Full Text DA-94-001 DRUG DEPENDENCE RESEARCH CENTER GRANT PROGRAM NIH GUIDE, Volume 22, Number 36, October 8, 1993 RFA: DA-94-001 P.T. 34 Keywords: Drugs/Drug Abuse Treatment, Medical+ Biomedical Research, Multidiscipl National Institute on Drug Abuse Letter of Intent Receipt Date: December 17, 1993 Application Receipt Date: January 18, 1993 PURPOSE Grant support from the National Institute on Drug Abuse (NIDA) is available to establish Drug Dependence Research Centers (DDRCs). DDRCs are defined in two categories: (1) Treatment Research Centers (TRCs) or (2) Medications Development Research Centers (MDRCs). DDRCs that primarily conduct interdisciplinary research on the efficacy of treatment of drug dependence will be considered to be Treatment Research Centers (TRCs). DDRCs that primarily conduct interdisciplinary research on medications development for drug dependence will be considered to be Medications Development Research Centers (MDRCs). Applicants are expected to develop proposals that are primarily TRC or MDRC in their integrative research theme, but may choose to include components consistent with either category (e.g., a TRC application may include project(s) that are medications development or vice-versa). The Drug Dependence Research Center Grant Program is designed to complement the regular research grant program of NIDA by providing long-term support for interdisciplinary drug dependence treatment research. The program is intended to attract clinical investigators in the behavioral and medical sciences to conduct research designed to (1) maximize the efficacy of behavioral and pharmacologic drug dependence treatment or (2) pursue the identification and development of pharmacologic interventions for drug dependence treatment. One purpose of this program is to provide a stable environment for investigators to engage in drug dependence treatment research. Each DDRC supported is expected to become a significant regional or national research resource. 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 Request for Applications (RFA), Drug Dependence Research Center Grants, 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 domestic, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State or local governments, and eligible agencies of the Federal government. However, the proposed TRC or MDRC must be affiliated with an institution, such as a university, medical center, or research center, that has the resources to sustain a long-term, coordinated research program around a central theme relating to maximizing and establishing the efficacy of drug dependence treatment including medications development. An applicant institution must demonstrate the ability to attract high quality scientists from biomedical, behavioral, and/or social science disciplines who are willing to make a long-term commitment to drug dependence treatment research. The proposed TRC or MDRC should have the clear capability to conduct clinical research in existing treatment or medications development programs. Applicants should demonstrate explicitly how this research will be integrated within the treatment program. Applications from minority individuals and women are encouraged. Foreign organizations are ineligible. MECHANISM OF SUPPORT The National Institutes of Health (NIH) center grant (P50) will be the mechanism of support used under this RFA. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. This RFA is a one-time solicitation. Any applications received after the receipt date will be returned to the applicant without further review. FUNDS AVAILABLE It is anticipated that up to $14 million will be available to support the first year of this grant program. Because the nature and scope of the research proposed in response to this RFA may vary, the size of an award will also vary. However, it is anticipated that approximately 8 to 10 new awards will be made under the RFA. Many promising treatment interventions cannot be readily studied due to lack of availability of services necessary to provide comprehensive treatment to research subjects. In such cases research is only possible if financial support is provided to support treatment- related as well as research costs. Under this announcement, support may be provided to DDRCs for comprehensive treatment services essential for carrying out the proposed research. If required in support of research activities, funds may be expended on drug abuse treatment costs, rental and operation of facilities, approved renovation and modification of facilities (subject to limits and conditions specified in Public Health Service grant policy), and other costs normally allowable under existing Public Health Service grants policy. Funds may not be used for new construction or to replace existing treatment funding. In general, funds will not be provided for the purchase and installation of expensive, new equipment. For MDRCs, funds may be requested for subject accrual and recruitment. Once approved, however, reimbursement for patient accrual is for this purpose only and may not be rebudgeted to other categories. RESEARCH OBJECTIVES This research program is intended to support the establishment of DDRCs (TRCs or MDRCs) to conduct interdisciplinary research on the efficacy of treatment for drug addiction. Effort is to be made to use state-of-the-science approaches. Drug dependence treatment efficacy research within a DDRC should involve the systematic development and integration of knowledge derived from a variety of sources and should utilize a number of designs. The proposed research must be organized around a central theme. The theme of the DDRC (TRC or MDRC) should clearly relate to investigating the efficacy of drug dependence treatments. DDRCs funded under this announcement may conduct research on: TRC 1. psychobehavioral treatments and/or 2. currently marketed pharmacological treatments MDRC 3. medications development Applicants for DDRCs may include components in their applications for both treatment and medications development research, but it is expected that each will have a primary emphasis: TRC or MDRC. Treatment Research Centers (TRCs): TRCs may investigate: 1. the efficacy of psychotherapies, behavior therapies, and counseling strategies for all phases of drug dependence treatment. TRCs may also perform work on the development, refinement, and pilot testing of such behavioral therapies; 2. optimizing the efficacy of currently marketed pharmacotherapies for drug dependence; 3. the effects of ancillary services on therapy; 4. the efficacy of well-defined comprehensive treatment approaches; 5. psychobehavioral and neurobiological factors predictive of treatment efficacy, including research aimed at identifying patient characteristics that interact with the therapy or treatment provided; 6. methodological issues related to the proposed clinical research. TRC Research Themes Possible TRC themes may include, but are not limited to, any of the following research areas: 1. Development and efficacy testing of psychobehavioral interventions, complementary adjunctive services, or well-defined comprehensive treatments for special populations of drug addicts, such as: a. Racial and ethnic minorities b. Adolescent drug abusers c. Addicted women, pregnant women and/or mothers d. Individuals at high risk for AIDS or HIV positive individuals e. Dually diagnosed individuals 2. Development and efficacy testing of psychobehavioral interventions, complementary ancillary services, and explicitly described comprehensive treatment approaches designed to: a. Treat specific drug dependence problems/patterns, such as IV drug abuse or poly-drug abuse b. Enhance recruitment into treatment and motivation to achieve sobriety, increase retention, and improve adherence with treatment regimens c. Improve the ability of the drug addict to maintain gains made during the acute treatment period (continuing care) d. Be integrated with and optimize the efficacy of currently approved pharmacotherapies for drug dependence 3. Investigations of marketed drug dependence pharmacotherapies for particular populations of drug addicts, such as the dually diagnosed. 4. Relationship of psychobehavioral and/or neurobiological factors to therapy/treatment efficacy Medications Development Research Centers (MDRCs) MDRCs may emphasize the study and development of new pharmacotherapeutic medications to: 1. block the effects of abused drugs; 2. reduce the craving for abused drugs; 3. moderate or eliminate withdrawal symptoms; 4. block or reverse the toxic effects of abused drugs; 5. prevent relapse in persons who have been detoxified from drugs of abuse; 6. be used in special populations such as racial or ethnic minorities, adolescent drug abusers, addicted women, or pregnant women. Identified pharmacologic agents for the treatment of drug dependence, primarily for the treatment of cocaine and opiate addiction, may be assessed in clinical pharmacologic paradigms and/or in clinical trials. Such studies can include clinical pharmacologic assessments including human laboratory assessments and/or clinical trials at one or more sites designed to comply with Good Clinical Practice (GCP) standards of the Food and Drug Administration (FDA). Documentation of GCP is available from the program officer of the MDRC. Development and integration of new methods and technology for the study of new pharmacotherapeutic agents for drug dependence treatment are encouraged. The range of studies envisioned can include: 1. clinical concept confirmation studies; 2. studies designed to address pharmacokinetic parameters; 3. studies designed to assess conclusively (by appropriate methodology and rigorous statistical analysis) questions of efficacy of new potential pharmacotherapeutic agents for drug dependence treatment; 4. studies that develop and evaluate rapid and efficient clinical methods to predict efficacy of new pharmacologic agents to treat drug dependence; 5. studies to develop methods that advance or improve the development of new medications for drug dependence treatment. MDRC Research Themes MDRC applications can incorporate theme(s) from a range of clinical pharmacologic and clinical trials topics. Applicants are encouraged to include studies that seek to: 1. determine in both drug abusers and normal volunteers the pharmacokinetic profile of a new or novel investigational agent with available preclinical testing data for use in drug dependence treatment including safety and toxicity profiles; 2. evaluate in cocaine and opiate dependent patients the efficacy and safety of new or novel investigational compounds with available preclinical testing results; 3. evaluate the combined efficacy of potential investigational pharmacotherapeutic agents and other treatment parameters such as behavioral interventions or cross subject comparisons. 4. evaluate or develop laboratory parameters that may correlate with or predict pharmacotherapeutic response; 5. evaluate the potential abuse liability and effects on performance of investigational compounds in cocaine and opiate dependent patients; 6. evaluate pharmacotherapy in selected populations of cocaine and opiate dependent patients including neonates, adolescents, females and HIV seropositives. The major emphasis will be on clinical pharmacologic evaluations and clinical trials, including clinical concept confirmation studies, to evaluate the dose-response, efficacy and safety profiles for further medication development. These clinical trials can include studies initiated by the MDRC as well as relevant multisite trials sponsored by NIDA or pharmaceutical sponsors or both. Applicants should indicate their willingness to participate in such trials in letters appended to their applications. SPECIAL REQUIREMENTS The applicant should provide a detailed plan (for up to five years) describing the DDRC's proposed research program, focused on the central theme. This plan should include specific information on the proposed research projects, identification of scientists who are to be affiliated with the DDRC, and their roles in the program of research. Existing research programs and projects that are essential to the plan should be identified and arrangements for integrating these into the DDRC's activities delineated. Letters of cooperation should be obtained from Principal Investigators whose data will be used in DDRC activity, except for those programs whose data bases are in the public domain and routinely made available for public use. Letters of cooperation will also be needed for multi-site investigations where identified programs are to be used for control or manipulation of variables. The nature and mix of investigators will be dependent on the particular theme selected. However, potential is seen for interrelated studies involving scientists in the areas of clinical, counseling and experimental psychology, medical specialties (including psychiatry), clinical pharmacology, clinical toxicology, social work, and statistics as are relevant to the theme of the application. Relationship of individual projects/studies to the core program should be clearly delineated. There must be at least three scored projects and a core which collectively meet the criteria for a Center. There is no maximum limit to the number or projects or cores, however, it must be demonstrated that they are administratively manageable. Upon initiation of the program, the Clinical and Experimental Therapeutics Branch, Division of Clinical Research, and the Clinical Trials Branch, Medications Development Division, NIDA, will sponsor periodic meetings for TRCs and MDRCs to encourage exchange of information among investigators who participate in this program, and to stimulate collaboration. Applicants should request additional travel funds for one or two one-day meetings each year, to be held in the Bethesda/Rockville Maryland area. Applicants should also include a statement in their applications indicating their willingness to participate in these meetings. Facilities and Environment Each applicant must demonstrate that it has available adequate laboratory, clinical, and office facilities suitable for carrying out the objectives of the proposed DDRC program. Components of the treatment and/or medications development research facility should be identified and arrangements for integrating clinical research into the DDRC's facilities explicitly described. Although not required, it is desirable that sufficient contiguous space be committed to give the DDRC a high degree of cohesion and visibility. In addition, adequate reference facilities that will afford access to the relevant drug abuse literature must be readily available. It is expected that such reference facilities will be the primary repository of additional reference materials that may be obtained through the DDRC. Relevant support services and adequate data processing facilities must also be readily accessible within or through the institution. Reasonable assurances of such support must be included with the application. Organization and Administration An applicant must designate an individual to serve both as Principal Investigator (PI) for the DDRC grant and Director of the DDRC. This person must have eminent scientific credentials and be capable of providing the leadership essential to the success of the research program. The PI and Director of the DDRC will have overall scientific responsibility, responsibility for planning and coordination of the DDRC program, preparation of the budget and oversight of expenditures, staff appointments, space allocation, and other aspects of administration and operation of the DDRC. This individual will be responsible and accountable to the recipient institution for the proper conduct of the DDRC program. The recipient institution is, in turn, responsible to the Public Health Service for the performance and financial aspects of the grant supported activity. The PI will be responsible for assuring interaction and collaboration among scientists conducting research within the DDRC, in order to promote a concerted approach to the research theme of the DDRC. The PI will be invited to participate in NIDA's periodic research coordination meetings. The PI also will be responsible for the direct monitoring of ongoing research and for identifying (with the assistance of his or her colleagues) research activities to be expanded or decreased and needs for additional resources or reallocation of resources. The applicant may also designate a DDRC Coordinator, who will be responsible to the DDRC Director and provide assistance to the Director in budget preparation, oversight of financial aspects, and administrative duties essential to the smooth operation of the DDRC. In order to ensure an institutional commitment for space, staffing, and other resources essential to the DDRC, including active collaboration with clinical leaders, a letter of commitment from the applicant institution is required as part of the application. A DDRC must be an identifiable organizational unit, and it must have an administrative structure and lines of authority which will facilitate coordination among DDRC personnel and assure maximum accountability and efficiency in DDRC operations. It is expected that the nature of investigators' affiliations with the DDRC will reflect the applicant institution's policies on appointments. Research Training While the primary function of each DDRC is the conduct of high quality interdisciplinary research, an important, but non-mandatory, component related to the DDRC and its research efforts is the training of research personnel. It is anticipated that efforts made to produce well-trained drug dependence therapy researchers will enhance the overall DDRC program. The applicant institution must give evidence of the capacity to train predoctoral and postdoctoral students for careers in research on drug dependence. The DDRC need not have formal training programs of its own, but must make specific provision for coordination between the DDRC and training programs of the applicant institution and/or affiliated institution. While DDRC grant funds may not be used to pay stipends or other trainee costs, DDRC staff may participate in the development of training programs and DDRC resources may be made available for the use of trainees. Applicants are encouraged to seek training support from other funding sources within and outside NIDA. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS Applications for clinical research grants and cooperative agreements that involve human subjects are 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 applies to all research involving human subjects and human materials, and applies to males and females of all ages. If one gender and/or minorities are excluded or are inadequately represented in this 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, together with a rationale for its choice. 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. 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 minorities populations (i.e., Native Americans [including American Indians or Alaskan Natives], Asian/Pacific Islanders, Blacks, Hispanics). Investigators must provide the rationale for studies on single minority population groups. Applications for support of research involving human subjects must employ a study design with minority and/or gender representation (by age distribution, risk factors, incidence/prevalence, etc.) appropriate to the scientific objectives of the research. It is not an automatic requirement for the study design to provide statistical power to answer the questions posed for men and women and racial/ethnic groups separately; however, whenever there are scientific reasons to anticipate differences between men and women, and racial/ethnic groups, with regard to the hypothesis under investigation, applicants should include an evaluation of these gender and minority group differences in the proposed study. If adequate inclusion of one gender and/or minorities is impossible or inappropriate with respect to the purpose of the research, because of the health of the subjects, or other reasons, or if in the only study population available, there is a disproportionate representation of one gender or minority/majority group, the rationale for the study population must be well-explained and justified. The NIH funding components will not make awards of grants, cooperative agreements or contracts that do not comply with this policy. For research awards which are covered by this policy, awardees will report annually on enrollment of women and men, and on the race and ethnicity of subjects in the non-competing competitive application. LETTER OF INTENT Prospective applicants are asked to submit, by December 17, 1993, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains allows NIDA staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to: Director, Office of Extramural Program Review National Institute on Drug Abuse 5600 Fishers Lane, Room 10-42 Rockville, MD 20857 Telephone: (301) 443-2755 APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91). These forms 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 RFA label in the PHS 398 application kit must be affixed to the bottom of the original face page. Failure to use the RFA label and to follow instructions could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition the RFA title and number must be typed in Item 2a of the face page and YES box marked. Submit a signed, typewritten original of the application, including Checklist, and three signed photocopies in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies of the application must also be sent to: Director, Office of Extramural Program Review National Institute on Drug Abuse 5600 Fishers Lane, Room 10-42 Rockville, MD 20857 Schedule Letter of Intent Receipt Date: December 17, 1993 Application Receipt Date: January 18, 1994 Initial Review: April 1994 Advisory Council: June 1994 Earliest Award Date: July 1, 1994 Applications received after the receipt date will be returned to the applicant without review. 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 RFA will be assigned to a special review group convened by the NIDA. The review group, consisting of experts in psychobehavioral and pharmacological drug abuse treatment research, and medications development clinical trials, as warranted by the applications, will review the applications for scientific and technical merit in accordance with the standard NIH peer review procedures. Pre-review site visits will not be made, and applications may not be deferred for site visit; therefore, applications must be complete when submitted. Notification of the review recommendations will be sent to the applicant after the initial review. Applications 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 initial review group and Council may be considered for funding. The review criteria are: 1. Program as an Integrated Effort o The significance of the overall program goals and the development of a well-defined central research focus of importance and relevance to the goals and mission of NIDA. o The multidisciplinary or multifaceted character of the program, i.e., its coordination, cohesiveness, interrelationship of the components and relationship to the central theme, and synergistic potential among the individual projects and core. o The justification for, and usefulness of the core facilities to the research projects. Each core unit must provide essential facilities or services for three or more approved individual projects. o The scientific stature of the investigators and the extent to which each contributes to the overall program goals as well as their commitment to the program. o Capacity to provide a variety of quality training opportunities. o Potential of the proposed DDRC to become or continue as a regional and national resource as appropriate to research objectives of this RFA. o Administrative arrangements and organizational structure, through the administrative core, to facilitate and monitor the attainment of objectives and internal quality control. For example, these factors will include plans to enhance communication and cooperation among the investigators involved in the program and mechanisms for the allocation of funds for day-to-day management, long-term planning and periodic evaluation, contractual agreements, and procedures for the replacement of key personnel, e.g., the Principal Investigators, if required on an interim or permanent basis. o Reasonableness of the overall budget for the proposed work. o In addition, applications from currently funded grantees who are applying for competing continuation support under this RFA will be evaluated in terms of the degree to which they have achieved the originally stated goals, with special attention to the following: the scientific merit of completed research, implementation of innovative research areas, recruitment of new scientists into drug abuse research and the training of young scientists, development of a multidisciplinary research team, coalescence of the Center staff into an effective team, and increase of professional and public awareness of drug abuse problems. 2. Individual Projects and Core Units o The scientific and technical merit of each research project, merit and justification of each core unit. o The qualifications, experience, and commitment of the investigators responsible for the research projects or core units, including their ability to devote adequate time and effort to the project. o The appropriateness of the budget for each of the proposed projects and core units. 3. Resources and Environment o The academic climate and physical environment in which the research will be conducted, including the availability of space, equipment, research subjects, etc., and the potential for interaction with scientists from other departments and/or institutions. o Adequacy of the clinical and research facilities to perform the proposed research including access to subjects, instrumentation, and data management systems when needed. o The institutional strength, stability, and commitment to research and support for the proposed Center and its ability to attract highly qualified scientists. AWARD CRITERIA Applications recommended for further consideration by an National Drug Abuse 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. Funding for the MDRC applications will also be considered on the basis of: (1) demonstrated ability to comply with FDA guidelines for Good Clinical Practice (GCP) and (2) demonstrated capacity to recruit evaluable patients and submit acceptable data in appropriate time frames to permit optimal analysis of clinical trial results. The anticipated date of award is July 1, 1994. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applications is welcome. Direct inquiries regarding programmatic issues to: Dr. Jack Blaine Division of Clinical Research National Institute on Drug Abuse 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-4060 Direct inquiries regarding fiscal matters to: Gary Fleming, J.D., M.A. 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, Sections 301 and 464P, and administered under PHS grants 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) |
||||||||