PA-04-024: HIV/AIDS, SEVERE MENTAL ILLNESS AND HOMELESSNESS

Department of Health
and Human Services (HHS)

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HIV/AIDS, SEVERE MENTAL ILLNESS AND HOMELESSNESS RELEASE DATE: November 18, 2003 PA NUMBER: PA-04-024 November 27, 2006 - The R01 portion of this funding opportunity has been replaced by PA-07-090, which now uses the electronic SF424 (R&R) application for February 5, 2007 submission dates and beyond. 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 R03 and R21 Non-AIDS Applications: March 2, 2006 EXPIRATION DATE for R03 and R21 AIDS and AIDS-Related Applications: May 2, 2006 EXPIRATION DATE for R01 Non-AIDS Applications: November 2, 2006 EXPIRATION DATE for R01 AIDS and AIDS-Related Applications: January 3, 2007 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov) COMPONENTS OF PARTICIPATING ORGANIZATION: National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov/) National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov) National Institute on Alcohol Abuse and Alcoholism (NIAAA) (http://www.niaaa.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.242, 93.279, 93.273 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 This PA replaces PA-98-080. The overall focus of this Program Announcement (PA), sponsored by the NIMH, NIAAA and NIDA, is to refocus research on persons with severe mental illness (SMI), either before or after HIV infection, and to expand HIV-related research to homeless persons. This PA solicits studies on the SMI population and/or homeless persons with special attention to the development, implementation, and evaluation of effective HIV-prevention interventions and their dissemination and translation to the community and public health service organizations. We also solicit studies on the SMI population and/or homeless persons that propose improved methodologies to study descriptive/analytic epidemiology of HIV infection and epidemiology of the behavior associated with risk and the spread of HIV infection. An important objective of this PA is to encourage integration both across and within the different research areas by establishing multidisciplinary research teams and collaborative alliances. RESEARCH OBJECTIVES Over the past decade there have been significant advances in research on the U.S. epidemic of HIV infection among people with the most severe and persistent mental illnesses. To date, research has concentrated largely on the following areas: (1) cross sectional studies of regional HIV seroprevalence in SMI in predominantly urban sections of the country, (2) studies of risk, transmission, and behavioral epidemiology, and (3) research on cognitive behavior and skill- based risk reduction interventions in adult SMI. However, research is still needed in a number of crucial areas on HIV/AIDS and the SMI, and the links with homeless persons have become more obvious, demanding immediate research attention (discussed below). Epidemiological estimates indicate that about one-third of all homeless, single adults have severe and persistent mental illness and have marked neuropsychological impairments in attention, executive functioning, verbal memory, and general intellectual functioning. Substance use and abuse estimates are extremely high for homeless adolescents and adults, including alcohol and injection drug use (ranging from 20-80%). Available data suggest that in major urban areas, 10-20% of homeless persons who suffer from chronic mental illnesses are infected with HIV. Nationwide, homeless adults are a population at high risk for HIV, due to disproportionate rates of injection drug use, unprotected sexual activity, prostitution, and victimization. Moreover, those who are often marginalized, such as the homeless, suffer from other co-infections (e.g., tuberculosis, hepatitis C virus), multiple comorbidities (e.g., substance abuse, mental illness), and a wide range of chronic health conditions (e.g., arthritis, heart disease, high blood pressure, emphysema/bronchitis, cirrhosis, kidney disorder, seizure disorder). The multiple conditions affecting HIV disease in homeless persons may accelerate HIV disease course, add significant complications to the manifestations of HIV disease and its CNS sequelae, and challenge the available prevention strategies and service delivery systems. Research is needed to better understand the prevalence of HIV and AIDS among persons with SMI, with drug abusing behaviors, and/or who are homeless across the U.S. Epidemiological research must look broadly at HIV-related risk behavior and examine the extent and social organization of sexual and drug-use behavior. Research efforts might begin by targeting high-risk individuals in community samples and then extend into the general population of individuals troubled by the most severe mental illnesses. Epidemiological research needs to be broadened to samples of patients with preexisting mental illness, mental illness secondary to HIV infection, and to others suffering from mental illness within the community. Research is needed to address: improved methodological procedures; longitudinal studies in multiple U.S. regions including incidence data; validating self-reported data; increased generalizability to the general population; the role of contextual factors; linking risk taking to specific aspects of SMI; and longitudinal studies on patterns of risk taking over time; and connecting between the content of HIV preventive interventions to potentially risky situations actually encountered by SMI individuals. HIV research in homeless persons must address: the relative role of co-infections and comorbidities; a range of settings including forensic, shelters, new admissions and long-stay; developmental trajectories to and out of homelessness in youth; risk research in children of homeless adults; and adherence research in homeless persons with multiple comorbidities. In spite of some positive behavior change outcomes of HIV preventive interventions for this population, research on risk reduction approaches for mentally ill persons is still in its very early stages. We must develop a combination approach to HIV prevention in the SMI and homeless that incorporates a range of biomedical, behavioral, and social interventions that work on all levels of social organization from individuals to whole societies. We need a broader repertoire of intervention models and these models must be assessed at multiple levels including individual, system, network, care provider and community. HIV prevention programs will have to be integrated into outreach, transitional living, and community services for the SMI by translating effective HIV prevention methods for the SMI to applied mental health and public health care systems. Strategies should be developed for sustained long-term effectiveness of HIV preventive programs across multiple care and social service systems for the SMI and/or homeless through integration, coordination and linkages with psychiatric, alcohol, drug abuse, and medical therapies. Better implementation of effective interventions will require a dialogue among researchers, public health practitioners, policymakers, and community constituencies as well as an improved science of research dissemination. Implementation must be followed by assessment of the extent to which people with SMI do in fact actually receive HIV-related medical care. Interventions will succeed only if they are linked to efforts to address the macrosocial conditions that contribute to HIV vulnerability and other infectious diseases and their consequences. This is especially important for the SMI and the homeless because of the layers of stigma from infection, psychiatric illness, alcohol/drug abuse, life style, and inequalities based on race/ ethnicity, discrimination, economic class, or sexual identity. Areas of Research Interest The following are examples of broad research topics that might be the focus of research on HIV/AIDS in persons with SMI and/or homelessness (mentally ill populations other than the SMI may sometimes be relevant). The list of examples is not meant to be comprehensive nor exclusive of other topics. Epidemiology, Risk, and Protective Factors o Epidemiological multisite research of population-based samples on at-risk and HIV infected individuals with a psychiatric diagnosis and alcohol/drug abuse disorders, including all races and ethnic groups, children, adolescents, and adults living in multiple urban, suburban, and rural regions of the U.S. o Due to the multiple stigmas around mental illness, homelessness, alcohol and substance abuse disorders, and HIV/AIDS, research is needed to examine ways in which stigma and discrimination or other social, economic cultural and environmental conditions contribute to, or create sources of, HIV-related risk and develop interventions based on this understanding. o Because traditionally underserved populations with mental illness, homelessness, alcohol and drug abuse, and HIV/AIDS are skeptical about treatment and care, novel recruitment, engagement and retention strategies are needed to reach and retain persons least likely to seek help and to conduct research on effectiveness of alternative access methods that may involve either faith-based or other community organizations. o Increased attention to individually perceived protective factors (e.g., reason for living) in the context of known risk factors, trait or state dimensions (such as impulsivity or impaired executive functioning), that increase risk of HIV infection and the role of cultural factors and acculturative processes that can modify risk and its perception as well as influencing protective factors (e.g., religiosity). o Longitudinal research of HIV-related risk taking at individual and community levels in the SMI and homeless. Comorbidities and Complications o Studies of medical or neuropsychiatric manifestations of HIV infection that may result in onset of SMI or may co-occur with homelessness (e.g., neurocognitive disorders related to HIV with or without Hepatitis-C co-infection, psychotic disorders, delirium, CNS opportunistic infections and tumor, systemic abnormalities, psychoactive agents, adverse effects of certain medical treatments, Hepatitis C Virus). o Research to evaluate the effect of co-infection (especially with HBV, HCV or TB) on the management of HIV in SMI or homeless persons and to determine the bi- directional effects of co-infection and treatments on disease progression and drug interactions. o Evaluation of potential therapies for the prevention and treatment of HIV- associated infections and co-infections and research on treatment of comorbidities; prevention of early comorbid patterns in reducing risk, increasing the efficacy of HIV risk-reduction and adherence interventions in the SMI or homeless persons. o Studies to determine the impact co-infection with HBV, HCV, or TB on immune dysfunction, HIV progression and HIV-therapy associated reconstitution in SMI. o Research to discover mechanisms underlying the relationships among co-occurring disorders and HIV and potentially modifiable biological substrates that link co- infections and comorbidites to HIV disease in the SMI and homeless persons. Multilevel Prevention and Treatment Services o Studies of structural, community, social network and societal/cultural level interventions to reduce high risk behaviors and prevent HIV infection in the SMI and homeless and go beyond the standard individual-level randomized trial interventions. o Studies to adapt effective HIV preventive interventions to the SMI, homeless, and other underserved marginalized populations. o Research to address the multiple comorbidities and complications in HIV-infected individuals with SMI and/or homelessness through the development of integrated treatment and care of mental illness and substance abuse and improved linkages with the specialty medical care system. o Increased attention to under-developed prevention modalities and sub- populations of the SMI and homeless, such as the development of newer methods of prevention (e.g., microbicides, vaccines) and HIV prevention among infected individuals. o Research on mental health and substance abuse service needs or service system organization and assessment of the most effective methods for providing and financing services to HIV-infected individuals with SMI and homelessness. Technology Transfer and Information Dissemination o Studies that translate research results into community programs for HIV-infected persons with SMI and homelessness, moving from research interventions to ongoing public health programs and cost effectiveness. o Development of outcome measures and suitable methodologies for dissemination and dissemination/implementation approaches that accurately assess the success of an approach to move evidence into practice. o Studies on the fidelity of implementation efforts, including the identification of components of implementation that will enable fidelity to be assessed meaningfully. o Studies on the dissemination of effective HIV-intervention strategies that also test the utility of alternative dissemination strategies for service delivery systems targeting the SMI, homeless, and/or other related underserved populations. o Research to identify factors (system, organizational, individual) necessary to enhance an alliance of trust between the provider and client, facilitate treatment readiness and maximize consumer participation and engagement in HIV prevention, outreach, transitional living and community services for the homeless and/or persons with SMI MECHANISMS OF SUPPORT This PA will use the NIH Research Project Grant (R01), collaborative R01s, Small Grant (R03), Exploratory/Developmental Grant (R21) award mechanism(s). As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. Information on the Collaborative R01 mechanism is available at: http://grants.nih.gov/grants/guide/pa-files/PA-01-123.html Information on the Small Grant (R03) is available at: http://grants.nih.gov/grants/guide/pa-files/PA-03-108.html Information on the Exploratory/Developmental Grant (R21) is available at: http://grants.nih.gov/grants/guide/pa-files/PA-03-107.html This PA uses just-in-time concepts. It also uses the modular budgeting format. (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 format. 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. 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: David M. Stoff, Ph.D. Division of Mental Disorders Behavioral Research and AIDS National Institute of Mental Health 6001 Executive Boulevard, Room 6210, MSC 9619 Bethesda, MD 20892-9619 Telephone: (301) 443-4625 FAX: (301) 443-9719 Email: dstoff@nih.gov Mike Hilton, Ph.D. Office of Collaborative Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 302 Bethesda, MD 20892-7003 Telephone: (301) 402-9402 Fax: (301) 480-2358 Email: mhilton@niaa.nih.gov Jerry Flanzer, Ph.D. Division of Epidemiology, Services and Prevention Research National Institute on Drug Abuse 6001 Executive Boulevard, Room 4222, MSC 9565 Bethesda, MD 20892-9565 Telephone: (301) 443-4060 FAX: (301) 443-6815 Email: Jflanzer@nida.nih.gov Helen Cesari, MSc. Center of Center on AIDS and Other Medical Consequences of Drug Abuse National Institute on Drug Abuse 6001 Executive Boulevard, Room 5173 Bethesda, MD 20892 Telephone: (301) 443-1801 FAX: (301) 480-4544 Email: Hcesari@nida.nih.gov o Direct your questions about financial or grants management matters to: Brian Albertini Division of Mental Disorders, Behavioral Research, and AIDS National Institute of Mental Health 6001 Executive Boulevard, Room 6135, MSC 9605 Bethesda, MD 20852-9605 Telephone: (301) 443-0004 FAX: (301) 443-6885 Email: albertib2@mail.nih.gov Judy Fox (formerly Simons) Chief, Grants Management Branch National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 504 Bethesda, MD 20892-7003 Telephone: (301) 443-4704 FAX: (301) 443-3891 Email: jsimons@willco.niaaa.nih.gov Diana Haikalis, MBA Office of Extramural Affairs National Institute on Drug Abuse 6101 Executive Boulevard, Suite 242, MSC 8403 Bethesda, MD 20892-8403 (express/courier service) Telephone: (301) 443-6710 FAX: (301) 443-7595 Email: dhaikali@nida.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. The title and number of the PA must be typed in line 2 of the face page of the application form and the YES box must be checked. 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: 1) Contact the IC program staff at least 6 weeks before submitting the application, i.e., as you are developing plans for the study; 2) Obtain agreement from the IC staff that the IC will accept your application for consideration for award; and, 3) Identify, in a cover letter sent with the application, the staff member and IC who agreed to accept assignment of the application. This policy applies to all investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended or revised version of these grant application types. Additional information on this policy is available in the NIH Guide for Grants and Contracts, October 19, 2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the checklist, and five signed photocopies in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) APPLICATION PROCESSING: Applications must be mailed on or before the receipt dates described at http://grants.nih.gov/grants/funding/submissionschedule.htm. The CSR will not accept any application in response to this PA that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an unfunded version of an application already reviewed, but such application must include an Introduction addressing the previous critique. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. PEER REVIEW PROCESS Applications submitted for this PA will be assigned on the basis of established PHS referral guidelines. Appropriate scientific review groups convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit. As part of the initial merit review, all applications will: o Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score o Receive a written critique o Receive a second level review by the appropriate national advisory council or board REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss your 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 these 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: 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. 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.health.gov/healthypeople. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

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