This Program Announcement expires on October 24, 2002, unless reissued.

SHORT-TERM COURSES IN HUMAN EMBRYONIC STEM CELL CULTURE TECHNIQUES

RELEASE DATE:  February 1, 2002

PA NUMBER:  PA-02-054 (This PA has been reissued, see PAR-05-133)

PARTICIPATING INSTITUTES AND CENTERS (ICs):

National Heart, Lung, and Blood Institute (NHLBI)
 (http://www.nhlbi.nih.gov)
National Cancer Institute (NCI)
 (http://www.nci.nih.gov)
National Center for Research Resources (NCRR)
 (http://www.ncrr.nih.gov)
National Institute of Allergy and Infectious Diseases (NIAID)
 (http://www.niaid.nih.gov)
National Institute of Child Health and Human Development (NICHD)
 (http://www.nichd.nih.gov)
National Institute of Dental and Craniofacial Research (NIDCR)
 (http://www.nidr.nih.gov)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
 (http://www.niddk.nih.gov)
National Institute of General Medical Sciences (NIGMS)
 (http://www.nigms.nih.gov)
National Institute of Mental Health (NIMH)
 (http://www.nimh.nih.gov/)
National Institute of Neurological Disorders and Stroke (NINDS)
 (http://www.ninds.nih.gov)
National Institute on Aging (NIA)
 (http://www.nia.nih.gov)
Center for Biologics Evaluation and Research, FDA (CBER/FDA)
 (http://www.fda.gov/cber)

APPLICATION RECEIPT DATES:  April 23, 2002 and October 23, 2002

THIS PA CONTAINS THE FOLLOWING INFORMATION

o Purpose of the PA
o Research Objectives
o Mechanism of Support
o Funds Available
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

The National Institutes of Health (NIH) invites applications for grants to 
develop, conduct, evaluate, and disseminate short-term courses on laboratory 
research techniques for human embryonic stem cell lines. The courses should 
include hands-on experience to improve the knowledge and skills of biomedical 
researchers to maintain, characterize, and utilize human embryonic stem cells 
in basic research studies and be made available to investigators in research 
areas of interest to all of the institutes and centers of the NIH.

RESEARCH OBJECTIVES AND SCOPE

Background

Recent scientific discoveries about the ability of human embryonic stem cells 
to proliferate in an undifferentiated state and to be directed to develop 
into a wide array of cell types present opportunities for research that aims 
to repair or replace cells and restore vital functions.  Advancing these 
discoveries will require a dissemination of technical knowledge and skills in 
cell culture techniques across a variety disciplines and disease research 
areas.  Because of the brief period of time these stem cells have been 
available to the researchers, there is a paucity of investigators who have 
experience with this research tool.  The growth and maintenance of human 
embryonic stem cells in an undifferentiated state represents a significant 
technical challenge.  Taken together, these issues underscore the need for 
educational courses focused on the cell culture techniques for human 
embryonic stem cells.

Research Objectives and Scope

The objective of this grant program is to support the development, 
implementation and evaluation of short-term courses on skills and techniques 
applied in human embryonic stem cell research.  The courses should improve 
the skills of biomedical researchers in the maintenance of human embryonic 
stem cells in culture and their application of this research tool in basic 
research studies.  The long-term objective is to increase the number of 
researchers who have both the knowledge and skills in the use of human 
embryonic stem cells in basic research.  Further, applicants are encouraged 
to propose innovative programs with new approaches for teaching and learning 
the maintenance and use of human embryonic stem cells.

There is a broad array of applications for the use of human embryonic stem 
cells that can benefit from the short course approach.  The following are 
examples of topic areas of emphasis for the courses to enhance research 
skills and knowledge. They are not all inclusive and applicants may propose 
other topic areas:

o Demonstration of proper growth conditions for cells including preparation 
of culture media, microseparation techniques for dissection and isolation of 
cells from embryoid bodies, preparation and use of feeder/support cells and 
growth factors

o Proper freeze-thaw cycling, repetition of the preparation of cell passages, 
and the cryopreservation, vitrification, storage, and shipment of cells

o Use of co-culture techniques to support maintenance of the undifferentiated 
cell state

o Use of cell separation procedures including fluorescence-activated cell 
sorting (FACS)

o Review of basic good laboratory practices for use of human biological 
materials including proper exposure precautions, safe methods of disposal, 
and record keeping

o Development of protocols that support the characterization of molecular, 
cellular, and genetic characteristics of embryonic stem cells including the 
use of monoclonal antibodies, polymerase chain reaction techniques, 
fluorescent in situ hybridization techniques and karyotype analysis 
(including staining technologies and application of confocal microscopy)

o Establishment of xenograft procedures for the use of animal models (e.g., 
immune-deficient mice) for in situ culturing and differentiation of stem 
cells and the pathological examination of tumor growth

o Application of standard research protocols for directed differentiation of 
embryonic stem cells to specific cell populations (e.g., insulin producing 
cells, cardiomyocyte, neuronal subtypes)

o Employment of standard detection methods for infectious organisms or 
other contaminants

o Introduction to microarray techniques for DNA and transcriptional profiling 

o Molecular biology applications to existing cell lines to create mutations 
yielding cell lines with overexpressed or repressed protein expression and/or 
the reporter gene constructs

o Application of single cell recording methods for measurement of electrical 
potential (e.g., cardiomyocyte and neuron recordings)

o Cross-training of techniques used in other applications of stem cell 
biology tools, training may also include the use of non-human embryonic stem 
cells and adult stem cells (e.g., hematopoietic stem cells, neurospheres, or 
other precursor/progenitor cells), but these should not be the dominant 
research tools used in the training exercises

All courses should be developed to meet the training needs of junior through 
senior biomedical researchers.  Each topic area of the application should be 
addressed in sufficient depth to show how it significantly improves the 
skills and knowledge of the trainee.  Given the complexity of many of the 
areas of emphasis listed above relative to the short duration of the courses, 
applicants are strongly encouraged to target the skills courses to 
researchers with current expertise clearly related to human embryonic stem 
cell culture.

In both developing and teaching the courses, applicants are encouraged to 
take an interdisciplinary approach and involve a wide array of perspectives 
of the biological sciences including genetics, reproductive biology, 
physiology, cell biology, oral biology, neurobiology, biochemistry, 
microbiology, immunology, and toxicology.  It is important that the teaching 
program involve scientists from a variety of relevant fields and to include 
those with recognized expertise in the field of embryonic stem cell biology.  
Courses should include information on stem cell regulations and ethical issues.
Applicants to this program will be required to disseminate their educational 
materials widely.  Applicants should describe what specific mechanisms they 
will employ for dissemination and should indicate what resources will be 
available for continuing education when trainees return to their home 
institutions.  In the case of internet-based materials used in the training, 
applicants are encouraged to submit plans on how these materials will be 
advertised and made available to the appropriate research communities and 
evaluated for effectiveness. 

Proposals for courses should indicate criteria for student selection, the 
number of students expected per class, and should include clear plans for 
evaluating the effectiveness of the course(s) in terms of attendees" 
perceptions of the material and conduct of the course.  Importantly, there 
must be plans in place to assess the longer-term impact, as measured by 
attendees" subsequent activities or responsibilities in their institutions in 
the areas of embryonic stem cell biology.  

Applicants should also address plans to include attendees from groups 
currently underrepresented in the field of embryonic stem cell biology.  

MECHANISM OF SUPPORT 

This PA will use the NIH Continuing Education Training Grant (T15) award that 
funds institutions to establish or expand programs of continuing professional 
education.  As an applicant, you will be solely responsible for planning, 
directing, and executing the proposed project.   Using this PA, human 
embryonic stem cell research training courses may be of any duration up to 
three months as long as they are consistent with the goals of the proposed 
program.  For organizations wanting to teach human embryonic stem cell 
research training courses, such courses should be offered at least once a 
year.  Courses can be developed that have Internet, CD-ROM, DVD, and/or 
videotape components.

Although not considered for funding by this PAS, alternative mechanisms to 
support training experiences for human embryonic stem cell research include 
National Research Service Awards for Senior Fellows (F33), Education Project 
Grants (R25), Conference Grants (R13), National Research Short-Term Training 
Award (T35), existing Institutional Training Grants (T32), and courses 
developed using the Fast-Track Small Business Innovation Research (SBIR) and 
Small Business Technology Transfer (STTR) Grant mechanisms. 

This PA uses just-in-time concepts.  This mechanism (T15) uses the non-
modular budgeting format.

Applicants may request up to three years of support.  Allowable costs include 
personnel, rental of laboratory facilities and equipment for the period of 
the course offering, purchase of laboratory supplies required for cell 
culture and supporting experiments, travel and per diem for faculty, and 
other costs such as printing, telephone, audio-visuals, postage, recruitment 
materials, and computer software.  The purchase of equipment is not an 
allowable cost.  In addition, travel and per diem funds for trainees 
attending courses developed by applicants are appropriate when necessary.  
However, it is expected that courses will be partially funded through 
registration fees paid for by the trainees and their home institutions.  
Trainees may be recruited locally (at the grantee institution), regionally, 
or nationally.  The facilities and administration rate for T15 awards is 
eight percent.  

FUNDS AVAILABLE

The twelve sponsoring Institutes and Centers have committed approximately 
$1,000,000 for total costs for the first year of support in FY 2002.  Award 
of grants is contingent upon the availability of such funds for this purpose.  
It is anticipated that four to five grants may be awarded under this program 
in FY 2002. The specific number to be funded will depend on the merit and 
scope of the application received.

Direct costs of the awards made under the T15 mechanism are limited to 
$150,000 for each of the planned years of the planned three years of support.  
The facilities and administration rate for T15 awards is eight percent.  
Additional solicitations may be available in FY 2003 pending availability 
of funds.  

ELIGIBLE INSTITUTIONS

You may submit an application is your institution has any of the 
following characteristics:

o For-profit or non-profit
o Public or private institutions, such as universities, colleges, 
hospitals, laboratories
o Units of state and local governments
o Eligible agencies of the Federal government
o Domestic or foreign
	
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.  

SPECIAL REQUIREMENTS 

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.

Applicants should also be aware of the exclusion of certain procedures using 
human embryonic stem cells.  These prohibitions are described in 
http://grants.nih.gov/grants/stem_cell_faqs_topic.htm#prohibitions.

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, training, and financial or grants 
management issues:

o Direct your questions to:

John W. Thomas, Ph.D.
Division of Blood Diseases and Resources
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 10154, MSC 7950
Bethesda, MD  20892-7950
Telephone:  (301) 435-0050
FAX:  (301) 451-5453
Email:  ThomasJ@nhlbi.nih.gov

Dr. John Sogn
Deputy Director, Division of Cancer Biology
National Cancer Institute
Executive Plaza North, Room 5050
6130 Executive Boulevard
Rockville, MD  20892
Phone:  (301) 594-8782
Email:  js150x@nih.gov

Anthony Hayward, M.D., Ph.D. 
Director, Division of Clinical Research 
National Center for Research Resources
One Rockledge Centre, Room 6030
6705 Rockledge Drive, MSC 7965
Bethesda, MD  20892-7965
Telephone:  (301) 435-0790
FAX:  (301) 480-3661
Email:  haywarda@ncrr.nih.gov

Kristy Kraemer, Ph.D. 
Division of Allergy, Immunology and Transplantation 
National Institute of Allergy and Infectious Diseases 
Room 5144. SC 7640 
6700-B Rockledge Drive 
Bethesda, MD  20892-7640 
(Express Mail:  20817) 
Phone:  301-496-1886 
Fax:  301-402-0175
Email:  KKraemer@niaid.nih.gov
 
Richard J. Tasca, Ph.D.
Reproductive Sciences Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8B01
Bethesda, MD  20892
Tel:  (301) 435-6973
FAX:  (301) 496-0962
Email:  rt34g@nih.gov

Eleni Kousvelari, DDS, D.Sc.
Division of Basic and Translational Sciences
National Institute of Dental and Craniofacial Research
Natcher Building, Room 4AN 18A
Bethesda, MD  20892
Phone:  (301) 594-2427
Email:  kousvelari@de45.nidr.nih.gov
 
Judith Podskalny, Ph.D.
Division of Digestive Diseases and Nutrition
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd., Room 667, MSC 5450
Bethesda, MD  20892-6600
Telephone:  (301) 594-8876
Email:  jp53s@nih.gov

Judith H. Greenberg, Ph.D.
Director, Division of Genetics and Developmental Biology
National Institute of General Medical Sciences
Natcher Building, Room 2As25
45 Center Drive, MSC 6200
Bethesda, Maryland  20892-6200
Phone:  (301) 594-0943
Fax:  (301) 480-2228	
e-mail:  greenbej@nigms.nih.gov

Beth-Anne Sieber, Ph.D.
Chief, Developmental Neurobiology Program
National Institute of Mental Health
Neuroscience Center, Room 7186, MSC 9641
Bethesda, MD  20892-9641
Telephone:  (301) 443-5288
FAX:  (301) 402-4740
Email:  sieberb@helix.nih.gov

Arlene Y. Chiu, Ph.D.
Program Director, Repair and Plasticity Program
National Institute of Neurological Disorders and Stroke
Neuroscience Center, Room 2206, MSC 9525
Bethesda, MD  20892-9525
Telephone:  (301) 496-1447
FAX:  (301) 480-1080
Email:  chiua@ninds.nih.gov

Jill L. Carrington, Ph.D.
Chief, Systems Branch, Director, Musculoskeletal Biology
Biology of Aging Program
National Institute on Aging
Telephone:  (301) 496-6402
FAX:  (301) 402-0010
E-mail:  carringtonj@nia.nih.gov

Donald W. Fink, Jr., Ph.D.
Division of Cell and Gene Therapy
Office of Therapeutics Research and Review
Laboratory of Stem Cell Biology/Neurotrophic Factors 
Center for Biologics Evaluation and Research, US-FDA
1401 Rockville Pike/Suite 200N
Mail Code: HFM-524
Rockville, MD  20852-1448
Ph:  301.827.1787
FAX:  301.827.0449
E-Mail:  finkd@cber.fda.gov

Direct your questions regarding training to:

Ellen Werner, Ph.D.
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 10154, MSC 7950
Bethesda, MD  20892-7950
Telephone:  (301) 435-0077
FAX:  (301) 480-0868
Email:  WernerE@nhlbi.nih.gov

Direct your questions about financial or grants management matters to:

Marsha Mathis
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7158
Bethesda, MD  20817-7926
Telephone:  (301) 435-0171
FAX:  (301) 480-3310
Email:  MathisM@nhlbi.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.

SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of 
the application, including the checklist, and five signed photocopies in one 
package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD  20892-7710
Bethesda, MD  20817 (for express/courier service)

APPLICATION PROCESSING

Applications must be received by or mailed before the receipt dates April 23, 
2002 and October 23, 2002.  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.

PEER REVIEW PROCESS

Applications submitted for this PA will be assigned on the basis of 
established PHS referral guidelines.  An appropriate scientific review group 
convened by the Center for Scientific Review 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 goal of this short course training program is to develop skills and 
knowledge among investigators that will enable their application in basic 
research studies. The review criteria will include:

o  The course and its potential effectiveness in training researchers 
in laboratory research techniques for human embryonic stem cell lines.

o  Quality of the course content and adequacy of the syllabus.

o  Training, experience, and competence of the faculty in stem cell and human 
embryonic stem cell issues applicable to this program.

o  Criteria for selecting trainees and for awarding scholarships, for 
publicizing the availability of the course to the target audience of active 
researchers, and plans to reach out to underrepresented investigators.

o  Plans for evaluating the effectiveness and the extent of dissemination of 
the course including longer-term impact, as measured by attendees" subsequent 
activities or responsibilities in their institutions in the areas of 
embryonic stem cell biology.  

o  Plans for disseminating curricula to a broad audience.

o  Adequacy and availability of any necessary institutional facilities, such 
as the laboratory and tissue culture resources.

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.

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

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

REQUIRED FEDERAL CITATIONS

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. 93.839, and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.  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. 

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

	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, RealPlayer, Video or Flash files, see Help Downloading Files.