ALCOHOL TREATMENT, SERVICES, AND PREVENTION STUDIES OF HIGH PRIORITY TO 
PROVIDERS

RELEASE DATE:  Sseptember 16, 2002

PA NUMBER:  PA-02-167

EXPIRATION DATE: This PA expires on August 15, 2005, unless reissued.

National Institute on Alcohol Abuse and Alcoholism (NIAAA)
 (http://www.niaaa.nih.gov)

THIS PA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this 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 Special Requirements
o Required Federal Citations

PURPOSE OF THIS PA

The National Institute on Alcohol Abuse and Alcoholism (NIAAA) seeks 
applications for alcohol treatment, services, and prevention studies that 
have been suggested by providers as areas of high research priority. 

While significant research has accumulated over recent years, the alcohol 
treatment and prevention fields have also witnessed a troubling gap in 
communication between those who conduct alcohol research and those who 
provide services (Lamb et al. 1998; Brown 2000, CSAT 2000).  An important 
part of that gap is the sentiment that research results are not as useful as 
they should be to practitioners. Sometimes this is because topics of pressing 
interest to providers are not addressed in proposed research projects. 
Sometimes this is because the intervention protocols studied in tightly 
controlled trials can not be duplicated in typical clinical settings.  
Sometimes this is because the patient pool that survives the exclusion 
criteria of a trial does not resemble a real world clinical population.  
Sometimes this is because the translation of research findings into clinical 
guidance and the development of tools to help put findings into practice are 
left underdeveloped at the close of a research project.

This announcement addresses the first of these problems.  It directs 
researchers' attention to research topics that providers have suggested as 
having a high priority.  Providers' suggestions cover a variety of subjects 
in treatment, prevention, and health services research.  Some suggestions 
repeat calls for research that have appeared in other program announcements.  
This repetition does no harm.  Rather it re-emphasizes the need for further 
study in these areas.

The specific topics covered in this announcement include: clinical outcomes 
under managed care, robustness of outcomes to applied conditions, case 
management, tools for improved services delivery, treatment of individuals 
with co-occurring mental disorders, treatment for other special populations, 
improved prevention practices, behavior and management of providers, linkages 
to other medical and social services, and studies of treatment policy 
decisions.

RESEARCH OBJECTIVES

With the aim of narrowing the provider-researcher gap, NIAAA has increased 
its attention to research suggestions emanating from the provider community.  
The most significant of these efforts was the Institute's convening of a 
working group entitled "Research Priorities Suggested by Providers" on April 
19, 2002 to solicit suggestions for the Institute's research portfolio.  The 
Institute also gathered provider suggestions through participation in the 
process that led to the issuance of the Center for Substance Abuse 
Treatment's (CSAT) Improving Substance Abuse Treatment: The National 
Treatment Plan Initiative, especially Panel IV of that process, "Connecting 
Services and Research" (CSAT 2000).  Insights also emerged from the 
Institute's collaborative work with providers in New York and North Carolina 
during the Research in Residence project 
(http://www.niaaa.nih.gov/publications/newyork.PDF).  The Institute has also 
tried to keep abreast of provider-generated suggestions that have emerged 
from CSAT's Practice Improvement Collaboratives program and the National 
Institute on Drug Abuse's (NIDA) Clinical Trials Network, which has 
emphasized the blending of research priorities suggested by both providers 
and researchers.  From these various sources has emerged a picture of the 
provider viewpoint on projects that should be encouraged within NIAAA's 
research agenda.  This announcement explicitly calls for grant applications 
on these subjects.

Providers have identified several broad areas where additional research is 
needed.  They also suggested several specific research topics within each 
area.  Applications in any of these areas are encouraged, as are applications 
in other related areas not specifically listed below.

1.  The highest priority for many providers is the study of managed care.  In 
particular, providers are interested in the effects of managed care on both 
the amount of alcohol treatment delivered and the clinical outcomes of that 
treatment.  A related concern is to estimate whether and to what extent 
decrements in treatment outcomes are experienced as a result of providing the 
least intensive or least costly courses of treatment.  Providers are also 
interested in how managed care payment mechanisms can be either used in their 
present form or modified to improve their applicability to the treatment of a 
chronic condition.

2.  An issue of considerable importance to providers is how robust the 
outcome findings of controlled trials might be when treatment techniques are 
adapted to applied settings.  The average provider rarely has the resources 
to replicate a new treatment intervention with complete fidelity to the 
conditions under which it was delivered in a clinical trial.  The provider is 
thus caught between two unsatisfactory options: abandoning the effort to 
adopt the practice improvement or making compromises in the treatment 
protocol whose impact on clinical outcome is unknown.  Research needs to help 
providers make informed decisions about how to best strike a balance between 
fidelity and practical constraints.

3.  Other studies advocated by providers are outcome studies of case 
management.  Included are: What is the effectiveness and cost effectiveness 
of case management in alcohol treatment?  Would case management help improve 
long-term outcomes?  and  Does case management show any special promise for 
improving outcomes among clients who are frequent relapsers?

4.  Providers are also interested in the development of tools that would 
promote better treatment outcomes.  First among these is a simple, practical, 
low cost, standardized protocol for measuring treatment outcomes.  Widespread 
adoption of such a tool would facilitate comparisons, making it easier to 
know which innovations are promising.  Protocols and materials are needed for 
motivational enhancement therapy delivered in group as opposed to individual 
settings.  Research could provide better guidance on which medication 
compliance strategies work best in alcohol dependent populations.  Finally 
there is interest in engaging family members in the therapeutic process and 
the development of family strategies to help engage the treatment resistant.

5.  Research should develop methods of treating individuals who have co-
occurring mental health disorders.  Especially needed are approaches for 
clients who have personality disorders, who often don't respond well to 
standard treatments.  Another pressing need is approaches for incorporating 
suicide prevention (including the relevant pharmacotherapies) into alcohol 
treatment.

6.  Effective treatments for several demographically-defined populations need 
to be developed.  Establishing the effectiveness of standard treatments among 
minority clients is long overdue.  Research should also remedy the lack of 
knowledge about effective treatment approaches for adolescents.  In 
particular, it should determine which versions of multi-systemic therapy are 
most effective for treating adolescents.  Another need is to understand the 
changing demographic, substance abuse, mental health, and physical health 
characteristics of 17 to 25 year old clients currently presenting at 
treatment centers.  Finally, the effectiveness of standard treatments among 
minority clients needs to be established.

7.  Prevention practices are also important to providers.  Research needs to 
provide better methods of evaluating the effects of environmentally-focused 
prevention initiatives.  It also needs to give providers better guidance on 
how to adapt prevention strategies to applied settings in ways that best 
preserve effectiveness.  Studies should examine the effectiveness of common 
prevention approaches among children of alcoholics, among minority 
individuals, and within all three of the cultures present on the U.S. 
Southern border.  Providers also note that the set of risk and protective 
factors that has emerged from the prevention literature is too broad to 
provide useful guidance in planning community initiatives.  They ask whether 
the existing list could be reduced to a more focused set.

8.  Important contributions could be made by studying the behavior of 
providers.  Studies could identify the kinds of provider training and the 
types of clinical supervision that produce better treatment outcomes.  It 
could also identify the training and supervision strategies that promote both 
effectiveness and innovation.  Research should also continue to investigate 
the elements of counseling style that produce the best results and that work 
best with specific types of clients.

9.  It is also important that research advance our understanding of the 
knowledge adoption process.  The overall question here is how research 
findings are incorporated into routine clinical practice.  Other questions 
include: What are the appropriate criteria for determining that a treatment 
practice is evidence-based?  How can one preserve fidelity while adapting a 
model practice to a given applied situation? and How can one overcome 
professional resistance toward new techniques (especially the use of 
pharmacotherapy).
 
10.  The way that alcohol treatment is linked to the provision of other 
medical and social services is also important.  Linkages between alcohol 
treatment and primary care take several forms, and the effectiveness and cost 
effectiveness of each deserve study.  These forms include placing alcohol 
specialists in primary care clinics, improving referral linkages between 
primary care physicians and alcohol treatment providers, and creating fully 
integrated health care systems.  Also of interest is the effectiveness of 
linking substance abuse treatment to such other social services as welfare, 
child and protective services, job training, housing programs, and criminal 
justice programs.  Research could help identify the most effective approaches 
to creating these linkages.

11.  Finally, there are many policy decisions that bear on the availability 
and effectiveness of alcohol treatment services, but often such decisions 
must be taken without adequate knowledge about how they affect treatment 
delivery or effectiveness.  Studies that would help inform policy decisions 
include: estimates of costs saved (from a burden of illness framework) by 
adopting specific treatment or prevention policies; analyses of treatment 
finance patterns and the correlates, including clinical outcomes, of those 
patterns; and studies of how consumer groups effect the allocation of 
resources to alcohol treatment.  

MECHANISMS 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).

ELIGIBLE INSTITUTIONS 

You may submit (an) application(s) if your institution has 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 and local governments
o Eligible agencies of the Federal government 
o Domestic or foreign
o Faith-based or community-based organizations 

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 always 
encouraged to apply for NIH programs. 

WHERE TO SEND INQUIRIES 

We encourage your inquiries concerning this PA and welcome the opportunity 
answer questions from potential applicants. Inquiries may fall into two 
areas: scientific/research and financial or grants management issues: 

Direct your questions about scientific/research 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 your questions about financial or grants management matters to:

Judy Simons
Chief, Grants Management Branch
Office of Planning and Resource Management
National Institute on Alcohol Abuse and Alcoholism
Willco Building, Suite 504
6000 Executive Boulevard, MSC 7003
Bethesda, MD 20892-7003
(301) 443-4704 (telephone)
(301) 443-3891 (fax)
email:  jsimons@willco.niaaa.nih.gov

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  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) 435-0714, 
Email: GrantsInfo@nih.gov.

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.

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting 
up to $250,000 per year in direct costs must be submitted in a modular grant 
format.  The modular grant format simplifies the preparation of the budget in 
these applications by limiting the level of budgetary detail.  Applicants 
request direct costs in $25,000 modules.  Section C of the research grant 
application instructions for the PHS 398 (rev. 5/2001) at 
http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step 
guidance for preparing modular grants.  Additional information on modular 
grants is available at 
http://grants.nih.gov/grants/funding/modular/modular.htm.

SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR: 
Applications requesting $500,000 or more in direct costs for any year must 
include a cover letter identifying the NIAAA staff member who has agreed to 
accept assignment of the application.   

Applicants requesting more than $500,000 must carry out the following steps:
	
1) Contact the IC program staff at least 6 weeks before submitting the 
application, i.e., as you are developing plans for the study; 

2) Obtain agreement from the IC staff that the IC will accept your 
application for consideration for award; and,
  
3) Identify, in a cover letter sent with the application, the staff member 
and IC who agreed to accept assignment of the application.  

This policy applies to all investigator-initiated new (type 1), competing 
continuation (type 2), competing supplement, or any amended or revised 
version of these grant application types. Additional information on this 
policy is available in the NIH Guide for Grants and Contracts, October 19, 
2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html. 

SENDING AN APPLICATION TO THE NIH: 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)

APPLICATION PROCESSING: Applications must be received by or mailed 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.

PEER REVIEW PROCESS

Applications submitted for this PA will be assigned on the basis of 
established PHS referral guidelines.  An appropriate scientific review group 
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 Receive a written critique
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 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 your application in order to judge the likelihood that the 
proposed research will have a substantial impact on the pursuit of these 
goals: 

o Significance 
o Approach 
o Innovation
o Investigator
o Environment
  
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.  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.

(1) SIGNIFICANCE:  Does your study address an important problem? If the aims 
of your application are achieved, how do they advance scientific knowledge?  
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?  Do you acknowledge potential problem areas and consider alternative 
tactics?

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

(4) INVESTIGATOR: Are you appropriately trained and well suited to carry out 
this work?  Is the work proposed appropriate to your experience level as the 
principal investigator and to that of other researchers (if any)?

(5) ENVIRONMENT:  Does the scientific environment in which your 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?

PROTECTIONS:  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.

INCLUSION:  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.  Plans for the recruitment and retention of 
subjects will also be evaluated. (See Inclusion Criteria included in the 
section on Federal Citations, below)

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

SPECIAL REQUIREMENTS

Applicants should demonstrate substantial collaboration with alcohol 
treatment or prevention providers.  This includes participation of providers 
in the design of the research project and collaboration with providers during 
the conduct of the research.  Providers should appear as project staff or 
consultants.  Projects should also contain well-developed plans for 
disseminating the results of the research to the provider community.

REQUIRED FEDERAL CITATIONS 

MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components 
involving Phase I and II clinical trials must include provisions for 
assessment of patient eligibility and status, rigorous data management, 
quality assurance, and auditing procedures.  In addition, it is NIH policy 
that all clinical trials require data and safety monitoring, with the method 
and degree of monitoring being commensurate with the risks (NIH Policy for 
Data Safety and 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 AMENDMENT "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 a 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 No. 93.273, and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.  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 described at 
http://grants.nih.gov/grants/policy/policy.htm  and under Federal Regulations 
42 CFR 52 and 45 CFR Parts 74 and 92. 

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.
http://grants.nih.gov/grants/guide/pa-files/PA-02-015.html. 


Return to Volume Index

Return to NIH Guide Main Index


Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy


Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.