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HEALTH DISPARITIES AMONG MINORITY AND UNDERSERVED WOMEN RELEASE DATE: August 27, 2004 PA NUMBER: PA-04-153 EXPIRATION DATE: August 28, 2007 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 Nursing Research (NINR) (http://www.nih.gov/ninr) National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov/) National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov) National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (http://www.niddk.nih.gov) Office of Research on Women’s Health (ORWH) (http://www4.od.nih.gov/orwh/) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): No. 93.361, 93.865, 93.279, 93.847 THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanism(s) of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Where to Send Inquiries o Submitting an Application o Supplementary Instructions o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PA The purpose of this initiative is to stimulate research aimed at reducing health disparities among racial/ethnic minority and underserved women. More specifically, this initiative seeks applications for: (1) research related to health promotion or risk reduction among minority and underserved women age 21 and older; and, (2) intervention studies that show promise for improving the health profile of minority and underserved women. Investigators responding to this announcement should focus on enhancing the body of knowledge of a variety of factors (e.g., social, economic, demographic, community, societal, personal, cultural) influencing the health promoting and health compromising behaviors of racial and ethnic minority women and underserved women and their subpopulations. The focus of this program announcement is on women age 21 and older, but investigators may also focus on the childhood antecedents of adult health disparities. Each of the sponsors of this initiative has a strategic plan, which addresses health disparities and minority health. This can be found on each of the respective web sites. For purposes of this initiative, the definitions of health disparities and minority populations are those outlined in the NINR’s Strategic Plan on Reducing Health Disparities located at www.nih.gov/ninr. Health Disparities are defined as differences in the incidence, prevalence, mortality, and burden of diseases and other adverse health conditions that exist among specific population groups in the United States when compared to non-Hispanic Whites. Specific population groups are identified as African- Americans, Asian and Asian Pacific Islanders, Hispanic and Latino, Native American and Native Alaskan. Medically Underserved Populations are defined as populations that have inadequate access to, or reduced utilization of high quality health care. Included are low literacy, rural and low-income populations, including older minority women, geographically isolated women, lesbians, hearing and visually impaired women, physically or mentally disabled women, migrant workers, immigrant and refugee women, and language minority women. (Language minority individuals are those who do not speak the most common language or languages in a country or region, which in the United States means individuals who do not speak English. For information on language minority populations, see http://www.nichd.nih.gov/publications/pubs/diverse_voices.htm.) (For NICHD’s plan to reduce health disparities, see http://www.nichd.nih.gov/strategicplan/disparities/disparities.pdf.) RESEARCH OBJECTIVES Racial and ethnic minorities represent one of the fastest growing segments of our society. Women in particular are becoming increasingly diverse as well. Of the 281 million people counted by the 2000 Census, more than half were women. Approximately 41 million of these were women of color, representing 29% of all the U.S. population. Of these, 43% were classified as black non- Hispanic, 41% Hispanic, 13% Asian non-Hispanic, 0.4% Native Hawaiian or other Pacific Islander (non-Hispanic) and 2.5% American Indian/Alaska Native (non- Hispanic). While the population of racial/ethnic minority groups is growing in this country, the disparities in health between minorities and the majority group remain large in some cases. Furthermore, according to the latest figures from the U.S. Bureau of the Census, in March 2002, there were 32.5 million foreign-born individuals living in the United States, representing 11.5 percent of the U.S. population. Foreign-born individuals represent increasing shares of the minority population of the United States, and immigrant status is related to many health outcomes, although the mechanisms are not fully understood. It is well noted that many of the disparities in health are related to a variety of lifestyle factors and may be amenable to primary and or secondary preventive measures. For example, physical activity aids in preventing coronary heart disease (CHD); physical inactive people are almost twice as likely to develop CHD. Regular physical activity is also noted to enhance muscle function and physical performance. Studies show that women are less likely to engage in physical activity when compared to men across the life span. In 1997, at least 50% of women of color led sedentary lifestyles never engaging in any vigorous, moderate, or light physical activity. A higher percentage of African American and Hispanic women report no leisure-time physical activity when compared with non-Hispanic White women. Low levels of physical activity are also noted among women residing in rural areas. For example, 60% of African American and American Indian/Alaska Native women residing in rural areas report sedentary lifestyles during a two week span of time, followed by 48% White women and 42% Hispanic/Latino women. A similar profile is reported when discussing overweight and obesity as a major contributor to a number of preventable causes. Obesity is more prevalent among African American and Hispanic women when compared to whites. Between 1988 and 1994, 69.6% Mexican American women were considered overweight, as were 68.5% African American women. This compares with 47.2% White (non Hispanic) women who were overweight. Women of lower income and lower education are also more likely to be overweight or obese. While tobacco use has declined since the late 1980’s among African American and white females, younger Hispanic and Asian American women have increased their use of tobacco. In a survey between 1997-1999, the age adjusted percent of women age 18 and older who reported smoking included 31.7% American Indian/Alaska Native, followed by 24.0% non-Hispanic Whites, 21.5% African American, 13.1% Hispanic/Latino and 10.3% Asian/Pacific Islander. Higher rates of tobacco consumption are also noted among women with less income and education. With respect to HIV/AIDS, between 1985 and 2000, HIV/AIDS has affected a growing number of women in the United States, increasing from 7 to 17% with the disease disproportionately affecting women of color. African American and Hispanic women accounted for approximately 77% of all cases reported by 1998, 61,874 and 21,937 cases respectively. In 2002, the majority of HIV/ADIS cases occurred among African American and Hispanic women. These disparities in health are further influenced by low-income status and lack of access to health care. Racial and ethnic minority and underserved women, including foreign-born women, are disproportionately represented among the 43 million people who lack health insurance. Women in this category are at an increased risk for a variety of chronic illnesses including hypertension, heart disease, cancer, and diabetes. It is important to note that not all racial and ethnic minority women are categorized as underserved, and not all underserved women are characterized as being racial and ethnic minority women. In an effort to improve the nation’s health, Healthy People 2010 encourages the design of strategies and action plans to address one or more of the leading health indicators. Successful interventions that target these indicators are integral to improving the quality of life and reducing the incidence of the leading causes of death for all people. Specifically, this initiative will target minority and underserved women with a special emphasis on six of the leading health indicators: physical activity, overweight and obesity, tobacco use, substance abuse, responsible sexual behavior, and injury and violence. Many of the leading health indicators are interrelated and thus may be amenable to interventions that target one or more indicators simultaneously. Studies targeting a group of health indicators may be more successful in improving the overall health profile of minority and underserved women. Thus, applicants responding to this initiative may address one leading health indicator in a single application or two or more of the aforementioned health indicators as a complex or group in a single application. OBJECTIVES: Potential research topics include but are not limited to: o Interventions that incorporate an array of factors such as, physiological, social, economic and demographic, emotional, environmental, cultural and genetic factors thought to influence the development of two or more of the leading health indicators. o Interventions designed to reduce risk factors and exposures that lead to development of one or more of the leading health indicators. o Unique and culturally sensitive interventions that promote increased physical activity and healthier dietary intake or other health enhancing behaviors. o Innovative interventions that target prevention or cessation of tobacco use, substance abuse, and injury and violence simultaneously. o Unique interventions that incorporate technology in decision making related to health promotion. o Interventions that target the specific health promotion needs of minority women with a known illness and/or disability. o Studies that test and evaluate the cost effectiveness of health promotion interventions conducted in nontraditional settings. o Studies that evaluate how gender and immigrant status (including legal and visa status) affect health and access to health care. o The development, implementation, and/or evaluation of interventions based on the science of social/sexual networks to help prevent the sexual transmission of HIV and other STDs among ethnic/racial minority and underserved women. Descriptive components of the research may be proposed specific for understudied populations. Investigators must provide a strong justification and rationale along with a discussion of how such descriptive work will lead to the design of interventions aimed at reducing health disparities among racial/ethnic minority and/or underserved women in future studies. Potential research topics that are descriptive or analytical and will lead to the development of interventions include but are not limited to: o Studies on how social and cultural understandings of gender, gender-related beliefs and expectations, and gender dynamics affect HIV and other STD risk among women from different racial, ethnic, and socioeconomic groups. o Studies on how interpersonal and peer-related factors impact on HIV and other STD risk among women from different racial, ethnic, and socioeconomic groups. o Studies on barriers to prevention, diagnosis, and treatment of STDs among racial/ethnic minority and underserved women. o Studies that identify specific social, cultural, and community factors that lead to racial/ethnic and socioeconomic differences in: 1) responses to disabilities and to rehabilitation interventions, 2) access and use of outpatient rehabilitation services with varying impacts on health outcomes, 3) risks in developing secondary conditions associated with disabilities among women, and, 4) return to work, school, and other educational opportunities. MECHANISMS OF SUPPORT This PA will use the NIH R01 and R21 award mechanisms. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. The objective of the R01 mechanism is to support a discrete, specified circumscribed project. Investigators are encouraged to explore the feasibility of an innovative research question or approach that will provide a basis for future research projects. Exploratory/developmental grants (R21) are limited to 2 years of support 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. Please see the NIH-wide R21 program announcement (PA-03-107) (see http://grants.nih.gov/grants/guide/pa-files/PA-03-107.html). Please see the "Submitting an Application" section for more details. This PA uses just-in-time concepts. It also uses the modular budgeting as well as the non-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. Otherwise follow the instructions for non-modular budget research grant applications. 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. 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 or foreign institutions/organizations 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. SPECIAL REQUIREMENTS Data and safety monitoring is required for all types of clinical trials. The establishment of data and safety monitoring boards (DSMBs) is required for clinical trials involving interventions that entail potential risk to the participants. 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: Yvonne Bryan, PhD, RN Program Director National Institutes of Health Office of Extramural Programs National Institute of Nursing Research 6701 Democracy Blvd, Room 710, MSC 4870 Bethesda, MD 20892-4870 Telephone: (301) 594-6908 Fax: (301) 480-8260 Email: bryany@mail.nih.gov Rebecca L. Clark, Ph.D. Health Scientist Administrator National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8B07, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-1175 Fax: (301) 496-0962 Email: rclark@mail.nih.gov Lisa Begg, Dr.P.H., R.N. Director of Research Programs Office of Research on Women's Health DHHS/NIH/OD Bethesda, MD. 20892 Telephone: 301/496-7853 Fax: 301/402-1798 Email: beggl@od.nih.gov Lawrence Agodoa, MD Director of Office of Minority Health Research Coordination 2 Democracy Plaza Room 653 Bethesda, MD 20892 Telephone: 301-594-1932 Fax: 301-594-9358 Email: la21j@nih.gov Cora Lee Wetherington, Ph.D. Women & Gender Research Coordinator National Institute on Drug Abuse 6001 Executive Boulevard, Room 4282, MSC 9555 Bethesda, MD 20892-9555 Phone: 301-435-1319 FAX: 301-594-6043 Email: cwetheri@nida.nih.gov Direct your questions about financial or grants management matters to: Ms. Cindy McDermott Office of Grants and Contracts Management NIH, National Institute of Nursing Research 6701 Democracy Blvd, Room 710, MSC 4870 Bethesda, MD 20892-4870 Telephone: (301) 594-6869 FAX: (301) 451-5650 Email: cindy_mcdermott@nih.gov Ms. Annette Hanopole Chief Grants Management Officer Grants Management Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, 8A01 , MSC 7510 8A01 Bethesda, MD 20892-7510 Telephone: (301) 496-5001 FAX: (301) 402-0915 Email: hanopola@mail.nih.gov Lisa Begg, Dr.P.H., R.N. Director of Research Programs Office of Research on Women's Health DHHS/NIH/OD Bethesda, MD. 20892 Telephone: 301/496-7853 Fax: 301/402-1798 Email: beggl@od.nih.gov Gary Fleming, J.D., M.A. Chief Grants Management Officer National Institute on Drug Abuse National Institutes of Health 6101 Executive Blvd. Suite 270, MSC 8403 Bethesda, MD 20892-8403 Telephone: (301) 443-6710 FAX: (301) 594-6849 E-mail: gf6s@nih.gov David Mineo Chief Grants Management Officer National Institute of Diabetes, and Digestive, And Kidney Diseases National Institutes of Health 2 Democracy Plaza Bethesda, MD 20892 Telephone: 301-594-8854 Fax: 301-480-3504 Email: mineod@niddk.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 Grants Info, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov. The title and number of this PA must be typed on line 2 of the face page of the application form and the YES box must be checked. SUPPLEMENTARY INSTRUCTIONS When submitting an R21 application, all instructions for the PHS 398 (rev. 5/2001) must be followed, with these exceptions: o Research Plan Items a - d of the Research Plan (Specific Aims, Background and Significance, Preliminary Studies, and Research Design and Methods) may not exceed a total of 15 pages. No preliminary data is required but may be included if it is available. Please note that a Progress Report is not needed; competing continuation applications for an exploratory/developmental grant will not be accepted. Appendix. Use the instructions for the appendix detailed in the PHS 398 except that no more than 5 manuscripts, previously accepted for publication, may be included. APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted at the standard application deadlines, which are available at http://grants.nih.gov/grants/dates.htm. Application deadlines are also indicated in the PHS 398 application kit. SPECIFIC INSTRUCTIONS FOR MODULAR BUDGET GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs must be submitted in a modular budget grant format. The modular budget 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. 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 $500,000 or more must carry out the following steps: 1) Contact the IC program staff at least 6 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 http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html. SENDING AN APPLICATION TO THE NIH: 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 mailed on or before the receipt dates described at http://grants.nih.gov/grants/funding/submissionschedule.htm. 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 unfunded version 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 8 weeks. PEER REVIEW PROCESS Applications submitted for this PA will be assigned on the basis of established PHS referral guidelines. Appropriate scientific review groups convened 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 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 evaluate application in order to judge the likelihood that the proposed research will 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? 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? 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? INNOVATION: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? 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 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, the following items will be considered in the determination of scientific merit and the priority score: The NIH R21 exploratory/developmental grant is a mechanism for supporting novel scientific ideas or new model systems, tools or technologies that have the potential to significantly advance our knowledge or the status of health- related research. Because the research plan is limited to 15 pages, an exploratory/developmental grant application need not have extensive background material or preliminary information as one might normally expect in an R01 application. Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Reviewers will place less emphasis on methodological details and certain indicators traditionally used in evaluating the scientific merit of R01 applications including supportive preliminary data. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R21 applications. 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). http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm 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). 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 Sharing Research Data Applicants requesting $500,000 or more in direct costs in any year of the proposed research are expected to include a data-sharing plan in their application. The reasonableness of the data-sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data-sharing plan into the determination of scientific merit or priority score. The Final NIH Statement on Sharing Research data is found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html 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 ANIMAL WELFARE PROTECTION: Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf), as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm), as applicable. 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 DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for all types of clinical trials, including physiologic, toxicity, and dose- finding studies (phase I); efficacy studies (phase II), efficacy, effectiveness and comparative trials (phase III). The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risk to the participants. (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). SHARING RESEARCH DATA: Investigators submitting an NIH application seeking more than $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible. http://grants.nih.gov/grants/policy/data_sharing Investigators should seek guidance from their institutions, on issues related to institutional policies, local IRB rules, as well as local, state and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score. 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. 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. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide, in the project description and elsewhere in the application as appropriate, the official NIH identifier(s)for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review. 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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