SPECIALIZED CENTERS OF RESEARCH (SCORs) IN SYSTEMIC LUPUS ERYTHEMATOSUS AND
IN OSTEOARTHRITIS
Release Date: January 4, 2001
RFA: RFA-AR-01-005
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Letter of Intent Receipt Date: September 7, 2001
Application Receipt Date: October 16, 2001
PURPOSE
The National Institute of Arthritis and Musculoskeletal and Skin Diseases
(NIAMS) invites applications for Specialized Centers of Research (SCORs) in
osteoarthritis or in systemic lupus erythematosus. A SCOR should foster a
coordinated research effort that strongly emphasizes basic disciplines, but
also involves significant interaction between basic research and clinical
investigations in one of these two disease areas. A SCOR is envisioned as a
national resource associated with one or more major medical complexes and
dedicated to working with the NIAMS in furthering the research effort to
translate basic research to clinical application.
HEALTHY PEOPLE 2010
The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of "Healthy People 2010," a PHS-
led national activity for setting priority areas. This Request for
Applications (RFA), Specialized Centers of Research, is related to one or
more of the priority areas. Potential applicants may obtain a copy of
"Healthy People 2010" at http://www.health.gov/healthypeople/.
ELIGIBILITY REQUIREMENTS
Applications may be submitted by domestic for-profit and non-profit
organizations, public and private, such as universities, colleges, hospitals,
laboratories, units of State and local governments, and eligible agencies of
the Federal government. An established clinical and research program in the
disease area should be present. Foreign organizations are not eligible.
International collaborations in domestic applications will only be accepted
if the resources are clearly shown to be unavailable in the United States.
Applications from racial/ethnic minority individuals and women and persons
with disabilities are encouraged.
MECHANISM OF SUPPORT
Support of this program will be through the NIH specialized center (P50)
award. Responsibility for the planning, direction, and execution of the
proposed project will be solely that of the applicant. Investigators are to
request five years of support.
The anticipated award date is July 1, 2002.
FUNDS AVAILABLE
The direct costs requested cannot exceed $750,000 each year (exclusive of
facilities and administrative costs of subcontracts with collaborating
organizations). The NIAMS intends to fund up to 3 new and/or competing
continuation applications responding to this RFA in FY 2002 subject to the
availability of resources and receipt of sufficiently meritorious
applications. The estimated funds (total costs) available for the first year
of support of these centers are $3.4 million.
RESEARCH OBJECTIVES
The objective of the SCOR program is to expedite development and application
of new knowledge to human diseases, to learn more about the etiology of these
diseases, and to foster improved approaches to treatment and/or prevention.
A SCOR consists of at least three individual, but interrelated, research
projects, each with high scientific merit and clear research objectives and,
in the aggregate, devoted to a specific major health area. Each SCOR should
provide a multidisciplinary approach utilizing both laboratory and clinical
research to focus on a particular health problem and provide for a mutually
supportive interaction between basic scientists and clinical investigators.
Clinical research is defined as (1) patient-oriented research, (2)
epidemiologic and behavioral studies, and (3) outcomes research and health
services research. Patient-oriented research is research conducted with
human subjects (or on material of human origin such as tissues, specimens and
cognitive phenomena) for which an investigator (or colleague) directly
interacts with human subjects. Excluded from this definition are in vitro
studies that utilize human tissues but do not deal directly with patients.
Patient-oriented research includes mechanisms of human disease, therapeutic
interventions, clinical trials and development of new technologies.
Although research programs will vary among institutions according to local
expertise, interests, and resources, each SCOR should have a central theme
related to the disease area to which individual projects relate and which
serves as an integrating force. Emphasis in proposed projects should be on
development of innovative approaches, elaboration of new and significant
hypotheses, and generation of improved strategies for approaching current
issues relating to the disease area addressed. Collaboration among
institutions is encouraged within a given SCOR to share scarce patient
resources.
Funding may also be requested for one or more core resources. A core is
defined as a resource shared by multiple investigators that enhances research
productivity and increases the functional capacity of the SCOR. Ongoing
projects may be absorbed into the SCOR if their original funding source is
relinquished.
Support for large clinical trials or for applications that contain
exclusively clinical or exclusively basic studies will not be provided within
this SCOR program.
Applicants from institutions which have a General Clinical Research Center
(GCRC) funded by the NIH National Center for Research Resources may wish to
identify the GCRC as a resource for conducting the proposed research.
Details of the interactions of the SCOR staff with the GCRC staff and
research personnel may be provided in a statement describing the
collaborative linkages being developed. A letter of agreement from the GCRC
Program Director must be included with the application.
SPECIAL REQUIREMENTS
The director and co-director should budget for an annual one-day meeting in
Bethesda, MD with NIAMS staff. The director should be prepared to devote at
least 15 percent effort as the director and 20 percent effort as a project
PI. Each project and core PI should be prepared to devote at least 20
percent effort.
To be funded, a SCOR must include at least three highly meritorious projects
recommended for five years. One of these must have the SCOR director as the
principal investigator, and the highly meritorious projects must include both
basic and clinical research.
INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS
It is the policy of the NIH that women and members of minority groups and
their sub-populations must be included in all NIH-supported biomedical and
behavioral research projects involving human subjects, unless a clear and
compelling rationale and justification are 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 research involving human subjects should read the
UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in
Clinical Research," published in the NIH Guide for Grants and Contracts on
August 2, 2000
(https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html);
a complete copy of the updated Guidelines is available at
https://grants.nih.gov/grants/funding/women_min/guidelines_update.htm. The
revisions relate to NIH defined Phase III clinical trials and require: a) all
applications or proposals and/or protocols to 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) all
investigators to report accrual, and to conduct and report analyses, as
appropriate, by sex/gender and/or racial/ethnic group differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS
It is the policy of NIH that children (i.e., individuals under the age of 21)
must be included in all human subjects research, conducted or supported by
the NIH, unless there are 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 was published in the NIH Guide for
Grants and Contracts, March 6, 1998, and is available at the following URL
address: https://grants.nih.gov/grants/guide/notice-files/not98-024.html
Investigators also may obtain copies of these policies from the program staff
listed under INQUIRIES. Program staff may also provide additional relevant
information concerning the policy.
URLS IN NIH GRANT APPLICATIONS OR APPENDICES
All applications and proposals for NIH funding must be self-contained within
specified page limitations. Unless otherwise specified in an NIH
solicitation, internet addresses (URLs) should not be used to provide
information necessary to the review because reviewers are under no obligation
to view the Internet sites. Reviewers are cautioned that their anonymity may
be compromised when they directly access an Internet site.
LETTER OF INTENT
Prospective applicants are asked to submit, by September 7, 2001, a letter of
intent that includes a descriptive title of the proposed research, the name,
address, and telephone number of the Principal Investigator, the identities
of other key personnel and participating institutions, and the number and
title of the RFA in response to which the application may be submitted.
Although a letter of intent is not required, is not binding, and does not
enter into the review of subsequent applications, the information that it
contains allows NIAMS staff to estimate the potential review workload and to
avoid conflict of interest in the selection of reviewers. The letter of
intent is to be sent to Dr. Julia B. Freeman at the address listed under
INQUIRIES.
APPLICATION PROCEDURES
Special guidelines have been developed by NIAMS for the SCOR program. These
guidelines should be used in assembling the application. See INQUIRIES for
obtaining a copy of these guidelines.
The research grant application form PHS 398 (rev. 4/98) is to be used in
applying for these grants. Applications kits are available at most
institutional offices of sponsored research and may be obtained from the
Division of Extramural Outreach and Information Resources, National
Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-
7910, telephone 301/710-0267, email: grantsinfo@nih.gov and on the internet
at https://grants.nih.gov/grants/forms.htm
The RFA label available in the PHS 398 (rev. 4/98) application form must be
affixed to the bottom of the face page of the application. The sample RFA
label is available at: https://grants.nih.gov/grants/funding/phs398/label-bk.pdf.
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,
"Specialized Centers of Research" and number, "AR-01-005" must be typed on
line 2 of the face page of the application form and the YES box must be
marked.
Submit a signed, typewritten original of the application, including the
Checklist, and three signed photocopies of the application 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, send two additional copies of the application to:
Review Branch
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Natcher Building, Room 5AS.25U - MSC 6500
Bethesda, MD 20892-6500
Bethesda, MD 20814 (for express/courier service)
Applications must be received by October 16, 2001. If an application is
received after that date, it will be returned to the applicant without
review.
REVIEW CONSIDERATIONS
Upon receipt, applications will be reviewed for completeness by CSR and for
responsiveness to the RFA by the NIAMS staff. 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 NIAMS in accordance with the review criteria stated
below. As part of the initial merit review, a process may be used by the
initial review group in which all applications receive a written critique and
undergo a process in which only those applications with the highest
scientific and technical merit will be discussed, assigned a priority score,
and receive a second level review by the National Arthritis and
Musculoskeletal and Skin Diseases Advisory Council.
Site visits will not be made.
Review Criteria
Major factors to be considered in evaluation of applications will include:
1. How the proposed SCOR combines basic and clinical research into the
scientific goals and research theme;
2. If a competing continuation application, the quality and significance of
the progress made in the previous funding period;
3. Scientific merit of each proposed project. [Each project will receive a
priority score. This score reflects not only the feasibility of the project
and adequacy of the experimental design, but also the design of the project
to advance both the theme of the SCOR and the interaction between basic
research and clinical investigation];
4. Scientific merit of combining the component parts into a SCOR;
5. Technical merit and justification of each core unit;
6. Competence of the investigators to accomplish the proposed research
goals, their commitment, and the time they will devote to the research
program;
7. Adequacy of facilities to perform the proposed research, including
laboratory and clinical facilities, instrumentation, and data management
systems, when needed;
8. Adequacy of plans for interaction among investigators, and the
integration of the various projects and core units;
9. Qualifications, experience and commitment of the SCOR Director and
his/her ability to devote time and effort to provide effective leadership;
10. Scientific and administrative structure, including internal and external
procedures for monitoring and evaluating the proposed research and for
providing ongoing quality control and scientific review;
11. Institutional commitment to the program, and the appropriateness of
resources and policies for the administration of a SCOR;
12. Adequacy of plans to include both genders and minorities and their
subgroups and children as appropriate for the scientific goals of the
research. Plans for the recruitment and retention of subjects will also be
evaluated.
AWARD CRITERIA
The anticipated award date is July 1, 2002. The primary factors determining
the award will be the priority score, the overall balance of meritorious
projects (clinical and basic research) within the application relative to the
disease area, and the availability of funds. Since the NIAMS is interested
in funding only the best research, individual projects or cores of lesser
quality may not be funded, even if approved, under the "umbrella" of the SCOR
mechanism.
INQUIRIES
Inquiries are encouraged. The opportunity to clarify any issues or questions
from potential applicants is welcome. Inquiries regarding programmatic
issues and letters of intent may be directed to:
Dr. Julia B. Freeman
Centers Program, EP
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Natcher Building, Room 5AS.19F - MSC 6500
Bethesda, MD 20892-6500
Bethesda, MD 20814 (for express/courier service)
Telephone: (301) 594-5052
FAX: (301) 480-4543
Email: Julia_B_Freeman@nih.gov
Copies of the guidelines for the NIAMS SCOR program may be obtained from:
NIAMS Clearinghouse
1 AMS Circle
Bethesda, MD 20892-3675
Telephone: (301) 495-4484
FAX: (301) 587-4352
Guidelines are also available on the internet:
http://www.nih.gov/niams/grants/ep7.htm
Direct inquiries regarding fiscal matters to:
Melinda Nelson
Chief Grants Management Officer
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Natcher Building Room 5AS.49F - MSC 6500
Bethesda, MD 20892-6500
Telephone: (301) 594-3535
FAX: (301) 480-5450
Email: nelsonm@exchange.nih.gov
AUTHORITY AND REGULATIONS
This program is described in the Catalog of Federal Domestic Assistance No.
93.846, Arthritis, Musculoskeletal and Skin Diseases Research. Awards will
be made under the authority of the Public Health Service Act, Title III,
Section 301 (Public Law 410, 78th Congress, as amended, 42 USC 241) and
administered under PHS grant policies and Federal regulations 42 CFR Parts 52
and 45 CFR Parts 74 and 92. This program is not subject to intergovernmental
review requirements of Executive Order 12372 or Health Systems Agency review.
The PHS strongly encourages all grant and contract recipients to provide a
smoke-free workplace and promote the non-use of all tobacco products. In
addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking
in certain facilities (or in some cases, any portion of a facility) in which
regular or routine education, library, day care, health care or early
childhood development services are provided to children. This is consistent
with the PHS mission to protect and advance the physical and mental health of
the American people.