NEI INSTITUTIONAL CLINICAL SCIENTIST DEVELOPMENT PROGRAM

RELEASE DATE:  February 10, 2003 (see clarification NOT-EY-03-001)

PA NUMBER:  PAR-03-068 (Reissued as PAR-09-083)



Update: The following update relating to this notice has been issued: April 27, 2006 (NOT-EY-06-003.html) - See this notice for Extension of the Submission Date for PAR-03-068: NEI Institutional Clinical Scientist Development Program (K12) EXPIRATION DATE: May 10, 2006, unless reissued. National Eye Institute (NEI) (http://www.nei.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.867 THIS PAR CONTAINS THE FOLLOWING INFORMATION o Purpose of the PAR 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 PAR The National Eye Institute (NEI) is soliciting applications from U.S. educational institutions for Institutional Mentored Clinical Scientist Development Awards (K12) in vision research. These awards are intended to support the career development of clinician scientists and patient-oriented clinical investigators to conduct research related to all aspects of vision. Under this award, recently trained clinicians are to be selected and appointed to the program by the grantee institution. Funds provided by this award may be used to support full or partial completion of an advanced degree in health-related research (e.g., M.S., M.P.H., Ph.D.). RESEARCH OBJECTIVES Background Clinician scientists are critical for bridging the interface between basic and clinical vision research. Well-trained clinical investigators can assure that the findings of basic research are translated into the clinical setting. Programs designed to provide clinicians with the fundamental skills needed to engage in the many facets of modern clinical and patient-oriented vision research will help meet this objective. Our purpose is to train clinician scientists to conceptualize, conduct, and lead cutting edge clinical and patient-oriented vision research. Clinical and patient-oriented research has become increasingly complex, and often requires an integrative or systems approach conducted by a multidisciplinary research team. Coordinated multidisciplinary training programs that integrate both research and didactic training can be an important and effective means to accomplish these training and career development goals for the clinician. Program Description The NEI Institutional Clinical Scientist Development Program is an institutional program. The program should be designed to accommodate candidates with varying levels of research experience who require an individualized career development program ranging from two to five years. Applications for this award should propose a structured, phased development plan overseen by a Program Director and a Program Advisory Committee. A designated Period of didactic training should be followed by a period of supervised research experience. Candidates should be exposed to both research that is typically undertaken with a few investigators and to research approaches that require a multidisciplinary team to address complex research questions as appropriate. It is expected that at the end of the career development period, appointees will transition successfully into positions as independent investigators. Applications must include a description of the activities, including didactic courses and ancillary training experiences, that will be incorporated into the career development and mentored research experience. Course offerings should be relevant to diverse areas of clinical and patient-oriented vision research and should provide opportunities in more than one discipline (e.g., genetics, neuroscience, biostatistics, psychology, bioethics, epidemiology). Programs must include courses of instruction in Federal regulations, policies on the protection of human subjects, and the ethical conduct of research. Opportunities to learn how to communicate research results and develop coherent research applications that are essential to future success in an independent research career should be provided. The didactic and the research experiences provided under this award are expected to help participants acquire the necessary knowledge and research skills in scientific areas relevant to their career goals. Skills in data management, statistics, epidemiology, study design, clinical trial design, hypothesis development, drug development, etc., are indispensable to a research program and therefore candidates must be provided the opportunity to participate in such courses. In all cases, the candidates must participate in an intensive research experience under the guidance of qualified mentors distinguished in vision research. The relationship should optimize the opportunity for interdisciplinary communication and collaboration. Environment The institution must have a well-established vision research and clinical career development program. The research environment should include active basic/behavioral/clinical research collaborations that exemplify a dynamic exchange of information and ideas between laboratory and clinical scientists. The research environment should also promote the rapid translation of research into clinical questions and stimulate new ideas for laboratory experiments based on observations and results from the clinic. The institution must demonstrate a commitment to the development of trainees as productive, independent investigators. Applications may be from a regional consortium, submitted by a lead institution. Such a consortium could provide cross-disciplinary opportunities through local collaborations. All institutional members of the consortium need not be equally strong in the entire range of research areas to be offered, but the lead institution must have the requisite staff and facilities to carry out the proposed program. Awardees must agree to provide the NEI with information on career outcomes for those appointed to the program. Program Directors can satisfy this requirement by providing curriculum vitae for each of their graduates in the annual progress report, including information about current address and title, employment history, publications, and research grants and contracts received. Program Director The proposed Program Director should possess the scientific expertise, leadership, and administrative capabilities required to coordinate and supervise an interdisciplinary career development program relevant to vision research. The Program Director should also be experienced in the design and management of programs for developing investigators, and should be able to demonstrate a superior record of preparation of scientists for independent research careers. Program Advisory Committee A committee with representatives from the appropriate academic and or clinical departments should be established to advise the Program Director and to monitor the progress of participants. Committee composition, responsibilities, frequency of meetings, and other relevant information should be included in the application. An annual evaluation of the program by the Program Advisory Committee is recommended. This on-going evaluation should include an assessment of the curriculum, active mentors, and program staff; general recruitment and retention goals, including a plan for the recruitment and retention of underrepresented minorities, individuals with disabilities, and women; completion success; and overall outcome. Mentors The application should identify mentors capable of guiding the research candidates admitted to the program. Each candidate appointed in the program must have a primary mentor who is recognized as an accomplished investigator, is actively involved in basic or clinical research, and has a successful record of providing the type of training required under this award. This Lead Mentor must be committed to continue this involvement throughout the candidate's total period of development under this award. The Lead Mentor will assist the appointee in developing an individualized career plan based on the candidate's research experience. For example, a candidate with limited research experience would require a structured, phased developmental program, including a block of time devoted to didactic training followed by a period of mentored research. Appointees Appointees must hold a clinical doctorate (such as M.D., Ph.D., D.O., O.D., D.V.M.) and must have completed their clinical training (i.e., completed residency/fellowship and are board-eligible). At least 75% of the candidate's full-time professional effort must be devoted to the program, with the remainder devoted to developing other clinical and teaching pursuits consonant with the objectives of the award. The recruitment and retention of underrepresented minorities, individuals with disabilities, and women into the program should be a continuing program goal. MECHANISM OF SUPPORT This PAR will use the NIH K12 Mentored Clinical Scientist Development Program Award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. The program award provides five years of support and is renewable based on a successful competing continuation application, programmatic needs, and the availability of funds. This PAR is an on-going initiative with one annual receipt date on May 10. If the receipt date falls on a weekend, it will be extended to the following Monday. This PAR uses just-in-time concepts. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/archive/grants/policy/nihgps_2001/part_i_1.htm. ELIGIBLE INSTITUTIONS You may submit an application if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Domestic Foreign Institutions are not eligible to apply. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research training program is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. SPECIAL REQUIREMENTS Candidate Eligibility Clinician candidates appointed to the proposed program must be U.S. citizens, non-citizen nationals, or permanent residents. Individuals who were former Principal Investigators (PI) on NIH Small Grants (R03) or Exploratory/Developmental Grants (R21) are eligible. However, former PIs on NIH individual career development awards (K08, K23, K24); research project grants (R01, R29); or subprojects on Program Project Grants (P01), center grants and their equivalent, and cooperative clinical trials are not eligible. Candidates who have been supported on NIH or non-NIH career development awards dedicated to training clinician scientists and patient- oriented researchers are not eligible. Candidates may not have more than five years of research training experience beyond their last doctoral degree nor have held a tenure track position for more than four years. Allowable Costs Clinician research candidates may be provided salary support plus fringe benefits commensurate with the applicant institution's salary structure for persons of equivalent qualifications, experience, and rank. It should be noted that the NEI does not impose any salary restriction beyond that imposed legislatively. The institution may supplement the NEI contribution; however, supplementation may not be from Public Health Service funds. Institutional supplementation of salary may not require extra duties or responsibilities that would interfere with the purpose of this award. The total salary required must be based on a full-time, 12 month staff appointment for at least 75% effort. Salary support for up to 10% effort for the Program Director and up to 5% for the Lead Mentor is permitted, unless these individuals hold an NIH K24 award. Typically, there will be one Lead Mentor per candidate. Salary for up to 20% effort of a part-time secretary may be requested, but no other administrative assistants or other ancillary staff salaries are allowed. Up to $30,000 per candidate may be requested for the following types of expenses: research supplies, equipment, and technical personnel; tuition, fees, and books related to didactic courses or career development; travel to research meetings or training; and statistical services including personnel and computer time. These costs must be specifically documented for each proposed candidate and must be specifically and directly related to the candidate's research activities and individualized career development program. Costs cannot be pooled and used for advertising, recruitment, or other programs unrelated or indirectly related to the research activities of individual candidates or appointees. Facilities and Administrative Costs will be reimbursed at 8% of modified total direct costs. Other Income 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. 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 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 Funds may be used for health-related research. o Funds may be paid to the 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 payment. Leave In general, appointees may receive salary during the normal periods of vacation and holidays observed by individuals in comparable positions at the grantee institution. For the purpose of these awards, however, the period between the spring and fall semesters is considered to be an active time of research and is not considered to be a vacation or holiday. Appointees may receive salary from annual and sick leave, according to the institution's policy. Appointees also may receive salaries for up to 30 calendar days of parental leave per year for the adoption or birth of a child when those in comparable positions at the grantee institution have access to paid leave for this purpose and the use of parental leave is approved by the Program Director. A period of terminal leave is not permitted and payment may not be made from grant funds for leave not taken. Individuals requiring periods of time away from their research career development experience longer than specified here must seek prior approval from the NEI for an unpaid leave of absence. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PAR and welcome the opportunity answer questions from potential applicants. Inquiries may fall into three areas: scientific/research/training, peer review, and financial or grants management issues: o Direct your questions about scientific/research/training issues to: Chyren Hunter, Ph.D. Division of Extramural Research National Eye Institute Executive Plaza South, Suite 350 6120 Executive Blvd, MSC 7164 Bethesda, MD 20892-7164 Telephone: (301) 451-2020 FAX: (301) 402-0528 Email: clh@nei.nih.gov o Direct your questions about peer review issues to: Samuel C. Rawlings, Ph.D. Chief, Scientific Review Branch Division of Extramural Research National Eye Institute Executive Plaza South, Suite 350 6120 Executive Blvd, MSC 7164 Bethesda, MD 20892-7164 Telephone: (301) 451-2020 FAX: (301) 402-0528 Email: rawlings@nih.gov o Direct your questions about financial or grants management matters to: William W. Darby Grants Management Officer Division of Extramural Research National Eye Institute Executive Plaza South, Suite 350 6120 Executive Blvd, MSC 7164 Bethesda, MD 20892-7164 Telephone: (301) 451-2020 FAX: (301) 496-9997 Email: wwd@nei.nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov. APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted at the standard application deadlines, which are available at http://grants.nih.gov/grants/dates.htm. Application deadlines are also indicated in the PHS 398 application kit. SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR: Applications requesting $500,000 or more in direct costs for any year must include a cover letter identifying the NEI staff member who has agreed to accept assignment of the application. Applicants requesting more than $500,000 must carry out the following steps: 1) Contact the NEI program staff at least six weeks before submitting the application, i.e., as you are developing plans for the study; 2) Obtain agreement from the NEI staff that the IC will accept your application for consideration for award; and, 3) Identify, in a cover letter sent with the application, the NEI staff member who agreed to accept assignment of the application. This policy applies to all investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended or revised version of these grant application types. Additional information on this policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html. SUPPLEMENTAL GUIDELINES: In preparing an application for this PAR, follow PHS 398 instructions, but substitute the following specific instructions where indicated: o Face Page: Item 2, Check "Yes" and enter the PAR # and the title, "NEI INSTITUTIONAL CLINICAL SCIENTIST DEVELOPMENT PROGRAM". o Form Page 2: Key Personnel, include the Program Director and all other individuals contributing substantively to the mentoring activities. Do not include the candidates. o Form Page 3: The title should be changed to Research Career Table of Contents. Include the following sections: Section 1: Basic Administrative Data 1. Description and Key Personnel 2. Research Career Table of Contents 3. Detailed Budget for Initial Budget Period (Form Page 4) 4. Budget for Entire Proposed Period of Support (Form Page 5) 5. Biographical Sketches – Include the Program Director, Program Advisory Committee Members, and Mentors. Use the Biographical Sketch Format Page, not to exceed four pages for each individual. 6. Resources (Resources Format Page) Section 2: Specialized Information Introduction to Revised Application (not to exceed three pages) Introduction to a Supplemental Application (not to exceed one page) 2. Research Career Program Plan (not to exceed 25 pages for items a - f) a. Career Development Program The application should give an overview describing the overall theme of the program, the particular career development activities planned for candidates and the expected outcomes for candidates. It should describe the core didactic and mentored research experiences that candidates will complete. It should document the experience of the Program Director and other faculty as mentors, including information on the career outcomes of former candidates. It should include a clear commitment of staff time. Particular developmental activities mentioned, such as seminars, scientific meetings, training in responsible conduct of research, and presentations should be linked to the overall theme and goals of the program. Existing clinician scientist training programs should be described, and the application should indicate how they would be integrated into the K12 Program. This section should identify explicitly the advantages to this site of the K12 program-based career development award as opposed to, or in addition to, individual efforts by junior faculty to obtain career development and similar awards. The application should indicate what other teaching and/or clinical responsibilities, if any, are expected of the candidates and the extent to which these activities complement or enrich the research and research development experiences proposed in the award. The application must describe plans to give instruction in the responsible conduct of research. These plans must detail the proposed subject matter, format, frequency, and duration of instruction, and amount and nature of senior staff participation. No award will be made if an application lacks this component. Candidates and the sponsor may wish to explore opportunities described at the website of the Office of Research Integrity at http://ori.dhhs.gov. b. Recruitment and Selection Processes Describe the selection criteria for candidates recruited to this program. Present the nature of any other competing institutional programs that might limit the number of candidates and describe the strategies for addressing this competition. The institutional plan for the recruitment and retention of underrepresented minorities, individuals with disabilities, and women must be included in the proposal. c. Research Activities Applicants should describe the funded research activities of the mentoring team. They should indicate how the ongoing research offers candidates opportunities to develop research ideas and strategies and to combine methods or concepts from different funded projects that will further their own research careers. This description should show how the ongoing research exemplifies the organizing theme of the program and offers candidates ways to establish research consonant with that theme. The research plan should detail how individual candidates' research experiences will be/have been developed and evaluated prior to initiation. If an outside advisory committee is used to select projects, applications should not name advisors in the application but describe how they will be chosen. Applications should provide an example of an individual training plan that the Program would employ for at least two candidates. The individual descriptions should include a statement of long-range career goals; didactic courses; research project, including hypothesis, specific aims, background, significance, rationale, and research design and methods; and the particular mentors and mentoring resources that would be assigned to the candidate during the project. d. Ongoing Activities Existing resources and programs relevant to the K12 program should be identified. These may include existing training grants, institutional clinical research curriculum awards, or centers with resources for supporting junior faculty and individual clinician scientist awards (K08, K23, K24). The application should indicate how the K12 program will interact with these existing activities and add to the capacity to advance clinical research at the institution. Support letters from other resource director should be included in the Appendix. Competing continuation and supplemental application should use this section to provide a progress report on the current funded activities. The aims of the current award should be briefly summarized. Significant accomplishments of current and past candidates should be described, including present appointment, past faculty positions, and grant funding. Published work relevant to their training should be summarized. Emphasis should be placed on how the program aspects of the K12 have facilitated or are facilitating the progress of the candidates. e. Environment and Institutional Commitment Describe what current and future resources are or will be used to encourage research by candidates and to facilitate developing their research careers. Document what equipment, facilities, and resources will be made available to the candidates. In addition, for each candidate identified in the application and for future appointments to the K12 program, the institution must submit the Agreement to support the candidate as described in the PHS 398 form (rev. 05/2001) Section IV, pp. 60-61, with signatures as described in that section. For candidates named in the application, the form must be included in the Appendix. f. Program Management Describe the qualifications and role of the Program Director to provide scientific and administrative leadership and coordination of the Program. Describe how the Advisory Committee will function in providing oversight of the development, implementation, and evaluation of recruitment strategies; in the recruitment and selection of candidates; in the evaluation of special curricula; in the monitoring and evaluation of each candidate's progress with recommendations for changes in the training plan, if necessary, or termination of a candidate who is not making adequate progress; and in monitoring and evaluation of the overall effectiveness of the Program. Describe how individualized trainee career development plans will be developed that take into account past experiences and competencies before providing new experiences and skills by the Program. Describe any certification, degree, or other forms of recognition, if any, that trainees will receive. Section 3: PHS Form 398 Required Elements Human Subjects Vertebrate Animals Consortium/Contractual Arrangements Checklist Appendix 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 mailed on or before the receipt dates described at http://grants.nih.gov/grants/funding/submissionschedule.htm. The CSR will not accept any application in response to this PAR that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight weeks. PEER REVIEW PROCESS Applications submitted for this PAR will be assigned to the NEI. 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 will: o Receive a written critique o Undergo a selection process in which applications will be discussed and assigned a priority score o Receive a second level review by the National Advisory Eye Council. REVIEW CRITERIA The goal of NIH training programs is to help ensure that highly trained scientists will be available in adequate numbers and in appropriate research areas to carry out the Nation's biomedical and behavioral research agenda. 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 program will have a substantial impact on the pursuit of these goals o Significance o Approach o Candidates o Program Director and Mentors o Environment o Program Advisory Board The scientific review group will address and consider each of these criteria in assigning your application's overall score, weighting them as appropriate for each application. Your application does not need to be strong in all categories to be judged likely to have major scientific and technical merit and thus deserve a high priority score. (1) SIGNIFICANCE: Does the proposed program offer training and career development experiences in an important area of vision research and/or public health significance? Are the needs for additional researchers and K12 program well justified? (2) APPROACH: Are the planned activities adequately developed, consistent with the theme of the program, and sufficient to achieve the aims of the program? Are they appropriately tailored to the experience and interests of the candidates? Does the application provide evidence for the development and implementation of the didactic training phase; the organization and quality of cross-disciplinary and interprofessional research career development; the criteria for progression to the mentored research phase of training, including review of the independent research project; and the quality of the plan for evaluating the program? (3) CANDIDATES: Does the application demonstrate well-defined recruitment procedures, potential sources of high-quality candidates, candidate selection criteria, and retention strategies? Are these processes adequate to achieve high-quality candidates? (4) PROGRAM DIRECTOR AND MENTORS(S): Is there evidence of scientific and administrative expertise; experience in or potential for managing research career development programs and development of research skills; time commitment; other research support; assignment of mentors and projects; and evaluation of progress? Is there evidence of a strong past research career development record of the program director and co-director(s) as determined by the success of former trainees in seeking further career development and in establishing productive scientific careers? Such evidence can include, but is not limited to, receipt of fellowships, career awards, additional career development and training appointments and a record of successful competition for research grants, receipt of special honors, record of publications, receipt of patents, and promotion to scientific positions. Do the proposed mentors complement the skills and experience of the Program Director? Is their experience in research and prior success in training appropriate to their role? Have the mentors committed sufficient time to ensure the success of the program? (5) ENVIRONMENT: Do existing facilities and resources enrich the potential of the proposed K12 award to provide strong research mentoring and development experiences for the candidates? Are support letters available from individuals who control access to these resources that show their willingness to collaborate? Does the institution indicate that the candidates will be provided a minimum of 75% time for career development experiences and show that they will be protected from other administrative, teaching, or clinical duties? (6) PROGRAM ADVISORY BOARD: Does the application demonstrate the high quality of individuals on the Board, describe procedures for selection, and delineate the specific role of the Board? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following items will be considered in the determination of the scientific merit and the priority score: PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section of Federal Citations, below). INCLUSION OF WOMEN, MINORITIES, AND CHILDREN IN RESEARCH: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the section of Federal Citations, below). CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used in the project, the five items described under Section f of the PHS 398 research grant application instructions (rev. 5/2001) will be assessed. ADDITIONAL CONIDERATIONS BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. AWARD CRITERIA Applications submitted in response to this PAR 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 MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data Safety and Monitoring,: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating 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 clinical research should read the AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html; a complete copy of the updated Guidelines are available at http:// grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must 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) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy 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 is available at http://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. 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. 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 PAR in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA(R) 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 at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies described at http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm. 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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