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." .
Return to NIH Guide Main Index
Office of Extramural Research (OER) |
National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892 |
Department of Health and Human Services (HHS) |
||||||||
Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files. |