This Program Announcement expires on December 2004, unless reissued.

RESEARCH ON QUALITY OF CARE FOR MENTAL DISORDERS

Release Date:  October 1, 2001

PA NUMBER:  PA–01-145

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

THIS PA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS FOR ALL APPLICATIONS 
SUBMITTED IN RESPONSE TO THIS PA.  MODULAR BUDGET INSTRUCTIONS ARE PROVIDED IN 
SECTION C OF THE PHS 398 (REVISION 5/2001) AVAILABLE AT 
http://grants.nih.gov/grants/funding/phs398/phs398.html.

PURPOSE

The National Institute of Mental Health (NIMH) invites research grant 
applications for multidisciplinary research, especially mixed-methods, that 
will characterize, examine, and assess the quality of mental health services 
provided to people with mental disorders.  The goals of this program 
announcement (PA) are to encourage mental health researchers to question 
current conceptualizations and assessments of quality, work collaboratively 
with social and behavioral scientists, including those who study organizations 
and marketing, to develop conceptualizations that can be measured and are 
reliable and valid within or across populations, and design studies of quality 
that can lead to real improvements in how mental health services are 
delivered.  

This program announcement supercedes PA-95-066, issued May 26, 1995.  It 
addresses priorities laid out in Bridging Science and Service:  A Report by 
the National Advisory Mental Health Council's Clinical Treatment and Services 
Research Workgroup (http://www.nimh.nih.gov/research/bridge.htm) and in the 
NIMH Strategic Plan for Reducing Health Disparities 
(http://www.nimh.nih.gov/strategic/strategicdisparity.cfm).  It is also in 
line with a recently published report from the Institute of Medicine, which 
contains recommendations for improving the quality of health care and reducing 
the burden of disease in the United States 
(http://www.nap.edu/books/0309072808/html/).

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, Research on Quality of Care for 
Mental Disorders, 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/.

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic for-profit and non-profit 
organizations, public and private, such as universities, colleges, hospitals, 
laboratories, units of State and local governments, and eligible agencies of 
the Federal government.  Faith-based organizations are eligible to apply for 
these grants.  Foreign institutions, while eligible for R01 grants, are not 
eligible for R03 grants.  Racial/ethnic minority individuals, women, and 
persons with disabilities are encouraged to apply as principal investigators.

MECHANISM OF SUPPORT

This PA will use the National Institutes of Health (NIH) research project 
grant (R01), exploratory/developmental grant (R21), and small grant (R03) 
award mechanisms.  Responsibility for the planning, direction, and execution 
of the proposed project will be solely that of the applicant.  The total 
project period for an R01 application submitted in response to this PA may not 
exceed 5 years.  For R21 applications, the project period cannot exceed 2 
years and $100,000 in direct costs in each of those years.  For R03 
applications, the project period cannot exceed 2 years and $50,000 in direct 
costs in each of those years.  Applicants are strongly encouraged to read the 
R21 and R03 announcements, which specify the goals and guidelines for each 
program (http://grants.nih.gov/grants/guide/pa-files/PA-00-073.html) and 
(http://grants.nih.gov/grants/guide/pa-files/PAR-99-140.html).

For all competing R03 and R21 applications, and those R01 applications 
requesting up to $250,000 direct costs per year, specific application 
instructions have been modified to reflect "MODULAR GRANT" and "JUST-IN-TIME" 
streamlining efforts that have been adopted by the NIH.  Complete and detailed 
instructions and information on Modular Grant applications have been 
incorporated into the PHS 398 (rev. 5/2001).  Additional information on 
Modular Grants can be found at 
http://grants.nih.gov/grants/funding/modular/modular.htm.  R01s greater than 
$250,000 per year require detailed budgets and do not follow Modular Grant 
format.

RESEARCH OBJECTIVES

Quality of care research typically compares actual care provided in everyday 
practice to clinically- or scientifically-derived standards of care.  Variance 
in practice patterns across clinicians or geopolitical areas has been 
interpreted as a warning sign, signaling a need to examine the cause of the 
discrepancy.  Ultimately, however, quality of care studies seek to compare the 
degree of clinician adherence to these standards with outcomes experienced by 
patients or clients.  Studies in this area often separate out the elements of 
care into structure (e.g., community, service system), process (the 
intervention), and outcomes (e.g., clinical status, cost, satisfaction).  This 
general approach to understanding quality, comparing actual practice to a 
standard of care and to other practices, has been a staple of health services 
research.  However, this approach to understanding quality can lead 
investigators to make a simplifying assumption that a single standard of or 
approach to providing care is optimal for all populations receiving care for a 
single disorder.  While this is a useful way to begin to think about quality, 
the cultural, educational, and socioeconomic diversity of the population of 
the United States makes it necessary to move the field beyond comparing 
clinician behavior to uniform standards and to focus on client outcomes.

This announcement is designed to encourage mental health investigators to 
think beyond “standards of care” and “treatment guidelines” when defining 
“quality.”  It is designed to provide the resources necessary for 
multidisciplinary collaborative teams to experiment with new perspectives and 
methods to understand and assess quality for diverse population groups.  

Research Issues

Listed below are examples of questions that suggest different ways of thinking 
about and designing research to investigate quality of care in mental health.  
The list of examples is illustrative, not exhaustive.  It is expected that 
additional important research questions will be identified by investigators 
who work collaboratively in multidisciplinary teams to respond to this 
announcement.

o  Is patient or client satisfaction related to quality, as defined by 
treatment guidelines or standards of care, or to client outcomes?  Do these 
relationships hold constant across cultural groups, disorders, and age groups?  

o  How do typically measured aspects of quality (e.g., fidelity to the model) 
relate to client or parent satisfaction, clinician motivation and involvement, 
and clinical and functional outcomes for clients?

o  What factors associated with the relationship between the client and the 
clinician could be measured in studies of quality that would improve our 
understanding of quality, e.g., participatory decision making or goal setting?  
Do different cultural or age groups have different needs or requirements from 
this relationship?  Do those differences have an impact on clinical and 
functional outcomes? 

o  Do personality and cultural differences between clients and clinicians 
affect the client’s expectations from treatment, perception of quality, and 
his/her clinical and functional outcomes?

o  How do staff and organizational factors impact the delivery of care?  Which 
are the most critical factors for producing quality or improved outcomes for 
clients:  clinician training, clinician experience, clinician satisfaction, 
organizational culture, “fit” between clinician and client, financial 
incentives, family “buy-in”?  Is the power of these factors invariant across 
settings?  How do factors outside the clinical setting have an impact on 
client outcomes that organizational quality standards cannot affect?

o  Particularly for children and adolescents, how can families be involved in 
improving the quality of care and outcomes?  

o  How can quality be evaluated in psychotherapeutic Internet interventions?  
Are standards of care, credentialing, and ethical guidelines associated with 
increased quality?  Can client satisfaction and clinical and functional 
outcomes be assessed on-line?  Do certain clinical, cultural, or age groups 
respond better to on-line therapy than to face-to-face therapy?

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

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 biomedical and 
behavioral research projects involving human subjects, unless a clear and 
compelling rationale and justification are 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 research involving human subjects should read the 
UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in 
Clinical Research," published in the NIH Guide for Grants and Contracts on 
August 2, 2000 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html); 
a complete copy of the updated Guidelines are available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm.  The 
revisions relate to NIH defined Phase III clinical trials and require:  a) all 
applications or proposals and/or protocols to 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) all 
investigators to report accrual, and to conduct and report analyses, as 
appropriate, by sex/gender and/or racial/ethnic group differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of NIH 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 was published in the NIH Guide for 
Grants and Contracts, March 6, 1998, and is available at the following URL 
address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html.

Investigators also may obtain copies of these policies from the program staff 
listed under INQUIRIES.  Program staff may also provide additional relevant 
information concerning the policy.

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.  This policy announcement is found in the NIH Guide for Grants and 
Contracts Announcement dated June 5, 2000, at the following website: 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.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.  Reviewers are cautioned that their anonymity may 
be compromised when they directly access an Internet site.

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.

APPLICATION PROCEDURES

The PHS 398 research grant application instructions and forms (rev. 5/2001) at 
http://grants.nih.gov/grants/funding/phs398/phs398.html are to be used in 
applying for these grants and will be accepted at the standard application 
deadlines (http://grants.nih.gov/grants/dates.htm) as indicated in the 
application kit.  This version of the PHS 398 is available in an interactive, 
searchable PDF format.  Although applicants are strongly encouraged to begin 
using the 5/2001 revision of the PHS 398 as soon as possible, the NIH will 
continue to accept applications prepared using the 4/1998 revision until 
January 9, 2002.  Beginning January 10, 2002, however, the NIH will return 
applications that are not submitted on the 5/2001 version.  For further 
assistance contact GrantsInfo, Telephone 301/435-0714, Email: 
GrantsInfo@nih.gov.

Applicants planning to submit an investigator-initiated new (Type 1), 
competing continuation (Type 2), competing supplement, or any amended/revised 
version of the preceding grant application types requesting $500,000 or more 
in direct costs for any year are advised that he or she must contact the 
Institute or Center (IC) program staff before submitting the application, 
i.e., as plans for the study are being developed.  Furthermore, the 
application must obtain agreement from the IC staff that the IC will accept 
the application for consideration for award.  Finally, the applicant must 
identify, in a cover letter sent with the application, the staff member and 
Institute or Center who agreed to accept assignment of the application.  

This policy requires an applicant to obtain agreement for acceptance of both 
any such application and any such subsequent amendment.  Refer to the NIH 
Guide for Grants and Contracts, March 20, 1998 at 
http://grants.nih.gov/grants/guide/notice-files/not98-030.html.

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS

The modular grant concept establishes specific modules in which direct costs 
may be requested as well as a maximum level for requested budgets. Only 
limited budgetary information is required under this approach.  The 
just-in-time concept allows applicants to submit certain information only when 
there is a possibility for an award. It is anticipated that these changes will 
reduce the administrative burden for the applicants, reviewers and NIH staff.  
The research grant application form PHS 398 (rev. 5/2001) at 
http://grants.nih.gov/grants/funding/phs398/phs398.html is to be used in 
applying for these grants, with modular budget instructions provided in 
Section C of the application instructions.  Applicants are permitted, however, 
to use the 4/1998 revision of the PHS 398 for scheduled application receipt 
dates until January 9, 2002.  If you are preparing an application using the 
4/1998 version, please refer to the step-by-step instructions for Modular 
Grants available at http://grants.nih.gov/grants/funding/modular/modular.htm.  
Additional information about Modular Grants is also available on this site.

The title and number of the program announcement must be typed on line 2 of 
the face page of the application form and the YES box must be marked.

Submit a signed, typewritten original of the application, including the 
Checklist, and 5 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)

REVIEW CONSIDERATIONS

Applications will be assigned on the basis of established PHS referral 
guidelines.  Applications will be evaluated for scientific and technical merit 
by an appropriate scientific review group convened in accordance with the 
standard NIH peer review procedures.  As part of the initial merit review, all 
applications will receive a written critique and undergo a process in which 
only those applications deemed to have the highest scientific merit, generally 
the top half of applications under review, will be discussed, assigned a 
priority score, and receive a second level review by the National Advisory 
Mental Health Council.

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 the application in order to judge the likelihood that the proposed research 
will have a substantial impact on the pursuit of these goals.  Each of these 
criteria will be addressed and considered in assigning the overall score, 
weighting them as appropriate for each application.  Note that 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.

(1) 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?

(2) 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?

(3) Innovation:  Does the project employ novel concepts, approaches or method? 
Are the aims original and innovative?  Does the project challenge existing 
paradigms or develop new methodologies or technologies?

(4) 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)?

(5) 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?

In addition to the above criteria, in accordance with NIH policy, all 
applications will also be reviewed with respect to the following:

o  The adequacy of plans to include both genders, minorities and their 
subgroups, and children as appropriate for the scientific goals of the 
research.  Plans for the recruitment and retention of subjects will also be 
evaluated.

o  The reasonableness of the proposed budget and duration in relation to the 
proposed research.

o  The adequacy of the proposed protection for humans or the environment, to 
the extent they may be adversely affected by the project proposed in the 
application.

o  The adequacy of the proposed plan to share data.

o  The adequacy of a multidisciplinary collaborative research perspective and 
team.

AWARD CRITERIA

Award criteria that will be used to make award decisions include:

o  scientific merit (as determined by peer review)
o  availability of funds
o  programmatic priorities

INQUIRIES

Inquiries are encouraged.  The opportunity to clarify any issues or questions 
from potential applicants is available.

Direct inquiries regarding programmatic issues to:

Karen Anderson Oliver, Ph.D.
Division of Services and Intervention Research
National Institute of Mental Health
6001 Executive Boulevard, Room 7138, MSC-9631
Bethesda, MD  20892-9631
Telephone:  (301) 443-3364
FAX:  (301) 443-4045
Email:  koliver1@mail.nih.gov

Direct inquiries regarding fiscal matters to:

Diana S. Trunnell
Grants Management Branch
National Institute of Mental Health
6001 Executive Boulevard, Room 6115, MSC-9605
Bethesda, MD  20892-9605
Telephone:  (301) 443-3065
FAX:  (301) 443-6885
Email:  Diana_Trunnell@nih.gov

AUTHORITY AND REGULATIONS 

This program is described in the Catalog of Federal Domestic Assistance No. 
93.242.  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 and Federal Regulations 42 CFR 52 and 45 CFR Parts 
74 and 92.  This program is not subject to the intergovernmental review 
requirements of Executive Order 12372 or Health Systems Agency review.

The PHS strongly encourages all grant and contract recipients to provide a 
smoke-free workplace and promote the non-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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