and Human Services (HHS)
EXPIRED
SPECIALIZED CENTERS OF CLINICALLY ORIENTED RESEARCH (SCCOR) IN PEDIATRIC HEART
DEVELOPMENT AND DISEASE
RELEASE DATE: March 21, 2002
RFA: HL-02-027
National Heart, Lung, and Blood Institute (NHLBI)
(http://www.nhlbi.nih.gov)
LETTER OF INTENT RECEIPT DATE: December 16, 2002
APPLICATION RECEIPT DATE: January 16, 2003
THIS RFA CONTAINS THE FOLLOWING INFORMATION
o Purpose of this RFA
o Research Objectives
o Mechanism of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS RFA
The primary objective of the Specialized Centers of Clinically Oriented Research
(SCCOR) programs is to foster multidisciplinary research on clinically relevant
questions enabling basic science findings to be more rapidly applied to clinical
problems. The clinical and basic research supported through this RFA will be
related to congenital and acquired pediatric heart diseases. It is expected
that results from these SCCOR grants will have a positive effect on the
prevention, diagnosis, and treatment of congenital cardiovascular malformations,
pediatric disorders of myocardial function, pediatric arrhythmias and conduction
disturbances, and acquired pediatric cardiac diseases such as Kawasaki Disease
and myocarditis.
RESEARCH OBJECTIVES
The National Heart, Lung, and Blood Institute (NHLBI) revised the Specialized
Centers of Research (SCOR) program, based primarily on recommendations from the
National Heart, Lung, and Blood Advisory Council. The new program is called the
Specialized Centers of Clinically Oriented Research (SCCOR) program. The
original SCOR program required both basic and clinical research, but the
preponderance of funded projects were in the basic science arena. The new title
and the revisions to the program reflect the Institute=s desire to capitalize on
basic research advances by encouraging their translation to the clinical arena.
The guiding principle of the new SCCOR program is the central focus on
clinically relevant research, and the key change to achieve this goal is the
requirement that at least one-half of funded projects be clinical. The specific
components of the new SCCOR program are detailed in this RFA.
Pediatric heart disease is an important public health problem that comprises
several major categories: congenital cardiovascular malformations, disorders of
myocardial function and electrical conduction, and acquired heart disease.
Congenital Cardiovascular Malformations. In the nearly 60 years since the first
Ablue baby@ operation, there has been a revolution in the diagnosis and
treatment of congenital cardiovascular malformations. Advances in
echocardiography permit in utero diagnosis of congenital cardiovascular
malformations as early as the first trimester of pregnancy; advances in surgery,
bypass and myocardial preservation have made repair of complex cardiac
malformations possible in tiny infants; and advances in interventional
cardiology have made minimally-invasive treatment of certain lesions a reality.
As a result, the mortality rate for children with heart disease has decreased
considerably. Unfortunately, however, birth defects remain the leading cause of
infant mortality, and cardiovascular malformations remain the largest
contributor to birth-defect-related-mortality. In addition, as the number of
survivors increases, it is becoming clear that attention must be paid to long-
term morbidities, especially in those children with non-cardiac malformations.
Enormous strides also have been made in understanding the molecular and
morphogenetic underpinnings of normal and abnormal cardiovascular development.
In the past 15 years, the role that multiple transcription factors play in the
developmental process has been elucidated, several genes and proteins that
govern left-right cardiac asymmetry and specify cardiac valves and chambers have
been identified, and aspects of molecular regulation of coronary artery
development have been worked out. Much remains to be learned, however, and work
is required in order to translate the progress that has been made at the bench
to the bedside.
The pulmonary circulation is integral to congenital heart disease and is also
inextricably linked to cardiac development. Many patients with congenital heart
disease also have abnormal pulmonary vasculature that persists even after the
initial cardiac malformation has been repaired. Because the pulmonary
circulation is one of the few vascular beds in which the most expansive growth
occurs in the perinatal and postnatal period, it offers a potentially accessible
target for therapeutic intervention. However, further study into the mechanisms
regulating cardiopulmonary vascular development and remodeling are required
before rational therapy can be designed.
Because children grow and artificial valves and conduits do not, pediatric
patients who receive heart valve or blood vessel replacements require subsequent
operations to replace their bioprostheses. Investigators have begun using
tissue engineering technology to attempt to develop cardiac tissue substitutes
that are durable, biocompatible, and grow with young patients. Their
approaches, such as growing cells on biodegradable scaffolds configured to the
shape of heart valves or conduit vessels, are still in their infancy, but
provide hope for the development of cardiovascular tissue substitutes, which
would reduce the need for multiple surgeries for children with congenital
cardiac lesions. Tissue engineered structures may also reduce the risks of
infection and thrombosis associated with prosthetic and bioprosthetic materials,
thereby reducing the need for anticoagulant and anti-platelet therapies with
their attendant risk of bleeding. Other cell-based therapies may have potential
for treatment of cardiomyopathy and structural heart disease. For example, it
may be possible to combine gene and stem cell therapies by genetically modifying
stem cells with vectors that program the expression and secretion of therapeutic
proteins.
Disorders of myocardial function and electrical conduction. In addition to
structural abnormalities, children=s heart disease also includes primary and
secondary disorders of myocardial function such as heart failure, cardiomyopathy
and arrhythmias. Heart failure can be acute or chronic, and can occur in a
variety of circumstances in pediatrics including congenital cardiovascular
malformations before and after repair, cardiac infection or inflammation,
cardiomyopathy, and arrhythmia. Understanding the molecular, cellular, and
myocardial components of heart failure in children may lead to improvements in
therapy for both children and adults.
As in adults, cardiomyopathies can be dilated, hypertrophic, and restrictive,
and can be due to primary abnormalities in muscle or structural proteins, or can
arise secondary to diverse causes such as cardiac infections or inflammation,
cardiotoxic drugs, or systemic illnesses such as lupus. The etiology of many
cardiomyopathies remains obscure although some are due to genetic mutations of
contractile proteins, connective tissue proteins, or ion channels. Treatment of
cardiomyopathy is typically supportive and of variable effectiveness. Novel
treatment paradigms are needed to improve the outcome for these conditions.
The conduction system arises during late cardiac development and is essential
for normal electrophysiological function throughout life. Knowledge about
normal and abnormal conduction system development has lagged behind discoveries
concerning cardiac structural development. Arrhythmias such as supraventricular
tachycardia, congenital and acquired heart block, and ventricular tachycardia
are substantial causes of morbidity and occasionally mortality in children.
Recent advances in delineating the molecular genetic basis of the Long QT
Syndrome, congenital heart block, and the Brugada syndrome suggest that
mutations in sodium, potassium, and calcium channel genes predispose patients to
these life-threatening arrhythmias. However, environmental and structural
factors, including interactions with common drugs, may also affect conduction in
relationship to these particular ion channels and may result in lethal
arrhythmias.
Acquired Heart Disease. Some children with previously normal hearts
subsequently develop heart disease. The most common cause of acquired heart
disease in children is Kawasaki Disease, an inflammatory disorder of unknown
etiology that affects the coronary vasculature. Current treatment is aimed at
minimizing the inflammatory process and results in decreases in coronary artery
involvement. Identification of a specific etiology and an understanding of
genetic and environmental influences on outcome, however, would permit more
focused therapy. Rheumatic carditis and myocarditis are two additional forms of
acquired heart disease that affect the pediatric population for which improved
understanding of the pathyphysiology may identify novel treatment options.
The objective of the Pediatric Heart Development and Disease SCCOR is to
stimulate clinically relevant, multidisciplinary collaborations leading to
clinical and basic science research efforts on important public health problems
for children with congenital or acquired heart disease. The translation of
knowledge into clinical practice should be a goal of applications submitted in
response to this initiative. Recent advances in understanding the molecular
biology of cardiovascular development offer new directions for the study of
normal and abnormal heart formation, the development of early diagnostic tools,
potential risk stratification based on genotype as well as phenotype, and many
other endeavors related to clinical problems in pediatric cardiology.
The following examples of research topics are intended to provide a perspective
on 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 the new
Pediatric Heart Development and Disease SCCOR program. A unified program of
clinical and basic research is needed to address such areas as:
o stem cell differentiation, proliferation, and interactions during development
to provide the basis for their use as potential sources of cardiomyocytes,
endothelial cells, and vascular smooth muscle cells to treat cardiovascular
disease in childhood;
o novel therapeutic approaches, including cell-based therapies, improved
myocardial and pulmonary preservation, improved neurological preservation, and
biomechanical advances to treat cardiovascular disease in childhood;
o the influence of genomic variation, genotype-phenotype correlations, modifier
genes, and gene-environment interactions on the development and progression of
pediatric heart disease, and on therapeutic success and the incidence of adverse
clinical events;
o relationships between congenital cardiovascular disease and pulmonary
vascular malformations;
o relationships between congenital cardiovascular disease and extracardiac
malformations; and
o normal and abnormal mechanisms of cardiac development, including both
structure and cardiac conduction, emphasizing multidisciplinary approaches and
new animal models as well as new technologies such as gene profiling or
proteomic approaches.
The SCCOR mechanism provides both the incentive and the structure to maintain
critical collaborative cores or other resources necessary for translational
research. For example, the SCCOR mechanism affords the ability to establish and
maintain a large clinical/DNA sample database of patients with congenital heart
disease.
Clinical Research Skills Development Core
The newly developed Specialized Centers of Clinically Oriented Research (SCCOR)
program mechanism requires clinical and basic scientists with a broad range of
skills to work together on a unified theme. It, therefore, presents a rich
environment for young clinical investigators to be exposed to and develop
additional research skills. The individual centers can be expected to include
among their research staffs clinical personnel who are newly trained and
relatively inexperienced in research. To assist the SCCOR grants in enhancing
the developmental environment for their new clinical investigators, the NHLBI
will permit applicants for a new SCCOR to request up to $100,000 in direct costs
per year for a Clinical Research Skills Development Core. The objective of the
Core is to support activities to assist new clinical investigators in
progressing to more senior status by enhancing their research skills. This
support is in addition to the usual cap on the SCCOR mechanism that is updated
annually. A Clinical Research Skills Development Core is not required, however,
and its absence will not disadvantage an applicant. The quality of the Clinical
Research Skills Development Core, if proposed, will be evaluated based on the
specific components listed below. The priority score on the Core will have no
effect on the overall score of an application.
Developmental opportunities that provide experience with new technologies and
skills are encouraged for inclusion in the Core. Innovative strategies should
be proposed for cross-disciplinary career development to achieve the goal of
exposing new clinical investigators to additional research techniques and
opportunities. Examples include a program of seminars focusing on scientific
topics that include an integration of basic and clinical studies or an
Aexchange@ program wherein clinical investigators spend time in basic science
labs. In addition to developing the research skills of new clinical
investigators, the Cores must ensure that the participating new clinical
investigators receive the mentoring they need to foster their research careers.
The Clinical Research Skills Development Core is intended for staff
investigators with limited clinical research experience, including fellows and
junior faculty members. Investigators who have had a previous K series award
are not eligible to participate as new investigators under this program.
Individuals with an active K grant can participate until the end of the award
period for the K grant. The Core should also address other skills necessary for
a successful research career, such as grant writing, ethical conduct of
research, and clinical trial design.
If a Clinical Research Skills Development Core is proposed, it must be directed
by an investigator with strong educational and mentoring credentials who will
devote a minimum of 5 percent effort as its Leader. To facilitate mentoring and
multidisciplinary developmental activities, active involvement by the principal
investigator and other senior investigators within the SCCOR is strongly
encouraged.
An application for a Clinical Research Skills Development Core will be evaluated
in terms of its potential effectiveness in developing the skills and research
capabilities of new clinical investigators as reflected in the following
required elements of the application:
1. A summary of the types of skills that would be developed and a description of
proposed project-specific activities;
2. A detailed discussion of how mentoring and the professional development of
the new clinical investigators will be achieved, including their progression to
more independent status;
3. The credentials and track records of the Clinical Research Skills Development
Core Leader, the Principal Investigator, and other participating senior staff in
developing new investigators;
4. A plan for coordinating the activities of participating senior investigators;
5. A plan for monitoring the progress of the new clinical investigators;
6. A description of existing opportunities within the applicant=s institution
for supporting investigator development and steps taken to avoid overlap with or
duplication of these efforts; and
7. A detailed development plan for each proposed new investigator (or a
representative plan and proposals for tailoring it to needs of multiple new
investigators) including required course work and scientific enrichment
activities such as special lectures, visiting scientist symposia, seminars, and
workshops.
Costs allowable for inclusion within the $100,000 direct costs per year limit
for the Clinical Research Skills Development Core include salary support for the
Core Leader and other participating senior investigators and staff, travel costs
for new investigators, supplies and equipment to be used in support of
developmental activities, and costs for courses, seminars, workshops, and other
activities directly related to the development plan. All costs requested in
this Core must be justified with respect to developmental activities and may not
be used to supplement the costs of research proposed in the rest of the SCCOR.
Since the Core is intended to serve new clinical investigators who occupy
positions and receive salary support from the SCCOR grant, salary support for
the new investigators is neither needed nor allowable as a Core cost. All new
clinical investigators supported by the SCCOR grant should be eligible to
participate in Core-sponsored activities so long as they have not attained
independent status. However, attaining independent status should be an
objective of the Core activities so participating new investigators should be
encouraged to apply for either a Career Development Award, a patient-oriented
regular research grant, or any other source of independent research or career
development support. Although the participating new investigators will be
expected to devote essentially full-time effort to research during this period,
they may devote an appropriate percentage of their time to maintaining clinical
skills.
An application for a Clinical Research Skills Development Core will be evaluated
in terms of its potential effectiveness in developing the skills and research
capabilities of new clinical investigators as reflected in the required
application components identified above.
MECHANISM OF SUPPORT
This RFA will use the NIH P50 award mechanism. All applications received in
response to the Pediatric Heart Development and Disease SCCOR program will be
considered as new applications and must meet the requirements for the new SCCOR
program. As an applicant you will be solely responsible for planning,
directing, and executing the proposed project. The anticipated award date is
January 1, 2004.
Each NHLBI SCCOR 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 SCCOR program.
Under this policy, a given SCCOR 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 SCCOR program is recommended for
extension.
The NHLBI comprehensive evaluation of the Pediatric Heart Development and
Disease SCCOR program will be conducted during the second project period
according to the following timetable:
Program Announced: FY 2002
Project Period (First Competition): FY 2004 through FY 2009
Program Reannounced: FY 2007
Project Period (Second Competition): FY 2009 through FY 2014
Letter to Principal Investigators
Regarding SCCOR Evaluation Plans: FY 2010 (mid-way through year 02
of 2nd project period)
SCCOR Evaluation Meeting: FY 2011 (late in year 02 of 2nd
project period)
The NHLBI does not limit the number of SCCOR applications in a given SCCOR
program from one institution. However, each application must have a different
principal investigator and must be self-contained and independent of the
other(s). Institutions envisioning more than one application should discuss
their plans with the program contact listed under Inquiries.
FUNDS AVAILABLE
NHLBI intends to commit approximately $11,625,000 in fiscal year 2004 to fund
three to four new grants in response to this RFA. An applicant should request a
project period of five years and may request up to $2.5 million direct costs,
not including indirect costs for collaborating institutions, in the first year.
All applications will be considered as new applications. An increase of no
more than 3 percent may be requested in each additional year. Because the
nature and scope of the proposed research will vary from application to
application, it is anticipated that the size of each award will also vary.
Although the financial plans of the NHLBI provides support for this program,
awards pursuant to this RFA are contingent upon the availability of funds and
the receipt of a sufficient number of meritorious applications. At this time,
it is not known if this RFA will be reissued.
Consortium Arrangements
If a grant application includes research activities that involve institutions
other than the grantee institution, the application will be considered a
consortium effort. Such applications are permitted, but it is imperative that
the application be prepared so that the programmatic, fiscal, and administrative
considerations are explained fully. However, at least 50 percent of the
projects (including at least one clinical project) and 50 percent of the cores
must be located at the applicant institution. The published policy governing
consortia is available in the business offices of institutions that are eligible
to receive Federal grants-in-aid and should be consulted before developing the
application. For clarification of the policy, contact Mr. Anthony Agresti,
Grants Operations Branch, NHLBI, (301) 435-0186. Applicants for SCCOR grants
should exercise great care 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.
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
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
Individuals with the skills, knowledge, and resources necessary to carry out the
proposed research are 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
1. The overall concept of a SCCOR program focuses on clinical and basic
scientific issues related to diseases and disorders relevant to the mission of
the NHLBI. To be considered responsive to this announcement, all applications
must include both clinical and basic research and at least 50 percent of the
projects must be clinical. For example, if an application has a total of three
projects, two of the projects must be clinical. In addition, interactions
between clinical and basic scientists are expected to strengthen the research,
enhance the translation of fundamental research findings to the clinical
setting, and identify new research directions. Translation of findings from
basic to clinical studies is an important focus of the SCCOR program.
2. 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 PHS398 (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 Aresearch 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, 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.
Clinical research projects, whether on human subjects or human specimens, will
be subject to the standard NHLBI policies and procedures regarding human
subjects monitoring.
3. The number of clinical projects in each NHLBI SCCOR must be equal to or
greater than the number of basic science projects, at the time of submission,
award, and throughout the 5-year project period. Neither a clinical component
in a basic science project nor a clinical core fulfills the requirement for a
clinical project. However, a single project can integrate basic and clinical
research. If the majority of the project is clinical, it will be considered a
clinical project; if the majority is basic, it will be considered a basic
project. Because a SCCOR grant is a 5-year program, an applicant should submit
a 5-year plan for all the projects.
4. Each awarded SCCOR must consist of three or more projects, all of which are
directly related to the SCCOR program topic. At least 50 percent of the
projects and 50 percent of the cores must be located at the applicant
institution and at least one of the clinical projects must be at the applicant
institution. All basic research projects must be related to the overall
clinical focus of the SCCOR. Each component project, whether clinical or basic,
requires a well-described clinically relevant hypothesis, preliminary data, and
a time-table for conducting the proposed investigations.
5. The relationship of each core to each component project should be described.
A core must provide services to two or more projects.
6. Applicants are encouraged to establish links with existing resources,
including General Clinical Research Centers, the NHLBI Program in Genomic
Applications, and NHLBI clinical research networks, as appropriate.
7. Each SCCOR must have a well-delineated organizational structure and adminis-
trative mechanism that foster interactions between investigators, accelerate the
pace of research, accelerate translation of basic research findings to clinical
applications, and ensure a productive research effort.
8. 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. There may be isolated cases when the
Institute may wish to convene a Data and Safety Monitoring Board to oversee the
clinical projects in a SCCOR program. This will be determined after review and
selection of the SCCOR centers.
9. The principal investigator should be an established research scientist with
the ability to ensure quality control and the experience to administer both
clinical and basic 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 SCCOR 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.
10. 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. Leaders of clinicaI projects should have experience in clinical
research as defined in Item 2, above. 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.
WHERE TO SEND INQUIRIES
We encourage inquiries concerning this RFA and welcome the opportunity to answer
questions from potential applicants. Inquiries may fall into three areas:
scientific/research, peer review, and financial or grants management issues:
o Direct your questions about scientific/research issues to:
Gail D. Pearson, MD, ScD
Division of Heart and Vascular Diseases
National Heart, Lung, and Blood Institute
Rockledge II, Room 9200
Bethesda, MD 20892
Telephone: (301) 435-0510
FAX: (301) 480-1454
Email: [email protected]
o Direct your questions about peer review issues to:
Anne Clark, Ph.D.
Chief, Review Branch
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
6701 Rockledge Dr., Room 7178 (MSC 7924)
Bethesda, MD 20892-7924 (20817 for Courier)
Telephone: (301) 435-0270
FAX: (301) 480-0730
Email: [email protected]
o Direct your questions about financial or grants management matters to:
Mr. Anthony Agresti
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
Rockledge II, Room 7138
Bethesda, MD 20892
Telephone: (301) 435-0186
Email: [email protected]
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that includes the
following information:
o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel
o Participating institutions
o Number and title of this RFA
Although a letter of intent is not required, is not binding, and does not enter
into the review of a subsequent application, the information that it contains
allows IC staff to estimate the potential review workload and plan the review.
The letter of intent is to be sent by the date listed at the beginning of this
document. The letter of intent should be sent to Dr. Anne Clark at the address
listed under Where to Send Inquires.
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant application
instructions and forms (rev. 5/2001). The PHS 398 is available at
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive
format. For further assistance contact GrantsInfo, Telephone (301) 710-0267,
Email: [email protected].
SUPPLEMENTAL INSTRUCTIONS: Because of the size and complexity of a SCCOR,
prospective applicants are urged to consult with the staff of the Division of
Heart and Vascular Diseases early in the preparation of the application (see
INQUIRIES Section). Special instructions are needed for preparing a SCCOR
application and are available from the program contact listed under Where to
Send Inquiries or at http://www.nhlbi.nih.gov/funding/inits/dhvdsccor.htm. 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.
USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001)
application form must be affixed to the bottom of the face page of the
application. Type the RFA number on the label. Failure to use this label could
result in delayed processing of the application such that it may not reach the
review committee in time for review. In addition, the RFA title and number must
be typed on line 2 of the face page of the application form and the YES box must
be marked. The RFA label is also available at:
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the
application, including the Checklist, and three signed, photocopies, in one
package to:
Center For Scientific Review
National Institutes Of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710
Bethesda, MD 20817 (for express/courier service)
At the time of submission, two additional copies of the application must be sent
to Dr. Anne Clark at the address listed under Where to Send Inquires.
Please note that applications delivered by individuals are no longer accepted;
all applications must either come via courier delivery or the USPS
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html).
APPLICATION PROCESSING: 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
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 sent 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 have not received such a letter within three weeks after
submitting the application, contact Dr. Anne Clark at the address listed under
Where to Send Inquires.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by the CSR and
responsiveness by the NHLBI. Incomplete and/or non-responsive applications will
be returned to the applicant without further consideration.
Applications that are complete and responsive to the RFA will be evaluated for
scientific and technical merit by an appropriate peer review group convened by
the NHLBI in accordance with the review criteria stated below. As part of the
initial merit review, all applications will:
o Receive a written critique
o Undergo a process in which only those applications deemed to have the highest
scientific merit, generally the top half of the applications under review, will
be discussed and assigned a priority score
o Receive a second level review by the National Heart, Lung, and Blood Advisory
Council.
REVIEW CRITERIA
The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health. Factors
to be considered in the evaluation of each application will be similar to those
used in the review of traditional clinical and basic research grant applications
and, in addition, will include overall proposed interactions between clinical
and basic research projects. The review panel will include a majority of
clinical researchers who will receive special instructions to place emphasis on
strong clinical components. Major factors to be considered in the evaluation of
applications include:
1. Scientific merit of the proposed clinical and basic 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 between clinical and basic research components,
the required number of clinical projects, 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 (except the Clinical
Research Skills Development 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.
The Clinical Research Skills Development Core will receive a priority score
based on the review criteria below, but the priority score will not enter into
the overall priority score.
Review Criteria for Clinical Research Skills Development Core
The Clinical Research Skills Development Core will be evaluated for its
effectiveness in developing the skills and clinical research capabilities of new
investigators. This will include an evaluation of:
1. Credentials and track record of the Principal Investigator, Clinical
Research Skills Development Core Project Leader, and other participating senior
investigators.
2. Methods by which new investigators are to be recruited and selected
including plans to recruit women and minority individuals.
3. Plans for developing the skills of new investigators; the types of skill and
technologic development proposed.
4. Means by which the new investigators' professional development will be
achieved.
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application
will also be reviewed with respect to the following:
o PROTECTIONS: 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 INCLUSION: The adequacy of plans to include subjects from both genders, all
racial and ethnic groups (and subgroups), and children as appropriate for the
scientific goals of the research. Plans for the recruitment and retention of
subjects will also be evaluated. (See Inclusion Criteria included in the section
on Federal Citations, below)
o DATA SHARING: The adequacy of the proposed plan to share data.
o BUDGET: The reasonableness of the proposed budget and the requested period of
support in relation to the proposed research.
RECEIPT AND REVIEW SCHEDULE
Letter of Intent Receipt Date: December 16, 2002
Application Receipt Date: January 16, 2003
Peer Review Date: June/July, 2003
Council Review: September 4-5, 2003
Earliest Anticipated Start Date: January 1, 2004
AWARD CRITERIA
Award criteria that will be used to make award decisions include:
o Scientific merit (as determined by peer review)
o Availability of funds
o Programmatic priorities.
REQUIRED FEDERAL CITATIONS
MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components
involving Phase I and II clinical trials must include provisions for assessment
of patient eligibility and status, rigorous data management, quality assurance,
and auditing procedures. In addition, it is NIH policy that all clinical trials
require data and safety monitoring, with the method and degree of monitoring
being commensurate with the risks (NIH Policy for Data Safety and Monitoring,
NIH Guide for Grants and Contracts, June 12, 1998:
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the
NIH that women and members of minority groups and their sub-populations must be
included in all NIH-supported clinical research projects unless a clear and
compelling justification is provided indicating that inclusion is inappropriate
with respect to the health of the subjects or the purpose of the research. This
policy results from the NIH Revitalization Act of 1993 (Section 492B of Public
Law 103-43).
All investigators proposing clinical research should read the AMENDMENT "NIH
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical
Research - Amended, October, 2001," published in the NIH Guide for Grants and
Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-
files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are
available at
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the new PHS Form 398; and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a) all
applications or proposals and/or protocols must provide a description of plans
to conduct analyses, as appropriate, to address differences by sex/gender and/or
racial/ethnic groups, including subgroups if applicable; and b) investigators
must report annual accrual and progress in conducting analyses, as appropriate,
by sex/gender and/or racial/ethnic group differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The
NIH maintains a policy that children (i.e., individuals under the age of 21)
must be included in all human subjects research, conducted or supported by the
NIH, unless there are scientific and ethical reasons not to include them. 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://grants.nih.gov/grants/stem_cells.htm 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 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.
URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for
NIH funding must be self-contained within specified page limitations. Unless
otherwise specified in an NIH solicitation, Internet addresses (URLs) should not
be used to provide information necessary to the review because reviewers are
under no obligation to view the Internet sites. Furthermore, we caution
reviewers that their anonymity may be compromised when they directly access an
Internet site.
HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving
the health promotion and disease prevention objectives of "Healthy People 2010,"
a PHS-led national activity for setting priority areas. This RFA is related to
one or more of the priority areas. Potential applicants may obtain a copy of
"Healthy People 2010" at http://www.health.gov/healthypeople.
AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal
Domestic Assistance No. 93.837, and is not subject to the intergovernmental
review requirements of Executive Order 12372 or Health Systems Agency review.
Awards are made under authorization of Sections 301 and 405 of the Public Health
Service Act as amended (42 USC 241 and 284) and administered under NIH grants
policies described at http://grants.nih.gov/grants/policy/policy.htm and under
Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.
The PHS strongly encourages all grant recipients to provide a smoke-free
workplace and discourage the use of all tobacco products. In addition, Public
Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain
facilities (or in some cases, any portion of a facility) in which regular or
routine education, library, day care, health care, or early childhood
development services are provided to children. This is consistent with the PHS
mission to protect and advance the physical and mental health of the American
people.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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