SILVIO O. CONTE CENTERS TO DEVELOP COLLABORATIVE NEUROSCIENCE RESEARCH

RELEASE DATE:  July 1, 2002

PA NUMBER:  PAR-02-123 (Reissued as PAR-07-434)

(See Partial Replacement PAR-07-430)
(See Notice NOT-MH-06-120)
(See Notice NOT-MH-06-118 
Extending the expiration dates and change the cost limitations and application receipt dates)

EXPIRATION DATE:  October 26, 2006, unless reissued

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

LETTER OF INTENT RECEIPT DATE:  August 1 2002, July 1 annually thereafter

APPLICATION RECEIPT DATE:  October 21, 2002, October 20 annually thereafter

This program announcement (PA) replaces PAR-98-056, which was published in the 
April 17, 1998 issue of the NIH Guide.

THIS PA CONTAINS THE FOLLOWING INFORMATION

o  Purpose of this PA
o  Research Objectives
o  Mechanism of Support
o  Eligible Institutions
o  Individuals Eligible to Become Principal Investigators
o  Special Requirements
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 PA

Interdisciplinary, multidisciplinary, and integrative research is paramount to 
better understand the structure and function of the brain in health and mental 
illness.  Nevertheless, such cross-cutting research is often difficult to 
execute, as it commonly requires collaboration among scientists who work in 
different intellectual contexts, use different tools, and sometimes speak 
seemingly different languages.  Despite the importance of such collaborative 
efforts, support for teams of investigators—even established investigators—with 
little or no track record as a team, is difficult to obtain.

The National Institute of Mental Health (NIMH) invites research grant 
applications for Silvio O. Conte Centers to Develop Collaborative Neuroscience 
Research (CDCNRs).  This initiative is intended to facilitate the development of 
collaborative research teams of established investigators by providing support 
for interactive research projects and cores to serve them.

RESEARCH OBJECTIVES

Background

Neuroscience is built upon a wide range of disciplines, levels of analysis, 
approaches and technologies, and has produced a tremendous amount of highly 
detailed and diverse data.  While the increasingly detailed level of 
understanding presents great scientific opportunities, it also presents 
challenges for individual investigators to address complex and important issues, 
such as the neural basis of mental health and disease.  Such complex issues 
require interdisciplinary, multidisciplinary, and integrative research 
approaches, often best performed by highly interactive teams of collaborating 
investigators.

Objectives and Scope

The primary purpose of a CDCNR is to support early stage development of 
collaborative teams of high caliber investigators from diverse disciplines to 
study basic and/or clinical neuroscience issues related to the mission of the 
NIMH, and to position those teams to compete for support as either a Silvio O. 
Conte Center for Neuroscience Research (PAR-02-121) 
http://grants.nih.gov/grants/guide/pa-files/PAR-02-121.html) or a Silvio O. Conte 
Center for the Neuroscience of Mental Disorders (PAR-02-122)  
http://grants.nih.gov/grants/guide/pa-files/PAR-02-122.html). Therefore, 
those considering applying for CDCNR support are strongly 
urged to read the program announcements of the larger Conte Center mechanisms 
(see URLs above) before preparing a CDCNR application.

A CDCNR is characterized as follows:

o  The CDCNR should bring together a team of collaborative investigators with 
different scientific perspectives to address one, or a small number of, 
specific, well focused research hypotheses or questions related to brain 
function or dysfunction.  The research question may be posed in any area(s) of 
neuroscience related to the mission of the NIMH, and may be basic neuroscience 
research or combined basic and clinical neuroscience research.

o  It is expected that a Center will be organized specifically to address 
innovative, creative, and potentially high risk/high impact research questions 
that are especially well addressed by collaborative research.  Centers must 
rigorously test proposed hypotheses and generate new ones.

o  A CDCNR will comprise specific, interactive research projects and may include 
cores to serve those particular projects.  A high level of scientific 
interaction and integration across constituent projects is expected, as is the 
synergy resulting from such interactions.  Cores should not be intended to
provide general infrastructure support to an institution.

o  The CDCNR mechanism may not be used as a substitute for individual grant 
support.  It is, therefore, expected that investigators participating in centers 
will have independent, peer reviewed research support.  A CDCNR should be viewed 
as a unique scientific opportunity to develop collaborative research teams to 
investigate leading edge research questions not currently being addressed in 
optimal ways.

o  The CDCNR Director should be an outstanding neuroscientist and have a 
demonstrated ability to organize, administer, and direct the Center.  This 
individual should be the scientific leader of the Center, and thus must also 
head at least one of the constituent projects, with a minimum total time 
commitment of 20 percent to the Center.

o  Investigators heading projects in a CDCNR must be outstanding scientists in 
basic or clinical neuroscience research.  Investigators with the qualifications 
to contribute to a unique enterprise such as a CDCNR may be located in different 
geographic areas.  In such cases, collaborations among different institutions 
are encouraged, if scientifically appropriate.

o  A CDCNR should provide opportunities for young investigators who have the 
potential for independent research careers to benefit from the collaborative 
research supported.  In addition, there should be close coordination between the 
Center and relevant predoctoral and/or postdoctoral research training programs 
of the participating institutions.  Special attention should also be given to 
the recruitment and training of minority students.

o  Each CDCNR should provide outreach that makes the public aware of the 
importance and implications of the CDCNR research for addressing basic 
neuroscience issues and their relationship to mental illness and mental health.

Research Topics

Silvio O. Conte Centers to Develop Collaborative Neuroscience Research are 
intended to support collaborative research in basic and/or clinical neuroscience 
relevant to the mission of NIMH.  Since appropriate research covers the breadth 
of neuroscience represented in the Division of Neuroscience and Basic Behavioral 
Science, prospective applicants are referred to the website for that Division.  
The URL is http://www.nimh.nih.gov/diva/index.htm.  
Please note that although program staff are listed on the website, program 
inquires about CDCNRs should be directed to the program staff listed under 
INQUIRIES.

MECHANISM OF SUPPORT

This PA will use the National Institutes of Health (NIH) exploratory center 
award mechanism (P20), which provides support for developing collaborative teams 
of high caliber investigators using diverse scientific approaches to the 
investigation of a highly focused research problem.  As an applicant, you will 
be solely responsible for planning, directing, and executing the proposed Center.

Applicants for CDCNRs may request support for only one period of up to four 
years, direct costs requested may not exceed $500,000 in any one year.  In an 
effort to allow for multi-institutional involvement, for the purposes of this 
program announcement, Facility and Administrative (F&A) costs for consortium 
activity at collaborating institutions will not be counted against the $500,000 
limit to direct costs (but these costs should be delineated as instructed in 
form PHS 398 [rev. 5/2001]).

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

Foreign institutions are not eligible for exploratory center grants.
 
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.  Racial/ethnic minority individuals, women, and persons 
with disabilities are encouraged to apply as CDCNR Directors and heads of 
projects or cores.

SPECIAL REQUIREMENTS

Sharing Data, Biological Material Resources, and Tools

Public Health Service (PHS) policy requires that investigators make unique 
research resources readily available to qualified individuals within the 
scientific community for research purposes following publication (the current 
NIH Grants Policy statement is dated March 1, 2001 and may be found at 
http://grants.nih.gov/grants/policy/nihgps_2001/).  
The intent of this policy, however, is not to discourage, impede, or prohibit 
the organization that develops unique research resources or intellectual 
property from commercializing the products.

The NIMH requires applicants to develop detailed plans for the dissemination of 
data and materials generated through the proposed Center through commercial or 
non-commercial means.  (It should be noted that even with non-commercial 
paradigms, the cost of developing such resources for distribution and the cost 
of distributing them may be charged to those requesting them.)

The plan should be described in the Operational Plan for the CDCNR, and the 
adequacy of the plan will be considered by NIMH staff in determining whether the 
grant should be awarded.  The initial review group will comment on the proposed 
plan for sharing and the adequacy of the plan is among the review criteria.  The 
sharing plan as approved, after negotiation with the applicant when necessary, 
will be a condition of the award.

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 related to basic neuroscience research to:

Laurie S. Nadler, Ph.D.
Division of Neuroscience and Basic Behavioral Science
National Institute of Mental Health
6001 Executive Boulevard, Room 7194, MSC 9645
Bethesda, MD  20892-9645
Rockville, MD  20852 (for express/courier service)
Telephone:  (301) 443-3563
FAX:  (301) 443-1731
Email:  lnadler@mail.nih.gov

o  Direct questions related to translational research integrating basic and 
clinical approaches to:

Steven J. Zalcman, M.D.
Division of Neuroscience and Basic Behavioral Science
National Institute of Mental Health
6001 Executive Boulevard, Room 7177, MSC 9639
Bethesda, MD  20892-9639
Rockville, MD  20852 (for express/courier service)
Telephone:  (301) 443-1692
FAX:  (301) 402-4740
Email:  szalcman@mail.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 (for express/courier service)
Telephone:  (301) 443-1340
FAX:  (301) 443-4720
Email:  mkozak@mail.nih.gov

Direct inquiries regarding fiscal matters to:

Ms. Carol J. Robinson
Grants Management Branch
National Institute of Mental Health
6001 Executive Boulevard, Room 6118, MSC 9605
Bethesda, MD 20892-9605
Rockville, MD  20852 (for express/courier service)
Telephone:  (301) 443-3858
FAX:  (301) 443-6885
Email:  crobinso@mail.nih.gov

LETTER OF INTENT

Prospective applicants are strongly encouraged to contact the program staff 
member listed under Inquiries in this program announcement as early as possible 
in the conceptualization of a possible application for a CDCNR.

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, telephone number of the Principal Investigator
o  Identities 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 to plan the 
review.

The letter of intent is to be sent by the date listed at the beginning of this 
document.  For basic neuroscience Centers, the letter of intent should be sent 
to:

Laurie S. Nadler, Ph.D.
Division of Neuroscience and Basic Behavioral Science
National Institute of Mental Health
6001 Executive Boulevard, Room 7194, MSC 9645
Bethesda, MD  20892-9645
Rockville, MD  20852 (for express/courier service)
Telephone:  (301) 443-3563
FAX:  (301) 443-1731
Email:  lnadler@mail.nih.gov

For translational research Centers integrating basic and clinical approaches, 
the letter of intent should be sent to:

Steven J. Zalcman, M.D.
Division of Neuroscience and Basic Behavioral Science
National Institute of Mental Health
6001 Executive Boulevard, Room 7177, MSC 9639
Bethesda, MD  20892-9639
Rockville, MD  20852 (for express/courier service)
Telephone:  (301) 443-1692
FAX:  (301) 402-4740
Email:  szalcman@mail.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 Format Guidelines

The primary purpose of this initiative is to support early stage development of 
collaborative teams which conduct multidisciplinary, integrative research on a 
single, highly focused research question (or a small number of closely related 
questions).  The application must describe the hypothesis to be tested, the 
goals of, and the approaches used in the Center.

The application should utilize PHS Form 398 and include the following components 
in the specified order:

Information for the Entire Center:

o  Face Page (noting this program announcement in Item 2) - Information provided 
here should pertain to the entire Center.

o  Description, Performance Sites, and Key Personnel (Form Page 2) - Information 
provided here should pertain to the entire Center.

o  Table of Contents (Form Page 3)

o  Budget Information (Form Pages 4 and 5) - Categorical figures should be 
provided to reflect the budget of the overall Center.  Since detailed budget 
justification will be provided separately for each project and core (as 
described below), only items for which a narrative justification is not provided 
elsewhere should be described here.

o  Biographical Sketches of Key Personnel - Biographical sketches should be 
provided for key personnel of the entire Center, and should be arranged 
alphabetically based on the individual"s surname.

o  Resources - Resources described here should be restricted to those not 
described separately for the individual projects and cores (as described below).

o  General Description of the Overall Center (not to exceed 7 pages, for revised 
and resubmitted applications, a one-page introduction is allowed to describe 
changes from the previously submitted version):

Provide an overview of the entire proposed Center describing the central 
hypothesis to be tested and goals to be achieved.  Describe how the overall 
Center will achieve its major scientific objectives, and how the Center will 
facilitate the development of collaborative research efforts.  Explain the 
proposed contribution of each of the projects and cores in achieving the 
objectives of the Center and how these components, especially the projects, 
relate to each other scientifically.  Interaction and collaboration across 
laboratories and projects must be described in detail.

o  Preliminary Findings (not to exceed 5 pages, for revised and resubmitted 
applications, a one-page introduction is allowed to describe changes from the 
previously submitted version)

Present preliminary results and evidence of competence in the areas of research 
proposed.  Also describe briefly the history of interactions of investigators 
whose collaborative efforts will be developed in the CDCNR.

o  Operational Plan for Overall Center (not to exceed 11 pages, for revised and 
resubmitted applications, an extra one-page introduction is allowed to describe 
changes from the previously submitted version)

The working administrative and logistical arrangements, as well as the resource 
support necessary to implement the research, should be fully elaborated in the 
application.  When multiple institutional sites are involved, a detailed 
description of the cooperative administrative arrangements should be included 
(documentation of these arrangements should be included in the "Letters of 
Support" section).

Also included in this section is the manner in which an external advisory board 
will advise the Center.  Prospective board members should not be chosen or 
contacted prior to a funding decision and therefore should not be named.

The plan for sharing data, biological material resources, and tools generated by 
the Center should also be included in this section.

o  Research Career Development and Outreach Plans (not to exceed 2 pages)

A description of the manner in which Center activities will provide 
opportunities for young investigators and how the proposed CDCNR relates to 
existing training programs of participating institutions should be given.  Also, 
plans for disseminating information to the public regarding the activities of 
the Center should be given.

Information for Each Project or Core:

For each project or core, the information should be arranged in the following 
order:

o  Cover Page - Information provided here should pertain specifically to the 
project or core.

o  Description, Performance Sites, and Key Personnel (Form Page 2) - Information 
provided here should pertain specifically to the project or core.

o  Budget Information (Form Pages 4 and 5) - Detailed budget information should 
be provided for each project or core, with a narrative justification given for 
all budget items.

o  Resources - Resources should be described for each project or core.

o  Research Plan for Individual Projects (Not to exceed 10 pages for any one 
project, for revised and resubmitted applications, an additional one-page 
introduction for each project is allowed to describe changes from the previously 
submitted version.)

The research plan for each project should describe the specific aims, background 
and significance.  In these sections, the research question to be addressed and 
the hypothesis to be tested by the proposed research project should be highly 
focused and fully explained.  Full discussion is required on:  the status of 
current research efforts addressing the issue (both within the Center and 
elsewhere), the limitations of existing research strategies, why the particular 
research question lends itself to a multidisciplinary, integrative, 
collaborative research approach, and, how the proposed project is to be linked 
and integrated with other proposed Center projects and laboratories.

The research plan for each project should also include a description of the 
research design and methods.  This will not require extensive details for 
individual experiments.  Description of the experimental design should outline 
the strategies proposed to accomplish the specific aims of the project and 
should include a discussion of the innovative aspects of the approach.  
Experimental procedures need not be spelled out in great detail if those 
procedures have already been extensively published and widely accepted by the 
scientific community, the methods to be used should be cited and referenced.  
Any new methodology, however, and its advantage over existing methodologies, 
should be more fully described.  Further, the feasibility of the proposed 
experiments, potential pitfalls, alternative approaches, if necessary, and 
relevance to Center goals should be discussed, as should be plans for data 
sharing.

o  Descriptions of Individual Cores (Not to exceed 8 pages for any one core, for 
revised and resubmitted applications, an extra one-page introduction is allowed 
to describe changes from the previously submitted version.)

Describe how the core will contribute to the overall goals of the Center as well 
as which projects will be supported by the core and the manner in which that 
support will be rendered by the core.  The description of each core should 
clearly indicate the facilities, resources, services, and professional skills 
that the facility will provide to the proposed Center.

o  Human Subjects - For each individual project and core involving human 
subjects describe the plans for protection of subjects from research risks, as 
well as plans for the inclusion of women, minorities and children, as described 
in the PHS 398 application instructions (Rev. 5/2001).

o  Vertebrate Animals - For each individual project and core involving 
vertebrate animals, provide a detailed description and justification for the use 
of animals as described in the PHS 398 application instructions (rev. 5/2001).

Other Information:

o  Literature Cited - This section should include and compile literature cited 
throughout the application.

o  Letters of Support from Institutions and Collaborators - Also included in 
this section should be assurances from Institutional Animal Care and Use 
Committees and/or Institutional Review Boards (though the latter are not 
required at peer review).

o  Checklist

o  Personal Data on Center Director

SENDING AN APPLICATION TO THE NIH:  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.

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 Noronha, Ph.D.
Division of Extramural Activities
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:  (303) 443-4720
Email:  jnoronha@mail.nih.gov

APPLICATION PROCESSING:  Applications must be received by the application 
receipt date listed in the heading of this PA.  If an application is received 
after that date it will be returned to the applicant without review.  The Center 
for Scientific Review (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 substantial revisions of applications already 
reviewed, but such applications must include an Introduction addressing the 
previous critique.

PEER REVIEW PROCESS

Upon receipt, applications will be reviewed by CSR for completeness and by the 
NIMH program staff to determine if they satisfy the objectives and requirements 
of a CDCNR as outlined in this program announcement (excluding scientific or 
technical merit).  Applications that do not meet these objectives and 
requirements will not be accepted and will be returned to the applicant.

Applications that are complete and responsive will be evaluated for scientific 
and technical merit by an appropriate scientific review group convened by the 
NIMH in accordance with the review criteria stated below.

As part of the initial merit review, all applications will:

o  Receive a written critique and priority score
o  Receive a second level review by the National Advisory Mental Health 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 
your 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 these criteria in assigning your 
application"s overall score, weighting them as appropriate for each application.

Criteria for scientific/technical review of CDCNR applications will include the 
following:

o  Intrinsic merit of the intellectual focus and research:  the overall quality, 
scientific merit, and innovation of the research to be done, the likelihood that 
the work will lead to fundamental advances within the field, to new discoveries, 
and/or to new technological developments, in addition, the research conducted 
must center around a highly focused and well-defined question.

o  Integration across projects and collaboration across laboratories:  the 
adequacy of the proposed Center to integrate across research projects including 
basic and clinical approaches (for applications that propose basic and clinical 
research) so that activities in each project inform and advance the others, the 
adequacy of the proposed collaborative activities to provide synergy to the 
proposed Center

o  Appropriateness of the CDCNR approach:  the need for and suitability of the 
collaborative research approach, whether a collaborative approach will add 
significantly to what could be done through other modes of research support, in 
this respect, the integration and synergy of the projects are of utmost 
importance and should be explicitly described.

o  Research competence:  the capability and scientific credentials of the Center 
Director and constituent project directors and participating scientists, who are 
expected to be regarded by their peers as well established in their respective 
fields

o  Center Director credentials:  ability of the Center Director to organize, 
administer, and direct the Center and, in addition, head at least one of the 
proposed projects, be it basic or clinical in nature, a Center Director will 
devote a minimum of 20 percent of his/her time to the Center.  The Director must, 
by necessity, be the scientific leader of the Center.

o  Institutional commitment:  the nature and level of resource commitments from 
the home institution and from other participant institutions, and plans for 
interactions with the rest of the participating institutions

o  Appropriateness of management plans and arrangements:  the feasibility and 
adequacy of the organizational and administrative plans, the appropriateness of 
the budget, and the mechanisms to evaluate the Center"s progress

o  Appropriateness of the proposed plan to share data, biological material 
resources, and tools (the plan may use commercial and/or non-commercial 
approaches)

o  Quality and appropriateness of the outreach and research career development 
components of the Center"s activities:  the adequacy of approaches used to 
disseminate information regarding the Center"s activities as they relate to 
public understanding of science and mental health and illness, the likely 
effectiveness of approaches to attract and involve young investigators and 
students who show potential for significant future contributions and independent 
research careers in the work of the Center

ADDITIONAL REVIEW CRITERIA:  In addition to the above criteria, your application 
will also be reviewed with respect to the following:

o  PROTECTIONS:  The adequacy of the proposed protection for humans, animals, or 
the environment, to the extent they may be adversely affected by the project 
proposed in the application

o  INCLUSION:  The adequacy of plans to include subjects from both genders, all 
racial and ethnic groups (and subgroups), and children as appropriate for the 
scientific goals of the research, plans for the recruitment and retention of 
subjects will also be evaluated.

o  DATA SHARING:  The adequacy of the proposed plan to share data

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

The initial review group will make an overall recommendation for approval (and 
assign a priority score) or disapproval of the entire Center application.  Under 
some circumstances, it may be appropriate for the initial review group to 
recommend disapproval of one or more project(s).

RECEIPT AND REVIEW SCHEDULE

To ensure a uniform review quality, all applications will be reviewed by a 
single review group, which will meet once per year.  In accordance with this 
objective, there will be one receipt date each year.  Applications received 
after this date will be returned to the applicant without review.

Letter of Intent Receipt Date:  August 1 2002, July 1 annually thereafter
Application Receipt Date:       October 21, 2002, October 20 annually thereafter
Administrative Review:          November
Scientific Review:              April/May
Advisory Council Review:        May/June
Earliest Starting Date:         July

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

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 
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 is 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.

NIH GRANTS POLICY STATEMENT:  The NIH Grants Policy Statement (NIHGPS) has been 
revised and reissued.  The provisions of the revised NIHGPS are effective for 
all funded NIH grants and cooperative agreements with budget periods beginning 
on or after March 1, 2001.  The revised NIHGPS is available at 
http://grants.nih.gov/grants/policy/nihgps_2001.

HUMAN EMBRYONIC STEM CELLS (hESC):  Criteria for federal funding of research on 
hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm 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.

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 No. 93.242.  Awards are made under authorization of sections 
301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and 
administered under NIH grants policies described at 
http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 
52 and 45 CFR Parts 74 and 92.  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 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


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


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