This Program Announcement expires on October 5, 2004, unless reissued.

HEALTH SERVICES RESEARCH ON ALCOHOL-RELATED PROBLEMS

Release Date:  September 27, 2001
 
PA NUMBER:  PA-01-142

National Institute on Alcohol Abuse and Alcoholism

THIS PA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS.  MODULAR 
INSTRUCTIONS MUST BE USED FOR RESEARCH GRANT APPLICATIONS UP TO $250,000 PER 
YEAR. 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 on Alcohol Abuse and Alcoholism (NIAAA) seeks research 
grant applications on the delivery of treatment and prevention services for 
alcohol-related problems, including alcohol dependence and alcohol abuse.  
Expanding the knowledge base about these services will help improve the 
delivery of treatment and prevention services.  This program announcement 
(PA) invites research applications to test strategies for improving the 
availability, accessibility, delivery, quality, effectiveness, cost-
effectiveness, and outcomes of alcohol-telated treatment and prevention 
services.

The research objectives include, but are not limited to, the effects of the 
organization, financing, and management of health services on the quality, 
cost, access to, and outcomes of care. Objectives also include studying the 
effectiveness and cost-effectiveness of alcohol prevention services in 
reducing the demand for health care services.  Also of key importance is 
improving the methodological tools and analysis techniques useful for 
conducting health services research.

This program announcement replaces the announcement “Health Services Research 
on Alcohol-Related Problems” (PA-98-037) issued March 6, 1998.

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), Adoption of Alcohol Research Findings in Clinical Practice, 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 and foreign, 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.  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.  Applications 
for R01s may request support for up to 5 years.  Facilities and 
Administrative (F&A) costs will be awarded based on the negotiated rate at 
the time of the award.  More detailed information on the R21 mechanism can be 
found at http://grants.nih.gov/grants/guide/pa-files/PA-99-131.html. More 
detailed information on the R03 mechanism can be found at 
http://grants.nih.gov/grants/guide/pa-files/PAR-99-098.html. 
Exploratory/Developmental Grants and Small Grants cannot be renewed: however, 
a no-cost extension of up to one year may be granted prior to expiration of 
the project period.  Investigators are encouraged to seek continued support 
after completing an Exploratory/Developmental Grant project or a Small Grant 
project through a Research Project Grant (R01).

RESEARCH OBJECTIVES

The National Institute on Alcohol Abuse and Alcoholism (NIAAA) is committed 
to supporting a strong program of health services research. As delineated by 
the Congressional definition  --  “research endeavors that study the impact 
of the organization, financing and management of health services on the 
quality, cost, access to and outcomes of care” (PL 101-321, Section 409) -- 
health services research at NIAAA includes research on both treatment and 
prevention services especially as these are delivered in applied settings.  
However, health services research does not include studies that establish the 
efficacy of specific preventive, diagnostic, or treatment modalities under 
carefully controlled research conditions (PL 103-43).

The following list of research topics is for illustrative purposes.  
Applications on topics not explicitly listed below, but which fall within the 
objectives described above, are also welcome.
 
1) Managed care.  A variety of practices are used to control costs of care, 
access to care, utilization of care, and quality of care.  NIAAA is 
interested in how these practices, either singly or in combination, affect 
the outcome, quality, access, utilization, and cost of care for alcohol-
related problems. Comparisons between more and less integrated systems of 
care and between more and less tightly managed systems of care are also 
encouraged.

2) Cost of treatment.  Economic analyses of several kinds are encouraged, 
including studies of the cost effectiveness of care, the cost offsets of 
care, and the cost benefits of care.  Also included are studies to improve 
and standardize the techniques for measuring costs, cost effectiveness, cost 
offsets, and cost benefits.

3) Finance.  This includes studies of financial access to care, studies of 
the consequences of being uninsured, and studies of the effects of insurance 
parity between alcoholism treatment and other medical treatment.

4) Improved methods for conducting services research.  This includes new 
techniques for conducting secondary analyses of administrative data and 
improved measurement techniques for outcomes, quality, cost, and patient 
satisfaction. Research that analyses selection bias and examines how the 
differences between participants sampled in clinical trials and patients 
sampled in real-world distributions may affect the generalizability of 
clinical trials results is also encouraged.

5) Brief interventions and other forms of care directed at drinkers who may 
be at risk for developing, but who are not yet diagnosable with, alcohol 
abuse or dependence.  NIAAA encourages studies of the effectiveness of such 
interventions, their costs, and how they might best be implemented in applied 
practice.  Also needed are studies of instruments designed to screen and 
identify individuals appropriate for such interventions.

6) Coordination of specialty alcohol treatment with other medical services.  
Linkages to medical settings that treat many persons with alcohol use 
disorders, such as primary care, emergency care, obstetric care, and mental 
health care systems, are of particular interest.  Research is needed to 
develop more effective methods for screening, identifying and referring 
patients to specialty alcoholism treatment.  Also of interest are studies of 
interventions such as extended case monitoring of treated patients that 
facilitate the return to treatment in case of relapse.

7) Alcohol treatment delivered within institutions not primarily concerned 
with health care.  Significant amounts of alcohol treatment are delivered 
through workplace programs, employee assistance programs, and programs 
located within the criminal justice, child protective services, and welfare 
systems.  The utilization, outcome, quality, cost, and coordination of such 
services are all areas of interest.

8) Pathways to entering alcohol treatment.  Studies of the processes that 
lead individuals to seek treatment, including individual decision-making, 
informal social influences from family and friends, and institutional 
pressures from employers or the legal system are encouraged.  A principal 
interest in this line of research should be the identification of barriers 
toward seeking treatment and approaches to reducing those barriers.

9) Enrollment, retention, and completion.  Research is encouraged to examine 
the characteristics of service systems that promote: (a) actual enrollment in 
treatment by individuals who have been referred to it; (b) retention in 
treatment; and (c) completion of treatment.

10) Long-term “treatment careers” of alcohol dependent and abusing 
individuals.  Little is known about the sequencing, timing, interactions, or 
collective impact of separate episodes of treatment that an individual may 
receive over a lifetime.  Studies that establish cohorts for long-term 
longitudinal study would be especially valuable.

11) Barriers to treatment faced by specific population groups.  Research is 
needed to identify barriers that may be faced by some population subgroups 
and steps that can be taken to reduce these barriers.  Groups of interest 
include women, ethnic minorities, residents of rural areas, residents of 
Indian reservations, adolescents, the elderly, persons with concurrent mental 
health illnesses, the uninsured, the homeless, and the handicapped.  Also of 
interest are evaluations of programs designed to reduce barriers and 
facilitate treatment access for members of any of these groups.

12) Status of the counseling workforce.  Studies could investigate trends in 
the training, accreditation, remuneration, and stability of employment of 
those who provide alcohol treatment.  Key studies here include how the advent 
of managed care and other organizational and financing developments has 
affected these trends.

13) Adoption of research findings in applied practice.  The Institute is 
specifically interested in studies that might facilitate wider use of 
pharmacotherapy, manualized behavioral treatments, screening and diagnostic 
instruments, and behavioral couples therapy in applied practice.  Studies 
that focus on the identification of barriers to adoption (both individual and 
institutional) and on the reduction of those barriers are especially 
encouraged.

14) Prevention.  This announcement invites studies of the potential of 
prevention activities to reduce the demand for health care services, 
including both alcohol treatment services and general medical services.  
Studies of both the effectiveness and the cost effectiveness of prevention 
activities in achieving these ends are sought.

15) Quality of care indicators and placement criteria.  Studies are needed to 
develop and evaluate indices of quality of care and patient placement 
criteria.

Applicants should adopt research designs appropriate to the research goals 
proposed (see Lettieri 1992; Sechrest et al. 1990; Cook and Campbell 1979; 
Gold et al. 1996; and Perl et al. 2000).  Research designs should contain a 
judicious mixture of scientific rigor and thoughtful response to the 
exigencies of conducting research in “real world” settings.

Applications whose main objective is to establish and support treatment or 
prevention service programs are not eligible for funding under this Request 
for Applications.  Support for the costs of research-related treatment, 
rehabilitation, or prevention services and programs may be requested only for 
those particular costs related to the implementation of the research project 
and for that period of time required by the research project.  These costs 
must be justified by research objectives, methods, and designs that promise 
to yield important, generalizable knowledge.

Summary

Studies are sought on a number of topics that promise to expand knowledge 
about alcohol treatment delivered in applied settings.  These include studies 
of treatment access, utilization, quality, cost and outcome.  Of special 
interest are studies of improved models of care, studies of underlying 
principles that promise such improvement, studies of barriers to improved 
treatment, and studies that assess new approaches to delivering treatment in 
applied settings.

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 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 the 
original application as well as any subsequent revisions.  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.

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 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 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:

1) 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.

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

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

Additional consideration pertinent to the review of Exploratory/Developmental 
Grant (R21) and Small Grant (R03) applications:

Pilot feasibility studies may contain little or no preliminary data.  Review 
should focus on whether the rationale for the study is well developed and 
whether the proposed research is likely to generate data that will lead to a 
regular research project grant or full-scale clinical trial.  Adequate 
justification for the proposed work may be provided through literature 
citations, data from other sources, or investigator-generated data.

AWARD CRITERIA

Applications will compete for available funds with all other recommended 
applications. 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.

AUTHORITY AND REGULATIONS 

This program is described in the Catalog of Federal Domestic Assistance No. 
93.273. 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, 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.

INQUIRIES

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

Direct inquiries regarding programmatic issues to:

Mike Hilton, Ph.D.
Division of Clinical and Prevention Research
National Institute on Alcohol Abuse and Alcoholism
Willco Building, Suite 505
6000 Executive Blvd., MSC 7003
Bethesda, MD  20892-7003
Telephone:  (301) 443-8753
FAX:  (301) 443-8774
Email:  mhilton@willco.niaaa.nih.gov

Direct inquiries regarding fiscal matters to:

Judy Simons
Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
Willco Building, Suite 504
6000 Executive Blvd., MSC 7003
Bethesda, MD  20892-7003
Telephone:  (301) 443-2434
FAX:  (301) 443-0788
Email:  jsimons@willco.niaaa.nih.gov

REFERENCES

Cook, T.D. and Campbell, D.T. Quasi-Experimentation: Design and Analysis 
Issues for Field Settings. Boston: Houghton Mifflin, 1979. 

Gold, M.J., Siegel, J.E., Russell, L.B., and Weinstein, M.C. Cost-
Effectiveness in Health and Medicine. New York: Oxford University Press, 
1996. 

Lettieri, D.J. A Primer of Research Strategies in Alcoholism Treatment 
Assessment. DHHS Pub. No. (ADM) 92-1882. Rockville, MD: National Institute on 
Alcohol Abuse and Alcoholism, 1992. 

Perl, H.I.; Dennis, M.; and Huebner, R.B.  “State-of-the-art methodologies in 
alcohol-related health services research.”  Addiction, #95 (Supplement 3), 
pp. S275-S280, 2000.

Sechrest, L.; Persin, E.; and Bunker, J., eds. Research Methodology: 
Strengthening Causal Interpretations of Nonexperimental Data. DHHS Pub. No. 
(PHS) 90-3454. Rockville, MD: Agency for Health Care Policy and 
Research, 1990.

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