and Human Services (HHS)
EXPIRED
SPECIALIZED CENTERS OF CLINICALLY ORIENTED RESEARCH (SCCOR) IN TRANSFUSION BIOLOGY AND
MEDICINE
RELEASE DATE: March 02, 2004
RFA Number: RFA-HL-04-018
EXPIRATION DATE: September 22, 2004
Department of Health and Human Services (DHHS)
PARTICIPATING ORGANIZATION:
National Institutes of Health (NIH)
(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): 93.839
LETTER OF INTENT RECEIPT DATE: August 17, 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 program in
transfusion biology and medicine is to support the development and application of new
knowledge essential for improved safety, efficacy, and availability of blood, blood
components, and plasma derivatives, and to transfer these research findings into
clinical evaluation and application.
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.
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.
Opportunities for research in transfusion medicine are increasing and have expanded to
include any blood component or bone marrow derived cell. There continues to be a
substantial need for performing evidence-based studies to evaluate the best approaches
to provide blood and bone marrow derived components to patients. Listed below are four
general areas of emphasis and specific examples are outlined for which studies would
be considered to be responsive to this RFA announcement. The different research
topics and approaches described below in the four areas of emphasis provide potential
applicants with examples of topics that interest the NHLBI. These examples, however,
are not meant to be all inclusive. Investigators are encouraged to consider pursuing
other important and innovative research topics as well. It should be emphasized,
however, that the topics chosen must relate directly to the four areas of emphasis
identified in this initiative. Furthermore, topics may address more than one area of
emphasis. For example, it would be appropriate for an application to propose projects
that address research issues pertaining to one area of interest such as immunologic
responses to blood components or platelet storage or a combination such as immunologic
responses to blood components and platelet substitutes. It should be noted, however,
that SCCOR investigations which focus exclusively on cellular therapy will not be
considered responsive to this RFA.
I. MANAGEMENT OF THE BLOOD SUPPLY
Maintaining an adequate supply of blood components to meet patient needs for
transfusion involves many factors including a broad donor base, methods of storing
blood components, and determining appropriate indications for their use to avoid
unnecessary and/or ineffective transfusions. Areas for research questions include:
Donors
o Determine the benefits of iron supplementation to donors;
o Evaluate donor safety issues such as: frequency of donations, quantity of blood
components removed, and effects of cytokines given to donors to enhance the
collection of blood components;
o Recruitment and retention of donors.
o Storage and Utilization of Blood Components
o Determine optimal transfusion triggers for cellular and plasma blood components
to reduce ineffective use;
o Assess the appropriate transfusion dose for each blood component;
o Evaluate methods of extending the storage time for cellular components,
particularly platelets;
o Determine how to judge the safety and efficacy of blood component therapy.
II. INCOMPATIBILITY AND BLOOD SAFETY IN TRANSFUSION MEDICINE
Substantial progress has been made over the last several years in the identification
of and testing for viruses that are capable of being transmitted by transfusion. The
following areas of blood transfusion safety have received little emphasis and now
represent the biggest transfusion risks for patients:
Safety of blood products
o Develop methods of blood product and recipient identification to ensure the
correct product is given to the designated recipient;
o Identify processes to either detect bacterial contamination or inhibit the
growth of bacteria in transfused blood products B particularly platelets;
o Identify ligands and/or receptors on erythrocytes for microbe binding.
Blood Group Incompatibility
o Develop improved methods of antigen typing to insure a compatible transfusion;
o Identify systems to reduce alloimmunization in transfusion dependent patients;
o Determine the pathophysiological events in Hemolytic Disease of the Newborn and
identify preventative clinical intervention.
III. IMMUNOLOGIC RESPONSES TO BLOOD COMPONENTS OR MARROW DERIVED CELLS
There are both desirable and undesirable immunologic consequences of the transfusion
of blood components or marrow derived cells. For all of these transfusion related
effects, additional studies are needed to understand the factors associated with their
development. These factors include the influence of the type, amount, and timing of
transfusions on their occurrence, ways that desirable effects can be enhanced while
undesirable effects are eliminated, and the pathophysiologic events associated with
these conditions. Topics include:
Desirable Effects
o Graft vs. Leukemia;
o Induction of tolerance to organ grafts.
Undesirable Effects
o Alloimmunization and refractoriness to platelet transfusions;
o Alloimmunization to red cells with reduction in the available compatible donor
pool;
o Transfusion associated acute lung injury (TRALI);
o Immunomodulatory effects of transfusion such as infection and tumor
recurrence/metastasis;
o GVHD
IV. CELLULAR THERAPY
Transfusion medicine has traditionally been involved in the production and storage of
red cells, platelets, granulocytes, and plasma components. Another topic of interest
has been the evaluation of their use in transfusions. However, it has become clear
that there are many other types of blood and bone marrow derived cells that have
important biologic functions. Therefore, of substantial interest are studies on the
characterization of these cell types by exploring their role in the pathophysiology of
human diseases, and methods for the manipulation and transfusion of these cells to
provide a therapeutic benefit to patients. Examples of these therapies are listed
below:
Mononuclear Cell Fractions
o Identify and characterize the stem cells that are associated with rapid and long
term engraftment;
o Develop methods for proliferation of stem cells in vitro;
o Characterize the cells associated with GVHD and determine how this adverse
effect can be eliminated/modified;
o Identify factors associated with the development of peripheral blood stem cells
as well as other blood cells.
Pluripotent Stem Cells
o How can the use of marrow derived cells in organogenesis be potentiated;
o What factors are associated with the development of "plasticity" and how can this
be facilitated;
o What governs the trafficking of cells to desired locations.
Cellular Engineering of New Blood Components
o Develop blood "substitutes" which can take the place of "classic" blood component
transfusions.
Modification of Leukocytes to Act as Vaccines for the Treatment of Malignancies or
Infectious Diseases
o What are the best cells to use for targeted vaccine therapy;
o What are the best ways to develop "vaccinated cells";
o How should they be used, and how is their effectiveness determined.
Gene Therapy
o Use cells to "cure" genetic diseases by inserting into cells the genetic material
of interest;
o Identify the most appropriate cells to use as the hosts for genetic material;
o Determine how should the genetic material be inserted;
o Determine how should genetically modified cells be infused (locally or
systemically), the frequency of administration;
o Establish ways to monitor the effectiveness of this therapy.
Treatment of Autoimmune Diseases by Cellular Therapy
Adoptive Immunotherapy
o Peripheral blood mononuclear cells can be manipulated ex vivo and transfused to
decrease or enhance immune function.
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 "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. All applications received in response
to the Transufsion Biology and Medicine Diseases 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 February 1, 2006.
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 Transfusion Biology and Medicine 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.
FUNDS AVAILABLE
The NHLBI intends to commit approximately $4.0 million in FY 2006 to fund 2 to 3 new
grants in response to this RFA. An applicant may request a project period of up to 5
years and a budget for direct costs up to $2.0 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 ($2.0 million direct costs) for a Clinical Research Skills
Development Core. 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 and duration of each award will also vary. Although the
financial plans of the NHLBI provide 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.
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 programmatic, fiscal, and administrative considerations are explained fully.
At least 50 percent of 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 Operation 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 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 Foreign institutions are not eligible to apply.
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. 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 and minorities to conduct valid analyses of subgroup effects. 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.
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:
Dr. Luiz H. Barbosa
Division of Blood Diseases and Resources
National Heart, Lung, and Blood Institute
Building Two Rockledge Center, Room 10140
Bethesda, MD 20892
Telephone: (301) 435-0075
FAX: (301) 480-1060
Email: [email protected]
o Direct your questions about peer review issues to:
Dr. Anne P. Clark
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7214, MSC 7924
Bethesda, MD 20892-7924
Telephone: (301) 435-0270
Fax: (301) 480-0730
Email: [email protected]
o Direct your questions about financial or grants management matters to:
Ms. Shelia L. Ortiz
Division of Extramural Affairs
National Heart, Lung & Blood Institute
6701 Rockledge Drive, Suite 7044
Bethesda, MD 20892-7926
(301)435-0166 FAX (301)480-3310
[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 by mail or email to Dr. Anne Clark at
the address listed under Where to Send Inquiries .
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) 710-0267, Email:
[email protected].
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 (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/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 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/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 and all copies of
the appendix material must be sent to:
Anne P. Clark, Ph.D.
Chief, Review Branch
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7214, MSC 7924
Bethesda, MD 20892-7924
Bethesda, MD 20817 (for express/courier service)
Telephone: (301) 435-0270
FAX: (301) 480-0730
Email: [email protected]
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.
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.
Principal investigators should not send supplementary material without first
contacting the Scientific Review Administrator (SRA). The SRA will be identified in
the letter sent to you indicating that your application has been received. If you 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 Inquiries .
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 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. 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:
o 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.
o Leadership, scientific expertise, experience, 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.
o Collaborative interaction between clinical and basic research components and the
adequacy of plans for transfer of potential findings from basic to clinical
studies.
o 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.
o 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:
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 and minority individuals.
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.
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: August 17, 2004
Application Receipt Date: September 21 , 2004
Peer Review Date: January / February 1, 2005
Council Review: May/September, 2005
Earliest Anticipated Start Date: January 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
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://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.
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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