Full Text AI-92-04
 
NIAID INSTITUTIONAL TRAINING AWARDS FOR CLINICAL RESEARCH ON THE
ACQUIRED IMMUNODEFICIENCY SYNDROME
 
RFA:  AI-92-04
 
P.T. 44

Keywords: 
  Biomedical Research Training 
  AIDS 
  Clinical Medicine, General 

 
National Institute of Allergy and Infectious Diseases
 
Letter of Intent Receipt Date:  February 28, 1992
Application Receipt Date:  April 8, 1992
 
The National Institute of Allergy and Infectious Diseases (NIAID)
announces a Request for Applications (RFA) for NIAID Institutional
Training Awards for Clinical Research on the Acquired
Immunodeficiency Syndrome (AIDS), and invites applications for a
limited number of awards to be made in FY 1992.
 
PURPOSE
 
The NIAID plays a central role in the support of biomedical research
on HIV disease, AIDS, and AIDS-associated opportunistic infections.
In fulfilling its mission, it is crucial that the NIAID support
training to ensure the availability of outstanding scientists and
clinicians performing clinical research in HIV disease in the future.
 
The purpose of this RFA is to solicit applications from institutions
able to develop a clinical research training program that provides
training opportunities to outstanding new investigators who have
shown an interest in, and commitment to, clinical research on HIV
disease and the AIDS.  Trainees will learn the tools of research to
solve clinical problems in HIV infection.  This program will target a
variety of disciplines that work with patient clinical material or
other clinical data in clinical research.
 
HEALTHY PEOPLE 2000
 
The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of "Healthy People 2000,"
a PHS-led national activity for setting priority areas.  This RFA,
NIAID Institutional Training Awards for Clinical Research on AIDS, is
related to the priority area of HIV infection.  Potential applicants
may obtain a copy of "Healthy People 2000" (Full Report:  Stock No.
017-001-00474-0) or "Healthy People 2000" (Summary Report:  Stock No.
017-001-00473-1) through the Superintendent of Documents, Government
Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238).
 
OBJECTIVES AND SCOPE
 
The goals of the NIAID Institutional Training Awards for Clinical
Research on AIDS are to:
 
o  Increase the number of clinical researchers with a broad
background in clinical research methodology working in the field of
HIV disease.
 
o  Provide support to post-doctoral fellows, advanced graduate
students, and physicians for training in disciplines that are
directly relevant to clinical biomedical research on HIV disease.
 
o  Provide a training experience that integrates the range of
disciplines necessary for the conduct of clinical research.
 
o  Provide a training experience in an environment committed to
interdisciplinary collaboration among faculty/investigators active in
the field of HIV research.
 
Programs must include a range of disciplines requisite for the
development of research skills in clinical studies on HIV/AIDS.
These include:  epidemiology, surveillance, natural history and
transmission studies, biostatistics, theoretical fundamentals of
clinical research design, protocol development, regulatory
requirements, ethical considerations, clinical research execution,
data collection, quality assurance, data management and analyses,
clinical immunology, virology, microbiology, infectious diseases,
molecular biology, pharmacology, biochemistry, scientific writing,
scientific integrity, and manuscript preparation.
 
Examples of programs that would qualify for support include the
following:
 
o  Clinical epidemiology programs that build a strong
multidisciplinary foundation for the skills required to design,
implement, and analyze clinical trials and clinical cohort studies,
including research, administrative, and regulatory aspects.
 
o  Applied clinically based research training programs that build a
broad and thorough knowledge of laboratory evaluations correlated
with clinical study including immunology, virology, and microbiology.
 
o  Biostatistical training programs that include both mathematical
statistics and biostatistics, as well as course work in the biology
and epidemiology of HIV/AIDS disease and participation in HIV-related
research such as ongoing clinical trials, epidemiological studies,
animal studies, and modeling efforts.
 
The intent of this RFA is not to support clinical trials, although a
trainee may participate in the conduct of such studies.  The program
is primarily for post-doctoral training but may include advanced
predoctoral candidates, such as biostatisticians and epidemiologists
who have a definite career goal of clinical research.
 
MECHANISM OF SUPPORT
 
Awards for this program will be made as Institutional National
Research Service Awards (NRSA) (T32) and thus are subject to the
eligibility and evaluation criteria developed for that award.  The
service payback requirement for individuals supported under NRSA and
other provisions also apply.  Applicants should carefully review
those criteria, a copy of which is available from the institution's
Office of Sponsored Programs or its equivalent, from the Office of
Grants Inquiries, Division of Research Grants, National Institutes of
Health Room 449, Westwood Building, 5333 Westbard Avenue, Bethesda,
MD 20892, telephone (301) 496-7441.
 
Training grant funds are to be used exclusively for trainee stipends,
medical insurance, tuition, fees, and travel.  Applicants are
required to request funding for travel to meetings as described in
SPECIAL REQUIREMENTS.  The applicants may request up to the NRSA
maximum of $2,500 for post-doctoral and $1,500 for pre-doctoral for
institutional allowances in support of necessary supplies, equipment
for trainees.  In considering the budget, the NIAID expects that the
proposed faculty are located in research facilities with adequate and
active research support.  The usual indirect cost rates for
institutional training grants will apply in accordance with NIH
policy.
 
FUNDS AVAILABLE
 
The NIAID has set aside $750,000 in total costs for the first year of
this RFA.  The number of awards will be influenced by the
availability of funds, the overall scientific merit of the
applications, and their relevance to the program goals.  Awards
pursuant to this RFA are contingent on the continuing availability of
funds for this purpose.  It is estimated that five to seven awards of
up to $150,000 total costs will be made to each successful applicant.
The earliest date of award will be September 30, 1992.
 
SPECIAL REQUIREMENTS
 
An annual Progress Report on the achievements attributable to the
clinical research training program must be submitted.  It is to
include an update on the success in recruiting under-represented
minorities and women as trainees, specifically addressing their
degree status and extent of participation.  Additional special
reporting requirements may be necessary from time to time to document
fulfillment of the stated objectives under this RFA.
 
All publications and oral presentations arising from research
supported by this clinical research training program must cite the
grant as a contributing source of support:  "This work was supported
in part by an NIAID Institutional Training Award for Clinical
Research on AIDS, T32 AI-92-04".  In addition, each clinical research
training program must maintain a current and complete bibliography of
program-related publications for inclusion in the annual report,
listed alphabetically by first author, and catalogued by calendar
year in which they were published.  Abstracts may be listed
separately.
 
Both post- and pre-doctoral trainees will be required to attend both
an annual meeting of AIDS fellows sponsored by the NIAID and an
AIDS-related scientific meeting.
 
GENERAL REQUIREMENTS
 
NIH and ADAMHA policy is that applicants for NIH/ADAMHA clinical
research grants and cooperative agreements are 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 policy of the NIH and the NIAID is to promote broad and
systematic efforts to recruit women and individuals from minority
groups that are under-represented in biomedical research.  Applicants
must provide a description of special plans to recruit individuals as
trainees from these groups.  Applications without such specific plans
will be judged not responsive and returned without review.  Potential
mechanisms for woman and/or minority recruitment include:
advertisements actively recruiting women and minorities to the
program; posters and flyers actively recruiting women and minorities;
visits by the program to minority institutions; cooperative programs
with minority institutions; procedures to identify women and minority
applicants; mailings to women and minorities on various lists;
invitations to prospective women and minority applicants using
institutional funds.  Applicants must provide detailed descriptions
and explore other options.
 
ELIGIBILITY REQUIREMENTS
 
It is the intention of the NIAID that awardees will be chosen from
highly meritorious applications that document ongoing, high quality
AIDS clinical research programs within the applicant institution or
in association with the applicant institution.  Applications from or
in collaboration with institutions funded by NIAID or other
institutes in AIDS clinical research are encouraged.
 
Only domestic academic, non-profit, private and public institutions
are eligible to apply for this award.
 
A trainee must be a United States citizen or a non-citizen national,
or must have been officially admitted to the United States as a
permanent resident at the time of appointment.  Individuals on
temporary or student visas are not eligible.
 
REVIEW PROCEDURE
 
Applications will be reviewed by NIAID staff to determine
completeness and administrative and programmatic responsiveness to
this RFA.  Applications that are incomplete for review or are not
responsive to this RFA will be identified by NIAID staff upon receipt
and returned to the applicants without further consideration.
 
Those applications that are complete and responsive may be subjected
to a triage by a peer review group to determine the scientific merit
relative to the other applications received in response to this RFA.
The NIH will withdraw from competition those applications judged by
the triage peer review group to be noncompetitive and will notify the
applicant and the institutional business official.  Those
applications judged to be competitive will be further reviewed for
scientific and technical merit by a subcommittee of the AIDS Research
Review Committee, Division of Extramural Activities, NIAID.  The
second level of review will be provided by the National Advisory
Allergy and Infectious Disease Council.
 
The review and funding of this RFA falls within the realm of
accelerated review.  The requirements for accelerated review and
subsequent award are mandated by Section 2302 of Title II (AIDS
amendment of 1988).  The receipt date announced in this RFA must be
strictly adhered to.  No exceptions will be made.  Any application
received after the receipt date will be returned to the applicant.
 
REVIEW CRITERIA
 
Applicants must address the following criteria that will be employed
by reviewers in evaluating the applications.  The criteria are the
same as those employed for evaluating other NRSA applications but
have been expanded to take into account the special emphases of the
program:
 
o  Scientific merit of the long-term training program including
program objectives and program design.
 
o  Relevance of the training program to the ongoing AIDS clinical
research at the applicant institution and the role of the trainees in
these programs.
 
o  Scientific environment and the active resources of the applicant
institution including current AIDS research support.
 
o  Cohesiveness of the program including mechanisms for promoting
interdisciplinary exchange of information such as seminar series,
journal clubs, laboratory rotations, and research presentations.
 
o  The applicant's ability to attract high caliber candidates.
 
o  Qualifications of training faculty, the relevance of their current
research activities to AIDS research, and their previous research
training experience.
 
o  Extent of commitment of the institution to the proposed training
program.
 
o  Where the application involves activities that could have an
adverse effect upon humans, animals, or the environment, the adequacy
of the proposed means for protecting against or minimizing such
effects.
 
Compliance to requirements listed under GENERAL REQUIREMENTS will be
addressed by the reviewers.
 
LETTER OF INTENT
 
Prospective applicants are asked to submit by February 28, 1992, a
letter of intent that briefly describes the proposed training
program, 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 is helpful in planning for the review of
applications.  It allows the NIAID staff to estimate the potential
review workload and to avoid possible conflict of interest in the
review.
 
The letter of intent is to be sent to:
 
Evelyn M. Rodriguez, M.D.
Division of AIDS
National Institute of Allergy and Infectious Diseases
Solar Building, Room 2A23
6003 Executive Boulevard
Bethesda, MD  20892
Telephone:  (301) 496-6177
Rockville, MD 20852 for overnight express mail
 
METHOD OF APPLYING
 
NOTE:  THE FOLLOWING INSTRUCTIONS DIFFER FROM AND SUPERSEDE THE
INSTRUCTIONS THAT ARE IN FORM PHS 398 (rev. 10/88).  FAILURE TO
FOLLOW THE SPECIAL MAILING INSTRUCTIONS FOR THIS RFA WILL CAUSE THE
APPLICATION TO BE CONSIDERED NON-RESPONSIVE TO THE RFA.
 
The deadline for receipt of applications is April 8, 1992.
Applications received after this date will be returned without
review.
 
The research grant application form PHS 398 (revised 10/88) must be
used in applying.  The application kit contains special instructions
for preparing NRSA institutional fellowship award applications.  The
PHS 398 forms are available at most institutional business offices
and from the Office of Grants Inquiries, Division of Research Grants,
National Institutes of Health Room 449, Westwood Building, 5333
Westbard Avenue, Bethesda, MD 20892, telephone (301) 496-7441.
 
TO ASSURE THE IDENTIFICATION OF THE APPLICATION WITH THIS RFA:
 
The application form must have NIAID Institutional Training Awards
for Clinical Research on AIDS RFA AI-92-04 typed on line 2 of the
face page of the application form.
 
The RFA label provided with the form PHS 398 must be affixed to the
bottom of the face page of the original signed application.  Failure
to use this label could result in delayed processing of the
application so that it may not reach the review committee in time for
review.
 
Submit the a signed, typewritten original application, including the
Checklist, and four signed, exact, photocopies WITHOUT any appendices
to:
 
Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892
 
The photocopies must be clear and single-sided.  Do not bind or
staple these copies in any way; use large binder clips, accordion
folders, rubber bands or string to secure individual copies.
 
In addition, submit nineteen photocopies of the application
(preferably double-sided) and six copies of appendices (optional
materials) to:
 
Hortencia Hornbeak, Ph.D.
Deputy Chief, Program and Project Review Branch
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Solar Building, Room 4C19
6003 Executive Boulevard
Bethesda, MD  20892
Telephone:  (301) 496-0123
Rockville, MD 20852 for overnight express mail
 
INQUIRIES
 
Inquiries regarding programmatic aspects of this RFA may be addressed
to:
 
Evelyn M. Rodriguez, M.D.
Division of AIDS
National Institute of Allergy and Infectious Diseases
Solar Building, Room 2A23
6003 Executive Boulevard
Bethesda, MD  20892
Telephone:  (301) 496-6177
Rockville, MD 20852 for overnight express mail
 
Inquiries pertaining to the review of these applications may be
addressed to:
 
Hortencia Hornbeak, Ph.D.
Deputy Chief, Program & Project Review Branch Section
National Institute of Allergy and Infectious Diseases
Solar Building, Room 4C19
6003 Executive Boulevard
Bethesda, MD   20892
Telephone:  (301) 496-0123
 
Inquiries regarding fiscal and policy matters may be addressed to:
 
Ms. Jane Unsworth
Chief, AIDS Grants Management
Grants Management Branch, DEA
National Institute of Allergy and Infectious Diseases
Solar Building, Room 4C19
6003 Executive Boulevard
Bethesda, MD  20892
Telephone:  (301) 496-7075
 
AUTHORITY AND REGULATIONS
 
This program is described in the Catalog of Federal Domestic
Assistance No. 93.856 - Microbiology and Infectious Diseases
Research, and No. 93.885 - Immunology, Allergic and Immunologic
Diseases Research.  Grants are awarded under the authority of the
Public Health Service Act, Title IV, Section 487, 42 USC 288 and
administered under the PHS grants policies and Federal Regulations,
most specifically 42 CFR Part 66.  This program is not subject to the
intergovernmental review requirements of Executive Order 12372 or a
Health Systems Agency review.
 
.

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