This Program Announcement expires on March 2, 2006, unless reissued.

COLLABORATIVE R01S FOR CLINICAL AND SERVICES STUDIES OF MENTAL DISORDERS AND 
AIDS (CSMD)

Release Date:  July 31, 2001

PA NUMBER:  PA-01-123 (Reissued as PA-06-154)
                      (The expiration date for this PA has been extended, see NOT-MH-06-101)
                      (NIMH policy for recruitment, see NOT-MH-05-013)

National Institute of Mental Health
 (http://www.nimh.nih.gov)
National Institute on Drug Abuse
 (http://www.nida.nih.gov)

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 purpose of this Program Announcement (PA) is to support collaborative 
intervention trials and other clinical and services studies at two or more 
sites.  The studies typically share a specific protocol across the sites and 
are organized in order to increase sample size, accelerate recruitment, or 
increase sample diversity and representation.  Each site has its own principal 
investigator (PI) and the program provides a mechanism for cross-site 
coordination, quality control, database management, statistical analysis, and 
reporting.  This PA supercedes PAR-98-017 published December 19, 1997.

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, Collaborative R01s for Clinical 
and Services Studies of Mental Disorders and AIDS, 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.  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) award mechanism.  Responsibility for the planning, direction, and 
execution of the proposed project will be solely that of the applicant.  The 
total project period for an application submitted in response to this PA may 
not exceed 5 years.

Specific application instructions have been modified to reflect "MODULAR 
GRANT" and "JUST-IN-TIME" streamlining efforts that have been adopted by the 
NIH.  Complete and detailed instructions and information on Modular Grant 
applications have been incorporated into the PHS 398 (rev. 5/2001).  
Additional information on Modular Grants can be found at 
http://grants.nih.gov/grants/funding/modular/modular.htm

RESEARCH OBJECTIVES

Summary

Collaborative studies are appropriate to address research questions that are 
beyond the capacity of any single-site investigation.  Considerations such as 
increased sample size, representation, and diversity may all support the need 
for multi-site studies.  The following are given as examples of the types of 
studies that can be supported under this mechanism these are meant to be 
illustrative only and are not intended to be restrictive or exclusive.

o  Large scale, public health oriented intervention studies (treatment, 
prevention, or rehabilitation) using pharmacologic, psychosocial, or somatic 
approaches individually or in combination in appropriate clinical populations

o  Large-scale human genetic studies, in which pedigree recruitment and 
ascertainment must occur in parallel fashion across multiple sites

o  Smaller scale studies of unique clinical populations or low base rate 
outcomes that would be difficult to recruit from a single clinical setting

o  Large scale studies of risk factors for psychopathology, particularly 
studies which are addressed to elucidate potential mechanisms of disorders

o  Studies of social or cultural processes as risk or protective factors for 
disorders, in which appropriate variation is sampled across multiple sites 

o  Studies within the context of clinical trials that assess population 
pharmacokinetics, identify candidate biomarkers that correlate with treatment 
response, optimize procedures for assessing capacity and obtaining informed 
consent, or investigate methods to enhance recruitment, participation and 
retention of ethnically diverse participant samples 

o  Studies of diffusion strategies (i.e., dissemination and implementation) to 
improve adoption of evidence-based treatments in practice settings (These can 
include patient, provider, or organizational level targets and may also 
consider the role and impact of differential incentives and resources to 
achieve adoption.) 

o  For HIV/AIDS relevant applications, studies of the development of behavior 
change and prevention strategies to reduce the further spread of the epidemic, 
interventions to prevent the sequelae of HIV infection and adherence to HIV 
treatment regimens, central nervous system (CNS) effects of HIV infection and 
behavioral outcomes, clinical phenomena of HIV-related neuropsychological and 
neuropsychiatric disorders, mental health services relevant to HIV infection 
and the severely mentally ill, the development of therapeutic agents, 
behavioral issues in vaccine trials, the role of families in preventing and 
adapting to HIV/AIDS, and the history and prevention of HIV-related mental 
disorders

o  For applications relevant to drug abuse, all of the aforementioned issues 
may be addressed in populations with drug abuse and co-morbid mental 
disorders. Studies are sought that elucidate the mutual interactions between 
drug abuse and co-morbid mental disorders that have implications for 
epidemiology, genetics, etiology and pathogenesis, treatment, and other 
aspects of service delivery. For example, comparisons may be made among 
populations showing:  (1) particular drug abuse patterns without other mental 
disorders, (2) mental disorders without drug abuse, (3) mental disorders that 
precede, occur simultaneous with, or follow the development of drug abuse and 
(4) non-substance-related forms of behavioral dependence, e.g., gambling. 

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 IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS

All investigators proposing research involving human subjects should read the 
policy that was published in the NIH Guide for Grants and Contracts, June 5, 
2000 (Revised August 25, 2000), available at the following URL address:  
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.  The receipt dates for AIDS-related research applications 
are:  January 2, May 1, and September 1.  This version of the PHS 398 is 
available in an interactive, searchable PDF format.  Although applicants are 
strongly 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 301/710-0267, Email: 
[email protected].

Applicants who are 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 for any individual application or for the 
combined budget of a set of collaborative R01s, must contact the appropriate 
Institute program staff (see INQUIRIES) 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 who agreed to accept assignment of the 
application.

This policy requires an applicant to obtain agreement from Institute staff for 
acceptance of any such application and any such subsequent amendment.  Refer 
to the NIH Guide for Grants and Contracts, March 20, 1998 at: 
http://grants.nih.gov/grants/guide/notice-files/not98-030.html.) 

The application from each site must contain an OVERVIEW that is no longer than 
2 pages.  The overview should provide an overall rationale for applying as a 
collaborative study, the role of each site, the approach to project 
management, and any elements unique to this site.

The RESEARCH PLAN - Section 2 A - D, should describe those aspects of the 
project that are common to all sites of the collaboration.  Investigators 
should use this section to describe the research procedures or protocol, the 
study population from which samples are drawn, resources, data analyses, and 
any other characteristics that support each site"s importance to the overall 
project.  Where there are even minor variations in the research plan between 
sites, these should be highlighted in a subsection of Section 2 D with the 
heading "ELEMENTS UNIQUE TO THIS SITE."

Applications must describe a feasible mechanism for scientific integration of 
research procedures, overall managerial and administrative responsibilities, 
and cross-site comparability of training to assure reliability and quality 
control.  The PIs may or may not wish to designate a Steering Committee or 
other decision making body, or identify one individual as the contact person 
for the group as a whole, for purposes of NIMH correspondence. Plans for 
ensuring access to data by all sites, analytic resources, publication and 
authorship rights, the possibility of public use research materials and data, 
or other means of distributing research materials to the wider scientific 
community, and a means of arbitrating disagreements on publication and other 
issues should be found in this section of the application.

Any site that contracts out some portions of this work should list this fact 
under "ELEMENTS UNIQUE TO THIS SITE," and provide a full description of the 
nature, purpose and oversight of this contractual arrangement.

Revised collaborative CSMD applications must include an Introduction and 
highlight the changes made in the Research Plan in response to the previous 
critique and describe in item (I) how the delay in initiating the 
collaboration will be managed.  This is particularly important if some 
projects in the collaborative CSMD group were awarded and research on those 
projects has already begun.

SPECIFIC APPLICATION INSTRUCTIONS FOR MODULAR GRANTS

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 beginning on page 
13 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.

The title and number of the program announcement must be typed on line 2 of 
the face page of the application form and the YES box must be marked.

All collaborating sites must be listed under Performance site(s) on Page 2 of 
the application.
 
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.

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:  Are the investigators 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 is to be 
performed 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?

(6) Collaboration:  Is there a feasible mechanism for collaboration to achieve 
scientific integration of research procedures, overall managerial and 
administrative responsibilities, appropriate quality control and reliability 
assurance, and planning for data management, analysis and reporting of 
results?

In addition to the above criteria, in accordance with NIH policy, all 
applications will also be reviewed with respect to the following:

o  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.

o  The reasonableness of the proposed budget and duration in relation to the 
proposed research

o  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.  A data and safety monitoring board comprised of 
individuals external to the study is required in all multi-site intervention 
studies.

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.

INQUIRIES

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

Direct inquiries regarding programmatic issues to:

Bruce B. Cuthbert, Ph.D.
Division of Mental Disorders, Behavioral Research, and AIDS
National Institute of Mental Health 
6001 Executive Boulevard, Rm. 6184, MSC 9625
Bethesda, MD 20892-9625
Telephone:  (301) 443-3728
FAX:  (301) 443-4611
Email:  [email protected] 

Sander G. Genser, M.D., M.P.H.
Center on AIDS and Other Medical Consequences of Drug Abuse
National Institute on Drug Abuse
6001 Executive Boulevard, Rm. 5198, MSC 9593
Bethesda, MD 20892-9593
Telephone:  (301) 443-1801
FAX:  (301) 443-4100
Email:  [email protected]

Barry D. Lebowitz, Ph.D. 
Division of Services and Intervention Research 
National Institute of Mental Health 
6001 Executive Boulevard, Rm. 7160, MSC 9635
Bethesda, MD  20892-9635
Telephone:  (301) 443-1185
FAX:  (301) 594-6784
Email:  [email protected]

Dianne M. Rausch, Ph.D.
Center for Mental Health Research on AIDS
Division of Mental Disorders, Behavioral Research, and AIDS
National Institute of Mental Health
6001 Executive Boulevard, Room 6212, MSC 9619
Bethesda, MD 20892-9619
Telephone:  (301) 443-7281
FAX:  (301) 443-9719
Email:  [email protected] 

Steven J. Zalcman, M.D.
Division of Neuroscience and Basic Behavioral Science
National Institute of Mental Health 
6001 Executive Boulevard, Rm. 7177, MSC 9639
Bethesda, MD 20892-9639
Telephone:  (301) 443-1692
FAX:  (301) 443-4822
Email:  [email protected]

Direct inquiries regarding fiscal matters to:

Diana S. Trunnell
Grants Management Branch
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6115, MSC 9605
Bethesda, MD 20892-9605
Telephone: (301) 443-2805
FAX:  (301) 443-6885
Email:  [email protected]

Gary Fleming, J.D., M.A.
Grants Management Branch
Office of Planning and Resource Management
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3131, MSC 9541
Bethesda, MD  20892-9541
Telephone:  (301) 443-6710
FAX:  (301) 594-6847
Email:  [email protected]

AUTHORITY AND REGULATIONS 

This program is described in the Catalog of Federal Domestic Assistance No. 
93.242 (NIMH) and 92.279 (NIDA).  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, 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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