Subject: RFAAI-91-02 2/8/9l NIH Guide
From: Dot Baker <[email-masked]>
To: [email-masked]
Date: Thu, 07 Feb 91 08:37 EST

Hello,
    Six of six.  Please post to the listserver as:
RFAAI-91-02.910208
    Thanks for being such a nice guy.   Dottie
 ---------------------------- Text of forwarded message -----------------------
 
REQUEST FOR COOPERATIVE AGREEMENT APPLICATIONS
 
RFA AVAILABLE:  AI-91-02
 
CHRONIC FATIGUE SYNDROME COOPERATIVE RESEARCH CENTERS
 
P.T. 04; K.W. 0715043, 0715026, 0715125, 0715150, 0710070, 1002045
 
National Institute of Allergy and Infectious Diseases
 
Letter of Intent Receipt Date:                       March 1, 1991
Application Receipt Date:                            April 1, 1991
 
The Virology Branch (VB) of the Division of Microbiology and
Infectious Diseases (DMID) of the National Institute of Allergy
and Infectious Diseases (NIAID) invites applications for the
establishment of Chronic Fatigue Syndrome Cooperative Research
Centers (CFS CRCs) to augment the existing grant program for CFS
research.  The CRCs are intended to provide a sustained
multi-disciplinary approach to CFS research that will advance the
field by bridging the basic science and clinical research arenas
and facilitating confirmatory testing and follow-up of new
hypotheses and observations.
 
Successful applicants funded under this Request for Applications
(RFA) will be supported through Cooperative Agreements (U01s).
This type of funding mechanism is utilized when it is desired to
encourage investigator-initiated research projects in areas of
special importance to the National Institutes of Health (NIH) and
when substantial programmatic assistance by NIH staff is
anticipated.  This RFA solicitation represents a single
competition with a specified deadline for receipt of
applications.  Although there are no plans at this time to
reissue this RFA, NIAID intends to accept competitive renewal
multi-project applications upon expiration of the initial funding
period, contingent on the continued availability of funds for
this purpose.
 
I. BACKGROUND INFORMATION
 
CFS is a multisystem syndrome thought to be triggered by viral
infection and characterized by months of debilitating fatigue
frequently associated with sore throat, low grade fever, myalgia,
headache, gastrointestinal symptoms, and tender lymph nodes.
Cognitive deficits, symptoms of depression and sleep disorders
have been reported and abnormal brain images derived by different
techniques have been described.  CFS patients are reported to
have neuroendocrine response patterns that differ from those of
controls.  CFS is diagnosed more frequently in women than in men.
There have been numerous reports of specific immune dysfunctions,
but no single impairment has regularly been associated with the
syndrome.  Similarly, viruses from several taxonomic groups have
been reported to be involved, but none as yet has been confirmed
to be consistently associated with disease onset or progression.
Patients have a high prevalence of allergies and recent reports
indicate that a state of chronic immune activation may exist in a
significant fraction of patients.
 
There have been many formidable obstacles to the effective study
of this syndrome, the most serious of which has been the lack of
objective diagnostic criteria.  Progress has been made in case
definition and a number of testable hypotheses recently have been
proposed.  It is timely to consider coordinated multidisciplinary
studies that may lead to a better understanding of the causative
factors and to improved diagnosis and treatment.
 
II.  RESEARCH OBJECTIVES AND SCOPE
 
The purpose of this RFA is to stimulate the establishment of
centers of CFS research excellence in which coordinated projects
in the fields of immunology, virology, medicine, and clinical
epidemiology are pursued in order to further our understanding of
CFS.  It is not necessary or expected that expertise in all these
areas be available at a single institution.  Input from the NIAID
Scientific Coordinator is intended to facilitate technology
transfer, assist in the identification of expert consultants,
collaborators and resources, enhance communication between
awardees and help to ensure that new studies will complement and
not unnecessarily duplicate existing or planned CFS research
endeavors.
 
Applicants are encouraged to capitalize on the expertise at their
institution to explore one or more aspects of the pathogenesis,
natural history, or etiology of CFS.  Well-designed studies with
adequate sample sizes are sought to confirm and extend
preliminary findings and to test biologically rational hypotheses
concerning etiology or pathogenesis.  For example, it has been
postulated that an inherent or acquired immunologic dysfunction
may lead to chronic reactivation of latent viruses which then
drives a cytokine-mediated illness.  Components of this postulate
that are amenable to testing include the assessment of
immunologic competence, the determination of reactivated viral
burden, and the examination of cytokine profiles and responses.
Other hypotheses also lend themselves to critical evaluation.
Originality in concept and approach are encouraged.
 
Investigators are referred to "Considerations in the Design of
Studies of Chronic Fatigue Syndrome," Schluederberg A, Straus SE,
Grufferman S, Eds. Reviews of Infectious Diseases supplement,
January 1991, in press.
 
CLINICAL FACILITIES:  CFS CRCs should be based at universities or
at university-affiliated medical facilities that have a strong
clinical facility with accessible well-defined CFS patient
populations.  Clearly specified inclusion and exclusion criteria
for case definition are essential [Holmes, et.al., Annals of
Internal Medicine:  108, 387-389, 1988].  Evidence for patient
willingness to cooperate in research programs and success in
patient follow-up should be provided to establish feasibility.
The cohort approach will allow the study of serially collected
specimens and clinical data so that attention can be given to
control of the variables, including disease activity, which
impact on the parameters under study.  CRC Directors will
collaborate with the assistance of the NIAID Scientific
Coordinator in the development of basic data collection and
specimen banking procedures to facilitate study replication and
meaningful collaborations both now and in the future.
 
WORKSHOP PARTICIPATION:  Successful applicants will be expected
to participate in regularly scheduled workshops.  These workshops
will be held at least once a year to provide the setting in which
to share CFS research advances and to discuss CFS research needs
and opportunities with awardees under this RFA as well as with
other investigators active in CFS research or working in relevant
related areas.  SUPPORT FOR TRAVEL TO WORKSHOPS SHOULD BE
INCLUDED IN THE CRC BUDGET REQUEST.
 
III.  MECHANISM OF SUPPORT
 
Awards will be made as COOPERATIVE AGREEMENTS (U01s).  This
mechanism is used when an interactive assistance relationship
exists between NIAID staff and the investigative team as outlined
under "TERMS OF AWARD:  AWARDEE RIGHTS AND RESPONSIBILITIES;
NATURE OF PARTICIPATION OF NIAID STAFF."
 
NIAID has set aside a total of $488,000 (direct plus indirect)
per year to support this RFA and anticipates making at least one
(1) award in FY 1991.  The final number of awards to be made will
be dependent upon the availability of funds and the number, cost,
and scientific merit of research proposals received.  Awards will
be made for a project period of up to four years.  The earliest
possible award date is September 30, 1991.  Funding beyond the
first and subsequent years of the award will be contingent upon
satisfactory progress during the preceding years and upon
availability of funds.  NIAID intends to accept competitive
renewal multi-project applications contingent upon the continued
availability of funds for this purpose.
 
In addition to support for personnel, supplies, travel to annual
workshops and other necessary costs justified in the application
for conducting the CRC research projects, award funds may be
utilized to support the following research-related activities:
 
Administrative Costs:  This category includes the costs necessary
for the central administration and management of the CRC, such as
secretarial support.  The amount requested should be well
justified and in keeping with the overall complexity and size of
the budget.  In any case, such costs may not duplicate or replace
costs included in the institution's indirect cost base.
 
Shared Research Resources (Cores):  CFS CRCs may include funds
for equipment, supplies and services to expand and/or maintain
clinical, laboratory, biostatistical, and data management
facilities that are shared by research staff from at least two
CRC research projects.
 
Developmental Fund for Pilot Studies:  Applicants may request
that a limited pool of funds, not to exceed $40,000 annually, be
made available as a Developmental Fund Core.  This fund would be
set aside and restricted solely to cover salaries and other
research costs for small pilot studies to follow-up on new
observations and novel hypotheses.  Such pilot studies need not
be restricted to the awardee institution.  IT IS EMPHASIZED THAT
INDIVIDUAL CFC RESEARCH PROJECTS (SUBPROJECTS) ARE DISTINCT FROM
DEVELOPMENTAL FUND PILOT STUDIES.  It is envisioned that this
fund would increase flexibility and responsiveness to important
new scientific observations and medical reports.
 
The total amount for this purpose may not exceed $40,000 annually
nor $40,000 for any single study.  Funds awarded under this
section may be used for salary, technical support, laboratory
supplies, and equipment.  The duration of support for each study
would typically be 1 year, but may be up to 3 years, unless the
study is independently funded through a traditional research
grant (R01) or a FIRST (R29) award prior to the end of the 3-year
period.  In these instances, the pilot study must be terminated,
and unexpended funds must be returned to the developmental fund
award pool.
 
Procedures for selection of pilot studies should be described if
this option is chosen.  It is anticipated that studies
recommended by the CFS CRC Director would be reviewed and
selected by a local review committee comparable to the
institutional Biomedical Research Support Grant Review Committee.
Examples of criteria that could be used by the local review
committee are the scientific merit of the proposal, the medical
relevance of the result and the need for data to advance the
research objectives of the CRC.  Studies involving Human Subjects
would require prior approval by the Institutional Review Board
like all other projects supported by NIH.  Finally, release of
funds set aside for this purpose would require approval by the
NIAID Scientific Coordinator.
 
Pilot studies, unlike the individual CRC research projects, need
not be described in the CRC application unless a pilot study has
been identified that is appropriate for pursuit at this time.
However, in order to facilitate NIH review of this section, in
addition to the selection method and criteria mentioned above, a
synopsis of the kind of pilot study that the CRC would expect to
fund under this mechanism should be submitted.  The synopsis
should be no longer than one page.  Approval of the developmental
fund portion of the CFS CRC application does not in any way
commit the investigators to execution of the sample study.
 
It is the NIAID's intent that developmental funding provide a
flexible means for the CFS CRC Director to achieve the short- and
long-term goals of the CFS CRC.  Applicants are reminded,
however, that funds requested for developmental studies
constitute a restricted portion of the total CRC budget and will
thus not be available for other CRC activities.  The CRC must
maintain detailed records of disbursements and expenditures of
developmental funds to facilitate peer review of future
competitive renewal applications.
 
In addition to the above categories, budget requests may also
include research-related costs for patient involvement, funds for
limited investigator travel, and costs of publication.  Since the
program cannot provide funds for new construction, adequate
physical facilities must be available to meet the primary needs
of the CRC.
 
In light of the desire to develop an integrated infrastructure to
address CFS research needs in the United States, applications
will be limited to domestic institutions.  Applications from
domestic academic, non-profit, or for-profit research
institutions are eligible for awards.  Awards will be made to an
institution on behalf of a CRC Director (Principal Investigator)
who will be responsible for the coordination of CFS CRC
scientific and administrative activities.
 
Although this program is provided for in the financial plans of
NIAID, the award of Cooperative Agreements pursuant to this RFA
is also contingent upon the continuing availability of funds for
this purpose.
 
All policies and requirements of the Public Health Service (PHS),
and NIH apply to applications submitted in response to this RFA.
 
IV.   TERMS OF AWARD:  AWARDEE RIGHTS AND RESPONSIBILITIES; NATURE OF
      PARTICIPATION OF NIAID STAFF
 
Under the Cooperative Agreement, a partnership relationship
exists between the recipient of the award and NIAID in which
successful applicants are responsive to the guidelines and
conditions set forth in the RFA.  At the same time, investigators
are expected to define research objectives and approaches in
accord with their own interests and perceptions of novel and
exploitable approaches to the research that ultimately are likely
to result in improved understanding of the etiology,
pathogenesis, and natural history of CFS.
 
The CRC Director (the Principal Investigator for the CRC) will
have ultimate responsibility for the coordination of efforts
within the CRC and ensuring that the results obtained are
analyzed appropriately and published in a timely manner.
However, it will be the responsibility of each CRC Project Leader
(the Principal Investigator for an individual research project
within the CRC) to plan and conduct the research stipulated in
the project proposal.  NIAID may periodically review and generate
internal reports from data and progress reports developed under
this cooperative agreement.  The data obtained will, however, be
the property of the awardee.
 
The multi-disciplinary and cooperative nature of the CFS CRCs
creates an extraordinary opportunity for information exchange and
scientific advancement in high quality CFS research.  It is
expected that Awardees will take advantage of this opportunity by
participating in both formal events established expressly for
this purpose and informal investigator-initiated dialogues.
 
The NIAID Scientific Coordinator will be the Program Officer
designated to administer the CFS CRC program, currently Virology
Program Officer, Virology Branch, DMID.  During the award period,
the NIAID Scientific Coordinator will work closely with the CRC
Director TO FACILITATE BUT NOT DIRECT THE ACTIVITIES OF THE CRC.
It is anticipated that decisions in all activities outlined
within this RFA will be reached by consensus of the investigators
and the NIAID Scientific Coordinator.
 
NIAID will facilitate research at CFS CRCs through the following:
 
  o  assistance in overall research planning, data analysis, and
     reporting;
 
  o  facilitation of information exchange between CFS CRCs and
     other CFS grantees and investigators;
 
  o  reduction of duplication of efforts by CFS CRCs and other
     NIAID awardees;
 
  o  assistance in development of standardization procedures
     applicable to current and future CFS CRCs and to other
     grantees with regard to case definition, laboratory
     procedures, and selection of reagents;
 
  o  facilitation of access to new research reagents and
     technologies;
 
  o  identification of experts and other important resources not
     otherwise available to the CFS CRCs; and
 
  o  assistance in locating potential replacements for key
     personnel vacancies including Principal Investigators,
     Project Leaders, and Co-Investigators.
 
The CRC Directors, Project Leaders, and the NIAID Scientific
Coordinator will meet periodically to review progress, plan and
design research activities, and establish CFS CRC priorities.  In
addition, each year, NIAID staff will coordinate at least one
workshop at the NIH in Bethesda, Maryland (or at a site
designated by NIAID).  These workshops will provide a forum for
CRC and other CFS research grant awardees to share research
advances, to discuss CFS research needs and opportunities, and to
develop collaborations.  Funds for travel to these meetings
should be included in the budget.
 
In the unlikely event that a scientific or programmatic dispute
should arise that is resistant to productive negotiation between
the CFS CRC and NIAID, the decision of a three-member arbitration
team will be binding.  One member of this team will be chosen by
the CRC Program Director and the second will be chosen by the
NIAID Scientific Coordinator.  These two members of the
arbitration team will select the third member.  These special
arbitration procedures, however, do not in any way affect the
awardee's right to appeal an adverse action in accordance with
PHS regulations at 42 CFR Part 50, Subpart D, and HHS regulations
at 45 CFR Part 16.
 
In the event that research supported by the Cooperative Agreement
results in development of a therapeutic or other medical
intervention, NIAID will retain the option to cross-file, or
independently file, an application for investigational clinical
trial; i.e., an Investigational New Drug Application (INDA) to
the United States Food and Drug Administration.  Reports of data
generated by the CRC or any of its members that are required for
inclusion in INDAs and Clinical Brochures, and for cross-filing
purposes, will be submitted by the CRC Director to the Scientific
Coordinator upon request.  Such reports will be in final draft
form and will include background information, methods, results,
and conclusions.  They will be subject to approval and revision
by NIAID and may be augmented with test results from other
Government sponsored projects prior to submission to the
appropriate regulatory agency.
 
The special "TERMS OF AWARD:  AWARDEE RIGHTS AND
RESPONSIBILITIES; NATURE OF PARTICIPATION OF NIAID STAFF"
described in this section are in addition to, and not in lieu of,
otherwise applicable OMB administrative guidelines, HHS Grant
Administration Regulations at 45 CFR Part 74, and other HHS, PHS,
and NIH grant administration policy statements.
 
V. MINIMUM REQUIREMENTS FOR APPLICATION
 
Before preparing an application, the applicant should carefully
read the information brochure that is available from Dr.
Schluederberg (address below):  "Program Project and Center
Grants, NIAID."  Instructions outlined in the brochure for the
formatting of the application should be followed carefully.
Failure to follow the instructions may result in unnecessary
delays in the review process.  If more than one institution is to
be involved, the applicant is advised to consult the NIH
Guidelines for Establishing and Operating Consortium Grants.
 
Investigators are urged to contact NIAID staff early in the
development of the application.  It should be noted that THE
STATE-OF-THE-SCIENCE AND FUNDS ALLOTTED FOR THIS EFFORT ($488,000
TOTAL COSTS PER YEAR) MAKE IT ESSENTIAL THAT MODEST CENTERS
PROGRAMS BE PROPOSED.  Future applications for supplemental
support would be subject to NIH peer review.  Particular
attention should be given to the following areas when responding
to the application instructions found in the brochure:
 
A minimum of three (3) projects including the clinical component
should be proposed.
 
The detailed description of each research project should
demonstrate that it contributes to the attainment of the CRC's
overall objectives.
 
In describing the clinical and laboratory facilities available to
conduct each project, specific information should be included on
the institution's present CFS patient load and projections for
patient involvement in clinical investigations.  Because of the
apparent higher frequency of occurrence of CFS in females, it
will be unacceptable to exclude females from CRC study
populations.  Applicants also are urged to give added attention
where feasible and appropriate to the inclusion of minorities in
study populations for CFS CRCs.  If minorities are not included
in the study population, a clear rationale for their exclusion
must be provided.  Applications submitted without careful
documentation on these issues will not be accepted for review
(see below, "Special instructions to applicants regarding
implementation of NIH policies concerning inclusion of women and
minorities in clinical research study populations").
 
Included in the information under the "Other Support" section
must be an explicit written plan that explains how applicant CRC
Directors who also hold Principal Investigator status on grants
other than the CFS CRC application (particularly on Program
Project, Training, or Center grants) will be able to successfully
and fully meet the responsibilities demanded by all endeavors.
 
In addressing the Organization and Administrative Structure of
the CRC, the mutually reinforcing inter-relationships among the
members of the CFS CRC and the contribution of each to
fulfillment of CFS CRC objectives should be clearly described.
This section must include an organizational chart showing the
name, the organization, and the scientific discipline of the
Program Director, the Project Leaders (Principal Investigators of
individual research projects), and other key personnel for the
projects.
 
The application must include a signed letter of agreement from
each collaborator and/or consultant to the program indicating 1)
willingness to participate in the program and 2) the exact nature
of the participation.
 
Also required is a plan to assure the maintenance of close
coordination and effective communication among members of the CFS
CRC and between members and the NIAID Scientific Coordinator.
This plan should be co-signed by the Program Director and all
Project Leaders to indicate acceptance of participation by the
NIAID Coordinator and to show commitment to the protocols of the
proposed studies.
 
A written commitment by the sponsoring institution that
explicitly defines the institution's willingness and preparedness
to commit resources to ensure development, function, and
maintenance of the proposed CFS CRC must be included in the
application.  This letter should be co-signed by the relevant
departmental chairperson(s) and dean of the institution.
 
VI.  REVIEW PROCEDURES AND PEER REVIEW CRITERIA
 
REVIEW PROCEDURES:
 
Applications that are judged to be incomplete or non-responsive
to this RFA will be screened out by NIAID staff upon receipt and
returned to the applicant without further consideration.  Those
applications that are complete and responsive to the RFA may be
subjected to triage review by an NIAID peer review group to
determine their scientific merit relative to the other
applications received in response to the RFA.  The NIAID will
withdraw from further competition those applications judged by
the triage peer review group to be noncompetitive for award, and
will notify the applicant Principal Investigator and the
institutional business office.  Those applications considered to
be competitive for award will be reviewed for scientific and
technical merit in June or July 1991, by a committee convened by
the Division of Extramural Activities, NIAID.  The second level
of review will be provided by the National Advisory Allergy and
Infectious Disease Council in September 1991.  The earliest award
date is September 30, 1991.
 
PEER REVIEW CRITERIA:
 
It is again emphasized that prospective applicants should
carefully read the information brochure "PROGRAM PROJECT AND
CENTER GRANTS, NIAID" that is available from Dr. Schluederberg
(address below).  The brochure describes program projects and
other large, multi-disciplinary grants; outlines review criteria
for such programs; and includes other important information that
will aid in formatting the application.  The review criteria
outlined in the brochure are the review criteria to be used by
the peer review group in the evaluation of applications received
in response to this RFA.  Specifically, proposals will be
evaluated for scientific merit including the originality,
uniqueness, and technical excellence of the research projects.
Programmatic relevance and overall responsiveness to the research
objectives stated within this RFA will also be considered.
 
In addition to the review criteria stated above, proposals must
satisfy the previously mentioned specific programmatic
requirements which are summarized below.  These requirements
appear in greater detail in Section III - "RESEARCH OBJECTIVES
AND SCOPE" and applicants are urged to review this section
carefully.
 
CFS CRCs must offer a strong clinical facility with accessible
patient populations that are appropriate to answering CFS
research questions and are available for follow-up.
 
The value of studies of patients or their specimens will be
directly related to the care exercised in selection and initial
characterization of cases and controls.  A detailed description
of case ascertainment procedures, the criteria to be used for
case definition and the manner in which the criteria are to be
applied must be included.
 
The CRC research program must focus on one or more aspects of CFS
related to etiology, natural history, or pathogenesis and involve
the multidisciplinary expertise necessary to obtain meaningful
results.
 
Each individual research project proposal must demonstrate the
investigator's awareness of the requirements for sound data
collection, management, and analysis procedures.
 
The proposal must include evidence that the CRC Director and
project directors have sufficient experience and expertise to
make a significant contribution to the establishment of
standardized procedures for studying CFS.
 
VII.  METHOD OF APPLYING
 
LETTER OF INTENT:
 
Prospective applicants are asked to submit, by March 1, 1991, a
letter of intent that includes a descriptive title and the names
and affiliation(s) of proposed key investigators for each of the
proposed research projects.  The letter of intent is requested in
order to provide an indication of the number and scope of
applications to be reviewed.  The letter of intent does not
commit the sender to submit an application, nor is it a
requirement for submission of an application.
 
The letter of intent must be sent to:
 
Dr. Olivia Preble
Chief, Microbiology and Immunology Review Section
Program and Project Review Branch
National Institute of Allergy and Infectious Diseases
National Institutes of Health
Westwood Building, Room 3A10
Bethesda, MD  20892
Telephone:  (301) 496-8208
 
FORMAT OF APPLICATIONS:
 
Applications must be submitted on form PHS 398 (rev.  10/88,
reprinted 9/89), the application form for research grants.
Application kits are available at most institutional business
offices and may also be obtained from the Office of Grants
Inquiries, Room 449, Westwood Building, Division of Research
Grants, National Institutes of Health, Bethesda, Maryland 20892.
The format and detail applicable to regular research grant
applications should be followed, and the requirements specified
under Section VI - "REVIEW PROCEDURES AND PEER REVIEW CRITERIA"
must be fulfilled.  In addition, investigators should read
carefully the guidelines, "PROGRAM PROJECT AND CENTER GRANTS,
NIAID."
 
APPLICATION PROCEDURE:
 
To assure the identification of your application with this RFA,
the application must have "CHRONIC FATIGUE SYNDROME COOPERATIVE
RESEARCH CENTERS" RFA AI-91-02 typed on item 2 of the face page.
 
A signed, typewritten original of the application, including the
checklist, and four (4) signed, exact, single-sided copies must
be sent or delivered, in one package, to:
 
Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**
 
TWO ADDITIONAL COPIES MUST ALSO BE SENT DIRECTLY TO DR.  OLIVIA
PREBLE AT THE ADDRESS GIVEN ABOVE.
 
The RFA label available in the form PHS 398 (rev.  10/88,
reprinted 9/89) must be affixed to the bottom of the face page of
the original signed application.  Failure to use this label may
result in delayed processing of the application such that it may
not reach the committee in time for review.
 
CONSEQUENCES OF LATE APPLICATIONS
 
To ensure their review, applications must be received by both DRG
and Dr. Olivia Preble by April 1, 1991.  Applications received
after April 1, 1991 will be returned without review.  If the
application submitted in response to this RFA is substantially
similar to a research grant application already submitted to the
NIH for review, but has not yet been reviewed, the applicant will
be asked to withdraw either the pending application or the new
one.  Simultaneous submission of identical applications will not
be allowed, nor will essentially identical applications be
reviewed by different review committees.  Therefore, an
application cannot be submitted in response to this RFA that is
essentially identical to one that has already been 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.
 
VIII.  INQUIRIES
 
Investigators seeking information relevant to this RFA should
contact:
 
Ann Schluederberg, Sc.D.
Chief, Virology Branch
Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases
Westwood Building, Room 736
Bethesda, MD  20892
Telephone:  (301) 496-7453
FAX:  (301) 402-0804
 
Questions regarding review procedures and compliance with NIH
application requirements should be addressed to Dr. Preble, at
the address given above.  Questions regarding fiscal matters
should be addressed to:
 
Mrs. Jane Unsworth
Grants Management Branch
Division of Extramural Activities
NIAID, NIH
Westwood Building, Room 718
Bethesda, MD  20892
Telephone:  (301) 496-7075
FAX:  (301) 480-3780
 
SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF
NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN
CLINICAL RESEARCH STUDY POPULATIONS
 
NIH and ADAMHA policy is that applicants for NIH/ADAMHA clinical
research grants and cooperative agreements will be required to
include minorities and women in study populations so that
research findings can be of benefit to all persons at risk of the
disease, disorder or condition under study; special emphasis
should be placed on the need for inclusion of minorities and
women in studies of diseases, disorders and conditions which
disproportionately affect them.  This policy is intended to apply
to males and females of all ages.  If women or minorities are
excluded or inadequately represented in clinical research,
particularly in proposed population-based studies, a clear
compelling rationale should be provided.
 
The composition of the proposed study population must be
described in terms of gender and racial/ethnic group, together
with a rationale for its choice.  In addition, gender and
racial/ethnic issues should be addressed in developing a research
design and sample size appropriate for the scientific objectives
of the study.  This information should be included in the form
PHS 398 in Section 2, A-D of the Research Plan AND summarized in
Section 2, E, Human Subjects.
 
Applicants/offerors are urged to assess carefully the feasibility
of including the broadest possible representation of minority
groups.  However, NIH recognize that it may not be feasible or
appropriate in all research projects to include representation of
the full array of United States racial/ethnic minority
populations (i.e., Native Americans (including American Indians
or Alaskan Natives), Asian/Pacific Islanders, Blacks, Hispanics).
The rationale for studies on single minority population groups
should be provided.
 
For the purpose of this policy, clinical research includes human
biomedical and behavioral studies of etiology, epidemiology,
prevention (and preventive strategies), diagnosis, or treatment
of diseases, disorders or conditions, including but not limited
to clinical trials.
 
The usual NIH policies concerning research on human subjects also
apply.  Basic research or clinical studies in which human tissues
cannot be identified or linked to individuals are excluded.
However, every effort should be made to include human tissues
from women and racial\ethnic minorities when it is important to
apply the results of the study broadly, and this should be
addressed by applicants.
 
For foreign awards, the policy on inclusion of women applies
fully; since the definition of minority differs in other
countries, the applicant must discuss the relevance of research
involving foreign population groups to the United States
populations, including minorities.
 
If the required information is not contained within the
application, the review will be deferred until the information is
provided.  (For RFAs, change to read; If the required information
is not contained within the application, the application will be
returned.)
 
Peer reviewers will address specifically whether the research
plan in the application conforms to these policies.  If the
representation of women or minorities in a study design is
inadequate to answer the scientific question(s) addressed AND the
justification for the selected study population is inadequate, it
will be considered a scientific weakness or deficiency in the
study design and will be reflected in assigning the priority
score to the application.
 
All applications for clinical research submitted to NIH are
required to address these policies.  NIH funding components will
not award grants or cooperative agreements that do not comply
with these policies.