INTERVENTIONS AND PRACTICE RESEARCH INFRASTRUCTURE PROGRAM (IP-RISP)
RELEASE DATE: October 28, 2003
PA NUMBER: PAR-04-015
EXPIRATION DATE: May 1, 2006 (This PA has been reissued as PAR-06-441)
Department of Health and Human Services (DHHS)
PARTICIPATING ORGANIZATION:
National Institutes of Health (NIH)
(http://www.nih.gov)
COMPONENTS OF PARTICIPATING ORGANIZATION:
National Institute of Mental Health (NIMH)
(http://www.nimh.nih.gov)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 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
This program announcement supercedes three prior announcements for the support
of research infrastructure: Interventions and Practice Research Infrastructure
Program (PAR-00-096), Interventions Infrastructure Program (PAR-99-064),
and the Research Infrastructure Support Program (PAR-94-096).
The National Institute of Mental Health (NIMH) seeks to expand the number of
partnerships between community-based, clinical/services settings and academic
institutions. The goal is to enhance the national capacity to provide evidence-
based mental health care in community settings that is sensitive to the social
and cultural needs of patients and providers and to the feasibility concerns of
the community organizations involved. This program announcement (PA),
Interventions and Practice Research Infrastructure Support Program (IP-RISP),
responds to recommendations made by the National Advisory Mental Health
Council’s (NAMHC) report, Bridging Science and Service
(http://www.nimh.nih.gov/research/bridge.htm).
The IP-RISP seeks to foster an active, synergistic partnership between mental
health researchers and community-based, clinical/services staff, clinicians and
patients/clients to: (1) advance our knowledge about developing research
infrastructure in community settings and the establishment of collaborative
partnerships; (2) identify and incorporate those factors (e.g., organizational,
sociocultural, interpersonal) in community settings that may be associated with
quality care and optimal outcomes for patients and clients; and (3) test
adapted, evidence-based interventions (treatment, rehabilitative, and
preventive) in community settings.
RESEARCH OBJECTIVES
Background
The 1999 NAMHC report, Bridging Science and Service, was written to focus the
attention of NIMH and the research community on the gulf between what is known
about treatments for mental illness and what is available and provided to people
in the community who need care. The report’s conclusions indicate that many
changes need to take place to bridge that gulf. Three of the recommendations
focused on increasing academic-community partnerships in research:
o NIMH should revise and renew program announcements (PAs) in the spirit of the
Public-Academic Liaison (PAL) Program to maintain and promote existing
partnerships between academic researchers and public care systems, health plans,
both carve-outs and health maintenance organizations (HMOs), and employers
providing health benefits and their representative groups.
o NIMH should stimulate new alliances by providing developmental funds to
establish shared research resources such as data banks, staff time, consultant
time, etc.
o NIMH should commit resources to identify, describe, and disseminate models of
successful partnerships.
This PA is designed to provide tangible support and encouragement for researchers
and community mental health providers to establish working and sustainable
partnerships to make evidence-based mental health services available and
acceptable for people in need of mental health care. The IP-RISP mechanism is
applicable to a wide range of possible partnerships. Community settings may
include general and primary health care, public or tribal health and mental
health clinics, community-based specialty care, long-term care facilities,
schools, family service or faith-based organizations, State or tribal components
of the Cooperative State Research, Education, and Extension Service, and
elements of local and/or State correctional systems.
The ultimate goal of the IP-RISP partnerships is to make available evidence-
based care for those in need of mental health care. However, to make that goal
possible, NIMH expects the partnerships to be: sustainable, even after NIMH
infrastructure funding has ended; synergistic, leading to mutual learning for
both researchers and community providers; productive, with additional mental
health services research grant applications submitted; receptive to providing
information to others seeking to form partnerships; and based in theoretical
and/or conceptual models of action research, human behavior, and/or
organizational/systems behavior so that the mechanisms or process underlying
successful partnerships can be understood and tested in other settings. A plan
for continuous assessment and improvement of the infrastructure development is
required. The result should be an environment capable of nurturing and
sustaining researchers, providers, and the infrastructure development and
research plans.
The application must present a focused and linked two-part plan for five years
of proposed NIMH IP-RISP funding. The plan should include: (1) background
information on the community setting needs for research infrastructure;
(2) evidence of the fit and strengths of the partner institutions;
(3) description of the activities that have been and will be undertaken to
develop and strengthen the unique community-academic partnership; (4) at least
two pilot or developmental/exploratory studies intended to provide the data and
foundation for subsequent research applications from the partnership in mental
health interventions and services research. The partnership development
activities and the research studies should be unambiguously linked and
justified; both development and research activities should have clearly
articulated and justified aims and methods.
Listed below are examples of research topics that can contribute to scientific
knowledge about mental health interventions in diverse, community settings. The
list is not exhaustive; it is meant only to be illustrative. Also consider all
the research questions presented in the Research Programs page of the Services
Research and Clinical Epidemiology Branch website:
http://www.nimh.nih.gov/srceb/resprogs.cfm. The IP-RISP research projects
are not expected to be major research proposals, providing definitive data.
They are intended to provide preliminary data to be used to guide the design of
larger scale, more complex research applications. IP-RISP projects are similar
to the ones typically supported under the NIMH developing grant mechanism (R34):
From Intervention Development to Services: Exploratory Research Grants,
http://grants.nih.gov/grants/guide/pa-files/PAR-03-078.html
o Assess and test methods to more quickly and effectively synthesize and
incorporate existing evidence into clinical practice
o Determine patient, provider and contextual factors that may enhance or
detract from the effective delivery of interventions
o Evaluate the effectiveness, safety, and costs of efficacious interventions
but not adequately tested in practice settings
o Evaluate alternative methods of adapting assessment and treatment protocols
originally developed in academic settings
o Determine whether fidelity (by patients and providers) to adapted
interventions is related to patient outcomes
o Test methods to improve the recruitment and retention of patients and
providers in community-based intervention studies
o Determine whether patient and provider treatment choice is related to
positive patient outcomes
o Determine different stakeholders perceptions of quality of care and develop
instruments to assess the relationship between various definitions of quality
and patient/client outcomes
o Test the effectiveness of evidence-based care for subsyndromal and comorbid
populations.
o Determine how economic factors (e.g., at the patient and community
organization levels) affect the provision and receipt of services and
pharmaceuticals
o Test state-of-the-art dissemination and implementation strategies
Listed below are examples of research questions that can inform our
understanding of community-academic partnerships. Again the list is not
exhaustive; it is meant only to be illustrative.
o What theoretical conceptualizations best explain the functioning of the
partnership?
o How do provider and patient perceptions of researchers (and vice versa)
change over time and is change related to patient outcomes?
o What factors best predict individual provider-researcher alliances?
o What are provider concerns about evidence-based practice and what processes
are acceptable for working through barriers and addressing concerns?
o What mechanisms can be implemented and accepted by providers and researchers
to allow for sharing of power/control and trust?
o How do financial constraints for the community partner affect the research
relationship? Are there innovative ways that researchers can help alleviate
stress caused by financial cutbacks?
o Under what circumstances do conflict resolution procedures aid the
collaborative partnership?
Allowable costs
A central principle of the IP-RISP is that different partnerships will require
different types of research infrastructure and development support. A
substantial part of the support should be targeted to the community settings.
Examples of types of support under this program are:
o Database and information management system construction or conversion,
ongoing data management, and related technical support
o Research on the partnership process
o Training and supporting research assistants from the community or the partner
setting
o Treatment protocol and instrument adaptation and/or translation
o Partial salary support for persons engaged in the research of the partnership
(including practice site staff)
o Methodological, statistical, or theoretical consultation
o Costs related to subject recruitment and retention.
o Costs related to testing dissemination and implementation strategies
MECHANISM(S) OF SUPPORT
This PA will use the NIH resource related research projects (R24) award
mechanism. As an applicant, you will be solely responsible for planning,
directing, and executing the proposed project. This mechanism is used to
support projects that enhance capabilities to contribute to extramural research
of the PHS. 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.
Although the Facilities and Administrative (F&A) costs associated with all
contractual and consortium arrangements are considered as direct costs to the
applicant organization, for the purposes of this program announcement, these
will not count against the program direct costs cap of $400,000 per year.
(However, these costs should be indicated as instructed on Form 398, rev. 5/01.)
This PA uses just-in-time concepts. Follow the instructions for non-modular
research grant applications. This program does not require cost sharing as
defined in the current NIH Grants Policy Statement at
http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm.
ELIGIBLE INSTITUTIONS
You may submit (an) application(s) if your institution and partnering
institution(s) have 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, local, and tribal governments
o Eligible agencies of the Federal government
o Domestic
o Faith-based or community-based organizations
o Foreign institutions are not eligible to apply
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 strongly 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 three areas:
scientific/research, peer review, and financial or grants management issues:
o Direct your questions about scientific/research issues to:
Junius J. Gonzales, M.D.
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
o Direct your questions about peer review issues to:
Michael Kozak, Ph.D.
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6138, MSC 9608
Bethesda, MD 20892-9608
Telephone: (301) 443-1340
FAX: (301) 443-4720
Email: kozakm@mail.nih.gov
o Direct your questions about financial or grants management matters to:
Joy 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: jk173r@nih.gov
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant application
instructions and forms (rev. 5/2001). Applications must have a Dun and
Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal
Identifier when applying for Federal grants or cooperative agreements. The DUNS
number can be obtained by calling (866) 705-5711 or through the web site at
http://www.dunandbradstreet.com/. The DUNS number should be entered on
line 11 of the face page of the PHS 398 form. 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) 710-0267, Email: GrantsInfo@nih.gov.
The title, Interventions and Practice Research Infrastructure Program (IP-RISP),
and number of this program announcement (PAR-04-015) must be typed in Item 2 of
the face page of the application form and the YES box must be checked.
APPLICATION PAGE LIMITS: The description of Sections A-D should be limited to a
total of no more than 30 pages and should be equally balanced between
descriptions of the infrastructure and research plans.
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.
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the
application, including the checklist, and three 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)
At the time of submission, two additional copies of the application and all
copies of the appendix material must be sent to:
Jean G. Noronha, Ph.D.
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6154, MSC 9609
Bethesda, MD 20892-9609
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-3367
FAX: (301) 443-4720
Email: jnoronha@mail.nih.gov
APPLICATION PROCESSING: Applications must be mailed on or before 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. Appropriate scientific review groups 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 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 written critique
o 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 evaluate your application in order
to judge the likelihood that the proposed research will have a substantial
impact on the pursuit of these goals. 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.
o Significance
o Approach
o Innovation
o Investigator
o Environment
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.
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 in community settings? Will the infrastructure
development contribute to broader theoretical and conceptual frameworks?
APPROACH: Is the approach appropriately conceived? Is the approach likely to
successfully develop the partnerships needed to carry out relevant and wide-
reaching studies? Does the applicant exhibit knowledge of and appreciation for
the challenges involved in building infrastructure and conducting research in
practice settings? Thus, does the applicant acknowledge potential problem areas
and consider alternative tactics? Is the infrastructure proposed adequate to
sustain research capacity? How well linked are the research aims and the plans
for infrastructure development?
INNOVATION: Does the applicant acknowledge the complexity of the specific
settings, populations, and professions engaged in each study? Does the IP-RISP
employ novel concepts, approaches or methods? Are the aims (for both the
infrastructure development and research plans) original and innovative? Does
the project challenge existing paradigms or develop new methodologies for both
research and establishing partnerships?
INVESTIGATOR: Do the partners have a commitment to the mission of the IP-RISP
and the necessary expertise to organize, administer and direct the IP-RISP? Is
the work proposed appropriate to the experience level of the principal
investigator and to that of other key personnel?
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 and
leadership from all partners?
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:
INFRASTRUCTURE: Is there specificity in the infrastructure plans that are
tailored to the organizations involved, the nature of the partnership and the
services/interventions research aims? Are the infrastructure aims informed by a
conceptual framework and/or theory? Do they propose an assessment of the
feasibility, progress, and accountability? Are there plans to assure the
sustainability of the infrastructure after the grant is over? Will the
knowledge gained about infrastructure development be transferable to other
sectors?
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).
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
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 REVIEW CONSIDERATIONS
SHARING RESEARCH DATA: Applicants requesting more than $500,000 in direct costs
in any year of the proposed research are expected to include a data sharing plan
in their application. The reasonableness of the data sharing plan or the
rationale for not sharing research data will be assessed by the reviewers.
However, reviewers will not factor the proposed data sharing plan into the
determination of scientific merit or priority score.
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
DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for all
types of clinical trials, including physiologic, toxicity, and dose-finding
studies (phase I); efficacy studies (phase II), efficacy, effectiveness and
comparative trials (phase III). The establishment of data and safety monitoring
boards (DSMBs) is required for multi-site clinical trials involving
interventions that entail potential risk to the participants. (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.
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.
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.
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