INTERVENTIONS AND PRACTICE RESEARCH INFRASTRUCTURE PROGRAM (IP-RISP)

Release Date:  May 24, 2000

PA NUMBER:  PAR-00-096 (superceded by PAR-04-015)

National Institute of Mental Health

PURPOSE

The National Institute of Mental Health (NIMH) seeks to expand the number of 
partnerships between typical clinical/services settings and academic 
institutions in order to enhance the national capacity to transfer state-of-the-
art interventions into those non-academic settings.  This Interventions and 
Practice Research Infrastructure Program (IP-RISP) is in response to 
recommendations made by the National Advisory Mental Health Council’s Bridging 
Science and Service Report (http://www.nimh.nih.gov/research/bridge.htm).  This 
IP-RISP seeks to foster the scientific interaction of mental health 
intervention/treatment and services researchers with typical clinical/services 
settings, clinicians and patients/clients to: (1) study and conduct 
interventions (treatment, rehabilitative, and preventive) in non-academic health 
care settings, and (2) describe practice patterns and care variations in those 
settings.  These two scientific aims should also seek to identify and utilize 
those factors (organizational, sociocultural, interpersonal) in day-to-day 
practice settings which may be associated with quality care and optimal outcomes 
for patients and clients.

This program announcement clarifies and supercedes the prior announcements for 
the support of the Interventions Infrastructure Program (PAR-99-064) and the 
Research Infrastructure Support Program (PAR-94-096) and will govern all 
applications submitted in FY 2000 and beyond.

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 Program Announcement (PA), 
Interventions and Practice Research Infrastructure Program, is related to the 
priority area of Mental Health and Mental Disorders.  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.  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) resource related 
research projects (R24) award mechanism.  This mechanism is used to support 
projects that enhance capabilities to contribute to extramural research of the 
PHS.  Responsibility for the planning, direction, and execution of the proposed 
project will be solely that of the applicant.  The total project period for an 
application submitted in response to this PA may not exceed 5 years and is not 
renewable.  These grants are not transferable.

The funding cap for each year for the IP-RISP awards is $400,000 maximum direct 
costs, plus negotiated indirect costs.  Annual awards will be made subject to 
continued availability of funds and progress achieved.

Because the R24 mechanism may have special eligibility requirements, application 
formats, and review criteria, applicants are strongly encouraged to consult with 
program staff (listed under INQUIRIES) and to obtain the appropriate additional 
announcements for those grant mechanisms.

RESEARCH OBJECTIVES

Background

This Interventions and Practice Research Infrastructure Program (IP-RISP) is 
designed to enable partnerships between clinical practice/service settings, with 
little or no research, and academic institutions with ongoing interventions or 
health services research.  The primary aim of these partnerships is to enhance 
the national infrastructure for mental health research focused on either the 
delivery of interventions in non-research settings and/or practice research 
(i.e., research which examines how and which treatments/services are provided to 
which individuals in typical settings [e.g., variations in care]) and focuses on 
characterizing and improving care in these settings.  Little is known about how 
to best incorporate interventions into diverse settings or about what mental 
health care is in the day-to-day practices of different providers.  These 
partnerships can help  bridge  the science-service gaps highlighted in the 
recent report of the National Advisory Mental Health Council 
(http://www.nimh.nih.gov/research/bridge.htm)

This IP-RISP provides support for research infrastructure development by 
partnering academic settings with non-academic clinical and services settings 
which have large and diverse patient and provider populations but may lack the 
resources needed to conduct strong scientific research programs.  Such settings 
may include general and primary health care, community specialty care, long-term 
care, public mental health or health care systems, and prisons, jails and other 
correctional system settings.  The non-academic settings can benefit from 
research by providing empirical validation for treatment approaches and 
variations in care, creating robust evaluations of programmatic benefit and 
outcome, and assessing ways to improve care.  The academic settings can benefit 
from these partnerships by strengthening and diversifying their study 
populations and perspectives.

A central principle underlying the IP-RISP is that different clinical/service 
settings will require different types of research infrastructure support and 
development activities which should be guided by focusing on specific research 
needs and questions.  A substantial part of the support should be targeted to 
the non-academic clinical/service settings.  Examples of types of support under 
this program are:

o  Database construction or conversion, ongoing data management, and related 
technical support

o  Systems and personnel to follow patients and clinicians longitudinally

o  Developmental, pilot, and feasibility studies

o  Protocol adaptation and instrument development for use in studies in non-
academic settings

o  Research training for junior or non-research investigators and staff

o  Partial salary support for persons engaged in the project (including practice 
site staff)

o  Methodological and statistical consultation, including expenses incurred by 
scientific and practice advisory committees

o  Research subject costs

The application must present a focused plan for the proposed IP-RISP.  It 
should, using targeted research questions, (1) assess the current 
practice/service setting needs for research infrastructure, (2) identify the fit 
with and strengths of the partner academic institution, and (3) describe the 
activities that will be undertaken to develop and strengthen the unique clinical 
practice-academic partnership.  The plan should cover a period of five years and 
provide the partnership an improved capacity to conduct mental health 
interventions and/or practice research.

Many of the research gaps in trying to bridge science and service fall in the 
interventions and practice research domains.  The primary research challenge for 
the delivery of interventions in actual practice is to determine whether and how 
efficacious interventions can have a clear and beneficial effect when carried 
out in such settings with diverse and representative populations.  Similarly, 
the primary research challenge for practice research is to carefully  
characterize variations in care for individuals in typical practice settings, 
track pathways into care, delineate real practice factors associated with those 
variations, and use that knowledge to direct quality improvement and 
dissemination.  Both of these research challenges may be best approached by 
carefully considering the multiple dimensions of context relevant to clinical 
care in non-academic settings.

Listed below are examples of research topics that can inform the practice-
academic partnerships and contribute to scientific knowledge about mental health 
interventions in diverse, non-academic settings and mental health practice as 
delivered today. 

Interventions in Typical Clinical Settings:

o  Determining patient, provider and encounter factors that may enhance or 
detract from the effective delivery of interventions

o  Evaluating the effectiveness, safety, and costs of interventions proven 
efficacious in research settings, but not adequately tested in practice settings

o  Evaluating the methods (and their effects) of adapting assessment and 
treatment protocols originally developed in academic settings (including factors 
such as visit frequency and duration)

o  Assessing the levels of fidelity (by patients and providers) to adapted 
interventions, possible barriers to fidelity, and possible barrier reduction

o  Improving the recruitment and retention of patients and providers in real 
practice intervention studies

o Describing the role and impact of patient and provider treatment choices on 
effective intervention delivery

Practice Research:

o  Determining usual and/or  best  mental health practices in real settings, 
their relationship to patient, provider, and system factors, to outcomes, and to 
evidence

o  Describing different stakeholders  perceptions of quality of care and 
appropriately incorporating these into quality assessments, improvement efforts, 
and day-to-day practice

o  Assessing and testing methods to more quickly and effectively synthesize and 
incorporate existing evidence into clinical practice 

o  Using treatments and services delivered to better understand the needs and 
clinical characteristics of subgroups (e.g., person with subsyndromal conditions 
or comorbidity)

o  Characterizing system and organizational factors/processes that may impede 
the effective practice of care, and ways to improve those

o  Considering how economic factors (e.g., at the patient and provider levels) 
affect the provision and receipt of services and pharmaceuticals

o  Developing methods and instruments to better assess and characterize typical 
day-to-day practice (i.e., usual care)

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 
subpopulations must be included in all NIH supported biomedical and behavioral 
research projects involving human subjects, unless a clear and compelling 
rationale and justification is provided 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 
"NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical 
Research," which have been published in the Federal Register of March 28, 1994 
(FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Vol. 23, No. 
11, March 18, 1994 available on the web at the following URL address: 
http://grants.nih.gov/grants/guide/notice-files/not94-100.html

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.

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.

APPLICATION PROCEDURES

Applications are to be submitted on the grant application form PHS 398 (rev. 
4/98) and will be accepted at the standard application deadlines as indicated in 
the application kit.  Application kits are available at most institutional 
offices of sponsored research and may be obtained from the Division of 
Extramural Outreach and Information Resources, National Institutes of Health, 
6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 435-
0714, Email: GrantsInfo@nih.gov.  The application is also available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html

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 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)

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 by NIMH 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 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 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 the IP-RISP address important problems?  If the aims of 
the application are achieved, how will scientific knowledge of intervention 
effectiveness and real world practice be advanced?  What will be the effect on 
the provision and receipt of care?

(2) Approach:  Is the approach to interventions and/or practice research 
appropriately conceived?  Is the approach likely to successfully develop the 
partnerships needed to carry out relevant and wide-reaching studies?  Does the 
applicant acknowledge potential problem areas and consider alternative tactics?

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

(4) Investigator:  Are the investigators appropriately trained and well suited 
to carry out this work?  Do the practice partners and academic personnel have a 
commitment to the mission of the IP-RISP and the necessary expertise to 
organize, administer and direct the IP-RISP?

(5) Environment:  Do the practice and academic environments in which the work 
will be done contribute to the probability of success?  Do the proposed research 
projects take advantage of the unique features of the practice context 
(patients, providers, system)?  Is there evidence of institutional support from 
both sides of the partnership?

The initial review group will also examine: the appropriateness of proposed 
project budget and duration, the adequacy of plans to include both genders, 
minorities and their subgroups, and children as appropriate for the scientific 
goals of the research and plans for the recruitment and retention of subjects, 
the provisions for the protection of human and animal subjects, and the safety 
of the research environment.

AWARD CRITERIA

Applications will compete for available funds with all other recommended 
applications assigned to the Institute.  The following will be considered in 
making funding decisions:  Quality of the proposed project as determined by peer 
review, availability of funds, and program priority.

INQUIRIES

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

Direct inquiries regarding programmatic issues to:

Junius J. Gonzales, M.D.
Services Research & Clinical Epidemiology Branch
Division of Services and Intervention Research
National Institute of Mental Health
6001 Executive Boulevard, Room 7141 MSC 9631
Bethesda, MD 20892-9631
Telephone:  (301) 443-3364
FAX:  (301) 443-4045
Email:  jgonzale@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) 443-2805
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 the Public Health Service Act, 
Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 
and 285) and administered under PHS grants policies and Federal Regulations 42 
CFR 52 and 45 CFR Part 74.  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, and 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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