INDIVIDUAL MENTORED RESEARCH SCIENTIST DEVELOPMENT AWARD IN GENOMIC RESEARCH AND ANALYSIS Release Date: May 1, 1998 PA NUMBER: PAR-98-061 P.T. National Human Genome Research Institute (This is a revision of the Program Announcement that appeared in the NIH Guide for Grants and Contracts, Vol. 20, No. 34, part 1 of 2 parts, September 13, 1991.) PURPOSE The National Human Genome Research Institute (NHGRI) is soliciting applications for Individual Mentored Research Scientist Awards (K01), formerly known as the Special Emphasis Research Career Award (SERCA), from highly qualified scientists seeking careers in interdisciplinary genomic research and analysis. These K01 awards are intended to foster the career development of individuals with expertise in scientific disciplines that would further technological developments critical to the success of the Human Genome Program and the understanding of the genetic basis of diseases. Eligibility is limited to individuals with degrees in computer sciences, mathematics, chemistry, engineering, physics and closely related scientific disciplines, such as bioinformatics, computational biology, statistics, biomathematics, bioengineering. Applications for this award should propose a development plan that has both intrinsic research importance and will also serve as a suitable vehicle for learning the methodology, theories, and conceptualizations necessary for well trained independent, interdisciplinary researchers. Awardees are expected to enter a structured, phased developmental program, including a designated period of didactic training followed by a period of supervised research experience. It is expected that at the end of the career development period, individuals will transition successfully into positions as independent investigators. HEALTHY PEOPLE 2000 The Public Health Service is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000,"a PHS-led national activity for setting priority areas. This PA, Individual Mentored Research Scientist Development Award in Genomic Research and Analysis, is related to the priority area of human resource development. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) from the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202/512-1800). ELIGIBILITY REQUIREMENTS Applicants must hold a Ph.D. or equivalent professional degree in a scientific discipline other than biology, such as engineering, mathematics, computer sciences, physics, chemistry or a closely related scientific discipline, such as bioinformatics, computational biology, statistics, biomathematics, bioengineering, and show evidence of expertise in their discipline (e.g., by scholarly publications or comparable accomplishments in other settings). In exceptional cases, individuals who do not have doctoral degrees, but have significant research experience, may be eligible. Applicants must demonstrate a commitment to pursue a career in genomic research following completion of the award. This program is open to scientists at all career levels. Eligibility for this K01 program is being expanded to include individuals who have had one or two years postdoctoral experience and need additional time in order to transition into independent investigators. Former recipients of Sloan/DOE Fellowships are especially encouraged to apply. Because these fellows have already had two years of postdoctoral research experience, they would generally be eligible for a maximum of three years of support. Minorities, women and individuals with disabilities are encouraged to apply. Applicants appointed under this program award must be U.S. citizens or noncitizen nationals, or have been lawfully admitted for permanent residence and possess an Alien Registration Receipt Card (I-151 or I-551) or some other verification of legal admission as a permanent resident. Noncitizen nationals, although not U.S. citizens, owe permanent allegiance to the U.S. They are usually born in lands that are not states, but are under U.S. sovereignty, jurisdiction, or administration. Individuals on temporary or student visas are not eligible. Applicants who are or have been former principal investigators on NIH research projects (R01), FIRST Awards (R29), sub-projects of program project (P01) or center grants (P50), or the equivalent, are not eligible to apply for a K01 award. Applicants may not concurrently hold any other PHS award that duplicates the provisions of this award. K01 awardees are encouraged to apply for independent research grant support during the period of support under this award. MECHANISM OF SUPPORT Awards in response to this program announcement will use the Mentored Research Scientist Development Award (K01) mechanism. The project period may be for three, four, or five years and will depend upon the number of years of prior research experience, and the need for additional experiences to achieve independence. Planning, direction, and execution of the program will be the responsibility of the candidate and her/his mentor on behalf of the applicant institution. Awards are not renewable. RESEARCH OBJECTIVES I. BACKGROUND The NIH Human Genome Program has been initiated as a 15-year project that has very specific goals: completion of a high-density genetic linkage map of the human genome, construction of a high-resolution physical map comprised of large overlapping contigs, development of a "sequence-tagged site" map, development of technology to reduce the expense of DNA sequencing significantly below current cost, development of new technologies for interpreting the genome, development of computer tools to manage and provide access to mapping and sequencing data, examination of the ethical, legal, and social implications of the Human Genome Program, and research training. Several of the biological goals have been completed or adequate resources are in place for completion. These include: dense genetic maps of the human and mouse genomes using microsatellite markers, a human physical map containing 30,000 uniquely ordered sequence tagged sites (STS) markers, the complete DNA sequence of E. coli and S. cerevisiae (and several other bacterial genomes), and the anticipated DNA sequence of C. elegans by 1998. There goals could have not been met without the development and implement of efficient, cost-effective, robust technologies that are required for large-scale projects. Although the genome project itself is predicated on the new and powerful methods that have become available in the past decade, further technology development will be essential to facilitate the sequencing goals of the Human Genome Program and to interpret all the data resulting from the mapping and sequencing projects. The planning of the course of the Human Genome Program has assumed that new ideas, instrumentation, and approaches will be developed to further reduce the cost and increase the efficiency of DNA sequencing and to improve the management of data emanating from large-scale mapping and sequencing projects. The development and successful introduction of new technologies require both an understanding of biology and the fundamentals of the technology to be applied, so that the solutions derived are appropriate and implementable. The NHGRI believes that advances in genomic research will depend, in part, upon a cadre of scientists and scholars who have been trained intensely in more than one discipline and have the capabilities to develop innovative, appropriate, and cost-effective solutions for the problems of large-scale mapping, sequencing, and interpretation of the genome. To stimulate the training of scientists who are facile in more than one scientific discipline, the NHGRI has emphasized interdisciplinary training as one of its goals. In addition to interdisciplinary training of young scientists, there is also the opportunity to recruit scientists who have the appropriate training and experiences to design and conduct such interdisciplinary or cross-disciplinary research as it relates to the construction of various types of maps, improved or new sequencing technologies, development of new and improve existing technologies to help interpret the genome, and informatics needs in support of such projects. II. PROGRAM The purpose of the Individual Mentored Research Scientist Development Award is to recruit scientists interested in and capable of interdisciplinary research in areas critical to the advancement of the research goals of the Human Genome Program. The K01 award offers opportunities for training in the biological sciences to individuals with doctoral degrees in scientific disciplines that have the potential to further the technological developments essential to the success of the Human Genome Program, such as mathematics, engineering, computer sciences, chemistry and physics, and related scientific disciplines in order to enable such individuals to pursue a career in genomics research. (Individuals with doctoral degrees in the biological sciences may receive additional research training through the National Research Service Award Program.) Individual appointees programs are often divided into two distinct phases--a basic science component and an intensive research experience under the general guidance of a qualified mentor. The basic science component must develop knowledge and research skills in scientific areas relevant to the career development goals of the candidate and must include relevant didactic and laboratory experiences. In all cases, the types of developmental experiences provided should be consistent with the candidate"s prior experience and needs. During the 3-5 year period of the award, individuals will participate in career development activities and research projects under the supervision of mentors who have distinguished themselves in the area of genomics research. At the conclusion of their program, awardees are expected to pursue an independent career in genomics research. The award aims to develop a close and extended working relationship between the awardee and one or more highly qualified scientists working in genomics research or a closely relevant field. The relationship should optimize the opportunity for interdisciplinary communication and collaboration. As a result of the experience, the awardee should develop the capacity to apply the knowledge and research methods of her (his) discipline to relevant problems in genomics research. For the sponsoring institution, the relationship should stimulate awareness among scientists of the potential for interdisciplinary or cross- disciplinary research in genomics research. III. MENTOR(S) The mentor must have extensive research experience in genomics research or in developing genomic approaches for genetics research or functional genomics. During the granting period, the mentor will sponsor and oversee the proposed training and research program, and will ensure that the awardee receives the proper experience for a future career of interdisciplinary genomic research. The mentor is expected to be a collaborator on the awardee"s research project. However, the awardee may conduct collaborative research with other experienced genome researchers, subject to the approval of the mentor. Where feasible, women, minorities and individuals with disabilities should be involved as role models. IV. ENVIRONMENT The institution must have a well-established research program in genomics research or genomic approaches to genetics or functional analyses. Institutions where there are highly integrated clusters of biologists working with computer scientists, mathematicians, engineers, physicists, chemists or scientists in closely related disciplines working in the area of genomics research or genomic approaches to genetics or functional analyses are particularly appropriate training environments for awardees. The awardee, mentor and institution must be able to maximize the use of relevant research and educational resources. V. ALLOWABLE COSTS A . Awardee"s Salary. Up to a maximum of $125,000 for full-time professional effort salary support may be requested. The total salary requested must be based on a full-time 12 month staff appointment. It must be consistent both with the established salary structure at the institution and with the 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. The institution may supplement the NIH contribution up to a level that is consistent with the institution’s salary scale, however, supplementation may not be from Federal funds unless specifically authorized by the Federal program from which such funds are derived. In no case, may DHHS funds be used for salary supplementation. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the K01 award. It is expected that the awardee will devote full-time professional effort to career development and research activities. However, up to 15 percent of the awardee"s time may be used for activities, such as teaching and research-related activities which make use of the awardee"s own discipline as a special contribution of the NHGRI K01 program to relevant interdisciplinary research programs of the sponsoring institution. In the case of tenure-track faculty, it is expected that the awardee will be able to spend a substantial amount of her/his professional effort in research and career development activities related to the K01 program. B. Research Development Support. In addition to the awardee"s salary, up to a maximum of $20,000 in each year of the award may be requested to partially defray the research expenses: e.g. instrument development, computer time, data collection, analysis costs, domestic travel, publication costs, and other appropriate expenses which are essential to the proposed research program. Requests for research support must be well-justified in the application. C. Tuition. If essential to the awardee"s individual development program, funds for tuition for training courses may be requested during the first year or two of the award on a course-by-course basis. D. Ancillary Personnel Support. Salary for mentors, secretarial and administrative, etc., is not allowed. E. Indirect Cost. Indirect cost will be reimbursed at eight percent of modified total direct costs, or at the actual indirect cost rate, whichever is less. F. Evaluation. In carrying out its stewardship of human resources related programs, the NIH may request information essential to an assessment of the effectiveness of this program. Accordingly, recipients may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants and contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program. G. Other Income: Fees resulting from professional consultation or other comparable activities required by the research and research-related activities of this award may not be retained by the career award recipient. Such fees must be assigned to the grantee institution for disposition by any of the following methods: The funds may be expended by the grantee institution in accordance with the NIH policy on supplementation of career award salaries and to provide fringe benefits in proportion to such supplementation. Such salary supplementation and fringe benefit payments must be within the established policies of the grantee institution. The funds may be used for health-related research purposes. The funds may be paid to miscellaneous receipts of the U.S. Treasury. Checks must be made payable to the Department of Health and Human Services, NIH and forwarded to the Director, Division of Financial Management, NIH, Bethesda, Maryland 20892. Checks must identify the relevant award account and reason for the payment. Awardees may retain royalties and fees for activities such as scholarly writing, service on advisory groups, or honoraria from other institutions for lectures or seminars, provided these activities remain incidental and provided that the retention of such pay is consistent with the policies and practices of the grantee institution. Usually, funds budgeted in an NIH supported research or research training grant for the salaries or fringe benefits of individuals, but freed as a result of a career award, may not be rebudgeted. The awarding component will give consideration to approval for the use of released funds only under unusual circumstances. Any proposed retention of funds released as a result of a career award must receive prior written approval of the NIH awarding component. H. Special Leave: Leave to another institution, including a foreign laboratory, may be permitted if directly related to the purpose of the award. Only local, institutional approval is required if such leave does not exceed three months. For longer periods, prior written approval of NHGRI is required. To obtain prior approval, the award recipient must submit a letter to the NHGRI describing the plan, countersigned by his or her department head and the appropriate institutional official. A copy of a letter or other evidence from the institution where the leave is to be taken must be submitted to assure that satisfactory arrangements have been made. Support from the career award will continue during such leave. Leave without award support may not exceed 12 months. Such leave requires the prior written approval of the NHGRI and will be granted only in unusual situations. Support from other sources is permissible during the period of leave. Such leave does not reduce the total number of months of program support for which an individual is eligible. Parental leave will be granted consistent with the policies of the NIH and the grantee institution. I. Termination or Change of Institution. When a grantee institution plans to terminate an award, the NIH funding component must be notified in writing at the earliest possible time so that appropriate instructions can be given for termination. If the individual is moving to another eligible institution, career award support may be continued provided: A new career award application is submitted by the new institution, All conditions of the award are met at the new institution including the presence of a qualified mentor, The period of support requested is no more than the time remaining within the existing award period, and The new application is submitted far enough in advance of the requested effective date to allow the necessary time for review. The funding component may require a review by an initial review group and/or the National Advisory Council for Human Genome Research. Alternatively, review may be carried out by staff within the NIH funding component depending upon the circumstances. The Director of the NIH may discontinue an award upon determination that the purpose or terms of the award are not being fulfilled. In the event an award is terminated, the Director of the NIH shall notify the grantee institution and career award recipient in writing of this determination, the reason thereof, the effective date, and the right to appeal the decision. A final progress report, invention statement, and Financial Status Report are required upon either termination of an award or relinquishment of an award in a change of institution situation. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. Investigators may obtain copies from these sources or from the program staff or contact person listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. NIH POLICY AND GUIDELINES ON THE INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects that was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: APPLICATION PROCEDURES Applications are to be submitted on grant application form PHS 398 (rev. 5/95) and will be accepted on the application receipt deadlines indicated in the application kit. Forms are available at most institutional offices of sponsored research and from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email:, and from the program administrator listed under INQUIRIES. Submit a signed, typewritten original of the application, including the Checklist, and three signed photocopies, in one package to: CENTER FOR SCIENTIFIC REVIEW NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, SUITE 1040-MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must be sent to: Office of Scientific Review National Human Genome Research Institute Building 38A, Room 609 Bethesda, MD 20892-6050 To identify the application as a response to this PA, check "YES" on item 2 of page 1 of the application and enter "PAR-98-061, NHGRI Mentored Research Scientist Development Award." The application must address the following issues: Candidate o Establish the candidate"s commitment to a career in genomics research and analysis, o Establish the candidate"s potential to develop into a successful independent investigator, o Summarize the candidate"s immediate and long-term career objectives, explaining how the award will contribute to their attainment, and o Letters of recommendation. Three sealed letters of recommendation addressing the candidate"s potential for an independent research career must be included as part of the application. Career Development Plan o Describe the career development plan, incorporating consideration of the candidate"s goals and prior experience. It should describe a systematic plan to obtain the necessary basic biomedical background and research experience to launch or reinitiate an independent research career. o Describe the plan for ensuring that the applicant receives the necessary theoretical and conceptual background in biology. The didactic nature of the plan must be tailored to the needs of the applicant and the ultimate goal of achieving independence as an independent investigator. o Applicants must describe plans to receive instruction in the responsible conduct of research. These plans must detail the proposed subject matter, format, frequency, and duration of instruction as well as the amount and nature of faculty participation. No award will be made if an application lacks this component. Research Plan o Describe the research plan and how it will make maximum use of the candidate s area of expertise. The candidate and mentor together must describe the research plan as outlined in form PHS 398 including sections on the Specific Aims, Background and Significance, Progress Report/Preliminary Studies, Research Design and Methods. The research plan is divided into two phases (1) developmental phase and (2) project phrase. Developmental Phase: During the first one to two years the awardee is expected to develop capabilities for conducting interdisciplinary research in some aspect of genome mapping, sequencing or informatics. The awardee"s activities may include participation in ongoing research, formal courses, workshops, symposia, and scientific and professional meetings. These activities should be oriented around an area of genomic research in which, subsequent to the grant period, the awardee contemplates the future development of a research program. Individuals who have had a previous postdoctoral experience, but who have not received any didactic training in biology will be expected to propose appropriate didactic activities as part of their career development program. Project Phase: Beginning as early as possible, the awardee is expected to become engaged in a collaborative research project with an mentor. The project, which should be designed as a basis for a future research project, should be exploratory in nature and should serve as the basis for the awardee"s future independent project. Mentor"s Statement o The application must include information on the mentor(s) including information on research qualifications as a genomics researcher and previous experience as a research supervisor. The application must also include information that describes the nature and extent of supervision that will occur during the proposed award period. Environment and Institutional Commitment o The sponsoring institution must document a strong, well-established research program related to the candidate"s area of interest including a high-quality research environment with staff capable of productive collaboration with the candidate. The sponsoring institution also must provide a statement of commitment to the candidate"s development into a productive, independent investigator. Budget o Budget requests must be provided according to the instructions in form PHS 398. The request for tuition and fees, books, travel, etc., must be justified and specified by category. REVIEW CONSIDERATIONS Applications will be reviewed for completeness by the Center for Scientific Review (CSR). Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council or board. The following review criteria will be applied: Candidate o Quality and breadth of prior scientific training and experience, including, where appropriate, the record of previous research support and publications, o Commitment to an independent research career in genomic research and analysis, and o Potential to develop (or evidence of the capacity to develop) as an independent investigator. Career Development Plan o Likelihood that the plan will contribute substantially to the scientific development of the candidate and the achievement of scientific independence, o Likelihood that the plan will contribute substantially to the candidate s ability to make conceptual advances in genomics research and analysis, o Appropriateness of the research plan to the career goals of the candidate, o Appropriateness of the plan to update conceptual and theoretical knowledge, and the proposed award duration, o Consistency of the career development plan with the candidate"s prior research and academic experience and the stated career goals, o Clarity of the goals and scope of the plan and the need for the proposed research experience, and o Quality of the proposed training in the responsible conduct of research. Research Plan Applicants for this award most likely will not have had previous research experience in a biological area and in some cases will have been Principal Investigators in other scientific fields, thus the research plan should be consistent with the career development plan and the candidate"s level of understanding of the new field. o Usefulness of the research plan as a vehicle for enhancing existing research skills as described in the career development plan, o Scientific and technical merit of the research question, design and methodology, judged in the context of the candidate"s previous training and experience, o Relevance of the proposed research to the candidate"s career objectives, and o Adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. Mentor o History of research productivity and support, o Appropriateness of mentor"s research qualifications in the area of this application, o Quality and commitment of the mentor to supervising and guiding the candidate throughout the award period, and o Previous experience in fostering the development of independent researchers. Institutional Environment and Commitment o Applicant institution"s commitment to the scientific development of the candidate and assurances that the institution intends the candidate to be an integral part of its research program, o Adequacy of research facilities and training opportunities, and o Quality of environment for scientific and professional development. Budget o Justification of budget requests in relation to career development goals and research aims and plans. AWARD CRITERIA The NHGRI will notify the applicant of the National Advisory Council on Human Genome Research action shortly after its meeting. Funding decisions will be made based on the recommendations of the initial review group and Council, the need for research personnel in specific program areas, and the availability of funds. INQUIRIES Written and telephone inquiries concerning this program announcement are encouraged, especially during the planning phase of the application. The program and grants management officials welcome the opportunity to clarify any issues or questions related to this program announcement and encourage written, telephone, or email inquiries. Direct inquiries regarding programmatic issues to: Bettie J. Graham, Ph.D. National Human Genome Research Institute Building 38A, Room 614 Bethesda, MD 20892 Telephone: (301) 496-7531 Email: For information about PHS Grant Policy, applicants may contact: Ms. Jean Cahill Grants and Contracts Management Section National Human Genome Research Institute Building 38A, Room 613 Bethesda, MD 20892 Telephone: (301) 402-0733 Email: AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.172. Awards will be made under the authority of the Public Health Service Act, Sections 301 (Public Law 78-410, as amended 42 U.S.C. 241) and administered under PHS grants policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirement of Executive Order 12372 or to Health Systems Agency review. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-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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