DEVELOPMENTAL GRANTS FOR COLLABORATIVE INTERNATIONAL PROJECTS Release Date: December 20, 2000 PA NUMBER: PAR-01-038 National Institute on Alcohol Abuse and Alcoholism THIS PROGRAM ANNOUNCEMENT (PAR) 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. This Program Announcement (PA) replaces PA-96-033, which was published in NIH Guide March 8, 1996 and will expire three years from the date of issuance, unless reissued. PURPOSE The National Institute on Alcohol Abuse and Alcoholism (NIAAA) is soliciting applications for exploratory/developmental grants for collaborative international projects. The goal of this program announcement is to establish new or strengthen existing cooperative relationships between U.S. and foreign alcohol research scientists. While awards under this program are intended to enhance and extend the research of the U.S. scientist, it is expected that the projects supported will be mutually beneficial to advancing research on alcohol abuse and alcoholism in the collaborating nation. The objective of the exploratory/developmental grant mechanism (R21) is to encourage applications from individuals who are interested in testing innovative or conceptually creative ideas that are scientifically sound and may advance our understanding of alcohol abuse and alcoholism. Another objective is to encourage necessary initial development to provide a basis for important future research. Investigators are encouraged to use this mechanism to explore the feasibility of an innovative research question or approach, which may not be justifiable through extant research, or competitive as a standard research project grant (R01). The issues related to alcohol use, abuse, alcoholism, and the reduction of alcohol-related problems are global. Much has been learned from the international exchange of research findings and observations on the etiology, prevention and treatment of alcohol abuse and alcoholism. While much is gained from the exchanges that occur at international meetings and workshops, there is a need to assure that some exciting and potentially seminal findings reported by foreign investigators are more fully explored and developed through mutually beneficial collaborative research. 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), Developmental Grants for Collaborative International Projects 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, 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. The U.S. scientist must apply as principal investigator with a colleague or colleagues from foreign laboratories or research sites. It is recognized that scientific opportunities may arise that warrant a formal collaborative effort between the U.S. investigator and individuals from more than one country. The foreign collaborator(s) must hold a position at a public or private non-profit institution that will allow him or her adequate time and provide appropriate facilities to conduct the proposed research. The linkages for international collaborative efforts may be between institutions in the United States and those in industrialized nations or developing countries. Simultaneous submissions of both an exploratory/developmental and regular research grant application on the same topic will not be accepted. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT This PA will use the National Institutes of Health (NIH), exploratory/developmental grant (R21) mechanism. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. These are short-term awards with limited funding. Normally, grants under this PA will be for $50,000 or $75,000 per year for direct costs for two years. If strongly justified, grants can be considered up to the $100,000 (direct costs per year) and three year maximum levels. Facilities and Administrative (F&A) costs will be awarded based on the negotiated rate at the time of the award. These awards are not renewable, however, a no-cost extension of up to one year may be granted to the grantee institution prior to expiration of the project period. Investigators are encouraged to seek continued support for their research projects through a research project grant (R01). Awards are made to the U.S. applicant institution to support a collaborative research project that will be performed, in part, at the foreign collaborator’s research site. F&A costs will not be allocated to any funds sent for collaborative purposes to another country. Funds may be included to purchase supplies for the foreign collaborator’s laboratory and to support travel for both the U.S. and foreign collaborators, as justified by the needs of the research proposed. Annual awards will be made subject to progress achieved and continued availability of funds. Specific application instructions have been modified to reflect "MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts being examined by the NIH. Complete and detailed instructions and information on Modular Grant applications can be found at http://grants.nih.gov/grants/funding/modular/modular.htm. RESEARCH OBJECTIVES The NIAAA Exploratory/Developmental Grant (R21) Program provides limited financial support for exploring the feasibility of innovative or creative research questions within the research interests of the NIAAA. This includes basic and applied research on biochemical, physiological, genetic, and behavioral mechanisms leading to pathological drinking behavior, mechanisms of alcohol-induced organ damage, including fetal injury, and clinical, behavioral, and epidemiological approaches to more effective diagnosis, prevention, and treatment of alcoholism, alcohol abuse and alcohol-related problems. This Program Announcement also requests research applications that address epidemiology, behavior and biomedical research in alcohol abuse and infectious disease with a specific focus on the global epidemic of HIV infection. Such research studies could include: the impact of alcohol abuse and dependence on the progression of infection, epidemiology of alcohol problems and infectious disease, and the effect of alcohol abuse and dependence on compliance with medical therapies. While applications may involve a wide variety of biomedical, behavioral, clinical, social, cultural, or other disciplines, relevance to the mission of the NIAAA must be clear. The Institute"s mission statement, extramural research program descriptions, list of special emphasis areas, and active program announcements may be found at the NIAAA"s Internet web site: http://www.niaaa.nih.gov. The purpose of this program announcement is to encourage exploratory/developmental studies that would complement U.S. alcohol research efforts. The program will allow the accumulated knowledge and experience of U.S. alcohol research scientists to enhance collaboration with their colleagues on a global basis to address common issues and problems. While the problems and issues around alcohol use, abuse and alcoholism are universal, cross-national comparisons of research findings have been difficult. Differences in terminology and definition, study design, research methodology, and data analysis often yield reports which are inconsistent. Differences in drinking patterns, alcohol policies, the type of alcohol (alcoholic beverage) consumed, or differences in the social and medical consequences of abuse present obstacles to cross national comparisons. Because the United States is a multi-cultural, multi-ethnic nation with variations in the patterns, trends and practices around alcohol use and abuse, much can be gained from international research partnerships in this field where the experience of other cultures and availability of unique research opportunities will be helpful. It is anticipated that this program will provide support to pursue or verify intriguing research observations reported in foreign literature using different technologies or methodologies, to collaboratively pilot-test a hypothesis before a larger more complex project is developed, to develop new technology or to assure the study of appropriate comparison groups. The intent is to advance global understanding, contribute meaningfully to the international literature, and to significantly advance alcohol research efforts in the United States. Although international meetings and workshops have led to an increase in collaborative projects and constructive dialogue, more joint project planning and implementation would be beneficial. It is anticipated that collaborative efforts established through this program would facilitate the following: a) standardized assessments of epidemiological, biomedical, behavioral, treatment, prevention, and policy research observations, b) studies to explore more fully intriguing observations and innovations which might be critical to the advancement of the field, c) the development of unique methods or resources, and d) development of the foundation for the coordinated conduct of scientifically sound studies and interventions on an international basis. Applications may be made for support of research in any scientific area relevant to alcohol abuse. While applications may involve a wide variety of biomedical, biobehavioral, or clinical disciplines, relevance to the mission of the Institute must be clear. Applications for studies aimed at problems outside these areas will be returned without review. Areas of interest to NIAAA are described in program announcements, which can be obtained on the Internet (http://www.niaaa.nih.gov) or from the National Clearinghouse for Alcohol and Drug Information, P.O. Box 2345, 11426-28 Rockville Pike, Suite 200, Rockville, MD 20852, telephone (301) 468-2600. Travel costs must be for collaborative research purposes only and should be kept to a minimum. Travelers must use economy class airfare on a U.S. carrier. Per diem costs should be reduced for visits exceeding two weeks. Foreign collaborators must submit a signed letter from their institution and/or Public Health authority, as appropriate, stating approval to conduct the research. The foreign collaborator must also submit a signed letter describing his/her commitment to the collaborative effort. Domestic applicants should also be aware of the program announcements for the NIAAA Small Grant (R03) Program PA-99-098 and the NIAAA Behavioral Science Track Awards for Rapid Transition (B-START) PA-99-043. These two programs are for Small grants (R03) for pilot studies for up to $50,000 per year for direct costs for up to two years. The two NIAAA R03 programs limit the Research Plan (Sections A-D) to a total of 10 pages and also provide for expedited review and funding in a six or seven month period. This is two to three months shorter than the normal funding cycle for regular research grants (R01). The Small Grant (R03) and B-START program announcements are also available on the NIAAA Home Page. Foreign Institutions are not eligible for Small Grants or B-START awards. Applicants are requested to contact appropriate program staff at NIAAA for assistance in preparation of an application. Appropriate staff contacts are listed under INQUIRIES. 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. 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. 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 $100,000 per year. 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 $100,000) 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. o 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. - List selected peer-reviewed publications, with full citations, 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. 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. 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) REVIEW CONSIDERATIONS Applications will be assigned on the basis of established PHS referral guidelines. 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 National Advisory Council on Alcohol Abuse and Alcoholism. 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? What is the potential of the proposed study as a building block in the development of future research, particularly international collaboration? (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? Does the collaboration present opportunities for furthering alcohol research through the use of unusual talents, resources, populations, or environmental conditions in other countries which are not readily available in the United States or which provide augmentation of existing U.S. resources? (3) Innovation: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? (4) Investigator: 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)? What is the extent of past international collaboration, research, research training, scientific exchange, and joint publications and extent of prior research support from NIH or other Federal, State or private funding organizations? Does the foreign investigator have the ability to undertake and direct the foreign research activities of the project? (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? At the foreign institution? In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: 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 will also be evaluated. The reasonableness of the proposed budget and duration in relation to the proposed research. 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. In addition, applications will be evaluated by criteria specifically related to the intentions of this Program Announcement as outlined above. Additional consideration pertinent to the review of Exploratory/Developmental Grant (R21) applications: Pilot/feasibility studies may contain little or no preliminary data. Review should focus on whether the rationale for the study is well developed and whether the proposed research is likely to generate data that will lead to a regular research project grant or full-scale clinical trial. Adequate justification for the proposed work may be provided through literature citations, data from other sources, or investigator-generated data. AWARD CRITERIA Applications will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: scientific merit of the proposed project as determined by peer review, availability of funds, and program priorities. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Margaret M. Murray, M.S.W. Coordinator International Research and Training National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-2594 Fax: (301) 443-7043 E-mail: pmurray@willco.niaaa.nih.gov Faye J. Calhoun, D.P.A., M.S. Director Office of Collaborative Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-1269 Fax: (301) 443-7043 E-mail: fcalhoun@willco.niaaa.nih.gov Direct inquiries regarding fiscal matters to: Ms. Judy Simons Grants Management Branch National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-2434 Fax: (301) 443-3891 E-mail: js182a@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.273. 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, and 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.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices



NIH Office of Extramural Research Logo
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy
NIH... Turning Discovery Into Health®



Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.