Substance Abuse & Mental Health Services Administration

CMHS Consumer Affairs E-News
July 2, 2003, Vol. 03-53

Research on Community Reintegration for People With Psychiatric Disabilities

RELEASE DATE: June 20, 2003

PA NUMBER: PA-03-144

EXPIRATION DATE: June 2006, unless reissued.

National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov/)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.242

THIS PA CONTAINS THE FOLLOWING INFORMATION

• Purpose of the PA
• Research Objectives
• Mechanism(s) of Support
• Eligible Institutions
• Individuals Eligible to Become Principal Investigators
• Where to Send Inquiries
• Submitting an Application
• Peer Review Process
• Review Criteria
• Award Criteria
• Required Federal Citations

PURPOSE OF THIS PA

The National Institute of Mental Health (NIMH) invites research grant applications for multidisciplinary/translational research, especially mixed-methods research, that will explore (a) the individual, social, and service system conditions necessary for people with psychiatric disabilities to reintegrate into community life; (b) the organizational and service system conditions necessary to enable service providers to facilitate that reintegration; and (c) the effectiveness of rehabilitation strategies and programs in helping socioculturally diverse individuals who have widely varying goals, material and social resources, and clinical needs. This research has typically been called "disability" or "psychiatric rehabilitation" research. Historically, however, this research has focused fairly narrowly on the use of services; compliance; symptom reduction; easily assessed criteria of social and vocational success; and cost. The goal of this program announcement (PA) is to encourage researchers to think beyond usual assumptions underlying "psych rehab," program fidelity, and outcomes assessment and to encourage a focus on the individuals within and outside rehabilitation programs, who must function within personal, organizational, service system, cultural, and societal boundaries to achieve a return to community life.

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RESEARCH OBJECTIVES

For more than 30 years, the research in psychiatric rehabilitation has become increasingly sophisticated and rigorous. However, the conclusions that one can draw from the literature that are relevant to consumers remain unchanged: People with severe psychiatric disorders can learn skills and adaptive behaviors that make community living possible; drug treatment alone is not sufficient; neither the diagnostic label nor the symptomatology determines adaptive capabilities; the benefits of therapies received and skills learned in one context do not automatically transfer to other contexts; and the academic credentials of the mental health professional providing care do not predict consumer outcomes. Recent reviews of the literature support these conclusions.

However, it is now time to focus on research that will do more than replicate old findings. This PA is designed to encourage researchers to move beyond traditional questions, perspectives, and methods of research. The goal is to change the focus from assessing therapies, skills training, service models, and program fidelity to a focus on research designed to expedite and ease the reintegration into the community of those with psychiatric disabilities. The research should address the social and physical isolation experienced by consumers who need to develop socioculturally meaningful and useful bridges back to valued social roles. It also needs to deal with the regulatory, organizational, and professional barriers that case workers, whether they are licensed social workers or peer providers, experience in trying to do their jobs.

Research Topics

The following are examples of broad research topics that might be the focus of research on reintegration of people with psychiatric disabilities. This list is not meant to be comprehensive, nor are the examples meant to be exclusive of other topics.

• Using social and behavioral science theories, such as those on social support, social networks, and culture, determine under what conditions self-help, peer providers, and peer-run programs and organizations can improve outcomes for consumers. Determine under what conditions nonprofessional, nonpeer, community-based supporters can improve outcomes.
  
  
• Determine how organizational culture and climate impact the effectiveness of self-help organizations, Assertive Community Treatment (ACT) teams, Independent Placement and Support (IPS) programs, and other rehabilitation programs.
  
  
• Identify system, organizational, dyadic, and individual components that are necessary to maximize consumer engagement in rehab programs, the transition to rehab readiness, and an alliance of trust between the provider and client. Identify necessary components of community support and how these components vary across individuals from various sociocultural and economic backgrounds.
  
  
• Identify and test strategies to help employers accept, train, and support employees with mental illnesses who are working to reintegrate into the community. Using behavioral science theory as a guide, identify conditions required in employment situations for coworkers to accept those with severe mental illness as fellow employees.
  
  
• Test assessment strategies (such as computerized adaptive testing), validation techniques (such as cognitive testing), and measurement theories (such as Item Response Theory (IRT)) to improve the assessment capabilities of DSM Axes IV and V, across populations and settings.
  
  
• Investigate methods to allow for outcome measurement based on consumer preferences and reintegration goals.
  
  
• Improve the measurement validity of concepts critical to reintegration: continuity of care; alliance/trust/attachment; readiness; recovery; meaningful, though not necessarily dramatic, measures of progress (smiling, joining a group); empowerment; self-determination; quality of life (a quality that is contextually and personally relevant); future orientation (goals, hopes, dreams for a life beyond illness). Develop or adapt measures that assess the social and psychological context in which a person with psychiatric disabilities lives (such as the presence of acceptance, warmth, respect, understanding, an "environment of opportunities"; and an "atmosphere of dependency".
  
  
• Using behavioral and social theories to understand the underlying dynamics, test the components of multicomponent rehabilitation interventions (such as ACT and IPS) across populations and settings to determine how and why they work when they do. Determine if there are components of a program that are culturally inappropriate or irrelevant for some populations.
  
  
• Determine how, when, and with whom neurocognitive testing can be used to identify specific remedial strategies to further client reintegration into the community. Develop and test interventions that specifically target cognitive deficits to determine their effectiveness. Investigate the links among remediation strategies, cognitive test results, brain scan changes, and improved functioning.
  
  
• Investigate methods for disseminating programs to populations in sociocultural environments, economic circumstances, and geographic regions different from those in which the programs were created. Investigate the validity and utility of mixed methods approaches for determining whether a program is adhering to standards (fidelity) and improving client outcomes.

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MECHANISMS OF SUPPORT

This PA will use the NIH Research Project Grant (R01), Exploratory/Developmental Grant (R21), and Small Grant (R03) award mechanisms. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

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 as well as the non-modular budgeting formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular format. Otherwise follow the instructions for non-modular research grant applications.

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ELIGIBLE INSTITUTIONS

You may submit (an) application(s) if your institution has any of the following characteristics:

• For-profit or non-profit organizations
• Public or private institutions, such as universities, colleges, hospitals, and laboratories
• Units of State and local governments
• Eligible agencies of the Federal government
• Domestic or foreign
• Faith-based organizations

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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.

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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:

• Direct your questions about scientific/research issues to:
  Ann A. Hohmann, Ph.D., M.P.H.
  Division of Services and Intervention Research
  National Institute of Mental Health
  6001 Executive Boulevard, Room 7135, MSC 9631
  Bethesda, MD 20892-9631
  Telephone: (301) 443-4235
  Email: ahohmann@nih.gov
  
  
• Direct your questions about financial or grants management matters to:
  Joy R. Knipple
  Grants Management Branch
  National Institute of Mental Health
  6001 Executive Boulevard, Room 6115, MSC 9605
  Bethesda, MD 20892-9605
  Telephone: (301) 443-8811
  FAX: (301) 443-6885
  Email: jk173@nih.gov

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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 http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 435-0714, 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 http://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 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 received by 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 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.

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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:

• Receive a written critique
• 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
• Receive a second level review by the appropriate national advisory council or board

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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:

• Significance
• Approach
• Innovation
• Investigator
• 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, the following items will be considered in the determination of scientific merit and the priority score:

PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below).

INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research 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 CONSIDERATIONS

DATA SHARING: The adequacy of the proposed plan to share data.

BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research.

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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:

• Scientific merit of the proposed project as determined by peer review
• Availability of funds
• Relevance to program priorities

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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://ohrp.osophs.dhhs.gov/humansubjects/guidance/45cfr46.htm.

MONITORING PLAN AND DATA AND SAFETY 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 and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://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 "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://stemcells.nih.gov/registry/). It is the responsibility of the applicant to provide 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/.

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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