Full Text DA-95-005

HEALTH SERVICES RESEARCH CENTERS

NIH GUIDE, Volume 24, Number 5, February 10, 1995

RFA:  DA-95-005

P.T. 04

Keywords: 
  Drugs/Drug Abuse 
  Health Services Delivery 


National Institute on Drug Abuse

Letter of Intent Receipt Date:  April 3, 1995
Application Receipt Date:  May 9, 1995

PURPOSE

The purpose of this Request for Applications (RFA) is to support a
program of Health Services Research Centers to conduct
interdisciplinary research on the financing, organization, access,
and utilization of health services for drug abusers.  The program is
designed to complement the research grant programs of the National
Institute on Drug Abuse (NIDA) by providing long-term support for
interdisciplinary health services research.  Each funded Center will
have a coherent focus on a set of issues of current importance, and
will provide scientific leadership to influence the field and
stimulate additional health services research both regionally and
nationally.

HEALTHY PEOPLE 2000

The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of "Healthy People 2000,"
a PHS-led national activity for setting priority areas.  This RFA,
Health Services Research Centers, is related to the priority area of
alcohol and other drugs.  Potential applicants may obtain a copy of
"Healthy People 2000" (Full Report:  Stock No. 017-001-00474-0 or
Summary Report:  Stock No. 017-001-00473-1) through the
Superintendent of Documents, Government Printing Office, Washington,
DC 20402-9325 (telephone 202-783-3238).

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic for-profit and non-profit
organizations, 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.  Foreign institutions are not
eligible for this mechanism of support.

MECHANISM OF SUPPORT

This RFA will use National Institutes of Health (NIH) research center
grants (P50).  Responsibility for the planning, direction, and
execution of the proposed project will be solely that of the
applicant.  Support will be provided for a period of up to five years
(renewable for subsequent periods) subject to continued availability
of funds and progress achieved.  Because the nature and scope of the
research proposed in response to this RFA may vary, the size of
awards may also vary.

This RFA is a one-time solicitation.  Future unsolicited competing
continuation applications will be accepted and will compete with all
investigator-initiated applications and be reviewed according to the
customary peer review procedures.

FUNDS AVAILABLE

It is anticipated that approximately $2.0 million will be available
to support the first year of the Health Services Research Center
program.  It is expected that approximately two Centers will be
funded in FY 1995.  The NIDA intends to fund at least one center that
will have a primary focus on drug abuse health services financing
and/or organization and management of care.

If required in support of research objectives, funds may be expended
on drug abuse service costs, rental and operation of facilities,
approved renovation and modification of facilities (subject to limits
and conditions specified in Public Health Service grant policy), and
other costs normally allowable under existing PHS grants policy.
Funds may not be used for new construction or to replace existing
service funding.

RESEARCH OBJECTIVES

Background

Health services research is defined by its focus on the impact of the
organization, financing, and management of health services on the
quality, cost, access to, and outcomes of care.  The NIDA's health
services research program is interdisciplinary and focuses on how
services are organized, managed, financed, delivered, and utilized in
established service delivery settings and at system-wide levels, as
well as on the effectiveness of these services.

The Health Services Research Centers program is intended to attract
investigators in the behavioral, social, and economic sciences to
conduct research on drug abuse health services and delivery systems,
and to provide stable environments for such persons to engage in
health services research.  Each Center that is supported is expected
to become a significant regional and national resource that will
provide leadership in developing and conducting programs of health
services research.  Such leadership would be based primarily on the
development and promulgation of a coherent and timely body of
research that influences and advances the field of drug abuse
services research nationwide.  It will also result from various
shareable resources provided by or available through the center and
from a diversity of research training and information dissemination
activities.

Leadership is especially needed with respect to expanding the body of
research on the impact of the organization, financing, and management
of care on outcomes for drug abusers.  The NIDA will therefore give
higher programmatic priority to applications that address gaps in
knowledge in these areas.  In addition, wherever possible,
applications should consider how the organization, management, and
delivery of drug abuse services can reduce the spread of HIV/AIDS, by
clarifying issues of access, utilization, and effectiveness of such
services and other AIDS prevention measures.  Studies of services
that target high-risk populations (such as drug abusers who exchange
sex for drugs or money) are also encouraged.

Health Services Research Center Plan and Research Focus

The application must describe the Center's Proposed Research Program
in a detailed five-year plan, organized around a central drug abuse
services research theme.  The relationship of individual projects to
the Core program must be clearly delineated.  A Health Services
Research Center must be an identifiable organizational unit, and it
must have an administrative structure and clear lines of authority,
as described under "Organization and Administration," below.

Health Services Research Centers are expected to develop advances in
knowledge and cross-fertilization of research beyond that which could
be achieved in a cluster of individual research projects.  The
multidisciplinary or multifaceted character of the program, (i.e.,
its coordination, cohesiveness, interrelationship of the components
and relationship to the central theme, and synergistic potential
among the individual projects and core) are important aspects of
Centers.  Thus, it is essential that the Center plan and
organizational structure include provision for leadership,
monitoring, and coordination of research, internal quality control,
communication with the research (and, where appropriate, provider)
communities, ongoing assessment of research issues and needs, and
sustaining high levels of research productivity and quality
publication of results.  In addition, attention should be given to
training and development of researchers.  Although research training
costs are not an allowable item in Center budgets, provision for
training and plans to actively seek separate funding for training
will strengthen an application.

In addition to supporting projects described in the application, the
Center should be designed to stimulate and develop new lines of
research, and take advantage of emerging opportunities to address
important research issues.  The Core might, for example, include a
data management unit to analyze existing data (that is, data not
necessarily collected by the Center) and a component to review and
support small pilot projects.  The Core budget may include a maximum
of $50,000 per year for direct costs to support such efforts.

Each Center program plan must include specific information on
proposed research projects, identification of scientists to be
affiliated with the proposed Center, and their roles in the program
of research.  Existing research programs and projects essential to
the plan should be identified, and arrangements for integrating these
into the Center's activities should be detailed.  For data that are
to be used by the Center but that are not in the public domain,
letters of cooperation should be included from investigators in
control of the data.  For proposed multisite investigations, letters
of cooperation should be included from identified programs.

Health services research issues are diverse and often overlapping,
and applications may focus on research within or across the areas
noted below.  These areas are illustrative only, and research areas
not mentioned below are not necessarily excluded from consideration
under this RFA.  Each application should, however, emphasize how the
Center would focus on selected themes and sets of issues that connect
in a coherent whole, and how the Center would provide regional and
national leadership in stimulating and supporting the conduct of
further such research in other research settings.

Financing and economic research.  Research is needed on how public
and private reimbursement and financing policies and practices
influence the structure, operation, and effectiveness of health
services for drug abusers.  Research might focus, for example, on
specific strategies for managing the cost and utilization of
services, such as managed care systems, health maintenance
organizations, and Medicaid waivers for managed care provided under
fixed budgets.  Research is needed to develop and test different cost
models of drug abuse health services, including modeling total cost
of health services, patient costs, cost effectiveness, cost and
economic benefits, and social and health cost offset models.

A number of States have instituted health care reform initiatives,
which include cost and utilization controls, emphasis on preventive
care, and other features that are of interest to health service
research and public health audiences.  Studies of the implementation
and impact of health care financing, organization, and management of
care in those States are needed, either with a focus on a single
State or system of care, or in a comparative framework.

Organization and management.  Organizational structure and
environment, management, service configuration, staffing patterns,
and patterns of clinical training and expertise can influence
outcomes for drug abusers.  Research is needed on effective service
provider management practices; effective strategies and procedures
for managing the impact of HIV/AIDS, tuberculosis, and other
co-occurring medical and psychological problems; and on managed
service systems such as health maintenance organizations.

Research is needed on the coordination and integration of drug abuse,
medical, and other health and social services; the effectiveness and
efficiency of various organizational and manpower configurations;
counselor selection and training; the use of external resources; and
systematic evaluation of patient progress and provider performance.
Focus on provision, organization, and management of HIV/AIDS related
services such as testing and counseling, and services to groups at
high risk for HIV/AIDS is also encouraged.

Health services integration models.  Many service delivery approaches
treat the acute symptoms of drug addiction and are unable to maximize
the cumulative impact of treatment and other health services.  Health
service models are needed based on integration of drug abuse
treatment and primary medical care, continuity of care, service
utilization management, stages of recovery and change, or other
approaches that emphasize the long-term, relapsing nature of drug
abuse and dependence.  Models should be developed and tested in
relation to access and utilization, matching services to patient
needs, financing and cost constraints, and cost effectiveness and
cost-benefits.

Research is needed to develop and evaluate integrated health service
models that take into account not only patient characteristics and
behavior, but also internal and external delivery system factors.
Internal factors might include staffing issues, patient assessment,
treatment planning, and monitoring of care; external factors include
community relations, labor markets, law enforcement and criminal
justice influence, and linkages to other providers.  Special
attention should be devoted to the relationship of these factors to
the availability, quality, utilization, cost, and effectiveness of
services.

Need, demand, availability, access, and utilization.  Health service
providers and planners need to estimate need and demand for health
services for drug abusers.  The concept of need for treatment is
complex and does not translate directly into demand for or
utilization of services.  Research is needed to establish the
relationship between need, demand, and utilization of treatment and
other health services in the general drug abusing population and in
defined sub-groups.

Entry, retention, and outcomes may be influenced by the accessibility
of available services.  For example, subpopulations eligible for
Medicaid coverage may fail to obtain care because of primary provider
referral requirements.  Research is needed to improve accessibility
of services and to reduce barriers to services for populations with
defined needs.

Research is needed to improve service utilization, including
recruitment of target populations, monitoring utilization to modify
intensity or type of service provided, efficient sequencing of
services, and eliminating unneeded or inappropriate services.
Applications that focus on AIDS-relevant health services research
questions are encouraged.

Centers are expected to develop knowledge on health services
availability and utilization.  A Center might, for example, gather
information on:  the incidence and prevalence of drug abuse problems
in a region; short-term and long-term costs; demands on existing
service systems for drug abusers; incentives and disincentives for
providers to deliver and for clients to utilize services; and the
short-term and long-term costs and benefits of existing and improved
health services for drug abusers.  Centers are encouraged to conduct
research in conjunction with government authorities or private
entities wherever appropriate.

Facilities and Environment

The proposed Center application must demonstrate that there are
available adequate research and office facilities to carry out the
objectives of the proposed Center program.  It is desirable that
sufficient contiguous space be committed to give the Center a high
degree of cohesion and visibility.  In addition, adequate reference
facilities that will afford access to the relevant drug abuse and
health services literature must be readily available. It is expected
that such reference facilities will be the primary repository of
additional reference materials that may be obtained through the
Center.  Relevant support services and adequate data processing
facilities must also be readily accessible within or through the
institution.  Reasonable assurances of such support must be included
with the application.

Organization and Administration

An individual must be designated to serve both as Principal
Investigator for the Center grant and Director of the Center (PI/CD).
This person should have outstanding scientific credentials and be
capable of providing the leadership essential to the success of the
research program.  The PI/CD will have overall scientific
responsibility, responsibility for planning and coordination of the
Center program, preparation of the budget and oversight of
expenditures, staff appointments, space allocation, and other aspects
of administration and operation of the Center.  The PI/CD will be
responsible and accountable to the grantee institution for the proper
conduct of the Center program.  The grantee institution is, in turn,
responsible to PHS for the performance and financial aspects of the
grant supported activity.  The PI/CD will be responsible for assuring
interaction and collaboration among scientists conducting research
within the Center, in order to promote a concerted approach to the
research theme of the Center.  The PI/CD will be invited to
participate in NIDA's periodic research coordination meetings.  The
PI/CD also will be responsible for the direct monitoring of ongoing
research and for identifying (with the assistance of his or her
colleagues) research activities to be expanded or decreased and needs
for additional resources or reallocation of resources.

The applicant may also designate a Center Coordinator, who will be
responsible to the Center Director and provide assistance to the
Director in budget preparation, oversight of financial aspects, and
administrative duties essential to the smooth operation of the
Center.

A letter from the applicant institution for commitment of space,
staffing, and other resources essential to the Center is required as
part of the application.

A Center must be an identifiable organizational unit, and it must
have an administrative structure and lines of authority that will
facilitate coordination among Center personnel and assure maximum
accountability and efficiency in Center operations.  It is expected
that the nature of investigators' affiliations with the Center will
reflect the applicant institution's policies on appointments.

An external Program Advisory Committee must be established and
chaired by the Center Director.  Its membership, selected by the
Center Director from individuals outside the Center, can assume
responsibility for review of the Center's program and for making
recommendations to the Center Director on the conduct of Center
activities.  In addition, an internal planning committee consisting
of the Center Director, Principal Investigators of each individual
Center project, and others designated by the Center Director, is
required.

The PI is encouraged to make provisions to carry out pilot studies or
innovative developmental research in promising areas of health
services research.  If such work is planned, the processes for
identifying its scientific merit and significance to health services
research and for distributing funds to pilot or developmental work
should be described.  If the applicant plans to sponsor meetings to
identify health services research opportunities, the rationale,
approach, and cost of such meetings should be included.

SPECIAL REQUIREMENTS

This program of research emphasizes timely transfer of results, and
PIs must be willing to participate in research coordination
activities to maximize the utility of the research, including review
and dissemination activities.  Centers should budget for costs of
travel twice yearly to attend coordination meetings in the
Washington, D.C. area.

Center Directors are expected to coordinate with other drug abuse
treatment and health services researchers to develop comparable data
collection and measurement procedures where possible in order to
maximize the utility of knowledge that will inform fundamental
government decisions regarding health services for drug abusers.

The proposed Center should have clear capability to gain the
cooperation of existing drug abuse health service providers and a
plausible strategy for gaining access to drug abusing populations
where needed.

INCLUSION OF MINORITIES AND WOMEN 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 rational and justification is provided
that inclusion is inappropriate with respect to the health of the
subjects or the purpose of the research.  This new policy results
from the NIH Revitalization Act of 1993 (Section 492B of Public Law
103-43) and supersedes and strengthens the previous policies
(Concerning the Inclusion of Women in Study Populations, and
Concerning the Inclusion of Minorities in Study Populations), which
have been in effect since 1990.  The new policy contains some
provisions that are substantially different from the 1990 policies.

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 reprinted
in the NIH Guide for Grants and Contracts, Volume 23, Number 11,
March 18, 1994.

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

LETTER OF INTENT

Prospective applicants are asked to submit, by April 3, 1995, a
letter of intent that includes a descriptive title of the proposed
research, the name, address, and telephone number of the Principal
Investigator, the identities of other key personnel and participating
institutions, and the number and title of the RFA in response to
which the application may be submitted.  Although a letter of intent
is not required, is not binding, and does not enter into the review
of a subsequent application, the information that it contains allows
NIDA staff to estimate the potential review workload and to avoid
conflict of interest in the review.  The letter of intent is to be
sent to:

Director, Office of Extramural Program Review
National Institute on Drug Abuse
5600 Fishers Lane, Room 10-42
Rockville, Maryland  20857
Telephone:  301-443-2755

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 9/91) is to be used
in applying for these grants.  These forms are available at most
institutional offices of sponsored research; from the Office of Grant
Information, Division of Research Grants, National Institutes of
Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone
301/710-0267; and from the program administrator listed under
INQUIRIES.

The RFA label in the PHS 398 (rev. 9/91) application form must be
affixed to the bottom of the face page of the application.  Failure
to use this label could result in delayed processing of the
application such that it may not reach the review committee in time
for review.  In addition, the RFA title and number must be typed on
line 2a on 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 three signed photocopies in one package to:

Division of Research Grants
National Institutes of Health
6701 Rockledge Drive, Room 1040
Bethesda, MD  20892
Bethesda, MD  20817 (express mail)

At the time of submission, two additional copies of the application
must be sent to:

Director, Office of Extramural Program Review
National Institute on Drug Abuse
5600 Fishers Lane, Room 10-42
Rockville, MD  20857

Applications must be received by May 9, 1995.  If an application is
received after that date, it will be returned to the applicant
without review.  The Division of Research Grants (DRG) will not
accept any application in response to the RFA that is essentially the
same as one currently pending initial review, unless the applicant
withdraws the pending application.  The DRG will not accept any
application that is essentially the same as one already reviewed.
This does not preclude the submission of substantial revisions of
applications already reviewed, but such applications must include an
introduction addressing the previous critique.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by DRG
and responsiveness by NIDA.  Incomplete applications will be returned
to the applicant without further consideration.  If the application
is not responsive to the RFA, NIDA staff will return the application
to the applicant.

Applications that are complete and responsive to the RFA will be
evaluated for scientific and technical merit by an appropriate peer
review group convened by NIDA in accordance with the review criteria
stated below.  Following peer review, site visits may be conducted
prior to award to obtain additional information.

Review Criteria

The review criteria are:

1.  Program as an Integrated Effort

o  The significance of the overall program goals, and the development
of a well-defined central research focus of importance and relevance
to the goals and mission of NIDA.

o  Provision for interdisciplinary coordination and collaboration,
and the multidisciplinary or multifaceted character of the program
(i.e., its coordination, cohesiveness, interrelationship of the
components and relationship to the central theme, and synergistic
potential among the individual projects and core).

o  Feasibility and reasonableness of plans and mechanisms proposed
for the center to promote communications between different sites
and/or collaborating institutions.

o  Role of the center director and senior investigators in providing
leadership and direction in pursuing interprogrammatic opportunities
for interdisciplinary research.

o  Composition and expertise of external advisory committee
membership in relation to the research and needs of the center.

o  Feasibility and suitability of planned mechanisms for internal
advisory and coordination functions.

o  The justification for, and usefulness of the core facilities to
the research projects.

o  The scientific stature of the Investigators and the extent to
which each contributes to the overall program goals as well as their
commitment to the program.

o  Capability to provide training opportunities.

o  Potential of the proposed Center to become a regional and national
resource as appropriate to research objectives of this RFA.

o  Administrative arrangements and organizational structure, through
the administrative core, to facilitate and monitor the attainment of
objectives and internal quality control.  For example, these factors
will include plans to enhance communication and cooperation among the
investigators involved in the program and mechanisms for the
allocation of funds for day-to-day management, long-term planning and
periodic evaluation, contractual agreements, and procedures for the
replacement of key personnel, e.g., the Principal Investigators, if
required on an interim or permanent basis.

o  Reasonableness of the overall budget for the proposed work.

o  Specification of the process whereby pilot and developmental
projects of high scientific and technical merit and high practical or
theoretical significance to health services research are funded
through the center.

o  If meetings are planned to identify health services research
opportunities, specification of rationale, approach(es), and costs
for these meetings.

2.  Individual Projects and Core Units

o  Scientific and technical merit of each individual research
project, and potential scientific and theoretical significance of
each project.

o  Scientific and technical merit of core unit activities.

o  Feasibility of the proposed health services research projects.

o  Adequacy of the research design and analytic methodology proposed
to conduct individual health services research projects and to carry
out proposed pilot research.

o  The qualifications, experience, and commitment of the
investigators responsible for the research projects or core units,
including their ability to devote adequate time and effort to the
project.

o  Utility of the proposed health services research to applied
clinical and health service delivery practices; extent to which
results are likely to improve the treatment of drug dependence and
ancillary problems.

o  Provision for health services research training opportunities in
the center, and clear intent to either provide funding from
applicant's own resources or seek funding from other identified
sources, such as NIDA Research Fellowships (F31 or F32 awards) or
Institutional Research Training Grants (T32 awards).

o  The appropriateness of the budget for each of the proposed
projects and core units.

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

3.  Resources and Environment

o  The academic climate and physical environment in which the
research will be conducted, including the availability of space,
equipment, research subjects, etc., and the potential for interaction
with scientists from other departments and/or institutions.

o  Adequacy of the clinical and research facilities to perform the
proposed research including access to subjects, instrumentation, and
data management systems when needed.

o  Institutional commitment to health services research, its support
for the proposed Center, and its ability to attract highly-qualified
scientists.

The initial review group will also examine the provisions for the
protection of human subjects.

AWARD CRITERIA

Applications recommended for further consideration by the National
Advisory Drug Abuse Council will be considered for funding on the
basis of overall scientific, clinical and technical merit of the
application as determined by peer review, appropriateness of budget
estimates, program needs and balance (e.g., need for studies of
financing, organization, and management of care), policy
considerations, adequacy of provisions for the protection of human
subjects, and availability of funds.  Because of programmatic
significance of HIV/AIDS risk among drug abusers, AIDS relevance of
center themes and components will be a criterion in funding
decisions.

INQUIRIES

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

Direct inquiries regarding programmatic issues to:

Frank M. Tims, Ph.D.
Services Research Branch
National Institute on Drug Abuse
5600 Fishers Lane, Room 10A-30
Rockville, MD  20857
Telephone:  (301) 443-4060
Email:  FTIMS@AOADA.SSW.DHHS.GOV

Direct inquiries regarding fiscal matters to:

Gary Fleming
Grants Management Branch
National Institute on Drug Abuse
5600 Fishers Lane, Room 8A-54
Rockville, MD  20857
Telephone:  (301) 443-6710
Email:  GFLEMING@AOADA.SSW.DHHS.GOV

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic
Assistance No. 93.279.  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 recipients to provide a
smoke-free workplace and promote the non- use of all tobacco
products.  This is consistent with the PHS mission to protect and
advance the physical and mental health of the American people.

.

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