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.


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