PA-03-011: SERVICES RESEARCH IN THE NATIONAL DRUG ABUSE CLINICAL TRIALS NETWORK

Department of Health
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SERVICES RESEARCH IN THE NATIONAL DRUG ABUSE CLINICAL TRIALS NETWORK RELEASE DATE: October 17, 2002 July 26, 2006 - This PA has been replaced by PA-06-495 (R01), PA-06-496 (R21) and PA-06-497 (R03) PA NUMBER: PA-03-011 EXPIRATION DATE: October 31, 2005, unless reissued. National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov) THIS PROGRAM ANNOUNCEMENT (PA) CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanisms of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Submitting an Application o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PA The National Institute on Drug Abuse (NIDA) invites applications to conduct health services research on the practice and delivery of drug treatment in the National Drug Abuse Treatment Clinical Trials Network (CTN). By encouraging the use of the existing CTN network of treatment providers and research centers as a platform for new research, this PA enhances research efforts to improve the delivery of drug abuse treatment, and translate science-based treatments into practice in community treatment settings. RESEARCH OBJECTIVES This PA is meant to support health services research in connection with the CTN, a research partnership of community treatment providers (CTPs) and drug abuse researchers in multiple sites across the country. With its extensive network of providers serving diverse populations of drug users, the CTN provides a ready platform for investigating the accessibility, delivery, quality, and portability of drug treatment services as well as research on the organization and financing of treatment programs and the adaptation of innovative strategies for the treatment of drug abuse and addiction. The researcher-practitioner partnership that characterizes the CTN is designed to accelerate the pace of research and determine the effectiveness of drug abuse treatment approaches in real-life treatment settings. In addition, services research conducted through the CTN is meant to enhance the translation of science-based treatments into practice in community-based treatment settings. Background NIDA inaugurated the CTN in 1999 as a cooperative agreement research program consisting of drug abuse researchers, community treatment providers, and NIDA staff. Since its beginning, the primary mission of the CTN was to conduct studies of behavioral, pharmacological, and integrated behavioral- pharmacological treatment interventions in rigorous, multi-site clinical trials. Primary objectives were to: (1) determine the effectiveness of therapies across a broad range of community-based treatment settings and diverse patient populations, and (2) find ways to integrate proven medications and behavioral interventions into mainstream clinical practice. Under this PA, CTN and non-CTN investigators will be in a position to conduct health services research in collaboration with existing regional research and training centers (RRTCs) and CTPs. Although not all RRTCs have the capacity to initiate health services research themselves, all Nodes are expected to collaborate in such research and to aid in the recruitment of appropriate subjects. The CTN currently consists of 14 investigator-led research Nodes representing California, the Delaware Valley, Florida, the Great Lakes region, New York City, Long Island, the Mid-Atlantic area, New England, North Carolina, the Ohio Valley, Oregon, the Rocky Mountain region, South Carolina, and Washington State. Each Node consists of an RRTC and five or more participating CTPs. Plans call for the addition of new Nodes in 2002 as well as increased numbers of treatment providers allied with each Node. (Further description of the CTN and currently participating RRTCs and CTPs can be found at http://www.nida.nih.gov/CTN/Index.htm.) New Studies This PA encourages investigators to focus on research that will enhance the adoption of effective treatment strategies, especially: (1) systems research to identify organizational features, policies, and financing systems that affect treatment delivery and the adoption of treatments found to be effective in the CTN; and (2) practice research to identify and improve program parameters that influence quality and accessibility of care, clinical epidemiology, and innovation. In as much as recent research has shown that drug abuse and addiction present different challenges to women's health and may require different services approaches and strategies, researchers are encouraged to take a gender-based approach to generating hypotheses that will ultimately enhance the delivery of effective drug abuse treatments for women. Possible research topics include but are not limited to the following examples: o Application of the chronic disease model to drug abuse treatment. Research is needed to test drug abuse treatment and recovery models that account for drug use as a chronic, relapsing disease, e.g., treatments that target the underlying biological disorder as well as the behavioral and social aspects of drug seeking and addiction, and that take into account the patient's sex and ethnic background. o Cost of various treatment services/interventions delivered in the CTN. Cost analyses of several kinds are encouraged, including studies of the cost effectiveness of CTN-tested drug abuse treatment and ancillary services; cost offsets of treatment (medical or social costs); and cost/benefits of care. Studies are also needed to improve and standardize measurements of costs, cost effectiveness, cost offsets, and cost benefits. o Financing of drug treatment. Studies are needed to examine the impact of health plan parity benefits, managed care practices, and other cost control measures on the coverage of, access to, and utilization of treatment for drug abuse and addiction. Comparisons between more and less integrated treatment services and between more or less tightly managed systems of care are welcome. Research is also needed to develop outcome measures related to the quality and management of resources. o Linkage of drug treatment with other medical services. Research is needed to understand how drug treatment can be effectively linked to medical service where drug users, including those who are HIV-positive, are likely to seek access to care, e.g., such settings as primary care, emergency care, obstetric and gynocologic care, and mental health care. Research is needed to develop effective methods for screening, identifying, and referring medical patients to drug treatment services. o Adaptation and change within CTPs. Little is known about the processes by which innovations in treatment and service delivery are identified, evaluated, initiated, and adopted by CTPs. Understanding the process of adaptation and change includes research in the areas of organizational culture, learning, and innovativeness; capacity and readiness for change; change management and follow-through; and performance management approaches. o Adoption of research findings in applied practices. Research is welcome on the adoption of behavioral and pharmacological therapies found to be effective in CTN studies, including studies of organizational motivation, leadership, and social influence; management strategies to transfer new methods and technologies; and mechanisms to facilitate adoption of CTN-tested treatment approaches, such as manualized behavioral treatments, professional society workshops, and technology transfer centers. o Adoption of injection-related HIV risk reduction interventions by drug treatment providers. Investigators are invited to examine factors related to the organizational culture, policies, and treatment philosophies which encourage or discourage providers to offer clients instruction in the avoidance of risky injection practices, such as showing how to clean injection equipment or providing referrals to syringe exchange programs. o Status of the counseling workforce. Investigators are welcome to study trends in the training, accreditation, remuneration, and stability of employment of drug treatment counselors, especially as these trends are affected by economic or other social factors (such as cost containment measures, employment rates, infectious disease transmission, and so on). o Quality of care studies. Studies are needed to identify specific components or characteristics of care that affect treatment outcomes. Examples include clinical practice guidelines; patient subpopulation (e.g., women, ethnic minorities, adolescents) outcomes linked with quality of care; and the impact of system changes on quality of care. Additionally, studies are needed to develop and evaluate measures of quality of care and patient placement criteria. o Clinical epidemiology. Studies are welcome to identify processes and interactions of population groups with treatment providers, e.g., variations in prevalence of substance use; clinical practices with respect to subpopulations (such as women, ethnic minorities, adolescents, individuals with comorbid mental health problems, and individuals who are HIV-positive), barriers to treatment faced by specific population groups, and programmatic features designed to reduce such barriers. The topics bulleted above are meant only as illustrations of the types of health services research that an applicant can propose. All applications are welcome that are appropriate to the research objectives of this PA. MECHANISMS OF SUPPORT This PA will use the NIH project grant (R01), NIDA small grant (R03), and the NIDA exploratory/developmental grant (R21) award mechanisms. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. The total project years for an application submitted in response to this PA may not exceed five years for the R01; two years for the NIDA R03 (see http://grants.nih.gov/grants/guide/pa-files/PA-02-170.html), and three years for the NIDA R21 (see http://grants.nih.gov/grants/guide/pa-files/PA-02-171.html). This PA uses just-in-time concepts. It also uses the modular budgeting format. (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular format. ELIGIBLE INSTITUTIONS You may submit (an) application(s) if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic or foreign o Faith-based or community-based organizations INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. PARTICIPATION OF CTN INVESTIGATORS Most research projects proposed under this PA will require participation, collaboration, cooperation, or other support by CTN investigators or community treatment provider staff or patients. Although the CTN is creating a research infrastructure that will support studies such as those encouraged here, some studies involving the CTN may not be feasible given the mission, goals, and timetables of the CTN cooperative studies. Thus, it is incumbent on the principal investigator of proposed research to get general preapproval of a 1-2 page research concept from the CTN Concept Review and Development Subcommittee, to submit evidence of support from affected CTN participant organizations, and to obtain written approval to access any required data that is controlled by the RRTCs or the CTN Steering Committee. Information about the CTN, including contact information, is available at http://www.nida.nih.gov/CTN/index.htm. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into two areas: scientific/research and financial or grants management issues: o Direct your questions about scientific/research issues to: Jerry Flanzer, D.S.W. Services Research Branch Division of Epidemiology, Services, and Prevention Research National Institute on Drug Abuse 6001 Executive Boulevard, Room 4222, MSC 9565 Bethesda, MD 20892-9565 Telephone: (301) 443-4060 Fax: (301) 443-6815 E-mail: jf199i@nih.gov o Direct your questions about financial or grants management matters to: Gary Fleming, J.D., M.A. Grants Management Branch Office of Planning and Resource Management National Institute on Drug Abuse 6001 Executive Boulevard, Room 3131, MSC 9541 Bethesda, MD 20892-9541 Telephone: (301) 443-6710 Fax: (301) 594-6847 E-mail: gf6s@nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted at the standard application deadlines, which are available at http://grants.nih.gov/grants/dates.htm. Application deadlines are also indicated in the PHS 398 application kit. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs must be submitted in a modular grant format. The modular grant format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular grants. Additional information on modular grants is available at http://grants.nih.gov/grants/funding/modular/modular.htm. SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR: Applications requesting $500,000 or more in direct costs for any year must include a cover letter identifying the NIH staff member within one of NIH institutes or centers who has agreed to accept assignment of the application. Applicants requesting more than $500,000 must carry out the following steps: 1) Contact NIDA program staff at least 6 weeks before submitting the application, i.e., as you are developing plans for the study; 2) Obtain agreement from the IC staff that NIDA will accept your application for consideration for award; and, 3) Identify, in a cover letter sent with the application, the staff member and NIDA who agreed to accept assignment of the application. This policy applies to all investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended or revised version of these grant application types. Additional information on this policy is available in the NIH Guide for Grants and Contracts, October 19, 2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the checklist, and five signed photocopies in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) APPLICATION PROCESSING: Applications must be received by or mailed on or before the receipt dates described at http://grants.nih.gov/grants/funding/submissionschedule.htm. The CSR will not accept any application in response to this PA that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique. PEER REVIEW PROCESS Applications submitted for this PA will be assigned on the basis of established PHS referral guidelines. An appropriate scientific review group convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit. As part of the initial merit review, all applications will: o Receive a written critique o Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score o Receive a second level review by the National Advisory Council on Drug Abuse REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of your application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning your application's overall score, weighting them as appropriate for each application. Your 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, you may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) SIGNIFICANCE: Does your study address an important problem? If the aims of your application are achieved, how do they advance scientific knowledge? What will be the effect of these studies on the concepts or methods that drive this field? (2) APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Do you acknowledge potential problem areas and consider alternative tactics? (3) INNOVATION: Does your project employ novel concepts, approaches or methods? Are the aims original and innovative? Does your project challenge existing paradigms or develop new methodologies or technologies? (4) INVESTIGATOR: Are you appropriately trained and well suited to carry out this work? Is the work proposed appropriate to your experience level as the principal investigator and to that of other researchers (if any)? (5) ENVIRONMENT: Does the scientific environment in which your work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: PROTECTIONS: The adequacy of the proposed protection for humans, animals, or the environment, to the extent they may be adversely affected by the project proposed in the application. INCLUSION: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria included in the section on Federal Citations, below) BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. AWARD CRITERIA Applications submitted in response to a PA will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: o Scientific merit of the proposed project as determined by peer review o Availability of funds o Relevance to program priorities REQUIRED FEDERAL CITATIONS MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating 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). All investigators proposing clinical research should read the AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy 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 that is available at http://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide the official NIH identifier(s)for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review. HIV/AIDS COUNSELING AND TESTING POLICY FOR THE NATIONAL INSTITUTE ON DRUG ABUSE: Researchers funded by NIDA who are conducting research in community outreach settings, clinical, hospital settings, or clinical laboratories and have ongoing contact with clients at risk for HIV infection, are strongly encouraged to provide HIV risk reduction education and counseling. HIV counseling should include offering HIV testing available on-site or by referral to other HIV testing services. Persons at risk for HIV infection including injecting drug users, crack cocaine users, and sexually active drug users and their sexual partners. For more information see http://grants.nih.gov/grants/guide/notice-files/NOT-DA-01-001.html. NATIONAL ADVISORY COUNCIL ON DRUG ABUSE RECOMMENDED GUIDELINES FOR THE ADMINISTRATION OF DRUGS TO HUMAN SUBJECTS: The National Advisory Council on Drug Abuse recognizes the importance of research involving the administration of drugs to human subjects and has developed guidelines relevant to such research. Potential applicants are encouraged to obtain and review these recommendations of Council before submitting an application that will administer compounds to human subjects. The guidelines are available on NIDA's Home Page at www.nida.nih.gov under the Funding, or may be obtained by calling (301) 443-2755. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance No. 93.279, and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284 and administered under NIH grants policies described at http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the 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.

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