RFA-RR-02-001: MENTORED CLINICAL RESEARCH SCHOLAR PROGRAM AWARD

Department of Health
and Human Services (HHS)

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MENTORED CLINICAL RESEARCH SCHOLAR PROGRAM AWARD Release Date: November 6, 2001 RFA NUMBER: RFA-RR-02-001 National Center for Research Resources (http://www.ncrr.nih.gov) Letter of Intent Date: January 22, 2002 Application Receipt Date: February 20, 2002 PURPOSE The purpose of the National Center for Research Resources (NCRR) Mentored Clinical Research Scholar (CRS) Program Award (K12) is to support an institutional career development program for physicians and dentists to develop the skills to become independent patient-oriented clinical investigators. The institutional programs are to include activities that will provide candidates a comprehensive understanding of clinical research approaches that are fundamental and not necessarily disease-specific. Under this award, recently trained physicians and dentists will be selected to participate in an integrated didactic and mentored research program and be overseen by the Program Director and Program Advisory Committee. Candidates selected for the program must have a clinical doctorate (e.g., M.D. D.O., D.D.S./D.M.D.). 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.). In concert with a proposed mentor, an applicant for the CRS program proposes a comprehensive, individualized career development program that will prepare the physician or dentist candidate for an independent career in clinical research including patient-oriented research. The didactic and research phases of this program must include acquiring expertise across a broad spectrum of research methodologies, technologies, concepts, use and management of large datasets, bioinformatics and other research tools as well as communication skills required for a participating physician or dentist to be well trained in their selected research discipline. The program should be designed to accommodate candidates with varying levels of research experience. If appropriate, 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. The team research approach fosters cross- disciplinary collaborations. For the purposes of this award, patient-oriented research is defined as research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. Patient-oriented research includes mechanisms of human disease, therapeutic interventions, clinical trials, and development of new technologies (http://www.nih.gov/news/crp/97report/execsum.htm). ELIGIBILITY REQUIREMENTS INSTITUTIONS: Applications will be accepted from domestic, non-profit organizations, public and private, such as universities, or medical or dental schools, or from comparable institutions of higher education that have strong, well-established clinical research and training programs. The applicant institution must have an adequate pool of highly trained faculty investigators in clinical research and who have the commitment and capability to provide career development guidance to promising physicians and dentists who aspire to become independent clinical investigators. The environment must stimulate and enhance interactions among basic scientists and clinical investigators. Institutions with an NCRR-supported General Clinical Research Center (GCRC) are strongly encouraged to use the resources of that Center in the career development of physicians and dentists selected for this program. Applicant institutions without an NCRR-funded GCRC are to identify comparable resources to facilitate clinical or patient-oriented research for candidates. PROGRAM DIRECTOR (PD)/PRINCIPAL INVESTIGATOR: The CRS Program Director/Principal Investigator must be an established patient-oriented researcher who can provide both administrative and scientific leadership to the Program. Minorities, women and individuals with disabilities are encouraged to apply as program directors/Principal Investigators. MENTORS: A Lead Mentor should be an established clinical or patient-oriented research investigator who holds a faculty position. The Lead Mentor must interact closely with the candidate in order to develop a tailored career development plan. A CRS Advisory Committee will review the credentials of the proposed Lead Mentor. The Advisory Committee and PD must approve both the plan and proposed mentor before a candidate is accepted into the program. CANDIDATES: Institutions awarded a Mentored CRS Program Award (K12) must recruit and select candidates with the potential to develop into independent patient- oriented investigators. Candidates must have an M.D., D.O., or D.D.S./D.M.D. degree, must have completed residency training (or its equivalent) and must be committed to a career in clinical or patient-oriented research. The candidate also must be willing to spend a minimum of 75 percent (preferably, 90 percent) of full-time professional effort conducting didactic training, research, career development, and/or research related activities. Candidates may have initiated clinical specialty or subspecialty training but to be eligible, must devote from 2 to 5 years to this full-time career development program. Funds provided by this award may support full or partial completion of an advanced degree in health-related research (e.g., M.S. or Ph.D. in clinical investigation, M.P.H.). Candidates with fewer than 3 years of support under this award will remain eligible to compete for individual career development awards such as the K08 and K23. The maximum duration of support for a candidate cannot exceed 5 years. Candidates selected for the Mentored Clinical Research Scholar (CRS) Program may be eligible for the Loan Repayment Program (LRP) for clinical investigators that provides for repayment of the educational loan debt of physicians and dentists. Information regarding the eligibility requirements and benefits for the program may be obtained via the LRP website (http://lrp.info.nih.gov) Candidates appointed under this CRS program award must be U.S. citizens or non- citizen 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. Non-citizen 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. Candidates who were former Principal Investigators on NIH Small Grants (i.e., R03s) or Exploratory/Developmental Grants (i.e., R21s) are eligible. However, Principal Investigators who have current or prior support on NIH research projects grants (R01), FIRST Awards (R29), sub-projects of program project (P01) or center grants (P50), or the equivalent, are not eligible for appointment under this program. Candidates who have been previously supported on NIH or non-NIH career development awards dedicated to training patient-oriented researchers are not eligible. However, candidates whose prior training did not focus on patient- oriented research but wish to shift focus to this area are eligible. Candidates may not concurrently hold any other PHS award that duplicates the provisions of this award. CRS candidates are encouraged to apply for independent research grant support during the period of support under this award. MECHANISM OF SUPPORT Support for this National Center for Research Resources (NCRR) Mentored Clinical Research Scholars (CRS) Program award is through a K12 mechanism. Responsibility for the planning, direction, and execution of the proposed institutional program will be that of the CRS Program Director and CRS Program Advisory Committee on behalf of the applicant institution(s). Institutions in close proximity may form a consortium, however, one institution must be identified as the lead institution and be the applicant. The program award provides five years of support. This Request for Applications (RFA) is for a pilot CRS program that may become an on- going activity after an initial evaluation in two to three years to assess key aspects of the CRS program. At that time, the program may be expanded. The NCRR initially intends to make approximately ten CRS K12 awards. Although the financial plans of the NCRR provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of applications of outstanding scientific and technical merit. RESEARCH OBJECTIVES Background: Over the last 30 years, the number of physician scientists submitting NIH research grant applications has decreased significantly. In the 1970s, 40% of NIH research applications were submitted by MDs. Of concern is that less than twenty percent of research applications are now submitted by MDs. The submission rate for dentists is extremely low. Since MDs are critical for the interface between basic and clinical research, it is essential that well-trained physician and dental investigators assure that the findings of basic research are translated to clinical settings. The recent National Research Council Report, Addressing the Nation’s Changing Needs for Biomedical and Behavioral Sciences (http://grants.nih.gov/training/nas_report/index.htm), recommended that NIH and other research agencies intensify their efforts to train and retain physicians in clinical research in order to reverse the dramatic decline of clinical investigators entering the clinical research workforce. Furthermore, the Clinical Research Enhancement Act authorized the NIH to develop a graduate training program in clinical investigation. This program is intended to address the declining number of physician scientists and to provide them with the fundamental skills needed for a broad spectrum of clinical or patient- oriented research. To attain these objectives, well-designed career development programs are essential. Patient-oriented research has become more complex, requiring an integrative or systems approach conducted by a multidisciplinary research team with complementary expertise. Candidates for this program, when appropriate, should be trained in order to conceptualize and conduct cutting-edge clinical research. The scope of research tools available for patient-oriented research is unparalleled. To take advantage of those research tools, CRS programs need to include research and didactic training expertise that represent multiple disciplines. General Requirements Applicant institutions are required to include the following elements in their proposal: Program Description: Applications must include a description of the activities, including didactic courses that will be incorporated into the career development and mentored research experience. The courses should be relevant to diverse areas of patient-oriented clinical research and should provide opportunities in more than one discipline (e.g., genetics, neuroscience, biostatistics, psychology, bioethics, epidemiology). Both the didactic and research experiences provided by the award are expected to allow participants to acquire the necessary knowledge and research skills in scientific areas relevant to the career goals of the candidate. The institutional program should be designed to accommodate candidates with varying levels of research experience that may require development programs that range between two and five years. For example, a candidate with limited research experience may require a structured, phased developmental program, including a block of staged time to participate in didactic training followed by a period of supervised research. Programs also are to provide instruction and mentoring in Federal regulations/policies on the protection of human subjects and bioethics. In addition, candidates must learn how to communicate their research and develop coherent research applications that will aid the candidate in transitioning to an independent research career. Instruction in the Responsible Conduct of Research: Every individual supported by a research career development award must receive instruction in the responsible conduct of research. Applications must include a description of a program to provide formal or informal instruction in bioethics, scientific integrity and the responsible conduct of research. Applications without such plans will be considered incomplete and will be returned to the applicant without review. Although NCRR does not establish specific curricula or formal requirements, all institutional CRS programs are encouraged to include instruction in the following areas: conflict of interest, responsible authorship, policies for handling misconduct, policies and regulations that impact clinical and animal research, and security in data management. Plans must address the subject matter of the instruction, the format of the instruction, the extent of faculty participation, trainee attendance, and the frequency of instruction. The rationale for the scope of the proposed plan of instruction must be provided. Program reports on the type of instruction provided, topics covered, and other relevant information, such as attendance by appointees and faculty/mentors, must be included in future competing continuation and non-competing applications. The institutional CRS Plan for the recruitment and retention of underrepresented minorities, individuals with disabilities, and women must be included in the proposal: The NCRR is committed to increasing the participation of women and individuals from ethnic or racial groups underrepresented in the biomedical and behavioral sciences. The following groups have been identified as under- represented in biomedical and behavioral research nationally: American Indian or Alaska Native, Asian, Black or African American, Hispanic or Latino, and Native Hawaiian or Other Pacific Islander. Full descriptions of these categories can be found in Form PHS 398 (Rev. 05/01.) Plan for on-going evaluation of the program: The application must include a plan for program evaluation in terms of recruitment and retention goals, the curriculum and program staff, appointee completion success, and overall outcome. Input for these evaluations should be obtained from faculty mentors, staff, and candidates. Applicants are encouraged to: prospectively set benchmarks for the goals of their institutional programs, provide a brief summary of the research opportunities available to candidates and course work to be offered to participating physicians and dentists, and provide a summary of the research degrees earned and relationship with career research goals. For purposes of evaluating the impact of the Mentored CRS Program, awardees must agree to provide NCRR with information on the career outcomes for those appointed to the program. This information must be provided annually in the progress report and include information for each candidate regarding academic appointments, awards related to scholarly activity, publications, and research grants and contracts received. CRS Program Advisory Committee: Plans must be provided for the appointment of an advisory body to monitor the progress of participants in the career development program. Composition, responsibilities, frequency of meetings and other relevant information should be included. An annual evaluation of the program by the CRS Advisory Committee is recommended. OTHER REQUIREMENTS Environment: The primary institution must have well-established research and clinical career development programs and highly qualified faculty mentors in clinical research with an emphasis on patient-oriented research. The academic setting is to include opportunities for research collaborations that exemplify a dynamic two-way exchange of information and ideas between basic and clinical investigators. The research environment should stimulate the development of new research hypotheses, novel experiments, and foster exploration of fundamental mechanistic questions that build on clinical observations. Finally, the institution must demonstrate a commitment to the development of promising physicians and dentists as productive, independent patient-oriented clinical investigators. Number of Candidate Positions: The applicant institution can request support for up to three candidates in each of the initial and second year of the award. Up to two additional candidates may be added in each subsequent year, but the collective total should not exceed twelve five-year equivalents (For example, if one candidate is supported for three years and another supported for two years, that combination is one five-year equivalent.) The award provides support to institutions for up to five consecutive 12-month periods. Appointments of candidates to the program are provided in 12-month increments. The Mentored CRS Program requires at least 75 percent (preferably, 90 percent) of candidate’s time and effort for participation in didactic training, research experiences, and supervised research. A Statement of Appointment form (PHS 2271) must be completed and sent to the NCRR whenever an individual is appointed or reappointed to the program. ALLOWABLE COSTS Salary: Physician and dentist program candidates may be provided salary support of up to $90,000 (for 90 per cent effort) each year commensurate with the applicant institution’s salary structure for persons of equivalent qualifications, experience, and rank. The institution may supplement the NCRR contribution, however, the supplementation may not be from Federal funds unless specifically authorized by the Federal program from which such funds are derived. In no case may PHS funds be used for salary supplementation. Institutional supplementation of salary may not require extra duties or responsibilities that would interfere with the purpose of this award. The total salary requested must be based on a full-time, 12-month staff appointment. Research and Development Support: Up to $30,000 per candidate can be requested for the following types of expenses: (a) research supplies, equipment and technical personnel, (b) tuition and fees and books related to didactic courses or career development, (c) travel to research meetings or training, and, (d) statistical services including personnel and computer time. If an applicant institution has a GCRC, biostatistical and related computation costs can generally be provided at no charge to the investigator through the GCRC. 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. They cannot be pooled and used for advertising, recruitment, or other programs unrelated or indirectly related to the research activities of individual candidates or appointees. Ancillary Salary Support: Salary for the Program Director (up to .10 FTE) and the Lead Mentor (up to .05 FTE) plus fringe benefits will be allowed---unless the PD or Mentor holds an NIH-funded K24 award, which provides mid-career, established clinical investigators with salary support to mentor promising clinical investigators. Typically, there will be one Lead Mentor per candidate. Salary for a part time secretary (up to .25 FTE) may be requested, but no other administrative assistants or other ancillary staff salaries are allowed. Facilities and Administrative Costs: These costs, which were formerly called indirect costs, will be reimbursed at 8 percent of modified total direct costs. The Mentored CRS Program award, using a K12 mechanism and administered by the NCRR, is not subject to the Streamlined Non-competing Application Process (SNAP). In general this means that all reporting of budgetary information and program progress are provided in greater detail in an annual progress report. While the K12 is subject to Expanded Authorities, the one exception to this is carry forward of funds from one fiscal year to the next must be approved by the NCRR Grants Administration staff (see INQUIRIES). 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: 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. 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 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. 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 for 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 approval from the NCRR for an unpaid leave of absence. PROGRESS REPORTS An Annual Progress Report for the grant is required. This report should provide information about changes in the Program, a summary of the on-going evaluation results, a summary report from the Program Advisory Committee, and a description of the research and career progress of each candidate. These Annual Progress Reports will be closely monitored by NCRR staff to ensure that the grant is achieving the goals of the Mentored CRS Program. Progress reports are submitted using the Form PHS 2590, which can be obtained at the following website address: http://grants.nih.gov/grants/funding/2590/2590.htm. Forms are also available at most institutional offices of sponsored research. LETTER OF INTENT Prospective applicants are asked to submit, by January 22, 2002, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the principal investigator, the identities of other key personnel, and the number and title of this RFA. Although a letter of intent is not required, the information that it contains allows Center staff to estimate the potential review workload. The letter of intent is not binding, does not commit the sender to submit an application, and does not enter into the review of a subsequent application. The letter of intent is to be sent (e-mail, fax, or post) to Dr. John Meyer at the address listed under INQUIRIES. APPLICATION PROCEDURES The PHS 398 research grant application instructions and forms (rev. 5/2001) available at http://grants.nih.gov/grants/funding/phs398/phs398.html must be used in applying for these grants. This version of the PHS 398 is available in an interactive, searchable format. For further assistance contact GrantsInfo, Telephone 301/710-0267, Email: GrantsInfo@nih.gov. The instructions in the Form PHS 398 do not fully apply to the special needs of this grant application. Therefore, please follow the modified instructions in preparing an application for a Mentored Clinical Research Scholar Program Award (K12). These instructions have been adapted to accommodate the Form PHS 398 and the special needs of the K12 grant and can be obtained at the following website address: http://www.ncrr.nih.gov/clinical/cr_crcd.asp The original application and three legible copies must be sent to or delivered to: CENTER FOR SCIENTIFIC RESEARCH NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (For express/ courier service) At the time of submission, two additional copies must also be sent to: Dr. John Meyer Deputy Director, Office of Review National Center for Research Resources 6705 Rockledge Drive, Room 6116 Bethesda, MD 20892-7965 Telephone: (301) 435-0807 FAX: (301) 480-3660 Email: meyerj@ncrr.nih.gov Applications for the initial submission in response to this RFA must be received by February 20, 2002. Applications received later than that date will be returned without review. The Center for Scientific Review (CSR) will not accept any application in response to the 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 an application already reviewed, but such applications must include an Introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the Center for Scientific Review and by the NCRR for adherence to the guidelines. Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NCRR 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 of review by the National Advisory Research Resources Council. Review Criteria All applications are evaluated for merit based on the following criteria: Purpose and Objectives: Clarity of the CRS Program"s objectives o Adequacy in meeting the NCRR intent to prepare candidates who can design and implement all phases of patient-oriented research and effectively lead a cross-disciplinary research team o Track record of the institution in the development of trainees as productive independent patient-oriented researchers o Track record of the consortium institution, if applicable o Adequacy of the commitment of the institution assuring that candidates will spend a minimum of 75% of a full-time professional effort in research or research-related career development Career Development Program Description: o Adequacy of the nature and duration of required didactic for training appointees in clinical research o Adequacy of the nature and duration of required research experiences and forums in clinical approaches o Adequacy of the cooperative arrangements between consortium institutions, if applicable o Adequacy of the nature and duration of any specialized didactic, research forums, or research experiences o Evidence of a multi-disciplinary program faculty and their involvement in didactic, research forums, and research experiences. o Evidence of the availability and commitment of the faculty mentors now and for the duration of the program to provide high-quality mentoring in patient- oriented research o Evidence that the didactic and research experiences are distinct yet integrated with other training programs at the institution, such as K30 or T32 programs. Research Environment, Resources, and Facilities: o Adequacy of the funded patient-oriented research activities o Adequacy of the interactive nature of the research environment, including evidence of interdisciplinary research collaborations among the program faculty o Adequacy of the available research infrastructure, access to technologies and methodologies, equipment, facilities, clinical resources, and patient populations o Quality of the faculty mentors? research experience, productivity, and track record in training patient-oriented researchers Program Management: o Program Director - adequacy of the Program Director"s qualifications to provide scientific leadership in patient-oriented research and administrative direction and coordination of the Program, experience in or potential for managing research career development programs, evidence of availability and commitment, both now and for the duration of the program. o Lead Mentor - adequacy of qualifications, likelihood for providing high- quality mentoring in patient-oriented research. Evidence of commitment to mentoring. o CRS Program Advisory Committee - appropriateness of the experience of the membership, adequacy of involvement in the oversight of the program"s candidate selection, didactic and curricula, research experiences and mentoring, and evaluating appointee progress and overall program effectiveness. o Recruitment/ Retention Plans - adequacy of plans to recruit and select candidates, adequacy of plans for recruiting and retaining candidates from underrepresented minorities. o Instruction in the Responsible Conduct of Research - adequacy of plans for providing formal and informal instruction in the bioethics, scientific integrity, and the responsible conduct of research. o Evaluation Plan - adequacy of the plans to be followed by the Program Director, faculty mentors, staff, and appointees in evaluating program recruitment and retention strategies, curriculum and mentoring, appointee progress and completion, and overall program effectiveness. Budget: Appropriateness of the budget to achieve the objectives of the proposed Program Appropriateness of the number of appointees proposed for each year of the Program. ADDITIONAL REVIEW CONSIDERATIONS FOR ALL APPLICATIONS Recruitment Plan for Underrepresented Minorities: Reviewer evaluation of the recruitment of underrepresented minorities will be included in an administrative note in the summary statement. If the minority recruitment plan or if the record of recruitment and retention of minorities is judged to be unacceptable, funding will be withheld until a revised plan that addresses the deficiencies is received. Staff within the NCRR will determine whether amended plans and reports submitted after the initial review are acceptable. Training in the Responsible Conduct of Research: Reviewer evaluation of the training in the responsible conduct of research will be described in an administrative note in the summary statement. Regardless of the priority score, applications with unacceptable plans will not be considered for funding until the applicant provides a revised, acceptable plan. NCRR staff will judge the acceptability of the revised plan. Notification: Shortly after the review meeting, each applicant will be sent notification of the Initial Review Groups recommendation and the name and phone number of the NCRR official responsible for the application. When the NCRR official receives the summary statement of the review, prepared by the Scientific Review Administrator after the review meeting, a copy will be forwarded to the applicant. Following the review by the National Advisory Research Resources Council, the NCRR program official will notify each applicant of the final disposition of the application. Schedule Letter of Intent Receipt Date: January 22, 2002 Application receipt Date: February 20, 2002 Earliest Anticipated Start Date: August, 2002 AWARD CRITERIA Applications are selected for funding primarily on the basis of scientific and educational merit and sound administrative organization. However, other factors are considered, such as: availability of funds, research program priorities, the balance among types of research training and career development supported by NCRR, the acceptability of the plan for minority recruitment, and the acceptability of the plan for instruction in the responsible conduct of research. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify and issues or question from potential applications is welcome. Direct inquiries regarding programmatic issues to: Dr. Geoffrey Cheung Division of Clinical Research National Center for Research Resources 6705 Rockledge Drive, Room 6118 Bethesda, MD 20892-7965 Telephone: (301) 435-0768 FAX: (301) 480-3661 Email: cheungG@ncrr.nih.gov Direct inquiries regarding fiscal matters to: Ms. Mary Niemiec Office of Grants Management National Center for Research Resources 6705 Rockledge Drive, Room 6208 Bethesda, MD 20892-7965 Telephone: (301) 435 - 0844 FAX: (301) 480-3777 Email: niemiecm@ncrr.nih.gov 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 Request for Applications (RFA), Mentored Clinical Research Scholar Program 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/. 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 are 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 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: http://grants.nih.gov/grants/guide/notice-files/not98-024.html Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. 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. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. 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. This policy announcement is found in the NIH Guide for Grants and Contracts Announcement dated June 5, 2000, at the following website: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. 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 RFA 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. AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.333. Awards are made under authorization of title III, Section 301 of the Public Health Service Act as amended. The Code of Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92 are applicable to this program. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or 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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