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 https://grants.nih.gov/grants/stem_cells.htm and at
https://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
https://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
https://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive
format. For further assistance contact GrantsInfo, Telephone (301) 710-0267,
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
https://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
https://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.