INTERVENTIONS TO IMPROVE HYPERTENSION CONTROL RATES IN AFRICAN AMERICANS RELEASE DATE: September 2, 2003 RFA Number: RFA-HL-04-007 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATIONS: National Institutes of Health (NIH) ( COMPONENTS OF PARTICIPATING ORGANIZATIONS: National Heart, Lung, and Blood Institute (NHLBI) ( CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.837 LETTER OF INTENT RECEIPT DATE: December 23, 2003 APPLICATION RECEIPT DATE: January 20, 2004 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism(s) of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Letter of Intent o Submitting an Application o Supplementary Instructions o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA The National Heart, Lung, and Blood Institute invites applications for research project grants (R01) to evaluate clinically feasible interventions to effect changes in medical care delivery leading to an increase in the proportion of treated hypertensive African American patients whose blood pressure is controlled to levels specified by Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure (JNC) guidelines. The ultimate goal is to prevent complications of hypertension, and thus increase quality and years of healthy life in African Americans - a group with highest prevalence and earliest onset of hypertension, and disparately high premature cardiovascular mortality and morbidity. For the purpose of this initiative, components of medical care delivery consist of patients, clinicians, interactions between patients and clinicians, and physical, social and administrative environments in which these interactions occur. This solicitation addresses both overarching goals of Healthy People 2010 (increasing quality and years of healthy life, and eliminating health disparities) and is responsive to the first of two research needs recommendations of the 2002 IOM report, Unequal Treatment (Recommendation 8-1: Conduct further research to identify sources of racial and ethnic disparities and assess promising intervention strategies), and to the first of the eight top-tier priorities of the 2001 NHLBI Task Force Report on Research in Prevention of CVD (Evaluate approaches to enhance implementation of efficacious preventive interventions in medical systems at all stages of clinical practice). RESEARCH OBJECTIVES Background Cardiovascular mortality rates in African Americans for ages 35-64 are more than twice those in Caucasians, and for men the gap has increased since 1960. While some of this disparity may be explained by more frequent poverty among African Americans, a recent report based on a national probability sample of over 600,000 persons identified hypertension as the single initiating cause of death independent of socioeconomic status that contributed the most to the racial disparity between African Americans and Caucasians in potential life-years lost. The 1999-2000 National Health and Nutrition Evaluation Survey (NHANES) data reveal low rates of hypertension control in treated African American men and women, in addition to a long-recognized high prevalence of hypertension (defined as BP>140/90 mm Hg or current drug treatment). Notably, both observational (e.g. MRFIT screenees) and clinical trial data (e.g. HDFP) show that cardiovascular benefit attributable to a given decline in blood pressure is similar in African Americans and Caucasians. In NHANES 1999-2000, one out of five African American men age 30-39 had hypertension (versus one out of eight amongst Caucasian and Mexican American men). By age 50-59, nearly 60% of African American men were hypertensive compared to less than 40% of Caucasian and Mexican American men. Prevalence rates for women aged 30-39 were relatively low for all race/ethnic groups (9% for African American and 6% for Caucasian and Mexican American women). However, by age 40-49, nearly half of African American women had hypertension (compared to one fifth of Caucasian and Mexican American women). In the age group 60-74, 75% of African American men and 81% of African American women had hypertension numbers considerably higher than for either Caucasians or Mexican Americans. In African Americans aged 40 and over, awareness of hypertension was high (71-83% across gender/age groups) and a large majority of those aware of their hypertension reported being treated (83-97% across gender/age groups), numbers similar to those in Caucasians and considerably higher than in Mexican Americans. However, the proportion of treated African American patients whose hypertension was controlled to below 140/90 mm Hg remained low (<50%), and in those aged 40-59 was more than one third lower than in Caucasians (49 versus 75% for men and 41 versus 72% for women). Given the importance of blood pressure levels in determining future risk of cardiovascular events, intervention in this age group should lead to a decline in cardiovascular mortality and morbidity in African Americans, and thus decrease premature disability. Efficacious strategies exist for both lifestyle and pharmacological treatment of hypertension. However, these strategies are not being translated into effective blood pressure lowering, especially in African American hypertensive patients. Two important barriers to effective treatment of hypertension in African Americans, lack of clinical trial data in African Americans on drugs other than diuretics and cost of drugs, were recently addressed by the results of The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). This largest ever antihypertensive treatment trial, which included 15,094 African Americans, determined that thiazide-type diuretics are the preferred first-step (initial or single drug) therapy for hypertension in both African American and non-black patients. This evidence and the recent release of JNC 7 guidelines provide opportune timing to conduct intervention studies aimed at improving quality of treatment of hypertension in African Americans. To date, intervention research in African Americans has primarily focused on bringing individuals with elevated blood pressure levels to medical attention and increasing patient adherence to prescribed treatment and clinic visits. Yet, recently published observational studies point to the importance of additional factors, such as patient experience with clinicians, clinicians' acceptance of less than optimal blood pressure levels, clinicians' experience with a variety of antihypertensive medications, patients' participation in treatment decisions, and commercial influences. While many of these factors may be common across racial groups, intervention approaches may need to differ to address race/ethnicity-specific issues, both cultural/social and clinical. Many hypertensive African American patients are younger than non-African American due to earlier onset of hypertension. In addition, long-standing hypertension and associated co-morbidities make selection of treatment regimens more difficult and may affect adherence due to increased potential for side effects. Finally, African American patients report less satisfaction with care, and perceived racial bias, stereotyping, and prejudice continue to affect quality of care and treatment outcomes. Researchers consistently point to the need for more culturally acceptable and effective methods of delivering hypertension care. Results of three NHLBI-funded randomized studies suggest that clinic-based programs can successfully increase the proportion of treated hypertensive African American patients who have adequately controlled blood pressure. Notably, better hypertension control (62% versus 40-48%) was obtained when the intervention included change in an institutional environment/culture, feedback to clinicians, and access to specialized care. In addition, ALLHAT a large, simple trial conducted in a variety of primary care settings achieved blood pressure control to below 140/90 mm Hg in over 60% of both African American and non-black patients using organizational-level approaches. While representing substantial improvements, these rates are far from optimal. Goals and Scope This initiative will fund multiple intervention studies aimed to increase the proportion of treated African American hypertensive patients whose BP levels meet JNC 7 guidelines (primary outcome). Studies may focus on other special risk populations only if local and/or national data exist documenting both poor blood pressure control and disparately high premature morbidity and/or mortality. Interventions should be institution/clinic-based (including small practices) and target one or preferably more components of medical care delivery (patients, clinicians, interactions between patients and clinicians, and physical, social and administrative environments in which these interactions occur). However, given prior and ongoing research, interventions targeting exclusively patient-level variables and/or limited to improving patient adherence to prescribed treatment, will not be responsive to this RFA. In general, a randomized design should be used. A quasi-experimental design may be used if scientifically appropriate and justified. A concurrent control group is required, and two or more interventions may be compared. If "usual care" is used as a control group, participants should at minimum receive a copy of JNC 7 treatment guidelines (clinicians) and related patient education materials (patients). Research plans should take into consideration differences in practice settings. NOTE: Proposed programs should be feasible and practical for implementation beyond research settings. Applications should include an institutionalization phase with evaluation. Also to be included are cost- effectiveness evaluation and plans for dissemination of study results and intervention, if successful. If appropriate and representing substantial opportunity, the investigators are encouraged to include plans for collection and storage of blood samples, including consent, to be used for genetic, pharmacogenetic, or other ancillary studies to be conducted in the future and funded separately. Consideration should be given to collection of other information that may be needed to make these samples useful in the future. NOTE: This RFA is not budgeted for any ancillary studies; only collection and storage of blood specimens (through the end of the study) will be an allowable expense. It is estimated that for a patient-randomized trial, a total of about 300 patients would be required to achieve 90% power to detect a difference in blood pressure control rates between 45% (usual care) and 65% (intervention). For a clinic-randomized trial (i.e. cluster randomized trial), it is estimated that about 30 clinics with 30 patients each would be required to detect with 90% power a difference in blood pressure control rates between 45% (usual care) and 65% (intervention). Clinic-randomized trials must use appropriate statistical methodology to deal with the hierarchical nature of the data. Interventions to be tested may include but are not limited to the following examples: o one-on-one or small group onsite education (academic detailing) and advice by opinion leaders o Use of hypertension treatment guidelines in a patient-oriented context o Facilitation of patient-clinician interactions o Specialized teams, academic partnerships o Continuous quality improvement process o Access to free or reduced price drugs o Decision support and reminder systems using information technology o Multi-component combinations Program Organization While the Program will consist of independent research projects, grantees will meet annually to discuss progress, share experiences and discuss overall progress of relevant scientific areas. Collaboration amongst investigators will be encouraged and facilitated, if appropriate. MECHANISM OF SUPPORT This RFA will use the NIH R01 award mechanism. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. Future unsolicited, competing-continuation applications based on this project will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. The anticipated award date is September 30, 2004. Applications that are not funded in the competition described in this RFA may be resubmitted as NEW investigator-initiated applications using the standard receipt dates for NEW applications described in the instructions to the PHS 398 application. This RFA uses just-in-time concepts. It also uses the modular 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 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 FUNDS AVAILABLE The NHLBI intends to commit approximately $3 million in FY 04 and a total of $17.5 million over five years to fund three to six new grants in response to this RFA. An applicant may request a project period of up to five years. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the NHLBI provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. ELIGIBLE INSTITUTIONS You may submit (an) application(s) if your institution is domestic and has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Faith-based or community-based organizations o Foreign institutions are not eligible to apply 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 THE FOLLOWING CRITERIA WILL GUIDE THE NHLBI STAFF IN DETERMINING RESPONSIVENESS OF THE APPLICATIONS TO THIS RFA: o Primary endpoint: Proportion of patients in the organization that achieve blood pressure levels meeting JNC 7 recommendations. o Patient Population: The primary endpoint should be measured in treated hypertensive African American patients or, as specified under Goals and Scope above, another group of treated hypertensive patients if local and/or national data exist documenting both poor blood pressure control and disparately high premature morbidity and/or mortality. Data on other patients may be evaluated in secondary analyses and for comparative purposes. o Interventions: Interventions should be delivered at the organization/clinic level and be feasible (including cost) for implementation outside research settings. NOTE: Interventions targeting exclusively patient-level variables and/or limited to improving patient adherence to prescribed treatment will not be responsive to this RFA. o Study design: The study design should be concurrently controlled. A randomized design is preferred quasi-experimental designs are allowed if strongly justified. Providers/clinics/organizations or patients may be randomized. Detailed sample size calculations with assumptions should be provided. o Dissemination Plan: The purpose of this RFA is to improve translation of knowledge into everyday clinical practice. Applicants must include in their application a plan for dissemination of research results and of the intervention. The latter will be implemented if the intervention is successful and should aim to enhance utilization of the study intervention in clinical practice. Such plan should include: identification and description of target audience for the dissemination plan; description of methods to be used to reach the audience; appropriate benchmarks for success; appropriate additional personnel for developing and implementing the dissemination activities; an appropriate budget for the proposed dissemination activities for the last year of requested funding; a statement that the investigators agree to discuss and finalize the dissemination plan with Institute staff prior to its implementation. NOTE: Applications that do not include a dissemination plan will be considered non-responsive and not eligible for review. Funds budgeted for dissemination activities will be held in reserve until the final year of the study and released only with the approval of the Institute. The dissemination plan implementation can continue up to one year beyond the award period as a no-cost extension. THE FOLLOWING ARE SPECIAL REQUIREMENTS OF THIS RFA: o Timelines: Funding will be provided for up to 5 years. Projects should include an institutionalization phase with evaluation and a dissemination plan. An initial planning phase may be included to refine interventions. o Cost-effectiveness analysis: Must be included and budgeted for in the application. o Blood sample collection: Applicants who are planning to collect blood samples for genetic, pharmacogenetic or other ancillary studies must describe blood sample collection and storage for the duration of the trial, and budget for these activities. o Informed Consent: Applications should describe how informed consent will be obtained and include a sample consent form (does not have to be approved by the IRB). If the application includes plans for future genetic or other ancillary studies, such plans should be included in the consent form, which may be tiered to allow participation in the main study for individuals who refuse participation in the blood sample collection. o Monitoring Plan: Applications should include a data and safety monitoring plan. A Data and Safety Monitoring Board (DSMB) appointed by the participating Institution is required and should be budgeted for. Please see "Establishing Data and Safety Monitoring Boards and Observational Study Monitoring Boards" and "Responsibilities of DSMBs Appointed by Participating Institutions" under "NHLBI Clinical Research" at o Recruitment: Recruitment plans should be described and documented to the extent possible. o Meetings: Investigators from each research project will be required to attend annual meetings in the Washington, DC metropolitan area. The travel budget should therefore reflect appropriate allocation for this activity. o Data sharing: Applicants seeking $500K or more in direct costs in any year of the project period are expected to include a data sharing-plan in their applications stating how they will share the data or, if they cannot share the data, why not. Reviewers will assess the adequacy of the proposed plan. More information on data sharing can be found at WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct your questions about scientific/research issues to: Paula T. Einhorn, M.D., M.S. Division of Epidemiology and Clinical Applications National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Room 8111 Bethesda, MD 20892-7936 Telephone: (301) 435-0563 FAX: (301)480-1669 Email: o Direct your questions about peer review issues to: Anne Clark, Ph.D. Chief, Review Branch Division of Extramural Affairs National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Room 7214 Bethesda, MD 20892 7924 Bethesda, MD 20817 (for express/courier service) Telephone: (301) 435-0270 FAX: (301) 480-0730 Email: o Direct your questions about financial or grants management matters to: Mr. Kieran Kelley Senior Grants Management Specialist Division of Extramural Affairs National Heart, Lung, and Blood Institute/NIH 6701 Rockledge Drive, Room 7170 Bethesda, Maryland 20892-7926 Telephone: (301) 435-0154 FAX: (301)-480-3310 (fax Email: email: LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to Anne Clark, Ph.D. at the address listed under WHERE TO SEND INQUIRIES. 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 The DUNS number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 document is available at in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: SPECIFIC INSTRUCTIONS FOR MODULAR 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 includes step-by-step guidance for preparing modular budget grants. Additional information on modular budget grants is available at USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the Checklist, and three signed, photocopies, in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application plus all five collated sets of appendix material must be sent to Anne Clark, Ph.D. at the address listed under WHERE TO SEND INQUIRIES. APPLICATION PROCESSING: Applications must be received on or before the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to an RFA, it is to be prepared as a NEW application. That is, the application for the RFA must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NHLBI. Incomplete applications will not be reviewed. If the application is not responsive to the RFA, NIH staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next appropriate NIH review cycle. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the National Heart, Lung, and Blood Institute in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed and assigned a priority score o Receive a written critique o Receive a second level review by the National Heart, Lung, and Blood Institute Advisory Council. 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 the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals and the specific goals of this RFA. 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? Is the proposed intervention appropriate for the proposed clinical setting and culturally sensitive to the patient population? Does the applicant acknowledge potential problem areas and consider alternative tactics? Are the institutionalization and dissemination plans (including evaluation) appropriate for the proposed settings? Is cost-effectiveness analysis appropriate for the intended utilization of the program? 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: PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below). INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the sections on Federal Citations, below). ADDITIONAL REVIEW CONSIDERATIONS SHARING RESEARCH DATA: Applicants requesting more than $500,000 in direct costs in any year of the proposed research must 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. See for guidance. BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: December 23, 2003 Application Receipt Date: January 20, 2004 Peer Review Date: June, 3004 Council Review: September 2, 2004 Earliest Anticipated Start Date: September 30, 2004 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Availability of funds o Programmatic priorities. REQUIRED FEDERAL CITATIONS HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. 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: 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. . 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 (; a complete copy of the updated Guidelines are available at 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 RFA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule," on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Those who must comply with the Privacy Rule (classified under the Rule as "covered entities") must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website ( 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 URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This RFA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance at 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) CFDA 93.837 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 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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