and Human Services (HHS)
EXPIRED
GUIDANCE FOR BEHAVIORAL TREATMENT PROVIDERS: RESEARCH ON KNOWLEDGE AND SKILL ENHANCEMENT Release Date: September 16, 2002 RFA: DA-03-005 National Institute on Drug Abuse (NIDA) (www.nida.nih.gov) Letter of Intent Receipt Date: November 15, 2002 Application Receipt Date: December 16, 2002 THIS REQUEST FOR APPLICATIONS (RFA) CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanisms of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA The National Institute on Drug Abuse (NIDA) is committed to promoting research activities that result in improved drug abuse treatment and reductions in HIV/AIDS risk behavior in drug-dependent individuals. NIDA's behavioral therapies development program has supported the development and testing of a number of efficacious therapies for drug abuse and dependence and HIV/AIDS risk. The purpose of this initiative is to support studies for developing and testing novel, creative approaches to clinical training and supervision that will enhance community treatment providers' knowledge and skills to administer behavioral treatments with some evidence of efficacy for drug abuse and/or interventions for HIV/AIDS risk reduction among in-treatment drug abusers. This RFA especially encourages theory-driven approaches to the development of novel training and supervision methods, i.e., approaches that apply knowledge derived from cognitive neuroscience, psychology, medical education, and other fields of science to training and supervision. It is NOT intended to support the development of new behavioral therapies, studies of strategies to reduce organizational barriers to implementing training in a given program, program evaluation studies of existing training approaches, or development of training and supervision methods for treatments without any documented evidence of efficacy. Evidence of efficacy for the purpose of this RFA is defined as findings published or in press in a peer reviewed journal, from one or more well-designed randomized clinical trials conducted with drug users that demonstrated reductions in drug use, HIV/AIDS risk behavior or other closely related outcomes. An entire treatment or a single component of an efficacious treatment may be selected for training. The term "behavioral therapy" is used here in a broad sense and includes various forms of psychotherapy, behavior therapy, cognitive therapy, family therapy, skills training, counseling, and other rehabilitative therapies. For the purpose of this RFA, "treatment providers" includes therapists, counselors, and others who provide behavioral therapies (as defined above) to people in drug treatment and who would be targets for clinical training and supervision. RESEARCH OBJECTIVES Background and Rationale A heterogeneous group of public and private treatment programs, including small local clinics and large complex programs sponsored by medical centers and managed care organizations, comprise the community- based drug and alcohol treatment system in the United States. A study by the Institute of Medicine (Lamb et al, 1998) devoted to bridging the gap between drug abuse treatment providers and researchers determined that despite the availability of a number of behavioral treatments with evidence of efficacy, established research-based treatments have not been adopted widely in clinical practice. To facilitate the adoption of such treatments by community programs methods for training and supervising community-based providers are needed. Weissman, Rounsaville, and Chevron (1982) describe the essential components of training and supervision programs for behavioral therapists in clinical trials. They suggest that investigators should select therapists with extensive background in the theoretical rationale for the treatment and, when possible, actual experience delivering the treatment under study. Additionally, they describe training and supervision efforts which are now standard for clinical trials, intensive efforts featuring didactic workshops, completion of a number of "practice clients," actual clients with which the new research therapist demonstrates his/her new skills, and ongoing long- term supervision augmented by review of audio or videotapes of sessions. Waltz et al (1993) describe two important constructs related to training, "competence" defined as the level of skill shown by a therapist in delivering a treatment, and "adherence" defined as the extent to which a therapist uses interventions and approaches prescribed by the treatment and avoids using those proscribed by the manual. Supervisors and independent raters, who review practice and ongoing therapy session tapes or transcripts using standardized checklists or rating forms, ensuring high levels of fidelity to a treatment manual during a trial, are typically used to assess these constructs for behavioral therapy trials. Although a well-defined and relatively efficient methodology exists for training research therapists, no such methodology exists for updating or enhancing the skills of community therapists, many of whom will practice for thirty years or more, during which time many changes take place in the field. While the techniques to train research therapists can be applied to training community therapists, these are not necessarily time efficient. For example, Morgenstern et al (2001) trained community therapists to deliver Cognitive Behavioral Treatment using procedures similar to those used for training clinical trial therapists. On average community therapists required 105 hours of training and supervision over a five-month period in order to achieve ratings of "adequate" competence and adherence. Although this may seem like a reasonable timeframe for treating a complex disorder, it is unlikely that most community treatment programs clinics will be able to support treatments that require such extensive training. Many continuing education programs advertise instruction in science- based behavioral therapies for community-based treatment providers. These programs typically consist of a workshop lasting from a few hours to a few days. These workshops rarely provide the opportunity for ongoing supervision or support when providers return to their offices and clinics to initiate the new therapy skills. Investigators are beginning to examine whether the typical continuing education workshop approach is adequate for helping community providers consolidate their new therapy skills. A study by Miller and Mount (2001) showed that for at least one behavioral treatment with evidence of efficacy, Motivational Interviewing (MI), a brief workshop alone is insufficient to help community practitioners achieve sufficient competence and adherence to this counseling approach. In short, existing methods for training community providers in behavioral therapies with evidence of efficacy, including use of methods originally developed for training research therapists, appear to be less than optimal approaches for training community treatment providers. New methods are needed for training and supervising community therapists in empirically supported therapies for drug abuse and HIV/AIDS risk reduction. Recent developments in science have resulted in a large body of knowledge and a number of theories related to learning and training that are available to enhance training and supervision method development. For example, during the past several decades researchers have learned a great deal about facets of cognition that are directly relevant to how people learn and how to train. Cognitive neuroscience researchers have provided both functional and neurobiological accounts of phenomena such as: facets of memory, how knowledge is represented and organized, forms of learning, stages in concept acquisition, the development of expertise, automatic and controlled forms of thinking, attention and remembering, to name just a few of the domains that have been extensively studied. These are but a few of the themes that are directly applicable to the design of effective training/learning methods and environments and development of clinical skills and expertise in the use of science-based behavioral therapies. Additionally, innumerable technological advances hold promise for creating innovative and potentially efficacious therapy training methodologies. Computer advances offer ways to standardize training and make it available to many more providers than ever before. Technologies that offer ways to observe and supervise therapist behavior in real time, may allow therapists to make changes to their therapy techniques long before proscribed behaviors become ingrained habits. Other technological applications like the Internet and wireless technologies offer a way to communicate with people over large distances making expert assistance available to rural and remote providers. Finally, virtual reality applications may standardize training experiences and facilitate the development and practice of skills without fear of making mistakes on human clients. NIDA is interested in studies that use these and similar advances in knowledge, theory and technology that might inform the development and pilot testing of creative and innovative methods to train and supervise community-based providers so they may reach a high level of proficiency in administering behavioral therapies for drug abuse and dependence, including dependence on nicotine as well as HIV/AIDS risk behavior. Innovative and creative studies on clinical training and supervision for community providers are encouraged. For more information on behavioral treatments, please see Principles of Drug Addiction Treatment: A Research-Based Guide at http://165.112.78.61/PODAT/PODATindex.html. Conceptual framework for the development and pilot testing of clinical training and supervision methods in this RFA: NIDA is committed to a comprehensive program of treatment research to ensure that empirically supported science-based treatments and HIV/AIDS risk reduction strategies for in-treatment populations are developed and ultimately used by community treatment providers. This RFA should be understood in the context of NIDA's Behavioral Therapies Development Research Program. For more information on this program consult PA NUMBER: PA-99-107 http://grants.nih.gov/grants/guide/pa-files/PA-99-107.html. This RFA supports research on the development and pilot testing of innovative training and supervision approaches for community-based providers, ultimately a critical activity for meaningful clinical trials of behavioral treatments in community settings. Areas of Research Interest: This initiative targets for funding research needed for developing, modifying, and pilot testing innovative clinical training and supervision methods for use with behavioral treatments having some evidence of efficacy. Ultimately, these training and supervision methods are intended to help community treatment providers, such as drug abuse counselors, therapists, private practitioners and primary care physicians, deliver efficacious behavioral treatments effectively. Behavioral treatments selected for use in the development of training procedures may be for drug addiction, comorbid drug abuse and mental disorders, and/or HIV/AIDS risk for individuals in drug abuse treatment settings. It is expected that all studies will use accepted methods for determining therapist competence and adherence of therapists trained with the method under development, and although large randomized trials of training methods are not required, it is expected that these studies will provide a pilot assessment of the method's ability to produce competent and adherent therapists. Illustrative examples of research described below serve as a guide and are not meant to subsume all research topics that would be appropriate under this RFA. Examples of activities that are encouraged: o Studies that develop novel, creative, and innovative methods for training and supervising community treatment providers in behavioral therapies based on a theory or body of knowledge from fields of science including, but not limited to, cognitive neuroscience, psychology, medical education, and computer science such as: a. Mapping of knowledge organization, i.e., what are some of the types of knowledge (including attitudes) that need to be in place prior to training b. Explicit and implicit knowledge c. Concept learning and paradigm shifts in thinking d. Development of expertise e. The effects of spaced and massed training on learning f. Advantages of experiential learning activities g. Context based learning h. Learner centered approaches such as making exercises relevant to community therapist challenges and issues or matching training and supervision to counselor learning styles by presenting materials in visual, schematics, oral, and written modalities i. Behavioral principles such as principles of reinforcement and learning theory o Studies that apply technologies to the clinical training and supervision of community-based counselors and therapists to administer behavioral treatments, including, but not limited to, methods which utilize: a. Computer technologies, especially methods of communication via the Internet, including interactive networking, virtual classrooms, e- consultation b. Compressed or streaming video and teleconferencing, chat rooms c. Widely accessible services such as telephone, telephone hotlines, or email d. Video training and supervision e. Standardized and/or virtual reality practice clients f. Multimedia CD-ROM or DVD self-guided learning programs g. Methods to shape therapy skills in real time such as in room teleprompting and "Bug-in-ear" electronic technologies h. Personalized Systems of Instruction (PSIs) This RFA is NOT intended to support the following types of studies: o Studies on new therapy development o Research on strategies to reduce organizational barriers to implementing training in a given program or programs o Training program evaluation studies o Studies of training methods for therapies that do NOT have any evidence of efficacy (see earlier definition of evidence of efficacy in Purpose section) MECHANISMS OF SUPPORT This RFA will use the National Institutes of Health (NIH) research project (R01), NIDA's small grant (R03), and NIDA's exploratory/developmental grant (R21) award mechanisms. Foreign applicants are not eligible for NIDA's R03 awards. 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. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. The anticipated award date is July 2003. The exploratory/developmental (R21) grants are limited to 3 years and small grants (R03) are limited to 2 years. Both are non-renewable and limited in direct cost amount per year (R03, $50,000; R21, $100,000). The R03 mechanism is intended for newer, less experienced investigators, for investigators at institutions without well-developed research traditions and resources, or for experienced investigators wishing to change research directions or test new methods or techniques. The R21 mechanism is intended to encourage exploratory research projects with sound methodology and strong rationales in underdeveloped research areas of drug abuse, such as the areas covered in this RFA. Investigators may also choose to include methods development as one component within any of the other mechanisms. This RFA uses just-in-time concepts. It also uses the modular as well as the non-modular budgeting formats (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. Otherwise follow the instructions for non-modular research grant applications. FUNDS AVAILABLE NIDA intends to commit approximately $2,000,000 in FY 2003 to fund 6-8 grants in response to this RFA. For the R01 mechanism, an applicant may request a project period of up to five years and a budget for direct costs of up to $250,000 per year for all years. For the R03 mechanism, an applicant may request up to $50,000 in direct costs in each of the 2 years. For an R21 mechanism, an applicant may request up to $100,000 in direct costs in each of the 3 years. Because the nature and scope of the research proposed may vary, it is anticipated that the size of each award will also vary. Although the financial plans of NIDA provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. ELIGIBLE INSTITUTIONS You may submit an application 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. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct your questions about scientific/research issues to: Cecelia L. McNamara, Ph.D. Division of Treatment Research and Development Behavioral Treatment Development Branch National Institute on Drug Abuse 6001 Executive Boulevard, Room, MSC 9551 Bethesda, MD 20892-9551 Telephone: (301) 402-1488 FAX: (301) 443-6814 Email: [email protected] o Direct questions about peer review matters to: Teresa Levitin, Ph.D. Office of Extramural Affairs National Institute on Drug Abuse 6001 Executive Boulevard, Room 3158, MSC 9547 Bethesda, MD 20892-9547 Telephone: (301) 443-2755 FAX: (301) 443-0538 Email: [email protected] o Direct questions about financial or grants management matters to: Gary Fleming, J.D., M.A. Grants Management Branch National Institute on Drug Abuse 6001 Executive Boulevard, Room 3131, MSC 9541 Bethesda, MD 20892-9541 Telephone: (301) 443-6710 FAX: (301) 443-6847 Email: [email protected] LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to: Director Office of Extramural Affairs National Institute on Drug Abuse 6001 Executive Blvd., Room 3158, MSC 9547 Bethesda, MD 20892-9547 Rockville, MD 20852 (for express/courier service) Telephone: (301) 443-2755 Email: [email protected] 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: [email protected]. 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. USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label 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 on line two of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the Checklist, and three 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) At the time of submission, two additional copies of the application must be sent to: Director Office of Extramural Affairs National Institute on Drug Abuse 6001 Executive Boulevard, Room 3158, MSC 9547 Bethesda, Maryland 20892-9547 Rockville, MD 20852 (for express/courier service) Telephone: (301) 443-2755 FAX: (301) 443-0538 Email: [email protected] APPLICATION PROCESSING Applications must be received by the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept any application in response to this RFA 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 substantial revisions of applications already reviewed, but such applications must include an Introduction addressing the previous critique. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by NIDA. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications failing to provide required information about human subjects; data safety and monitoring; data sharing; and inclusion of gender, minorities, and children will be considered incomplete. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIDA in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Receive a written critique o Undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the 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 the 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 this study address an important problem? If the aims of the 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? Does the study design provide a way to begin to determine if and to what extent therapists trained and/or supervised with the method under development gain the knowledge and skills necessary to deliver the therapy with integrity? Has the applicant selected a reasonable behavioral treatment with sufficient efficacy, as demonstrated by peer-reviewed publication in scholarly research journals? (3) INNOVATION: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the 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 the experience level as the principal investigator and to that of other researchers (if any)? (5) ENVIRONMENT: Does the scientific environment in which the 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: o 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. o 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) o DATA SHARING: The adequacy of the proposed plan to share data. o BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: November 15, 2002 Application Receipt Date: December 16, 2002 Peer Review Date: March/April 2003 Council Review: May 2003 Earliest Anticipated Start Date: July 2003 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Availability of funds o Programmatic 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. 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 the recommendations of the Council before submitting an application that will administer compounds to human subjects. The guidelines are available on NIDA's Home Page at http://www.nida.nih.gov/ under Funding or may be obtained by calling (301) 443-2755. 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 include 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. 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 RFA 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. http://grants.nih.gov/grants/guide/pa-files/PA-02-015.html. REFERENCES: Lamb, Sara (Ed); Greenlick, Merwyn R. (Ed); McCarty, Dennis (Ed). Bridging the gap between practice and research: Forging partnerships with community-based drug and alcohol treatment. [Authored Book] Washington, DC, US: National Academy Press. (1998). Miller, W. R., & Mount, K. A. (2001). A small study of training in motivational interviewing: Does one workshop change clinician and client behavior? Behavioural and Cognitive Psychotherapy, 29, 457-471. Morgenstern, J., Morgan, T.J., McCrady, B.S., Keller, D.S., & Carroll, K.M. (2001) Manual-guided cognitive-behavioral therapy training: a promising method for disseminating empirically supported substance abuse treatments to the practice community. Psychology of Addictive Behavior, 15, 83-98. Waltz, J., Addis, M.E., Koerner, K., & Jacobson, N.S. (1993). Testing the integrity of a psychotherapy protocol: Assessment of adherence and competence. Journal of Consulting and Clinical Psychology, 61, 620- 630. Weissman, M.M, Rounsaville, B.J., & Chevron, E. (1982). Training psychotherapists to participate in psychotherapy outcome studies. American Journal of Psychiatry, 139, 1442-1446.
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