HIV-AIDS AND RELATED ILLNESSES RESEARCH COLLABORATION 

Release date:  December 18, 1998

PA NUMBER:  PA-99-029

P.T.

Fogarty International Center

This PA replaces PAR-95-012, which was published in the NIH Guide, Vol. 23,
No.44, Dec.16, 1994.

PURPOSE

The Fogarty International Center (FIC) has enhanced its HIV-AIDS and Related
Illnesses Research Collaboration Award (AIDS-FIRCA) which provides small
individual research grants for collaboration between U.S. and foreign scientists
in most countries, consistent with U.S. foreign policy considerations.  These
changes include increased funding levels and more flexible eligibility
requirements.  Support is available for research on human immunodeficiency virus
(HIV) infection, acquired immunodeficiency syndrome (AIDS) and for research
related to AIDS.

U.S. investigators holding currently active NIH grants for research related to
HIV infections, AIDS and other related health problems, are eligible to apply
with their foreign collaborator for the AIDS-FIRCA. A similar program of Fogarty
International Research Collaboration Awards (FIRCA) is available in all non-AIDS
biomedical sciences research subjects for collaborative projects involving U.S.
scientists and investigators in developing countries: see program announcement
number PAR-99-008 in the NIH Guide or on the FIC web site:
http://www.nih.gov/fic/ under "Research and Training Opportunities."

Up to $32,000 in direct costs per year, for a maximum of three years, is
available for U. S. investigators and their foreign collaborators to conduct
research, mainly at the foreign site.  AIDS-FIRCA grants will provide funds to
the foreign collaborator, through the U.S. grantee institution, for a small
stipend for the foreign investigator, for supplies at the foreign institution,
and for research-related travel and subsistence expenses for both the U.S. and
foreign investigators.  If the foreign collaborator is in a developing country,
applicants may also request funds for small pieces of equipment necessary to the
AIDS-FIRCA project at the foreign site.

ELIGIBILITY REQUIREMENTS 

Most countries are eligible for collaboration under the AIDS-FIRCA, consistent
with U.S. foreign policy considerations.  For the purpose of this program,
developing countries eligible to use AIDS-FIRCA funds for equipment are
considered to include those in the following regions: Africa, Asia (except Japan,
Singapore, South Korea and Taiwan), Central and Eastern Europe (Hungary, Poland,
the Czech and Slovak Republics, Romania, Bulgaria, Albania and the countries of
the former Yugoslavia), Russia and independent countries of the former Soviet
Union,  Latin America, the Middle East, and the Pacific Ocean Islands (except
Australia and New Zealand).

The U.S. scientist will apply as principal investigator with a colleague from a
single laboratory or research site in an eligible country.  Occasionally,
scientific opportunities may arise that warrant a formal collaborative effort
between the U.S. investigator and individuals from more than one country.  Such
applications may be considered if well-justified and only after consultation with
FIC program staff.

Applications may be submitted by U.S. non-profit organizations, public and
private, such as universities, colleges, hospitals and laboratories. 
Racial/ethnic minority individuals, women, and persons with disabilities are
encouraged to apply as principal investigators and collaborators.

To be eligible for an AIDS-FIRCA, the following requirements must be met:

o U.S. applicants must be principal investigators or project directors on NIH
research grants (referred to as the "parent grant") that will be active and
funded at the start of the proposed FIRCA budget period.  Eligible mechanisms are
the R01, P01, or U01 with other mechanisms from the R, P and U series considered
on a case by case basis after consultation with the AIDS-FIRCA program officer. 
Under exceptional circumstances some research contracts (N01 series) may be
eligible "parent" funding for the AIDS-FIRCA.  Center Core Grants (P30), Shannon
Awards (R55), Small Grants (R03), training grants and research contracts are
among the mechanisms generally not accepted as parent grants.  The parent grant
must have a minimum of 12 months of funding remaining at the time of application
deadline to be eligible for AIDS-FIRCA funding.  Grants in a no-cost extension
period are not generally eligible to act as parent grants.  However, for
programmatic reasons they may be considered eligible with the prior approval of
the FIRCA program officer.  Grants in a no-cost extension period must also have
sufficient funds still available at the time of application to clearly support
12 months of parent grant effort.

o The proposed AIDS-FIRCA research should, in general, be an extension or a new
direction of the parent grant.  However, the proposed research must not be
already supported by the U.S. investigator's parent grant or by other sources. 
When well justified, the proposed research may be for AIDS-related work that is
not directly related to the aims of the parent grant.  In that case the research
should be clearly within the expertise and interests of both collaborators, as
indicated by the parent grant.  It should also make use of unique or special
resources, circumstances or environment of the foreign site and of the
comparative strengths of the U.S. and foreign investigators.

o The foreign collaborator must hold a position at a public or private non-profit
institution that will allow him or her adequate time and provide appropriate
facilities to conduct the proposed research.

o There is no limit to the number of distinct AIDS-FIRCA grants an applicant may
be awarded over time and applicants may already be AIDS-FIRCA grantees at the
time of application.  However, only one AIDS-FIRCA application may be submitted
by the same investigator per review cycle.

o Applicants may apply for only one competitive renewal of a given AIDS-FIRCA
award, providing the above-mentioned criteria are satisfied at the time of
application for the renewal.

MECHANISM OF SUPPORT

The AIDS-FIRCA will use the NIH small research project grant (R03) mechanism. 
The AIDS-FIRCA grant will provide up to $32,000 per year in direct costs for up
to three years.  All proposed expenditures must be well justified and clearly
related to the research objectives of the proposed project.  Funds may be used
for materials and supplies necessary to conduct the collaborative research in the
foreign scientist's research laboratory or site and for travel directly related
to the research project.  For collaborations in developing countries (as defined
under "Eligibility Requirements") equipment requests will be considered,
including computers or fax machines to facilitate both research and
communication, but will require strong justification.

Travel funds may be requested up to 20 percent of the total direct costs (up to
$6,400) for the U.S. Principal Investigator, the foreign collaborator, and/or
their colleagues or students, for visits to each other's laboratory or research
site.  Such visits must be directly related to the subject of the collaborative
research.

If the foreign collaborator is in a developing country (as defined under
"Eligibility Requirements") then, of the $32,000 per year: 

1) up to $5,000 per year may be allocated as a stipend for the foreign
collaborator (or shared with other collaborators at the foreign site who are
actively involved in the proposed research), if well-justified.  It is expected
that the stipend will enable the foreign investigator(s) to better focus their
efforts, and those of their lab on the collaborative research.

2) up to $2,000 of the $32,000 per year may be allocated for the foreign
collaborator to attend a AIDS-related scientific conference.  All proposed
expenditures must be well justified and clearly related to the research
objectives of the proposed project. 

The awards will be made to U.S. institutions which will be responsible for the
administration of funds.  The minimum small grant project period will be for one
year; the maximum will be for three years.  Continuation of the AIDS-FIRCA
project depends upon research progress, availability of funds, and continuation
of appropriate NIH support for the U.S. Principal Investigator's research.  The
AIDS-FIRCA grant will remain active if the parent grant expires and is not
renewed during the AIDS-FIRCA project period provided the U.S. principal
investigator states his/her continued involvement in and support for the  FIRCA
research.  The FIC accepts applications for competing continuation of AIDS-FIRCA
grants on a merit basis, for one time only.  Applicants may want to consider
whether their collaboration has developed to the point where they can submit an
R01 research grant with a foreign component.

The research under the FIRCA award is expected to occur mainly at the foreign
site and the major portion of the funds should be spent at the foreign site to
support this research.  Therefore, indirect costs will be calculated on the basis
of the off-site rate of the U.S. sponsoring institution

RESEARCH OBJECTIVES

The main objective of this AIDS-FIRCA program is to facilitate unique and highly
promising collaborative basic and applied research efforts between U.S. and
foreign scientists.  It is expected that the research will both expand and
enhance the HIV- and AIDS-related research interests of the U.S. Principal
Investigator and benefit the scientific interests of the collaborating foreign
scientist.  In developing countries, an additional goal of the collaboration
should be to increase the capacity of the foreign investigator and institution
for sustained and productive research and research collaborations.

All areas of research directly and indirectly related to HIV infection and AIDS
are eligible for consideration.  Eligible topics are those contained in the NIH
plan for HIV-related research which is available at the Office of AIDS Research
(OAR) Web site: http://www.nih.gov/od/oar/index.htm.  The site is updated on an
annual basis.

Protection of Research Subjects

Applicants should be aware that applicable provisions for protection of human
research subjects and laboratory animals must be met in both domestic and foreign
settings, including obtaining any necessary single project assurances. 
Applicants should see Title 45 CFR, Part 46, for information concerning the
Department of Health and Human Services regulations for the protection of human
subjects and the PHS Policy on Humane Care and Use of Laboratory Animals.  These
are available from:

The Office for Protection from Research Risks
National Institutes of Health
6100 Executive Boulevard, MSC 7507
Rockville, MD  20892-7507. 
http://www.hhs.gov/ohrp/

Information on these assurances is included in the special application
instructions available from the FIC web site: http://www.nih.gov/fic under
Research and Training Opportunities.

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
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).

All investigators proposing research involving human subjects, should read the
"NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical
Research," which were published in the Federal Register of March 28, 1994 (59 FR
14508-14513) and printed in the NIH Guide for Grants and Contracts, Volume 23,
Number 11, March 18, 1994.  They are also available on the web at the following
URL address:
http://www.nih.gov/grants/guide/notice-files/not94-105.html

INCLUSION OF CHILDREN IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of NIH that children (i.e., individuals under the age of 21)
must be included in all human subjects research, conducted or supported by the
NIH, unless there are scientific and ethical reasons not to include them.  This
policy applies to all initial (Type 1) applications submitted for receipt dates
after October 1, 1998.

All investigators proposing research involving human subjects should read the
"NIH Policy and Guidelines on the Inclusion of Children as Participants in
Research Involving Human Subjects" that was published in the NIH Guide for Grants
and Contracts, March 6, 1998, and is available at the following URL address:
http://www.nih.gov/grants/guide/notice-files/not98-024.html

As part of the scientific and technical merit evaluation of the research plan,
reviewers will be instructed to address adequacy of plans for including children
as appropriate for the scientific goals of the research, or justification for
exclusion.  Program staff may provide additional relevant information concerning
the policy.

APPLICATION PROCEDURES

Special application instructions are necessary to fill out the application for
the program and are available as a link from the AIDS-FIRCA description on the
FIC web site:  http://www.nih.gov/fic/ under "Research and Training
Opportunities."

The application should be completed by the U.S. Principal Investigator on
standard form PHS 398.  Some additional information must be provided by the
foreign collaborator as described in the "Special Instructions" mentioned above. 
The application along with all required information must be submitted as a single
package, by the U.S. grantee institution.

Standard form PHS 398 (rev. 4/98) is available from most U.S. institutional
offices of sponsored research and from the NIH web site:
http://www.nih.gov/grants/forms.htm.  The application may also be obtained from the
Division of Extramural Outreach and Information Resources, National Institutes
of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, email:
GrantsInfo@nih.gov.

NOTE: the title and number of this program announcement must be typed on line 2
of the face page of the application form and the YES box must be marked.

Submit a signed, typewritten original of the application, including the Checklist
and all supplemental information as described in the "Special Instructions"
mentioned above, along with four signed photocopies 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)

IN ADDITION, one copy of the application (NOT the original) and all supplemental
information must be sent to the Fogarty International Center at:

AIDS-FIRCA PROGRAM
FOGARTY INTERNATIONAL CENTER
BUILDING 31, ROOM B2C39
31 CENTER DR.  MSC 2220
BETHESDA, MD  20892-2220

Postmark dates for completed applications are September 1, January 2, and May 1. 
If the deadline falls on a weekend or a holiday, it is automatically extended to
the following workday.

REVIEW CONSIDERATIONS

Applications will be assigned to the Fogarty International Center.  Applications
will be reviewed for scientific and technical merit by the AIDS and Related
Research Initial Review Group in the Center for Scientific Review (CSR), NIH. 
As part of the initial merit review, all applications will receive a written
critique and undergo a process in which applications under review will be
discussed and assigned a priority score.  Following scientific-technical review,
the applications will receive a second level review by the Fogarty International
Center Advisory Board.

The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health.  The
AIDS-FIRCA program specifically addresses AIDS-related research but also
addresses important factors associated with international collaborative research
and, in the case of developing countries, research capacity building at the
foreign research site.  In the written comments, reviewers will be asked to
discuss these aspects of the application in order to judge the likelihood that
the proposed research will have a substantial impact on the pursuit of these
goals.

Each of the criteria below will be addressed and considered in assigning the
overall score, weighting them as appropriate for each application.  Note that the
application does not need to be strong in all categories to be judged likely to
have major impact on the scientific field and/or capacity-building and may thus
deserve a high priority score.  In one example, an investigator may propose to
carry out important work that by its nature is not innovative but is essential
to move the field forward.  In another, an investigator may propose research on
an important topic in a developing country with underdeveloped research
infrastructure but with unique resources, environment or knowledge not readily
available in the U.S. or other developed nations. Such projects may be slower to
achieve their scientific goals but offer the potential for building research
capacity along with significant scientific impact in the long-term.  The criteria
are as follows:

o Significance and Innovation: scientific, technical, or medical significance and
originality of proposed research; 

o Approach:  1) appropriateness and adequacy of the experimental approach and
methodology proposed to carry out the research; 2) appropriateness of the
proposed collaborative effort as a format for accomplishing the stated aims;

o Investigators: 1) appropriateness of the relationship of the proposed research
to the research interests and expertise of the U.S. Principal Investigator and
the foreign collaborator; 2) ability of the foreign collaborator to undertake and
direct the foreign research efforts; 

o Environment: Does the scientific environment in which the work will be done
contribute to the probability of success? Do the proposed experiments take
advantage of unique features of the scientific environment and of the
collaborative arrangements? Is there evidence of institutional support? Are the
resources necessary to perform the research available or obtainable?

In addition, when a developing country is involved as the foreign site, the
following additional criterion should be considered:

o Research Capacity Building:  potential of the collaboration to enhance the
research capability of the foreign collaborator and the foreign site.  Does the
research constitute a substantial scientific endeavor for the foreign
collaborator, including creative and scientific input to the proposed research
program? The foreign site and investigator should not be used merely to gather
biological samples (clinical, plants etc), or behavioral data (interviews,
surveys etc.) unless a strong and compelling scientific rationale for such use
can be presented.  In all cases, the foreign investigator should be actively
involved in analyzing and interpreting the data.

After the priority score has been determined, in accordance with NIH policy, all
applications will also be reviewed with respect to the following criteria:

o The appropriateness of the proposed budget and duration in relation to the
proposed research;

o The adequacy of plans to include both genders, children and 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 adequacy of the proposed protection of humans, animals or the environment,
to the extent they may be adversely affected by the project proposed in the
application.

AWARD CRITERIA

Applications will compete for available funds with all other approved
applications assigned to the Fogarty International Center.  The following will
be considered in making funding decisions:

o quality of the proposed project as determined by peer review,
o availability of funds, and
o program priority, which may include regional balance of the foreign sites.

Note that although a number of NIH institutes (e.g. NCI, NIMH) have expressed a
particular interest in this program, no specific co-funding arrangements have
been developed. We encourage all ICs to advise their grantees, who may be
interested in international collaborative work, about the opportunities available
through the AIDS-FIRCA as well as our general FIRCA program.  If necessary, to
ensure that all high-priority proposals are funded, FIC will work with all
interested ICs with respect to possible co-funding arrangements.

INQUIRIES

Inquiries are encouraged.  The opportunity to clarify any issues or questions
from potential applicants is welcome.  Direct inquiries regarding programmatic
issues to:

FIRCA PROGRAM
Dr. Kathleen Michels 
Division of International Research and Training 
Fogarty International Center
Building 31, Room B2C39
Bethesda, MD  20892-2220
Telephone:  (301) 496-1653
FAX:  (301) 402-0779
Email:  FIRCA@nih.gov

For grants management and fiscal matters, contact:

Ms. Heidi Bishop
Program Specialist
Division of International Research and Training
Fogarty International Center
Building 31, Room B2C39
Bethesda, MD  20892-2220
Telephone:  (301) 496-1653
FAX:  (301) 402-0779
Email:  Heidi_Bishop@nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No.
93.934.  Awards are made under authorization of the Public Health Service Act,
Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241
and 285) and administered under PHS grants policies and Federal Regulations 42
CFR 52 and 45 CFR Part 74.  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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