INTERNATIONAL COLLABORATIVE ORAL HEALTH RESEARCH PLANNING GRANT Release Date: November 23, 1999 PA NUMBER: PAR-00-012 National Institute of Dental and Craniofacial Research THIS 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 of Dental and Craniofacial Research (NIDCR) will provide grant support for planning and protocol development of biomedical, epidemiological and behavioral studies in priority international research areas as identified in the Institute's Strategic Plan and facilitated by the Office of International Health (OIH), in consultation with the international research community. The purpose of this initiative is to bring together international researchers through collaborative partnerships that conduct research according to common protocols. The planning grant is intended to provide support for the development of a refined study design, organizational plan, detailed protocol criteria, and budget, for implementation of cross-national studies whose rationale and basic design are considered scientifically meritorious, and which cannot be accomplished solely within the U.S. (For the purposes of this PA, cross- national means that at least three countries are involved.) After these are completed, planning grant awardees may submit applications to conduct the full-scale study, in collaboration with international funding partners. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS- led national activity for setting priority areas. This PA, NIDCR International Collaborative Oral Health Research Planning Grant, addresses the priority areas of dental, oral and craniofacial health. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by foreign and 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. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. All multi-center applications must include a coordinating center. Applicants must demonstrate linkages for international collaborative efforts with institutions in other industrialized and/or developing nations as may be appropriate to address the scientific question. Applicant institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC Program Director or Principal Investigator should be included with the application. MECHANISM OF SUPPORT The mechanism of support for the NIDCR International Collaborative Oral Health Research Planning Grant is the exploratory/developmental research grant (R21). Applicants may request up to $75,000 in direct costs per year for each of two years. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. 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 For this PA, funds must be requested in $25,000 direct cost modules. A maximum of three modules can be requested for each of 2 years. A feature of the modular grant is that no escalation is provided for future years, and all anticipated expenses for all years of the project must be included within the number of modules being requested. Only limited budget information is required and any budget adjustments made by the Initial Review Group will be in modules of $25,000. RESEARCH OBJECTIVES Dental, oral and craniofacial diseases and disorders are among the most common health problems affecting the people of the United States and around the world. The burden imposed by a variety of dental, oral and craniofacial diseases and disorders range from birth defects such as cleft lip and palate, which occurs in every 1 in 525 to 714 live births, to injuries to the head and face, resulting in nearly 20 million emergency room visits per year, to devastating head and neck cancers, accounting for 8000 deaths and over 30,000 new cases per year in the U.S. alone. In the U.S., the treatment of over 1.2 million cancer patients each year can lead to painful mouth ulcers, mucositis, rampant dental caries, fungal infections, impaired taste and loss of function of the salivary glands. Oral infections still remain common in our populations. Dental caries is experienced by 45% of school children and 94% of adults have experienced this infection at some point in life. Periodontal infections occur in 90% of individuals older than 13 years and may be associated with other systemic diseases or conditions such as diabetes, cardiovascular disease, respiratory infections, and pre-term/low birth weight babies. Orofacial pain is likely to have been experienced by over 20% of adults in the past six months, is a major component of temporomandibular joint diseases (TMD) for at least 6% of adults, and is a major component of Bell's palsy, trigeminal neuralgia and fibromyalgia. Salivary gland dysfunction in the form of Sjogren's syndrome affects between 1 and 4 million Americans while over 30,000 individuals who have cystic fibrosis are also at higher risk for concomitant salivary gland dysfunction. Further, over 500 prescription drugs have xerostomic (dry mouth) side effects, increasing the risk for both bacterial and fungal oral infections as well as other oral conditions. Oral candidiasis is commonly found in HIV- infected patients. These health issues, though prevalent in the U.S., know no geographic boundaries. Oral conditions affect populations around the globe. Some of these conditions are more prevalent in certain countries or regions, while others are found in virtually all countries, but to varying degrees. There are many research topics that require international collaboration for questions to be appropriately addressed. For example, there are many areas of research that, because of limited access to patient populations within any single country, can only be conducted by international teams of scientists with access to large groups of people with the disease/condition to be studied. Similarly, there are areas of research where progress would be enhanced with the addition of unique scientific expertise only found internationally. The purpose of this initiative is to bring together international researchers through collaborative partnerships that investigate these special research issues according to common protocols. In pursuing new scientific opportunities, the NIDCR outlined its Strategic Plan, which focuses on and reorganizes its work into the following areas of research: o Inherited Diseases and Disorders The objective of this scientific program is to promote research that will advance our understanding of the underlying causes of craniofacial dysmorphologies such as ectodermal dysplasia, enamel dysplasia, cleft lip and palate, and osteogenesis imperfecta. These genetic malformations are estimated to occur in about five percent of the entire U.S. population, but prevalence is even higher within some groups in the U.S. and internationally. International collaboration in relevant areas such as genetic research, epidemiology, genetic registries, and treatment modalities can help speed progress toward the goal of improved prevention, diagnosis and treatment by combining scientific talents from different countries to focus on selected populations at high risk. An international approach that includes all disciplines relevant to specific craniofacial anomalies might dramatically enhance the possibility of resolving the many complex issues surrounding these malformations. o Infectious Diseases and Immunity This program encourages and supports basic, applied and developmental research in four broadly based scientific areas that will provide the basis for rapid development of knowledge of the etiology, pathogenesis, epidemiology, prevention, diagnosis, and treatment of oral infectious diseases such as periodontitis, dental caries, and oral candidiasis, and other infectious diseases which affect the oral and craniofacial complex such as HIV/AIDS, noma, and leishmaniasis. Although some of these emerging or re- emerging infectious diseases are rare in many of the industrialized parts of the world, they are quite prevalent in some developing countries, and are increasing rapidly in areas of poverty, malnutrition, and poor sanitary conditions. International collaboration can help to bring together researchers and resources to study these infectious diseases, and help to shed light on the epidemiology, the disease process and the role of the environment. Important areas of research might include factors contributing to microbial virulence, colonization and transmission; sequence analysis of the genome of oral microorganisms; molecular and cellular pathogenesis; and, host response and inflammation and the use of novel immunizing strategies, as well as other prevention interventions targeted on behavioral, social and environmentally-based determinants of infection and immunity. o Neoplastic Diseases This scientific program encompasses basic and applied research related to the prevention, etiology, early detection, progression, metastasis and treatment of oral cancer. The continuing poor prognosis for patients with oral cancers and the extreme disfigurement caused both by these malignancies and the treatments currently utilized to combat them emphasize the importance of multifaceted and innovative approaches to research in this area. A significant cause of mortality and poor quality of life, oral cancer is especially prevalent in Asian countries, parts of Europe, and the United States. Fortunately, the international community has numerous centers of expertise from which to draw for important collaborative studies. International collaboration can provide new perspectives in all aspects of the disease, from the clarification of risk factors to the control of these risk factors, early detection, pain management, the provision of effective treatment, and ultimately the prevention of disease. o Chronic and Disabling Diseases This multifaceted scientific program addresses research involving the chronic disabling diseases associated with the oral/craniofacial complex such as osteoporosis and related bone disorders, temporomandibular joint disorders, neuropathies and neurodegenerative diseases including those involving oral sensory and motor function, and autoimmune diseases such as Sjogren's syndrome and rheumatoid arthritis. Other research areas include studies aimed at elucidating the relationship between diseases of the oral/craniofacial complex and other systemic diseases (e.g., periodontitis in relation to diabetes, oral pathogens and cardiovascular disease, and oral pathogens and low birthweight infants). o Biomaterials, Biomimetics and Tissue Engineering This scientific program supports and encourages basic, clinical and applied research in the areas of biomimetics, tissue engineering and biomaterials in order to enhance the development of natural and synthetic materials used for the repair, regeneration, restoration and reconstruction of oral and craniofacial tissues and organs. The biomimetics aspect of the portfolio focuses on interdisciplinary materials science research that combines information from the study of biological structures and their function with physics, mathematics, chemistry and engineering, with the goal to develop novel materials (e.g., adhesives, new filling materials, temporomandibular joints). International coordination and networking is required for developing promising materials in the laboratory, conducting biologic assessment, and implementing clinical trials. o Behavior, Health Promotion and Environment This scientific program encourages and supports research aimed at assessing the interactive role of socio-environmental, behavioral, genetic and biomedical factors in oral/craniofacial diseases and conditions. Oral health promotion and disease prevention are keys to meeting public health objectives and enhancing clinical and biomedical interventions related to oral health. Removing inequalities in oral health is a prominent component of the U.S. Healthy People 2000 goals. International collaborative research is vital to understanding differences in health status among subgroups in a population resident in various settings, as well as the impact of various national systems of oral health care and education on oral health outcomes. Other topics for international research include traditional health beliefs and practices, systems of health care financing, and targeted community-based health promotion/disease prevention programs which would serve o reduce health disparities within a society. Applications under this PA must contain research planning proposals which fit within these strategic areas. Further information about these research topics may be obtained from NIDCR's Extramural Research website at http://www.nidcr.nih.gov/research/extramural/sciprog.htm. In each of these priority areas, a broad-based coalition of scientific talent is envisioned to encompass research needs in areas from molecular biology to the translational patient-oriented, epidemiological, behavioral, social and related health promotion sciences as may be appropriate for the research questions involved. The product of these research planning grants would be the enhanced or new infrastructure needed to enable submission of full-scale studies in the given subject area. These applications could then be submitted as investigator-initiated projects to the US government and/or any other potential collaborating funding agency, institution or foundation. Those applications coming subsequently to the NIH also will be peer-reviewed according to standard NIH procedures. Applicants should note that NIDCR funding of a planning grant does not imply a commitment by NIDCR to fund the proposed full-scale study. Applicants for research planning grants may include funds for activities such as but not limited to: o Travel expenses of individuals from multiple sites to planning meetings for the project. o Preliminary studies to guide selection of and/or refine research agenda, questions, and hypotheses o Analyses of existing data needed for refinement of study design and protocols o Preparation of detailed protocols. These protocols must be included in the Final Report for this award. The planning grant proposal should describe: o Importance and relevance of the scientific question. Describe the research project(s) under consideration and the potential for advancing the science and improving health. o The principal hypotheses to be tested, and the rationale for doing so. o Justification of the need for a global approach. Is the problem global in nature? Why is a multicountry project necessary to answer the question? Why can't the question be answered with a single-site study? o The organizational approach and timetable to be followed in building an international coalition, defining the research agenda and developing a specific international collaborative research protocol. o The participants in the planning process, their roles in the development of the plan, and their experience in related studies. o Ability of the Principal Investigator to bring together the necessary international network. While the actual building of the network is to be done after the planning grant is awarded, there must be clear evidence of commitment from researchers and institutions in other countries. Letters of commitment, including biosketches, by collaborating partners should be included. Describe the mechanism for identification and selection of additional collaborators. A proposal involving several (three or more) countries is expected. o Identifiable outcome of the grant. What products/documents are expected from the grant? How will this be used in developing the next stages of research? 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 is 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 "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 20, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 28, 1994, available on the web at: http://grants.nih.gov/grants/guide/notice-files/not94-100.html. INCLUSION OF CHILDREN 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 subject 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 children as subjects should read the "NIH POLICY AND GUIDELINES ON THE INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS," which were published in the NIH Guide for Grants and Contracts, Volume 27, No. 8, March 6, 1998, and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html. 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. Applications kits are available at most institutional offices of sponsored research and maybe obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892- 7910, telephone 301/435-0714, email: [email protected]. The title and number of the program announcement must be typed in Section 2 on the face page of the application. As with most applications to NIH, the research plan is limited to 25 pages. All information for review of the NIDCR International Collaborative Oral Health Research Planning Grant application must be included in the body of the application; appendices will not be considered during the review for this mechanism. 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 PHS398 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. o Under Personnel, List key 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 key 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; 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. The completed original application and three legible copies must be sent or delivered to: CENTER FOR SCIENTIFIC REVIEW NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892 BETHESDA, MD 20817 (for express/courier service) In order to facilitate the review of applications assigned to the NIDCR, the applicant must, at the same time, mail or deliver two copies of the application to: Dr. H. George Hausch Division of Extramural Research National Institute of Dental and Craniofacial Research 45 Center Drive, Room 4AN-38D MSC 6402 Bethesda, MD 20892-6402 REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by NIDCR. Applications that are complete and responsive will be reviewed and evaluated for scientific and technical merit by an appropriate peer review group convened by the NIDCR in accordance with the review criteria stated below. 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 Dental and Craniofacial Research Council. 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. Significance. Does this proposal address an important U.S or international 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? To what degree does the proposed collaboration present opportunities for furthering research through the use of unusual talents, resources, populations, or environmental conditions in other countries? Approach. Are the conceptual framework, design and methods 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 applicant propose concepts and strategies sensitive and appropriate to the potential research partners internationally? 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? Investigators. Are the investigators 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 partners? Environment. Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed collaborative arrangements take advantage of unique features of the scientific environment? Is there evidence of collaborative institutional support? The initial review group will also examine: the appropriateness of proposed project budget and duration; the adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research and plans for the recruitment and retention of subjects; the provisions for the protection of human and animal subjects; and the safety of the research environment. AWARD CRITERIA Applications will compete for available funds with all other recommended applications. Quality of the proposed project as determined by peer review, availability of funds, and program priority will be considered in making funding decisions. Applicants should be aware that, in addition to scientific merit, program priorities and program balance, the total cost of the proposed project and the availability of funds will be considered by the NIDCR staff and the National Advisory Dental and Craniofacial Research Council in making funding recommendations. In addition, the NIDCR values complementary funding from other public and private sources including foundations and industrial concerns. In circumstances in which applications have similar scientific merit, but vary in cost-competitiveness, the NIDCR is likely to select the more cost-competitive application for funding. INQUIRIES Written, email and telephone inquiries are encouraged early in the development of the application. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Dr. Judy Small Craniofacial Anomalies and Injuries Branch National Institute of Dental and Craniofacial Research Natcher Building, Room 4AN-24 Bethesda, MD 20892-6402 Telephone: (301) 594-2425 FAX: (301) 480-8318 Email: [email protected] Dr. Dennis Mangan Infectious Diseases Branch National Institute of Dental and Craniofacial Research Natcher Building, Room 4AN-24 Bethesda, MD 20892-6402 Telephone: (301) 594-2421 FAX: (301) 480-8318 Email: [email protected] Dr. Ann Sandberg Neoplastic Diseases Branch National Institute of Dental and Craniofacial Research Natcher Building, Room 4AN-24 Bethesda, MD 20892-6402 Telephone: (301) 594-2419 FAX: (301) 480-8318 Email: [email protected] Dr. Eleni Kousvelari Biomaterials and Biomimetics and Tissue Engineering Branch National Institute of Dental and Craniofacial Research Natcher Building, Room 4AN-24 Bethesda, MD 20892-6402 Telephone: (301) 594-2427 FAX: (301) 480-8318 Email: [email protected] Dr. Ken Gruber Chronic Diseases Branch National Institute of Dental and Craniofacial Research Natcher Building, Room 4AN-24 Bethesda, MD 20892-6402 Telephone: (301) 594-4836 FAX: (301) 480-8318 Email: [email protected] Dr. Norman Braveman Clinical, Behavioral and Health Promotion National Institute of Dental and Craniofacial Research Natcher Building, Room 4AN-24 Bethesda, MD 20892-6402 Telephone: (301) 594-2089 FAX: (301) 480-8318 Email: [email protected] Direct inquiries regarding fiscal matters to: Mr. Martin Rubinstein Office of Grants Management National Institute of Dental and Craniofacial Research Natcher Building, Room 4AN-44A Bethesda, MD 20892-6402 Telephone: (301) 594-4800 FAX: (301) 480-8301 Email: [email protected] AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.121. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. 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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