responses;
o Identification of the factors that contribute to the high level of co-
morbidity of craniofacial with musculoskeletal, gastrointestinal, and pelvic
pain disorders through exploration of the central integration and processing
of afferent input from craniofacial structures with that from non-
craniofacial structures;
o Elucidation of the role of acid-sensitive ion channels in deep tissues of
the head and neck in onset of pain and the development of abnormal pain
responses and chronic pain;
o Determination of factors that underlie gender, age, and ethnic variations
in pain experience of craniofacial disorders in order to provide more
appropriate and individualized pain management for these groups;
o Characterization of sensory, cognitive, affective, and other biobehavioral
responses to noxious stimulation and pain perception in humans;
o Determination of the usefulness of exercise in pain management through
clinical trials (inhibition of hyperalgesia and allodynia, and alleviation of
chronic pain);
o Determination of the role of growth factors in pathophysiology of chronic
pain associated with head and neck structures disorders and integration of
relevant findings with clinical trials to assess pain therapies;
o Determination of the role of hormonal systems (genomic and non-genomic
effects) and the potential interactions between steroidal hormones and growth
factors in pathophysiology and management of pain associated with migraine
headache and other pain disorders of head and neck structures;
o Development and testing of novel mechanism-based therapies for improved
management of chronic pain associated with craniofacial disorders through
appropriate clinical trials.
SUMMARY
The purpose of this PAS is to stimulate novel, multidisciplinary research
that will lead to better understanding and treatment of craniofacial/deep
tissue persistent pain. Integration of preclinical and clinical research
will be a critical factor towards achieving this goal.
MECHANISMS OF SUPPORT
This PAS will use the NIH R01 and R21 award mechanisms. As an applicant, you
will be solely responsible for planning, directing, and executing the
proposed project. 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
NINDS has set aside $1,200,000 total costs, in addition to funds available
for applications sent in response to this program announcement that score
within the NINDS payline (see NINDS Funding Strategy
http://www.ninds.nih.gov/funding/ninds_funding_strategy.htm), depending on the
overall scientific merit of the application and the availability of funds
throughout the duration of this solicitation ($400,000/year for 3 years).
The NIDCR has set aside $300,000 in total costs in FY 2004 and 2005 to fund
one meritorious application each year that is appropriate to basic science
related to the NIDCR mission.
Although the National Institute on Drug Abuse (NIDA) is not a co-sponsor of
this PA, it is interested in the support of research related to pain mediated
by the trigeminal nerve. As such, the NIDA would be interested in
meritorious applications submitted in response to this announcement that are
relevant to its mission and competitive within its funding plan. Direct your
questions about research/scientific issues to: David Thomas, Ph.D.; National
Institute of Drug Abuse; Telephone: (301)443-6975; Email: dt78k@nih.gov.
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 and 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 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:
Linda Porter, Ph.D.
Systems and Cognitive Neuroscience
National Institute of Neurological Disorders and Stroke
6001 Executive Blvd., Room 2113
Bethesda, MD 20892-9521
Telephone: (301) 496-9964
FAX: (301) 402-2060
Email: lp216a@nih.gov
John W. Kusiak, Ph.D.
Director
Molecular and Cellular Neurobiology Program
Division of Basic and Translational Sciences
National Institute of Dental and Craniofacial Research
Natcher, Building 45, Room 4AN-18A
Bethesda, MD 20892-6402
Telephone: 301-594-7984
FAX: 301-480-8319
Email: kusiakj@mail.nih.gov
o Direct your questions about financial or grants management matters to:
Denise Chatman
Grants Management Branch
National Institute of Neurological Disorders and Stroke
6001 Executive Blvd., Room 3269
Bethesda, MD 20892
Telephone: (301) 496-3993
Email: dc55g@nih.gov
Mary Daley
Chief Grants Management Officer
Division of Extramural Activities
National Institute of Dental and Craniofacial Research
Natcher, Building 45, Room 4AN-44B
Bethesda, MD 20892-6402
Telephone: 301-594-4808
FAX: 301-480-3562
Email: daleym@mail.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 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 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 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 discuss the following
aspects of the application in order to judge the likelihood that the proposed
research will have a substantial impact on the pursuit of these goals. The
scientific review group will address and consider each of these criteria in
assigning the application's overall score, weighting them as appropriate for
each application.
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?
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following
items will be considered in the determination of scientific merit and the
priority score:
PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human
subjects and protections from research risk relating to their participation
in the proposed research will be assessed. (See criteria included in the
section on Federal Citations, below).
INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of
plans to include subjects from both genders, all racial and ethnic groups
(and subgroups), and children as appropriate for the scientific goals of the
research will be assessed. Plans for the recruitment and retention of
subjects will also be evaluated. (See Inclusion Criteria in the sections on
Federal Citations, below).
CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to
be used in the project, the five items described under Section f of the PHS
398 research grant application instructions (rev. 5/2001) will be assessed.
ADDITIONAL CONSIDERATIONS
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. See
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.
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://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals
for NIH funding must be self-contained within specified page limitations.
Unless otherwise specified in an NIH solicitation, Internet addresses (URLs)
should not be used to provide information necessary to the review because
reviewers are under no obligation to view the Internet sites. Furthermore,
we caution reviewers that their anonymity may be compromised when they
directly access an Internet site.
HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to
achieving the health promotion and disease prevention objectives of "Healthy
People 2010," a PHS-led national activity for setting priority areas. This
PA is related to one or more of the priority areas. Potential applicants may
obtain a copy of "Healthy People 2010" at
http://www.health.gov/healthypeople.
AUTHORITY AND REGULATIONS: This program is described in the Catalog of
Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the
intergovernmental review requirements of Executive Order 12372 or Health
Systems Agency review. Awards are made under the authorization of Sections
301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284)
http://www.cfda.gov/ and under Federal Regulations 42 CFR 52 and 45 CFR Parts
74 and 92. All awards are subject to the terms and conditions, cost
principles, and other considerations described in the NIH Grants Policy
Statement. The NIH Grants Policy Statement can be found at
http://grants.nih.gov/grants/policy/policy.htm.
The PHS strongly encourages all grant recipients to provide a smoke-free
workplace and discourage the use of all tobacco products. In addition,
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in
certain facilities (or in some cases, any portion of a facility) in which
regular or routine education, library, day care, health care, or early
childhood development services are provided to children. This is consistent
with the PHS mission to protect and advance the physical and mental health of
the American people.
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NIH Funding Opportunities and Notices
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