This Program Announcement expires on February 28, 2004. MINORITY INSTITUTIONS' DRUG ABUSE RESEARCH DEVELOPMENT PROGRAM (MIDARP) Release Date: October 22, 2001 PA NUMBER: PAR-02-016 (This PA has been reissued, see PAR-05-069) National Institute on Drug Abuse Application Receipt Dates: February 21 and August 21, 2002; February 21 and August 21, 2003 and February 23 and August 23, 2004 PURPOSE The purpose of this program is to increase the capacity of minority institutions with limited sponsored research experience in the biomedical, social, and behavioral sciences to conduct research in drug abuse and addiction. Grants will be provided to develop the capacity of minority institutions and their minority faculty, staff and students, in particular, to conduct rigorous drug abuse research in all areas of research supported by the NIDA including neuroscience, epidemiology, behavioral, clinical, social science, public health, biological, HIV/AIDS, health disparities, and health services areas. 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, "Minority Institutions' Drug Abuse Research Development Program (MIDARP)," 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 Institutions applying for this award must demonstrate eligibility through (a) minority status and (b) research capacity development need. Applications may be submitted by an organization, university or college that meet one of the following criteria regarding minority status: (1) A public or private nonprofit university, four-year college, or other institution offering undergraduate or graduate degrees with a traditionally high (more than 50 percent) minority (Black, Hispanic, Native American or Alaskan Native, Asian or Pacific Islander) student enrollment. This category includes Historically Black Colleges and Universities (HBCUs), Hispanic Serving Institutions (HSIs), and Tribal Colleges. An Indian tribe, which in conjunction with one or more institutions of higher learning, offers undergraduate and graduate degrees in disciplines relevant to drug abuse, which has a recognized governing body, and which performs substantial governmental functions, or an Alaska Regional Corporation (ARC) as defined in the Alaska Native Claims Settlement Act (43 U.S.C. 1601 et seq.) is eligible. (2) A college or university with a minority student enrollment of at least 25% in each of the previous five years. In addition, applicants must demonstrate commitment to minority research development goals through (a) evidence of efforts to recruit faculty and students who are members of minorities nationally underrepresented in behavioral and biomedical research, and (b) demonstration of efforts to provide research support and resources to minority faculty and students. Applicant institutions meeting the minority status requirement must also demonstrate that they have a need for research capacity development in drug abuse and addiction. They cannot have received over $500,000 in direct costs from NIH per year over the last five (5) years for research in drug abuse and addiction. Awards specific to minority institutions and research capacity development awards, including support for current MIDARP grantees, are excluded in calculating this total. Excluding the Principal Investigator/Program Director, faculty participating as Project Directors in the proposed MIDARP cannot have been the Principal Investigator on an NIH award in the last five years. Applications must indicate which of the above eligibility conditions apply to the institution and provide documentation in support of the eligibility claim. (See APPLICATION PROCEDURES, below.) MECHANISM OF SUPPORT This PA will use the National Institutes of Health (NIH) R24 award mechanism. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. An application may request no less than three or no more than five years of support. MIDARP awards are renewable. RESEARCH OBJECTIVES Background Participation of minority institutions and individuals in sponsored biomedical and behavioral research is low. Reasons for this under- representation in research include the following: (1) the primary, historic mission of many minority institutions has been to provide excellent teaching in order to prepare its students for work and/or advanced studies at other institutions, (2) community service has been an important, time-consuming expectation of faculty and staff members, (3) many minority-serving institutions have not had graduate research programs, and (4) support for research (e.g., facilities, equipment, release time, library resources, personnel) has been either unavailable or inadequate. Many minority institutions, however, are redefining and expanding their mission to include a strong emphasis on research and have made strides in recent years to broaden and strengthen their research infrastructure and endeavors. In addition, minority institutions have increased their interest and involvement in drug prevention and treatment programs and are particularly poised to expand these endeavors into the research arena. For example, many are engaged in various drug and HIV/AIDS education, prevention, and training activities; some have current but limited drug abuse research; some have strong ties to community-based organizations, agencies, and schools that are addressing drug abuse problems; and almost all have indicated interest in developing competency in drug abuse research. This program is intended to provide support to minority institutions that demonstrate a commitment to developing a supportive environment for fostering faculty and student involvement in drug abuse research and careers and conducting drug abuse research. Research Goals The goals of the MIDARP are to: (1) develop the drug abuse research infrastructure of minority institutions; (2) provide research development support and experiences to faculty and staff to facilitate independent drug abuse research careers; and (3) encourage drug abuse career research interest in students and provide them research experiences. The development of minority faculty and students is particularly encouraged. Research in any areas of drug abuse research supported by NIDA is encouraged. NIDA is interested in biomedical, social, and behavioral research and supports research on drug abuse in the following broad areas: epidemiology, etiology, prevention, treatment and services, basic research, and medications development. Research areas of particular interest are on HIV/AIDS as it relates to drug use and abuse and understanding disparities in health related to drug abuse and addiction experienced by racial/ethnic populations. Applicants are encouraged to contact staff at NIDA if additional information regarding specific research interests is needed. Each MIDARP must have a thematic research focus around which all research and training activities are directed. Each application must include plans for four core activities as well as detailed descriptions of the Program Director and the External Advisory Board and a letter of institutional commitment. The core activities are: (1) an Institutional Research Development Plan, (2) a Faculty/Project Directors Development Plan, (3) Primary and/or Pilot Research Projects, and (4) a Student Development Plan. The descriptions of the MIDARP Program Director and the External Advisory Board should include explanations of the roles and responsibilities of the Program Director and External Advisory Board in the MIDARP. The letter of institutional commitment must be signed by a Dean or other institutional official with authority to commit the institution to meeting the needs of the MIDARP. Institutional Research Development Plan The strategy for building research capacity should be based upon assessments of the applicant institution's current level of drug abuse research, its capacity for research in areas other than drug abuse, environmental factors, levels of commitment, and availability of support. Assessments should examine not only needs but also strengths and resources which currently exist and upon which further capacity could be built. The plans should provide for a MIDARP Program Director, with or without additional administrative personnel, who has the necessary research experience and expertise and who is appropriately positioned within the applicant institution to be able to lead the MIDARP program effectively. To achieve the capacity building goals, activities that will strengthen the institution's research infrastructure and enhance the capability of individual faculty members and students to engage in competitive drug abuse research should be considered. These activities may include establishment of consultant and collaborative arrangements with investigators at other institutions, and the development of courses, curricula and seminars relevant to drug abuse research, including training in the responsible conduct of research. Enhancement of business-related (e.g., grants administration) and research-relevant (e.g., IACUC and IRB) capacities may be part of the strategy. The application must describe the support the institution needs in order to meet the drug abuse research capacity, and faculty and student development objectives proposed. The application should plan to address the institution's needs for resources and facilities that are important to conducting research in the specific drug abuse research area in which the institution proposes to focus. The plan should address, for example, research equipment, laboratory space, administrative support, faculty development and support needs, collaborative arrangements, consultant expertise, and data management and analysis support that are necessary for the research focus area proposed. A strategy for establishing and evaluating courses, curricula and seminars in areas relevant to research on drug abuse and addiction should also be included. Any plans for the enhancement of business and research administration capacity should be given. A critical assessment of the probable impact of the proposed program should be provided. The application should discuss the probable success of the proposed plan by describing the realistic changes in institutional policies, procedures, resources, and programs germane to the proposed program for drug abuse research and faculty and student development that are likely to occur. Applicants are expected to identify areas where development or change is desirable but may be difficult or not possible to address within the scope of this announcement, and show how the proposed plan of infrastructure development is likely to have a significant impact on the impetus and capacity of the institution to engage in drug abuse research. Discuss, for example, how the proposed plan will change the institution's ability to develop a drug abuse research focus and agenda; seek and support drug abuse research; prepare its students and faculty for drug abuse research careers and participation in sponsored research, in general; provide sufficient time and incentives for faculty to engage in drug abuse research; develop collaborations with established researchers/research institutions or drug abuse facilities; and expand library and resource materials. Faculty/Project Directors Development Plan This plan should detail the experiences and support intended for faculty members and how providing these will increase their capacity to independently conduct drug abuse related research. Much of the faculty development is expected to come from active involvement in the primary and/or pilot research projects supported by the program and through other career development activities such as workshops and training. Brief individualized plans must be submitted for faculty members serving as current and future research project directors supported under this program. Plans should include support for publishing research study results and scientific writing, in general. In addition, activities may be proposed for general research development activities for all faculty, e.g., seminars, grants development workshops. Faculty members who are currently conducting drug abuse research sponsored by other sources (e.g., federal, state, private sector) may be designated as Associate Project Directors. They may request funds to support minority undergraduate or graduate students to serve as Associate Research Assistants on their already funded projects. MIDARP funds may not be used to replace any research assistant positions supported by other federal or non-federal awards, and strong explanation of the benefits to be gained by the proposed research assistants and the research itself must be provided. Research Projects The program will provide support for primary or pilot research projects by one or more faculty members. New applications must not propose more than five research projects. Primary research projects refer to research studies that are fully developed with well-specified specific aims, background/significance, methods, hypotheses, and data analysis plans. Primary research projects should not exceed 10 pages in length each (see Application Procedures). They are not necessarily expected to meet the rigorous scientific review requirements of R01 applications expected of applicants who have drug abuse research experiences and resources. Pilot projects refer to research studies with convincing arguments of the potential significance of the research to the field but where methods and hypotheses are in their early formative stages. Pilot projects should not exceed five pages in length each (see Application Procedures). Pilot projects are expected to result in confirmation of the significance of the research, feasibility of the methods, and refinement/delineation of the hypotheses. At least two research projects, one of which must be a primary project, must be proposed. These projects must relate to the core research focus area and the institutional infrastructure support that is requested and be of significance to the drug abuse research field. The expectation is that this support in concert with the institutional infrastructure enhancement plan will enable the individual project investigators to become competitive in other sponsored research programs. In addition to costs associated with the particular study proposed, individual investigators may request support for minority undergraduate and graduate students underrepresented in the biomedical and behavioral sciences to serve as research assistants. The MIDARP Program Director may apply for a research project. Research Project Directors are responsible for the administration and implementation of their projects, with the guidance and support of the MIDARP Program Director and the institution. Project Directors should have sufficient training to enable them to conduct the research they propose, whether primary or pilot projects. It is expected that participating faculty will vary in the level of support they will need to become independent drug abuse researchers. To remain viable, the MIDARP must have research projects ongoing throughout the duration of the award, although individual research projects need not last throughout the full period of support, and start-up time is expected. For example, if five years of support are requested for the MIDARP, one or more primary or pilot research projects must be ongoing during the project period. Securing other support for research projects under the MIDARP umbrella such as from the university, foundations or other NIDA mechanisms is encouraged. Student Development Plan The goal of the Student Development Plan is to stimulate student interest in drug abuse and addiction research and to prepare students to pursue careers in drug abuse and addiction related areas through research development experiences. Students are expected to participate in research projects supported by the program and to be encouraged to pursue programs of study that will prepare them for careers in biomedical, behavioral and clinical research. It is also expected that students selected for participation in research activities will be provided with other research development opportunities such as participation in relevant conferences and mentoring in scientific writing. In addition, activities may be proposed to increase knowledge about drug abuse and career opportunities in drug abuse research for all students, e.g., seminars. MIDARP Program Director Each MIDARP must have a designated Program Director who will be responsible for the scientific and technical direction of the MIDARP. He/she will be responsible for the implementation of the institutional research development plan and will provide scientific oversight for the individual research project(s). He/she should be a scientist with appropriate training and experience and institutional authority and support to provide effective leadership to the project and guidance and support to project director(s). The Program Director will have overall responsibility for the goals, organization, administration, integrity, and conduct of the MIDARP. He/she will be responsible for: (1) recruiting faculty to participate in the individual research development activities; (2) assisting faculty in obtaining appropriate consultation and research training during the grant period; (3) developing the institutional infrastructure required to implement drug abuse research; (4) providing needed fiscal and other project support; (5) recruiting students and providing them with drug abuse research career support and experiences, and (6) providing the overall administration of the grant. External Advisory Board Plans should include details on the establishment of an Advisory Board to help guide the overall MIDARP and the development and implementation of the research projects. Ideally such a panel would consist of three to five external individuals with expertise in the drug abuse research focus area of the MIDARP and in the development of research development programs. Applications should contain a biographical sketch and a letter of commitment to serve from each proposed member of the advisory panel. Letter of Institutional Commitment The application should include a signed letter from an institutional official with authority to commit the institution to the establishment of the MIDARP program. It should detail the resources the institution is willing to provide including office and laboratory space, computer and internet access, library resources, and guarantees of protected time for faculty and students to perform the research and training activities enumerated in the application. The letter should also describe the institution’s level of confidence that the MIDARP program, under the guidance of the proposed Program Director, will be successful in achieving its goals. Progress Report for MIDARP Renewals (Competing Continuations) and Former MIDARP Grantees A progress report must provide the work accomplished as a result of the MIDARP award. A section on progress and continued needs must be included for applications to renew MIDARP awards (competing continuations). MIDARP awards may be renewed through the competing application process after the initial period of funding. The application’s assessment of needs and plans must demonstrate a need for continued development. Further, a Progress Report section must be included that provides evidence that the initial funding period did result in development of the capacity of the institution and its faculty, staff and students to conduct and pursue drug abuse research and research careers. Examples of evidence of progress should be noted (e.g., changes over time in drug abuse related publications, success in obtaining funding, faculty service as peer reviewers, evidence of growth in skills, creation of courses or seminars, recruitment and retention of high quality researchers and students, patents). Allowable Costs Up to $350,000 in direct costs per year may be requested for a project period ranging from three to five years. Funds may be used for activities needed to implement a MIDARP including but not limited to such expenses as salaries and benefits of MIDARP faculty, students and staff at levels commensurate with percent effort expended on MIDARP related administration, research and training activities; time devoted to developing, teaching or participating in courses and/or seminars in drug abuse and addiction; travel by faculty and students to scientific meetings; and travel to or by consultants, including an External Advisory Panel. Costs for resources designed to enhance recruitment and retention of scientists may be requested. Equipment, administrative personnel, enhancement of IRB/IACUC expertise and similar needs may be funded, as congruent with the assessment of needs and developmental plans. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations 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 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 are 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 the policy. 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. This policy announcement is found in the NIH Guide for Grants and Contracts Announcement dated June 5, 2000, at the following website: 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 these recommendations before submitting an application that will administer compounds to human subjects. The guidelines (revised September, 2000) are available on NIDA's Home Page at http://www.nida.nih.gov under Funding, or they 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. 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. APPLICATION PROCEDURES The PHS 398 research grant application instructions and forms (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html must be used in applying for these grants. Application receipt dates are: February 21 and August 21, 2002; February 21 and August 21, 2003 and February 23 and August 23, 2004. This version of the PHS 398 is available in an interactive, searchable format. The NIH will return applications that are not submitted on the 5/2001 version. For further assistance contact GrantsInfo, Telephone 301/710-0267, Email: GrantsInfo@nih.gov. Organize the application according to PHS form 398 instructions, except as noted. Precede the section that would normally be the Research Plan (Sections a-d if following standard instructions) with a one-page introduction that establishes the eligibility of the applicant institution. This does not count toward the other page limits. Then use no more than 25 pages (this would normally be the Research Plan; Sections a-d) to present an assessment of needs and the plans for the MIDARP including the faculty and student development plans. If the application is a request to continue an established MIDARP (a competing continuation application), the 25 pages must include an assessment of progress in the previous funding periods. Following the 25 pages, Primary Research Projects and Pilot Research Projects should be presented. Primary Research Projects should not exceed 10 pages per project and Pilot Research Projects should not exceed 5 pages per project. Applications exceeding the page limits will be returned without review. The completed original and five legible copies must be sent or delivered to: CENTER FOR SCIENTIFIC REVIEW NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE MSC-7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for courier/overnight service) REVIEW CONSIDERATIONS PAR applications will be evaluated for scientific and technical merit by an appropriate scientific review group convened 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. Review Criteria It is important to bear in mind that an application to establish or continue MIDARP programs may come from institutions that vary in their level of research readiness. Consequently, the needs of programs at different institutions may be very different. Accordingly, it is expected that reviews will appropriately consider the current research capabilities of the applicant institution. In addition, the progress of the MIDARP should be evaluated for competing continuation applications. Current Capacity Assessment: Evaluate the assessment of the present capacity of the institution to support biomedical and/or behavioral research in general and drug abuse research in particular, considering such elements as: a. Current faculty involvement and interest in drug abuse related research including current/recent research and participation in drug abuse related professional development activities. b. Student interest and involvement in drug abuse related research. c. Current curriculum offerings including courses and seminars in or related to drug abuse research particularly as they relate to the research focus of the proposed MIDARP. d. Proposed Principal Director/Program Director involvement in research and other activities related to drug abuse. e. Other factors related to the appropriateness of the environment, such as physical plant, instrumentation, financial support, collaborative relationships and opportunities to participate in and discuss scientific research. f. Degree to which the assessment has taken into account strengths of the institution. Note: Because the MIDARP is designed to strengthen capacity, the focus of the review is on how well current capacity was assessed, not the level of capacity, per se. Capacity Development Plan: Evaluate the appropriateness and adequacy of the Institutional Research Development Plan for establishing or continuing a MIDARP at the applicant institution, consistent with the needs identified in the assessment of current capacity. The faculty and student development plan are included in this section. a. Plans for faculty/staff development in drug abuse research careers to include the extent to which the proposed program will provide an appropriate environment for participating faculty and staff to pursue independent drug abuse research careers. Assessments may include the appropriateness and feasibility of faculty goals relevant to drug abuse research, availability of career development assistance provided to faculty in areas such as scientific writing and publication, research design and analyses, seminars on drug abuse topics, participation in meetings and conferences, mentoring, and research opportunities and support. b. Plan for student development to include the extent to which the proposed program will stimulate drug abuse relevant research/research career interest in students and provide them research experiences. This may include the appropriateness and feasibility of student goals relevant to drug abuse research and careers, and career development assistance provided to students in areas such as scientific writing and publication, participation in meetings and conferences, mentoring, research experiences, and preparation for graduate study. c. Plan for establishing and evaluating courses and seminars in or related to the MIDARP’s focus. d. Qualities and qualifications of the Program Director to lead the MIDARP program to successful accomplishment of its goals. Criteria may include how well he/she can provide direction and leadership in the research proposed, support of the institution, and confidence of the faculty and students. e. Plans for the establishment of an external advisory panel to provide advice and consultation to the Program Director on the direction and progress of the MIDARP. f. Likelihood that the proposed MIDARP program will have a significant impact on the capacity of the institution to engage in drug abuse research/research career preparation and fill a gap in drug abuse research at the applicant institution. g. Institutional commitment to the MIDARP. This might include consideration of guarantees of protected time for faculty and students to engage in drug abuse research, research mentoring and research training; opportunities to recruit and retain quality faculty and students; opportunities for career development for faculty engaged in drug abuse research. h. Plan to address research resource needs such as laboratory equipment, additional space, enhanced business and research administration, etc. For competing continuation applications, evaluate the extent to which the program has enhanced the research infrastructure of the applicant institution and enabled the institution to encourage and foster increased research/research career development activities in drug abuse and addiction for faculty and students. Evidence of progress may include: participation of faculty and students in drug abuse research; increased support and conduct of drug abuse research; changes over time in submission and publication of manuscripts on drug abuse or resulting from drug abuse research; success obtaining other sources of funding; service in drug abuse related activities such as peer reviewers for research grants, contracts, or manuscripts; indication of developing skills in students and faculty; ongoing seminars or courses; improvements in institutional processes and procedures related to sponsored research such as IRBs and other review requirements; students entering graduate programs with expressed interest in drug abuse; established collaborations with others around drug abuse research or activities; securing patents related to drug abuse research or treatment; etc. Primary Research Projects Primary research projects refer to research studies that are fully developed with well-specified specific aims, background, methods, hypotheses and data analyses plans. Evaluate the primary research projects to determine the overall thoroughness of the research plan given the resources and environment currently available and the likelihood that the research as developed will make a worthwhile contribution to the field. (a) Value of the study to the field and to the MIDARP’s research focus; importance of the specific aims or hypotheses/research questions. (b) Approach of the study is the conceptual framework, design, methods, and analyses adequately developed and appropriate to the aims of the project at this stage? Does the applicant acknowledge potential problem areas and consider alternative tactics? (c) Innovativeness of the proposed research. (d) Capability of the investigator to carry out the work proposed. (e) Adequacy of institutional resources and support to be made available including sufficient release time, if needed. Pilot Research Projects Evaluate the pilot research projects recognizing that these are pilot projects and are not intended to be fully developed protocols. (a) Value of the research question to the faculty member’s development, the MIDARP program and the field. (b) Appropriateness/adequacy of the literature review to demonstrate knowledge of the field and support the research question. (c) Appropriateness of the proposed methods for pilot work. (d) Adequacy of the resources and support provided to the faculty investigator. (e) Likelihood that the faculty investigator can administer the project with support of the program director and other institutional resources and support as needed. For the entire MIDARP, reviewers will also address: adequacy of the budget; adequacy of plans to include both genders, as well as minorities and their subpopulations and children in the proposed research; adequacy of protections for human subjects; adequacy of data and safety monitoring plans and adequacy of protections for live vertebrate animals as appropriate. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Staff members are available for consultation concerning application development. Potential applicants are encouraged to contact NIDA staff for information and guidance in developing research applications. Lula Beatty, Ph.D. Special Populations Office National Institute on Drug Abuse 6001 Executive Boulevard Room 4216, MSC 9567 Bethesda, MD 20892-9567 Telephone: (301) 443-0441 FAX: (301) 480-8179 Email: lb75x@nih.gov A complete list of programmatic areas and staff may be found at http://www.drugabuse.gov/Funding/resfundslist.html. Direct inquiries regarding fiscal matters to: Gary Fleming, J.D., M.A. Grants Management Branch National Institute on Drug Abuse 6001 Executive Boulevard, Room 3131 Bethesda, MD 20892 Telephone: (301) 443-6710 FAX: (301) 594-6847 Email: gfleming@mail.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 Bethesda, MD 20892 Telephone: (301) 443-2755 FAX: (301) 443-0538 Email: tlevitin@mail.nih.gov AUTHORITY AND REGULATION 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 Public Health Service (PHS) strongly encourages all grant 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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