CMHS Consumer Affairs E-News July 2, 2003 Vol. 03-53
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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
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 Peer Review Process
o Review Criteria
o Award Criteria
o 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.
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.
o 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.
o 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.
o 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.
o 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.
o 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.
o Investigate methods to allow for outcome measurement based on consumer
preferences and reintegration goals.
o 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".
o 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.
o 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.
o 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.
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.
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
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:
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
o 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
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.
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, 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.
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://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://escr.nih.gov). 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/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.
Last Updated on
04/14/04
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