HIV PREVENTION IN TREATMENT SETTINGS: U.S. AND INTERNATIONAL PRIORITIES RELEASE DATE: July 26, 2002 RFA: MH-03-006 National Institute of Mental Health (NIMH) ( National Institute on Drug Abuse (NIDA) ( National Institute of Nursing Research (NINR) ( LETTER OF INTENT RECEIPT DATE: September 27, 2002 APPLICATION RECEIPT DATE: October 29, 2002 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 Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA The estimated annual number of new HIV infections in the U.S. has remained steady at 40,000 for nearly ten years and HIV rates in many countries continue to rise alarmingly. Domestic and international HIV prevention programs have generally focused on HIV-negative persons, to help them avoid becoming infected. However, it has become increasingly apparent that to stem the tide of new infections, additional attention and resources should be focused on persons living with HIV, especially those in treatment. Behavioral interventions in HIV/AIDS treatment settings represent a critical domestic priority and are an emergent international priority. To develop enhanced HIV prevention strategies in treatment settings, there are important research gaps in basic, behavioral science, medical, and policy areas that need to be addressed. Studies are needed to (a) better understand the associations among HIV treatment response, treatment adherence, risk behavior, and other psychosocial factors that are likely to impact these variables (e.g., housing instability, substance abuse, depression, domestic violence), (b) develop innovative approaches to risk behavior change based in treatment settings, especially interventions that combine behavioral and medical/biological components, (c) examine optimal mechanisms for referral to services for prevention needs that are not feasible in medical settings, (d) increase medical care providers" linkage of persons to care who had previously not known their HIV serostatus, and (e) improve utilization of systems to facilitate partner notification. This Request for Applications (RFA) briefly reviews the complex interaction of basic, behavioral science, medical, and public policy issues that present challenges for the integration of HIV prevention into clinical care settings, and outlines important research priorities. RESEARCH OBJECTIVES Background HIV prevention interventions based in medical treatment settings represent a critical domestic and international priority. To address this need, the NIMH Center for Mental Health Research on AIDS convened a meeting of HIV/AIDS experts in basic and behavioral science, medicine, and public policy to outline issues for integrating HIV prevention into clinical care settings. Topics of discussion included trends in HIV seroincidence and seroprevalence, associated behavioral epidemiology in the U.S., disparities in access to health care, challenges to HIV treatment and prevention in international contexts, issues related to physician and other provider-delivered interventions, important ethical considerations, and factors related to provider adoption and implementation of prevention guidelines. For new intervention strategies to be developed and evaluated, these issues will need to be more comprehensively understood. It is important to first note that most HIV-infected persons who are aware of their HIV serostatus tend to reduce behaviors that might transmit HIV to others. However, recent studies in the U.S. and elsewhere document significant increases in risk behavior and incident sexually transmitted infections (STDs) among some individuals receiving antiretroviral therapy (ART) and other medical treatment for HIV infection. These trends have already begun to have an impact. In San Francisco, for example, HIV incidence among men who have sex with men (MSM) was estimated at 2% for 1997 – 2000, twice the rate of previous years. These increases in risk may be attributable to declines in the perceived severity of HIV infection and to changes in community norms that previously favored risk reduction. However, these behavioral trends have not only occurred in HIV epicenters, a significant proportion of HIV-infected men and women of varied cultural backgrounds living in a range of geographic locations continue to engage in behaviors that place others at risk for HIV infection. Given the complexities of HIV infection, behavioral intervention must accompany medical treatment for HIV disease in order to curtail the initiation or resumption of sexual risk-taking and drug use during ART, particularly in treatment naïve populations. As ART becomes increasingly available in resource-poor countries, similar problems are likely to emerge on a much wider scale. Because substantial improvement in duration and quality of life with HIV/AIDS is a relatively recent advance, the associations among HIV treatment response, treatment adherence, sexual behavior, drug use and addiction, and a variety of psychosocial factors are as yet poorly understood. For many, HIV disease has become more of a chronic condition and other lifestyle concerns may be more immediate and important than maintenance of safer sexual choices (e.g., employment, medical care, day-to-day stressors, dyadic and sexual relationships, complacency about infectivity, drug and alcohol use). Studies are needed to better understand the antecedents, correlates, and topography of risky behavior throughout all phases of treatment and disease. These observational studies should include any periods without treatment -- for example, before treatment is initiated or during any treatment interruptions. Although treatment may be an ideal catchment point for basic and behavioral research, treatment considerations will make secondary prevention challenging among HIV infected individuals in these settings. The advantages are that treatment providers are uniquely positioned to screen for risk behaviors and STDs, encourage antibody testing for partners and partner notification, offer post-exposure prophylaxis (PEP), and provide risk reduction counseling. Many persons providing medical and psychosocial care for HIV/AIDS who have access to patients may be able to incorporate HIV prevention into their work (e.g., physicians, nurse practitioners, physician assistants, drug treatment counselors, psychologists, social workers). However, addressing behavioral issues is difficult in a venue where time pressures are already formidable. Clinicians must first ensure that the clinical needs of the patient are met, including viral suppression via treatment that maximizes efficacy and minimizes toxicities, treatment of comorbid infections, and facilitation of a provider-patient relationship that focuses on patients" needs. Intervention Choices Once primary medical treatment issues are addressed, there is a wide range of additional risk-reduction intervention options that warrant empirical study. Evidence indicates that theory-based provider delivered approaches have been effective with a variety of health issues, including depression, smoking cessation, alcohol use, weight loss, and increasing physical activity. This diverse experience with other health behaviors suggests that similar approaches may be effective in reducing HIV-infected patients" transmission risk behaviors. Through brief screening for HIV transmission risk behaviors, communicating prevention messages, discussing sexual and drug-use behavior issues with patients, and positively reinforcing changes to safer behavior, clinicians may have a significant impact on the risk for transmission of HIV to others. However, there are many unanswered research questions in this area, as only a handful of related studies have been conducted or are underway. Evidence suggesting that multi-session interventions by providers in other settings can be effective for HIV-infected patients is limited to a few randomized controlled trials. Studies on single session interventions for individual patients in clinical settings are limited to studies other than randomized controlled trials. Moreover, regarding several key issues, we do not know the appropriate message that should be delivered to patients. For example, there remains debate about the potential for reduced infectivity when viral load is suppressed. Lessons learned during HIV treatment advances suggest that caution is indicated. Several studies have suggested that optimism about ART effectiveness may be contributing to relaxed attitudes toward safer sex practices, increased sexual risk-taking, and other risk behaviors by some HIV-positive persons. Media coverage and marketing campaigns for medications may have had an unintended effect on risk behavior because sufficient consideration was not given to the long-term lifestyle implications of new treatments for HIV disease. Basic research should help to inform the appropriate clinical intervention regarding viral load and HIV transmission risk. It is assumed that reducing blood plasma viral loads via ART reduces viral load in semen. But, the benefits of ART for possible reduced infectivity may be offset by subsequent increases in risk behavior that are driven by a belief of certainty for non-infectiousness. Viral resistance to ART becomes an increasing concern in these conditions. This particular set of questions highlights the importance of proposals for translational research in response to this RFA, whereby basic and clinical/behavioral scientists are involved in joint efforts to integrate discoveries with meaningful clinical outcomes. Relatedly, it may be that the most effective efforts to reduce transmission will be through a combination of behavioral and medical/biological interventions. Effective screening/treatment of STDs may limit HIV transmission. However, in order to effectively allocate resources, behavioral (individual risk behavior) and epidemiological (local prevalence of STDs) will need to be considered. For whom is additional attention to STD treatment warranted? Is there indeed a group of "core transmitters?" Will interventions that address ulcerative STDs be more effective than treatment of inflammatory STDs? The potential impact of widespread post-exposure prophylaxis (PEP) in a variety of settings on transmission and subsequent behavior is still unknown. Additionally, with many candidate microbicides close to clinical trial readiness, the same kinds of questions regarding the interrelationships of treatment, adherence, and behavior are germane. Can individuals be identified who may increase risk behaviors secondary to microbicide trials? How ethical is it to enroll these individuals in clinical trials? Ensuring Access to High-Quality HIV Treatment and Prevention Services Another major area of concern, as we conceptualize enhanced HIV prevention in medical care, regards persons who may miss these opportunities because of limited access to care, because initial identification of HIV/AIDS is substantially delayed, or because HIV infection remains undetected. Despite advances in the monitoring and treatment of HIV infection, there is growing evidence that these benefits have been missed by minority communities. Factors common in minority communities that compete with medical treatment for HIV include homelessness, mental illness, injection and non-injection drug use, alcohol abuse, under-unemployment, single parent families, immigration status, and elderly issues. Other formidable barriers that merit attention are the issues of denial and stigma, and working with cultural norms that may not favor risk-reducing practices. In providing treatment to communities of color, primary care providers may be more likely to encounter limited treatment options, lack of adherence, growing risk of transmission of resistant virus, increasing sexual risk in the face of reduced viral loads, drug use and addiction, and the need to address competing life priorities in order to make progress in treatment and prevention. With respect to case-finding, especially in minority communities and other settings where HIV-testing is underutilized, medical care providers can be instrumental in linking persons to care who had previously not known their HIV serostatus. Some patients need more intensive or ongoing behavioral interventions than can feasibly be provided in these settings. Many patients have underlying issues that impede adoption of safer behaviors, and achieving behavioral change is often dependent on addressing such issues. Clinicians will usually not have time nor resources to fully address these issues, many of which can best be addressed through referrals for services such as HIV prevention interventions (e.g., support groups), medical services (e.g., substance abuse treatment), mental health services (e.g., treatment of depression), and social services (e.g., domestic violence). Some persons may miss opportunities for HIV treatment and prevention services because providers may insufficiently recognize that the individual"s comorbid alcohol abuse constitutes a significant risk factor for HIV transmission. Effective referral to services may be the intervention option of choice that is delivered in certain medical settings. Provider Training and Partner Notification In order to evaluate, implement, and encourage the adoption of many of the aforementioned interventions, clinician training at all levels will need to be improved. Clinicians can prepare themselves to deliver HIV prevention messages to their patients by obtaining training on speaking with patients about sex and drug-use behaviors and on giving explanations in simple, everyday language. In addition, providers in medical settings may not be fully aware of how best to handle the issues related to partner notification for a patient with HIV. Most states and some cities have laws and regulations related to partner notification, and it is important for clinicians to be aware of these requirements. Partners can be reached via health department notification, private provider (i.e., clinician) notification, or notification by the infected person. Some clinicians may wish to take on the responsibility for notifying partners, but some studies suggest that health department specialists were more successful than physicians in interviewing patients and locating partners. Although notified partners tend to indicate that the health department should continue partner notification services, no studies have directly shown that partner notification prevents disease in a community. However, preliminary studies suggest that partners change their behavior after they are notified, and notification by the health department appears to be more effective than notification by the infected person. The effects of follow-up questions in subsequent visits regarding partner notification, or partner re-notification has not been studied. The International Agenda Internationally, the recent United Nations General Assembly (UNGASS) declaration supporting the use of drugs in the management of HIV has raised concern about important implications for prevention. Safe and effective administration of antiretrovirals in the developing world requires enhanced behavioral counseling and laboratory services, improved logistics, determination of optimal treatment regimens and monitoring of viral loads. In addition, introduction of antiretrovirals requires public health programs to overcome prejudices and stigma about the use of medications in low-income populations. For all of the issues related to prevention in the context of treatment for the U.S., we know even less about international settings. However, we have an opportunity to learn from trends that have occurred in the U.S., since ART became available, as well as to use new translational research projects in the U.S. to inform similar projects in other countries. This RFA seeks a broad range of research on HIV prevention in treatment settings, including but not limited to the following topics. For each research priority, domestic and/or international efforts may be the focus. o Epidemiological studies, in order to effectively target resources for prevention, the dynamic epidemiology of risk behaviors responsible for the spread of HIV needs to be continually updated and reported. o Studies of the associations among HIV treatment response, treatment adherence, sexual behavior, drug abuse and addiction, and a variety of psychosocial factors that are likely to impact these behaviors (e.g., housing instability, alcohol abuse, depression, domestic violence). Studies are needed to better understand the antecedents, correlates, and topography of risky behavior throughout all phases of treatment and disease. These observational studies should include any periods without treatment -- for example, before treatment is initiated or during any treatment interruptions. o Development of innovative approaches to risk behavior change based in treatment settings. Approaches are particularly encouraged based on basic behavioral principles such as cognition, emotion, decision-making, motivation, social interaction, and cultural context. A well-articulated, empirically based conceptual framework is essential in applications solicited under this RFA. Interventions that appear promising are those that screen for HIV transmission risk behaviors, provide brief behavioral risk reduction interventions and make referrals for major underlying psychosocial barriers to behavior change, interventions that combine behavioral and medical/ biological components, and those that facilitate partner notification and counseling. o Concurrent studies designed to bring effective HIV prevention programming rapidly into medical settings. How to disseminate quickly and effectively? o Studies to adapt and tailor effective HIV prevention interventions for underserved, high risk, or special need populations in treatment, such as adolescents, ethnic minority populations, persons with severe mental illness, incarcerated individuals, and active drug and alcohol users. o Studies that utilize a variety of venues for primary and secondary prevention, such as STD clinics, drug treatment programs, and needle exchange programs. How best to link HIV counseling and testing with STD testing, drug use testing, and risk reduction counseling? How well utilized are these interventions? o Translational studies of the impact of antiretroviral treatment (and other biological interventions) on HIV transmission. What is the threshold at which transmission does not occur? Feasibility studies could examine the implications of an expanded public health approach to include medications to reduce transmission at the community level. o Observational studies are needed in different countries and cultures to study the effect of biological intervention on risk behavior. This could include greater examination of questions related to PEP as well as microbicide acceptability and use. o Factors related to message content for some behavioral prevention interventions remain unresolved. What information, if any, should be shared with patients about infectivity during ART? o Examination of the impact of local and federal laws on willingness to be tested for HIV or access to HIV care. For example, do changes in legal policies affect the stage at which HIV is detected? o International studies of how best to integrate prevention and treatment efforts. This may include how best to facilitate IRB/CHR approval in countries where biological treatments for HIV prevention are likely to be proposed. Studies may be designed to bring treatment to an existing prevention infrastructure, rather than prevention resources to treatment venues. o How will issues of stigma, discrimination and violence affect access to treatment and related behavioral interventions in these countries? If drugs are delivered, what will it take for people to get tested if they will face violence or discrimination? o Long-term training issues for providers need to be addressed. How best to incorporate prevention training into medical and other provider curricula? MECHANISM OF SUPPORT This RFA will use the NIH individual research project grant (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 March 2003. 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 format. Otherwise follow the instructions for non- modular research grant applications. FUNDS AVAILABLE The participating ICs intend to commit approximately $2.5 million in FY 2003 ($1,250,000 (NIMH), $500,000 (NIDA), $750,000 (NINR)) to fund 4 to 6 new and/or competitive continuation grants in response to this RFA. An applicant may request a project period of up to 5 years and a budget of up to $500,000 per year (direct costs and total subcontractual costs, the latter including direct and facilities and administrative (F&A)). 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 participating ICs 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 has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic or foreign o Faith or community-based organization o Indian Tribes, Tribal Organizations, Tribal Faith or Tribal community- based organizations INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. WHERE TO SEND INQUIRIES We encourage 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: Christopher M. Gordon, Ph.D. Division of Mental Disorders, Behavioral Research, and AIDS National Institute of Mental Health 6001 Executive Boulevard, Room 6204, MSC 9619 Bethesda, MD 20892-9619 Telephone: (301) 443-1613 FAX: (301) 443-9719 Email: Elizabeth Y. Lambert, M.Sc. Center on AIDS and Other Medical Consequences of Drug Abuse National Institute on Drug Abuse 6001 Executive Boulevard, Room 5179, MSC 9593 Bethesda, MD 20892-9593 Telephone: (301) 402-1933 FAX: (301) 480-4544 Email: Hilary D. Sigmon Ph.D., R.N. Office of Extramural Programs National Institute of Nursing Research 45 Center Drive MSC 6300 Building 45, Room 3 AN-12 Bethesda, MD 20892-6300 Telephone: (301) 594-5970 FAX: (301) 480-8260 Email: o Direct your questions about peer review issues to: Michael Kozak, Ph.D. Division of Extramural Activities National Institute of Mental Health 6001 Executive Boulevard, Room 6138, MSC 9608 Bethesda, MD 20892 Telephone: (301) 443-1340 FAX: (301) 443-4720 Email: o Direct your questions about financial or grants management matters to: Diana S. Trunnell Grants Management Branch National Institute of Mental Health 6001 Executive Boulevard, Room 6115, MSC 9605 Bethesda, MD 20892-9605 Telephone: (301) 443-2805 FAX: (301) 443-6885 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: Christopher M. Gordon, Ph.D. Division of Mental Disorders, Behavioral Research, and AIDS National Institute of Mental Health 6001 Executive Boulevard, Room 6204, MSC 9619 Bethesda, MD 20892-9619 Telephone: (301) 443-1613 FAX: (301) 443-9719 Email: SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs must be submitted in a modular grant format. The modular grant format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at includes step-by-step guidance for preparing modular grants. Additional information on modular grants is available at 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 must be sent to: Jean G. Noronha, Ph.D. Division of Extramural Activities National Institute of Mental Health 6001 Executive Boulevard, Room 6154, MSC 9609 Bethesda, MD 20892 For express/courier service use: Rockville, MD 20852 Telephone: (301) 443-3367 FAX: (301) 443-4720 Email: APPLICATION PROCESSING: Applications must be received by 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. 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. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an Introduction addressing the previous critique. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the participating ICs. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, CSR 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 NIMH in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Receive a written critique, 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 second level review by the assigned IC"s National Advisory Council or Board. REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of your application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning your application"s overall score, weighting them as appropriate for each application. Your application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, you may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) SIGNIFICANCE: Does your study address an important problem? If the aims of your application are achieved, how do they advance scientific knowledge? What will be the effect of these studies on the concepts or methods that drive this field? (2) APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Do you acknowledge potential problem areas and consider alternative tactics? (3) INNOVATION: Does your project employ novel concepts, approaches or methods? Are the aims original and innovative? Does your project challenge existing paradigms or develop new methodologies or technologies? (4) INVESTIGATOR: Are you appropriately trained and well suited to carry out this work? Is the work proposed appropriate to your experience level as the principal investigator and to that of other researchers (if any)? (5) ENVIRONMENT: Does the scientific environment in which your work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: o PROTECTIONS: The adequacy of the proposed protection for humans, animals, or the environment, to the extent they may be adversely affected by the project proposed in the application. o INCLUSION: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria included in the section on Federal Citations, below) o 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: September 27, 2002 Application Receipt Date: October 29, 2002 Peer Review Date: January/February 2002 Council Review: May, 2003 (or earlier) Earliest Anticipated Start Date: May 30, 2003 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 MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (, a complete copy of the updated Guidelines 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 PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This 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 No. 93.242 (NIMH), 93.279 (NIDA), and 93.361 (NINR). Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies described at and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. 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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