SERVICES AND INTERVENTION RESEARCH WITH HOMELESS PERSONS HAVING ALCOHOL, DRUG ABUSE, OR MENTAL DISORDERS RELEASE DATE: August 16, 2002 PA NUMBER: PA-02-150 EXPIRATION DATE: This PA expires on August 15, 2005, unless reissued. National Institute on Alcohol Abuse and Alcoholism (NIAAA) (http://www.niaaa.nih.gov) National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov) National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov) THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of this 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 Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PA The National Institute on Alcohol Abuse and Alcoholism (NIAAA), the National Institute on Drug Abuse (NIDA), and the National Institute of Mental Health (NIMH) invite applications for health services research projects designed to increase understanding of the efficiency, effectiveness and diffusion of services provided to homeless persons (adults, adolescents, children, or families) with alcohol, drug abuse and/or mental (ADM) disorders. This program announcement (PA) encourages innovative and theory-driven empirical research to examine the organization, management, integration, and financing of services as well as the impact of these factors on the quality, cost, access, utilization, outcomes, cost analyses of care. Of particular interest are investigations of services for persons who suffer from co-occurring alcohol, drug abuse, and mental disorders and for persons at risk for or who have HIV/AIDS or other serious health problems. This PA also encourages research that will expedite the dissemination, implementation, and adoption of effective treatment and prevention efforts for homeless persons with ADM disorders. Inter-disciplinary research teams, and research partnerships with providers and consumers across multiple systems in community settings are strongly encouraged. Such settings may include but are not limited to shelters and food programs, parole and correctional settings, non-traditional or ad hoc service settings, or street-based, transitional, and special housing programs. Proposed research may focus on any of the identified disorder areas, either alone or in combination with each other or with HIV/AIDS or other serious medical conditions. In fact, the joint sponsorship of this PA by NIAAA, NIDA, and NIMH results from the recognition that the co-occurrence of multiple problems and disorders among homeless persons is more typical than the presence of a single disorder by itself. RESEARCH OBJECTIVES A growing body of empirical literature has documented that homelessness and inadequate/unstable housing conditions significantly affect persons with alcohol, drug abuse, or mental (ADM) disorders, interfere with effective treatment and pose significant barriers to achieving optimal outcomes. The challenges posed by ADM disorders are often compounded by other life difficulties (e.g., HIV/AIDS or other serious medical conditions, lack of personal and financial resources, paucity of social support systems, limited availability of housing options, trauma, stigma, etc.) which further compromise treatment outcomes. These multiple factors are often co-occurring, fluctuating, and interactive in complex ways. This complexity has remained an on-going challenge to the development, implementation, and sustainability of effective, empirically based services, interventions and prevention efforts for the identified population. In addition, existing knowledge has not yet been applied to the development of interventions that affect the structural characteristics of the service systems that attempt to treat homeless persons with ADM disorders. In fact, public and private health care systems that serve homeless persons continue to struggle with ongoing changes in the patient population, new service technologies and new financing programs. These challenges present the opportunity for a new generation of research to develop more effective services and service delivery approaches. This next generation of research will need to investigate the structures, processes and functioning of service systems in the context of system and inter-system, community, agency, and provider and consumer factors with the goal of improving access, utilization, quality, effectiveness, cost-effectiveness and outcomes of services to treat homeless persons who suffer from alcohol, drug abuse, and mental health disorders. Consequently, this PA encourages health services research to investigate the effectiveness, long-term outcome and sustainability of services, interventions, and preventive and rehabilitative strategies targeted to homeless or unstably housed persons with ADM disorders. Research should address relevant factors from a developmental perspective as well as across systems (e.g., health care, parole/correctional, foster care, shelter programs, etc.). This may include the adaptation of pharmacological, psychosocial, behavioral, or environmental approaches -- individually or in combination -- and should target functional and symptomatic outcomes. Of particular interest are studies that examine treatment and prevention interventions that address HIV/AIDS and other infectious diseases as well as interventions aimed at reducing health and services disparities related to age, gender or minority status. Also of great interest are studies that address significant questions for homeless persons involved in the criminal justice system and homeless persons with co-occurring disorders. Listed below are examples of research topic areas that can advance knowledge on improving outcomes for the identified populations. This list is not prioritized, nor is it exhaustive; rather, it is expected that investigators who respond to this announcement will identify additional questions. o What are the beneficial components of commonly practiced but relatively unstudied community practices (e.g.-informal and non- traditional housing, care and assistance arrangements, etc) with homeless persons, with which sub-populations, and in what settings? How these can be incorporated into strategies for delivery of services and interventions? o What are the impacts of program and system characteristics (e.g., financing; jail diversion programs; specialized clinical or behavior- change services, interventions, or housing programs) on short- and long-term clinical, functional, and housing outcomes for homeless/unstably housed persons with ADM disorders? o How do social or other environmental contexts influence functioning and treatment including interactions among factors at the individual, family, sociocultural, provider, community, and systems levels? o How can behavioral, psychosocial, or environmental risk and protective factors be modified to improve outcomes for the identified populations? o What preventive intervention models can be tailored to focus on at- risk or HIV-infected homeless persons with co-occurring alcohol, drug and mental disorders (assessed at individual, system, network, care provider and community levels)? o What strategies can minimize the impact of trauma on homeless persons and reduce any subsequent barriers to providing effective services? o Which consumer, provider, service setting, and community factors and mechanisms contribute to successful outreach and engagement? o How do the competing demands posed by ADM and medical disorders interfere with help seeking or care across various settings? o How can assessment of treatments and services delivered be used to better understand the needs and clinical characteristics of subgroups (e.g., persons with subsyndromal conditions or comorbidity)? o How and why do the structure and financing of services affect quality of care and clinical outcomes? How do organizational behaviors and management policies foster communication, collaboration and service integration across different agencies to improve clinical, housing, and health outcomes? o How can evidence-based interventions and services be more readily adopted into ongoing clinical and community-based practice? o How can tools designed to measure the quality of care better assist policymakers, clinicians, and consumers with decision making? MECHANISMS OF SUPPORT This PA will use the National Institutes of Health (NIH) research project grant (R01), small grant (R03), and Exploratory/Developmental Research Grant (R21) award mechanisms. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Certain Career Development award mechanisms (K01, K02, K05, K08, K23, and K24) may also be eligible for consideration in response to this PA at the discretion of the awarding Institute. Institute policies and requirements for each of these support mechanisms may differ among NIAAA, NIDA, and NIMH. Therefore, prospective applicants are strongly encouraged to contact the program and grants management contacts listed below for specific information early in the application process. 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-based organizations Foreign institutions are not eligible for small grants (R03), but are eligible for the R01 and R21 mechanisms. 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 answer questions from potential applicants. o Direct your questions about scientific issues to: Harold I. Perl, Ph.D. Health Services Research Branch Division of Clinical and Prevention Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 505, MSC 7003 Bethesda, MD 20892-7003 Telephone: 301-443-0788 FAX: 301-443-8774 E-mail: perl@nih.gov Jerry Flanzer, D.S.W. Services Research Branch Division of Epidemiology, Services and Prevention Research National Institute on Drug Abuse 6001 Executive Boulevard, RM 4219, MSC 6504 Bethesda, MD 20892 Telephone: 301-443-4060 FAX: 301-443-2636 E-mail: jflanzer@nida.nih.gov Denise Juliano-Bult, M.S.W. Services Research and Clinical Epidemiology Branch Division of Services and Intervention Research National Institute of Mental Health 6001 Executive Boulevard, RM 7137, MSC 9631 Bethesda, MD 20892-9631 Telephone: 301-443-1638 FAX: 301-443-4045 E-mail: djuliano@nih.gov David Stoff, Ph.D. Center for Mental Health Research on AIDS Division of Mental Disorders, Behavioral Research and AIDS National Institute of Mental Health 6001 Executive Boulevard, RM 6210, MSC 9619 Bethesda, MD 20892-9619 Telephone: 301-443-4625 FAX: 301-443-9719 E-mail: dstoff@nih.gov Direct inquiries regarding fiscal matters to: Judy Simons Chief, Grants Management Branch Office of Planning and Resource Management National Institute on Alcohol Abuse and Alcoholism Willco Building, Suite 504 6000 Executive Boulevard, MSC 7003 Bethesda, MD 20892-7003 (301) 443-4704 (telephone) (301) 443-3891 (fax) email: jsimons@willco.niaaa.nih.gov Gary Fleming, J.D., M.A. Grants Management Branch Office of Planning and Resource Management National Institute on Drug Abuse 6001 Executive Boulevard, Room 3131, MSC 9541 Bethesda, MD 20892-9541 Telephone: (301) 443-6710 FAX : (301) 594-6847 E-mail: gf6s@nih.gov Diana S. Trunnell Grants Management Branch Division of Extramural Activities 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: Diana_Trunnell@nih.gov 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 https://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. APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted at the standard application deadlines, which are available at https://grants.nih.gov/grants/dates.htm. Application deadlines are also indicated in the PHS 398 application kit. 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 https://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 https://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 NIAAA staff member 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 https://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 received by or mailed on or before the receipt dates described at https://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 application already reviewed, but such application must include an Introduction addressing the previous critique. PEER REVIEW PROCESS Applications submitted for this PA will be assigned on the basis of established PHS referral guidelines. An appropriate scientific review group 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 Receive a written critique 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 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 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: 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. 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) 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 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: https://grants.nih.gov/grants/guide/notice-files/not98-084.html). 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 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at https://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 https://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 https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. 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 https://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. 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 a 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 No. 93.273, and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. 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 https://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. 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. https://grants.nih.gov/grants/guide/pa-files/PA-02-015.html.
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