Full Text AI-94-027


NIH GUIDE, Volume 23, Number 34, September 23, 1994

RFA:  AI-94-027

P.T. 34, FF

  Biomedical Research, Multidiscipl 

National Institute of Allergy and Infectious Diseases

Letter of Intent Receipt Date:  December 23, 1994
Application Receipt Date:  February 21, 1995


The goal of this support is to enable underrepresented minority
investigators to establish clinical or basic AIDS research programs.
To move towards this goal, the National Institute of Allergy and
Infectious Disease (NIAID) encourages applications from
underrepresented minority investigators for both basic and clinical
investigations in AIDS and AIDS-related research.  Several features
have been employed to achieve these goals.  These include the
fostering of specific collaborations between more established
investigators and the Principal Investigator (PI) to enhance
refinement and implementation of each proposed project to maximize
the chances for success.  Support will also be provided for
laboratory staff of the qualified PI, including postdoctoral
scientists who will augment the research program established by the
grantee.  Applications in all basic and clinical areas of HIV/AIDS
research are encouraged.


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 Request
for Applications (RFA), Enhancement Awards for Underrepresented
Minority Researchers in HIV/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).


Applications may be submitted by investigators from underrepresented
minority groups from domestic, for-profit, not-for-profit and
non-profit organizations, private and public institutions such as
universities, colleges, hospitals, laboratories, units of State or
local governments, and eligible agencies of the Federal government.
Foreign institutions are ineligible for awards under this program.
For this RFA, "underrepresented minorities" are defined as primarily
African Americans, Hispanics, Native Americans, and Pacific
Islanders.  Institutions must have sufficient research infrastructure
and a core of investigators already conducting basic, behavioral,
clinical, or epidemiological biomedical research to ensure a
nutritive environment for this award.  Reviewers will give priority
to investigators at those institutions having a graduate program in
the medical sciences and a minimum of 10 NIH research grants (P01,
R01, R03, R15, R29, R55, U01, U18) and/or a direct plus indirect cost
funding level for these awards totalling $3 million.

Successful applicants will have earned the Ph.D., D.V.M., D.D.S.,
M.D., or Pharmacy degree and must demonstrate training and expertise
in research commensurate with the requirements of this award.  In
general, applicants should have successfully completed at least two
years of postdoctoral training (or equivalent training for
clinicians) in relevant biomedical research at the time of submission
of the application.  Participants in NIH minority programs, such as
the NIH Research Supplements for Minority Investigators Program and
Research Centers in Minority Institutions (RCMI) Program with the
above qualifications are encouraged to apply, as well as those
individuals who have been funded by minority supplements from NIAID
(Initiatives for Underrepresented Minorities in Biomedical Research
Supplement (IUMBRS)).  More senior investigators with relevant
experience in fields other than AIDS research (which may include
R01-type funding) are also eligible to compete for this award as a
vehicle for entry into AIDS research.  However, investigators who
have previously received funding in AIDS research at the unsolicited
R01 or equivalent level are not eligible for this award and should
refer to other programs supported by NIAID.  NIAID staff listed under
INQUIRIES should be consulted for details concerning eligibility
requirements.  Applications from minority women are especially


The support mechanism for this program is the individual research
project grant (R01), under which it is the responsibility of the
applicants to plan, direct and execute the proposed projects.  This
award is not a supplement to ongoing, funded studies.  All potential
applicants are strongly encouraged to consult with NIAID staff listed
under INQUIRIES prior to preparation of the application regarding
eligibility requirements and scientific scope.  Because the nature
and scope of the research proposed as well as the facilities
available to the applicant in response to this RFA may vary, it is
anticipated that the size of the awards will also vary.  This RFA is
a one-time solicitation.  Following termination of this award, any
future unsolicited applications from the awardee will compete with
all investigator-initiated applications and be reviewed according to
the customary peer review procedures.


The NIAID anticipates awarding four to six R01 awards, for a total
(direct and indirect) cost of approximately $1.2 million for the
initial year of funding.  However, the total number and amount of
funding is dependent on the receipt of a sufficient number of
applications of high scientific merit and on the availability of



The disproportionate impact of the AIDS epidemic upon minority
populations within the United States and Puerto Rico may be viewed
from two different perspectives.  First, the frequency of occurrence
of the disease is increasing at a disproportionately high rate in
minorities.  Second, certain minorities are significantly
underrepresented as investigators in clinical and basic AIDS and AIDS
related research.

Increasing the participation of underrepresented minority
investigators in virtually all fields of biomedical research is a
continuing NIH priority.  The National Institutes of Health (NIH)
currently supports a wide variety of minority programs for biomedical
research, encompassing high school through postdoctoral training.
These include the Minority Access to Research Careers (MARC) Program,
Minority Biomedical Research Support (MBRS) Program, Research Centers
in Minority Institutions (RCMI), the NIH Research Supplements for
Minority Investigators Program  (also called Initiatives for
Underrepresented Minorities in Biomedical Research Supplement,
(IUMBRS)), the AIDS Planning Grant to the Association of Minority
Health Professions Schools (AMHPS), and the Minority Health
Initiative (MHI).

Although each of these minority programs has demonstrated success in
specific areas, recent studies indicate that only a few minority
investigators become well established in mainstream research,
primarily because of an absence of essential components necessary for
a competitive scientific career (see Science, "Minorities in
Science", 258:1175-1237, 1992).  Key components of a successful
career in competitive AIDS research include:

1.  Interaction with a critical mass of scientists at all levels, who
are involved in biomedical research at the PIs institution and are
available for advice and collaboration;

2.  Establishment of collaborations with investigators at other
institutions who are at the forefront of biomedical research;

3.  Securing sufficient release from a heavy teaching load, which
could otherwise significantly diminish the time available for
research and training of junior colleagues;

4.  Accessing a constantly increasing repertoire of current
state-of-the-art technology, needed for the proposed investigations.
This kind of growth is a career-long process that is enhanced and
maintained by the close collaborations listed above.

Goals and Objectives

The goal of this program is to increase the number of
underrepresented minority investigators performing independent
competitive HIV/AIDS research and enhance their long-term research

Applicants may propose research in any clinical or basic AIDS and
AIDS-related research areas including:

o  Pathogenesis:  especially, clinically based, multidisciplinary
research of HIV pathogenesis, HIV molecular biology, the study of
correlations of host factors with disease course, the influence of
cofactors such as cytokines or other infectious agents on disease

o  Epidemiology and natural history: clinical factors associated with
disease, natural history of HIV infection and clinical predictors of
disease course, behavioral change studies, design of more effective
risk-reduction interventions.

o  Vaccine research and development: studies of the natural immune
responses to HIV-related infection, mucosal immunity, genetic
variation, mechanisms by which opportunistic pathogens avoid immune
surveillance, novel ways of stimulating protective immune responses,
development of methods for enrollment and retention of minorities and
women in vaccine trials.

o  Therapeutics research and development:  primary infection and
opportunistic infections are targets for NIAID-funded research and
include discovery and development of better therapeutic strategies
and antiretroviral drugs, the emergence and mechanisms of viral
resistance to drugs, immune-based strategies, other novel approaches
to therapy including gene therapy and development of methods for
enrollment and retention of minorities and women in therapeutic

o  Pediatrics disease: mechanisms of perinatal transmission,
prevention of perinatal transmission, and pediatric pathogenesis and
therapeutics also encompassing opportunistic infections common to
HIV-infected children.

Specific research questions of the highest priority can be found in
the current NIAID HIV/AIDS Research Agenda.  Contact program staff
listed under INQUIRIES for additional information.


The special requirements are:

o  The PI be a member of an underrepresented racial minority group.

o  The PI must establish a collaborative network with at least three
established investigators with expertise relevant to the research
proposed by the PI.  At least two of the established investigators
should have expertise in AIDS or AIDS-related research.  See below
and under Special Instructions for additional details.

DAIDS staff may be consulted for assistance in identifying potential
collaborators.  However, responsibility for identifying and obtaining
commitments from collaborators rests solely upon the applicant.

The collaborators will have the following responsibilities to the

1.  Assist in the development of the application responding to this

2.  Provide assistance in scientific, technical and managerial areas
required for fulfilling the goals of this award throughout its

The PIs institution will have the following responsibilities:

1.  To authorize release time.  Each applicant is expected to commit
at least 75 percent of his/her time and effort.

Applicants should include a letter from the responsible institutional
official guaranteeing release from all but 25 percent of
administrative and teaching responsibilities should the grant be
awarded.  Failure to implement the agreed amount of release time may
result in termination of the award.

2.  To provide adequate facilities for the proposed studies.  This
may be confirmed during a pre-award site visit by DAIDS staff.

An annual meeting be held.

It is suggested that applicants include a request in the budget for
funds to cover attendance of the PI and one collaborator (preferably,
the more senior established investigator) at an annual meeting to be
held at the NIH or at a site designated by NIAID.  This will provide
an opportunity to discuss significant research findings, problems,
collaborations and overall progress and evolution of the program.


It is the policy of the NIH that women and members of minority groups
and their subpopulations 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 new policy results
from the NIH Revitalization Act of 1993 (Section 492B of Public Law
103-43) and supersedes and strengthens the previous policies
(Concerning the Inclusion of Women in Study Populations, and
Concerning the Inclusion of Minorities in Study Populations) which
have been in effect since 1990.  The new policy contains some new
provisions that are substantially different from the 1990 policies.
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 reprinted
in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume
23, Number 11.

Investigators also may obtain copies of the policy from the program
staff listed under INQUIRIES.  Program staff may also provide
additional relevant information concerning the policy.


Prospective applicants are asked to submit, by December 23, 1994, a
letter of intent that includes a descriptive title of the proposed
research, the names and affiliation(s) of the principal investigator
and other key personnel, including members of the collaborative
network and the number and title of this RFA.  While the letter of
intent is not required, is not binding, and does not enter into
subsequent peer review deliberation, it provides NIAID staff with
information on the number and scope of applications to be expected,
allows estimation of the potential review workload, and avoids
conflict of interest in the review.  The letter of intent is to be
sent to Dr. Dianne Tingley at the address listed under INQUIRIES.


Applications are to be submitted on form PHS 398 (rev.9/91), the
standard application form for research grants.  Application kits are
available at most institutional offices of sponsored research and
from the Office of Grants Information, Division of Research Grants
(DRG), National Institutes of Health, Westwood Building, Room 449,
Bethesda, Maryland 20892, telephone (301) 710-0267.  Applications
must adhere to the format and requirements specified in the PHS
application kit.  The official deadline for receipt of applications
in response to this RFA is February 21, 1995.

Applications that do not address the objectives of this RFA will be
considered nonresponsive and applicants will be contacted, as
described under REVIEW CONSIDERATIONS.  Therefore, applicants are
strongly encouraged to discuss their research plans with DAIDS
program staff before preparing their applications.

The RFA label available in the PHS 398 application kit must be
affixed to the bottom of the face page of the application.  To assure
the identification of your application with this RFA, the "YES" box
must be marked in item 2a of the face page of the application and the
RFA number (RFA AI-94-027) and title "Enhancement Awards for
Underrepresented Minority Researchers in HIV/AIDS" entered in the
provided spaces in item 2.

Submit, in one package, a signed typewritten original of the
application including the Checklist and appendices, and three signed,
exact single-sided photocopies of the application, to:

Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**

At the time of submission to the Division of Research Grants, also
submit two additional exact copies of the application including five
sets of appendices and letters of support and curricula vitae
directly to Dr. Dianne Tingley at the address listed under INQUIRIES.

Applications received after the receipt date will not be eligible for
this award.  DRG will not accept an application in response to this
RFA that is essentially the same as one pending initial review,
unless the applicant withdraws the pending application.  DRG will not
accept an application that is essentially the same as one already
reviewed.  This does not preclude the submission of a revision of an
application already reviewed.  Any revised application, however, must
include an introduction addressing the previous critique.

Special Instructions

The following information is provided in addition to the instructions
found in the PHS 398 form.

Collaborative Network

It is required that the PI establish an external committee consisting
of at least three established scientists who will form a
collaborative network, each scientist with expertise relevant to the
proposed study.  It is strongly recommended that one of the
scientists be a more senior individual who has been involved in AIDS
research for five to ten years, is a recognized leader in the field,
has authored or co-authored peer-reviewed papers in AIDS or
AIDS-related research, and is the leader of a substantial scientific
program.  The other two investigators (at least one of whom should be
involved in AIDS or AIDS-related research) should be established
scientists who are still very active in the laboratory, field, or
community, who have published at least three substantial,
peer-reviewed papers in their area of expertise, and are experienced
in the area of technical or theoretical aspects of the proposed

It is important that the applicant include letters from the
collaborators indicating their intent and availability to serve in
this capacity.  Collaborators should provide their curriculum vitae
to be submitted with the application in response to the RFA to
indicate the relevance of their area of expertise.  Letters must be
submitted with the original application and the entire package
submitted by the submission deadline.  DAIDS staff may be consulted
for assistance in identifying potential committee members.  However,
responsibility for identifying and obtaining commitments from
collaborators rests solely upon the applicant.

The collaborators will have the following responsibilities to the

1.  Assist in the development of the application responding to this

2.  Provide advice and assistance, as needed, in experimental design,
technical aspects of work and all areas of scientific and/or
administrative concern required for fulfilling the goals of this

3.  Visit the institution of the PI, as needed.  It is anticipated
that several trips by collaborators to the institution of the PI may
be necessary, especially in the first year of the award.
Collaborators will be reimbursed for limited travel to the laboratory
of the PI and can be paid as consultants or through consortium/
contractual arrangements.  One of the members of the collaborative
network per award will be reimbursed for travel to the annual meeting
of the program and this trip should be specifically included in the
budget request.

Travel and per diem fund requests for collaborators may not exceed
$4000 per year.

4.  Permit usage of equipment and facilities by the PI at the
collaborator's institution, as appropriate.  The cost of reagents and
materials including animals used by the PI to perform critical
experiments (as part of this proposal) that must be performed in the
laboratory of a collaborator may also be requested.  PIs can apply
for travel to/from the collaborators' laboratories.  Per diem
expenses for performance of critical experiments at collaborating
institutions by PIs may also be requested, when appropriate.

Other responsibilities of the PI and the PI's institution:

1.  Requests for support of one graduate student to begin year two
through four is permitted as appropriate.

2.  Requests for support of postdoctoral fellows are permitted as
appropriate.  If requested in later years, they will be supported
with program and collaborators' approval.

3.  The effort of the PI on this grant must be at least 75 percent.

4.  A letter of commitment from the PI's institution confirming the
release of 75 percent of the PI's time must be submitted with the


Upon receipt, applications will be reviewed for completeness by DRG
and responsiveness by the NIAID.  Incomplete applications will be
returned to the applicant without further consideration.  If NIAID
staff find that the application is not responsive to the RFA, it will
be returned without further consideration.

Applications that are complete and responsive to the RFA will be
evaluated for scientific and technical merit by an appropriate peer
review group convened by the NIAID in accordance with the review
criteria stated below.  As part of the initial merit review, a
process (triage) may be used by the initial review group in which
applications will be determined to be competitive or non-competitive
based on their scientific merit relative to other applications
received in response to the RFA.  Applications judged to be
competitive will be discussed and be assigned a priority score.
Applications determined to be non-competitive will be withdrawn from
further consideration and the principal investigator/program director
and the official signing for the applicant organization will be
promptly notified.

Review Criteria

The submitted applications will be assessed by the following review

o  The significance and novelty of the proposed studies and their
relevance to the AIDS epidemic should be clearly demonstrated.

o  The relative potential of the applicant to take maximum advantage
of the unique features of this award and to achieve the goals
described above is a critical factor in evaluation of the proposed
research program.  The applicant must have completed at least two
years of postdoctoral research, must be able to interact effectively
with administrators, colleagues, collaborators, subordinates and NIH
staff, and must be capable of establishing and directing an
independent research laboratory (see ELIGIBILITY REQUIREMENTS).

o  The scientific and technical merit of the proposed research,
including choice of appropriately sensitive and reproducible assay
systems, and/or culturally appropriate approaches to clinical
studies, will be carefully evaluated.

o  The suitability and feasibility of the proposed experimental
strategies for achieving the goals as outlined in the application.

o  The availability at the institution of appropriate equipment and
space needed to perform the studies.

o  The presence of a critical mass of scientists at the institution
funded by a minimum of 10 NIH research grants (P01, R01, R03, R15,
R29, R55, U01, U18) and/or a direct plus indirect cost funding level
for these awards totalling $3 M.

o  It should be documented that a minimum of three collaborators to
form an external committee or collaborative network have been
identified and are truly committed to facilitating the success of
this award.  The appropriateness and usefulness of the collaborators'
scientific and technical expertise should be demonstrated.

o  The budget and time frame should be appropriate for all research


The final number and specific amounts of awards to be made will
depend upon the consideration of the following and upon the
availability of funds:

o  Results of the initial scientific and technical merit review and
pre-award site visit (if applicable);

o  Potential contribution of the proposed research to the goals and
objectives of the RFA;

o  Program balance;

o  Diversity of applicants and scientific approaches;

o  In making awards, preference may be given to proposed projects
that will impact upon the disease in minority populations
disproportionately affected by the epidemic in the United States.


Inquiries concerning this RFA are encouraged.  The opportunity to
clarify any issues or questions from potential applicants is welcome.

Direct inquiries regarding programmatic issues to:

Dr. Janet M. Young
Division of AIDS
National Institute of Allergy and Infectious Diseases
Solar Building, Room 2C36
6003 Executive Boulevard
Bethesda, MD  20892-7620
Telephone:  (301) 402-0755
FAX:  (301) 480-5703
INTERNET:  enhance@nih.gov

Direct letters of intent and inquiries regarding the scientific
review process to:

Dr. Dianne Tingley
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Solar Building, Room 4C07
6003 Executive Boulevard
Bethesda, MD  20892-7610
Telephone:  (301) 496-0818
FAX:  (301) 402-2638
INTERNET:  dianne_tingley@nih.gov

Direct inquiries regarding fiscal matters to:

Ms. Carol Alderson
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Solar Building, Room 4B27
6003 Executive Boulevard
Bethesda, MD  20892-7610
Telephone:  (301) 496-7075;
FAX:  (301) 480-3780
INTERNET:  carol_alderson@nih.gov


Technical Meeting for Applicants:  September 28, 1994
Letter of Intent Receipt Date:     December 23, 1994
Application Receipt Date:          February 21, 1995
Scientific Review Date:            June 1995
Advisory Council Date:             September 1995
Anticipated Award Date:            September 1995


This program is described in the Catalog of Federal Domestic
Assistance, 93.856 -Microbiology and Infectious Diseases Research and
93.855 - Immunology, Allergic and Immunological Diseases Research.
Grants are awarded under the authority of the Public Health Service
Act, Section 301 (42 USC 241) and administered under the PHS grant
policies and Federal Regulations, most specifically at 42 CFR Part 52
and 45 CFR Part 74.  This program is not subject to the
intergovernmental review requirements of the Executive Order 12372 or
Health Systems Agency Review.

The Public Health Service strongly encourages all grant recipients to
provide a smoke-free workplace and promote the non-use of all tobacco
products.  This is consistent with the PHS mission to protect and
advance the physical and mental health of the American people.


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