GROUP THERAPY FOR INDIVIDUALS IN DRUG ABUSE OR ALCOHOLISM TREATMENT

RELEASE DATE:  December 10, 2003

RFA Number:  RFA-DA-04-008 

Department of Health and Human Services (DHHS)

PARTICIPATING ORGANIZATION: 
National Institutes of Health (NIH) 
 (http://www.nih.gov)

COMPONENTS OF PARTICIPATING ORGANIZATION:
National Institute on Drug Abuse (NIDA) 
 (http://www.nida.nih.gov)
National Institute on Alcohol Abuse and Alcoholism (NIAAA) 
 (http://www.niaaa.nih.gov)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER:  93.279, 93.273

LETTER OF INTENT RECEIPT DATE:   January 20, 2004
APPLICATION RECEIPT DATE:        February 20, 2004 

THIS REQUEST FOR APPLICATIONS (RFA) CONTAINS THE FOLLOWING INFORMATION:

o Purpose of this RFA
o Research Objectives
o Mechanisms of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS RFA

The purpose of this Request for Applications (RFA) is to invite research 
applications addressing group-format behavioral treatments for drug abuse 
and/or alcohol use disorders (AUD). Applications that focus on interventions 
to reduce the spread of infectious disease in substance abuse treatment 
populations are also of interest.  This RFA builds on a meeting convened by 
the National Institute on Drug Abuse (NIDA) in 2003 on the challenges in 
conducting research on group therapy, and is part of an ongoing commitment of 
NIDA and National Institute on Alcohol Abuse and Alcoholism (NIAAA) to 
support the development and testing of behavioral treatments for drug abuse 
and AUD that can be delivered in community substance abuse treatment 
settings.  Most behavioral treatments for drug abuse/dependence in community 
settings are delivered via group format, yet relatively few systematic 
studies of group therapy for drug abuse or AUD have been conducted.  Further, 
the many methodological and logistical challenges in conducting group therapy 
research present significant obstacles to the development of this area of 
research.  For these reasons, NIDA and NIAAA wish to support additional 
scientifically-sound and clinically-relevant research in this area.  
Applications are encouraged that: (1) develop new group therapies, based on 
strong clinical theory, or on translation of findings from basic behavioral, 
cognitive, affective, and social science studies and/or on current knowledge 
in neuroscience; (2) adapt existing group therapies originally developed for 
clinical problems other than drug abuse/AUD to incorporate drug abuse, AUD, 
and/or infectious disease risk reduction as targets of treatment; (3) adapt 
existing behavioral treatments originally developed as non-group format 
treatments to be delivered via group format; (4) develop treatment manuals 
for existing group therapies that have not yet been systematized, and test 
these therapies (i.e., reverse-engineering of existing group treatments); and 
(5) address the methodological and statistical tools necessary for examining 
the effects of group-format treatments.  In addition, all applications should 
strive to incorporate tests of the mechanisms of action of group therapies, 
identifying important mediators and moderators of treatment effects.

RESEARCH OBJECTIVES

Background

Rather than being a unified treatment approach, group therapy encompasses a 
wide range of behavioral treatment approaches with the common element of a 
group format.  The theoretical foundations of group therapy vary widely, with 
typical 12-step groups grounded in a disease model of addiction, skills-based 
groups grounded in behavioral or cognitive theory, some psychoeducational 
groups grounded in a health-belief treatment model, other groups grounded in 
psychodynamic theory, and still others taking an eclectic approach.  Group 
therapies also vary in the degree to which they focus on group process as a 
mechanism of change, with group treatments such as therapeutic communities 
relying heavily on feedback from other participants for therapeutic change, 
other approaches using group members’ experiences as an additional 
therapeutic tool, and still others largely delivering individual treatment in 
a group format.  Such wide variability within this treatment modality makes 
it difficult to draw general conclusions about therapeutic effectiveness, 
especially given the small number of studies conducted on group treatment of 
drug abuse and AUD.  Not surprisingly, the small number of controlled studies 
on group treatments for drug abuse/AUD shows mixed results, and the 
variability in the approaches, target populations, timing, and other 
dimensions of the therapies is likely to account for differential 
effectiveness found in these studies.    

Given the state of the science of group therapy research, more controlled 
studies of group therapies for drug abuse, AUD, and infectious disease risk 
reduction are needed.  NIDA and NIAAA are guided by a three-stage model of 
behavioral treatment development.  This RFA should be considered in the 
context of this model, which is described in detail in the Behavioral 
Therapies Development Program Announcement 
(http://grants.nih.gov/grants/guide/pa-files/PA-03-126.html).  In this 
model, Stage I, or early therapy development, involves research on the 
development, refinement, and pilot testing of behavioral interventions.  
Stage-I group therapy development may be based on compelling theory, clinical 
observation, and/or the translation of findings from existing research, 
including basic behavioral, cognitive, affective, and social science and/or 
neuroscience. Stage II involves the efficacy testing of clearly defined 
treatments that have shown promise.  Stage III is research aimed at 
determining if and how efficacious behavioral treatments may be transported 
to community settings, through the development of therapist training methods 
and the community-based testing of efficacious treatments (e.g., “technology 
transfer” studies).  Another type of treatment development research that is 
especially applicable to group therapies involves cases in which existing 
group therapies are being delivered, but have not yet been manualized or 
rigorously tested.  In these cases, research might involve developing a 
therapy manual that captures the key elements of the therapy, and then 
testing this therapy in a pilot or controlled study.  This type of study, 
sometimes called “reverse-engineering” of treatment, may encompass aspects of 
several stages of therapy development, depending on the research questions 
and design.  Although research is needed at all stages of therapy development 
for group therapies, this RFA focuses on Stages I and II.  It is important to 
note that this includes, but is not limited to Stage I and II research on the 
development and testing of group therapies in community settings.  Of 
particular interest are the development of new group therapies, or the 
adaptation or manualization of existing group therapies, and the testing of 
these therapies in targeting drug abuse, AUD, and/or decreasing the spread of 
infectious disease.  Attention to potential mechanisms of action of group 
therapies is relevant to every stage of therapy development, and applications 
should consider measurement and methods that allow for tests of how the group 
therapy of interest produces change.  While applications that address either 
how a group therapy produces change, or whether a group therapy produces 
change (i.e., mechanisms of action or efficacy), are responsive to this RFA, 
strong applications will incorporate tests of both therapeutic mechanisms and 
efficacy.

Special Issues Related to Group Therapy Research 

Group therapy research poses particular methodological, logistical, and human 
subjects challenges that applicants are encouraged to consider.  Among the 
methodological challenges in conducting group therapy research are handling 
the heterogeneity within groups, handling changes in group membership, 
accounting for the potential non-independence of group members, deciding on 
randomization procedures (e.g., randomizing patients to groups vs. 
constituting groups and then randomizing to treatment conditions), and 
analyzing group data (e.g., choosing appropriate levels of analysis, scaling 
group data).  Among the logistical challenges in conducting group therapy 
research are recruiting sufficient numbers of participants to constitute 
therapy groups, preventing and managing patient drop-out, and minimizing the 
delay between the study intake and the beginning of treatment.  

Perhaps primary among the challenges in group therapy research is choosing 
between “closed” groups, in which group membership is relatively fixed, and 
“open” or “rolling” groups, in which new members may join the group and 
existing members may graduate from the group as progress indicates.  The 
choice between closed and open group therapy may have implications both for 
the study methodology and study logistics.  For instance, closed groups may 
require long delays before the start of treatment while group members are 
being recruited.  This may increase patient dropout, and pose questions about 
the necessity of offering an interim treatment.  Closed groups also may 
increase the interdependence of group members, and may limit the degree to 
which group member data can be analyzed at an individual level.  However, the 
variability in open groups may make following a treatment plan difficult, in 
which new group members are at different points in their treatment than 
existing members.  Variability in group membership also complicates data 
analysis, adding potential confounds in explaining therapeutic change. 

Applicants are encouraged to be sensitive to any special human subjects 
issues that group treatment might produce, such as additional issues of 
confidentiality, and/or issues concerning mixed gender groups, etc., and to 
address all relevant human subjects issues in their proposals. 

Specific Areas

The following are a few examples of group therapy research projects that 
would be responsive to this RFA.  These are meant to highlight projects of 
particular interest to NIAAA and NIDA, but this list is not intended to cover 
the full range of projects of interest.  Applications are encouraged to 
incorporate tests of therapeutic mechanisms of action, clarifying how 
therapies produce change, in addition to whether therapies produce change.  

o Develop and test a group therapy for a special population of alcohol and/or 
drug abusers (e.g., single-gender, adolescents with Conduct Disorder, etc.) 
based on findings that suggest a need for targeted treatments

o Identify and test possible counter-indications for behavioral treatment 
delivered in a group format (e.g., mismatches between group treatment 
approaches and certain populations of alcohol and /or drug abusers, goals of 
treatment, timing of treatment, etc.)

o Adapt and test a group therapy for drug and/or alcohol abuse and/or 
infectious disease risk-reduction from an efficacious group therapy for other 
clinical disorders (e.g., other addictive behaviors, anxiety disorders, mood 
disorders, chronic illness, etc.) 

o Adapt and test an individual-format treatment for delivery in a group 
format, or replicate and refine those methods, which are in the early stages 
of development.  For example, Motivational Enhancement Therapy was formalized 
in an individual format, and has been implemented in a group format with 
mixed results. Additional studies are needed in this area.

o Develop a treatment manual and therapist adherence and competence measures, 
and pilot test an existing group therapy with a promising clinical history, 
but which has not yet been studied systematically

o Test hypothesized mechanisms of action of group treatment, and their 
relationship to therapy outcome (e.g., social support, social influence and 
persuasion, modeling, exposure, skills acquisition, acceptance of difficult 
life experiences, learning emotional regulation, embracing powerlessness in 
the face of addiction, creating opportunities to re-visit unresolved 
developmental issues, spirituality and religiosity etc.)

o Test potential mediators and moderators of treatment effects, such as group 
cohesion, the role of powerful group members, the degree of group 
heterogeneity, group size, dropout, etc.

o Investigate the relationship to therapy process and/or outcome of therapist 
characteristics, stances, or interventions (e.g., therapist directiveness vs. 
neutrality, degree of therapist self-disclosure, having co-therapists, peer 
vs. professional group leaders, ethnicity, and cultural competency of 
therapist, etc.)

o Investigate possible common change processes across different group therapy 
approaches

o Analyze previously-collected therapy data to clarify the mechanisms of 
action and efficacy of a group therapy

o Develop and test measures necessary for research of group therapy, 
including measures of possible mechanisms of action, mediators and/or 
moderators of treatment effects, and therapy outcome

MECHANISMS OF SUPPORT

This RFA will use the NIH research project (R01), the small grant (R03) 
http://grants.nih.gov/grants/guide/pa-files/PA-03-108.html and the 
exploratory/development (R21) award mechanisms 
http://grants.nih.gov/grants/guide/pa-files/PA-03-107.html.  As an applicant 
you will be solely responsible for planning, directing, and executing the 
proposed project.  This RFA is a one-time solicitation.  Future unsolicited, 
competing-continuation applications based on this project will compete with 
all investigator-initiated applications and will be reviewed according to the 
customary peer review procedures.  The anticipated award date is September 30, 
2004.  Applications that are not funded in the competition described in this 
RFA may be resubmitted as NEW investigator-initiated applications using the 
standard receipt dates for NEW applications described in the instructions to 
the PHS 398 application.

This RFA uses just-in-time concepts.  It also uses the modular budgeting as 
well as the non-modular budgeting formats (see 
http://grants.nih.gov/grants/funding/modular/modular.htm).  Specifically, if 
you are submitting an application with direct costs in each year of $250,000 
or less, use the modular budget format.  Otherwise follow the instructions for 
non-modular budget research grant applications.  This program does not require 
cost sharing as defined in the current NIH Grants Policy Statement at 
http://grants.nih.gov/archive/grants/policy/nihgps_2001/part_i_1.htm.

FUNDS AVAILABLE 

NIDA intends to commit approximately $1.5 million and NIAAA will commit to 
$350,000 in FY 2004 to fund 5 to 6 new and/or competitive continuation grants 
in response to this RFA.  An applicant may request for the R01 a project 
period of up to 5 years. For the R03, the project period is 2 years and direct 
costs up to $50,000 for each of those years.  For the R21, the project period 
is 2 years and up to $275,000 in direct costs for the two-year period.  
Because the nature and scope of the proposed research will vary from 
application to application, it is anticipated that the size and duration of 
each award will also vary.  Although the financial plans of NIDA and NIAAA 
provide support for this program, awards pursuant to this RFA are contingent 
upon the availability of funds and the receipt of a sufficient number of 
meritorious applications. 

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 institutions/organizations
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 inquiries concerning this RFA 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:

For NIDA:
Melissa W. Racioppo, Ph.D.
Behavioral Treatment Development Branch
National Institute on Drug Abuse
6001 Executive Blvd. NSC Room 4230
Bethesda, MD 20892 (USPS)
Rockville, MD 20852  (FedEx and other couriers)
Tel: (301) 443-2261
Fax: (301) 443-6814
Email: mr313x@nih.gov

For NIAAA:
Charlene E. LeFauve, Ph.D.
Division of Treatment and Recovery Research
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard, Suite 505 MSC 7003
Bethesda, MD 20892-7003
For express mail use:
Rockville, MD 20852)
Telephone: (301) 402-9401
Fax: (301) 443-8774
Email: clefauve@NIAAA.nih.gov

o Direct your questions about peer review issues to:

For NIDA:
Teresa Levitin, Ph.D.
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Suite 220, MSC 8401
Bethesda, Maryland  20892-8401
Telephone:  (301) 443-2755
FAX:  (301) 443-0538
Email:  tlevitin@mail.nih.gov

o Direct your questions about financial or grants management matters to: 

For NIDA:
Gary Fleming, J.D., M.A.
Grants Management Branch
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Suite 242, MSC 8403
Bethesda, MD  20892-8403
Telephone:  (301) 443-6710
FAX:  (301) 594-6849
Email:  gf6s@nih.gov

For NIAAA:
Judy Fox
Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard, Suite 505 MSC 7003
Bethesda, MD 20892-7003
(For express mail use:
Rockville, MD 20852)
Telephone: (301) 443-2434
Email: jsimons@niaaa.nih.gov

LETTER OF INTENT
 
Prospective applicants are asked to submit a letter of intent that includes 
the following information:

o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel 
o Participating institutions
o Number and title of this RFA 

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 plan 
the review.
 
The letter of intent is to be sent by the date listed at the beginning of 
this document.  The letter of intent should be sent to:

Director
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Suite 220, MSC 8401
Bethesda, MD  20892-8401
Rockville, MD  20852 (for express/courier service)
Telephone:  (301) 443-2755
FAX:  (301) 443-0538
Email:  tlevitin@mail.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 document 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.

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.

USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) 
application form must be affixed to the bottom of the face page of the 
application.  Type the RFA number on the label.  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 2 of the face page of the application form 
and the YES box must be marked. The RFA label is also available at: 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.
 
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/DHHS
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:

Director
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Suite 220, MSC 8401
Bethesda, MD  20892-8401
Rockville, MD  20852 (for express/courier service)

APPLICATION PROCESSING: Applications must be received on or before the 
application receipt date listed in the heading of this RFA.  If an 
application is received after that date, it will be returned to the applicant 
without review.

Although there is no immediate acknowledgement of the receipt of an 
application, applicants are generally notified of the review and funding 
assignments within 8 weeks.
 
The Center for Scientific Review (CSR) will not accept any application in 
response to this RFA that is essentially the same as one currently pending 
initial review, unless the applicant withdraws the pending application.  
However, when a previously unfunded application, originally submitted as an 
investigator-initiated application, is to be submitted in response to an RFA, 
it is to be prepared as a NEW application.  That is, the application for the 
RFA must not include an Introduction describing the changes and improvements 
made, and the text must not be marked to indicate the changes from the 
previous unfunded version of the application.  

PEER REVIEW PROCESS  
 
Upon receipt, applications will be reviewed for completeness by the CSR and 
responsiveness by NIDA and NIAAA.  Incomplete applications will not be 
reviewed.  If the application is not responsive to the RFA, NIH staff may 
contact the applicant to determine whether to return the application to the 
applicant or submit it for review in competition with unsolicited 
applications at the next appropriate NIH review cycle.
 
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 and NIAAA in accordance with the review criteria stated 
below.  As part of the initial merit review, all applications will:

o Undergo a process in which only those applications deemed to have the 
highest scientific merit, generally the top half of the 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 Council on Drug 
Abuse and the National Institute on Alcohol Abuse and Alcoholism National 
Advisory 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 the 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 the following criteria in assigning 
the application's overall score, weighting them as appropriate for each 
application. 

o Significance 
o Approach 
o Innovation
o Investigator
o Environment
  
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 
methods? 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?

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:  

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).

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

ADDITIONAL REVIEW CONSIDERATIONS

Sharing Research Data 

Applicants requesting more than $500,000 in direct costs in any year of the 
proposed research must 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.  (See 
http://grants2.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm.)

BUDGET:  The reasonableness of the proposed budget and the requested period 
of support in relation to the proposed research.

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date:    January 20, 2004 
Application Receipt Date:         February 20, 2004
Peer Review Date:                 June/July 2004
Council Review:                   September 2004
Earliest Anticipated Start Date:  September 30, 2004

AWARD CRITERIA

Award criteria that will be used to make award decisions include:

o Scientific merit (as determined by peer review)
o Availability of funds
o Programmatic priorities.
 
REQUIRED FEDERAL CITATIONS 

HUMAN SUBJECTS PROTECTION:  Federal regulations (45CFR46) require that 
applications and proposals involving human subjects must be evaluated with 
reference to the risks to the subjects, the adequacy of protection against 
these risks, the potential benefits of the research to the subjects and 
others, and the importance of the knowledge gained or to be gained.
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm.

DATA SAFETY AND 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 Safety and Monitoring, NIH Guide for 
Grants and Contracts, June 12, 1998: 
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).  

SHARING RESEARCH DATA: Starting with the October 1, 2003 receipt date, 
investigators submitting an NIH application seeking more than $500,000 or 
more in direct costs in any single year are expected to include a plan for 
data sharing or state why this is not possible. 
http://grants.nih.gov/grants/policy/data_sharing. Investigators should seek 
guidance from their institutions, on issues related to institutional 
policies, local IRB rules, as well as local, state and Federal laws and 
regulations, including the Privacy Rule. Reviewers will consider the data 
sharing plan but will not factor the plan into the determination of the 
scientific merit or the priority score.

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.

HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research 
on hESCs can be found at http://stemcells.nih.gov/index.asp and at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.  Only 
research using hESC lines that are registered in the NIH Human Embryonic Stem 
Cell Registry will be eligible for Federal funding (see http://escr.nih.gov).   
It is the responsibility of the applicant to provide, in the project 
description and elsewhere in the application as appropriate, the official NIH 
identifier(s) for the hESC line(s)to be used in the proposed research.  
Applications that do not provide this information will be returned without 
review. 

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.

STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION:  The 
Department of Health and Human Services (DHHS) issued final modification to 
the “Standards for Privacy of Individually Identifiable Health Information”, 
the “Privacy Rule,” on August 14, 2002.  The Privacy Rule is a federal 
regulation under the Health Insurance Portability and Accountability Act 
(HIPAA) of 1996 that governs the protection of individually identifiable 
health information, and is administered and enforced by the DHHS Office for 
Civil Rights (OCR). Those who must comply with the Privacy Rule (classified 
under the Rule as “covered entities”) must do so by April 14, 2003 (with the 
exception of small health plans which have an extra year to comply).  

Decisions about applicability and implementation of the Privacy Rule reside 
with the researcher and his/her institution. The OCR website 
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule, 
including a complete Regulation Text and a set of decision tools on “Am I a 
covered entity?”  Information on the impact of the HIPAA Privacy Rule on NIH 
processes involving the review, funding, and progress monitoring of grants, 
cooperative agreements, and research contracts can be found at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

HIV/AIDS COUNSELING AND TESTING POLICY FOR THE NATIONAL INSTITUTE ON DRUG 
ABUSE:  Researchers funded by NIDA who are conducting research in community 
outreach settings, clinical, hospital settings, or clinical laboratories and 
have ongoing contact with clients at risk for HIV infection, are strongly 
encouraged to provide HIV risk reduction education and counseling.  HIV 
counseling should include offering HIV testing available on-site or by 
referral to other HIV testing service for persons at risk for HIV infection 
including injecting drug users, crack cocaine users, and sexually active drug 
users and their sexual partners.  For more information see 
http://grants.nih.gov/grants/guide/notice-files/NOT-DA-01-001.html.

NATIONAL ADVISORY COUNCIL ON DRUG ABUSE RECOMMENDED GUIDELINES FOR THE 
ADMINISTRATION OF DRUGS TO HUMAN SUBJECTS:  The National Advisory Council on 
Drug Abuse recognizes the importance of research involving the administration 
of drugs to human subjects and has developed guidelines relevant to such 
research.   Potential applicants are encouraged to obtain and review these 
recommendations of Council before submitting an application that will 
administer compounds to human subjects.  The guidelines are available on 
NIDA's Home Page at http://www.nida.nih.gov under the Funding, or may be 
obtained by calling (301) 443-2755.

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 
RFA 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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