EXPIRED
CAREER ENHANCEMENT AWARD FOR STEM CELL RESEARCH RELEASE DATE: March 1, 2002 PA NUMBER: PAR-02-069 (Reissued as PA-07-359) (This PAR has been reissued, see PAR-06-115) (Expiration Date extended, see NOT-HL-05-121) EXPIRATION DATE: December 30, 2005 National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (http://www.niddk.nih.gov/) National Institute on Alcohol Abuse and Alcoholism (NIAAA) (http://www.niaaa.nih.gov/) National Institute of Allergy and Infectious Diseases (NIAID) (http://www.niaid.nih.gov/) National Heart, Lung, and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov/) National Institute of Nursing Research (NINR) (http://www.ninr.nih.gov/) THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research 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 The purpose of this program announcement is to encourage investigators to obtain the training they need to appropriately use stem cells in their research. The Career Enhancement Award for Stem Cell Research will enable investigators to change the direction of their research careers or to take time from their regular professional responsibilities to broaden their scientific background by acquiring new research capabilities, specifically in the use of human or animal embryonic, adult, or cord blood stem cells. Two types of applicants should consider applying for support: (1) independent junior faculty who wish to expand their research by the use of stem cells, and (2) more senior, established investigators who wish to re-direct their research, in whole or in part, to include the use of stem cells. All applicants need to enlist a well-qualified stem cell expert, either within their own institution or elsewhere, to serve as a sponsor. The usual length of support will be from six months to one year and part-time training can be accommodated. Both didactic and laboratory training are appropriate means to acquire experience with the use, maintenance, and application of stem cells. Before submitting an application, investigators should verify that they will be able to pursue stem cell research after their training by familiarizing themselves with the policies governing the use of stem cells at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-014.html RESEARCH OBJECTIVES The use of stem cells in biomedical research offers the potential for significant advances in the next decades, provided investigators not only understand this potential, but are equipped to take advantage of it. Human embryonic stem cells (hESC) have only recently become available and most investigators are not prepared to handle, maintain, or properly study hESCs. Likewise, the potential of human adult or cord blood, and even animal, stem cells for understanding, treating, and curing human disease is great. This Career Enhancement Award is meant to provide the opportunity and necessary protected time for investigators to gain experiences that will enable them to take full advantage of stem cells in their research. Applicants must propose a training program suitable for their level of experience and scientific interests, and seek an environment where the training can occur. All training should be carefully tailored to meet the individual needs of the applicant and should, usually, include a description of a research project involving stem cells. The proposed training may include both didactic as well as laboratory-based instruction in the growth, management, and application of human, or animal, embryonic stem cells or adult stem cells for the broad areas of interest supported by the NIH. These areas, for each participating IC, are listed under INQUIRIES. MECHANISM OF SUPPORT This PA will use the NIH K18 award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. The project period will typically be six months to one year, although up to two years may be appropriate in some situations. Prospective applicants are advised to discuss the length of the training period they are proposing with the appropriate contact listed under "INQUIRIES". Awards are not renewable. All applicants must devote a minimum of 50 percent effort to the stem cell training and research activities, although a full time commitment for the six to 12 month period of time is encouraged and up to 24 months is allowable. The actual salary provided by the award will be based on your full-time, 12- month institutional salary and the level of effort requested, up to the maximum legislated salary rate in effect at the time of award. For example, in fiscal year 2002, the maximum allowable annual salary is $166,700 for a full-time position. In all cases, the salary requested must be consistent the level of effort and with the established salary structure at your institution as well as with salaries actually provided by the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities in the department concerned. If full-time, 12-month salaries are not currently paid to comparable staff members, the salary proposed must be appropriately related to the existing salary structure. The award will also provide fringe benefits on the calculated base salary at the established institutional rate. For K18 awards used to support a sabbatical period, the NIH award will take into account concurrent sabbatical salary support provide by the home institution and any other supplemental support. K18 award applicants may not concurrently apply for any other PHS award that duplicates the provisions of this award. K18 award recipients may hold independent research support, either Federal or private, concurrently with this award and may derive additional compensation for effort from other Federal sources or awards. However, the total salary derived from all Federal sources may not exceed the maximum legislated salary rate and the total percent effort cannot exceed 100 percent. Research Development support of up to $50,000 may be requested to pay for the cost of tuition and fees for courses, allowable research expenses, consultant fees for the sponsor, and travel to scientific meetings or to training courses. Facilities and Administration costs will be reimbursed at 8% to the applicant institution. Leave to another institution, including a foreign laboratory, is permitted if the leave is directly related to the purpose of the award (e.g. the proposed stem cell research training is to occur at another institution). You must obtain a letter, countersigned by your department head and the appropriate institutional official, indicating that your institution approves the leave. A letter from the sponsor and the host institution, where the training is to take place, must be submitted with the application to document that satisfactory arrangements have been made. Your own institution will pay your salary from the K18 award, while you are training at the host institution. ELIGIBLE INSTITUTIONS You may submit an application if your institution has any of the following characteristics: o Domestic o For-profit or non-profit organization o Public or private institution, such as a university, college, hospital, and laboratory o Unit of State or local government o Eligible agency of the Federal government INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research and research training is invited to work with their institution to develop an application for support. All applicants for this award must have a clinical or research doctoral degree and be actively engaged in research of interest to the NIH. Applicants should have completed at least three years of post-doctoral work prior to applying for this K18. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. SPECIAL REQUIREMENTS At the time of award, applicants must be citizens or noncitizen nationals of the United States, or must have been lawfully admitted to the United States for permanent residence (i.e., in possession of a currently valid Alien Registration Receipt Card I-551, or other legal verification of such status). Noncitizen nationals are generally persons born in outlying possessions of the United States (e.g., American Samoa and Swain"s Island). Individuals on temporary or student visas are not eligible. As a K18 award applicant, you must be able to devote at least 50 percent effort to your proposed program of didactic and/or research training in stem cell research. You may devote your full time effort to the award, however. All applicants must identify a stem cell expert with a record of providing the type of supervision required by this award who is willing to sponsor the training experience. The K18 application must include the following information: Candidate"s Background: Describe your commitment to a biomedical research career in an area of interest to the NIH, your immediate and long-term career objectives, and how training in the use of stem cells will further those objectives. Provide evidence that you have the capabilities and support to continue your research career and/or provide leadership as a stem cell researcher. You must include three letters of reference with your application from individuals familiar with your research. Career Development Activities: You must provide details of your overall plan for developing expertise with stem cell research techniques, tailoring the plan to your own goals, prior experience, and career level as well as to the intent of the K18 award. Provide details of any coursework to be taken, including any laboratory courses. Research Plan: As part of your research training experience, you are encouraged to pursue a research project that will make use of stem cells and thus provide practical experience in the required techniques. The research plan must be described as outlined in form PHS 398 including sections on Specific Aims, Background and Significance, Preliminary Studies, Research Design and Methods. You should consult with your sponsor to develop this section because the proposed project should reflect the expertise of the stem cell expert as well as your own interests and research needs. Training in the Responsible Conduct of Research: Describe your plans for training in the Responsible Conduct or Research or describe training that has already been completed. You must have already completed training in the Responsible Conduct of Research by the time the award begins. No award will be issued without confirmation of the completion of this requirement, or of confirmation that the intent of the requirement has been met (e.g. you are the person who teaches the Responsible Conduct course at your institution). Sponsor"s Statement: Your application must include a statement from the stem cell expert describing his/her research qualifications as well as previous experience as a research mentor. The sponsor must provide a description of the nature and extent of supervision that will occur during the proposed award period. You should also describe any plans for future, ongoing collaborations with the stem cell expert once the K18 award is completed. Environment and Institutional Commitment: Your own institution must agree to your plan to obtain additional research training in the techniques necessary for stem cell research either at another institution or your current location. Release time from administrative, clinical, teaching, and research duties is critical and must be documented. In addition, your institution must demonstrate a commitment to the development of a research program related to stem cell research. The institution "hosting" your stem cell research training must provide assurance that their facilities and the time of the stem cell expert are available to you. Biographical Sketches: You must submit Biographical Sketches for yourself, your sponsor, and any other key personnel, following the Biographical Sketch Format page in the PHS 398. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct your questions about all issues to the appropriate Institute staff, based on your areas of research interest, as listed below: NIDDK supports research in the areas of diabetes, metabolic diseases, endocrinology, gastrointestinal disorders, liver diseases, obesity, nutrition, urologic disorders, kidney diseases, and hematological disorders. Judith Podskalny, Ph.D. National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Blvd., Room 667, MSC 5450 Bethesda, MD 20892-5450 Telephone: (301) 594-8876 Email: jp53s@nih.gov NIAAA supports research in the areas of the mechanisms of alcohol addiction, alcohol-induced organ and system injury, and fetal alcohol syndrome. Laurie Foudin, Ph.D. National Institute on Alcohol Abuse and Alcoholism 6000 Executive Blvd., Room 402, MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-0912 Email: lf29z@nih.gov NIAID supports research in the areas of immune cell/system development, strategies to alleviate graft vs. host disease and chronic graft rejection, cell and organ transplantation, including beta islet cells for the treatment of type 1 diabetes, immune cell/system reconstitution, including gene therapy approaches, for treatment of HIV-infection and amelioration of drug side effects, and for the treatment or cure of primary immunodeficiencies and autoimmune diseases. Milton Hernandez, Ph.D. National Institute of Allergy and Infectious Diseases 6700 B Rockledge Drive, Room 2133 MSC 7610 Bethesda, MD 20892-7610 Telephone: (301) 496-3775 Email: mh35c@nih.gov NHLBI supports research in the areas of heart, vascular, and lung diseases, hematological disorders such as bone marrow suppression syndromes, anemias and sickle cell disease, thrombosis and homeostasis, blood resources and transfusion medicine , sleep disorders, organ transplantation, and stem cell research including blood, marrow, and cord blood stem cell transplantation, immune reconstitution, graft vs. host disease, gene therapy, stem cell plasticity, and embryonic stem cell developmental biology. Ellen M. Werner, Ph.D. National Heart, Lung, and Blood Institute 6701 Rockledge Drive, MSC 7950 Bethesda, MD 20892-7950 Telephone: (301) 435-0077 Email: wernere@nhlbi.nih.gov NINR supports doctorally prepared nurses in the areas of diabetes, AIDS, organ transplantation, cystic fibrosis, cancer, osteoporosis, heart failure, cachexia, immune dysfunction, and Alzheimer"s disease. Hilary D. Sigmon PhD, RN National Institute of Nursing Research 45 Center Drive, Room 3AN-18 MSC 6300 Bethesda, MD 20892-6300 Telephone: (301)594-5970 Email: hilary_sigmon@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. The special instructions for Research Career Awards in Section IV (http://grants.nih.gov/grants/funding/phs398/instructions2/p1_preparing _individual_CDA_app.htm) should be followed. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. Be sure to enter PAR-02-069, "Career Enhancement Award for Stem Cell Research" on line 2 of the face page of your application. APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted at the standard application deadlines for Research Career Awards, which are available at http://grants.nih.gov/grants/dates.htm. Application deadlines are also indicated in the PHS 398 application kit. 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 on or before the receipt dates described at http://grants.nih.gov/grants/funding/submissionschedule.htm for Research Career Awards. 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 an 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 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: o Will receive a written critique o May 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 Will receive a second level review by the appropriate national advisory council or board. REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of your application in order to judge the likelihood that the proposed training will have a substantial impact on the pursuit of these goals: Applicant o Evidence of excellence in academic, research, and, if appropriate, clinical activities o Potential to become, or continue as, an outstanding investigator, teacher, resource person, and leader in research programs related to the mission of the appropriate IC o Quality and breadth of prior scientific training and experience o Degree and extent of previous research support and publications, considering your academic level. Stem Cell Expert (Sponsor) o The stem cell expert"s qualifications as well as prior experience and record of fostering academic growth and productivity o The expert"s history of research productivity and peer-reviewed research support o Adequacy of active support for the proposed research project, if applicable. Research Training Plan o Quality and feasibility of your training plan, including plans after completion of the award o Relationship of the research training plan to your previous research focus as well as your future research plans O An assessment of the value of the proposed training experience as it relates to enhancing your capabilities as an independent investigator. Research Plan o Scientific and technical merit of the research question, design, and methodology o Relevance of the proposed research project to your own research interests o Appropriateness of the research plan to your career level and as a vehicle for developing the research skills described in the career development plan. Environment and Institutional Commitment o Adequacy of the research facilities and training opportunities for support of this award at the host institution, which may be the applicant institution, or at another institution o Clear evidence from your own institution that you will be given sufficient release time to complete the proposed training and research project o Level of commitment from your institution in supporting your future plans to use stem cells in your research. Training in the Responsible Conduct of Research o Quality of the proposed training in the responsible conduct of research that has been, or will be, completed. Budget o Justification of the requested budget in both time and amount, relevant to your research career goals and interests. AWARD CRITERIA Applications submitted in response to this 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 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. 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. 93.121 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 http://grants.nih.gov/grants/stem_cells.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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