and Human Services (HHS)
EXPIRED
SPECIALIZED CENTERS OF RESEARCH (SCOR) IN NEUROBIOLOGY OF SLEEP AND SLEEP APNEA
AND AIRWAY BIOLOGY AND PATHOGENESIS OF CYSTIC FIBROSIS
Release Date: December 11, 2001
RFA: RFA-HL-02-013
National Heart, Lung, and Blood Institute
(http://www.nhlbi.nih.gov)
Letter of Intent Receipt Date: September 11, 2002
Application Receipt Date: October 11, 2002
PURPOSE
The primary objective of the Specialized Centers of Research (SCOR) programs
is to foster multidisciplinary basic and clinical research enabling basic
science findings to be more rapidly applied to clinical problems. The basic
and clinical research to be supported through this RFA will be related to one
of the above two categories. It is expected that results from these SCOR
grants will have an impact on the prevention, diagnosis, and treatment of
disorders of sleep and cystic fibrosis. This is the second and final 5-year
solicitation for these two SCOR programs.
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 Request for Applications (RFA),
Specialized Centers of Clinical Research, 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/.
ELIGIBILITY REQUIREMENTS
Applications may be submitted by for-profit and nonprofit domestic
institutions, public and private, such as universities, colleges, hospitals,
and laboratories. Awards will not be made to foreign institutions. However,
under exceptional circumstances, a foreign component critical to a project may
be included as a part of that project. Women and minority investigators are
encouraged to apply.
This RFA is intended to support SCOR grants for basic and clinical
investigations. Applications that include only basic or only clinical
research will not be responsive to this announcement. Each awarded SCOR must
consist of three or more projects, all of which are directly related to the
SCOR program topic.
MECHANISM OF SUPPORT
This RFA will use the NHLBI SCOR (P50) grant to support this research program.
Applications received in response to the Neurobiology of Sleep and Sleep
Apnea and Airway Biology and Pathogenesis of Cystic Fibrosis programs may be
either new or renewal applications.
Responsibility for the planning, direction, and execution of the proposed
project will be solely that of the applicant. All current policies and
requirements that govern the research grant programs of the NIH will apply to
grants awarded under the RFA.
Basic and Clinical Research
The overall concept of a SCOR program focuses on scientific issues related to
diseases and disorders relevant to the mission of the NHLBI. It is essential,
therefore, that all applications include both basic and clinical research
projects. Interactions between basic and clinical scientists are expected to
strengthen the research, enhance transfer of fundamental research findings to
the clinical setting, and identify new research directions. Plans for
transfer of findings from basic to clinical studies should be described.
In order for a project to be considered clinical for the purposes of
responsiveness to this RFA, the research must fit the definition of clinical
research in the PHS 398
(http://grants.nih.gov/grants/funding/phs398/phs398.html, parts 1 and 2, but
not part 3). That is, the research must be either patient-oriented research,
or an epidemiologic or behavioral study.
For patient-oriented research, this is "research conducted with human subjects
(or material of human origin such as tissues, specimens and cognitive
phenomena) for which an investigator (or colleague) directly interacts with
human subjects." To be responsive, clinical investigations may include
studies of subjects with the disease of interest as well as normal healthy
subjects. In studies involving the use of human specimens, e.g., blood,
bronchoalveolar lavage, or biopsy, the investigators must have direct
interaction with the subject or patient and relate the research results to the
patient status or outcome for this to be considered a clinical project. It is
intended that the requirement for investigator interaction with the study
participants will eliminate research involving archived tissue.
Human biomedical and behavioral studies of etiology, pathogenesis, prevention
and prevention strategies, diagnostic approaches, and treatment of diseases,
disorders or conditions are also responsive. Small population-based
epidemiologic studies, where the research can be completed within 5 years, may
also be proposed. However, clinical research projects focused on large
epidemiologic studies or Phase III clinical trials will be considered
unresponsive to this RFA.
In addition, basic research projects must be included that relate to the
clinical focus. A SCOR may also contain one or more core units that support
the research projects. A core cannot be counted as a clinical project.
Applicants should provide a detailed data and safety monitoring plan for the
clinical research proposed; the monitoring plan will be considered as part of
the peer review of the application. This plan should address informed
consent, recruitment, reporting of adverse events, patient safety, oversight
of clinical issues in the protocols, storage and analysis of confidential
data, and dissemination of any research results. The NIH Policy for Data and
Safety Monitoring can be found at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html.
There may be isolated cases when the Institute may
wish to convene a DSMB to oversee the clinical projects in a SCOR program.
This will be determined after review and selection of the SCOR centers.
Principal Investigator (SCOR Director) and Project Leaders
The principal investigator should be an established research scientist with
the ability to ensure quality control and the experience to administer both
basic and clinical research effectively and integrate all components of the
program. A minimum time commitment of 25 percent is required for this
individual. The Principal Investigator must be the project leader of one of
the component research projects. If this project is not recommended by peer
review, the overall SCOR application will not be considered further. If this
project is judged by peer review to be of low scientific merit, this will
markedly reduce the overall scientific merit ranking assigned to the entire
application. Project leaders should have significant research experience and
must agree to commit at least 20 percent effort to each project for which they
are responsible.
Length of SCOR Programs
Each NHLBI SCOR program is limited to 10 years of support. Exceptions to this
policy will be made only if a thorough evaluation of needs and opportunities,
conducted by a committee composed of non-federal experts, determines that
there are extraordinarily important reasons to continue a specific SCOR
program.
Under this policy, a given SCOR grant is awarded for a 5-year project period
following an open competition. Only one 5-year competing renewal is
permitted, for a total of 10 years of support, unless the SCOR program is
recommended for extension.
The NHLBI comprehensive evaluation of the Neurobiology of Sleep and Sleep
Apnea and Airway Biology and Pathogenesis of Cystic Fibrosis SCOR programs
will be conducted during the second project period according to the following
timetable:
Program Announced: FY 1996
Project Period (First Competition): FY 1998 through FY 2003
Program Reannounced: FY 2002
Project Period (Second Competition): FY 2003 through FY 2008
Letter to SCOR Directors Regarding
SCOR Evaluation Plans: FY 2005 (mid-way through year 02 of 2nd
project period)
SCOR Evaluation Meeting: FY 2005 (late in year 02 of 2nd
project period)
The NHLBI does not limit the number of SCOR applications in a given SCOR
program from one institution nor does it limit the number of applications in
the two SCOR programs described in this announcement from one institution.
However, there must be a different SCOR principal investigator for each
application and each application must be self-contained and independent of the
other(s). This does not preclude cooperation planned or possible among
participants of SCORs after awards are made. Scientific overlap among
applications will not be accepted. If more than one application in a given
program is envisioned from an institution, the institution is encouraged to
discuss its plans with the NHLBI SCOR program administrator.
FUNDS AVAILABLE
For new applications, the applicants may request up to $1,420,000 direct
costs, not including facilities and administrative costs for collaborating
institutions, in the first year, and for renewal applications, the applicants
may request a ten (10) percent increase over the last year of the preceding
project period or a total of $1,420,000, whichever is less. An increase of no
more than 3 percent may be requested in each additional year. Award of grants
pursuant to this RFA is contingent upon availability of funds for this
purpose. It is estimated that a total of $11,600,000 will be available for
the first year of support for the two programs and it is anticipated a total
of up to seven awards will be made.
Equipment is included in the budget limitation. However, requests for
expensive special equipment that cause an application to exceed this limit may
be permitted on a case-by-case basis following staff consultation. Such
equipment requests require in-depth justification. Final decisions will depend
on the nature of the justification and the Institute's fiscal situation.
Consortium Arrangements
If a grant application includes research activities that involve institutions
other than the grantee institution, the program is considered a consortium
effort. Such applications are permitted, but it is imperative that a
consortium application be prepared so that the programmatic, fiscal, and
administrative considerations are explained fully. The published policy
governing consortia is available in the business offices of institutions that
are eligible to receive Federal grants-in-aid. Consult the latest published
policy governing consortia before developing the application. For
clarification of the policy, contact Mr. Ray Zimmerman, Grants Operations
Branch, NHLBI, 301-435-0171. Applicants of SCOR grants should exercise great
diligence in preserving the interactions of the participants and the
integration of the consortium project(s) with those of the parent institution,
because synergism and cohesiveness can be diminished when projects are located
outside the group at the parent institution. Indirect costs paid as part of a
consortium agreement are excluded from the limit on the amount of direct costs
that can be requested.
RESEARCH OBJECTIVES
Background
The SCOR program was initiated within the Division of Lung Diseases in 1971 as
a Pulmonary SCOR. Since then, several modifications and changes in program
direction have been made and new SCOR programs have been implemented. As a
result of a congressional mandate, two new SCOR programs, Cardiopulmonary
Disorders During Sleep and Cystic Fibrosis, were announced in 1988, resulting
in a total of five awards. In 1991 renewal programs in Cardiopulmonary
Disorders of Sleep and Cystic Fibrosis were announced. In FY 1993, a total of
four awards were made for centers in Cardiopulmonary Disorders of Sleep and
three in Cystic Fibrosis.
In response to the new Institute policy that each SCOR program is limited to
10 years of support, unless a programmatic evaluation indicates that further
support is warranted, the Division convened an evaluation committee in 1995 to
review the SCOR programs in Cardiopulmonary Disorders of Sleep and Cystic
Fibrosis. They recommended that new SCOR programs be announced in
Neurobiology of Sleep and Sleep Apnea and in Airway Biology and Pathogenesis
of Cystic Fibrosis. In fiscal year 1998 three awards were made for centers in
Neurobiology of Sleep and Sleep Apnea and four awards in Airway Biology and
Pathogenesis of Cystic Fibrosis. This is the reannouncement for these two
SCOR programs for the second 5 year period of funding.
Justification for announcing a competition in the SCOR programs in
Neurobiology of Sleep and Sleep Apnea and Airway Biology and in Pathogenesis
of Cystic Fibrosis are based on the recommendations from the SCOR evaluation,
on past accomplishments, which have been provided in reports from the Division
and the Institute, and on opportunities for new research directions. Funding
for these two SCOR programs expires on August 31, 2003.
Proposed Research
Applications must be addressed to only one of the two categories identified in
this announcement to be acceptable for this competition. A SCOR grant is a 5-
year program, therefore, an applicant should submit a 5-year plan for all the
projects. If a project can be completed in less than 5 years, it should not
be included in the application.
Examples of research topics of interest for each SCOR program under
competition are listed below. These research topics are intended to provide a
perspective of the scope of research that would meet the objectives of this
program. It is not required that all or any of these topics be included;
investigators are encouraged to consider other topics that are relevant to the
goals of these programs.
Neurobiology of Sleep and Sleep Apnea
The objective of this SCOR program is to integrate clinical research on the
etiology and pathogenesis of sleep disorders, particularly sleep apnea, with
molecular, cellular, and genetic approaches to the study of sleep.
Neurobiological mechanisms underlying the relationship of sleep apnea to
cardiovascular, pulmonary, hematological, endocrine, immunological, and other
health consequences are also of interest. The scope of the program includes
repetitive episodes of complete or partial obstruction of the upper airway
during sleep (sleep-disordered breathing). The research topics identified
below are offered as examples that would be responsive to this announcement.
Sleep disordered breathing and snoring have been implicated as risk factors
for the development of hypertension, ischemic heart disease, and cerebral
infarction. Research is needed to examine the pathophysiologic role of the
nervous system in the association of sleep disordered breathing with heart,
lung, and blood diseases. Studies are also needed to elucidate neural
mechanisms underlying the influence of sleep on cardiovascular, vascular, and
immunological function.
Since excessive daytime sleepiness is a major clinical consequence of sleep
apnea, another important focus is to identify factors that can be quantified
with minimally invasive procedures to assess sleep status, the sleep
requirements of individuals, and the consequences of excessive daytime
sleepiness on normal health and development. The neurobiological basis of
impaired daytime performance due to sleep disordered breathing also needs to
be elucidated. The development of new therapeutic strategies for the
treatment of sleep disordered breathing and associated health consequences,
particularly pharmacologic approaches, remains an important goal of this SCOR
program.
Epidemiologic studies have provided new insights into the risks associated
with sleep disordered breathing. Studies are needed to better define the
clinical threshold at which sleep disordered breathing presents significant
health risks, and determine its predictors and antecedents, particularly in
its early phases. Evidence now suggests that the nature of sleep disturbances
associated with sleep apnea in children may be different than in adults.
Attention should be given to the relationship between pathologic and
physiologic abnormalities, gender specific factors, and age. Better objective
measures and standardized criteria for sleep apnea, including associated
morbidity and mortality also need to be investigated.
Recent findings indicate that sleep disordered breathing and several other
sleep disorders exhibit patterns of familial aggregation and suspected genetic
predisposition. Studies are needed to elucidate the genetic programs
regulating normal human sleep and phenotypic variations in the amount, timing,
architecture, and electrophysiologic characteristics of sleep. Polymorphisms
at multiple loci are likely to be involved, but very few studies have
attempted to identify the underlying genetic factors or estimate the role of
inheritance in human sleep disorders. Mammalian genes with strong effects on
endogenous circadian rhythmicity such as Clock have been identified in various
tissues including brain, heart, and lung. Genes encoding receptors and
metabolic enzymes for neurotransmitters critically involved in the regulation
of sleep (and in functions related to sleep disorders such as breathing and
neuroendocrine/immune function) have been cloned and mapped. Some of these
genes are polymorphic, but whether these polymorphisms influence
sleep/circadian rhythms in human populations, are associated with disorders
such as sleep disordered breathing, or contribute to disease development or
progression in other physiologic systems needs to be determined.
The elucidation of neural pathways and the molecular processes regulating
normal sleep and sleep disordered breathing continues to be an area of
interest. For example, molecular neurobiologic approaches should be applied
to determine what neurons express sleep regulating factors, whether sleep
disordered breathing changes the expression of sleep regulating factors, and
to elucidate the regulatory signals involved in these events. It is also
important to determine how the levels of endogenous sleep regulating compounds
vary with the sleep/wake cycle. Studies are needed to investigate the
neurobiologic significance of sleep disorders, particularly sleep apnea, in
the maintenance of brain functions such as learning, and to characterize its
role in neurologic disease processes. Integrating clinical research on sleep
apnea with the neurobiology of sleep will advance our understanding of major
clinical consequences of sleep apnea, including excessive daytime sleepiness
and increased risk of cardiovascular disease.
Airway Biology and Pathogenesis of Cystic Fibrosis (CF)
The Airway Biology and Pathogenesis of CF SCOR program seeks to develop
multidisciplinary collaborations focused on fostering the translation of basic
research to clinical applications. Current knowledge of CFTR will be utilized
to promote research advances on the pathogenesis of CF, the role of CFTR in
airway biology, and the development of new prevention and treatment
strategies. Information on how CF begins and progresses in the airway with
respect to inflammation and/or infection, and their inter-relationship, is
particularly important as is understanding the role of host defense mechanisms
and inflammatory mediators in preventing or contributing to pathogenesis.
Novel therapeutic approaches directed at controlling these processes need to
be developed and tested. Understanding the nature of the vulnerability of CF
patients to infection and excessive inflammation is critical for planning
therapeutic strategies for CF patients at all stages of disease. Further
investigation is essential into the mechanisms generating and controlling the
airway surface fluid (ASF), which may be critical to pulmonary homeostasis and
lung defense, and how normal and mutant CFTR affect it. Pertinent clinical
data relevant to these responses need to be generated. The contribution of
the submucosal glands versus the surface epithelium to normal fluid and
electrolyte balance and to the pathogenesis of CF needs to be determined.
Information on stem or progenitor cells in the airways is critical to our
understanding of basic aspects of lung biology and would be helpful for
therapeutic approaches. Our knowledge of the biology, structure and function
of normal and mutant CFTR remains superficial. The interaction of CFTR with
other membrane and cellular proteins needs to be defined, as well as its
functional consequences. Factors other than the primary defect in CFTR govern
the fate of patients with CF such as environmental factors, the acquisition of
certain infections, bacterial gene products, and genetic modifiers of the CF
phenotype. These factors need to be identified and characterized.
New therapies are needed which correct the primary defect or activate
alternative pathways to prevent airway disease. Thus, there is a critical
need to translate the new knowledge regarding the pathogenesis of CF and the
function of CFTR into new treatment strategies. The development of novel
pharmacologic and gene therapies are important, such as the development of
agents which correct defective CFTR, enhance expression or activity of CFTR,
facilitate trafficking of CFTR to the apical cell membrane, or interfere with
bacterial colonization. Barriers to persistent correction of defective CFTR
function such as vector-induced inflammatory and immune responses and low
efficiency of airway cell transduction should be eliminated. Identification
of appropriate lung cell targets for gene transfer such as progenitor, surface
and submucosal gland cells is important. Translational research is essential
for potential treatment modalities resulting from ongoing pathophysiologic
analyses of cytokines, chemoattracants, adhesion molecules and other potential
immunotherapies; gene therapy; mucus production and composition; natural
peptide antibiotics (e.g., defensins); and alternative ion channels.
A better understanding would be helpful of the processes of protein processing
and degradation operative in CF airways and pharmacologic interventions to
disrupt downstream pathology. As potential sites of therapeutic targets
designed to provide alternate pathways for fluid production in CF airways, it
would be important to study alternate ion channels, uncover new receptors
which control lung function and develop methods of overcoming aberrant
processing of mutant CFTR. The molecular and physiologic defects in CF need
to be linked with the clinical aspects of CF lung disease.
SPECIAL REQUIREMENTS
Special features of SCOR grants are:
o They provide opportunities for investigators with mutual or complementary
interests to engage in multidisciplinary research focusing on a specific
respiratory disorder.
o Inherent in the SCOR program is a special interaction among the principal
investigator, the grantee institution and the Division of Lung Diseases.
Funds are specifically allocated in a SCOR grant for investigators from
different SCORs to meet and discuss problems of mutual interest and to
participate in workshops addressing common research areas.
o The Division's SCOR programs undergo periodic evaluations.
Requirements of SCOR grants:
1. Research conducted at the individual centers must include both basic and
clinical research to ensure that advances in the basic sciences are translated
rapidly into clinical applications and that clinical needs will provide a
direction for the basic research. Therefore, each SCOR grant application and
award must include one or more clinical research project(s) as specified under
the section "Basic and Clinical Research." The basic research projects should
clearly relate to the disease focus and contribute to elucidation of
mechanisms underlying the disease, or to improved diagnosis or management of
the disease.
2. Each component project whether basic or clinical requires a well-described
clinically relevant hypothesis, preliminary data and a time-table for
conducting the proposed investigations.
3. The relationship of each core to the research projects should be
described. A core cannot be counted as a clinical project.
4. The principal investigator (SCOR director) should be an established
scientist with the ability to ensure quality control and the experience to
administer basic and clinical research effectively and integrate all
components of the program. A minimum time commitment of 25 percent is
required for this individual. The principal investigator must also be the
project leader of one of the component research projects. If this project is
not recommended by peer review, the overall SCOR application will not be
considered further. If this project is judged by peer review to be of low
scientific merit, it will markedly reduce the overall scientific merit ranking
assigned to the entire application by the review committee.
5. Project leaders should have significant research experience and must agree
to commit at least 20 percent effort to each project for which they are
responsible. Investigators with minimal research experience, but promising
credentials, may participate; however, it is expected that most of the
project leaders will be investigators with significant research experience.
6. Each SCOR must have a well-delineated organizational structure and
administrative mechanism that foster interactions between investigators,
accelerate the pace of research, and ensure a productive research effort.
7. If a project leader transfers to another institution, support for the
project will normally not be continued as a consortium.
Because of the size and complexity of a SCOR, prospective applicants are urged
to consult with the staff of the Division of Lung Diseases early in the
preparation of the application (see INQUIRIES Section). To provide
opportunity for such interactions, the time frame for implementation of this
program includes an ample interval between the release of this RFA, and the
receipt date for applications.
INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS
It is the policy of the NIH that women and members of minority groups and
their sub-populations must be included in all NIH-supported clinical research
projects unless a clear and compelling justification is provided indicating
that inclusion is inappropriate with respect to the health of the subjects or
the purpose of the research. This policy results from the NIH Revitalization
Act of 1993 (Section 492B of Public Law 103-43).
All investigators proposing clinical research should read the AMENDMENT "NIH
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical
Research - Amended, October, 2001," published in the NIH Guide for Grants and
Contracts on October 9, 2001
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines are available at
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of
clinical research; updated racial and ethnic categories in compliance with the
new OMB standards; clarification of language governing NIH-defined Phase III
clinical trials consistent with the new PHS Form 398; and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a)
all applications or proposals and/or protocols must provide a description of
plans to conduct analyses, as appropriate, to address differences by
sex/gender and/or racial/ethnic groups, including subgroups if applicable; and
b) investigators must report annual accrual and progress in conducting
analyses, as appropriate, by sex/gender and/or racial/ethnic group
differences.
NIH POLICY AND GUIDELINES ON THE INCLUSION OF CHILDREN AS PARTICIPANTS IN
RESEARCH INVOLVING HUMAN SUBJECTS
It is the policy of NIH 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 clear and compelling scientific and ethical reasons not
to include them. This policy applies to all initial (Type 1 and Type 2)
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 was published in the NIH Guide for
Grants and Contracts, March 6, 1998, and is available at the following URL
address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html.
Investigators also may obtain copies of these policies from the program staff
listed under INQUIRIES. Program staff may also provide additional relevant
information concerning the policy.
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. This policy announcement is found in the NIH Guide for Grants and
Contracts Announcement dated June 5, 2000, at the following website:
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.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. Reviewers are cautioned that their anonymity may be compromised when
they directly access an Internet site.
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 RFA 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.
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that includes a
descriptive title of the proposed research, the name, address, and telephone
number of the principal investigator, the names of participating institutions,
the identities of other key personnel, and the number and title of the RFA in
response to which the application may be submitted.
Although a letter of intent is not required, is not binding, and does not
enter into the review of subsequent applications, it assists the NHLBI staff
to estimate the potential review workload and plan the review.
The letter of intent is to be sent to the Chief, Review Branch, listed under
Inquiries no later than September 11, 2002.
APPLICATION PROCEDURES
The PHS 398 research grant application instructions and forms (rev. 5/2001)
available at http://grants.nih.gov/grants/funding/phs398/phs398.html must be
used in applying for these grants. This version of the PHS 398 is available in
an interactive, searchable format. For further assistance contact GrantsInfo,
Telephone 301-710-0267, Email: [email protected]. Special instructions are
needed for preparing a SCOR application and are available from the program
contact listed under Inquiries or at
http://www.nhlbi.nih.gov/funding/inits/dldscor.htm.
Plans for data safety monitoring must be included for the clinical research
proposed. Applicants should describe the organizational structures and
procedures they will employ to ensure the safety of participants and the
validity and integrity of the data; for a statement of issues and concerns,
see NIH Policy for Data and Safety Monitoring, NIH guide to Grants and
Contracts, Release Date: June 10, 1998,
http://grants.nih.gov/grants/guide/notice-files/not98-084.html. At the time
of the award, applicants should be prepared to make adjustments to their
procedures based upon NHLBI policy.
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:
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.
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 as well as
all five collated sets of Appendix material must be sent to Chief, Review
Branch, at the address listed under Inquiries. Applications must be received
by 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.
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. The
CSR also will not accept any application that is essentially the same as one
already reviewed. This does not preclude the submission of substantial
revisions of applications already reviewed, but such applications must include
an Introduction addressing the previous critique.
Principal investigators should not send supplementary material without first
contacting the Scientific Review Administrator (SRA). The SRA will be
identified in the letter sent to you indicating that your application has been
received. If you do not receive such a letter within three weeks after
submitting the application, contact Dr. Deborah Beebe at the address listed
under Inquiries.
REVIEW CONSIDERATIONS
Upon receipt, applications will be reviewed for completeness by CSR and
responsiveness by the NHLBI staff. Incomplete applications or applications
deemed not responsive to the RFA will be returned to the applicant without
further consideration. Applications that are submitted with only basic or
only clinical research will be considered nonresponsive.
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
the NHLBI in accordance with the review criteria stated below. APPLICANTS
SHOULD SUBMIT THE HIGHEST QUALITY APPLICATIONS POSSIBLE TO CSR AS NO SITE
VISITS NOR REVERSE SITE VISITS WILL BE HELD. As part of the initial merit
review, all applications will receive a written critique and 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,
assigned a priority score, and receive a second level review by the National
Heart, Lung, and Blood Advisory Council.
Factors to be considered in the evaluation of each application will be similar
to those used in review of traditional research grant applications and, in
addition, will include overall proposed interactions among basic and clinical
research projects. Major factors to be considered in the evaluation of
applications include:
1. Scientific merit of the proposed basic and clinical research projects,
including significance, importance, clinical relevance and appropriateness of
the theme; innovation, originality, and feasibility of the approach; and
adequacy of the experimental design.
2. Leadership, scientific stature, and commitment of the principal
investigator; competence of the investigators to accomplish the proposed
research goals and their time commitment to the program; clinical research
experience among the investigators; and the feasibility and strength of
consortium arrangements.
3. Collaborative interaction among basic and clinical research components,
the required clinical research component, and plans for transfer of potential
findings from basic to clinical studies.
4. Adequacy of the environment for performance of the proposed research
including clinical populations and/or specimens; laboratory facilities;
quality of the support cores; proposed instrumentation; quality controls;
administrative structure; institutional commitment; and, when needed, data
management systems.
5. Adequacy of the data and safety monitoring plan for the clinical research
proposed.
Each project will receive a priority score. Each core will be Recommended or
Not Recommended based on whether the core is essential for the proposed
research and has the capability to fulfill the proposed function. Reviewers
will evaluate the number of projects serviced by the core; strengths and
weaknesses of the proposed approaches, resources, and interactions; whether
the investigators are qualified for their role(s) in the core; and whether the
proposed budget for the core is appropriate. Each application will receive an
overall priority score based on the review criteria listed above.
In addition to the above criteria, in accordance with NIH policy, all
applications will also be reviewed with respect to the following:
o The adequacy of plans to include both genders, minorities and their
subgroups, and children as appropriate for the scientific goals of the
research. Plans for the recruitment and retention of subjects will also be
evaluated.
o The reasonableness of the proposed budget and duration in relation to the
proposed research.
o The adequacy of the proposed protection for humans, animals or the
environment, to the extent they may be adversely affected by the project
proposed in the application.
o The adequacy of the proposed plan to share data.
AWARD CRITERIA
The anticipated date of award is September 30, 2003 (FY2003) for these two
SCOR programs. A major factor guiding the Institute in selecting which
applications to fund will be the strength of the clinical research and its
integration with the basic research. Applications with weak clinical research
will unlikely be funded, regardless of the overall priority score.
Availability of funds and programmatic priorities will also be factored into
funding decisions.
INQUIRIES
Written and telephone inquiries concerning the RFA are encouraged. The
opportunity to clarify any issues or questions from potential applicants is
welcome. Special supplemental instructions for the preparation of grant
applications for SCORs may be obtained by contacting program staff at the
Division of Lung Diseases, as indicated below.
Direct inquiries regarding programmatic issues to:
Neurobiology of Sleep and Sleep Apnea
Michael Twery, Ph.D.
Division of Lung Diseases
National Heart, Lung, and Blood Institute
National Institutes of Health
6701 Rockledge Drive, MSC 7952
Bethesda, Maryland 20892-7952
Telephone: (301) 435-0202
Fax: (301) 480-3557
Email: [email protected]
Airway Biology and Pathogenesis of Cystic Fibrosis
Susan Banks-Schlegel, Ph.D.
Division of Lung Diseases
National Heart, Lung, and Blood Institute
National Institutes of Health
6701 Rockledge Drive, MSC 7952
Bethesda, Maryland 20892-7952
Telephone: (301) 435-0202
Fax: (301) 480-3557
Email: [email protected]
Direct inquiries regarding review issues, send letter of intent, and two
copies of the application to:
Chief, Review Branch
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7178(MSC 7924)
Bethesda, Maryland 20892-7924
Telephone: (301) 435-0270
Fax: (301) 480-3541
Email: [email protected]
Direct inquiries regarding fiscal matters to:
Raymond Zimmerman
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
National Institutes of Health
6701 Rockledge Drive, MSC 7926
Bethesda, Maryland 20892-7926
Telephone: (301) 435-0171
Fax: (301) 480-3310
Email: [email protected]
AUTHORITY AND REGULATIONS
This program is described in the Catalog of Federal Domestic Assistance No.
93.838. Awards are made under authorization of Sections 301 and 405 of the
Public Health Service Act as amended by Public Health Service Act (42 USC 241
and 284) and administered under NIH grants policies and Federal Regulations 42
CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the
intergovernmental review requirements of Executive Order 12372 or Health
Systems Agency review.
The Public Health Service (PHS) strongly encourages all grant recipients to
provide a smoke-free workplace and promote the non-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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