SOCIAL AND DEMOGRAPHIC STUDIES OF RACE AND ETHNICITY IN THE UNITED STATES RELEASE DATE: January 16, 2003 PA NUMBER: PA-03-057 EXPIRATION DATE: February 1, 2006, unless reissued. National Institute of Child Health and Human Development (NICHD) ( National Heart, Lung, and Blood Institute (NHLBI) ( National Human Genome Research Institute (NHGRI) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) ( National Institute of Mental Health (NIMH) ( National Institute on Aging (NIA) ( National Institute on Drug Abuse (NIDA) ( THIS PROGRAM ANNOUNCEMENT CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanism of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators 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), the National Heart, Lung and Blood Institute (NHLBI), the National Human Genome Research Institute (NHGRI), the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the National Institute of Mental Health (NIMH), the National Institute on Aging (NIA), and the National Institute on Drug Abuse (NIDA) invite qualified researchers to submit research grant applications on the demography and social science of race and ethnicity in the United States. The goal of this program announcement is to encourage research that will improve understanding of race and ethnicity in social science and demographic research. Demographic and social aspects of race and ethnicity include issues related to understanding how the changing composition and conceptualization of race and ethnicity are affecting the U.S. socially, economically, and demographically, including how increasing racial and ethnic diversity are affecting population health and health disparities; issues related to the development of racial and ethnic identity and to interactions between racial/ethnic identification and demographic, health, and other outcomes; and issues related to the measurement of race and ethnicity, including racial and ethnic self-identification. Potential applicants are strongly encouraged to contact the Program Contact for Scientific/Research issues listed under WHERE TO SEND INQUIRIES, below. RESEARCH OBJECTIVES Since the 1960s, a series of policy changes have profoundly altered the racial and ethnic composition of the U.S. One key change was the 1965 amendments to the 1962 immigration law, which ended the immigration system that had favored immigrants from Europe, and resulted in increases in immigration from Asia and Central America. Other policy changes also influenced the economic, social, and political opportunities available to racial and ethnic minority groups; these included the Civil Rights Act of 1964, the 1965 Voting Rights Act, the Fair Housing Act of 1968, and the Supreme Court's 1967 ruling in Loving versus Virginia that ruled anti- miscegenation laws unconstitutional. Recent policy changes, such as the Personal Responsibility and Work Opportunities Reconciliation Act of 1996 (PRWORA, often referred to as "Welfare Reform"), have also significantly affected racial and ethnic groups and immigrants. Over the last four decades, the proportion of the U.S. population that is non-Hispanic white has declined, while the proportions that are Hispanic and Asian have risen substantially. By 2000, Hispanics had surpassed blacks as the largest racial/ethnic minority group in the U.S. The share of the population that reports being of more than one race or of mixed race in vital statistics registries and in social science surveys has also risen. In response to these demographic changes, as well as to an heightened attention to racial and ethnic identity, the legacy of the civil rights movement, and recent advances in genetic research that call into question some commonly held beliefs about the biological basis for apparent racial and ethnic differences, Americans are grappling with how to best conceptualize race and ethnicity. In 1997, the U.S. Office of Management and Budget (OMB) announced new standards for Federal data on race and ethnicity. The 2000 Census used these new standards, a system that allows for tabulation of 126 racial and ethnic categories. (See Section C. Conceptualizing, Measuring, and Modeling Race and Ethnicity, below, for a more detailed explanation of the OMB standards.) But while categorizing race and ethnicity becomes more detailed and exact, the meaning of these distinctions is becoming less certain. Recent advances in our understanding of genetics made possible by the Human Genome Project show that while the frequency of certain genetic variants does vary to some extent among groups based on the groups' ancestral origins, no precise boundaries between identified racial groups can be drawn (Collins, 2001). In May 2001, the editor of the New England Journal of Medicine declared "I maintain that attributing differences in a biologic end point to race is not only imprecise but also of no proven value in treating an individual patient ...Race is a social construct, not a scientific classification" (Schwartz, 2001). The editors of the Archives of Pediatrics and Adolescent Medicine were particularly critical of past uses of race and ethnicity in medical research, stating that "[a]nalysis by race and ethnicity has become an analytical knee-jerk reflex." Noting that the Human Genome Project has established " there is a greater range of genetic differences within such groups as 'white' or 'black' than between groups," and that "[t]here is no biological or scientific basis for the term 'race' much less the categories commonly used to describe it," they asked authors not to use race and ethnicity "when there is no biological, scientific, or sociological reason for doing so," and further instructed authors not to use race as an explanatory variable when it is actually capturing socioeconomic variation (Rivara and Finberg, 2001). Race continues to be a key variable in most social science research. Goals of this PA are to clarify what is captured by "race" and "ethnicity" in social science analysis, and to elaborate the complex social, cultural, and psychological processes that underlie racial and ethnic identification and its meaning in social science analysis. This PA calls for research in three broad areas: (a) causes and consequences of the changing racial and ethnic composition of U.S. society, including effects on population health and health disparities; (b) issues related to the development, maintenance, and consequences of racial and ethnic identity; and (c) developing and validating methods of conceptualizing, measuring, and modeling race and ethnicity. Illustrative examples of possible research topics are listed below each of these headings in the sections that follow. A. Causes and Consequences of the Changing Racial and Ethnic Composition of U.S. Society In the past 30 years the U.S. has become increasingly diverse. The primary factor contributing to this diversity has been immigration; other influences are differential fertility among ethnic and racial groups and intermarriage. Social and economic factors influencing the trend may include changes in labor markets, economic restructuring, changing social and cultural attitudes and norms, and social policies that influence the opportunities for social and economic advancement of minority individuals. The consequences of increasing diversity on the economic, social, and cultural fabric of the U.S. are still largely conjectural, and may ultimately depend on how communities, institutions, individuals, and social policy respond to the changes in our population. Research can make a valuable contribution to understanding these consequences and how they may be moderated under different circumstances. Examples of topics that address the changing racial and ethnic composition of U.S. society include, but are not limited to, the following: o How are economic, social, and demographic factors and government policies affecting the racial and ethnic composition of the U.S.? How are immigration and intermarriage affecting the racial and ethnic composition of the U.S.? How can the racial and ethnic composition be expected to change in the future? How do population projections change depending on how assumptions about immigration, intermarriage, and racial/ethnic identification and assignment are varied? o What are the implications of racial and ethnic diversity for institutions, residential patterns, and individuals' experiences, attitudes, and outcomes? For example, how do schools manage diversity and how does diversity affect student achievement, student attachment to schools, and students' patterns of friendships? How have these outcomes been affected by programs that have bused children to achieve racial integration of schools? How have changes in the ethnic and racial diversity of workplaces, social organizations, and other institutions affected behavior, values, and attitudes? What factors influence how institutions and communities respond to racial and ethnic diversity? o How and why have patterns of interracial and interethnic friendship, courtship, marriage, and childbearing changed in the U.S.? How have attitudes about interracial and interethnic friendship changed and how do attitudes vary across socioeconomic and demographic groups? How has our notion of the family changed with increasing racial and ethnic diversity? o How has increasing racial and ethnic diversity affected population health and health disparities? How has increasing diversity in the population affected the health care system? How has increasing diversity, including that resulting from immigration, affected social programs such as Medicare and Social Security, and policy reform? Does the aging process differ for individuals of different racial/ethnic groups? What are the moderators, mediators, and mechanisms that contribute to racial and ethnic variations in the burden of mental disorders as they occur across the life span and to racial and ethnic variations in the patterns of psychiatric diagnoses? B. Development, Maintenance, and Consequences of Racial and Ethnic Identity As the U.S. becomes ethnically and racially more diverse, and as the prevalence of interracial and interethnic unions and unions between immigrants and non-immigrants increases, issues related to how individuals acquire racial and ethnic identity and the consequences of racial and ethnic identity become increasingly important. For instance, research suggests that interactions between racial/ethnic identity and socioeconomic status are complex and sometimes interdependent (Waters, 2000), and that racial identity among adolescents, especially mixed race adolescents, can be very fluid (Harris, 2000). Examples of topics that address the development, maintenance, and consequences of racial and ethnic identity include, but are not limited to, the following: o How are racial and ethnic identities formed? How are racial and ethnic identity affected by socioeconomic status, by neighborhood, school, and other contexts, by the prevailing culture, and by the media? What factors affect how parents assign a race to their children? How do children learn to identify themselves and how fluid is this identification? How do differences in self-identified race/ethnicity and race/ethnicity as perceived and assigned by others interact and how do they affect socioeconomic, health, and demographic outcomes? o How does racial/ethnic identity interact with immigration status? How do immigrants to the U.S., especially those from nations with completely different methods of conceptualizing race and ethnicity, come to categorize themselves -and others, including non-immigrants -in the U.S. racial/ethnic pantheon? What affects their racial/ethnic identity in the U.S., and how does their racial/ethnic identification affect and respond to their assimilation? How does racial/ethnic identification change across generations? How do socioeconomic, demographic, and cultural contexts affect racial/ethnic identification among immigrants and their descendants? Even with its new complexity, does the U.S. scheme of categorizing race and ethnicity have salience for recent immigrant groups? o How does racial/ethnic identity relate to socioeconomic and demographic outcomes? For individuals with fluid racial/ethnic identity, such as immigrants and individuals of mixed race, do their socioeconomic status and demographic behavior affect how they identify themselves racially and ethnically? o Research suggests that how individuals with ancestors from more than one racial group identify themselves racially differs by age: older mixed race individuals are more likely than mixed race younger individuals to identify themselves as belonging to only one racial group. Are such findings the result of cohort effects or aging effects? Within cohorts, among individuals with mixed racial/ethnic heritage, how does racial and ethnic self-identity change as individuals age? o How does macro-level racial and ethnic composition affect individual's racial and ethnic identity and individual demographic behavior, health, and socioeconomic outcomes? How does racial and ethnic identity change over the life course and what effect does it have on behavior, health, and socioeconomic status? o How has the increasing diversity of the U.S. population affected the meanings given to racial and ethnic origins and identity and the role they play in organizing social life and economic opportunity? How and why has this process varied across different regions, communities, and socioeconomic groups within our country? C. Conceptualizing, Measuring, and Modeling Race and Ethnicity In light of the new OMB standards on collecting and categorizing data on race and ethnicity, and questions about the salience of race from the biomedical community, there is a heightened focus on how demographic and other social science research can most appropriately integrate race and ethnicity. Two important issues are: (1) whether the racial and ethnic categories used to describe groups with shared identity, characteristics, and experiences are valid, and (2) how to develop models that elaborate the causal processes that explain why racial and ethnic differences in outcomes exist. OMB's 1997 standards for classifying Federal data on race and ethnicity call for recording Hispanic status and race separately, expanding the number of racial categories to five, and allowing respondents to report that they belong to more than one racial group. The five racial categories are American Indian or Alaska Native; Asian; Black or African American; Native Hawaiian or Other Pacific Islander; and White. While the 1960 Census reported information on three race groups -white, black, and "other" -the 2000 Census collected information that will allow for 126 racial/ethnic categories: 63 distinct racial categories with each category broken down into Hispanic and non-Hispanic. Besides changing the racial and ethnic composition of the U.S. overall, immigration in the latter part of the 20th century has also changed the composition of racial/ethnic groups themselves. While "Asians" once primarily included Japanese, Chinese, and Filipinos, this group now also encompasses large numbers of Southeast Asians, Koreans, and Indians and other South Asians. In addition, Pacific Islanders such as Native Hawaiians, and persons with origins in the original peoples of Guam, Samoa, once included in an overall group called "Asian and Pacific Islanders," are now classified as a distinct category. And while 40 years ago nearly all African Americans/Blacks were descendants of U.S. slaves, this group now also embraces increasing numbers of immigrants (and their descendents) from the Caribbean, whose ancestors also came to the New World as slaves, and from Africa. Even the meaning of "white" has changed, as this group now includes small but increasing numbers of Middle Easterners and immigrants from the former Soviet bloc. In relation to opportunity and achievement, there are some indications that these differences within racial/ethnic groups are as important as differences across racial/ethnic groups. Changing Federal standards for collecting information on race and ethnicity can result in some comparison problems. Changing how data on race and ethnicity are collected could make it difficult to track changes in characteristics and outcomes for a given ethnic or racial group. It also affects comparisons of racial and ethnic groups across data systems, that is, comparisons between the Federal data, that are based on the new data standards, and other data systems, such as some of those collected at the state and local level, that do not use the new data standards. Examples of topics that address the conceptualization, measurement, and modeling of race and ethnicity include, but are not limited to, the following: o Is the racial and ethnic classification scheme that is now being used in Federal data systems, including the 2000 Census -five racial categories plus Hispanic and non-Hispanic as described above -meaningful and appropriate for social science research? Do these categories have different meanings across racial/ethnic groups and across cohorts? How do the questions and categories used when collecting racial and ethnic data affect responses to race and ethnicity questions and to other questions? In modeling socioeconomic, demographic, and health outcomes, are ethnic differences within racial groups more or less important than differences across the major groups? o When racial and ethnic differences in social, economic, demographic, and other outcomes are observed, what are the mechanisms explaining these differences? How can possible explanations for racial and ethnic differences -such as culture, racism, and social constraints -be measured and tested? Do socioeconomic and demographic processes differ for different racial and ethnic groups? If these processes do differ, how should racial and ethnic differences be modeled in social science analysis? o How can demographers and other social scientists conceptualize and analyze individuals of mixed race/ethnicity and how do the categories used affect the analysis? How much are research findings determined by how race and ethnicity -especially individuals of mixed race -are defined? Recent evidence suggests that the apparent trends in residential segregation depend entirely on how individuals of mixed race are categorized. How does the racial/ethnic categorization scheme used affect other analyses? References Collins, Francis (2001). Transcript of "2001 Genomics Short Course Dr. Francis Collins: 'The Human Genome Project And Beyond' 8-7-2001" Harris, David R. (2000). "Demography's Race Problem," paper presented at the National Institute of Child Health and Human Development panel, "Visions of the Future: A Town Meeting on New Directions in Population Research," Annual Meeting of the Population Association of America, March 2000 Rivara, Frederick P. and Laurence Finberg (2001). "Use of the Terms Race and Ethnicity," Archives of Pediatrics and Adolescent Medicine, Volume 155, February 2001. Schwartz, Robert S. (2001). "Racial Profiling in Medical Research," The New England Journal of Medicine, Vol. 344, No. 18, May 3, 2001. Waters, Mary C. (2000). Black Identities: West Indian Immigrant Dreams and American Realities, New York: Russell Sage Foundation Books. Relevant Research Links The Demographic and Behavioral Sciences Branch, Center for Population Research, NICHD, recently completed a long-range planning activity that culminated in a planning workshop in June 2001 and a report on the Branch's new strategic plan, "Goals and Opportunities, 2002-2006." This strategic plan, which includes several recommendations about population research on race and ethnicity, can be found at Other documents related to the long-range planning activity can be found at The National Institute on Aging Strategic Plan to Address Health Disparities can be found at Potential applicants specifically concerned with methodological research related to behavioral and social science research on race and ethnicity should also see the program announcement "Methodology and Measurement in the Behavioral and Social Sciences" at Potential applicants interested in basic social science research on the social and cultural constructs and processes used in health research, including race and ethnicity, should also see the program announcement "Social and Cultural Dimensions of Health" at MECHANISM OF SUPPORT This PA will use the NIH research project grant (R01) award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. The total project period for a research project grant (R01) application submitted in response to this PA may not exceed five years. At the end of this five-year period, awardees may apply for a competing continuation. This PA uses just-in-time concepts. It also uses the modular as well as the non-modular budgeting formats (see Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular format. Otherwise follow the instructions for non- modular research grant applications. 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 Domestic or foreign 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 your inquiries concerning this PA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into two areas: scientific/research and financial or grants management issues: o Direct your questions about scientific/research issues to: National Institute of Child Health and Human Development (NICHD) Rebecca L. Clark, Ph.D. Center for Population Research Demographic and Behavioral Sciences Branch 6100 Executive Boulevard, Room 8B07, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-1175 Fax: (301) 496-0962 Email: National Heart, Lung and Blood Institute (NHLBI) Ebony Bookman, Ph.D. Division of Epidemiology and Clinical Applications 6701 Rockledge Drive, Room 8166, MSC 7934 Bethesda, MD 20892-7934 Telephone: (301) 435-0446 Fax: (301) 480-1455 Email: National Human Genome Research Institute (NHGRI) Jean E. McEwen, J.D., Ph.D. Ethical, Legal, and Social Implications Research Program 31 Center Drive, Room B2B07, MSC 2033 Bethesda, MD 20892-2033 Telephone: (301) 402-4997 Fax: (301) 402-1950 Email: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Lawrence Agodoa, M.D. Office of Minority Health Research Coordination 6707 Democracy Boulevard, Room 653, MSC 5454 Bethesda, MD 20892-5454 Telephone: (301) 594-1932 Fax: (301) 594-9358 Email: National Institute of Mental Health (NIMH) Cheryl A. Boyce, Ph.D. Developmental Psychopathology and Prevention Research Branch 6001 Executive Boulevard, Room 6200, MSC 9617 Bethesda, MD 20892-9617 Rockville, MD 20852 for delivery Telephone: (301) 443-0848 Fax: (301) 480-4415 Email: National Institute on Aging (NIA) Georgeanne E. Patmios, M.A. Behavioral and Social Research Program 7201 Wisconsin Avenue, Suite 533, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-3138 Fax: (301) 402-0051 Email: National Institute on Drug Abuse (NIDA) Yonette Thomas, Ph.D. Division of Epidemiology, Services and Prevention Research Epidemiology Research Branch 6001 Executive Boulevard, Room 5174, MSC 9589 Bethesda, MD 20892-9589 Telephone: (301) 402-1910 Fax: (301) 480-2543 Email: o Direct your questions about financial and grants management matters to: National Institute of Child Health and Human Development Kathy Hancock Grants Management Branch 6100 Executive Boulevard, Room 8A17G, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-5482 Fax: (301) 402-0915 Email: National Heart, Lung and Blood Institute Holly Atherton Grants Operations Branch 6701 Rockledge Drive, Room 7152, MSC 7926 Bethesda, MD 20892-7926 Telephone: (301) 435-0177 Fax: (301) 480-3310 Email: National Human Genome Research Institute Jean Cahill Grants Management Officer 31 Center Drive, Room B2B34, MSC 2031 Bethesda, MD 20892-2031 Telephone: (301) 435-7858 Fax: (301) 402-1951 Email: National Institute of Diabetes and Digestive and Kidney Diseases Trudy Hilliard Grants Management Branch 2 Democracy Plaza, Room 717, MSC 5456 Bethesda, MD 20892-5456 Telephone: (301) 594-8859 Fax: (301) 480-4237 Email: National Institute of Mental Health Brian Albertini Grants Management Branch 6001 Executive Boulevard, Room 6115, MSC 9605 Bethesda, MD 20892-9605 Telephone: (301) 443- 0004 Fax: (301) 443- 0219 Email: National Institute on Aging Traci Lafferty Grants and Contracts Management Officer National Institute on Aging 7201 Wisconsin Avenue, Suite 2N212, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-1472 FAX: (301) 402-3672 Email: National Institute on Drug Abuse Gary Fleming, J.D., M.A. Grants Management Branch 6001 Executive Boulevard, Room 3131, MSC 9541 Bethesda, Maryland 20892-9541 Telephone: (301) 443-6710 Fax: (301) 594-6849 Email: SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted at the standard application deadlines, which are available at Application deadlines are also indicated in the PHS 398 application kit. 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 includes step-by-step guidance for preparing modular grants. Additional information on modular grants is available at SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR: Applications requesting $500,000 or more in direct costs for any year must include a cover letter identifying the NIH staff member within one of NIH institutes or centers who has agreed to accept assignment of the application. Applicants requesting more than $500,000 must carry out the following steps: 1) Contact the IC program staff at least six weeks before submitting the application, i.e., as you are developing plans for the study; 2) Obtain agreement from the IC staff that the IC will accept your application for consideration for award; and, 3) Identify, in a cover letter sent with the application, the staff member and IC who agreed to accept assignment of the application. This policy applies to all investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended or revised version of these grant application types. Additional information on this policy is available in the NIH Guide for Grants and Contracts, October 19, 2001 at SENDING AN APPLICATION TO THE NIH: The title and number of the program announcement must be typed on line 2 of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the checklist, and five signed photocopies in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) APPLICATION PROCESSING: Applications must be received by or mailed on or before the receipt dates described at 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. PEER REVIEW PROCESS Applications submitted for this PA will be assigned on the basis of established PHS referral guidelines. An appropriate scientific review group convened in accordance with the standard NIH peer review procedures ( will evaluate applications for scientific and technical merit. As part of the initial merit review, all applications will: o Receive a written critique 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 second level review by the appropriate national advisory council or board. 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 your application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning your application's overall score, weighting them as appropriate for each application. Your 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, you may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) SIGNIFICANCE: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? (2) APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? (3) 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? (4) INVESTIGATOR: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the Principal Investigator and other researchers (if any)? (5) ENVIRONMENT: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: PROTECTIONS: The adequacy of the proposed protection for humans, animals, or the environment, to the extent they may be adversely affected by the project proposed in the application. INCLUSION: 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 included in the section on Federal Citations, below.) 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 REQUIRED FEDERAL CITATIONS MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: 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 AMENDMENT "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 (; a complete copy of the updated Guidelines is available at 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 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 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 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. 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 Program Announcement (PA) is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Nos. 93.864 (NICHD), 93.837 (NHLBI), 93.172 (NHGRI), 93.849 (NIDDK), 93.242 (NIMH), 93.866 (NIA), and 93.279 (NIDA) and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies described at and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. 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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