HIV, AIDS AND RELATED ILLNESSES COLLABORATION AWARD

NIH GUIDE, Volume 23, Number 3, January 21, 1994



PAR NUMBER:  PAR-94-029



P.T. 34, 48



Keywords:

  AIDS 



Fogarty International Center



PURPOSE



The Fogarty International Center (FIC) is expanding its AIDS

International Research and Training Program to provide small

individual research grants for collaboration between U.S. and foreign

scientists in any country, consistent with U.S. foreign policy

considerations.  Support is available for research on human

immunodeficiency virus (HIV) infection, acquired immunodeficiency

syndrome (AIDS), and for research related to AIDS.  Up to $20,000 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.  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 Fogarty International Research Collaboration Award

(AIDS-FIRCA).



Grants will provide funds to the foreign collaborator, through the

U.S. grantee institution, for supplies at the foreign institution;

for expenses incurred at the U.S. institution to support the

collaboration; 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.



For the purpose of this program, developing countries are considered

to include those in the following regions:  Africa, Asia (except Hong

Kong, Japan, Singapore, South Korea and Taiwan), Central and Eastern

Europe, Latin America, the Middle East (except Israel and the Persian

Gulf states), and the Pacific Ocean Islands (except Australia and New

Zealand).



ELIGIBILITY



To be eligible for the AIDS-FIRCA program, the following conditions

must be met:



o  The proposed U.S. Principal Investigator must be the Principal

Investigator (Project Director) of an NIH-sponsored AIDS or

AIDS-related research grant project (R, P, or U01 series) that will

be active and funded during the proposed grant award period (up to

three years).  Under exceptional circumstances, after consultation

with program officials, some research contracts (N01 series) may be

eligible "parent" funding for the AIDS-FIRCA.  On submission of an

application, at least 19 months of active research support must

remain on the listed parent grant.  Investigators may request the

full three years of support in the FIRCA application in cases where

less than three future years remain on the parent grant, presuming

that the renewal application will be submitted and awarded.



o  The foreign collaborator must hold a position at an institution in

a foreign country that will allow him or her adequate time and

provide appropriate facilities to conduct the proposed research.



o  The application must demonstrate that the award will enhance the

scientific contributions of both the U.S. and foreign scientists and

will enhance or expand the contribution of the NIH-sponsored research

project (parent grant).



MECHANISM OF SUPPORT



The small grants (R03) will provide up to $20,000 per year in direct

costs for up to three years.  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 costs

related to the AIDS-FIRCA project at the U.S. institution.  Equipment

requests are limited to items for use in the AIDS-FIRCA project at

foreign institutions in developing countries.



Travel and subsistence-related expenses may be requested for the U.S.

Principal Investigator, the foreign collaborator, and/or their

colleagues for visits directly related to the subject of the

collaborative research.  All proposed expenditures must be well

justified and clearly related to the research objectives of the

proposed project.



Applicants should request support to conduct research not already

being supported by the U.S. investigator's parent grant; however, the

research application must be an extension of or related to the

research project currently funded by the NIH.  The awards will be

made to U.S. institutions, which will be responsible for the

expenditures.  The minimum FIRCA project period will be for one year,

the maximum will be for three years, and depends on the continuation

of appropriate NIH support of the Principal Investigator's

AIDS-related research.  If the related NIH research project (parent)

grant expires in less than three years' time it may, upon renewal,

reestablish eligibility for a continuation of the AIDS- FIRCA award

for the full award period.  Since the research supported under this

award is mainly to occur at the foreign site, 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 that will both expand and enhance

the HIV- and AIDS-related NIH-supported research program of the U.S.

Principal Investigator and benefit the scientific interests of the

collaborating foreign scientist.  All areas of research directly and

indirectly related to HIV infection and AIDS are eligible for

consideration.  Examples of topics include, but are not limited to:



o  Research related to the development of HIV/AIDS vaccines;

o  Research on antiviral and other interventions for HIV/AIDS;

o  Research on HIV and infection by the virus;

o  Research on other retroviruses related to HIV;

o  Studies of maternal/pediatric HIV infections;

o  Cofactors involved in HIV infection;

o  Studies on the spread of HIV infection and AIDS into new locales;

o  The natural history of HIV infection;

o  Research on opportunistic infections and other disorders that

result from immunosuppression by the AIDS virus;

o  Studies of emerging/reemerging microbes and diseases linked to

factors known or suspected to relate to the spread of HIV; and

o  Research on the social and behavioral factors that affect HIV risk

and transmission.



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.  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, Building 31, Room 5B59, Bethesda, MD 20892.

Information on these assurances is included in the special

application instructions available from FIC (address below).



STUDY POPULATIONS



SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH

POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL

RESEARCH STUDY POPULATIONS



NIH policy is that applicants for NIH 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 must 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 must be provided.  FIRCA applicants should employ these

principles in the design of studies and the selection of subjects or

materials relative to the local population, and include a statement

indicating the relationship of the design to the U.S. population.



The composition of the proposed study population must be described in

terms of gender and racial/ethnic group.  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 must be included in the form PHS 398

(rev. 9/91) in Sections 1-4 of the Research Plan AND summarized in

Section 5, Human Subjects.  Applicants are urged to assess carefully

the feasibility of including the broadest possible representation of

minority groups.  However, NIH recognizes 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 must be provided.



For the purpose of this policy, clinical research is defined as 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.



If the required information is not contained within the application,

the review will be deferred until the information is provided.



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) 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.



APPLICATION PROCEDURES



Applications must be submitted by the U.S. Principal Investigator on

standard form PHS 398 (rev. 9/91), which is available from most U.S.

institutional offices of sponsored research and from the Office of

Grants Information, Division of Research Grants, National Institutes

of Health, Bethesda, MD 20892, telephone (301) 435-0714.



Special application instructions are required and are available from

FIC program staff listed under INQUIRIES.  All budget item requests

must be fully justified.



The application consists of a portion to be completed by the U.S.

Principal Investigator and a separate portion to be completed by the

foreign collaborator.  Both portions of this application must be

submitted as a single package by the U.S. grantee institution.



Receipt dates for completed applications are October 1, February 1,

and June 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 for review to, and awards made by, the

Fogarty International Center, utilizing the customary NIH peer review

process.  Scientific and technical merit are evaluated by a Fogarty

International Center initial review group.  Second level review is

provided by the Fogarty International Center Advisory Board.



AWARD CRITERIA



Award decisions are made by the Director, FIC, and are based on the

scientific merit of the applications, program policy considerations,

and the availability of funds.  Awards are announced as soon as

possible following each Advisory Board meeting.



INQUIRIES



Written and telephone inquiries are encouraged.  The opportunity to

clarify any issues or questions from potential applicants is welcome.



Direct inquiries regarding programmatic issues to:



Dr. Mirilee Pearl

International Research and Awards Branch

Fogarty International Center

Building 31, Room B2C39

Bethesda, MD  20892

Telephone:  (301) 496-1653

FAX:  (301) 402-0779



Direct inquiries regarding grants management and fiscal matters to:



Ms. Silvia Mandes

Grants Management Office

Fogarty International Center

Building 31, Room B2C39

Bethesda, MD  20892

Telephone:  (301) 496-1653

FAX:  (301) 402-0779



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.



.


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