INTERNATIONAL AIDS EPIDEMIOLOGY RESEARCH

NIH GUIDE, Volume 21, Number 10, March 13, 1992



PA NUMBER:  PA-92-52



P.T. 34



Keywords:

  AIDS 

  Epidemiology 

  Biomedical Research, Multidiscipl 



National Institute of Allergy and Infectious Diseases



Application Receipt Dates:  January 2, May 1, September 1



PURPOSE



The purpose of this program announcement is to stimulate international

collaborative research and research infrastructure development for the

investigation of a broad range of studies on the epidemiology of Human

Immunodeficiency Virus/Acquired Immunodeficiency Syndrome (HIV/AIDS) in

foreign countries.



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 program

announcement, International AIDS Epidemiology Research, is relevant 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 20402-0325 (telephone 202-783-3238).



ELIGIBILITY REQUIREMENTS



Research grant applications may be submitted by domestic and foreign,

for-profit and non-profit organizations, public and private, such as

universities, colleges, hospitals, laboratories, units of State and

local governments, and eligible agencies of the Federal Government.

Both foreign and domestic institutions are eligible to be the grantee

institution, although all grant applications must include the

participation of both eligible U.S. and foreign institutions.

Applications from minority individuals and women are encouraged.



MECHANISMS OF SUPPORT



The mechanism of support will be the individual research project grant

(R01).  Policies that govern research grant programs of the National

Institutes of Health will prevail.



RESEARCH OBJECTIVES



Applications are encouraged in areas relevant to the purpose of this

program announcement.  Research may include, but is not limited to:



o  study of the natural history of HIV infection;



o  identification of populations at high risk of HIV infection;



o  establishment of seroprevalence and seroincidence rates in selected

population groups;



o  identification of behavioral and biological co-factors associated

with HIV transmission and/or disease acquisition;



o  study of the clinical evolution of HIV and associated diseases;



o  assessment of immunological parameters of HIV infection acquisition

and disease development;



o  correlation of HIV genetic variants with disease presentation and/or

progression;



o  evaluation of biological and/or clinical markers of HIV infection

and associated disease development;



o  assessment of HIV intervention strategies; and



o  pilot studies of preventive and therapeutic strategies.



Applicants are encouraged to give high priority to research designs

that promote technology transfer, development of foreign research

infrastructure, and the development of self-direction and self-

sufficiency in the foreign country research team.



Applications for small-scale intervention studies (e.g., clinical

trials of behavioral interventions or sexually transmitted diseases

treatment programs) will fall within the purview of this program

announcement if these studies are logically linked to the epidemiology

studies, if they can be demonstrated appropriate for the given

developing country, and if they are complementary to, and not redundant

with, work that is already well supported.



STUDY POPULATIONS



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 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 that 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.



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 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 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.



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.



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.



APPLICATION PROCEDURES



Applicants are to use the research grant application form PHS 398 (rev.

9/91).  For purposes of identification and processing, check "yes" on

item 2 of the face page of the application and enter the title:

"PA-92-52, International AIDS Epidemiology Research."  Applications

will be accepted in accordance with the standard submission dates for

new investigator-initiated AIDS research grant applications:  January

2, May 1, and September 1.



Application kits are available at most institutional business offices

and may be obtained from the Office of Grants Inquiries, Division of

Research Grants, Westwood Building, Room 449, National Institutes of

Health, Bethesda, MD  20892, telephone (301) 496-7441.



The completed original application and five legible copies must be sent

or delivered to:



Division of Research Grants

National Institutes of Health

Westwood Building, Room 240

Bethesda, MD  20892**



REVIEW PROCEDURES



Applications will be assigned on the basis of established PHS referral

guidelines.  Applications will be reviewed for scientific and technical

merit by study sections (specifically assigned to review AIDS

applications) of the Division of Research Grants, NIH, in accordance

with the standard NIH peer review procedures.  Following

scientific-technical review, the applications will receive a

second-level review by an appropriate national advisory council or

board.



AWARD CRITERIA



Applications will compete for available funds with all other approved

applications.  The following will be considered in making funding

decisions: quality of the proposed project as determined by peer

review; availability of funds; and program balance among research areas

of the announcement.



INQUIRIES



Questions regarding programmatic aspects of this program announcement

may be directed to:



Robert D. Fischer, M.D., M.P.H.

Deputy Branch Chief for International Health

Epidemiology Branch, CRP, DAIDS

National Institute of Allergy and Infectious Diseases

6003 Executive Boulevard

Bethesda, MD  20892

Telephone:  (301) 496-6177

FAX:  (301) 402-0443



FOR EXPRESS MAIL CORRESPONDENCE WITH DR. FISCHER, USE THE SAME ADDRESS

ABOVE WITH THE EXCEPTION OF THE CITY AND ZIP. INSTEAD OF "BETHESDA, MD

20819", USE "ROCKVILLE, MD  20852."



Questions regarding fiscal matters may be directed to:



Ms. Jane Unsworth

Chief, DAIDS Section, Grants Management Branch

National Institute of Allergy and Infectious Diseases

6003 Executive Boulevard, Solar Building

Bethesda, MD  20892

Telephone:  (301) 496-6177

Fax:  (301) 402-1506



AUTHORITY AND REGULATIONS



This program is described in the Catalog of Federal Domestic Assistance

No. 93.856 Microbiology and Infectious Diseases Research, and No.

93.855 Allergy, Immunology, and Transplantation Research.  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.



Authority for the international aspects of this program are provided by

Public Law 86-610, the "International Health Act of 1960" and Public

Law 100-607, the "Health Omnibus Program Extension Act of 1988."



.

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