CENTERS PROGRAM FOR RESEARCH ON HIV/AIDS AND MENTAL HEALTH

RELEASE DATE:  June 20, 2003

PA NUMBER:  PAR-03-142 (Reissued as PAR-08-009)

(See Notice NOT-MH-06-127 The purpose of this 
notice is to extend the expiration date and change the eligibility.

(Addendum: Budget cap increased, see 
NOT-MH-04-010)

RECEIPT DATES:  January 2, 2004; January 2, 2005; January 2, 2006 for all 
applications

September 1, 2004; September 1, 2005; September 1, 2006 for competing renewal 
applications only   

EXPIRATION DATE:  January 3, 2007 unless reissued.

National Institute of Mental Health (NIMH)
 (http://www.nimh.nih.gov)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S):  93.242

THIS PA CONTAINS THE FOLLOWING INFORMATION

o  Purpose of the 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  Letter of Intent
o  Submitting an Application
o  Peer Review Process
o  Review Criteria
o  Award Criteria
o  Required Federal Citations

PURPOSE OF THIS PA

This program announcement replaces PAR-99-153, published in the guide on 
August 23, 1999.

The Center for Mental Health Research on AIDS at the National Institute of 
Mental Health supports research Centers that provide Core support for 
multi-disciplinary research programs focused on mental health and HIV/AIDS.  
The purpose of this Centers Program is to improve and expand research by 
supporting infrastructure for administrative coordination; subject recruitment, 
tracking, and retention; quality control and assurance procedures; performing 
laboratory testing; performing statistical analyses; database management; 
sponsoring training and education; and organizational capacity, in order to 
provide leadership in the integration of multidisciplinary approaches to 
HIV/AIDS and mental health research, and to expand and develop 
information-sharing, expertise, technology, and technology transfer in the 
institutional and clinical communities.  The support of this infrastructure 
will serve to enhance and extend the effectiveness and public health impact of 
research related to mental health and HIV/AIDS.

RESEARCH OBJECTIVES

The NIMH seeks to foster a synergistic approach to conducting research on mental 
health issues related to HIV infection.  The goal of the NIMH AIDS Centers 
Program is to encourage the application of multiple scientific perspectives and 
approaches to stimulate inter-disciplinary collaboration and coordination.  
NIMH AIDS Centers should stimulate translational AIDS research activities at 
institutions that receive significant AIDS funding.  NIMH AIDS Centers must 
have the potential to be broadly based investigative endeavors, encompassing 
or supporting research in a variety of areas including biological, biomedical, 
behavioral, neuroscience, prevention, clinical sciences, and services research.  
However, each successful NIMH AIDS Center should also demonstrate excellence 
and leadership in thematic areas that capitalizes on the experience and 
expertise of the Center investigators.  The Center can then serve as a 
catalyst to spearhead activities related to this theme within the institution 
and surrounding communities.

Some important specific research objectives that can be fostered by NIMH AIDS 
Centers are: 1) identification of mutable behavioral risk factors that put 
individuals at risk for HIV infection, and development of cost-effective 
interventions to change those behaviors; 2) development of methods and 
strategies to aid HIV-infected individuals and their families in coping with 
HIV infection and avoiding new sexually transmitted illnesses; 3) study of the 
effects of HIV infection of the CNS; 4) identification of the cellular and 
molecular mechanisms underlying HIV-induced CNS dysfunction; 5) development 
and testing of potential therapeutics to prevent or treat HIV/CNS disease; and 
6) study of issues influencing adherence and non-adherence, and identification 
of methods to improve long-term adherence to drug therapy regimens and 
behavioral modification.  The NIMH AIDS Centers will enable innovative, 
state-of-the-science research on HIV and mental health that could not or would 
not be conducted without the crucial support provided by them.  The overall 
integrative theme of an NIMH AIDS Center should be clearly described, and the 
need for the Center Cores' support to facilitate the research projects should 
be justified.

NIMH AIDS Centers are expected to serve as local, regional, national and 
international research resources for established and promising investigators, 
and to provide opportunities for research training, career development, and 
mentoring, with an emphasis on fostering the career development of minority 
scientists to become successful and productive HIV/AIDS researchers.  NIMH AIDS 
Centers are encouraged to use a variety of strategies to achieve the research 
objectives of the award, including: addressing challenges to enrollment and 
retention of women, heterosexual men, and ethnic minorities in AIDS clinical 
and behavioral trials; and developing and expanding collaborations with: other 
research institutions, research networks funded by other NIH Institutes or 
Federal agencies or private organizations, international research programs, 
international and domestic community networks, and industry.

Applicants are strongly encouraged to consult with NIMH program staff with 
regard to questions concerning program-specific requirements and research areas 
that are of highest priority.

Although the specific structure and organization of individual NIMH AIDS Centers 
will vary, the following characteristics must be included in each application.  
Applicants should carefully review these characteristics because they are 
important factors in the evaluation and scoring of the application by peer 
reviewers.

NIMH AIDS Center applications must describe in detail the essential function of 
each Core of the Center, how each Core will contribute to the overall theme and 
organization of the Center, and how each Core will be used by the participating 
research projects.  NIMH AIDS Center Cores should provide resources to its 
institution's AIDS research efforts through support of activities that cannot  
effectively be provided by standard research grants.  An example of such 
support is promoting translational research activities, i.e., studies bringing 
findings from the laboratory to the clinic, and vice versa.  Specific aims of 
the proposed components of each of the Center Cores should be defined, and a 
time line for addressing each of those aims should be presented.  A process for 
evaluating the progress of each Core should be developed, with identification 
of outcome measurements clearly defined.  Accountability and progress measures 
for each Core can include process indicators (e.g., specific services and 
technologies offered and utilized); workload indicators (e.g., numbers of 
faculty users, specific research projects or grants supported, and numbers and 
types of conferences, symposia, and workshops); and success indicators (e.g., 
number and quality of publications and grants supported by the Center, 
especially those concerning interdisciplinary and translational research).

Research Environment

Each NIMH AIDS Center must provide an environment that promotes the conduct of 
the highest quality, state-of-the-science research, exhibiting leadership and 
innovation in its particular area(s) of investigation.  Through its activities, 
the Center must demonstrate that it is a significant scientific research 
resource.  Applicants should be very specific in describing the advantages of 
the overall Center structure, how the Center will be beneficial, and how the 
Center will contribute to advancing the field.  The application of multiple 
scientific perspectives and a synergistic approach as well as thematic 
integration should be defining features of the Center.  For competing 
continuations, applicants should identify original approved specific aims and 
clearly describe the progress made on each specific aim as well as provide 
evidence of relevant publications produced in the previous funding period.  
Competing continuation Centers should also include a description of how the 
presence of the Center has improved the conduct of research in the thematic 
area of expertise, as evidenced by broad dissemination of research products, 
citations by other published materials, or other indicators of scientific 
advancement.  Specific examples of broad achievements should be detailed. 
Collaborations with community-based organizations (CBOs) should also included 
in descriptions of the research environment.

Center Director

The NIMH AIDS Center Director must be scientifically and administratively 
qualified to handle the complexity of the research objectives of the Center.  
A critical requirement is that the Center Director must be able to demonstrate 
leadership with regard to the scientific program and the team of individuals 
involved in that program.  The director will have final responsibility for the 
scientific, administrative, and operational aspects of the Center.  The Center 
Director is responsible for overall coordination of the Center and for the 
development of the Center as a significant local, regional, national, and 
international resource.  Because the role of the Center Director is so crucial 
to the success of the Center, an individual should not serve as Director of 
more than one NIH Center grant.  In addition, it is expected that the Center 
Director will make a significant and sustained justifiable commitment of time 
and effort to the Center, based on the breadth and complexity of the Center 
program and the effort needed to administer it, and foster the development of 
senior staff to ensure the Center is positioned to maintain its commitment to 
advancing HIV prevention well into the future.

Training

As a leader in its particular thematic areas of investigation, the NIMH AIDS 
Center should attract new investigators and provide for mentoring and career 
development.  An important component of the Center and its research efforts is 
the training, career development and mentoring of new investigators who show 
potential for significant contributions and independent research careers.  The 
applicant institution must therefore demonstrate that it has the capacity to 
train predoctoral and postdoctoral students for careers in HIV/mental health 
research, and the capacity to provide career development and mentoring 
opportunities for potential researchers.  Center grant funds may not be used to 
pay stipends or other trainee costs; however, the Center staff may participate 
in the development of training programs, and Center resources may be made 
available for trainee use.  In addition, as the Centers are considered to be 
local, regional, national, and international resources, Center applicants 
should also describe plans for facilitating the sharing of data with the 
scientific community, the mechanisms to be used for data-sharing, and the 
procedures for training staff in using those mechanisms. Evidence that training 
goals for new investigators have been met should be included in recompeting 
applications, and may include such indicators as recruitment and retention, 
scientific contributions (e.g., first authored publications), and small grant 
awards.

Travel

Limited support is available to cover travel of the Center Director and other 
investigators to scientific meetings that are justified as essential to the 
conduct of research supported by the Center.  Travel of technical staff for 
training that is justified as essential to enhancing the quality of the 
research projects is also allowed.

Organization

NIMH AIDS Center applications are expected to be multi-disciplinary in scope, 
applying multiple scientific perspectives and approaches to foster inter -
disciplinary collaboration and coordination, and are expected to include a 
depth of expertise and experience not ordinarily present in an individual 
research project application.  The mechanisms that will foster interactions 
and collaborations among Center investigators should be described in detail in 
a well- organized plan that explains how these interactions and collaborations 
will result in enhanced quality, productivity and overall progress in research 
in the Center.  An effective Center provides an environment that encourages 
cross-fertilization of ideas, provides an interactive research environment, and 
encourages creativity and innovation.  The applicant should describe clearly 
how interactions and collaborations of participating investigators will enhance 
and expand the development and productivity of their research efforts, and how 
participating investigators will benefit from shared resources, formal and 
informal planning activities, and developmental or pilot support provided 
through the NIMH AIDS Center grant.

NIMH AIDS Center must be organized to include the Cores listed below:

o  Administrative Core

The Center must have an appropriate and adequate administrative structure with 
an internal organization capable of planning and evaluating Center activities.  
A strategic plan must be outlined which identifies the immediate and long-term 
goals of the Center.  A process for implementing the activities to achieve the 
goals set by the Center should be clearly defined.  For new Center applications, 
the highest priority goals should be identified with a detailed plan outlining 
the activities proposed to meet those goals for each year of the grant.  Goals 
for each successive year should build on those identified for the first year 
of funding.  Competing continuation Centers must provide information on how the 
Center has achieved the goals of the previous funding period and how the goals 
of the future years build on the past successes.

A structure must be provided that has clear lines of authority to promote 
planning and evaluation activities as well as collaborations and interactions 
within, among and between programmatic elements of the Center in an efficient 
and cost-effective manner.  A mechanism for internal review, decision-making, 
and priority-setting processes appropriate to conduct the activities of the 
Center must be defined.  Appropriate criteria and review processes must be 
established and described to sustain investigator participation in the Center 
based on productivity, research direction, and overall contribution.  The 
administrative structure must include a standing outside advisory committee(s) 
charged with providing appropriate and objective advice and evaluation as 
needed to the Center Director.  The plan for meeting with the outside advisory 
committee(s) should be outlined, and a process for responding to recommendations 
of the committee(s) should be delineated.

The Administrative Core may include a limited number of administrative and 
clerical personnel, with a detailed description of their responsibilities for 
the Center and strong justification for the level of support requested.  
However, salary and support for central administrative personnel usually paid 
from institutional overhead charges, such as budget officers, grants assistants, 
and building personnel, are not allowable.  Administrative support services, 
including supplies, duplicating equipment, telephones, or maintenance contracts 
for equipment are allowed when not covered by institutional overhead charges.  
Salary and support for administrative activities such as public relations, 
fund-raising, or educational services unrelated to the research are not allowed.  
Rent may be allowed only in unusual and exceptional circumstances whereby the 
applicant institution has excellent researchers and potential for mental 
health-related HIV/AIDS research, but has documented insufficient on-site space. 

o  Research Cores

The structure of the NIMH AIDS Center will include the establishment of at 
least two Research Cores to support shared resources that are not easily funded 
through standard research funding mechanisms.  The number and goals of the 
Research Cores should be reflective of the overall level of funding requested 
for the Center.  Research Cores can be developed around any research activity 
that can provide resources to basic and clinical investigators.  The Research 
Cores are expected to be used as shared resources and services and are intended 
to provide access to knowledge and technology that enhances the research 
productivity of the Center, scientific interaction within the Center and 
consultation being provided by the Center.  These Research Cores also provide 
access to services that facilitate the research and strengthen the 
administrative and organizational cohesion of the Center.  Research proposed to 
be conducted within the Research Core structure is allowed when directed toward 
improving and expanding the resource.  Each Research Core should clearly 
describe a plan for identifying new or expanded services that it provides.  In 
addition, each Research Core should clearly describe a plan for identifying 
potential users of the shared resources, and for providing the resources to 
investigators who may request them.  The potential benefits of these resources 
and a mechanism to evaluate these benefits must be detailed in the description 
of the Research Core.

The Research Core Director must be scientifically qualified to handle the 
nature and complexity of the research objectives of the Research Core.  Each 
Core Director must be experienced in the scientific area in which the Core 
functions, and have demonstrated the ability to assume responsibility for the 
scientific, administrative, and operational aspects of the Research Core.  The 
time commitment of the Core Director should be based on the breadth and 
complexity of the Core and the effort needed to administer it.

o  Developmental Core

The NIMH AIDS Center structure must include a Developmental Core.  Funds 
allocated to this Core are to provide start-up funds for new, innovative pilot 
projects by independent investigators.  The intent of this Core is to support 
scientific studies for short periods of time to develop preliminary data for 
peer-reviewed research applications.  Funds from this Core can be used to 
support pilot projects, feasibility studies, new or emerging research 
opportunities, and AIDS research activities of newly recruited faculty; 
restricted to these uses only.

Generally, the total amount of money allocated to pilot projects should not 
exceed 10% of the Center grant's total annual direct costs (exceptions should 
be strongly justified).  These projects should have the potential for 
developing into larger projects that could compete for funds on their own.  The 
support of pilot projects or feasibility studies should be of relatively short 
duration (e.g., 1-2 years), depending upon the nature of the research.  A 
process by which high-quality, innovative pilot proposals are identified by or 
solicited from investigators must be developed and clearly described.  The 
mechanism for reviewing potential projects, making funding decisions and awards, 
and monitoring projects to ensure effective use of pilot project funds must be 
clearly described.  As with all research to be conducted under the Center's 
auspices, pilot projects must comply with applicable NIH policies, and the 
necessary human subject and animal welfare assurances must be submitted.

The Director of the Developmental Core must be scientifically qualified to 
direct the activities of the Core.  This Core Director must be experienced in 
the scientific areas in which the core proposes to develop pilot projects and 
must have an understanding of the scientific process of developing ideas into 
applications.  This Director should also demonstrate the ability to assume 
responsibility for the scientific, administrative, and operational aspects of 
the Developmental Core.

Competing continuation Center applications should supply information about the 
progress, accomplishments and relevant publications of all projects supported 
by the Developmental Core of the previous funding period of the Center.  This 
information should also include current funding status of completed pilot 
projects, whether data generated from pilot projects provided a basis for 
projects with independent funding, and whether investigators funded through 
this mechanism, particularly junior investigators, were successful at competing 
for independent funding.

o  Budgetary Items and Supportable Activities

Allowable costs in NIH grants are governed by rules set forth in the NIH Grants 
Policy Statement and the NIH Guide for Grants and Contracts, unless otherwise 
stated on the Notice of Grant Award.  Under these rules, the Center Director has 
flexibility to meet unexpected Center requirements by rebudgeting or requesting 
approval to rebudget among categories within the total direct cost budget of the 
Center (as shown on the Notice of Grant Award).  The Center is intended to 
provide reasonable costs for any or all of those activities noted below which 
are clearly related to the specialized research needs of the Center and allowed 
by NIH policy.

MECHANISM(S) OF SUPPORT

This PA will use the NIH core center grant (P30) award mechanism.  As an 
applicant you will be solely responsible for planning, directing, and executing 
the proposed project.  NIMH will provide up to a maximum of $2,000,000 total 
costs per year for an AIDS Center grant.

This PA uses just-in-time concepts.    

ELIGIBLE INSTITUTIONS 

You may submit (an) application(s) if your institution has any of the following 
characteristics:

o  Non-profit organizations
o  Public or private institutions, such as universities, colleges, hospitals, 
and laboratories
o  Domestic 
o  Faith-based or community-based organizations

Foreign institutions are not eligible to apply.

In order to be eligible for an NIMH AIDS Center grant, applicants must 
demonstrate a minimum funded research base of four NIMH-funded research grants, 
and at least two more peer-reviewed AIDS and AIDS-related research awards at 
the time that the Center is funded and throughout the award period.  The 
additional grants may be from other NIH Institutes or from peer-reviewed 
funding from alternate sources.  This research base must demonstrate synergy 
and collaboration for AIDS-related behavior research or research investigating 
the neurological and neurobehavioral complications of HIV infection.  The 
research base includes grants and contracts utilizing the following mechanisms: 
P01, R01, R03, R21, R35, R37, U01, U10, U19, and K series awards.

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 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:

Dianne Rausch, Ph.D.
Center for Mental Health Research on AIDS
National Institute of Mental Health
6001 Executive Boulevard, Room 6212
Bethesda, MD  20892-9619
Telephone:  (301) 443-7281
FAX:  (301) 443-9719
Email:  dr89b@nih.gov

o  Direct your questions about peer review issues to:

Michael Kozak, Ph.D.
Division of Extramural Activities
National Institute of Mental Health
6001 Executive Boulevard, Room 6138, MSC 9608
Bethesda, MD  20892-9608
Rockville, MD  20852-9608 (for express/courier service)
Telephone:  (301) 443-1340
FAX:  (301) 443-4720
Email:  kozakm@mail.nih.gov

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

Brian Albertini
Division of Mental Disorders, Behavioral Research, and AIDS
National Institute of Mental Health
6001 Executive Boulevard, Room 6135, MSC 9605
Bethesda, MD 20852-9605
Telephone:  (301) 443-0004
FAX:  (301) 443-6885
Email:  albertib2@mail.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 PA

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 NIMH staff to estimate the potential review workload and plan the review.

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

Dianne Rausch, Ph.D.
Center for Mental Health Research on AIDS
National Institute of Mental Health
6001 Executive Boulevard, Room 6212
Bethesda, MD  20892-9619
Telephone:  (301) 443-7281
FAX:  (301) 443-9719
Email:  dr89b@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 must be sent  on or before the 
application receipt date listed in the heading of this PA.  Revised applications 
of competitive renewals will be accepted on the September 1 following the first 
competitive renewal submission. This September 1 deadline is only applicable 
for revised competitive renewal applications.  Applications received after the 
application receipt date will be returned to the applicant without review.

SUPPLEMENTAL INSTRUCTIONS:

To facilitate the review process, the application should be organized according 
to  the outline described here.

o  Overview (not to exceed 10 pages)

An overview should include:  an overall description of the proposed Center, 
including objectives and integrating theme; justification of Center goals and 
proposed organization; evidence of the cohesiveness of the proposed Center; a 
brief description of background and responsibilities of the Center Director, 
key personnel, and participating investigators; and a diagram illustrating the 
organization and function of the programmatic and advisory structure of the 
Center.  The overview should describe how the Center functions will develop and 
expand collaborations, bringing the thematic expertise to the local, regional, 
national and international scientific community.  New Center applications should 
describe plans to develop these broad collaborations, delineating a process for 
evaluating progress.  Competing continuation Center applications must describe 
past successes and new goals as well as provide convincing justification that 
continued support under this mechanism will continue to be highly productive.  
Both new and competing Center applications should describe the institutional 
commitment to the Center.  A strong commitment of the parent institution can be 
demonstrated by providing sufficient resources and space to ensure 
organizational stability and fulfillment of Center objectives.  The 
organizational status of the Center within the institution should be comparable 
to that of other similar organizational units within the institution.  The 
parent institution should also provide assurance of its commitment to 
continuing support of the Center in the event of a change in Center 
directorship and have in place a well-defined plan for this situation.

o  Research Plan (not to exceed 25 pages)

The research plan must include: a detailed description of the goals of the 
Center and how leadership and expertise will be provided as a resource for the 
scientific personnel and projects that form the Center; an action plan to 
achieve those goals, and a short- and long-term timeline for achieving those 
goals; the strengths of and opportunities provided by the proposed Center; 
strengths of the methods to be used; information about resources and facilities 
available to augment the Center's capabilities; policies and procedures for 
strategic planning, monitoring, and evaluating the Center activities; an 
overview of the core structure, including a justification for specific cores 
and a plan for how the cores will interact with and support the programmatic 
elements of the Center; and a description of how the Center will facilitate 
the existing science at the Institution.  Competing continuation Centers should 
include some historical perspective describing the major successes of the 
previous funding periods and how continued funding will build on those 
successes.  Competing continuation Centers also must provide evidence of 
leadership and expertise appropriate for the thematic areas of the Center.

o  Cores (not to exceed 10 pages for each core)

A detailed description of each individual Core must include the aims and 
activities of the Core and a description of how the aims will be met; a 
justification and description of the personnel within each Core; the proposed 
users of the Center resources and the percent of time that they expect to use 
those resources; a plan for outreach to other potential users; a description of 
the core's resources and environment; and a plan for evaluating the activities 
of the Core.

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 NIH staff member within one of NIH 
institutes or centers 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 three 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)

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

Jean G. Noronha, Ph.D.
NIMH Referral Liaison
National Institute of Mental Health
6001 Executive Boulevard, Room 6154, MSC 9609
Bethesda, MD  20892-9609
Rockville, MD  20852 (for express/courier service)
Telephone:  (301) 443-3367
FAX:  (301) 443-4720
Email:  jnoronha@mail.nih.gov

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

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.

Although there is no immediate acknowledgement of the receipt of an application, 
applicants are generally notified of the review and funding assignment within 8 
weeks.

PEER REVIEW PROCESS

Applications submitted for this PA will be assigned on the basis of established 
PHS referral guidelines.  An appropriate scientific review group will be 
convened by NIMH 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 
the 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 the application's overall score, weighting them as appropriate for 
each application.  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.

Applicants must ensure that their applications are responsive to the research 
goals of NIMH and to the essential organizational and administrative 
characteristics of a NIMH Center as described below.

Review of re-competing Centers will include the necessity of strong 
accountability for past funding period.  Changes in structure or focus that 
have taken place over the previous funding period that have been done to 
strengthen or broaden the efforts of the Center should be clearly described.  
Evidence for future Center success should be clearly stated.

Overall Center Program Review Criteria

SIGNIFICANCE:

o  Scientific significance of the proposed program to furthering research on 
mental health and HIV, expand research collaborations, and provide leadership 
in the thematic area of expertise 
o  Evidence of thematic integration, synergy of approach, cohesiveness of 
objectives, and adequacy of evaluation plans to monitor progress
o  Multi-disciplinary scope, breadth, and overall quality of the Center's 
Program, and the core units, and provisions for coordinating and evaluating the 
resource provided to associated research projects
o  Re-competing Centers should provide a clear justification for the 
significance of continued support 

APPROACH:

o  Overall quality of the proposed administrative functions and infrastructure 
in relation to Center themes and research projects
o  Arrangements for internal quality control of ongoing functions, allocation 
of funds, day-to-day management, contractual agreements and internal 
communication and cooperation among investigators
o  Quality of plans for internal peer review of papers, chapters, and grant 
applications including procedures for determining authorship and other 
sensitive matters
o  Track record and quality of plans for mentoring and career development of 
promising investigators 
o  Quality of the data analytic functions and procedures for database 
management, including quality assessment and control procedures, extent of use 
of the data for analysis, publication, and development of additional hypotheses
o  Re-competing Centers should include a description of how continued funding 
will build on the success of the previous funding period

INNOVATION:

o  Unique strengths and contributions of the Center, including innovation, 
scientific productivity, and recognition, including publication record or 
participating investigators, new research grants, honors and awards
o  Extent of collaboration among investigators within the Center and with other 
research institutions, networks, programs, etc.
o  Quality and innovation of proposed pilot studies that would be anticipated, 
and quality of the procedures for selection and evaluation of new pilot study 
proposals
o  Re-competing Centers must include a justification for their ability to 
continue innovative efforts 

INVESTIGATOR:

o  Scientific and administrative qualifications of the Center Director, 
including evidence of scientific expertise and track record, strong leadership 
potential, administrative skills, and mentoring potential
o  Scientific qualifications and productivity of Center investigators, 
including quality and extent of the research expertise, degree of synergistic 
potential among the research groups
o  Quality of plans for personnel recruitment
o  Quality of plans for sponsoring workshops, seminars, and other educational 
activities for Center investigators and research staff
o  Track record of key personnel in mentoring and promoting career development 
of promising investigators, including summaries of training activities and new 
investigator accomplishments

ENVIRONMENT:

o  Institutional commitment to the program, including availability and 
accessibility of appropriate research laboratories, equipment, and subjects
o  Academic and physical environment as it bears on the potential for 
interaction with scientists from other departments and institutions
o  Evidence of cost-effectiveness of Center structure and function, and 
document of quality control of core units
o  As appropriate, the adequacy of the means proposed for protecting against 
risks to human subjects, animals, and/or the environment
o  As appropriate, the adequate representation of women and minorities in study 
populations

In addition, the proposed Center will be reviewed for the following:

o  Appropriateness of budget requested for the proposed structure and function
o  Appropriateness of the timeline for the proposed activities, and the quality 
of the proposed evaluation process for meeting the goals
o  Appropriateness of procedures for making allocations to core units and, 
reviewing and selecting pilot projects for support
o  Quality of plans to participate in scientific, professional, and public 
meetings and present research findings and, where concrete findings exist, 
plans for publishing the findings
o  Quality of plans for making data and methodologies available to the 
scientific community and for providing training in such methodologies
o  The quality of plans for participating in workshops and conferences, as well 
as disseminating information to non-researcher investigators and the local 
community when applicable

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

CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH:  If vertebrate animals are to 
be used in the project, the five items described under Section f of the PHS 398 
research grant application instructions (rev. 5/2001) will be assessed.

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

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. 

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 "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 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.

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 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 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.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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and Human Services (HHS)
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