PAR-01-039: COLLABORATIVE CLINICAL STUDIES IN DRUG ABUSE

Department of Health
and Human Services (HHS)

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This Program Announcement expires on November 30, 2003, unless reissued. COLLABORATIVE CLINICAL STUDIES IN DRUG ABUSE Release Date: January 2, 2001 PA NUMBER: PAR-01-039 (see replacement PAR-04-073) National Institute on Drug Abuse (http://www.nida.nih.gov) THIS PROGRAM ANNOUNCEMENT (PA) USES THE "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. IT INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS PA. PURPOSE The National Institute on Drug Abuse (NIDA) seeks to increase the collaboration of investigators at different sites in order to address clinical issues in drug abuse research that require sample sizes greater than a single site can reasonably attain. The expectation for the collaborative effort is that there will be implementation of common protocols across different sites in order to study patient outcomes, patient factors, provider factors, setting characteristics, interactions of these, or other effects where pooled samples are appropriate and necessary for the hypotheses under consideration. This announcement provides guidelines for the development, review, and funding of Collaborative Clinical Studies in Drug Abuse (CCSDA) projects. 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 Program Announcement (PA), Collaborative Clinical Studies in Drug Abuse, 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/. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and non- profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. The CCSDA requires more than one applicant organization, and each applicant organization must meet the eligibility requirements above. Multiple campuses of a single institution or university system are considered separate organizations for the purposes of eligibility to apply. MECHANISM OF SUPPORT This PA will use the R01 award mechanism, no other mechanisms may be used. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicants. The total project period for an application submitted in response to this PA may not exceed 5 years. RESEARCH OBJECTIVES In order to draw valid conclusions from clinical studies of drug abuse and drug abuse-related issues, a sufficient sample size is needed. Studies and analyses are sometimes limited by inadequate access to, or enrollment of, subjects. Even where main hypotheses can be addressed with the sample available, interesting hypotheses about subpopulations (based on gender, ethnicity, drug use patterns, age, etc.), interaction effects, or ancillary questions (e.g., such as about therapist characteristics, patient matching to treatment, unexpected outcomes, etc.) cannot be examined because of limitations in the sample size. For some questions, such as genetic studies or studies of relatively infrequent behaviors, the required sample size effectively prohibits a single site from being able to recruit sufficient numbers. Collaborative clinical studies allow multiple investigators to initiate and submit separate applications, each with a separate PI and applicant institution, that propose timely recruitment of an aggregate sample sufficient to address clinical concerns. By allowing multiple sites to recruit, a sample that otherwise could not be recruited or could not be recruited within a reasonable time frame can be enrolled. CCSDA seems ideally suited to foster the efficiency and creativity that can be obtained through investigator- initiated research and, at the same time, allow multiple investigators to coordinate a focus on a particular clinical issue relevant to drug abuse. Examples of possible foci for a CCSDA are: o Large scale trials of behavioral or psychopharmacological treatments, alone or in combination, focused on drug addiction and using common intervention protocols and cross-site analyses. Pharmacologic treatments may include new or already-marketed medications. Behavioral treatments may be intended to enhance medication compliance. o Genetic studies requiring large numbers of subjects. o Studies of interventions for relatively low prevalence conditions in drug abusing populations. o Clinically oriented psychometric studies that are normally hampered by low base rates of occurrence of the behavior of interest. o Clinically oriented neuroimaging studies that require multiple sites in order to study sufficient numbers of subjects of interest. o Analyses of impacts of interventions associated with gender, racial, ethnic, or linguistic group, sexual orientation, age, or other developmental variables, etc. o Studies of other clinical issues in drug abuse (e.g., HIV/AIDS and other infectious diseases) that require multiple sites to ensure a sufficiently large sample to answer the question posed. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS - UPDATED AUGUST 2, 2000 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 biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are 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 research involving human subjects should read the UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html), a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm. The revisions relate to NIH defined Phase III clinical trials and require: a) all applications or proposals and/or protocols to 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) all investigators to report accrual, and to conduct and report analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH 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 was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html. Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning these policies. 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. 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. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 4/98) and will be accepted at the standard application deadlines as indicated in the application kit. Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, email: GrantsInfo@nih.gov. Separate applications must be prepared by each applicant institution. Because the CCSDA is expected to address questions that were not addressable in previous single site studies, competing continuation applications would not be appropriate. Applicants planning to request $500,000 or more in direct costs for any year must contact the Institute program staff before submitting the application, i.e., as plans for the study are being developed. Furthermore, the application must obtain agreement from the Institute staff that Institute will accept the application for consideration for award. Finally, the applicant must identify, in a cover letter sent with the application, the staff member and Institute who agreed to accept assignment of the application. This requirement applies to any individual CCSDA application if that application will exceed $500,000 in direct costs. Also, if the overall total direct costs for all the CCSDA applicants in a group are $500,000 or more for any year, Institute staff must be contacted and agree to accept all the applications in that group, and the procedures noted above must be followed. This policy requires an applicant to obtain agreement for acceptance of both any such application and any such subsequent amendment. Refer to the NIH Guide for Grants and Contracts, March 20, 1998 at http://grants.nih.gov/grants/guide/notice-files/not98-030.html. The application must be organized in accordance with standard PHS Form 398 instructions, with the following modifications: Each application in a CCSDA group should be essentially identical to the others, with the exception of expected differences in elements such as numbers of available subjects, resources and environment, budgetary requirements, and staff. Each application must include an overview section that is no longer than 2 pages and constitutes the first pages of the RESEARCH PLAN section (i.e., immediately precedes the Specific Aims). This overview should list the individual applicant organizations participating in the CCSDA and the Principal Investigator for each. It should establish the need for applying as a CCSDA and justify the role for each applicant organization in the CCSDA. The investigators may also wish to identify one individual as the contact person for the group for the purposes of facilitating communication. If so, that should be noted in the overview. Sections A-D of the research plan should describe those aspects of the project that are common to all sites. The research procedures and protocol should be presented in detail, along with description of the study population from which samples are drawn, the anticipated samples themselves, resources, plans for data analysis, and characteristics that support each site’s (i.e., not simply the applicant’s site) role in the project. Where there are minor variations in plans, these should be noted in the text and then summarized in a separate subheading in Section D (which counts toward the 25 page limit) titled ELEMENTS UNIQUE TO THIS SITE. The research plan should describe a feasible strategy for integration of research procedures, managerial and administrative responsibilities, and training across sites to ensure the integrity of the research effort. The Principal Investigators may wish to designate a Steering Committee or other decision-making body. If so, the biosketches of these individuals should be included. If not, a feasible strategy for decision making must be detailed. Plans for ensuring access to data by all sites, analytic resources, publication and authorship procedures, public use of data, dissemination of results, and means of arbitrating disagreements should be addressed. Any site that contracts out elements of the research should note this as an element unique to the site, both in the main body of the research plan and in the separate section on unique elements. The nature, purpose, and oversight of the contractual arrangement should be fully described. Revised submissions of CSDAs must include an introduction to the revision that highlights changes in the research plan and how delays in initiating the project will affect the work. This is particularly important in cases where some but not all of the CCSDA sites have already begun work on a project. In accordance with NIH policy, incomplete applications will be returned to the applicant. Applications that are not responsive to the intent of the CCSDA will be returned. All applications submitted as part of the CCSDA should be mailed together in one package in order to assure that they are processed as CCSDA submissions. All of the applications constituting the proposed CCSDA group must be submitted in a single package, whether or not the applications are from the same institution. A cover letter must list the total number of applications submitted for the CCSDA group, clearly identifying each application and the principal investigator of each. For each component application in the CCSDA group, the original, five copies, and the appendix material must be bundled together and clearly identified The title and number of the program announcement must be typed on line 2 of the face page of the application form and the YES box must be marked. 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 PROCEDURES The modular grant concept establishes specific modules in which direct costs may be requested as well as a maximum level for requested budgets. Only limited budgetary information is required under this approach. The just-in- time concept allows applicants to submit certain information only when there is a possibility for an award. It is anticipated that these changes will reduce the administrative burden for the applicants, reviewers, and Institute staff. The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants, with the modifications noted below. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS BUDGET INSTRUCTIONS Modular Grant applications will request direct costs in $25,000 modules, up to a total direct cost request of $250,000 per year. (Applications that request more than $250,000 direct costs in any year must follow the traditional PHS 398 application instructions.) The total direct costs must be requested in accordance with the program guidelines and the modifications made to the standard PHS 398 application instructions described below: PHS 398 o FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs (in $25,000 increments up to a maximum of $250,000) and Total Costs [Modular Total Direct plus Facilities and Administrative (F&A) costs] for the initial budget period. Items 8a and 8b should be completed indicating the Direct and Total Costs for the entire proposed period of support. o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4 of the PHS 398. It is not required and will not be accepted with the application. o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the categorical budget table on Form Page 5 of the PHS 398. It is not required and will not be accepted with the application. o NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget Narrative page. (See http://grants.nih.gov/grants/funding/modular/modular.htm for sample pages.) At the top of the page, enter the total direct costs requested for each year. This is not a Form page. Under Personnel, list all project personnel, including their names, percent of effort, and roles on the project. No individual salary information should be provided. However, the applicant should use the NIH appropriation language salary cap and the NIH policy for graduate student compensation in developing the budget request. For Consortium/Contractual costs, provide an estimate of total costs (direct plus facilities and administrative) for each year, each rounded to the nearest $1,000. List the individuals/organizations with whom consortium or contractual arrangements have been made, the percent effort of all personnel, and the role on the project. Indicate whether the collaborating institution is foreign or domestic. The total cost for a consortium/contractual arrangement is included in the overall requested modular direct cost amount. Include the Letter of Intent to establish a consortium. Provide an additional narrative budget justification for any variation in the number of modules requested. o BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by reviewers in the assessment of each individual"s qualifications for a specific role in the proposed project, as well as to evaluate the overall qualifications of the research team. A biographical sketch is required for all key personnel, following the instructions below. No more than three pages may be used for each person. A sample biographical sketch may be viewed at: http://grants.nih.gov/grants/funding/modular/modular.htm. - Complete the educational block at the top of the form page, - List position(s) and any honors, - Provide information, including overall goals and responsibilities, on research projects ongoing or completed during the last three years, and - List selected peer-reviewed publications with full citations. o CHECKLIST - This page should be completed and submitted with the application. If the F&A rate agreement has been established, indicate the type of agreement and the date. All appropriate exclusions must be applied in the calculation of the F&A costs for the initial budget period and all future budget years. o The applicant should provide the name and phone number of the individual to contact concerning fiscal and administrative issues if additional information is necessary following the initial review. REVIEW CONSIDERATIONS This is a PAR . Applications will be evaluated for scientific and technical merit by an appropriate scientific review group convened by NIDA in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council or board. Individual applications may receive different priority scores. 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. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that the 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, an investigator 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 will scientific knowledge be advanced? 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? Does the applicant acknowledge potential problem areas and consider alternative tactics? (3) Innovation: Does the project employ novel concepts, approaches, or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? (4) Investigator: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and 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? (6) Rationale and feasibility of the collaboration: How well is the use of collaborating sites justified? How necessary is collaboration to address the scientific issues? How well does this application establish, through preliminary data or other means, that other sites will be able to contribute to the study? (7) Management plans: How well developed and reasonable are the plans for coordination, decision-making, quality control, and arbitration? In particular, how well have other administrative and managerial issues been addressed with respect to: o the reliability and accuracy of the main administrative site"s past performance and the potential of the main administrative site"s future performance in clinical trials, o the experience of the Principal Investigator and other key personnel in conducting clinical trials, o the ability of the main administrative site to manage and analyze data for the clinical trial, and, o the appropriateness of the proposed procedures for data management, data storage, and analytical activities. In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: o The adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects and for the analysis of subgroup data will also be evaluated. o The reasonableness of the proposed budget and duration in relation to the proposed research. o 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. AWARD CRITERIA Applications will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: Quality of the proposed project as determined by peer review, availability of funds, and program priority. Funding decisions will also consider whether there are sufficient high quality collaborating sites for the CCSDA project. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Ann Anderson, M.D. Division of Treatment Research and Development National Institute on Drug Abuse 6001 Executive Boulevard, Room 4123, MSC 9551 Bethesda, MD 20892-9551 Telephone: (301) 443-3318 Email: aanderson@nida.nih.gov Direct inquiries regarding review issues 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 Email: tl25u@nih.gov Direct inquiries regarding fiscal 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 Email: gf6s@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.279. 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 and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-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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