ALCOHOL TREATMENT, SERVICES, AND PREVENTION STUDIES OF HIGH PRIORITY TO PROVIDERS RELEASE DATE: Sseptember 16, 2002 PA NUMBER: PA-02-167 EXPIRATION DATE: This PA expires on August 15, 2005, unless reissued. National Institute on Alcohol Abuse and Alcoholism (NIAAA) (http://www.niaaa.nih.gov) THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of this PA o Research Objectives o Mechanism(s) of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Where to Send Inquiries o Submitting an Application o Peer Review Process o Review Criteria o Award Criteria o Special Requirements o Required Federal Citations PURPOSE OF THIS PA The National Institute on Alcohol Abuse and Alcoholism (NIAAA) seeks applications for alcohol treatment, services, and prevention studies that have been suggested by providers as areas of high research priority. While significant research has accumulated over recent years, the alcohol treatment and prevention fields have also witnessed a troubling gap in communication between those who conduct alcohol research and those who provide services (Lamb et al. 1998; Brown 2000, CSAT 2000). An important part of that gap is the sentiment that research results are not as useful as they should be to practitioners. Sometimes this is because topics of pressing interest to providers are not addressed in proposed research projects. Sometimes this is because the intervention protocols studied in tightly controlled trials can not be duplicated in typical clinical settings. Sometimes this is because the patient pool that survives the exclusion criteria of a trial does not resemble a real world clinical population. Sometimes this is because the translation of research findings into clinical guidance and the development of tools to help put findings into practice are left underdeveloped at the close of a research project. This announcement addresses the first of these problems. It directs researchers' attention to research topics that providers have suggested as having a high priority. Providers' suggestions cover a variety of subjects in treatment, prevention, and health services research. Some suggestions repeat calls for research that have appeared in other program announcements. This repetition does no harm. Rather it re-emphasizes the need for further study in these areas. The specific topics covered in this announcement include: clinical outcomes under managed care, robustness of outcomes to applied conditions, case management, tools for improved services delivery, treatment of individuals with co-occurring mental disorders, treatment for other special populations, improved prevention practices, behavior and management of providers, linkages to other medical and social services, and studies of treatment policy decisions. RESEARCH OBJECTIVES With the aim of narrowing the provider-researcher gap, NIAAA has increased its attention to research suggestions emanating from the provider community. The most significant of these efforts was the Institute's convening of a working group entitled "Research Priorities Suggested by Providers" on April 19, 2002 to solicit suggestions for the Institute's research portfolio. The Institute also gathered provider suggestions through participation in the process that led to the issuance of the Center for Substance Abuse Treatment's (CSAT) Improving Substance Abuse Treatment: The National Treatment Plan Initiative, especially Panel IV of that process, "Connecting Services and Research" (CSAT 2000). Insights also emerged from the Institute's collaborative work with providers in New York and North Carolina during the Research in Residence project (http://www.niaaa.nih.gov/publications/newyork.PDF). The Institute has also tried to keep abreast of provider-generated suggestions that have emerged from CSAT's Practice Improvement Collaboratives program and the National Institute on Drug Abuse's (NIDA) Clinical Trials Network, which has emphasized the blending of research priorities suggested by both providers and researchers. From these various sources has emerged a picture of the provider viewpoint on projects that should be encouraged within NIAAA's research agenda. This announcement explicitly calls for grant applications on these subjects. Providers have identified several broad areas where additional research is needed. They also suggested several specific research topics within each area. Applications in any of these areas are encouraged, as are applications in other related areas not specifically listed below. 1. The highest priority for many providers is the study of managed care. In particular, providers are interested in the effects of managed care on both the amount of alcohol treatment delivered and the clinical outcomes of that treatment. A related concern is to estimate whether and to what extent decrements in treatment outcomes are experienced as a result of providing the least intensive or least costly courses of treatment. Providers are also interested in how managed care payment mechanisms can be either used in their present form or modified to improve their applicability to the treatment of a chronic condition. 2. An issue of considerable importance to providers is how robust the outcome findings of controlled trials might be when treatment techniques are adapted to applied settings. The average provider rarely has the resources to replicate a new treatment intervention with complete fidelity to the conditions under which it was delivered in a clinical trial. The provider is thus caught between two unsatisfactory options: abandoning the effort to adopt the practice improvement or making compromises in the treatment protocol whose impact on clinical outcome is unknown. Research needs to help providers make informed decisions about how to best strike a balance between fidelity and practical constraints. 3. Other studies advocated by providers are outcome studies of case management. Included are: What is the effectiveness and cost effectiveness of case management in alcohol treatment? Would case management help improve long-term outcomes? and Does case management show any special promise for improving outcomes among clients who are frequent relapsers? 4. Providers are also interested in the development of tools that would promote better treatment outcomes. First among these is a simple, practical, low cost, standardized protocol for measuring treatment outcomes. Widespread adoption of such a tool would facilitate comparisons, making it easier to know which innovations are promising. Protocols and materials are needed for motivational enhancement therapy delivered in group as opposed to individual settings. Research could provide better guidance on which medication compliance strategies work best in alcohol dependent populations. Finally there is interest in engaging family members in the therapeutic process and the development of family strategies to help engage the treatment resistant. 5. Research should develop methods of treating individuals who have co- occurring mental health disorders. Especially needed are approaches for clients who have personality disorders, who often don't respond well to standard treatments. Another pressing need is approaches for incorporating suicide prevention (including the relevant pharmacotherapies) into alcohol treatment. 6. Effective treatments for several demographically-defined populations need to be developed. Establishing the effectiveness of standard treatments among minority clients is long overdue. Research should also remedy the lack of knowledge about effective treatment approaches for adolescents. In particular, it should determine which versions of multi-systemic therapy are most effective for treating adolescents. Another need is to understand the changing demographic, substance abuse, mental health, and physical health characteristics of 17 to 25 year old clients currently presenting at treatment centers. Finally, the effectiveness of standard treatments among minority clients needs to be established. 7. Prevention practices are also important to providers. Research needs to provide better methods of evaluating the effects of environmentally-focused prevention initiatives. It also needs to give providers better guidance on how to adapt prevention strategies to applied settings in ways that best preserve effectiveness. Studies should examine the effectiveness of common prevention approaches among children of alcoholics, among minority individuals, and within all three of the cultures present on the U.S. Southern border. Providers also note that the set of risk and protective factors that has emerged from the prevention literature is too broad to provide useful guidance in planning community initiatives. They ask whether the existing list could be reduced to a more focused set. 8. Important contributions could be made by studying the behavior of providers. Studies could identify the kinds of provider training and the types of clinical supervision that produce better treatment outcomes. It could also identify the training and supervision strategies that promote both effectiveness and innovation. Research should also continue to investigate the elements of counseling style that produce the best results and that work best with specific types of clients. 9. It is also important that research advance our understanding of the knowledge adoption process. The overall question here is how research findings are incorporated into routine clinical practice. Other questions include: What are the appropriate criteria for determining that a treatment practice is evidence-based? How can one preserve fidelity while adapting a model practice to a given applied situation? and How can one overcome professional resistance toward new techniques (especially the use of pharmacotherapy). 10. The way that alcohol treatment is linked to the provision of other medical and social services is also important. Linkages between alcohol treatment and primary care take several forms, and the effectiveness and cost effectiveness of each deserve study. These forms include placing alcohol specialists in primary care clinics, improving referral linkages between primary care physicians and alcohol treatment providers, and creating fully integrated health care systems. Also of interest is the effectiveness of linking substance abuse treatment to such other social services as welfare, child and protective services, job training, housing programs, and criminal justice programs. Research could help identify the most effective approaches to creating these linkages. 11. Finally, there are many policy decisions that bear on the availability and effectiveness of alcohol treatment services, but often such decisions must be taken without adequate knowledge about how they affect treatment delivery or effectiveness. Studies that would help inform policy decisions include: estimates of costs saved (from a burden of illness framework) by adopting specific treatment or prevention policies; analyses of treatment finance patterns and the correlates, including clinical outcomes, of those patterns; and studies of how consumer groups effect the allocation of resources to alcohol treatment. MECHANISMS OF SUPPORT This PA will use the National Institutes of Health (NIH) Research Project Grant (R01),Exploratory/Developmental Grant (R21), and Small Grant (R03) award mechanisms. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Applications for R01s may request support for up to 5 years. Facilities and Administrative (F&A) costs will be awarded based on the negotiated rate at the time of the award. More detailed information on the R21 mechanism can be found at https://grants.nih.gov/grants/guide/pa-files/PA-99-131.html. More detailed information on the R03 mechanism can be found at https://grants.nih.gov/grants/guide/pa-files/PAR-99-098.html. Exploratory/Developmental Grants and Small Grants cannot be renewed: however, a no-cost extension of up to one year may be granted prior to expiration of the project period. Investigators are encouraged to seek continued support after completing an Exploratory/Developmental Grant project or a Small Grant project through a Research Project Grant (R01). 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. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PA and welcome the opportunity answer questions from potential applicants. Inquiries may fall into two areas: scientific/research and financial or grants management issues: Direct your questions about scientific/research issues to: Mike Hilton, Ph.D. Division of Clinical and Prevention Research National Institute on Alcohol Abuse and Alcoholism Willco Building, Suite 505 6000 Executive Blvd., MSC 7003 Bethesda, MD 20892-7003 Telephone: 301-443-8753 FAX: 301- 443-8774 Email: mhilton@willco.niaaa.nih.gov Direct your questions about financial or grants management matters to: Judy Simons Chief, Grants Management Branch Office of Planning and Resource Management National Institute on Alcohol Abuse and Alcoholism Willco Building, Suite 504 6000 Executive Boulevard, MSC 7003 Bethesda, MD 20892-7003 (301) 443-4704 (telephone) (301) 443-3891 (fax) email: jsimons@willco.niaaa.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 https://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 https://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 https://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 https://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 NIAAA staff member who has agreed to accept assignment of the application. Applicants requesting more than $500,000 must carry out the following steps: 1) Contact the IC 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 the IC will accept your application for consideration for award; and, 3) Identify, in a cover letter sent with the application, the staff member and IC 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 https://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 before the receipt dates described at https://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 appropriate national advisory council or board 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? 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 SPECIAL REQUIREMENTS Applicants should demonstrate substantial collaboration with alcohol treatment or prevention providers. This includes participation of providers in the design of the research project and collaboration with providers during the conduct of the research. Providers should appear as project staff or consultants. Projects should also contain well-developed plans for disseminating the results of the research to the provider community. 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: https://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 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at https://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 https://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 https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.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 https://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 a 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. 93.273, 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 https://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. https://grants.nih.gov/grants/guide/pa-files/PA-02-015.html.
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