This PAR will expire on October 2, 2003 unless reissued. NCI TRANSITION CAREER DEVELOPMENT AWARD (K22) Release Date: September 4, 2001 PAR NUMBER: PAR-01-134 (see replacement PAR-04-040) National Cancer Institute This program announcement replaces PAR-99-094, which was published in the NIH Guide on May 10, 1999. PURPOSE This K22 award is intended to facilitate the transition of investigators from the mentored to the independent stage of their careers in CANCER research, by providing "protected time" for newly independent investigators to develop and receive support for their initial CANCER research programs. The award applies to clinicians who are pursuing basic science careers, clinicians who are pursuing careers in patient-oriented research, and to individuals pursuing careers in the prevention, control and population sciences. To apply, a candidate must have completed TWO YEARS OR MORE of postdoctoral, mentored research or have been in an independent position for LESS THAN TWO YEARS at the time the application is submitted. The unique feature of this award is that individuals may apply without a sponsoring institution while they are still in a "mentored" position. Successful postdoctoral applicants will be given up to 12 months to identify an independent, preferably tenure- track, position at a sponsoring institution before an award can be activated. For postdoctoral applicants, the sponsoring institution for a K22 award can be their current institution or a new institution. This PA incorporates the previously announced (NIH Guide, NOTICE CA-00-011, February 23, 2000) expansion of eligible candidates to include postdoctoral scientists working in basic research as Federal employees. Additionally, candidates already in their first independent research position may now apply for this award in the second year of this position, whereas in PAR-99-094, these candidates were eligible to apply only if they were in their first year of the position. RESEARCH OBJECTIVES Background Many individuals in fields critically important to the future of cancer research need protected time to develop successful independent research programs. This is particularly true for medically trained individuals in general and for doctorally degreed and medically trained individuals pursuing cancer research careers in the prevention, control, behavioral and population sciences. Individuals in these research career tracks often require extended periods of mentored research training beyond their original doctoral degrees (e.g., M.D., Dr.PH). In addition, upon completion of their mentored research training, these individuals are often at a competitive disadvantage in obtaining independent research support relative to their traditional basic science Ph.D. counterparts, who generally have many more combined years of research training and experience in their field of expertise. Finally, the survival of clinician and Ph.D. researchers in these critical research areas is being threatened by the current economics of medical care, which is increasingly emphasizing revenue-generating clinical practice at the expense of clinical research, and by a corporate culture of many of the nation"s academic institutions that continues not to provide academic homes and tenure-track positions for prevention, control, behavioral and population scientists in the beginning stages of the independent phase of their research careers. A critical mass of clinician cancer researchers and researchers in cancer prevention, control, behavioral and the population sciences capable of interacting with basic science researchers is needed to ensure effective translation of basic research discoveries into patient and population research settings if there is to be optimal progress in reducing cancer incidence, mortality and morbidity. The NCI Transition Career Development Award was developed to address this need and the issues raised earlier, by providing a mechanism for stabilizing the career tracks of the most promising of these investigators while they are establishing their first independent research programs. This award focused on individuals with health professional degrees and in a basic science or patient-oriented research career development track, and individuals with a science or clinical doctoral degree in a cancer prevention, control, behavioral or population sciences research career development track. Federal employees in relevant positions, viz. NIH intramural scientists or fellows, were initially not eligible candidates for this award. However, in order to create equal access of postdoctoral scientists working as Federal employees to extramural career development opportunities, the National Cancer Institute (NCI) subsequently announced in 2000 a specialized expansion of the eligibility requirements of the Transition Career Development Award (K22) to include postdoctoral scientists working in basic research as Federal employees and who proposed research directly relevant to human cancer. Goals and Scope The award provides support for three years to individuals who are currently postdoctoral trainees in CANCER research or have just started in an independent position (See ELIGIBILITY REQUIREMENTS). Recipients of this award must devote a minimum of 75 percent effort to the proposed basic, clinical or population science research program. The remaining 25 percent effort can be divided among other clinical and teaching activities only if they are consistent with the program goals, i.e. the candidate"s development into an independent clinical investigator or investigator in cancer prevention, control, behavioral and the population sciences. Under unusual and pressing circumstances, an awardee may submit a written request to the awarding component, requesting a reduction in professional effort below 75 percent. Such requests will be considered on a case-by-case basis during the award period. In no case, will it be permissible to work at a rate of less than 50 percent effort. The nature of the circumstances requiring reduced effort might include medical conditions, disability, or pressing personal or family situations such as child or elder care. Permission to reduce the level of effort will not be approved to accommodate other sources of funding, job opportunities, clinical practice, or clinical training. In each situation, the grantee institution must submit documentation supporting the need for reduced effort along with assurance of a continuing commitment to the scientific development of the awardee. Further, the awardee must submit assurance of his or her intention to return to full-time professional effort (at least 75 percent) as soon as possible. During the period of reduced effort, the salary and other costs supported by the award will be reduced accordingly. The sponsoring institution must have well-established research programs in basic, clinical and or cancer prevention/control/behavioral/population sciences. This research environment should be one in which there are active research collaborations that exemplify a dynamic two-way exchange of information and ideas between laboratory and clinical and/or population research settings. The sponsoring institution must also demonstrate a commitment to the development of junior faculty as productive, independent investigators. Allowable Costs Salary: The Transition Career Development Award (K22) will provide salary up to $75,000 plus fringe benefits. The total salary requested must be based on a full-time, 12 month staff appointment requiring the candidate to devote a minimum of 75 percent effort to conducting cancer research with the remaining effort being devoted to activities related to the development of a successful research career. The salary must be consistent both with the established salary structure at the institution and 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 institution may supplement the NIH salary 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. Because the salary amount provided by this award is based on the full-time institutional salary, no other PHS funds may be used for salary supplementation. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the K22. Under expanded authorities, however, institutions may rebudget funds within the total costs awarded to cover salaries consistent with the institution"s salary scale. Research Development Support: Up to $50,000 per year will be provided for the following types of expenses: (a) research expenses, such as supplies, equipment, and technical personnel, (b) statistical services including personnel and computer time, (c) tuition, fees, and books related to career development, and (d) travel to research meetings or for training. The level of research development support may be negotiated downward with the acquisition of any independent grant support from any source. Ancillary Personnel Support: Salary for mentors, secretarial and administrative assistance, etc. is NOT allowed. Facilities and Administrative Costs: These costs, which were formerly called indirect costs, will be reimbursed at 8 percent of modified total direct costs. Evaluation In carrying out its stewardship of human resource related programs, the NIH may begin requesting information essential to an assessment of the effectiveness of this program. Accordingly, recipients are hereby notified that they may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program. Other Income Fees resulting from clinical practice, 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: o 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, o The funds may be used for health-related research purposes, o The funds may be paid to miscellaneous receipts of the U.S. Treasury. Checks should 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, o 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, and fees resulting from clinical practice, professional consultation or other comparable activities, provided these activities remain incidental, are not required by the research and research-related activities of this award, 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. Special Leave Leave to another institution, including a foreign laboratory, with award support may be permitted if the proposed experience is directly related to the purpose of the award. Only local, institutional approval is required if such leave does not exceed 3 months. For longer periods, prior written approval of the NIH funding component is required. To obtain prior approval, the award recipient must submit a letter to the NIH funding component 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 NIH funding component 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 grantee institution. Termination of Award 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. 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 reasons therefore, the effective date, and the right to appeal the decision. Change of Institution Individuals planning a change of institution AFTER AN AWARD HAS BEEN INITIATED (see Award Criteria and Procedures below) must submit to the NCI in advance of the change a written request for transfer, countersigned by the appropriate institutional business official, describing the reasons for the change. The awardee must establish in this request that the specific aims of the research program to be conducted at the new institution are within the scope of the original peer reviewed research program. Staff within the NCI will review this request and may require a review by an initial review group and the appropriate National Cancer Advisory Board. Upon approval of this request the new institution must follow all of the procedures outlined in the section on AWARD CRITERIA AND PROCEDURES for submission and NCI approval of a "Statement of Environment and Institutional Commitment." Upon approval of the "Statement" a new career award application must be submitted by the new institution far enough in advance of the requested effective date to permit review. The period of support requested in the new application must be no more than the time remaining within the existing award period. 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. Special Restrictions Recipients of an NCI Transition Career Development Award (K22) must submit an R01 research grant application to the National Institutes of Health, or an R01 equivalent research grant application to an equivalent funding organization (for example, an American Cancer Society Research Project Grant) for peer review and funding consideration prior to the end of the second year of support. MECHANISM OF SUPPORT This PA will use the National Institutes of Health (NIH) K22 award mechanism. The total project period for an application submitted in response to this PA may not exceed 3 years. Planning, direction, and execution of the program will be the responsibility of the candidate. Awards are not renewable. ELIGIBILITY REQUIREMENTS Eligible candidates are doctorally degreed individuals who have been educated as clinicians (e.g. M.D.s, Oncology Nurses) or as prevention, control and population scientists (e.g., PhDs, Dr.PHs, M.D.s) and are ready to pursue independent careers in CANCER research. The Transition Career Development Award (K22) is NOT for basic scientists following a traditional basic science research career track (e.g., Ph.D.s in molecular biology). Individuals pursuing basic science cancer research careers should apply for the Howard Temin Award (K01). Candidates should refer to the following URL addresses for information on the Howard Temin Award: http://grants.nih.gov/grants/guide/pa-files/PAR-00-066.html, http://cancertraining.nci.nih.gov/research/basicphd/phdk01.html. Candidates must currently be in a "mentored" CANCER research postdoctoral position and have completed TWO YEARS OR MORE of research in this capacity at the time of the application, or be in a suitable independent position for LESS THAN TWO YEARS with continuous previous postdoctoral CANCER research training at the time of the application. Postdoctoral scientists working in basic research as Federal employees and who have at least three years of mentored postdoctoral research experience at the time of award, may also apply as long as the proposed research is directly relevant to human cancer. Candidates in a postdoctoral position are eligible to apply for an NCI Transition Career Development Award (K22) WITHOUT an institutional affiliation (See Application Procedures). A candidate for a K22 may not simultaneously submit or have pending an application for any other PHS award that duplicates any of the provisions of this award. Former or current principal investigators on any NIH research grants or non-PHS peer reviewed grants that are over $100,000 direct costs per year or project leaders on sub-projects of program project (P01) or center grants (P50) are NOT eligible to apply. Minorities and women are encouraged to apply. Candidates must be U.S. citizens or noncitizen nationals, or must 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. Only domestic non-Federal organizations, public or private, such as medical, dental or nursing schools or other institutions of higher education, may accept an award on behalf of an applicant. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: In the Clinical Sciences: Dr. Lester S. Gorelic Cancer Training Branch National Cancer Institute 6116 Executive Boulevard, Suite 7025, MSC 8346 Bethesda, MD 20892-7390 Telephone: (301) 496-8580 FAX: (301) 402-4472 Email: lg2h@nih.gov In the Basic Sciences: Dr. Cynthia Pond Cancer Training Branch National Cancer Institute 6116 Executive Boulevard, Suite 7023, MSC 8346 Bethesda, MD 20892-7390 Telephone: (301) 496-8580 FAX: (301) 402-4472 Email: cp32z@nih.gov In Cancer Prevention, Control, Behavioral, Population Sciences: Dr. Brian W. Kimes Cancer Training Branch National Cancer Institute 6116 Executive Boulevard, Suite 7001, MSC 8346 Bethesda, MD 20892-8346 Telephone: (301) 496-8537 FAX: (301) 402-0181 Email: bk34t@nih.gov Direct inquiries regarding fiscal matters to: Ms. Catherine Blount Grants Administration Branch National Cancer Institute Executive Plaza South, Room 243 Bethesda, MD 20892 Telephone: (301)-496-3179 FAX: (301)496-8601 Email: cb136g@nih.gov Direct inquiries regarding review matters to: Ms. Toby Friedberg Referral Officer Division of Extramural Activities National Cancer Institute 6116 Executive Boulevard, Room 8109, MSC 8329 Bethesda, MD 20892-8329 Telephone: (301) 496-3428 FAX: (301) 402-0275 Email: tf12w@nih.gov APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/2001) (http://grants.nih.gov/grants/funding/phs398/phs398.html) and should use the instructions in Section IV of the application kit. The application will be accepted at the standard application deadlines for other K-awards as indicated in the application kit. Applications for which the candidate already has a position must be completed as directed. Postdoctoral candidates with no sponsoring institution may leave out all information that is the grantee institution"s responsibility to provide, this information must be provided at a later time if the candidate is selected for funding (See section on AWARD CRITERIA AND PROCEDURES). This version of the PHS 398 is available in an interactive, searchable PDF format. Although applicants are strongly encouraged to begin using the 5/2001 revision of the PHS 398 as soon as possible, the NIH will continue to accept applications prepared using the 4/1998 revision until January 9, 2002. Beginning January 10, 2002, however, the NIH will return applications that are not submitted on the 5/2001 version. For further assistance contact GrantsInfo, Telephone 301/710-0267, Email: GrantsInfo@nih.gov. The title and number of the program announcement must be typed in Section 2 of the face page of the application. The YES box must be marked. For those applicants with Internet access, the 398 kit may be found at: http://grants.nih.gov/grants/funding/phs398/phs398.html. All clinical trials supported or performed by NCI require some form of monitoring. The method and degree of monitoring should be commensurate with the degree of risk involved in participation and the size and complexity of the clinical trial. Monitoring exists on a continuum from monitoring by the principal investigator/project manager or NCI program staff to a Data and Safety Monitoring Board (DSMB). These monitoring activities are distinct from the requirement for study review and approval by an Institutional Review Board (IRB). For details about the Policy of the NCI for Data Safety Monitoring of Clinical Trials see http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm. For Phase I and II clinical trials, investigators must submit a general description of the data and safety monitoring plan as part of the research application. See NIH Guide Notice on Further Guidance on a Data and Safety Monitoring for Phase I and II Trials for additional information: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html. Finally, for details on the essential elements of a data and safety monitoring plan for clinical trials funded by the National Cancer Institute and for how the NIH/NCI policies on data safety and monitoring apply to NCI K-awards, see: http://nci.nih.gov/clinicaltrials/conducting/dsm-guidelines. Submit a signed, typewritten original of the application, including the checklist, and three signed exact, single-sided photocopies, in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive Room 1040 - MSC 7710 Bethesda, MD 20892-7710 (20817 for express service) At the time of submission, two additional copies of the application must be sent to: Ms. Toby Friedberg Referral Officer Division of Extramural Activities National Cancer Institute 6116 Executive Boulevard, Room 8109, MSC 8329 Rockville, MD 20852 (express courier) Bethesda, MD 20892-8329 The Center for Scientific Review (CSR) will not accept any application in response to this RFA 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 substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. The information summarized below must be provided in the application: Candidate o (Only for applicants already in an independent position) Describe the current position in terms of its ability to enable the candidate to pursue an INDEPENDENT career in CANCER research, o Identify whether you are a clinician pursuing a basic science career, a clinician pursuing a clinical research/translational research career or an individual pursuing a career in prevention, control, behavioral or population research, o Describe all activities during the "mentored" period of CANCER research training. Include all research experiences and mentors, any pertinent didactic experiences and any other experiences designed to acquire critical skills, techniques and scientific perspectives for pursuing an independent career in the chosen area of CANCER RESEARCH (e.g., basic research, clinical or patient-oriented research, and prevention, control and population research), o Describe scientific productivity during the mentored period of career development, o Establish the potential to manage an independent research program, o Establish the ability to become an independent investigator during the three year term of the award, o Describe the ability to interact and collaborate with other scientists, o Establish the ability to make a commitment of at least 75 percent effort to the career objectives of this award, o Three letters of recommendation from established scientists familiar with the candidate"s potential and capability to become a successful independent investigator. These letters should be provided in sealed envelopes attached to the front page of the application. Research Plan o Describe an original research plan in basic, clinical, cancer prevention or cancer control research, or in the behavioral or population sciences research directly related to cancer. The research plan must be described as outlined in form PHS 398 including sections on the Specific Aims, Background and Significance, Progress Report/Preliminary Studies, Research Design and Methods, o Describe how the proposed research extends the mentored research training that has been completed into new concepts and ideas, o Describe the equipment, specialized facilities and personnel resources that will be needed to conduct the proposed research, o Describe the plans for inclusion of women, minorities and children in any clinical or population research activities, o Describe the plans for protection of humans, animals or the environment to the extent they may be adversely affected by activities proposed in the application. Budget o Within the limitation of $50,000 direct costs for research development support, provide a detailed description, with justification, for all equipment, supplies and personnel that will be used to help achieve the career development and research objectives of this award. Non-Competing renewals o In addition to the information requested in the Application for Continuation Grant form PHS 2590 (Rev. 5/2001), documentation must be provided with the Progress Report for the second year of the award showing that the awardee has submitted an R01-type research grant application for funding. This documentation should minimally be a copy of the face page of the application with all required institutional signatures. REVIEW CONSIDERATIONS Applications will be reviewed for completeness by the Center for Scientific Review and for adherence to guidelines by the National Cancer Institute. Incomplete or non-responsive applications will be returned to the applicant without further consideration. Applications that are not eligible (See ELIGIBILITY REQUIREMENTS), as judged by NCI staff will be returned without further consideration. Applications that are complete and responsive to the program announcement will be evaluated for scientific and technical merit by a peer review group convened by the Division of Extramural Activities of the National Cancer Institute. 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 National Cancer Advisory Board to ensure that the proposed program meets the broad programmatic needs of the National Cancer Institute and the National Cancer Program. The following review criteria will be applied: Candidate o (Only for candidates already in an independent position) Suitability of the position for the candidate to pursue an independent research career, o Quality of the mentored period of CANCER research training in terms of research experience(s), didactic experiences and other experiences (e.g., special skills, perspectives, techniques) that will enhance the candidate"s ability to pursue an independent CANCER research career in the chosen area of research (e.g., basic research, clinical or patient oriented research, or prevention, control, behavioral and population sciences research), o Scientific productivity during the mentored period of career development, o Potential ability to successfully manage an independent research project, o Ability to interact and collaborate with other scientists, o The potential to become a successful independent investigator during the 3-year term of this award, o Letters of reference on behalf of the candidate. Research Plan o The originality, innovativeness and scientific merit of the proposed Research Plan relative to the experience level of the applicant, o Extent to which the research plan goes beyond the mentored environment and will test new concepts and ideas, o The medical and/or health significance of the Research Plan to Cancer, o The adequacy of plans to include women, children and minorities in any clinical or population research activities, o The adequacy of the proposed protection of humans, animals or the environment to the extent they may be adversely affected by activities proposed in the application. Budget o Adequacy of the proposed budget items for the achievement of the career development and research objectives of the award. Non-Competing Renewals o Adequacy of the progress towards achieving the research and career development objectives of the program, o Adequacy of the efforts to obtain R01-type research grant support for the research program. AWARD CRITERIA AND PROCEDURES Applications will compete for available funds with all other recommended applications. The NCI will notify candidates who have competed successfully for funding with a "Letter of Intent to Commit Funds." Candidates in a postdoctoral position will then have one year from the date of the letter to find an institution that offers a position, preferably tenure-track, suitable for enhancing a research career. For a candidate who already has a position in a sponsoring institution, negotiations with the institution will begin without delay. Negotiations will be initiated by asking the candidate"s institution to submit a "Statement of Environment and Institutional Commitment" to the NCI. This statement will be evaluated by NCI staff using the following criteria: o Documentation of 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, o Agreement of the institution"s statement of commitment of equipment, physical and personnel resources with the peer-reviewed recommendation of needs, o Adequacy of the institutional commitment to the required 75 percent effort requirement of this award for the development of an independently funded research program, o Adequacy of the arrangements with the candidate to provide a permanent, preferably tenure-track, position, adequate facilities for conducting a research program, and additional resources conducive to the development of a research project and establishment of a successful research career. For postdoctoral candidates, if the NCI approves the "Statement of Environment and Institutional Commitment" offered by the institution, the institution will be asked to submit a completed PHS Form 398 application. For candidates who already have a position in a sponsoring institution, the NCI only needs to approve the Statement. After NCI approval and subject to the availability of funds, the institution will receive an award. At the time of the award to the grantee institution in support of the K22, any current award held or other support provided for the mentored training of the candidate will be terminated. An award can be terminated prior to the end of the third year by the NCI if the candidate does not submit an R01 type grant application or equivalent for peer review before the end of the second year (See SPECIAL REQUIREMENTS) 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 UPDATED "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research", published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html), a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm. The revisions relate to NIH defined Phase III clinical trials and require: a) all applications or proposals and/or protocols to provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable, and b) all investigators to report accrual, and to conduct and report analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. 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 NIH, unless there are clear and compelling 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: http://grants.nih.gov/grants/guide/notice-files/not98-024.html Investigators may also obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS All investigators proposing research involving human subjects should read the NIH policy on education in the protection of human research participants now required for all investigators, which is published in the NIH Guide for Grants and Contracts, June 5, 2000 (Revised August 25, 2000), available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. A continuing education program in the protection of human participants in research is now available online at http://cme.nci.nih.gov/. 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 a 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. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-004.html). REQUIREMENTS FOR SHARING RESEARCH RESOURCES NIH policy requires that investigators make unique research resources readily available for research purposes to qualified individuals within the scientific community when they have been published. All investigators should read the Guidelines available at the following URL address: (http://grants.nih.gov/grants/policy/nihgps_2001/part_iia_6.htm). See also: NIH Grants Policy Statement (http://grants.nih.gov/grants/policy/nihgps_2001/) and Sharing Biomedical Research Resources: Principles and Guidelines for Recipients of NIH Research Grants and Contracts: Final Notice, December 1999 (http://www.nih.gov/od/ott/RTguide_final.htm). It is expected that biomaterials and other patentable research resources (examples could be, but are not limited to, vectors, embryonic cell lines, mutant mice, etc.) produced in projects funded by this initiative will be made available and distributed to the broader scientific community. 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, The NCI Transition Career Development Award, is related to the priority area of human resource development. 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 Number 93.398, Cancer Research Manpower. Awards are made under the 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 and Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The Public Health Service strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of 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 for children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. REFERENCES 1. National Research Council, Committee on Dimensions, Causes, and Implications of Recent Trends in the Careers of Life Scientists. Trends in the Early Careers of life Scientists. Washington, D.C.: National Academy Press, 1998.


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