DRUG ABUSE HEALTH SERVICES RESEARCH NIH GUIDE, Volume 23, Number 10, March 11, 1994 PA NUMBER: PA-94-047 P.T. 34 Keywords: Drugs/Drug Abuse Health Services Delivery National Institute on Drug Abuse PURPOSE The purpose of this Program Announcement is to encourage applications for a new program emphasis on health services research in the field of drug abuse. 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 PA, Drug Abuse Health Services Research, is related to the priority area of alcohol and other drugs. Potential applicants may obtain a 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 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by for-profit and non-profit public and private organizations such as universities, colleges, hospitals, units of State or local governments, and eligible agencies of the Federal government. Women and minority investigators are encouraged to apply. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) awards. MECHANISM OF SUPPORT This program announcement will use the National Institutes of Health (NIH) individual research grant (R01), interactive research project grant (IRPG) (see NIH Guide, Vol 22, No. 16, April 23, 1993), small grant (R03), and FIRST award (R29). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Support will be provided for a period of up to five years (renewable for subsequent periods) subject to continued availability of funds and progress achieved. RESEARCH OBJECTIVES The ADAMHA Reorganization Act (Public Law 102-321) directed the National Institute on Drug Abuse (NIDA) to expand its program of health services research. Health services research is defined as research endeavors that study the organization, financing, and management of health services and their impact on the quality, cost, access to, and outcomes of care (Section 409). Subsequent legislative clarification included research to study the effectiveness of primary and secondary prevention activities. Research on the efficacy of services to prevent, diagnose, or treat medical conditions is excluded (Public Law 103-43), and investigators contemplating such studies should consult other relevant NIDA announcements. NIDA's health services research program includes interdisciplinary study of the structure, processes, and outcomes of the delivery of health services. Factors that influence the availability, accessibility, and utilization of health services and the efficiency and effectiveness of these services are studied within established service delivery settings and at a system-wide level. Research is sought on how services are organized, financed, delivered, and utilized as well as how effective these services are in addressing health issues and related concerns. This Program Announcement invites research grant applications in four major areas of health services research: (1) primary and secondary prevention activities; (2) HIV prevention services for drug abusers and their sexual partners, both in and out of health care settings; (3) health services for drug abusers in primary care settings, and linkages between primary care and drug abuse treatment programs/systems; and (4) drug abuse treatment services research at system, program, and client levels. Illustrative general or cross-cutting health services research areas include: o Assessment of need for services and factors influencing utilization of services; o Effectiveness and efficiency of alternative organizational and manpower configurations; o Client/patient, provider, and community/environmental characteristics that affect service delivery and outcome; o Financing and economic research on programs, practices, policies, and outcomes; o Assessment, matching and referral of patients to improve services and outcomes; o Impact of specific policies or cost/utilization control strategies on outreach, service delivery, retention, and effectiveness; and o Methodological development in research designs, analytic techniques, and measurement, including development of standards and criteria. Applications that focus on research within any of the four major areas or that cut across areas are encouraged. Topics not mentioned are not necessarily excluded from consideration under this Program Announcement. Applicants are advised to review existing information relevant to drug abuse health services research and to design studies using the most rigorous methodological and analytic designs feasible. Timely reporting of findings is emphasized. Applicants should be willing to participate in research coordination efforts to maximize the utility of the research, including review and dissemination activities. If investigators are studying populations that are at risk for HIV, they are encouraged to explicitly address AIDS-related issues in their applications. Investigators are encouraged to offer HIV testing and counseling in accordance with current guidelines to subjects identified during the course of the research as being at risk for HIV acquisition or transmission. In high-risk populations, investigators are encouraged to assess the effects of new interventions on the acquisition and transmission of infectious diseases, including HIV. Due to the growing AIDS problem in this country, special consideration will be given to applications that focus on AIDS-related issues such as services to reduce AIDS risk behaviors, services for high-risk subgroups such as prostitutes or injection drug users, or measures of program effect on AIDS risk behaviors (e.g., needle sharing, unprotected sex). Drug Abuse Prevention. The intent of health services prevention research is to assess the effectiveness and cost effectiveness of preventive interventions in reducing drug-related problems. Research is needed to improve the quality of prevention services, to expand access to prevention services to all populations, particularly minorities, and to lower costs of health care by reducing the extent of drug use and its adverse medical, psychological, and social consequences. In addition to intervention studies in health care settings, prevention services research may occur in a variety of other settings (e.g., worksites, schools, and local communities) and may focus on financing, organization, management, enforcement, and utilization of prevention services as well as their effectiveness. Illustrative drug abuse prevention services research areas include: o Qualitative and quantitative assessment of the impact of program service delivery at the community, State, regional, or national level; o Outreach research to assess strategies to expand prevention services to underserved populations and geographic areas, such as rural communities and inner cities; o Research on methods for diffusion of innovative clinical practices and management techniques to improve prevention services and lower costs; o Research on consumer choice, prevention program selection, and service retention resulting from innovative practices; and o Research to integrate drug abuse prevention with interventions directed at other related behavioral and societal problems such as violence, unwed pregnancy, school dropouts, and domestic abuse. HIV Prevention. Behavior change remains the only strategy available to prevent HIV infection. To date, research has focused on the implementation and testing of interventions designed to reduce drug-using and sexual behaviors that place the individual at high risk for HIV infection or transmission. Little research attention has been given to the need, demand, utilization, effectiveness, and cost effectiveness of HIV prevention and outreach in various settings and with specific subgroups. Further research is needed to develop and refine service delivery models for outreach to the population at risk of HIV infection. Results of community-based research indicate that over 40 percent of injecting drug users contacted, including many long-term users of illicit drugs, have never enrolled in drug abuse treatment. Given the threat of HIV/AIDS to drug abusers and their sexual partners, research is needed to develop and refine risk reduction intervention strategies and methods of referral to medical and drug treatment to intervene with these high-risk populations. Illustrative HIV prevention services research areas include: o Improving the effectiveness and cost effectiveness of HIV outreach and prevention services on reducing risk behaviors; o Delivery of HIV prevention and outreach services in nontraditional settings (e.g., in the community; in criminal justice settings), and barriers to delivery; o Delivery of HIV prevention interventions to non-treatment as well as treatment populations and for specific subgroups at risk, including criminal justice-involved, HIV+, adolescent, and those with chronic medical conditions (e.g., tuberculosis) or psychiatric problems; o Improving identification, liaison, and linkages with external resources, and managing information and access to service networks; o Development of valid and reliable measures of high-risk behaviors, of behavior change, of alternative HIV antibody testing and reporting strategies, and of measures to assess client need and match services to need. Primary Care for Drug Abusers. Individuals dependent upon illicit drugs often have limited access to primary medical care, resulting in overuse of expensive emergency treatment. The social costs of drug abuse are multiplied by poor rates of compliance with treatment for tuberculosis and other diseases. Health services research in primary care is needed to determine the effects of organizational and financing arrangements on access to primary care, on research to improve primary care/drug abuse treatment linkages, and to provide training opportunities for prevention, treatment, and primary care providers. Illustrative research areas in primary care for drug abusers include: o Health services research on programs combining drug abuse and primary care, including cross-training for primary care providers and drug abuse treatment providers; o Studies to improve how health care and other organizations receive, assimilate, and adopt or respond to knowledge (e.g., new treatment strategies; clinical records information) bearing on treatment of drug abusers; o Studies to enhance early identification of drug abuse and associated medical problems (e.g., HIV infection and its consequences, tuberculosis, hepatitis B, sexually transmitted diseases) in non-drug abuse treatment settings, such as STD clinics or educational settings; and o Research to enhance client/patient engagement in and compliance with medical treatment programs. Drug Abuse Treatment. Research is needed on treatment services and service delivery systems, on the influence of financing and health care coverage, and on the impact of these factors upon treatment outcomes. In the context of limited treatment resources, a need exists to determine the relative costs and benefits of providing augmented treatment services or improving drug abuse treatment service delivery systems. The intent of treatment services research is to assess the impact of health services and the effects of organizational and financing arrangements on the quality and outcomes of care provided to patients with drug abuse as well as medical and other problems related to drug abuse. Illustrative drug abuse treatment services research areas include: o Effects of financing, reimbursement, regulatory strategies, and insurance strategies, including the impact of differences in public and private financing and coverage, on access, quality, outcomes of care, and subsequent utilization of health care services; o Long-term aspects of drug abuse treatment utilization and recovery processes; o Client and program factors that influence treatment-seeking behavior, retention, compliance, effectiveness, and relapse, including program factors that influence change in AIDS risk behaviors, and factors related to engaging and retaining HIV+ drug users in treatment; and o Facility- or system-level studies to investigate the organization, management, financing, and quality of treatment and ancillary services in relation to client characteristics, treatment content, and outcome. 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 will be required to include minorities and both genders 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 should 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 for exclusion or inadequate representation should 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 objective of the study. This information should be included in the form PHS 398 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 the United States racial/ethnic minority populations (i.e., American Indian or Alaskan Natives, Asians or Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups should be provided. For the purpose of this policy, clinical research includes 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. 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 Applications are to be submitted on the grant application form PHS 398 (rev. 9/91) and will be accepted at the standard application deadlines as indicated in the application kit. The receipt dates for applications for AIDS-related research are found in the PHS 398 instructions. Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 240, Bethesda, MD 20892, telephone 301-710-0267. The title and number of the announcement must be typed in Item 2a on the face page of the application. FIRST award applications must include at least three sealed letters of reference attached to the face page of the original application. FIRST award applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. The completed original and five permanent, legible copies of the PHS 398 form must be delivered to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** REVIEW CONSIDERATIONS The Division of Research Grants, NIH, serves as a central point for receipt of applications for most discretionary DHHS grant programs. Applications received under this announcement will be assigned to an initial review group (IRG) in accordance with established PHS referral guidelines. The IRGs, consisting primarily of non-Federal scientific and technical experts, will review the applications for scientific and technical merit in accordance with the standard NIH peer review procedures. Notification of the review recommendations will be sent to the applicant after the initial review. Applications recommended for further consideration will receive a second-level review by an appropriate Advisory Council, whose review may be based on policy considerations as well as scientific merit. Only applications recommended for further consideration by the Council may be considered for funding. Small grant (R03) applications do not receive a second level review. AWARD CRITERIA Applications recommended for further consideration by a National Advisory Council will be considered for funding on the basis of overall scientific and technical merit of the application as determined by peer review, appropriateness of budget estimates, program needs and balance, policy considerations, adequacy of provisions for the protection of human subjects, and availability of funds. Special consideration will be given to applications that directly deal with AIDS-related issues. 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: Frank M. Tims, Ph.D. Treatment Services Research Branch National Institute on Drug Abuse 5600 Fishers Lane, Room 10A-30 Rockville, MD 20857 Telephone: (301) 443-4060 Direct inquiries regarding fiscal matters to: Grants Management Branch National Institute on Drug Abuse 5600 Fishers Lane, Room 8A-54 Rockville, MD 20857 Telephone: (301) 443-6710 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.279. Awards are made under authorization of the Public Health Service Act, Section 301, and administered under PHS policies and Federal Regulations at Title 42 CFR 52 "Grants for Research Projects," Title 45 CFR Part 74 & 92, "Administration of Grants" and 45 CFR Part 46, "Protection of Human Subjects." Title 42 CFR Part 2, "Confidentiality of Alcohol and Drug Abuse Patient Records" may also be applicable to these awards. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. .
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. |