and Human Services
9000 Rockville Pike
Bethesda, Maryland 20892
SPECIALIZED CENTERS OF CLINICALLY ORIENTED RESEARCH (SCCOR) IN HEMOSTATIC AND
THROMBOTIC DISEASES
RELEASE DATE: January 30, 2004
RFA: RFA-HL-04-016
Department of Health and Human Services (DHHS)
PARTICIPATING ORGANIZATION:
National Institutes of Health
(http://www.nih.gov)
COMPONENT OF PARTICIPATING ORGANIZATION:
National Heart, Lung, and Blood Institute (NHLBI)
(http://www.nhlbi.nih.gov)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.938, 93.939
LETTER OF INTENT RECEIPT DATE: August 24, 2004
APPLICATION RECEIPT DATE: September 21, 2004
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 focus
on diseases and function related to hemostasis and thrombosis. It is expected
that the results from these SCCOR grants will have a positive impact on the
prevention, diagnosis, and treatment of thrombotic and bleeding disorders.
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 clinical settings.
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.
Formation of a blood clot and the resulting ischemia leading to tissue damage
is the major cause of disability or death in the United States. The application
of innovative technologies in molecular biology, immunology, genetics and
protein chemistry has contributed to elucidation of the regulatory pathways of
hemostasis and the risk factors related to thromboembolic disease. Further
research is necessary to translate these advances to clinical care. The long
term goal of this SCCOR program is integration of science and clinical medicine
in the prevention and treatment of thrombotic and hemostatic disorders. Five
specific areas of emphasis are detailed below.
Arterial and Venous Thrombosis
The molecular basis of the involvement of inflammation and immune mediators in
thrombosis remains unclear and methods of predicting thrombotic disease
associated with abnormalities of these interactive pathways remain to be
determined. Many proteins, which are integral components of the coagulation
cascade, are also potent activators of leukocytes and endothelial cells.
Platelets are key mediators of inflammation. Microparticles from
platelets/leukocytes/endothelium may be an important source of tissue factor
for thrombus formation. Thus, studies that address the interaction of
inflammation and thrombosis, and the associated clinical sequelae are timely.
Thrombosis and Cancer
Thrombosis in cancer remains a significant problem in clinical medicine.
Coagulation mechanisms appear to be involved in metastasis and cancer
progression. The basic mechanisms underlying cancer related thrombosis, the
optimal treatment of the hypercoagulable state associated with malignancy, and
the role of the hemostatic system in cancer progression remain to be defined.
Despite prospective clinical trials suggesting that anticoagulants alter the
course of cancer, the nature of this effect remains uncertain. Better
understanding of the relationship between the coagulation system, fibrinolysis,
angiogenesis and their roles in tumor progression and host resistance to
thrombosis is needed.
Thrombotic Stroke
Ischemic stroke involves thrombosis, inflammation and reperfusion injury.
Little is known about the interactions of blood cells and proteins, the vascular
structures and the neuronal/glial compartment in normal and ischemic conditions.
New insights into mechanisms and risk factors may come from studies of genetic
polymorphisms linked to stroke and the level of expression of different genes.
The development of coagulant activity and the interaction of platelets with the
brain vasculature is a priority area of study.
Better means of intervention for acute stroke and stroke prophylaxis are needed.
Clinical studies of aspirin resistance in ischemic stroke patients may give
insights into both mechanisms and improved therapeutics for stroke.
Thrombolytic therapy with tissue plasminogen activator (t-PA) has proved
beneficial, but, only a small group of patients qualify and the treatment may
increase the risk of bleeding and neuronal damage. Decreased levels of
circulating activated protein C (APC), compared with controls, may be a marker
for increased risk for post-infection ischemic stroke. Recombinant APC, approved
for treating severe sepsis, exerts important biologic activities in vivo in
addition to its known anticoagulant activity. Studies in animal models show
that APC may have anti-inflammatory and anti-apoptotic activities, and it is
neuroprotective in ischemic stroke. Anti-platelet agents, such as an ecto
ADPase (CD39), and chimeric agents that block P-selectin and complement, have
been reported to produce beneficial results after stroke. These agents, as well
as the t-PA inhibitor, neuroserpin, are attractive candidates for combination
therapy of ischemic stroke.
Disorders of fibrinolytic system
Fibrinolysis plays an important role in the regulation and limitation of clinical
thrombosis. Hereditary deficiencies in these pathways are poorly defined. The
fibrinolytic system also has broad functions and its components may be involved
in angiogenesis and obesity-related thrombosis. Significant opportunities for
clinical studies might include in the development of more efficient and specific
thrombolytics, cell-based and targeted delivery of these agents, and the
efficacy/safety of catheter-directed thrombolysis. The interrelated roles of
fibrinolysis and inflammation require further investigation.
Bleeding Disorders
The molecular definition of the defects in the VWF gene or the protein in Von
Willebrand Disease (VWD) remain unclear. Gene therapy trials are continuing in
patients with hemophilia. Opportunities for additional patient-oriented
research include novel sites of FVIII/FIX synthesis or inducing synthesis of
modified factors that increase survival or efficacy of the expressed gene
product. Factors that affect the incidence or prevalence of inhibitors and
modulating their clinical impact are also important areas of investigation.
Defects in platelet function are diagnosed using assays that are essentially
similar to those that were in place 25-30 years ago. We have not developed
clinically-relevant measures of platelet function with the exception of
structural definitions of glycoprotein receptor deficiencies such as Glanzmann
Thrombasthenia and Bernard-Soulier syndrome. With the advent of proteomics and
gene arrays, opportunities exist to define new clinical syndromes and novel
therapeutics for platelet disorders. Studies on the bleeding complications of
uremia are also encouraged.
Research Topics
The objective of the SCCOR in Hemostatic and Thrombotic Diseases is to stimulate
multidisciplinary collaborations leading to clinical and basic science research
efforts in thrombotic and bleeding disorders. The following examples of
research topics are intended to provide a perspective on the scope of research
that could meet the objectives of this program. It is not required that all or
any of these topics be included. Applicants are encouraged to consider other
topics that are relevant to the goals of this new SCCOR program. Large clinical
trials will not be supported under this program.
o Study genetic and environmental risk factors, modifier genes, and disease
outcome in thrombotic and / or bleeding disorders utilizing proteomic,
genomic and other tools;
o Perform translational studies on anticoagulant and antiinflammatory agents;
evaluate pharmacogenetics, biomarkers, and monitoring of drugs;
o Define the molecular properties of the brain vasculature, its expression of
coagulant activity and platelet adhesion mechanisms; potential markers of
ischemic injury and methods to prevent neuronal damage;
o Explore age-dependent regulation of hemostasis, identify genetic switches,
and possible development of hypercoagulable state;
o Elucidate molecular and signal transduction processes involved in the
activation of platelets; develop assays of platelet function, and perform
translational studies on platelet inhibitors as potential therapeutic agents;
o Define the role of the fibrinolytic enzymes, their activators and inhibitors
in thrombosis / bleeding with special attention to obesity and diabetes;
o Elucidate the underlying pathophysiology of immune-mediated thrombosis or
bleeding and develop new approaches to its diagnosis and treatment;
o Develop imaging tools, assays and identify biomarkers of the subclinical
prothrombotic state that can be useful in early detection and diagnosis of the
disease process;
o Study the role of thrombosis in cancer and malignancy; evaluate drug therapy
targeted to hemostatic factors in the prevention of cancer-related morbidity and
mortality.
The SCCOR mechanism provides both the incentive and the structure to maintain
critical collaborative cores or other resources necessary for translational
research.
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 staff 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 "exchange" program wherein clinical investigators spend
time in basic science laboratories. 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, but may not receive
salary on the Skills Development Core. 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:
o A summary of the types of skills that would be developed and a description of
proposed project-specific activities;
o 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;
o 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;
o A plan for coordinating the activities of participating senior investigators;
o A plan for monitoring the progress of the new clinical investigators;
o 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;
o 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. As an applicant you will be solely
responsible for planning, directing, and executing the proposed project. This RFA is
a one-time solicitation. Future unsolicited, competing – continuation applications
based on this project will compete with all investigator – initiated applications and
will be reviewed according to the customary peer review procedures. The anticipated
award date is February 1, 2006. Applications that are not funded in the competition
described in this RFA may be resubmitted as NEW investigator-initiated applications
using the standard receipt dates for NEW applications described in the instructions of
the PHS 398 application.
This RFA uses just-in-time concepts. It also uses the modular budgeting 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 budget format. Otherwise follow the instructions for the non-modular budget
research grant applications. This program does not require cost sharing as defined in
the current NIH Grants Policy Statement at
http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm.
FUNDS AVAILABLE
The NHLBI intends to commit approximately $8,000,000 in fiscal year 2006 to fund two
to four new grants in response to this RFA. An applicant may request a project period
of up to five years and a budget for direct costs up to $2.5 million, not including
Facilities and Administrative (F&A;) costs for collaborating institutions, in the first
year. In addition, applicants for a new SCCOR may request up to $100,000 in direct
costs per year above the usual cap ($2.5 million direct costs) for a Clinical Research
Skills Development Core. 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.
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 Faith-based or community-based organizations
o Foreign institutions are not eligible to apply
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
Any individual with the skills, knowledge, and resources necessary to carry out the
proposed research is invited to work with their institution to develop an application
for support. Individuals from underrepresented racial and ethnic groups as well as
individuals with disabilities are always encouraged to apply for NIH programs.
SPECIAL REQUIREMENTS
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. 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. The number of clinical research 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. For example, if an application has a total
of three projects, two of the projects must be clinical research projects. 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 research within a project is clinical, it
will be considered a clinical project; if the majority of the research within a
project 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.
3. In order for a project to be considered clinical research for the purposes of
responsiveness to this RFA, the research must be patient-oriented research. Patient-
oriented research is research in which an investigator (or colleague) directly
interacts with patients having a disease or condition of interest. Normal healthy
subjects may be included, but only in combination with studies involving patients. In
studies involving the use of human specimens, the investigators must have direct
interaction with the patient from whom the specimen is obtained 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.
Applicants are encouraged to pursue patient-oriented research on topics related to
health disparities and the translation of this research to clinical practice for
affected minority populations. At a minimum, clinical research projects must include
women and minorities in the study population in representative numbers, unless such
inclusion can be demonstrated to be inappropriate. Clinical studies involving
interventions or treatments must give consideration to including sufficient numbers of
women, minorities and children to conduct valid analyses of subgroup effects. Human
biomedical and behavioral studies of etiology, pathogenesis, prevention and prevention
strategies, diagnostic approaches, and treatment of thrombotic and bleeding disorders
or conditions are responsive. However, epidemiologic studies or Phase III clinical
trials will be considered unresponsive to this RFA.
4. Each awarded SCCOR must consist of three or more projects, all of which are
directly related to the overall clinical focus of the SCCOR. 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.
Component projects not located at the applicant institution may be at a foreign
institution, but must conform to NIH policy regarding the protection of human
subjects. 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. Each SCCOR must have a well-delineated organizational structure and administrative
mechanism that foster interactions between investigators, accelerate the pace of
research, enable translation of basic research findings to clinical applications, and
ensure a productive research effort.
7. Applicants should provide a detailed data and safety monitoring plan for the
clinical research proposed; the monitoring plan will be considered as part of 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. After a decision has been made regarding SCCOR awards, the
Institute will determine whether to convene a Data and Safety Monitoring Board to
oversee one or more clinical projects in a SCCOR program.
8. 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.
9. 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 clinical 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.
10. Applicants are encouraged to establish links and utilize existing resources,
including the NHLBI Program in Genomic Applications, NHLBI clinical research networks,
and General Clinical Research Centers, as feasible and appropriate. If applicants
propose to utilize such resources, a letter of agreement from the program director or
principal investigator of the resource should be included with the application.
11. 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. 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 NIH 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) 435-0171. 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.
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:
Pan Ganguly, Ph.D.
Division of Blood Diseases and Resources
National Heart, Lung, and Blood Institute
Rockledge II, Room 10176
Bethesda, MD 20892 -7950 (20817 for courier / express service)
Telephone: (301) 435-0070
FAX: (301) 480-1046
Email: gangulyp@nhlbi.nih.gov
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 7214 (MSC 7924)
Bethesda, MD 20892-7924 (20817 for express/courier service)
Telephone: (301) 435-0270
FAX: (301) 480-0730
Email: ClarkA@nhlbi.nih.gov
o Direct your questions about financial or grants management matters to:
Ms. Mary Baylor
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
Rockledge II, Room 7126
Bethesda, MD 20892
Telephone: (301) 435-0152
FAX: 301-480-3310
Email: baylorm@nhlbi.nih.gov
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that includes the
following information:
o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel
o Participating institutions
o Number and title of this RFA
Although a letter of intent is not required, is not binding, and does not enter into
the review of a subsequent application, the information that it contains allows 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). 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 document 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.
SUPPLEMENTARY INSTRUCTIONS:
Because of the size and complexity of a SCCOR, prospective applicants are urged to
consult with the staff of the Division of Blood Diseases and Resources early in the
preparation of the application. Special instructions for preparing a SCCOR application
are available from the program contact listed under WHERE TO SEND INQUIRIES or at
http://www.nhlbi.nih.gov/funding/policies/sccor_desc.htm .
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 Hemostatic and Thrombotic Diseases SCCOR
program will be conducted during the second project period according to the following
timetable:
Program Announced: FY 2004
Project Period (First Competition): FY 2006 through FY 2011
Program Reannounced: FY 2009
Project Period (Second Competition):FY 2011 through FY 2016
Letter to Principal Investigators
Regarding SCCOR Evaluation Plans: FY 2012 (mid-way through year 02
of 2nd project period)
SCCOR Evaluation Meeting: FY 2013 (late in year 02 of 2nd
project period)
The NHLBI does not limit the number of applications for a given SCCOR program from one
institution. However, each SCCOR application from the institution must have a
different principal investigator and must be self-contained and independent of other
SCCOR applications from the same institution. Institutions envisioning more than one
application are encouraged to discuss their plans with the program contact listed
under Where to Send Inquiries.
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/labels.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 and all copies of
the appendix material must be sent to Dr. Anne Clark at the address listed under WHERE
TO SEND INQUIRES.
APPLICATION PROCESSING: Applications must be received on or before the application
receipt date listed in the heading of this RFA. If an application is received after
that date, it will be returned to the applicant without review.
Although there is no immediate acknowledgement of the receipt of an application,
applicants are generally notified of the review and funding assignment within 8 weeks.
The Center for Scientific Review (CSR) will not accept any application in response to
this RFA that is essentially the same as one currently pending initial review, unless
the applicant withdraws the pending application. However, when a previously unfunded
application, originally submitted as an investigator-initiated application, is to be
submitted in response to an RFA, it is to be prepared as a NEW application. That is,
the application for the RFA must not include an Introduction describing the changes
and improvements made, and the text must not be marked to indicate the changes from
the previous unfunded version of the application.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by the CSR and
responsiveness by the NHLBI. Incomplete and/or nonresponsive applications will not be
reviewed. 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 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 written critique
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. In the written comments,
reviewers will be asked to evaluate 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 the following
criteria in assigning the application’s overall score, weighting them as appropriate
for each application.
o Significance
o Approach
o Innovation
o Investigator
o Environment
The application does not need to be strong in all categories to be judged likely to
have major scientific impact and thus deserve a high priority score. For example, an
investigator may propose to carry out important work that by its nature is not
innovative but is essential to move a field forward.
o 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?
o 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?
o 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?
o 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?
o 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 the 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.
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:
o Credentials and track record of the Principal Investigator, Clinical Research Skills
Development Core Project Leader, and other participating senior investigators.
o Methods by which new investigators are to be recruited and selected including plans
to recruit women, minorities and children.
o Plans for developing the skills of new investigators; the types of skill and
technologic development proposed.
o Means by which the new investigators' professional development will be achieved.
PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects
and protection from research risk relating to their participation in the proposed
research will be assessed. (See criteria included in the section on Federal
Citations, below)
INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans to
include subjects from both genders, all racial and ethnic groups (and subgroups), and
children as appropriate for the scientific goals of the research. Plans for the
recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria
included in the section 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.
DATA SHARING: The adequacy of the proposed plan to share data.
ADDITIONAL REVIEW CONSIDERATIONS
Sharing Research Data
Applicants requesting more than $500,000 in direct costs in any year of the proposed
research must 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. See
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html for guidance.
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: August 24, 2004
Application Receipt Date: September 21, 2004
Peer Review Date: January / February, 2005
Council Review: September, 2005
Earliest Anticipated Start Date: February 1, 2006
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
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: 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).
SHARING RESEARCH DATA; Starting with the October 1, 2003 receipt date, investigators
submitting an NIH application seeking $500,000 or more in direct costs in any single
year are expected to include a plan for data sharing or state why this is not
possible. http://grants.nih.gov/grants/policy/data_sharing. Investigators should seek
guidance from their institutions, on issues related to institutional policies, local
IRB rules, as well as local, state, and Federal laws and regulations, including the
Privacy Rule. Reviewers will consider the data sharing plan but will not factor the
plan into the determination of the scientific merit or the priority score.
INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH
that women and members of minority groups and their sub-populations must be included
in all NIH-supported clinical research projects unless a clear and compelling
justification is provided indicating that inclusion is inappropriate with respect to
the health of the subjects or the purpose of the research. This policy results from
the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43).
All investigators proposing clinical research should read the "NIH Guidelines for
Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October,
2001," published in the NIH Guide for Grants and Contracts on October 9, 2001
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy
of the updated Guidelines are available at
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The
amended policy incorporates: the use of an NIH definition of clinical research;
updated racial and ethnic categories in compliance with the new OMB standards;
clarification of language governing NIH-defined Phase III clinical trials consistent
with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the
extramural community. The policy continues to require for all NIH-defined Phase III
clinical trials that: a) all applications or proposals and/or protocols must provide a
description of plans to conduct analyses, as appropriate, to address differences by
sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b)
investigators must report annual accrual and progress in conducting analyses, as
appropriate, by sex/gender and/or racial/ethnic group differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH
maintains a policy that children (i.e., individuals under the age of 21) must be
included in all human subjects research, conducted or supported by the NIH, unless
there are scientific and ethical reasons not to include them. This policy applies to
all initial (Type 1) applications submitted for receipt dates after October 1, 1998.
All investigators proposing research involving human subjects should read the "NIH
Policy and Guidelines" on the inclusion of children as participants in research
involving human subjects that is available at
http://grants.nih.gov/grants/funding/children/children.htm.
REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS:
NIH policy requires education on the protection of human subject participants for all
investigators submitting NIH proposals for research involving human subjects. You
will find this policy announcement in the NIH Guide for Grants and Contracts
Announcement, dated June 5, 2000, at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs
can be found at http://stemcells.nih.gov/index.asp and at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research
using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry
will be eligible for Federal funding (see http://escr.nih.gov). It is the
responsibility of the applicant to provide, in the project description and elsewhere
in the application as appropriate, the official NIH identifier(s) for the hESC
line(s)to be used in the proposed research. Applications that do not provide this
information will be returned without review.
PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION
ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to
provide public access to research data through the Freedom of Information Act (FOIA)
under some circumstances. Data that are (1) first produced in a project that is
supported in whole or in part with Federal funds and (2) cited publicly and officially
by a Federal agency in support of an action that has the force and effect of law
(i.e., a regulation) may be accessed through FOIA. It is important for applicants to
understand the basic scope of this amendment. NIH has provided guidance at
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this PA in a public archive, which
can provide protections for the data and manage the distribution for an indefinite
period of time. If so, the application should include a description of the archiving
plan in the study design and include information about this in the budget
justification section of the application. In addition, applicants should think about
how to structure informed consent statements and other human subjects procedures given
the potential for wider use of data collected under this award.
STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department
of Health and Human Services (DHHS) issued final modification to the “Standards for
Privacy of Individually Identifiable Health Information” the Privacy Rule, on August
14, 2002. The Privacy Rule is a Federal regulation under the Health Insurance
Portability and Accountability Act (HIPPA) 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 HIPPA
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 RFA is related to one or more of
the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at
http://www.healthypeople.gov/.
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 authorization of Sections 301 and 405 of the
Public Health Service Act as amended (42 USC 241 and 284) and under Federal
Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms
and conditions , cost principles and other considerations described in the NIH Grants
Policy Statement.. The NIH Grants Policy Statement can be found at
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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