HEALTH PROMOTION AMONG RACIAL AND ETHNIC MINORITY MALES RELEASE DATE: September 8, 2003 PA NUMBER: PA-03-170 Reissued as PA-07-421 (R21) and PA-07-422 (R01) (see addendum NOT-CA-03-041) 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 for these mechanisms. The non-AIDS portion of this funding opportunity for these mechanisms expires on the date indicated below. Other mechanisms relating to this announcement will continue to be accepted using paper PHS 398 applications until the stated expiration date below, or transition to electronic application submission. Parent R03 (PA-06-180) and R21 (PA-06-181) funding opportunity announcements have been issued for the submission date of June 1, 2006 and submission dates for AIDS and non-AIDS applications thereafter. Applications relating to R33 and R34 activities must be in response to NIH Institute/Center (IC)-specific announcements. EXPIRATION DATE for R21 Non-AIDS Applications: March 2, 2006 EXPIRATION DATE for R21 AIDS and AIDS-Related Applications: May 2, 2006 EXPIRATION DATE for All R01 Applications: August 31, 2006, unless reissued. Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATIONS: National Institutes of Health (NIH) (http://www.nih.gov) Agency for Health Research and Quality (AHRQ) (http://www.ahrq.gov) COMPONENTS OF PARTICIPATING ORGANIATIONS: National Institute of Nursing Research (NINR) (http://www.ninr.nih.gov) National Institute on Aging (NIA) (http://www.nia.nih.gov) National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov) National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (http://www.niddk.nih.gov) National Heart, Lung, and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov/) Office of Behavioral and Social Sciences Research (OBSSR) (http://obssr.od.nih.gov) Office of Disease Prevention (ODP) (http://odp.od.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.361 (NINR), 93.866 (NIA), 93.864 (NICHD), 93.849 (NIDDK), 93.837 (NHLBI), 93.226 (AHRQ) 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 and expand research in the health of minority men. Specifically, this initiative is intended to: 1) enhance our understanding of the numerous factors (e.g., sociodemographic, community, societal, personal) influencing the health promoting behaviors of racial and ethnic minority males and their subpopulations across the life cycle, and 2) solicit applications focusing on the development and testing of culturally and linguistically appropriate health-promoting interventions designed to reduce health disparities among racially and ethnically diverse males and their subpopulations age 21 and older. Each of the sponsors of this PA has a strategic plan, which addresses research related to minority health and health disparities. This is located on their websites. 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 http://www.ninr.nih.gov. 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 US. Specific population groups are identified as African American, Asian and Asian Pacific Islander, Hispanic and Latino, American Indian and Alaska Native. These groups are the target populations for this announcement. RESEARCH OBJECTIVES It is well documented that males experience approximately a seven-year shorter life expectancy when compared with females. During the 20th Century, life expectancy at birth increased from 48 to 74 years for males and from 51 to 79 years for females. Increases in life expectancy are, in part, attributed to improvements in lifestyle, nutrition, housing, hygiene and medical care. The disparities in life expectancy are more pronounced among men of color and economically disadvantaged males. For example, the life expectancy of European American males and African American males is 74.6 and 67.7 years respectively. In 2001, the National Center for Health Statistics reported the leading causes of death in males as heart disease, cancer (lung and prostate), stroke, accidents and unintentional injuries, lung disease, diabetes, pneumonia, and influenza, suicide, chronic liver disease, and kidney disease. Mortality rates from these causes of death are higher for minority males because their diseases are at a more advanced stage at diagnosis and are often complicated by co-existing conditions. To illustrate, while cardiovascular disease is the leading cause of death for all Americans, African American males in particular experience an earlier onset of the disease and experience a higher rate of complications. White males have the greatest mortality from cardiovascular disease, 39.2% of all deaths, followed by 36.1% of all deaths for Asian American and Pacific Islander males, and 34.2% of all deaths for African American males. While Hispanic males experience the lowest death rate from cardiovascular disease, 27.9%, they suffer disproportionately from other conditions related to heart disease namely hypertension, high cholesterol and diabetes. Similarly, minority males have a higher risk of fatality from stroke when compared to their White counterparts. Other examples of health disparities noted among minority males include the following: o HIV infection is the third leading cause of death for Hispanic males ages 25-44, and the second leading cause of death in African American males within the same age group. o Diabetes affects all racial and ethnic populations, but American Indians have the highest rate of diabetes in the world. Many of the disparities in health status noted among racial and ethnically diverse male populations are related to lifestyle and are either preventable or amenable to early detection or intervention. For example, tobacco use constitutes the single most preventable cause of premature death in the US. In 1999, an estimated 46.5 million adults in the United States were smokers - 25.7% of men and 21.5% of women. Male smoking use was highest among Alaska Natives (40.9%), followed by African Americans (28.7%), Hispanics (24.1%), and Asian/Pacific Islanders (23.3%). Similarly, many unintentional injuries are preventable and may be amenable to early intervention. According to epidemiologists, over 400 Americans die each day from unintentional injuries such as motor vehicle crashes, poisonings, drowning, falls, fires, suffocation, and firearms. A major objective outlined by Healthy People 2010 is to reduce deaths from unintentional injuries from baseline 35.0 deaths per 100,000 population to 17.5 deaths per 100,000 population. Males are more likely than females to experience death from unintentional injury. Minority males are more at risk to die from such injuries when compared with their White counterparts. For example, the death rate for unintentional injuries is 48.7 per 100,000 deaths for White males. This compares with 83.6 deaths per 100,000 for American Indian/Alaska Native males followed by 60.8 per 100,000 deaths for African American males and 46.2 per 100,000 deaths for Hispanic males. The disparities in health are often more pronounced among underserved and uninsured racial and ethnic minority males. There are ample data highlighting that uninsured individuals experience greater declines in health status and die prematurely from a variety of illnesses when compared to those with continuous health care coverage. This is particularly important given that racial and ethnic minority populations are disproportionately represented among the uninsured. For example, in 1998, 23% of African American males were uninsured followed by 37% of Hispanic males. This compares with 15% White males. These and other health disparities noted among minority males require greater elucidation and intervention. However, the focus of this PA is on health promotion and not on all aspects of disease. A scientific exploration of these disparities is central to all sponsors' commitment to reducing health disparities. Research in this area is essential to addressing Goal 2 outlined in Healthy People 2010: "To eliminate health disparities among segments of the population, including differences that occur by gender, race or ethnicity, education or income, disability, geographic location or sexual orientation." The following are potential areas of research related to this announcement. These suggested areas of research are not listed in any priority and are not to be viewed as an exhaustive or exclusive list. Investigators responding to this announcement may target other groups of minority males (e.g., men of diverse sexual orientation, migrant workers, disabled men, rural and immigrant men). Potential research topics include but are not limited to: o Studies that test innovative interventions to reduce risk factors associated with the leading causes of morbidity and mortality (e.g., smoking, poor nutrition, alcohol use, sedentary lifestyle, risky sexual behavior) among racial and ethnic minority men and their subpopulations in rural, urban, and nontraditional settings, including interventions addressing multiple risk factors in the same individual. o Multifaceted interventions designed to increase both initial and repeat health screenings and risk assessment among racial and ethnic minority and underserved men age 40 and older. o Studies that include innovative approaches involving families, social networks, or communities in interventions designed to enhance health- promoting behaviors. o Unique interventions developed to promote positive health seeking and health maintenance behaviors among diverse groups of men across the life cycle. o Interventions that incorporate cultural and family values and are designed to test the effects of unique and creative intergenerational health promotion activities. o Interventions that target two or more high-risk behaviors in a single application, e.g., tobacco use, risky sexual behaviors, unintentional (accidents) and intentional behaviors (firearm related injuries.) o Culturally and linguistically appropriate studies designed to enhance self- efficacy, competence, and skill development to support the initiation and maintenance of health promoting behaviors. o Studies that develop and test innovative interventions that improve patient-provider communication around preventive services. These interventions can be aimed at the provider and or the patient. o Studies that develop and test strategies to increase the use of best practices in men's health, such as evidence based guidelines or research syntheses, in health care settings. MECHANISM(S) 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. The objective of the exploratory/developmental mechanism (R21) is to encourage applications from individuals who are interested in testing innovative or conceptually creative ideas that are scientifically sound and may advance our understanding of health promotion among racial and ethnic minority males. 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. Starting with the October 1, 2003 receipt date, 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. 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: Dr. Janice Phillips Office of Extramural Programs NIH, National Institute of Nursing Research 6701 Democracy Blvd, Room 710, MSC 4870 Bethesda, MD 20892-4870 Telephone: (301) 594-6152 FAX: (301) 480-8260 Email: Janice.phillips@nih.gov Dr. Sidney M. Stahl Behavioral and Social Research Program NIH, National Institute on Aging 7201 Wisconsin Ave., Room 533 Bethesda, MD 20892-9205 Telephone: (301) 402-4156 FAX: (301) 402-0051 Email: Sidney_Stahl@nih.gov Dr. V. Jeffery Evans Director of Intergenerational Research Demographic and Behavioral Sciences Branch NIH, National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8B07, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-1176 FAX: (301) 496-0962 Email: evansvj@mail.nih.gov Dr. Lawrence Agodoa Office of Minority Health Research Coordination NIH, National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Boulevard, Room 653, MSC 5454 Bethesda, MD 20892-5454 Telephone: (301) 594-1932 FAX: (301) 594-9358 Email: la21j@nih.gov Dr. Jared B. Jobe Behavioral Medicine Scientific Research Group Division of Epidemiology and Clinical Applications NIH, National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Room 8122, MSC 7936 Bethesda, Maryland 20892-7936 Telephone: (301) 435-0407 FAX: (301) 480-1773 Email: jobej@nhlbi.nih.gov Dr. Lawrence J. Fine Medical Advisor NIH, Office of Behavioral and Social Sciences Research Building One, Room 256 One Center Drive Bethesda, MD 20892 Telephone: (301) 435-6780 FAX: (301) 402-1150 Email: finel@mail.nih.gov Ms. Martina Vogel-Taylor, M.T. Senior Advisor for Disease Prevention & Health Promotion NIH, OD, Office of Disease Prevention 6100 Executive Blvd., Suite 2B-03, MSC 7523 Bethesda, MD 20892-7523 Phone: (301) 496-6614 FAX: (301) 480-7660 Email: MartinaV@nih.gov Dr. Kaytura Felix Aaron Senior Advisor, Minority Health Agency for Healthcare Research and Quality 540 Gaither Road Rockville, MD 20850 Phone: (301) 427-1395 Fax: (301) 427-1562 Email: kfaaron@ahrq.gov o Direct your questions about financial or grants management matters to: Ms. Tara Mowery 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) 594-5979 FAX: (301) 451-5650 Email: tara.mowery@nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). Applications must have a Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number can be obtained by calling (866) 705-5711 or through the web site at http://www.dunandbradstreet.com. The DUNS number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 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 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 more than $500,000 must carry out the following steps: 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 more than $500,000 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 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: Starting with the October 1, 2003 receipt date, 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. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at http://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. 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). Those who must comply with the Privacy Rule (classified under the Rule as "covered entities") must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This 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.


Weekly TOC for this Announcement
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