This notice has expired. Check the NIH Guide for active opportunities and notices.

EXPIRED


MENTAL HEALTH RESEARCH EDUCATION GRANTS

RELEASE DATE:  March 21, 2002

PA NUMBER:  PAR-02-087 (This PAR has been reissued, see PAR-05-153)

EXPIRATION DATE:  November 2, 2004, unless reissued.

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

LETTER OF INTENT RECEIPT DATE:  1 month prior to application receipt date
APPLICATION RECEIPT DATE:       October 1 each year for new applications, November 
1 each year for revised applications

THIS PA CONTAINS THE FOLLOWING INFORMATION

o  Purpose of the PA
o  Education Program Objectives
o  Mechanism(s) of Support
o  Eligible Institutions
o  Individuals Eligible to Become Principal Investigators
o  Special Requirements
o  Where to Send Inquiries
o  Submitting an Application
o  Peer Review Process
o  Review Criteria
o  Award Criteria
o  Required Federal Citations

PURPOSE OF THIS PA

This PA replaces PAR-97-095.

Provisions of this program announcement (PA) are applicable to new and 
competing renewal applications received on or after October 2002.

The National Institute of Mental Health (NIMH) Research Education Grant is a 
flexible and specialized mechanism designed to foster the development of 
mental health researchers through creative and innovative educational 
programs.  Of particular interest are educational experiences that will 
attract, train and further the career development of physician scientists, 
underrepresented minority scientists, and pediatric and geriatric researchers 
interested in pursuing research relevant to the mission of the NIMH.  In 
addition, programs that focus on preparing researchers in cross-disciplinary 
integration and/or translational research of social, basic behavioral, 
neuroscience, clinical and services research, and programs that will prepare 
investigators to address issues related to health disparities are encouraged.

Grant applications will be accepted in response to this PA from organizations 
that propose providing creative and innovative educational research 
experiences at all levels of professional career development (i.e., 
independent scientist, postdoctoral fellows, clinical residents, medical 
students and/or graduate students).  Under special circumstances NIMH will 
consider accepting applications designed to provide educational experiences 
that will motivate college and high school students to pursue mental health 
research careers.  Applicants considering these types of educational 
initiatives are encouraged to contact appropriate program staff listed under 
INQUIRIES prior to preparing an application.

EDUCATION PROGRAM OBJECTIVES

The activities supported by Mental Health Research Education Grants can 
involve educational/research experiences of short duration (e.g., 3 months 
with or without provisions for further ongoing contacts) or longer-term 
programs.  Formats for the programs may vary to include a series of short 
courses, seminars, workshops, or structured short-term or long-term research 
experiences, or, curriculum development, design, implementation, and 
evaluation.  Individuals supported by NIH training and career development 
mechanisms (K, T, or F Grants) may receive, and indeed are encouraged to 
receive, educational experiences supported by these mechanisms, as 
participants, but may not receive salary or stipend supplementation from the 
R25 program.

Mental Health Research Education Grants support only educational activities 
focused on basic, clinical, services and other applied mental health 
research, and may not be used for support of non-research clinical training.  
This mechanism may be used, however, to provide Mental Health Research 
educational experiences to those in clinical training or in a clinical 
research track within a clinical training program.

Potential applicants are strongly encouraged to contact appropriate NIMH 
staff (listed under INQUIRIES) to determine whether their application meets 
the program priorities of the NIMH prior to preparing an application.  This 
action is of utmost importance since applications that do not adequately 
address the educational needs identified under the section PURPOSE OF THIS PA 
will not be accepted by NIMH for review.

The NIMH expects applicant institutions to propose their own creative and 
innovative programs.  Examples of potential programs include, but are not 
limited to, the following:

1.  Educational/research experiences that enhance the participation and 
commitment of clinical researchers to careers in mental health research.  
Examples include educational programs that:

o  Provide mentored clinical research opportunities designed specifically for 
students enrolled in medical or graduate school degree programs and clinical 
residents.

o  Encourage M.D., M.D./Ph.D. students and/or postdoctoral fellows/residents 
to embark on research projects directly applicable to clinical practice.

o  Develop or enhance the research curricula and mentoring provided during 
residency training and/or create research training tracks.

o  Improve the quality of mentoring in mental health relevant research areas, 
particularly improvements in the retention and advancement of physician/ 
scientists as well as pediatric and geriatric researchers.

o  Provide educational experiences relevant to the conduct of mental health 
related clinical research studies.

o  Provide clinical research career enhancement opportunities for new 
scientists (M.D., Ph.D., or M.D./Ph.D.) at the intersection of basic, 
clinical, and interventions and services research.

2.  Cross-disciplinary educational/research experiences that prepare mental 
health researchers to conceptualize and conduct research that integrates more 
than one discipline (e.g., integrate social, behavioral, neuroscience, 
genetic, epidemiological, clinical, computational, technical and economic 
perspectives) or to translate approaches from the basic behavioral, social 
and/or neurosciences to clinical and services research issues.  Examples of 
cross-disciplinary and translational approaches include:
 
o  The use of neuroscience (e.g., brain circuitry and development, neuronal 
and synaptic plasticity, signals and signal transduction) and/or 
neuroendocrine approaches in the study of emotion, cognition and 
psychopathology.

o  The use of neuroimaging techniques, epidemiological approaches, genetic 
methods, and/or economic analyses in the study of mental disorders, risk, 
intervention, and/or services research.

o  Integrating epidemiological methods and analysis, advanced research 
methods and statistics in the study of risk/protective factors, etiology, 
interventions, and/or services.

o  Treatment responses beyond symptom improvement, such as functioning, 
impairment, and disability.

o  Interdisciplinary approaches to the development, adaptation and 
modification of treatment, prevention and rehabilitative interventions to 
increase their public health relevance and facilitate the rapid advancement 
of research from bench to clinical and services settings.

o  Integrating the mechanisms and processes that account for mental health 
disparities and developing and adapting interventions to address these 
disparities.

o  The formal consideration of bioethical issues (e.g., harm to individuals 
and confidentiality) in mental health research.  Some areas in which such 
consideration might be of particular importance are research with vulnerable 
populations, pharmacological challenge studies, genetics, epidemiology and 
clinical trials.

3.  Educational/research experiences that enhance the participation and 
commitment of underrepresented minorities and/or women to careers in mental 
health research.  Examples include educational programs to:

o  Attract, facilitate, retain and advance underrepresented minorities and/or 
women during the transition from training to more independent research 
careers and during the transition from junior to mid-level and senior 
research careers.

o  Improve the quality of mentoring in mental health relevant research areas 
for underrepresented minorities and/or women.

o  Provide summer research experiences and mentoring for underrepresented 
minority and/or female junior faculty.

MECHANISM OF SUPPORT

This PA will use the NIH Education Research Program grant (R25) award 
mechanism.  As an applicant, you will be solely responsible for planning, 
directing, and executing the proposed project.  Mental Health Research 
Education Grants may be awarded for one to five years.  The length of the 
grant period should be consistent with the objectives of the program.  In 
some cases, these awards will be made to develop new educational approaches 
for which the institution will subsequently assume support.  In other cases, 
the awards will strengthen activities that the NIMH will support over periods 
of one to five years.  Funds requested under this mechanism are limited to 
$250,000 per year in direct costs.  Requests for lower direct costs are 
strongly encouraged.  The NIMH anticipates making three to five R25 awards 
each year, depending on their excellence and relevance as judged by peer 
review and program staff.

ELIGIBLE INSTITUTIONS

You may submit an application 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

It is anticipated that in most cases these programs will complement other 
ongoing research training occurring at the applicant institution and that a 
substantial number of program faculty would have active research projects in 
which students can gain relevant experiences.  If multiple sites are to be 
used, the applicant institution must be one of those sites and a strong 
justification must be included.  Institutions with existing Institutional 
National Research Training Grants (T32) or other federally funded training 
programs may apply for an education research grant provided the proposed 
educational experiences are distinct from those training programs receiving 
NIH support.

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

Any individual with the skills, knowledge, and resources necessary to carry 
out the proposed research education program 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.

Since this is an educational mechanism, and not a training mechanism, non-US 
citizens may participate in this program.  However, requests for the 
appointment and participation of non-US personnel into this education grant 
should be made with the understanding that this mechanism is not to be used 
to circumvent or supplement standard NRSA training mechanisms, and unless 
strongly justified on the basis of high NIMH Program relevance, should be 
used primarily for the education of US citizens.

Applicants are strongly encouraged to contact Program staff to discuss the 
appropriate utilization of this mechanism with respect to the eligibility, 
appointment, and participation of non-US citizens.

SPECIAL REQUIREMENTS

ALLOWABLE COSTS

Allowable costs must be consistent with NIH policy and be reasonable, 
allocable, and well documented and justified for the research education 
program.  Grant funds may not be used to supplant funds otherwise available 
at the applicant institution.

Personnel Costs - individuals participating in the design and implementation 
of the research education program may request salary and fringe benefits 
appropriate for the percent of time devoted to the program.  Normally, all 
personnel costs (including administrative and clerical costs) associated with 
directing, coordinating, and administering the program are not expected to 
exceed 25% of the total direct cost.  Salaries requested may not exceed the 
levels commensurate with the institution"s policy for similar positions and 
may not exceed the congressionally mandated cap.  (If mentoring interactions 
and other activities with students is considered a regular part of an 
individual"s academic duties, then mentoring and other interactions with 
students are non-reimbursable from grant funds).

Limited administrative and clerical salary costs associated distinctly with 
the program that are not normally provided by the applicant organization may 
be direct charges to the grant only when specifically identified and 
justified.  Consultation costs, equipment, supplies, necessary travel 
(including foreign travel for uniquely qualified foreign faculty), and other 
program related expenses must be justified as specifically required by the 
program proposed and not duplicate items generally available for educational 
programs at the host institution.

Participant Support - participants in the education program may receive 
subsistence allowance, which includes partial costs of meals and lodging 
(unless furnished as part of the fee for registration).  They may also 
receive partial tuition, other education-related, and travel expenses, 
including foreign travel, if strongly justified.  Note that effort and how 
the dollar amount is determined must be included when describing the 
participant support and also be listed in the budget justification area.

Individuals supported by NIH training and career development mechanisms (K, T 
or F Grants) may not receive stipend or salary support from the Mental Health 
Research Education Grant.  However, if funds are not available from other 
sources, limited support to defray participation costs (e.g., travel, meals, 
lodging) may be provided.

Partial costs for off-site rental space will be considered if it is short 
term and shown to be necessary for the implementation and execution of the 
educational program (seminar, workshop, etc.).  Matching funds from applicant 
institutions or other organizations for such off-site costs are strongly 
encouraged.

Facilities and Administrative (F&A) Costs, formerly known as "indirect 
costs," may be allowed for the applicant organization and any approved 
subcontract based on 8% of total direct costs exclusive of tuition and fees 
and expenditures for equipment.

Normally, funds will not be provided for fringe benefits or health insurance 
for participants involved in this education program.

Note that all costs associated with consortium/contractual arrangements, both 
direct and F&A costs, are considered direct costs and are included in the 
$250,000 direct costs ceiling limitation for this program.

Normally, funds for the research education evaluation plan are not expected 
to exceed 5% of the total direct cost.

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 two 
areas:  scientific/research and financial or grants management issues:

o  Direct your questions about scientific/research issues to:

DIVISION OF NEUROSCIENCE AND BASIC BEHAVIORAL SCIENCE
Debra Wynne, M.S.W.
6001 Executive Boulevard, Room 7195
Bethesda, MD  20892-9645 
Telephone:  (301) 443-3563
FAX:  (301) 443-1731
Email:  [email protected]

DIVISION OF MENTAL DISORDERS, BEHAVIORAL RESEARCH AND AIDS
Fred Altman, Ph.D.
6001 Executive Boulevard, Room 6220
Bethesda, MD  20892-9621
Telephone:  (301) 443-8962
FAX:  (301) 443-6000
Email:  [email protected]

DIVISION OF SERVICES AND INTERVENTION RESEARCH
Enid Light, Ph.D.
6001 Executive Boulevard, Room 7160
Bethesda, MD  20892-9635 
Telephone:  (301) 443-1185
FAX:  (301) 594-6784
Email:  [email protected]

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

Diana S. Trunnell
Grants Management Branch
6001 Executive Boulevard, Room 6115
Bethesda, MD  20892-9605
Telephone:  (301) 443-2805
FAX:  (301) 443-6885
Email:  [email protected]

LETTER OF INTENT

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

o  Descriptive title of the proposed education program
o  Name, address, and telephone number of the Principal Investigator
o  Names of other key personnel (including recruiting contact if different 
from PI
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 be sent at least one month in advance of the 
application receipt date.  The letter of intent should be sent to:

Walter Goldschmidts, Ph.D.
Division Of Neuroscience and Basic Behavioral Science 
National Institute of Mental Health
6001 Executive Boulevard, Room 7200, MSC 9645
Bethesda, MD  20892-9645 
Telephone:  (301) 443-3563
FAX:  (301) 443-1731
Email:  [email protected]

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) 710-0267, 
Email: [email protected].

APPLICATION RECEIPT DATE:  Applications submitted in response to this program 
announcement will be accepted on October 1/November 1 of each year.

Applicants must use the forms for regular research grants and follow the 
specific instructions in the PHS 398 application kit, with the exceptions 
listed below.  Note that the page limitations given in the instructions apply 
to this mechanism.  A complete detailed budget (Form Pages 4 & 5) with 
narrative justifications is required.  Applications that do not conform to 
the specific instructions detailed below will be returned without review.

Specific Instructions for Applications in Response to this Program 
Announcement:

1.  Application face page:  item number two on this page must include the 
program announcement number and the title, Mental Health Research Education 
Grants (R25).

2.  Description, Performance Sites, and Key Personnel (Form Page 2):  under 
Performance Sites include "Consortium/Contractual Arrangements," with a 
description of plans for collaborating with other institutions for purposes 
of exchange and sharing of resources, including faculty, equipment, and 
facilities. If multiple sites are to be used, the applicant institution must 
be one of those sites and for other sites a strong justification must be 
included.

3.  Resources (Resources Format Page):  describe the educational environment, 
include a description of the facilities, laboratories, participating 
departments, computer services, and any other resources to be used in the 
conduct of the proposed education program.  Use continuation pages, as 
necessary.

4.  Research Plan: part "c" of this section should be retitled "Preliminary 
Data and Activities" and included if applicable.  This section should contain 
information on steps that have led to the proposed Research Education 
program.  A section entitled "Progress Report" is required for competing 
continuation and supplemental applications.

5.  Research Plan: part "d" of this section should be retitled " Research 
Education Program Plan" and should contain material organized under the 
following subheadings, as `appropriate to the specific program:

a) Program Direction - describe arrangements for administration of the 
program, provide evidence that the Program Director is actively engaged in 
research and/or teaching in an area related to mental health, and can 
organize and administer the education program, as well as evidence of 
institutional and community commitment and support for the proposed program.

b) Program Faculty/Staff - describe the characteristics and responsibilities 
of the faculty, provide evidence that participating faculty and preceptors 
are actively engaged in research or other scholarly activities related to 
mental health.

c) Proposed Research Education Program - provide programmatic detail on the 
special activities proposed (e.g., courses, curricula), including a 
description of plans to provide education to participants regarding the 
responsible conduct of research.

d) Program Participants - provide detail about the proposed participants, 
include a description of plans for recruiting as participants individuals 
from underrepresented racial/ethnic groups, women and persons with 
disabilities.  Competing continuation applications must include a detailed 
account of experiences in recruiting and retaining individuals from 
underrepresented groups during the previous award period.

e) Research Education Evaluation Plan - include evaluation plans for 
determining success of the program in achieving its goals and objectives.  
Please note that applications that do not have an adequate evaluation plan 
will be considered non-responsive to this program announcement.  The 
inclusion of evaluation instruments is encouraged.

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:  [email protected]

APPLICATION PROCESSING:  Applications must be received by or mailed before 
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

Applications submitted in response to this PA will be assigned on the basis 
of established PHS referral guidelines.  An appropriate scientific review 
group convened by the NIMH 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 National Advisory Mental Health 
Council

REVIEW CRITERIA

Grant applications to the Mental Health Research Education Program should be 
characterized by innovation, scholarship, and responsiveness to the special 
and/or changing needs of mental health research.  In the written comments, 
reviewers will be asked to discuss the following aspects of your application 
in order to judge the likelihood that the proposed research will have a 
substantial impact on the pursuit of these goals:

o  Significance
o  Approach
o  Innovation
o  Investigator
o  Environment

(1) SIGNIFICANCE:  Does the proposed research education program address the 
objectives stated in this program announcement and the overall mission of the 
NIMH?

(2) APPROACH:  Is the proposed specialized curriculum appropriate and 
adequate to achieve the research education goals outlined.  Are the course 
requirements and sequence, and timetable for completing the planned 
activities also appropriate.  Is there an adequate plan for evaluating the 
effectiveness of the program in achieving its objectives?  For competing 
continuation applications, has the program been adequately evaluated and has 
the level of success been satisfactory?  Is the need for further R25 support 
clear?

(3) INNOVATION:  Does the curriculum include original and unique approaches 
or methods for addressing the needs put forth in the goals and objectives?  
Are plans to challenge existing paradigms or develop new approaches or 
techniques described?

(4) INVESTIGATOR:  Does the program leadership demonstrate a record of 
achievements and are their qualifications appropriate to meeting the proposed 
goals and implementing the stated plan?

(5) ENVIRONMENT:  Is the scientific/education environment described, 
indicating the unique features and probability of success of the program?  Is 
institutional commitment to the proposed program documented?  If multiple 
sites are to be used, is this adequately justified in terms of the 
educational experiences provided?  Are plans provided for the coordination 
and communication between multiple sites?

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

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

INCLUSION:  The adequacy of plans to include subjects from both genders, all 
racial and ethnic groups (and subgroups), and children as appropriate for the 
scientific goals of the research.  Plans for the recruitment and retention of 
subjects will also be evaluated. (See Inclusion Criteria included in the 
section on Federal Citations, below)

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

BUDGET:  Are justifications provided for each budgeted item and for each year 
of support that is requested?  If more than 25% in total direct cost is 
requested for administrative and clerical personnel, are appropriate 
justifications provided?  If more than 5% in total direct cost is requested 
for the Research Education Evaluation Plan, is an appropriate justification 
provided?

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date:    One month prior to application receipt date
Application Receipt Date:         October 1/November 1
Peer Review Date:                 February/March
Council Review:                   May
Earliest Anticipated Start Date:  August

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

MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD:  Research components 
involving Phase I and II clinical trials must include provisions for 
assessment of patient eligibility and status, rigorous data management, 
quality assurance, and auditing procedures.  In addition, it is NIH policy 
that all clinical trials require data and safety monitoring, with the method 
and degree of monitoring being commensurate with the risks (NIH Policy for 
Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 
1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH:  It is the policy of 
the NIH that women and members of minority groups and their sub-populations 
must be included in all NIH-supported clinical research projects unless a 
clear and compelling justification is provided indicating that inclusion is 
inappropriate with respect to the health of the subjects or the purpose of 
the research.  This policy results from the NIH Revitalization Act of 1993 
(Section 492B of Public Law 103-43).

All investigators proposing clinical research should read the AMENDMENT "NIH 
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical 
Research - Amended, October, 2001," published in the NIH Guide for Grants and 
Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-
files/NOT-OD-02-001.html), a complete copy of the updated Guidelines are 
available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm
.  The amended policy incorporates: the use of an NIH definition of clinical 
research, updated racial and ethnic categories in compliance with the new OMB 
standards, clarification of language governing NIH-defined Phase III clinical 
trials consistent with the new PHS Form 398, and updated roles and 
responsibilities of NIH staff and the extramural community.  The policy 
continues to require for all NIH-defined Phase III clinical trials that: a) 
all applications or proposals and/or protocols must provide a description of 
plans to conduct analyses, as appropriate, to address differences by 
sex/gender and/or racial/ethnic groups, including subgroups if applicable, 
and b) investigators must report annual accrual and progress in conducting 
analyses, as appropriate, by sex/gender and/or racial/ethnic group 
differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS:  
The NIH maintains a policy that children (i.e., individuals under the age of 
21) must be included in all human subjects research, conducted or supported 
by the NIH, unless there are scientific and ethical reasons not to include 
them.  This policy applies to all initial (Type 1) applications submitted for 
receipt dates after October 1, 1998.

All investigators proposing research involving human subjects should read the 
"NIH Policy and Guidelines" on the inclusion of children as participants in 
research involving human subjects that is available at 
http://grants.nih.gov/grants/funding/children/children.htm.

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS:  NIH 
policy requires education on the protection of human subject participants for 
all investigators submitting NIH proposals for research involving human 
subjects.  You will find this policy announcement in the NIH Guide for Grants 
and Contracts Announcement, dated June 5, 2000, at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

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 and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.  Awards are made under authorization of the Public 
Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public 
Law 99- 158, 42 USC 241 and 285) and administered under PHS grants policies 
and Federal Regulations 42 CFR 52 and 45 CFR Part 74.  Awards will be 
administered under NIH grants policies described at 
http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant and contract recipients to provide a 
smoke-free workplace and promote the nonuse 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
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