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NIH Guide for Grants and Contracts, October 6, 1998
Agency for Health Care Policy and Research
The Agency for Health Care Policy and Research (AHCPR) and the National Institute of Mental Health (NIMH) are encouraging applications for the support of research on the economic evaluation of either planned or completed studies of preventive interventions aimed at HIV/STDs, Mental Disorders or Dual Diagnoses. Included are studies to prevent the spread of HIV/STDs (human immunodeficiency virus/sexually transmitted diseases), help people cope with disease, or obtain health care or treatment of HIV/STD-related problems. The purpose of this Program Announcement (PA) is to encourage investigator-initiated research on cost-benefit, cost-effectiveness, and cost-utility analyses of both primary and secondary preventive interventions that are universal (targeted to the general public), selective (targeted to a subgroup whose risk is higher than average), or indicative (targeted to those who already have signs or symptoms [e.g., STDs]).
This PA is critical because in this era of diminishing AIDS and other prevention programs, and of health care programs for persons with AIDS, determining the cost-effectiveness of programs can be critical in establishing national priorities in health care research and in the adoption of successful prevention programs by local and state health agencies.
The urgency of the crisis demands that top priority be given to research with implications for developing cost-effective preventive interventions that access hard-to-reach populations which are at high risk for HIV infection. Even if an effective AIDS vaccine were to be identified in the next few years, prevention efforts would continue to be the primary way to stop further spread of HIV infection. The development of cost effective intervention programs, including those that combine psychosocial and pharmacologic interventions for HIV, is a priority for public health. Research is needed to develop methods and techniques to assess the cost and utility of prevention programs.
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 establishing priority areas. This PA, "Economic Evaluation in HIV and Mental Disorders Prevention" is related to the priority areas of mental health and mental disorders and HIV infection. Potential applicants may obtain a print copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents,Government Printing Office, Washington, DC 20402-9325 (telephone: 202-512-1800).
Applications may be submitted by foreign and domestic, for-profit and nonprofit organizations, both public and private, such as universities, colleges, hospitals,laboratories, units of State and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators.
AHCPR cannot, by law, make grants to for-profit organizations. However, for-profit organizations may participate as subcontractors or members of consortia. Organizations described in section 501(c)4 of the Internal Revenue Code that engage in lobbying are not eligible.
Mechanism of Support
This PA will use the individual research project (R01) mechanism. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant.
As many as one-third of American adults will suffer a diagnosable mental disorder or substance abuse disorder sometime in their lives, and 20 percent have a mental disorder at any given time. Although treatment of mental and substance abuse disorders remains vitally important, much greater effort than ever before needs to be directed to prevention. Prevention offers the hope that millions will avoid the emotional suffering caused by mental and substance abuse disorders. Furthermore, the costs to the Nation related to treatment for these disorders and lost productivity associated with them are staggering, ranging into billions of dollars annually.
Over 640,000 AIDS cases have been diagnosed and over 390,000 people have already died; over 40,000 new HIV infections are estimated to occur each year. An increasing percentage of the Nation's health and mental health care expenditures are being spent on the treatment of HIV infection and AIDS. The cost of treating HIV disease in 1993 has been estimated to have been $11.8 billion. NIMH has over a decade of prevention research findings which demonstrate that behavioral interventions can prevent the further transmission of the virus. More recent research on interventions for seropositive persons provides evidence of fewer hospital visits and enhanced quality of life after coping and stress reduction interventions.
Policymakers, community planning groups, and other key health and mental health decisionmakers need to balance the costs and effectiveness of interventions when planning their prevention programs aimed at HIV, mental disorders, or dual diagnoses. Well-designed economic evaluation studies can provide a data base on the cost-effectiveness of prevention programs to inform these health policy decisions.
Approximately 1.3 percent of the Nation's health care expenditures was spent on the treatment of HIV disease in 1993. Many persons with HIV infection, however, find that access to care is inadequate or unavailable to them because of lack of insurance or its cost. Current health care system changes provide a unique opportunity to demonstrate whether or not primary and secondary prevention efforts effectively contribute to major savings in health care costs. There is an urgent need to increase the data base concerning the cost-effectiveness of prevention programs aimed at HIV, mental disorders, or dual diagnoses.
Areas of Interest
The following section suggests areas of research to meet the economic evaluation of health promotion and disease prevention objectives of this PA. Researchers are encouraged to develop rigorous research designs to provide data on the cost-benefit, cost-effectiveness, and cost-utility analyses of existing or proposed AIDS preventive interventions. This list is not intended to be restrictive.
Cost-effectiveness. In order for effective HIV/AIDS and mental disorders preventive interventions to become the standard for care in public health agencies and community-based organizations, cost-effectiveness must be demonstrated. Studies are needed that evaluate:
Financing of health and mental health services. Financing is an integral part of the delivery of services. Studies are needed to assess:
Health insurance. Studies of the impact of health insurance benefits which provide important data on meeting the needs of persons at risk for, and with, HIV infection, mental disorders, and dual diagnoses are needed. Studies are needed that evaluate the:
Methodological research. Research is encouraged that will develop and test the application of new methods of cost-effectiveness analysis of HIV/AIDS prevention programs. Studies are needed that:
Inclusion of Women and Minorities in Research Involving Human Subjects
It is the policy of the National Institutes of Health (NIH) and AHCPR that women and members of minority groups and their subpopulations must be included in all 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 policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). AHCPR follows the revised NIH guidelines as applicable.
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 in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994.
NIH Policy and Guidelines on the Inclusion of Children as Participants 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" published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL: http://www.nih.gov/grants/guide/notice-files/not98-024.html
AHCPR also encourages investigators to consider including children in study populations, as appropriate. AHCPR announced in the NIH Guide, Volume 26, Number 15, May 9, 1997, that it is developing a policy and implementation plan on the inclusion of children in health services research (select to access policy).
Investigators also may obtain copies of the policies from the program staff listed under "Inquiries." Program staff may also provide additional relevant information concerning the policy.Application Procedures
Applications are to be submitted on the grant application form PHS 398 and will be accepted at the standard application deadlines as indicated in the application kit. The revised PHS 398 form is only available online. Applicants are encouraged to access the instructions and forms via the Internet because they provide valuable links to current policy documents and allow easy navigation of the instructions. PHS 398 application kits cannot be faxed to applicants.
State and local government applicants may use form PHS 5161-1, Application for Federal Assistance (rev. 5/96), and follow those requirements for copy submission. Applicants may obtain application materials by phoning NIH GrantsInfo at (301) 435-0714 or sending an E-mail to GrantsInfo@nih.gov.
An applicant planning to submit a grant application that requests $500,000 or more in direct costs for any 1 year is required to contact, in writing or by telephone, NIMH or AHCPR program staff when the application development process begins. Furthermore, the application must obtain agreement from the Institutes/Centers (IC) staff that the IC will accept the application for consideration for award. The applicant Principal Investigator must identify, in the cover letter sent with the application, the program staff member of NIMH or AHCPR who has agreed to accept assignment of the application. If NIMH or AHCPR is willing to accept assignment of the application for consideration of funding, the staff will notify the Center for Scientific Review before the application is submitted.
An application requesting $500,000 or more in any 1 year received without indication of prior staff concurrence and identification of that contact will be returned to the applicant without review. Refer to the NIH Guide for Grants and Contracts, March 29, 1998 for details or select to access at http://www.nih.gov/grants/guide/notice-files/not98-030.html
The title, "Economic Evaluation In HIV and Mental Disorders Prevention," and number of the program announcement must be typed in Section 2 on the face page of the PHS 398 application form.
The completed original application and five legible copies must be sent or delivered to:
Center for Scientific Review
*Change zip code to 20817 for express mail or courier service.
Note: Until further notice, applications delivered by individuals to the NIH Center for Scientific Review will no longer be accepted. They must come either via courier delivery or via the U.S. Postal Service. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html.
Applications will be assigned on the basis of established PHS referral guidelines. Applications will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with the standard NIH or AHCPR peer review procedures.
As part of the initial merit review, all applications will receive a written critique and may undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and may receive a second-level review by an appropriate national advisory council or board.
The goals of NIH-supported research are to advance the understanding of biologic systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following 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 these criteria 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 scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. These criteria are:
In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following:
The initial review group will also examine the provisions for the protection of human subjects and the safety of the research environment.
Applications will compete for available funds with all other approved applications; The following will be considered in making funding decisions:
Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues, to:
Willo Pequegnat, Ph.D.
Doreen S. Koretz, Ph.D.
Direct inquiries regarding fiscal matters to:
Diana S. Trunnell
Mable L. Lam
Although not a formal sponsor of this program announcement, the National Institute of Child Health and Human Development (NICHD) welcomes applications for the economic evaluation of programs that integrate prevention of AIDS and other sexually transmitted diseases with prevention of unintended pregnancy. NICHD also provides support for research applying economic concepts and frameworks to the study of AIDS-related sexual and protective behaviors. For further information potential applicants may contact:
Several other Institutes have an interest in research in this area, including the National Institute of Nursing Research, the National Institute on Alcohol Abuse and Alcoholism, the National Institute on Aging, and the National Institute on Drug Abuse. Applications submitted in response to this Program Announcement will be referred to initial review groups in accordance with PHS referral guidelines.
Authority and Regulations
This program is described in the Catalog of Federal Domestic Assistance, Nos. 93.242 (NIMH) and 93.226 (AHCPR). 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 Title IX (42 U.S.C. 299-299c-6) and administered under PHS grants policies and Federal Regulations 42 CFR 52, 42 CFR 67, Subpart A and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement (April 1, 1994).
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.
AHCPR Publication No. 99-R001
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