ALZHEIMER'S DISEASE CORE CENTERS
Release Date: May 16, 2000
RFA: AG-00-002
National Institute on Aging (http://www.nih.gov/nia/)
Letter of Intent Receipt Date: July 1, 2000
Application Receipt Date: September 15, 2000
PURPOSE
The National Institute on Aging (NIA) invites applications from qualified
institutions for support of Alzheimer's Disease Core Centers (ADCCs). These
are designed to serve as shared research resources to facilitate research in
Alzheimer's disease (AD) and related disorders and distinguish them from
normal aging. Alzheimer's disease may presently affect as many as 4 million
older people in the United States. Although it is occasionally identified in
patients in their forties and fifties, it is most frequently associated with
advancing age. It doubles in prevalence with every five years past the age
of 65; thus, extending life by ten years quadruples the probability of the
disease. Alzheimer's disease is the most frequent cause of
institutionalization for long-term care. It destroys the active, productive
life of its victims and devastates their families financially and
emotionally. It is estimated that the United States spends as much as 100
billion dollars/year for the direct and facilities and administrative (F&A)
costs of care for patients with Alzheimer's disease. With the rapidly
increasing percentage of the population over the age of 65, the number of
persons with AD will increase proportionately, as will the toll it takes.
Both the Executive and Legislative Branches of the Federal Government have
expressed concern about the enormity of the problem posed by this disease.
Congressional concern about Alzheimer's disease has focused on funding for
research on the causes and treatment of the disease, and on the cost of care.
In 1984, Congress directed the National Institutes of Health (NIH), and in
particular the National Institute on Aging (NIA), to foster further research
related to Alzheimer's disease. The NIA Alzheimer's Disease Centers (ADCs)
program is authorized by the Public Health Service Act, Section 445, and
includes seventeen Alzheimer's Disease Research Centers (ADRCs) and eleven
Alzheimer's Disease Core Centers (ADCCs).
Centers are expected to provide an environment and core resources which will
enhance ongoing research by bringing together biomedical, behavioral, and
clinical science investigators to study the etiology, pathogenesis,
diagnosis, treatment, and prevention of AD, and to improve health care
delivery. Centers will also foster the development of new lines of research
and provide a suitable environment for fellows and junior faculty to acquire
research skills and experience in interdisciplinary AD research. The Centers
provide investigators and research groups with well-characterized patients
and control subjects, family information, and tissue and biological specimens
for use in research projects. Each Center should develop in accordance with
local talents, interests, and resources, but should also be responsive to
national needs related to Alzheimer's disease. Centers are expected to work
together with other Alzheimer research groups in collaborative research
activities and cooperate with other Federal, State, and local agency-
supported Alzheimer's disease programs in furthering mutual goals. Potential
applicants are encouraged to utilize the strengths of their particular
institutions in preparing an application that will cover the spectrum of
required activities. While types of activities that should be included are
indicated in these guidelines, specific approaches to accomplish them are
left to the applicant.
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), Alzheimer’s Disease Core Centers, 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 or local governments, and eligible agencies of
the Federal government. Applications from racial/ethnic minority
individuals, women, and persons with disabilities are encouraged. At the
time of award, the applicant institution cannot have another Alzheimer's
Disease Center funded by the NIA.
Institutions eligible for Alzheimer's Disease Core Center Grants (P30s) are
those at which there are (1) at least five principal investigators with any
PHS agency research grant or comparable peer reviewed research project
(including those funded by State governments or private foundations) related
to Alzheimer’s disease, other neurodegenerative diseases or aging of the
nervous system, each with at least two years of committed support remaining
at the time of application or (2) one or more program project (P01) grant(s)
related to Alzheimer’s disease, other neurodegenerative diseases or aging of
the nervous system, which also have at least two years of committed support
remaining. If P01 grant(s) exist, the work supported by the P01 should be
different from that proposed in the ADCC and any overlap of the P01 cores
with the P30 cores will be examined and adjustments made before funding.
MECHANISM OF SUPPORT
The support mechanism for this program will be the NIH Center Core Grant
(P30). Investigators should request five years of support. Applications from
institutions not previously funded as Alzheimer’s Centers will compete on an
equal basis with competing continuation applications. The anticipated award
date is July 1, 2001.
FUNDS AVAILABLE
The NIA intends to commit approximately $7,000,000 to fund seven new and/or
competing renewal ADCC grants in Fiscal Year 2001. The specific number will
depend upon the merit of the applications received and the funds available.
Only applications of sufficiently high merit will be funded. The award of
grants pursuant to this RFA is contingent upon the availability of funds for
this purpose.
RESEARCH OBJECTIVES
ADCCs are required to include administrative, clinical, neuropathological,
and information transfer cores. Other cores can be proposed and at least two
pilot research projects per year should be requested. The ADCCs will provide
well-characterized patients, patient and family information, and tissue and
other biological samples primarily from persons with AD but also from persons
with other neurodegenerative diseases and from age-matched control subjects
for research projects. Research activities that use ADCC core resources can
be supported by the NIH and other federal agency granting mechanisms, in
addition to non-federal funding sources for the funding of investigator-
initiated applications.
The ADCCs provide a mechanism for integrating, coordinating, and fostering
the interdisciplinary cooperation of a group of established investigators
conducting programs of research on Alzheimer's disease and related dementing
disorders of older people. They provide financial, intellectual, patient and
tissue resources to support research projects that have been reviewed and
supported on an individual basis. A prime objective of the Center Grant is
to provide an environment that will strengthen research, increase
productivity, and generate new ideas through formal interdisciplinary
collaborative efforts. The central focus may be clinical research, basic
research or a combination.
The Center Grant may involve ancillary supportive activities such as
prolonged patient care necessary to support the primary research effort. The
spectrum of activities should comprise a multi-disciplinary approach to the
problem of Alzheimer's disease. The ADCCs have played and will continue to
play a major role in Alzheimer's disease research by providing an
infrastructure and core resources around which institutions can build
innovative research programs. Centers are expected to perform collaborative
studies on particular research topics or to serve as a regional or national
resource for special purpose research. The ADCCs provide a unique opportunity
for multi disciplinary/multi Center studies. These will be facilitated by
linkage to the new National Alzheimer's Coordinating Center, which was
established in 1999. This ADC network will be used to standardize clinical
and pathological diagnostic procedures, to pool patient information and to
study unique aspects and subtypes of this very complex and heterogeneous
disease process. Particular attention should be paid to the similarities and
differences in the pathogenesis and clinical presentation among the
neurodegenerative disorders that may be related to and confused with
Alzheimer’s disease. The NIA expects the ADCCs to participate in cooperative
studies involving many or all of the Centers as well as making Center data
and specimens available for collaborative studies with qualified
investigators not affiliated with an Alzheimer’s Disease Center. The
National Alzheimer’s Coordinating Center (NACC) will serve as a clearinghouse
for requests to use data and specimens from the ADCs by outside investigators
seeking to participate in collaborative projects.
An Alzheimer's Disease Core Center will be an identifiable organizational
unit formed by a single institution or a consortium of cooperating
institutions. Such a Center will involve the interaction of broad and
diverse elements. Therefore, lines of authority by the appropriate
institutional officials must be clearly specified. The existence of a base
of ongoing high quality research in Alzheimer's disease, other related
neurodegenerative disorders or aging of the nervous system is a prerequisite
for establishing an ADCC. For continuation as an Alzheimer’s center, there
must be a clear emphasis on AD but involvement of research subjects with
related dementias is encouraged.
Each applicant institution will name an ADCC Director (P.I.) who will be the
key figure in the administration, management and coordination of the ADCC
grant. The Director will be responsible for the organization and operation
of the Center. The Director should be a scientific leader experienced in the
field of Alzheimer's disease research and must be able to coordinate,
integrate, and provide guidance in the establishment of programs in
Alzheimer's disease research and allied areas. A significant time commitment
(at least 10%) must be made by the Director. An Associate Director may be
named who will be involved in the administrative and scientific efforts of
the Center.
Applicants must commit to cooperate fully and to share data concerning
patients, control subjects and specimen resources with the NIA -sponsored
National Alzheimer's Coordinating Center (NACC) where data from all ADCs are
centrally collected. The Steering Committee of the NACC in conjunction with
the ADC Directors will set policies that allow the individual Centers to
conduct research on patients, control subjects, and specimen resources
collected by that Center while also sharing common data sets with the NACC.
The required elements for an ADCC include administrative, clinical,
neuropathological, and education and information transfer cores, and a pilot
projects program. Additional cores may be proposed and justified as required
to advance the local research effort. Applicants must demonstrate a data
management capacity either by creating a data core with biostatistical
expertise or having a clearly defined data management section in the
administrative or clinical core, which also includes the capacity for
biostatistical consulting to the scientific staff, associated with the ADCC.
Specific instructions for preparing overall progress reports (competing
renewal applications), progress reports and plans for individual cores, and a
list of review criteria are detailed later in this RFA.
Cores
A core is a shared central laboratory or clinical research facility, service,
or resource. Each core is directed by an investigator with substantial
expertise related to the core. Facilities may be proposed that will enhance
productivity or in other ways benefit a group of investigators to accomplish
the stated goals. Two important and related considerations are (1) the
degree to which currently funded investigators will use and will benefit from
core resources and (2) the degree to which the resources will promote new
and/or expanded AD research efforts locally, regionally or nationally.
Applicants should document and describe briefly the projects, both existing
and planned, that will depend upon resources provided by the cores (clinical
and neuropathology cores, in particular).
The ADCC cores support resources that allow or provide for the following: the
acquisition of subjects for research; the evaluation, monitoring of clinical
course, and treatment of patients; the design and support of research
protocols; the neuropathological diagnosis of the disease; documentation of
the cognitive, behavioral and social aspects of Alzheimer's disease; a data
collection, storage and biostatistical analysis capacity; and training and
outreach programs related to Alzheimer's disease. Consequently, each
application should demonstrate the presence of, or propose, methods to
accomplish the above tasks. Within these parameters, it is expected that
individual Centers may develop along different lines related to local
interests and expertise and that one or more cores may have unique strengths
while other cores within the Center may perform more routine functions.
Administrative Core (required):
Effective development of Center programs requires interaction among the
Director, the principal investigators of the cores, the principal
investigators of research projects using the cores, appropriate institutional
administrative personnel, the staff of the awarding agency, and the members
of the community in which the Center is located. The ADCC should recognize
that it is part of a large network of ADCs and be prepared to work
cooperatively with the other Centers and the NACC.
The success of the ADCC is dependent upon the involvement of scientific and
professional personnel from a variety of disciplines and subspecialties who
must be willing to relate to each other in order to facilitate the
acquisition of new knowledge. An executive committee (composed of core
leaders and the administrator) will be established to assist the Director in
making the scientific and administrative decisions relating to the Center.
In addition to coordination of the ADCC, the Director, with the advice of his
or her executive committee, will be responsible for allocation and monitoring
of ADCC funds, oversight of ethical concerns involving human subjects and
animal research, and the identification and selection of key personnel. The
executive committee should be encouraged to seek outside advice and
consultation, both from within the institution and from other institutions,
in its monitoring and development of the scientific content and direction of
the program.
In addition to the executive committee, it will be necessary to establish an
ad hoc review committee advisory to the ADCC Director. The committee should
be composed of scientists from outside the ADCC with expertise relevant to
the programs and interest of the Center. The responsibility of this group
will be to review the applications for pilot studies and to make
recommendations to the ADCC Director.
An external advisory committee to the ADCC, consisting of scientists from
outside of the institution will also be established. Unless already
appointed, external advisory committee members should not be recruited until
the NIH review is complete. This committee will be used to evaluate the
programs of the ADCC, research progress, the effectiveness of communications
within the ADCC, and any other activities for which outside expertise is
required or desirable. The committee should meet annually and prepare a
report including recommendations to assist the ADCC. However, the nature of
its responsibilities may require occasional ad hoc meetings or
teleconferences. A member of the NIA extramural program staff should be
invited to attend each meeting as an observer and should receive a copy of
the advisory committee report and recommendations of the advisory committee
should be included in annual progress reports together with a short response
to the recommendations.
The administrative requirements of the ADCC will necessitate the assistance
of an administrator with business management expertise. It is important that
such an individual be identified and directly involved with the fiscal and
administrative aspects of the ADCC application and grant. The administrator
should be a member of the executive committee. While budget formulation and
planning will undoubtedly begin with the Director in collaboration with the
scientific staff, the administrator must be involved in the process and
provide consultation in matters of fiscal administration.
It is expected that the ADCC administrative structure will facilitate the
following:
1) coordination and integration of Center components and activities;
2) plan and review utilization of funds, including funds for pilot studies;
3) support and advice for the ADCC Director in his/her efforts to oversee the
activities of the Center;
4) interaction with the scientific and lay communities to develop relevant
goals for the ADCC within the immediate environment of the Center;
5) interaction and involvement with other research programs of the University
including the provision of core resources for development of related
projects;
6) interaction with other Centers and the NACC to develop trans-ADC research
projects;
7) timely and routine transmissions of the complete ADCC data set to the
NACC;
In order to assure active collaboration with other ADCs, the ADCC Director
and other staff should attend annual meetings of the ADC Directors and other
ad hoc meetings arranged by the ADCs or the NIA to share research findings
and plan for cooperative research or to refine and standardize operating
procedures among the Centers. The ADCC application should include funds for
travel of the Director and other key personnel 1) to the semiannual meetings
of the Center Directors, 2) for at least 2 ad hoc meetings on special topics,
3) for visits of investigators associated with the Center to other ADCs for
the exchange of scientific ideas, planning of multi Center research projects
and to receive training in specialized techniques, 4) for the Administrator
to attend the Administrators' meeting and 5) for core leaders to attend
meetings with core leaders from other ADCs.
Pilot Studies (required):
A plan to support pilot studies for basic and clinical biomedical,
epidemiological, or behavioral research should be included and budgeted in
the application. The description of a plan to solicit, review and administer
pilot grants should be included with the Administrative Core and a separate
budget including the total request for pilots should be submitted. Criteria
for review of pilot studies should be developed and included in the
application. These funds may be used for new investigators, investigators
from other fields willing to bring their research expertise to Alzheimer's
disease, and investigators whose proposed research would constitute
feasibility testing. This funding mechanism is intended to provide modest
support that will allow an investigator the opportunity to develop
preliminary data sufficient to provide the basis for an application for
independent research support through conventional granting mechanisms.
Pilot studies are typically limited to a nonrenewable single year of support.
If described and well justified, two years of support may be requested. Any
one investigator is eligible only once for pilot support, unless the
additional proposed pilot study constitutes a real departure from his or her
ongoing research. Pilot study support is not intended for large undertakings
of established investigators for which it would be appropriate to submit
separate research grant applications. Pilot funds are not intended to
support or supplement ongoing-supported research of an investigator. Since
eligibility for pilot studies is difficult to define, some examples may be
helpful:
1) A study proposed by an established investigator who has experience in
areas other than Alzheimer’s disease research, and who wants to work in the
Alzheimer research field; or study by an established investigator who wants
to try a new hypothesis, method, or approach that is not an extension of
ongoing research.
2) A study proposed by a new investigator, with an interest in research in
Alzheimer's disease, before the study has developed to the point of being
suitable to apply for individual grant support.
3) A study to determine the availability of sufficient subjects with specific
characteristics, such as ethnic or minority status, before undertaking a
larger study.
Each pilot project is limited to no more than $30,000 direct costs each year.
If the pilot project is requested and justified for two years, the direct
costs are limited to $30,000 per year.
No pilot applications should be submitted with the ADCC application but,
instead, the number requested for each year (2 minimum, 4 maximum) and the
plans for soliciting pilot proposals should be described. A plan must also
be presented within the administrative core for peer review of the pilot
studies including the structure and composition of the review panel. Pilot
proposals should be reviewed locally and those chosen for funding should be
submitted to the NIA for approval in the annual noncompeting renewal
application.
Clinical Core (required):
The clinical core serves the functions of patient and control subject
recruitment, patient registry, longitudinal follow-up of patients and control
subjects, evaluation, acquisition of clinical and laboratory data including
data pertaining to the last weeks of life, data coordination and
biostatistical analysis (if a separate data core does not exist). A research
database that maintains confidentiality of all patient and control subject
records should be established at the ADCC. This will include data necessary
for evaluation of differences among preclinical stages of AD, possible or
probable AD, other dementias and normal aging. The data must be shared with
the National Alzheimer's Coordinating Center according to standardized
protocols developed by the ADC Directors and the Steering Committee of the
NACC. A clinical core may perform a limited amount of developmental work,
but should not directly fund research per se. The developmental work
allowable in a clinical core must be directly related to the function of the
core. It may be directed toward improving and expanding the core functions,
e.g., improving of existing, or developing of additional methodologies,
techniques or services. Proposed developmental work should be described as
completely as possible in the application. Planning for patient and age-
matched control subject recruitment should include sensitivity to research
design and biostatistical analysis.
Describe the procedures for obtaining informed consent for research on
cognitively impaired human subjects and controls; attach samples of
information given to patients and families and copies of all consent forms.
Particular attention should be paid to obtaining autopsy permission from
patients and families and informed consent for current and future use of
biological samples from patients. While conducting clinical drug trials is
one function of a clinical core, it should not be the major effort of the
core. The application should include a description of the types (with
specific examples) of research projects and clinical trials that will use the
core and what benefits will obtain to other research activities from the
existence of the clinical core.
Efforts to recruit diverse population subgroups including minorities and
women and to involve them in studies are strongly encouraged. One option is
to set up Satellite Diagnostic and Treatment Clinics (SDTCs) designed to
increase the heterogeneity of the research patient pool and to enhance the
research capabilities of the ADC by extending the activities of the clinical
core. Existing Centers should retain any satellites already in existence
unless there are compelling reasons to restructure these components. New
satellite clinics may be proposed as part of the clinical core. The satellite
clinics do not conduct research but serve as vehicles for the recruitment,
diagnosis and management of AD patients and their families from rural and
minority communities, who can then be offered the opportunity to participate
in research protocols and clinical drug trials. The inclusion of patients
with different characteristics will assist investigators in providing answers
to questions about AD diagnosis, treatment and management strategies as well
as facilitate studies that address issues specific to minority populations.
Additionally, a more diverse patient pool will facilitate investigations of
the neuropathology and genetics of AD in minority groups as well as studies
of care giving and family burden in rural and minority group cohorts. These
studies can be addressed by Centers individually and/or by cooperative
studies involving multiple Centers and the NACC.
Neuropathology Core (required):
This core will provide post mortem diagnosis on dementia cases, other
cognitively impaired individuals and normal aged control subjects enrolled in
the clinical core and from other well documented AD cases and controls.
Procedures and facilities should be described related to criteria for
diagnosis, and the collection, storage, and distribution of brain tissue and
other biological samples, including, but not limited to, DNA, CSF and plasma.
Data gathering and storage activities should be coordinated with those of the
Clinical Core. Pathology data and a catalog of all samples should be included
in the data set transmitted to the NACC by mutually agreed upon protocols. To
facilitate data sharing and cross Center comparisons of diagnosis, all
Centers shall state clearly which neuropathological criteria they are using
for routine diagnoses and are encouraged to use NIA-Reagan Institute
Criteria. (Neurobiology of Aging, vol. 18, suppl 4, pp S1-S2,1997) More
detailed criteria for research purposes should also be described. The
Neuropathology Core may also perform a limited amount of developmental work,
but should not directly fund research per se. The developmental work
allowable must be directly related to the function of the core. It may be
directed toward improving and expanding the core functions, e.g., improving
existing, or developing additional methodologies, techniques or services.
Proposed developmental work should be described as completely as possible in
the application. Neuropathology core leaders from all of the ADCs meet
yearly to share ideas and discuss technical aspects of tissue sampling,
development of standardized tissue processing for diverse research protocols,
cataloging and data management, and banking and distribution of tissues and
biological samples.
The procedure for prioritizing the use of tissues and other biological
samples should be discussed along with a description of the research projects
that will use material from this core. Particular attention should be paid to
obtaining autopsy permission from patients and families and appropriate
informed consent for present and future use of biological samples.
Provisions for protecting the privacy of research subjects must be detailed.
A procedure to provide blinded samples to investigators should be described.
Details for collecting specimens, recording information about clinical status
of patients immediately before and at time of death, and procedures for
storage and distribution of all human biological samples to investigators
both within and outside the Center should be provided. Monies should be
budgeted to cover the costs of distributing tissue to scientists outside of
the ADC. Information about testing for infectious diseases and safe handling
of tissues and samples should be included. A mechanism to publicize
availability of tissue, evaluate requests for samples and prioritize their
use should be detailed. Cooperation with the NACC in cataloging the holdings
of biological specimens from all Centers is required.
Education and Information Transfer Core (required):
This core will support both the development of physicians and other
professional staff to improve clinical and research skills related to
Alzheimer's disease and outreach programs that will publicize the ADCC and
educate families and other care givers about the disease and serve as a
vehicle for recruitment of research subjects. The methods and techniques to
be employed to disseminate information and the audience targeted to receive
information should be defined including 1) approaches to training of
physicians and other professionals including possible reciprocal exchange
programs between Centers to provide access to different research environments
and technologies; 2) descriptions of seminar or lecture series, workshops and
continuing education programs; and 3) cooperation with other organizations
such as state and local agencies and the Alzheimer's Association. Attention
should be directed to issues of cultural sensitivity and, where appropriate,
the information should be structured so that it can effectively reach
minority populations, including non-English-speaking people. Clearly stated
objectives and a systematic plan as to how these objectives will be met are
required. Specific assessment methodology is also required to evaluate the
effectiveness of outreach programs. Consideration should be given to
cooperation with other ADCs and the ADEAR Center at NIA when developing
education programs for broader distribution.
Other Cores (optional):
The NIA, through the ADCC, will support additional cores that provide
opportunities for scientific accomplishments beyond those attainable solely
through support of the mandatory cores. It is important to note that support
should not be requested for cores that only replace or centralize resources
supported on individual project grants. In a Center grant application, it is
not sufficient for the principal investigator merely to identify such
centralized resources. Rather, it must be demonstrated exactly how each core
would augment or enhance the present capabilities of the investigators and
make possible new activities. There should be a thorough discussion of the
project(s) that will use resources of additional cores.
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 is provided 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
"NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical
Research," which have been published in the Federal Register of March 28,
1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts,
Volume23, Number 11, March 18, 1994, and is available on the web at
http://grants.nih.gov/grants/guide/notice-files/not94-100.html
URLS IN NIH GRANT APPLICATIONS OR APPENDICES
All applications and proposals for NIH funding must be self-contained within
specified page limitations. Unless otherwise specified in an NIH
solicitation, Internet addresses (URLs) should not be used to provide
information necessary to the review because reviewers are under no obligation
to view the Internet sites. Reviewers are cautioned that their anonymity may
be compromised when they directly access an Internet site.
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that includes a
descriptive title of the proposed research, the name, address, and telephone
number of the Principal Investigator, the 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
a subsequent application, the information that it contains allows IC staff to
estimate the potential review workload and avoid conflict of interest in the
review. The letter of intent is to be sent to the program staff listed under
INQUIRIES by the letter of intent receipt date listed in the heading of this
RFA.
APPLICATION PROCEDURES
The research grant application form PHS 398 (rev. 4/98) is to be used in
applying for these grants. These forms are available at most institutional
offices of sponsored research and 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. Applications are also available on the Internet at
http://grants.nih.gov/grants/funding/phs398/phs398.html
The application should be prepared using instructions in this RFA and those
in supplementary instructions for preparation of multi component applications
(P30 Centers version) available from the program staff listed in the
Inquiries section. Page Limitation: Applications may not exceed a total of
25 pages each for the overall introduction/progress report and parts a-d of
the research plan for each core. Prior to submission of the formal
application, consultation with NIA program staff concerning the technical
aspects of preparing the application is strongly encouraged.
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. 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 sample RFA label available at:
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to
allow for this change. Please note that this sample label is in pdf format.
Submit a signed 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 plus
all appendices to:
Mary Nekola, Ph.D.
Chief, Scientific Review
Scientific Review Office
National Institute on Aging
7201 Wisconsin Avenue, Room 2C212
Bethesda, MD 20892-9205
It is important to send these copies and the appendices at the same time as
the original and three copies are sent to the Center for Scientific Review.
These copies are used to identify conflicts and to help ensure the
appropriate and timely review of the application.
Applications must be received by the application receipt date listed in the
heading of this RFA. If an application is received after that date, it will
be returned to the applicant without review.
The Center for Scientific Review (CSR) will not accept any application in
response to this RFA that is essentially the same as one currently pending
initial review, unless the applicant withdraws the pending application. The
CSR will not accept any application that is essentially the same as one
already reviewed. This does not preclude the submission of substantial
revisions of applications already reviewed, but such applications must
include an introduction addressing the previous critique.
Progress Reports
Overall Progress Report: For competing renewal applications, the overall
progress report should include summaries of progress in achieving the major
aims of the Center during the last funding period, including major
publications. If an optional core has terminated, include a final report
with a summary of activities and publications. If an optional core is
continuing, include the progress report in the component write-up. Applicants
should include tables detailing 1) Publications and grants (source, amount
and title) resulting from each component funded by the ADCC 2) Publications
and grants (source amount and title) resulting from pilot projects, 3)
minority enrollment into research projects or clinical trials and
specifically, into any research projects addressing minority issues.
The overall progress report should also include details of how the presence
of the ADCC has brought new investigators into the field and has stimulated
funded research in the last funding period. In addition to text summaries,
applicants should also include summary tables or annotated lists detailing:
1) Funded grants and projects that use or have used major resources supplied
by the ADCC, including principal investigator, source and time of funding,
types and amount of resources (e.g., clinical or neuropathological diagnoses,
numbers of patients, specimens etc) and any resulting publications.
2) Collaborations with other AD researchers, other Alzheimer’s Centers, the
National Alzheimer’s Coordinating Center, the Alzheimer’s Disease Cooperative
Study, and with biotechnology and pharmaceutical companies.
3) Clinical trial participation by patients enrolled in the Center including
trial name, sponsor, number of patients, and dates. Detail separately NIH and
Pharmaceutical Industry sponsored trials.
4) Institutional, state and other public and private resources committed to
the Center and its investigators.
Clinical Core Progress Report: For competing continuations the Clinical Core
Progress report should include Clinical Core objectives and progress in
meeting them, including information about satellites (if applicable). Basic
functions of the core should be summarized (in tabular form, where
appropriate) including numbers, race, gender, age of patients and controls
recruited, diagnosis, percentage follow up and drop out rate, autopsy consent
and rate, diagnostic confirmation by autopsy, and clinicopathological
correlations. Functions of Clinical Core in providing services to funded
investigators should be clearly summarized. Include the numbers and kinds of
subjects recruited for each clinical trial and each clinical research
project, both local and national. How has the clinical core contributed to AD
research? What key findings and publications have resulted from use of core
patients? Any developmental work carried out by the core should be presented
and resulting publications listed.
Neuropathology Core Progress Report: For the neuropathology core, competing
renewal applications should outline core objectives and progress in meeting
them. Basic functions of the core such as number of AD, related
neurodegenerative disorders, and control autopsies, gender and minority
status, post mortem intervals, tissue dissection and storage, diagnoses, and
type and quantity of tissue provided to investigators both inside and outside
the Center should be clearly summarized (in tabular form, where appropriate).
Any developmental work carried out by the core should be presented and
resulting publications listed.
Education and Information Transfer Core Progress Report: Competing renewal
applications should include evidence for training activities that effectively
impart knowledge to clinicians and the lay public with the possibility of
leading to improved health care for patients. Include a table presenting the
nature of training activities and the types of professionals trained -
physicians (including medical students, residents, fellows), nurses, social
workers etc. Detail the history of cooperative ventures of the Center with
state and local agencies such as the Alzheimer's Association and community
groups in coordinating training and education programs. Also include
recruitment and outreach programs targeting ethnic and minority groups and
the success of these programs.
Data Management and Statistics: Summarize progress and activities related to
data collection, data management and statistical consulting activities at the
appropriate place in the core(s) where these services are located. Include
progress and interactions with the National Alzheimer’s Coordinating Center.
List projects and publications in which data management and statistical
consulting played a role.
Budget Considerations
All ADCC proposals should request and provide justification for five years of
support. The total costs (direct + F&A) requested for new applications may
not exceed $900,000 for the first year. Competing renewal applications may
request an increase up to 10% over final year total costs or $900,000, which
ever is higher. Direct cost requests for subsequent years may increase above
the prior year direct cost award no more than 3%.
The direct costs are to be distributed approximately as follows: (This
proposed distribution is intended only as a general guideline and proportions
may vary if needed and justified. If additional cores are proposed based on
local needs, the distribution may be adjusted accordingly.)
Administrative Core 10%
Pilot Studies 10%
Clinical Core 50%
Neuropathology Core 20%
Education and Information Transfer Core 10%
Where expensive items of equipment are requested, the application must
document what is already available and provide clear justification in terms
of use by core staff and how it relates to research projects dependent on the
core. General-purpose equipment needs should be included and justified only
after surveying the availability of such items within the institution.
Research patient care costs (both inpatient and outpatient expenses) will be
considered in the context of other existing institutional clinical resources.
Attempts should be made by the applicant institution to utilize existing
clinical facilities, such as General Clinical Research Centers and
individually supported beds. Costs relating to the clinical efforts of the
ADCC may be funded through the ADCC, provided there is no overlap of funding.
Only those research patient costs directly related to Center activities may
be charged to the ADCC.
Domestic and foreign travel of project personnel directly related to the core
and scientific activities of the ADCC is allowable. Budgeting should include
travel and lodging for 1) the semi-annual meetings of the Center Directors,
2) annual meetings of administrators, clinical core, neuropathology core, and
education core leaders, data managers, and, 3) representatives of the Center
to attend ad hoc meetings called by the ADCs or the NIA to discuss research
findings and plan cooperative projects, to promulgate data sharing, and to
discuss standardization of procedures among the ADCs.
Requests and commitments for pilots in competing applications (new and
renewal) will be budgeted, as a separate line in the "composite" budget at
$30,000 per pilot per year (without escalation). They should not be included
in the Administrative Core or elsewhere in the application. A brief
description of the first year pilot research and detailed pilot budgets for
the first year of Center funding will be due shortly before the award of
successful applications and future year pilots should be submitted with the
annual noncompeting renewal applications. F&A costs will be provided in
accordance with these budgets.
Pilot grants are allowed for consortium arrangements but direct cost should
not exceed $30,000 with total consortium cost budgeted not to exceed $35,000
for each pilot including the facilities and administrative costs of the
consortium institution. No F&A costs will be provided to the grantee for
pilot projects conducted by consortia. If consortium arrangements are
contemplated, the following information should be provided in the
application:
1) A list of all proposed performance sites both at the applicant institution
and at the collaborating institutions
2) A separate, detailed budget for each institution and, where appropriate,
for each unit of activity at each institution.
3) A composite budget for all units of activity at each institution for each
year, as well as a composite budget for the total proposed budget for each
year.
4) An explanation of the programmatic, fiscal, and administrative
arrangements made between the grantee institution and the collaborating
institutions.
REVIEW CONSIDERATIONS
Upon receipt, applications will be reviewed for completeness by the Center
for Scientific Review (CSR) and responsiveness by NIA. Incomplete and/or
non-responsive applications will be returned to the applicant without further
consideration.
Each application must be thorough and complete. Additional materials or
revisions will not be accepted after the receipt date. NIH has recently
revised its requirements for Institutional Review Board (IRB) approval. Now
IRB approval is not required prior to the NIH peer review of an application.
See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-031.html. This
change in policy is intended to provide flexibility at the institutional
level. The institution may still determine that certain lines of research
(e.g., scientifically or ethically controversial research) or mechanisms of
research (e.g., multicenter clinical trials) should receive IRB review prior
to submission of the application. Policy on Institutional Animal Care and Use
Committee (IACUC) approval has not changed. Therefore, it is strongly
recommended that IACUC approval be secured before the application is
submitted. Otherwise, it is the applicant's responsibility to ensure that
this certification is sent to the Scientific Review Office, NIA, within 60
days of the receipt date. Applications failing to comply with this
requirement will be returned without review. There will be no further
notifications on this issue.
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 NIA. As part of the initial merit review, a process may be
used in which all applications receive a written critique and undergo a
process in which only those applications deemed to have the highest
scientific merit, generally the top half of the applications under review
will be discussed, assigned a priority score, and receive a second level
review by the National Advisory Council on Aging.
Review Criteria
Applicants should clearly demonstrate the ways in which the ADCC will
contribute to the growth of local research programs, support on-going
projects, cooperate with ADCs and the NACC in collaborative research, and
attract both senior and new investigators to AD research.
Listed below are the review criteria to be used in the evaluation of the ADCC
applications; these criteria will be applied to competing continuations by
evaluating progress and plans for future activities and to new applications
by evaluating preliminary work and plans for implementation of the new
program.
The following review considerations will apply:
A. Center as a Whole:
1) For competitive renewal applications, impact of the Center on furthering
Alzheimer's disease research locally and nationally during the last funding
period including utilization of Center resources by non-Center funded
scientific projects (see details under Overall Progress Report section); for
new applications, the potential for such impact.
2) Extent of "Centerness", i.e., does the Center as a whole serve a purpose
greater than the sum of the individual components?
3) Unique contributions of the Center, including significance, innovation,
scientific productivity, and recognition, (publications, new research grants,
honors and awards).
4) Extent of Center interactions with the Alzheimer community including
cooperative interactions with local organizations and nationally with other
ADCs and cooperative studies.
B. Cores:
1) For competing continuation applications, progress in meeting stated aims
of cores in previous application, publications, and securing of other funding
listed separately for each core. (Refer back to overall and core progress
report sections)
2) How will the cores support research and educational activities of the ADCC
and what is the future anticipated use? The fit of each proposed core into
the overall research program. Will it enhance collaborative and/or
interdisciplinary research within the Center, across Centers (including the
NACC) and the wider research community?
3) Plan for recruitment of women and minority patients and control subjects
to the clinical core. In competing continuation applications, has progress
been made in increasing participation of diverse populations in ADCC
activities? If Center had funds for satellite clinics, how effectively have
they been used? Specifically include discussion of minority related research
in the Center.
4) Would any proposed optional cores duplicate existing resources or
services? If so, are the requested new resources justified? Do other grant
funds already provide any of the requested capabilities?
C. Research:
1) For new applications, the existence of a base of ongoing high quality
research in Alzheimer's disease, other related neurodegenerative disorders or
normal aging at the applicant institution and, for competing renewal
applications, evidence for progress in increasing research on Alzheimer’s
disease and related dementias.
2) For competing continuation applications, progress in meeting stated aims
of cores in previous application, including utilization of subjects/specimens
in other grants, publications, and securing of new funding. (Refer to
progress report sections for details)
3) The feasibility of the pilot grant program proposed in new applications
and the success of pilots funded in the previous award period for competing
continuations as judged by documentation of subsequent success in
publications and obtaining further funding.
4) The experience and commitment of the investigators responsible for the
individual research projects which will be associated with the ADCC and their
interrelations with the other elements of the ADCC and with other scientists
at their institution and elsewhere.
5) The expected role of the ADCC in increasing the quantity and quality of
research in Alzheimer's disease and related dementias within the applicant
institution and cooperative studies with other ADCs and the NACC.
D. Data Management:
1) Are data management and support procedures developed sufficiently to a)
allow ADCC investigators to access and utilize data, b) comply with data
requests from the NACC, and c) participate in cooperative studies with other
ADCs and the NACC. Does the Center provide statistical design and support to
aid ADCC investigators?
2) Is there a thoughtful plan to manage and utilize clinical and
neuropathological data? Are adequate safeguards to protect patient
confidentiality addressed? Are staffing, hardware and software adequate?
3) Statement of agreement to cooperate fully and share all core data with the
National Alzheimer's Coordinating Center and to share data and specimens and
participate in collaborative projects with other ADCs and outside
investigators according to guidelines being developed by the NACC and the
NIA.
E. Program Administration:
1) The creative scientific and administrative leadership of the ADCC Director
and his/her staff, and their commitment to devote adequate time to the
management of the ADCC program.
2) The proposed administrative organization including:
o Coordination of the ADCC resources including procedures for allocating
Center resources in response to requests made by investigators and
documentation of resources used and resulting publications.
o Procedures for internal communication and cooperation among the
investigators involved in the ADCC.
o Mechanisms for reviewing the use of, and administering, funds for pilot
projects.
o Management capabilities that include fiscal administration, procurement,
property and personnel management, planning, budgeting, etc.
o For competing continuation applications, composition of the advisory board.
Is it appropriate? Has it had regularly scheduled meetings? Are its
responsibilities defined? How has the ADC benefited from advisory board
input?
o Evidence for full cooperation with the NACC.
F. Investigators:
1) The qualifications of the participants. What are their academic
credentials and their research records? What is the current funding of
investigators associated with the ADCC?
2) Evidence of collaboration and interdisciplinary research among the
investigators who will be associated with the ADCC.
3) Involvement with studies using the NACC and /or the Alzheimer’s Disease
Cooperative Study.
G. Facilities:
1) Facilities should be adequate. Are they reasonably contiguous or
physically separated?
H. Institutional Commitment:
1) Evidence for institutional commitment to the program, including provision
of funding, space, faculty positions, or commitments for construction or
renovation.
2) The academic environment and resources, including equipment and
facilities, and the potential for interaction with scientists from other
departments and components.
In addition to the above criteria, in accordance with NIH policy, all
applications will also be reviewed with respect to the following:
o The adequacy of plans to include both genders, minorities and their
subgroups as appropriate for the scientific goals of the research. Plans for
the recruitment and retention of subjects will also be evaluated.
o The reasonableness of the proposed budget and duration in relation to the
proposed research.
o The adequacy of the proposed protection for humans, animals or the
environment, to the extent they may be adversely affected by the project
proposed in the application.
Schedule:
Letter of Intent Receipt Date: July 1, 2000
Application Receipt Date: September 15, 2000
Date of Initial Review: February, 2001
Review by Advisory Council: May, 2001
Anticipated Award Date: July, 2001
AWARD CRITERIA
Funding criteria will be scientific merit (based on the review criteria
listed above), availability of funds, and programmatic priorities.
INQUIRIES
Inquiries concerning the RFA are encouraged. The opportunity to clarify any
issues or questions from potential applicants is welcome.
Requests for supplementary guidelines, letters of intent and inquiries
regarding programmatic issues may be directed to:
Dr. Creighton H. Phelps
Alzheimer's Disease Centers Program
National Institute on Aging
7201 Wisconsin Avenue, Suite 3C307, MSC 9205
Bethesda, MD 20892-9205
Telephone: (301) 496-9350
FAX: (301) 496-1494
Email: phelpsc@exmur.nia.nih.gov
Direct inquiries regarding fiscal matters to:
Linda Whipp
Grants Management Office
National Institute on Aging
Gateway Building, Room 2N-212
Bethesda, MD 20892-9205
Telephone: (301) 496-1472
FAX: (301) 402-3672
Email: whippl@exmur.nia.nih.gov
AUTHORITY AND REGULATIONS
This program is described in the Catalog of Federal Domestic Assistance No.
93.866. 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 and Federal Regulations 42 CFR 52 and 45 CFR Parts
74 and 92. This program is not subject to the intergovernmental review
requirements of Executive Order 12372 or Health Systems Agency review
The 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.
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