DEVELOPMENTAL INFRASTRUCTURE FOR POPULATION RESEARCH RELEASE DATE: August 11, 2004 PA NUMBER: PAR-04-138 March 2, 2006 (NOT-OD-06-046) Effective with the June 1, 2006 submission date, all R03, R21, R33 and R34 applications must be submitted through Grants.gov using the electronic SF424 (R&R) application. This announcement will stay active for only the May 1, 2006 AIDS and AIDS-related application submission date. The non-AIDS portion of this funding opportunity expires on the date indicated below. A replacement R21 (PAR-06-362) funding opportunity announcement has been issued for the submission date of June 1, 2006 and submission dates for AIDS and non-AIDS applications thereafter. EXPIRATION DATE for R21 Non-AIDS Applications: March 2, 2006 EXPIRATION DATE for R21 AIDS and AIDS-Related Applications: May 2, 2006 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov) COMPONENT OF PARTICIPATING ORGANIZATION: National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.865 APPLICATION RECEIPT DATES: December 15, 2004 November 23, 2005 November 22, 2006 THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of this PA o Research Objectives o Mechanism of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Submitting an Application o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PA The National Institute of Child Health and Human Development (NICHD), through the Demographic and Behavioral Sciences Branch (DBSB), Center for Population Research (CPR), invites applications for developmental infrastructure grants in support of population research relevant to the DBSB mission. Applicants may request funds to support infrastructure development designed to: (1) enhance the quality and quantity of population research conducted at an institution; and (2) develop new research capabilities to advance population research through innovative approaches. A central goal of this program is to facilitate interdisciplinary collaboration and innovation in population research while providing essential and cost-effective core services in support of the development, conduct, and translation of population research based in centers or comparable administrative units. This is one of two announcements inviting applications under the Population Research Infrastructure Program. This announcement invites applications for Developmental Infrastructure Awards. A separate announcement, RFA-HD-04-022, invites applications for Research Infrastructure Awards. A table summarizing the differences between the Research Infrastructure Award and the Developmental Infrastructure Award is available at: http://www.nichd.nih.gov/PAR-04-138/PAR-04-138.htm. Developmental Infrastructure Awards are intended to support the development and demonstrate the feasibility of programs that have high potential for advancing population research, but have not yet fully developed the necessary resources and mechanisms to be competitive for a full-fledged Research Infrastructure Award. RESEARCH OBJECTIVES Background The Demographic and Behavioral Sciences Branch (DBSB) is one of three programs in the Center for Population Research of the NICHD. The mission of the Branch is to foster research on the processes that determine population size, growth, composition, and distribution, and on the determinants and consequences of those processes. This mission translates into a research portfolio that looks intensively at the demographic processes of fertility, mortality, and migration and at their broad interrelationships with larger social, economic, and cultural processes. Areas of supported research include fertility and family planning, sexually transmitted disease, family and household demography, mortality and health, population movement, population and environment, and population composition and change. Research supported by the Branch uses a broad spectrum of scientific approaches in the clinical, behavioral, and social sciences. During the years 1972-2000, NICHD provided infrastructure support for population research through the Center Core Grant (P30) and Specialized Research Center Grant (P50) mechanisms. In 1999, DBSB undertook a comprehensive review of this program to determine whether its structure and guidelines best served the future needs of population research. A report summarizing the results of this review is available at http://www.nichd.nih.gov/about/cpr/dbs/pubs/report.pdf and from the program contact named under WHERE TO SEND INQUIRIES, below. As a result of the review, DBSB is phasing out the P30 and P50 mechanisms in favor of the R24 and R21 mechanisms. This announcement uses the R21 mechanism. A corresponding announcement (RFA-HD-04-022) uses the R24 mechanism. Objectives and Scope The primary purposes of the Population Research Infrastructure Program are to provide resources to support and advance research that will improve understanding of the antecedents and consequences of population structure and change, facilitate interdisciplinary collaboration among investigators conducting population-related research, and promote innovative approaches to population research questions. An additional goal is to facilitate interaction among scientists in locations throughout the United States that contributes to the integration and coordination of population research. The Infrastructure Grant retains some of the characteristics of traditional P30 and P50 grants. It funds infrastructure to support a portfolio of population research housed in or coordinated by a center or other research unit (hereafter, "research unit" or "unit") at an institution. However, it is designed to move beyond the traditional center grant mechanism to allow institutions to aggressively pursue scientific opportunities appearing at the boundaries between traditional population research and allied fields, and to facilitate partnerships among diverse scientists and institutions. The Infrastructure Grant allows units to use funds to address not only the core support needs of existing projects, but to develop new directions and approaches to population research. It asks applicants to design and propose infrastructure programs that will advance the interdisciplinary reach, innovation, and impact of their research programs, in addition to serving the existing needs of researchers. The Developmental Infrastructure Award is intended to support the development of research units that have high potential for advancing population research. The award provides such units the opportunity to further develop the mechanisms and resources required to support and facilitate significant new contributions to the field, continue to build a substantial interdisciplinary portfolio of population research, and demonstrate their feasibility as full- fledged population research units. Applicants for Developmental Awards are expected to demonstrate the potential for becoming competitive for a Population Research Infrastructure Program Award (R24) within three to five years. Applicants must articulate a clear vision for their research unit and its current and future contributions to population research. Applicants must identify the signature population-related themes of the unit and these must be relevant to the DBSB mission. Signature themes are defined as research topics that exemplify the applicant program's most significant current and/or anticipated contributions to population research. The themes should reflect major strengths of the program and need not encompass all research topics covered by program researchers. Applicants must also articulate a vision for the potential future contributions of the program. Population Research Topics: A description of the DBSB mission is available at http://www.nichd.nih.gov/about/cpr/dbs/dbs.htm. Illustrative examples of population research topics that fall within the DBSB mission include, but are not limited to, the list that follows. Applicants may consult with program staff listed under WHERE TO SEND INQUIRIES to discuss the relevance of other topics to the DBSB mission. 1. Research on the antecedents and consequences of changes in population size, structure, and composition, including the documentation, analysis, and/or projection of population composition with respect to demographic, economic, social, and geographic characteristics; economic and social mobility; the relationship of economic, social, and cultural factors to population change; and the interrelationship between population and the physical environment. 2. Research on families and households, including studies of the determinants of trends in marriage, divorce, and cohabitation; the formation of and changes in household structures, fatherhood, patterns of child support and visitation with absent parents; the use of child care services; the relationship between changing fertility and family patterns and the well-being of children; intergenerational demography; and the implications of welfare and health policies on families. 3. Fertility research, including research on individual, social, economic, and cultural determinants and consequences of fertility and fertility trends, on the interrelationship between fertility patterns and education, work, union formation and dissolution, family structure, and health; and on contraceptive use, abortion, and sexual behavior. 4. Research on population movement and distribution, including studies of the determinants and consequences of international and internal migration and residential mobility, assimilation and adaptation of migrants; migrant selectivity; residential segregation; and spatial demography. 5. Demographic aspects of health, morbidity, disability, and mortality, including research on infant mortality and low birth weight; health disparities; research that relates demographic and social processes to mortality and health across the life course; and the health and well-being of children (see http://www.nichd.nih.gov/cpr/dbs/dbsb_mission.htm for more information). 6. Behavioral research on the sexual transmission of HIV, including demographic studies of sexual behaviors related to HIV transmission; studies of the interrelationships between social, institutional, economic, and cultural contexts and sexual behavior; studies of the interrelationships among pregnancy, pregnancy prevention, and HIV prevention; theoretically grounded intervention studies within these areas; and related methodological studies (see http://grants.nih.gov/grants/guide/pa-files/PAS-00-136.html). Infrastructure Support Applicants for the Developmental Infrastructure Award may request support in two categories: (1) Research Support Cores and (2) Developmental Infrastructure. Applicants are not required to request support in both categories; rather, they should request types and levels of support that best suit their needs and objectives. The NICHD expects that the amount and allocation of infrastructure support that applicants request will vary. For both categories of support, applicants must justify the types and amounts of support requested in terms of: (1) the scope, objectives, and current and potential impact of the applicant's research program; (2) the potential of the requested infrastructure to develop the resources and mechanisms required to build a substantial interdisciplinary portfolio of population research and facilitate significant new contributions to the field; and (3) the cost- effectiveness of the requested support. Applicants are expected to define guidelines for determining the eligibility of researchers and research projects to access resources provided under this program, and guidelines and procedures for allocating such resources. No restrictions on access (e.g., by students, investigators lacking research support, investigators in fields other than population research) are imposed under this announcement. However, applicants must demonstrate that their proposed guidelines and procedures for controlling access to core resources are consistent with the goal of effectively advancing the scientific program of the unit and the goals of this announcement. Definitions of Infrastructure Support Categories: 1. Research Support Cores provide shared resources that support the applicant's research program. Examples include: o Administrative Core, providing for coordination of research, editorial services, and/or assistance with grant application development and fiscal management of grants. o Computing Core, providing equipment and/or services supporting shared computing needs. o Information Core, providing support for retrieving information, materials, and data commonly used in population research. o Methodology Support Cores, providing support for specific methodologies employed in population research (e.g., GIS, statistical methods, biomarkers, survey methodologies). Research Support cores should be designed to advance the applicant's research program while providing essential, cost-effective services to support on-going research activities. Cores should be designed to facilitate and promote innovation in the science conducted by program researchers in addition to responding to researcher needs. Equipment and support services that are specific to individual research projects or researchers are not allowable. 2. Developmental Infrastructure refers to activities that promote the development of new research capabilities. Such activities may lead to outcomes such as innovative projects and approaches, new interdisciplinary collaborations, the scientific development of junior researchers, or the integration of experienced researchers from other fields into population research. Examples of potential developmental infrastructure activities include: o Seed grant programs, providing funds for the development of new research projects. Institutions proposing seed grant programs must develop guidelines and eligibility requirements appropriate to the goals of this PA, and procedures and policies for administration of the program. Issues that may be addressed include (but need not be limited to): (1) priorities for allocating funds (e.g., junior researchers, specified areas of research, interdisciplinary work, etc.); (2) procedures for reviewing applications; (3) requirements for leveraging funds or preparing research proposals to continue or expand the research project; (4) size of awards; (5) length of award periods; (6) number of awards permitted to an individual researcher; (7) mentoring arrangements; and (8) support for the program from the parent institution or other funding sources. o Faculty development, providing for partial salary support or other support for the recruitment of new faculty in scientific areas critical to the development of innovative and/or interdisciplinary research directions. Support for any one individual may not exceed three years in duration. o Activities that foster the development of new core services. For example, applicants may propose to hire consultants to assist with the design of GIS services, or conduct pilot studies to evaluate the cost-effectiveness of alternative modes of core service delivery. o Workshops, conferences, seminar series, and visiting scholar programs that lay the groundwork for new substantive work or foster new research collaborations. Applicants may propose to cooperate with other institutions in undertaking any of the above-mentioned infrastructure activities. Cooperative activities may include the development of research partnerships involving scientists in the applicant's program and colleagues in other institutions, and/or joint ventures with other institutions to provide research, developmental, or public infrastructure services. Proposed research partnerships must be justified in terms of the scientific advances to be gained through collaboration across institutions relative to those likely to emerge from within-institution partnerships. Examples of allowable activities include travel for project development and coordination and use of research support core, seed project, and research project funds. Applicants also may propose cooperative research support or developmental services in which the applicant and a Population Center or similar unit in another institution participate in joint funding and administration of a common service or resource. Examples might include a shared library, data archive or outreach effort. Partners in a cooperative venture need not be another funded applicant or Center. Applicants must clearly describe the rights and responsibilities of each proposed partner in the funding, administration, and use of shared resources. MECHANISM OF SUPPORT This PA will use the NIH Exploratory/Developmental Grant (R21) award mechanism. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. For this announcement, an applicant for an R21 award may request a project period of up to five years and a budget for direct costs of up to $150,000 per year. Developmental Infrastructure Awards are not renewable. This PA uses just-in-time concepts. It also uses the modular budgeting format (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 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_2003/NIHGPS_Part2.htm. ELIGIBLE INSTITUTIONS You may submit an application 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 Faith-based or community-based organizations o Domestic institutions Foreign institutions are not eligible to apply. Applicant institutions must have an established research center or other administrative unit (referred to as the "research unit" or "unit") that serves as a focal point for or coordinates population research across the institution. This unit must have a defined governance structure. The research conducted at the unit should reflect scientific benefits and cost-efficiencies resulting from cooperation and interaction among a pool of scientists with shared interests in population research. Applicants should have in place (or propose in their applications) effective mechanisms for fostering the development of an intellectual community that bridges investigators from different disciplines and different projects and promotes innovation in population research. To be eligible to apply, the unit must have at least three researchers who hold permanent (tenured or non-tenured) appointments with the applicant institution and can present evidence of research activity related to the mission of DBSB in all three of the following categories: (1) externally funded research grants or contracts in the past three years; (2) publications in peer-reviewed journals during the past three years; (3) papers in preparation and future plans for research. Because their association with the unit can be expected to be temporary, trainees, post-doctoral fellows, and visiting professors should not be counted toward this requirement. The "past three years" refers to the 36-month period preceding the application submission date for this announcement. "Externally funded" means funding is received from sources outside the institution; it may include funding from NIH, NSF, other federal agencies, state and local governments, and private foundations. Include only projects on which the individual has served as Principal Investigator or had substantial involvement, comparable to that indicated by identification of an investigator as "key personnel" on an NIH- funded grant. Note that the criterion used for unit eligibility above (at least three researchers with evidence of research activity in all three categories) differs from the criteria used to define page limitations under the Application Guidelines at http://www.nichd.nih.gov/PAR-04-138/PAR-04-138.htm. In latter case, the criterion of an "active researcher" is evidence of research activity in at least two of the three categories defined above. If your institution has held a P30, P50, or R24 grant from NICHD related to population research in the three years prior to the application date, you may not apply for a Developmental Infrastructure Award. Developmental awards are nonrenewable and institutions may not simultaneously hold a Developmental Award and a Population Research Infrastructure Program Award. Potential applicants may contact staff listed under WHERE TO SEND INQUIRIES, below, to discuss eligibility prior to submission of an application. 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 his/her 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. The Principal Investigator should be a scientist or science administrator who can provide effective administrative and scientific leadership. SPECIAL REQUIREMENTS Because the Infrastructure Program is expected to enhance the unit's competitiveness for NIH funding, the institution and pertinent departments are expected to show a strong commitment to the unit by providing additional infrastructure support at a level appropriate to the resources of the institution and the scope of the proposed program activities. Such commitment may be demonstrated by the provision of dedicated space, faculty appointments in subject areas relevant to the goals of the unit's research program, salary support for investigators or core staff, dedicated equipment, or other financial support for the proposed program. Applicants may consult with program staff listed under WHERE TO SEND INQUIRIES to discuss this requirement. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this announcement and welcome the opportunity answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct your questions about scientific/research issues to: Christine Bachrach, Ph.D. Demographic and Behavioral Sciences Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8B07, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-9485 FAX: (301) 496-0962 Email: bachracc@mail.nih.gov o Direct your questions about peer review issues to: Robert Stretch, Ph.D. Director, Division of Scientific Review National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 5B01, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-1485 FAX: (301) 402-4104 Email: stretchr@mail.nih.gov o Direct your questions about financial or grants management matters to: Rashawn Farrior Grants Management Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8A17, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-5482 FAX: (301) 402-0915 Email: farriorl@mail.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 D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dunandbradstreet.com/. The D&B number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 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. SUPPLEMENTARY INSTRUCTIONS: Applications for Infrastructure Development Awards (R21) should be prepared according to the Application Guidelines available at http://www.nichd.nih.gov/PAR-04-138/PAR-04-138.htm and from program staff listed under WHERE TO SEND INQUIRIES. All instructions and guidelines accompanying the PHS 398 are to be followed, with the exception of the sections modified by these guidelines. 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. 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: Robert Stretch, Ph.D. Director, Division of Scientific Review National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 5B01, MSC 7510 Bethesda, MD 20892-7510 Rockville, MD 20852 (for express/courier service) APPLICATION PROCESSING: Applications must be mailed on or before the receipt dates listed in the heading of this PA. The CSR will not accept any application in response to this PA that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight weeks. PEER REVIEW PROCESS Applications submitted for this PA will be assigned to NICHD. An appropriate scientific review group convened by the NICHD in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit. As part of the initial merit review, all applications will: o Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of 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 Child Health and Human Development Council. REVIEW CRITERIA Reviewers will evaluate each application for overall scientific merit according to the criteria provided below. Reviewers will also evaluate the merit of proposed Infrastructure Support Components. The size and scope of applicant programs are not a review criterion. NICHD believes that investments of infrastructure resources in small centers of excellence with focused scientific programs may be highly cost-efficient for the field. Reviewers are encouraged to take the number of researchers involved in a program into account in applying the additional review criteria below, particularly when evaluating current and potential program impact. While both larger and smaller programs are expected to demonstrate research activity of high quality, programs with fewer researchers would not be expected to demonstrate the same quantity of research productivity and program impact as programs with a greater number of researchers. OVERALL PROGRAM: One primary criterion will be used to evaluate the overall scientific merit of an application for a Developmental Infrastructure Award: The potential future contributions of the applicant program to population research: Reviewers will base their assessment of potential on such factors as the current level and trajectory of research productivity, innovation, quality, and significance; the significance of the applicant's central scientific objectives and signature population-related themes and the plan for advancing them; the program's plan for encouraging synergy and interaction among population researchers; and the applicant's success in contributing to the development of junior researchers. Applicants rated favorably on this criterion will have high potential for becoming competitive for a Research Infrastructure Award within three to five years. Three secondary criteria will also be used to assess the overall scientific merit of applications: o Quality and potential impact of proposed infrastructure program: Reviewers will examine the overall quality, scientific merit, and innovation of the activities to be supported. Reviewers will consider the likelihood, based on existing capabilities and proposed activities, that the proposed program will develop the resources and mechanisms required to build a substantial interdisciplinary portfolio of population research and facilitate significant new contributions to the field. o Research competence of key personnel: Reviewers will consider the capability and scientific credentials of the Principal Investigator to direct the program and maintain high standards of research collaboration; the specific technical qualifications of core directors; and the scientific accomplishments of all participating investigators. o Institutional commitment and environment: Reviewers will assess the nature and level of resource commitment from the institution in which the center is housed and any cooperating institutions, taking into account the institutional context. Reviewers also will consider the academic and physical environment as it bears on research opportunities, space, equipment, and the potential for interaction with scientists from various departments, institutions or disciplines. INFRASTRUCTURE SUPPORT COMPONENTS: Each individual element of the proposed infrastructure program will be evaluated separately based on the criteria below. Research Support Cores o Potential or actual contribution of the proposed core to advancing research within the applicant unit, by enhancing the productivity of the existing scientific program; fostering new scientific advances; facilitating interactions across disciplines and substantive areas of study; and/or advancing theoretical or technical approaches. o Appropriateness to the size and characteristics of the applicant's existing research program and the vision for the potential future contributions. o Qualifications, experience, and commitment to the program of the investigators responsible for the cores or activities and their ability to devote the required time and effort to the program; and o Cost-effectiveness of services or activities and appropriateness of cost- sharing arrangements with the institution, relevant departments, and other external infrastructure support programs. Developmental Infrastructure o Potential of the proposed activity to advance research within the applicant's unit by stimulating innovation in population research and/or fostering the development of junior researchers. o Appropriateness to the size and characteristics of the applicant's existing research program and the vision for the potential future contributions. o Qualifications, experience, and commitment to the program of the investigators responsible for the activities and their ability to devote the required time and effort to the program; and o Cost-effectiveness of services or activities and appropriateness of cost- sharing arrangements with the institution, relevant departments, and other external infrastructure support programs. o For seed grant programs proposed under "Developmental Infrastructure," the appropriateness and quality of procedures and policies for administering the program, such as guidelines for reviewing applications, priorities for allocating funds, requirements for leveraging funds, and size and length of awards, and other program guidelines. In the review of a subsequent application for R24 funding, seed grant programs will be reviewed for their success in developing funded research projects relevant to the mission of DBSB. Collaborations Applications proposing to undertake any infrastructure activity in cooperation with another institution will be evaluated for the value added by the involvement of other institutions and the appropriateness and adequacy of plans for the sharing of rights and responsibilities among proposed partners with respect to the funding, administration, and use of shared resources. 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 will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the sections on Federal Citations, below.) ADDITIONAL REVIEW CONSIDERATIONS BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. AWARD CRITERIA Applications submitted in response to a PA will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: o Scientific merit of the proposed project as determined by peer review o Availability of funds o Relevance to program priorities o Relevance of the applicant's research program to the DBSB mission. 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 is 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. 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 PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. 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). 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 PA 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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