NIDCR EXPLORATORY AND DEVELOPMENTAL GRANTS IN CLINICAL RESEARCH RELEASE DATE: November 14, 2003 RFA Number: RFA-DE-04-009 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov/) COMPONENTS OF PARTICIPATING ORGANIZATION: National Institute of Dental and Craniofacial Research (NIDCR) (http://www.nidcr.nih.gov/) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.121 (Oral Diseases and Disorders) LETTER OF INTENT RECEIPT DATE: March 5, 2004 APPLICATION RECEIPT DATE: April 14, 2004 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism(s) of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Where to Send Inquiries o Letter of Intent o Submitting an Application o Supplementary Instructions o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA The National Institute of Dental and Craniofacial Research (NIDCR) recognizes that developmental, exploratory, or pilot studies in epidemiology, behavioral/social science research, or other areas of clinical research may be needed to collect preliminary data or establish an adequate foundation for R01 level clinical research addressing oral and craniofacial diseases and conditions. Thus, the NIDCR invites research grant applications to conduct developmental, exploratory, or pilot clinical research in areas where data are sparse or do not exist or where exploratory studies can establish an improved foundation for planning and developing sound R01 level clinical research grant applications. The goal of this announcement is to broadly encourage developmental, exploratory, or pilot clinical research that documents oral conditions and risk factors for oral and craniofacial diseases and disorders, investigates new methods of diagnosing oral disease, addresses behavioral research topics relevant to oral health, dental care, or oral health promotion, and /or identifies promising culturally appropriate approaches to prevent and reduce oral health disparities. This R-21 mechanism cannot be used to support pilot clinical trials. RESEARCH OBJECTIVES Background The NIDCR research activities cover a broad range of disease and conditions affecting the oral, dental and craniofacial structures. Diseases and conditions of interest to NIDCR as well as prominent gaps in knowledge are briefly described below. Dental caries is one the most prevalent diseases. It can occur at any age after tooth eruption and primary teeth are especially vulnerable. In the U.S., 18% of preschoolers have experienced dental caries. Although the prevalence of dental caries has declined in the past three decades, this oral disease remains the most common chronic disease of childhood in the U.S. By age 17, more than 80% of adolescents are affected by dental caries. However, dental caries is not evenly distributed throughout the population. For example, approximately 25% of children 5-17 years of age experience 80% of dental caries. Studies have shown that the people at highest risk for dental caries are least able to seek help: the poor, the very young, the elderly, and those with compromising medical conditions or disabilities. Like dental caries, periodontal diseases are an infectious disease caused by bacteria in dental plaque. Periodontal diseases range from mild forms such as gingivitis to severe forms that result in loss of periodontal support and tooth loss. Almost half of U.S. adults ages 35 to 44 have gingivitis which is a reversible inflammation of the gingiva. Approximately one-fourth has the more severe condition of periodontitis that results in periodontal attachment loss of at least 4 millimeters. Severe periodontal disease (6 millimeters or more of attachment loss) affects 14 percent of adults ages 45 to 54, and 23 percent of people 65 to 74-years of age. Tobacco use is a major risk factor for the development and progression of periodontal diseases. Furthermore, diabetes, particularly if poorly controlled, increases the risk for periodontal disease. Overall, data on the prevalence and risk factors for the infectious diseases of caries and periodontal disease come from national surveys, which report on white Non-Hispanics, Black non-Hispanics and Mexican Americans. Limited data is available on other segments of the population such as other Hispanic subgroups, Asian and Pacific Islanders, Native Americans, other minority populations, and special needs populations. These data are critical to guide the development of effective and appropriate oral preventive and treatment modalities for people in these population groups. In addition, development and testing of new and innovative diagnostic methods for caries and periodontal diseases are needed to promote effective prevention and early intervention. Without adequate saliva individuals may experience rampant tooth decay, mucosal infections such as candidiasis, loss of taste, and considerable oral discomfort. Salivary gland dysfunction can occur as a result of Sj gren’s syndrome that affects between 1 and 4 million mostly middle- aged women. Over 30,000 individuals who have cystic fibrosis also are at higher risk for salivary gland dysfunction. In addition, each year, an estimated 40,000 people lose salivary gland function as a result of radiation treatment for head and neck cancer and many medications are associated with salivary gland dysfunction. Limited data exist on the epidemiology of salivary gland dysfunction and such data are needed to appropriately design research to prevent and treat this disorder. A number of chronic and disabling pain conditions have oral, dental, and craniofacial manifestations. Epidemiologic studies suggest that orofacial pain occurs in at least 10% of the adult population. Orofacial pain by itself or as a symptom of untreated oral problems is often a major source of poor quality of life. Sources of orofacial pain include caries, some types of periodontal diseases, and neuropathic and musculoskeletal conditions. Few well-designed studies on the prevalence, etiology and pathogenesis of orofacial pain of non- dental origin are available. In addition, limited data are available on the underlying causes of muscular and joint facial pain that may involve physiological, behavioral or environmental factors. Numerous hereditary diseases, syndromes, developmental and acquired disorders have oral and craniofacial manifestations with serious functional, esthetic and social consequences. Craniofacial anomalies are among the most common of all birth defects. Birth defects and developmental disorders can be isolated or may be part of complex hereditary diseases or syndromes. Cleft lip and cleft palate occurs in about 1 to 2 out of 1,000 births in the U.S. Diseases of the bones and connective tissue such as Paget’s disease and osteogenesis imperfecta, osteoporosis, and scleroderma can have devastating oral and craniofacial effects. Similarly, ulcers and erosive lesions associated with oral and pharyngeal cancer treatment, immune dysfunction, infectious diseases such as herpes simplex, HIV/AIDS, fungal infection, aphthae as well as dermatologic and hematologic diseases may also have serious oral and general health implications. Additional research is needed to identify risk factors associated with these diseases so that effective means of preventing and treating these conditions may be developed and tested in clinical trials. Oral facial injuries can lead to disfigurement and oral dysfunction. While it is recognized that the leading causes of oral and craniofacial injuries are sport, violence, falls and motor vehicle collisions, there has been only limited research on the epidemiology, prevention, and behavioral consequences of orofacial injuries. The age-adjusted incidence rate of oral cancer for total oral cavity and pharynx was 10.3 per 100,000 people in 1999 and this represents approximately 3% of all cancers in the United States. The overall five- year survival rate is 53%, and it has not changed in the past thirty years. This five-year survival rate represents one of the lowest five- year survival rates of any of the major cancer sites. These low survival rates may be attributed to the fact that these cancers tend to be diagnosed at advanced stages. Moreover, treatment for these malignancies can be extremely disfiguring and often results in severe loss of function including speech impairment and the inability to swallow. Identification of effective means of screening and early cancer diagnosis is an important priority of the NIDCR. For the purpose of this RFA, people with special needs include those with developmental or acquired physical or mental disabilities, people with mental retardation (MR), people living with HIV/AIDS, and frail or functionally dependent elders. There are limited data documenting that individuals with these special needs are at increased risk for dental and oral disease. Such data are critical to guide the development of effective and appropriate oral preventive and treatment modalities for people with special needs. Goal and Scope This RFA provides funds for exploratory, developmental, or pilot clinical research that can help expand the scope of the NIDCR’s clinical research portfolio and its potential impact on oral health in the U.S. Some relevant aims for exploratory studies include: 1) documenting the prevalence, incidence, and risk factors for oral and craniofacial diseases and disorders, 2) investigating new methods for diagnosing oral disease, 3) examining determinants of behaviors that influence oral health or treatment outcomes and identifying approaches to increase behaviors supporting oral health, 4) identifying culturally appropriate preventive and treatment approaches for reducing oral health disparities, and 5) stimulating research directed to improving the oral health of special needs populations, including those with developmental or acquired physical or mental disabilities, people with mental retardation, people living with HIV/AIDS, and frail or functionally dependent elders. Applicants are encouraged to review the NIDCR Strategic Plan (http://www.nidcr.nih.gov/about/strat-plan/) issued in 2003 and NIDCR’s Plan to Eliminate Oral Health Disparities (http://www.nidcr.nih.gov/research/healthdisp/hdplan.pdf). Examples of exploratory research that would be responsive to this RFA include, but are not limited to the following: o Development, testing, and validation of methods for determining prevalence, incidence, risk factors and determinants of disease for a wide variety of oral diseases and orofacial pain in the general population and in minority and special needs populations o Development and /or testing of new diagnostic methods for diagnosing oral or craniofacial diseases or conditions o Development, testing, and validation of methods to measure the impact of oral health-related quality of life on the general health in special needs populations o Development and preliminary testing of innovative ways to improve oral health of people with special needs o Development of innovative health promotion approaches (social, educational, legal, fiscal) to address environmental, behavioral and biological determinants of oral health and oral health-related quality of life o Development of ways to improve dissemination and implementation of research findings to people with special needs, their caregivers, and health care professionals o Testing novel use of technology to improve dissemination of oral health information, compliance with recommendations for oral health care, oral health literacy, and oral health. o Exploratory clinical studies on cognitive neuroscience and persistent orofacial pain conditions. o Studies on the genetic and environmental determinants of oral health. o Studies using available databases to explore factors related to oral diseases and conditions, especially for high risk or poorly studied population subgroups. o Studies assessing gaps in oral health knowledge, attitudes and behaviors of the public and providers and developing innovative strategies to address such gaps. o Investigations aimed at clarifying the determinants of behaviors influencing oral health and evaluating promising strategies to improve oral health. o Studies assessing oral health literacy and language skills as these relate to oral health or treatment outcomes. o Studies assessing the impact of parent-child education or other interventions in dental settings relative to injury prevention, prevention of tobacco use, or dietary changes promoting oral health. In summary, a central focus of this RFA is to encourage developmental, exploratory, or pilot epidemiological and behavioral science research that addresses goals and objectives identified in the NIDCR’s Strategic Plan and that have the potential for strengthening NIDCR’s portfolio of clinical research. Some of these exploratory projects may strengthen the capability for developing scientifically meritorious clinical trials by identifying pertinent risk factors or promising interventions that warrant larger scale research efforts or multi-site clinical trials (see also http://www.nidcr.nih.gov/clinicalTrials/Clinical_Trials_Program.asp). MECHANISM OF SUPPORT This RFA will use the NIH Exploratory/Developmental (R21) award mechanism(s). As an applicant you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. Future unsolicited, competing-continuation applications based on this project will compete with all investigator- initiated applications and will be reviewed according to the customary peer review procedures. The anticipated award date is September 30, 2004. Applications that are not funded in the competition described in this RFA may be resubmitted as NEW investigator-initiated applications using the standard receipt dates for NEW applications described in the instructions to the PHS 398 application. This RFA uses just-in-time concepts. It also uses the modular budgeting formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular budget format. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm. FUNDS AVAILABLE The NIDCR intends to commit approximately $1.5 million in FY 2004 to fund 8 to 10 new grants in response to this RFA. Applicants may request a project period of up to two years with a combined budget for direct costs of up $275,000 for the two-year period. For example, the applicant may request $100,000 in the first year and $175,000 in the second year. The request should be tailored to the needs of the project. Normally, no more than $200,000 may be requested in any single year. Although the financial plans of the NIDCR provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. ELIGIBLE INSTITUTIONS You may submit (an) application(s) if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic institutions/organizations o Foreign institutions are not eligible to apply o Faith-based or community-based organizations INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct your scientific questions about epidemiology research issues to: Maria Teresa Canto, DDS, MPH Director, Population Sciences Research Program Clinical, Epidemiology & Behavioral Research Branch Division of Population and Health Promotion Sciences National Institute of Dental & Craniofacial Research National Institutes of Health 45 Center Drive, Room 4AS43B Bethesda, MD 20892-6401 Telephone:(301) 594-5497 Fax: (301) 480-8319 E-mail: maria.canto@nih.gov o Direct your scientific questions about behavioral research issues to: Patricia S. Bryant, PhD Director, Behavioral and Social Science Research Program Clinical, Epidemiology & Behavioral Research Branch Division of Population and Health Promotion Sciences National Institute of Dental & Craniofacial Research National Institutes of Health 45 Center Drive, Room 4AS43A Bethesda, MD 20892-6401 Telephone:(301) 594-2095 Fax: (301) 480-8319 E-mail: patricia.bryant@nih.gov o Direct your scientific questions about special needs populations and oral health disparities research issues to: Ruth Nowjack-Raymer, MPH, PhD Director, Health Disparities Research Program Clinical, Epidemiology & Behavioral Research Branch Division of Population and Health Promotion Sciences National Institute of Dental & Craniofacial Research National Institutes of Health 45 Center Drive, Room 4AS43J Bethesda, MD 20892-6401 Telephone:(301) 594-5394 Fax: (301) 480-8319 E-mail: ruth.nowjack-raymer@nih.gov o Direct your questions about peer review issues to: H. George Hausch, PhD Division of Extramural Activities National Institute of Dental and Craniofacial Research National Institutes of Health Building 45, Room 4AN-44F Bethesda, Maryland 20892-6402 Telephone: (301)594-2904 Fax: (301)-480-8303 Email: George.Hausch@nih.gov o Direct your questions about financial or grants management matters to: Mary Daley Grants Management Branch Division of Extramural Activities National Institute of Dental and Craniofacial Research National Institutes of Health Building 45, Room 4AN44B Bethesda, MD 20892-6402 Telephone: 301-594-4808 FAX: 301-480-3562 Email: daleym@mail.nih.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to: H. George Hausch, PhD Division of Extramural Activities National Institute of Dental and Craniofacial Research National Institutes of Health Building 45, Room 4AN-44F Bethesda, Maryland 20892-6402 Telephone: (301)594-2904 Fax: (301)-480-8303 Email: George.Hausch@nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). Applications must have a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number can be obtained by calling (866) 705-5711 or through the web site at http://www.dunandbradstreet.com/. The DUNS number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 document is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs must be submitted in a modular grant format. The modular grant format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step- by-step guidance for preparing modular grants. Additional information on modular grants is available at http://grants.nih.gov/grants/funding/modular/modular.htm. USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the Checklist, and three 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) At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to: H. George Hausch, PhD Division of Extramural Activities National Institute of Dental and Craniofacial Research National Institutes of Health Building 45, Room 4AN-44F Bethesda, Maryland 20892-6402 Telephone: (301)594-2904 Fax: (301)-480-8303 Email: George.Hausch@nih.gov APPLICATION PROCESSING: Applications must be received on or before the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to an RFA, it is to be prepared as a NEW application. That is, the application for the RFA must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NIDCR. Incomplete applications will not be reviewed. If the application is not responsive to the RFA, NIH staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next appropriate NIH review cycle. Applications that are complete and responsive to the RFA will be 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: o Undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed and assigned a priority score o Receive a written critique o Receive a second level review by the National Advisory Dental and Craniofacial Council (NADCRC). REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. Reviewers will be asked to evaluate the R21 application in light of the goals of the subsequent full-scale study (R01 type) to evaluate whether the proposed research is likely to have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of the following criteria in assigning the application’s overall score, weighting them as appropriate for each application. o Significance o Approach o Innovation o Investigator o Environment 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 study address an important problem for which developmental, exploratory, or pilot research is needed prior to the initiation of a full-scale (R01 type) study? Will the proposed R-21 research generate concepts, methods, or findings that will support a subsequent full-scale (R01 type) study? Are the planned questions/aims that are posed for the full-scale study important and, if achieved, lead to significant advancement of scientific knowledge? APPROACH: Does the applicant identify gaps that are critical to carrying out the full-scale clinical research study? 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? To what degree will support of the proposed developmental, exploratory or pilot research assist in the conduct of the full- scale study? Does the applicant demonstrate that once the developmental/exploratory research is completed a full-scale study could be carried out? INNOVATION: Is it likely that the developmental, exploratory, or pilot project will lead to full-scale research that employs novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? 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)? ENVIRONMENT: Does the scientific environment in which the developmental, exploratory, or pilot research and full-scale study 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 and / or community support? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score: PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below). INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the sections on Federal Citations, below). CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used in the project, the five items described under Section f of the PHS 398 research grant application instructions (rev. 5/2001) will be assessed. ADDITIONAL REVIEW CONSIDERATIONS BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research will be evaluated. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: March 5, 2004 Application Receipt Date: April 14, 2004 Peer Review Date: June/July 2004 Council Review: August 2004 Earliest Anticipated Start Date: September 30, 2004 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Availability of funds o Programmatic priorities. REQUIRED FEDERAL CITATIONS HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub- populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH- defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at http://grants.nih.gov/grants/funding/children/children.htm REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this RFA 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. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the Standards for Privacy of Individually Identifiable Health Information , the Privacy Rule, on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Those who must comply with the Privacy Rule (classified under the Rule as covered entities ) must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on Am I a covered entity? Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html. 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. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This RFA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.healthypeople.gov/. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm. The PHS strongly encourages all grant recipients to provide a smoke- free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.


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