NHLBI MENTORED MINORITY FACULTY DEVELOPMENT AWARD (K01) RELEASE DATE: March 14, 2003 RFA: HL-03-011 (See continuation, RFA-HL-05-015 and see Notice of Additional Receipt Date, NOT-HL-04-015) National Heart, Lung, and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov/) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBERS: 93.233, 93.837, 93.838, 93.839 LETTER OF INTENT RECEIPT DATE: May 22, 2003 APPLICATION RECEIPT DATE: June 23, 2003 (see NOT-HL-04-015) THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism(s) of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA The NHLBI Mentored Minority Faculty Development Award is a three to five-year award made to underrepresented minority faculty members, with varying levels of research experience, who are committed to developing into independent biomedical investigators in research areas relevant to the mission of the NHLBI. The award will enable suitable faculty members holding doctoral degrees, such as the Ph.D., M.D., D.O., D.V.M., or an equivalent, to undertake special study and supervised research under a mentor who is an accomplished investigator in the research area proposed and has experience in developing independent investigators. RESEARCH OBJECTIVES The proportion of biomedical investigators who are members of underrepresented minority groups is strikingly lower than the percentage of minority U.S. citizens. There has been a dramatic increase in the number of underrepresented minorities in the basic biomedical workforce going from 1,076 in 1975 to 3,943 in 1997. In spite of this increase, minorities remain a small percentage of the overall biomedical workforce. In 1997, 4.2 percent of biomedical scientists were underrepresented minorities, compared to 2.6 percent in 1975. ("Addressing the Nation's Changing Needs for Biomedical Scientists, National Research Council, 2000"). One method of increasing the number of minority faculty members is to offer them additional research training and career development opportunities with experienced mentors. In so doing, the pool of minority biomedical and biobehavioral investigators in cardiovascular, pulmonary, and hematologic research, and sleep disorders can be increased. Furthermore, these minority individuals may serve as role models for minority undergraduate and graduate students, and stimulate these students to become more cognizant of research opportunities in cardiovascular, pulmonary, hematologic, and sleep disorders. The objective of this one-time award is to develop highly trained minority investigators whose basic or clinical research interests are grounded in the advanced methods and experimental approaches needed to solve problems related to cardiovascular, pulmonary, hematologic, and sleep disorders. This program provides research development opportunities for underrepresented minority faculty members with varying levels of research experience. The research development program of the candidate should be based on their scholastic background, previous research experience, past achievements, and potential to develop into an independent research investigator. Minority scientists and physicians with limited research experience needing guided course work and supervised laboratory experiences, as well as minority faculty needing only an intensive research experience under the guidance of an established scientist, are eligible to apply. MECHANISM OF SUPPORT This RFA will use the NHLBI Mentored Minority Faculty Development Award (K01) mechanism of support. Responsibility for the planning, direction, and execution of the proposed training project will be solely that of the applicant. The total project period for an application submitted in response to this RFA must be at least three but not more than five years. The anticipated award date is April 1, 2004. FUNDS AVAILABLE The estimated funds (total costs) available for the first year of support for the entire program is expected to be $1.2 million in Fiscal Year 2004 (October 1, 2003-September 30, 2004). The actual amount may vary, depending on the response to the RFA and availability of funds. Ten to twelve new awards are anticipated. Loan Repayment Program (LRP): Awardees under this program may be eligible to apply for the NIH Extramural Loan Repayment Program. Information regarding the eligibility requirements and benefits for the program may be obtained through the LRP website at http://www.lrp.nih.gov/. ELIGIBLE INSTITUTIONS Eligible institutions include: o For-profit and non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic institutions Foreign institutions are not eligible to apply. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS For the purpose of this program, underrepresented minority faculty members are defined as individuals belonging to a particular ethnic or racial group that has been determined by the grantee institution to be underrepresented in biomedical or behavioral research. Nationally, the NHLBI considers African American/Black, Hispanic, American Indian, Alaska Native and non-Asian Pacific Islanders to be underrepresented. At the time of award, it is required that at least two years have elapsed since the receipt of the doctoral degree and that the candidate have at least one year of documented research experience. Current or past Principal Investigators of an NIH grant or its equivalent, including the Clinical Investigator Award, Physician Scientist Award, Clinical Investigator Development Award, Mentored Clinical Scientist Development Award, or Mentored Patient-Oriented Research Career Development Award are not eligible for the NHLBI Mentored Minority Faculty Development Award. Similarly, individuals serving as responsible investigators or project leaders on large grants, such as a Program Project Grant, are not eligible for award. An individual who has previously received support from the Minority Access to Research Careers (MARC), Minority Biomedical Research Support (MBRS) Program, Academic Research Enhancement Award (AREA), or a minority supplement is eligible to apply. It is envisioned that most candidates for this award will hold non-tenured faculty appointments (such as instructor or assistant professor), although in some instances other individuals may be eligible to apply (such as individuals due to be appointed to a faculty position or individuals with tenured faculty positions). Guidelines for Special Leave: K01 Award recipients may take leave to train at another institution, take a leave of absence during the award period, or train at a lower level of effort for a longer period of time. K01 Award recipients should review a document describing the Special Leave Guidelines for Recipients of Mentored Career Awards at http://www.nhlbi.nih.gov/funding/training/redbook/sl_guide.htm which summaries NIH and NHLBI policies for these situations. SPECIAL REQUIREMENTS Applicant Institution Applications will be accepted from domestic colleges or universities, medical schools, or comparable institutions. The application must include a plan that identifies personnel and other resources to be devoted to the candidate. In addition, evidence of institutional commitment to the candidate's research development and level of effort should be included in a statement from the institution. The statement should also address the institution's plans for the candidate during and following the tenure of the award. The statement should be signed by an institutional official (e.g., a dean) and the candidate's department chair. Minority Candidate To receive an award under this program, individuals must have been awarded a doctoral degree, such as the Ph.D., M.D., D.O., D.V.M., or an equivalent degree at least two years prior to the award and have a full-time faculty appointment at an accredited college or university at the time of award. Candidates for this award must be either citizens or noncitizen nationals of the United States or have been admitted lawfully to the United States for permanent residence (i.e., in possession of the Alien Registration Receipt Card I-551, or some other legal verification of such status) by the time of the award. Noncitizen nationals are generally persons born in outlying possessions of the United States (i.e., American Samoa and Swains Island). An individual admitted lawfully for permanent residence must submit with the application a notarized statement indicating possession of the Alien Registration Receipt Card I-551. Individuals on temporary or student visas are not eligible. The candidate's academic background, previous experience, and career goals should determine both the necessary length and the kind of program that is appropriate. The applicant institution should provide a statement in the application that the candidate is a member of an underrepresented minority group and describe the evidence that this group is underrepresented. Three sealed letters addressing the candidate's potential for a research career must be submitted. The Mentor's Statement (see below) must not be included as one of these letters. Mentor Each candidate must identify a mentor(s) who is an accomplished investigator in the proposed research area and has experience in developing independent investigators. The mentor is not required to be affiliated with the applicant institution. If the mentor is affiliated with another institution, appropriate documentation must be provided concerning the relationship of the applicant institution and the mentor's institution, as well as a clear delineation of the arrangements proposed for the research development program at a location distinct from the applicant institution. The mentor must submit a written plan for the development of the candidate and provide guidance during the preparation of the research project. A secondary mentor may also be proposed, but the primary mentor must continue to be involved throughout the award period. In some cases candidates may choose to have both a basic research mentor or a research mentor and a career development mentor. The mentor must submit a report each year on the candidate's progress, which should be included in the annual progress report. Research Development Program All research development programs should be carefully tailored to meet the candidate's needs and must include a mentor(s) who is competent to provide appropriate research guidance. All candidates must provide a full description of the research and career development plan for the period of the award. The proposed plan must include hands-on research experience, with either a clinical or a basic science focus, for the entire three to five year period. Awardees, in conjunction with their mentor(s), are required to submit a detailed annual progress report. For minority candidates with minimal research experience, the development program may be designed to start with a creative and detailed scientific learning experience and progress to an intensive research activity under the guidance of an appropriate mentor(s). The first year or two of the program may incorporate any needed course work, and seminars and other educational experiences necessary to prepare the candidate for the subsequent research program, but must include a hands-on research experience. This initial phase of the program may resemble a traditional postdoctoral research training program. The remainder of the development plan could include an intensive, fully-described research program and research projects that can be reasonably completed within the planned period. During this latter phase, the program should provide for progressive development of the individual into an independent investigator. If the minority candidate has already acquired some research experience, as might be obtained through a research fellowship, but needs further development under the guidance of an appropriate mentor(s), the candidate may propose a three to five year program encompassing an advanced research experience focusing on a specific research project. Such a candidate may take additional courses or engage in special instruction in research techniques in other laboratories for a reasonable period of time if needed. During the latter phases of the award, the relationship of the mentor and candidate may more closely resemble that of collaborators. Individuals with significant research experience in the proposed field of study should not apply for this award but rather should consider applying for independent research grant support. Because the research training environment provides a powerful context in which to promote responsible research practices, all competing applications must include a description of formal or informal activities or instruction related to the responsible conduct of research that will be incorporated into the proposed research training program. Advisory Committee A committee composed of the candidate's mentor(s) and two or three other senior faculty members should be identified. This advisory committee should meet with the candidate to review the research development plan and research project, to evaluate the awardee's progress, and to provide guidance for scientific career development. The roles and scheduled meeting frequency of the Advisory Committee should be described in the application. Duration and Effort The award is granted for three to five years depending on the needs of the candidate and the evaluation of the initial review group and the National Heart, Lung, and Blood Advisory Council. It is not renewable and all funds must be used on behalf of the original candidate. Substitution of another mentor and/or a change of institution may be permitted with the prior approval of the NHLBI. A minimum of 75% effort must be devoted to the research program. The remainder may be devoted to other clinical and teaching pursuits that are consistent with the program goals; i.e., the candidate's development into an independent biomedical scientist or the maintenance of the teaching and/or clinical skills needed for an academic research career. The candidate must have a "full-time" appointment at the applicant institution. In general, candidates who have Veteran's Administration (VA) appointments may not consider part of the VA effort toward satisfying the "full-time" requirement at the applicant institution. However, it is permissible for part or all of the research program to be conducted in a VA laboratory, for example if the mentor has a VA appointment, so long as the above conditions are satisfied as they apply to the NHLBI Mentored Minority Faculty Development Award. Allowable Costs Salary - Individual compensation is based on the institution's salary scale for individuals at an equivalent experience level. The maximum salary for recipients of NHLBI K01 Career Awards is $75,000 per year plus commensurate fringe benefits for full-time professional effort (i.e., 75% to 100%). The salary must be consistent with both 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. The NHLBI Research Career Development Award Programs require the recipients to devote a minimum of 75% effort to the research plan being supported by the career development award; the remaining 25% effort should be devoted to research and research-related activities such as teaching, patient care, or other research-related activities. If 100% effort is to be devoted to the research program during the "summer months," the percent effort for the remainder of the year may be reduced provided that the effort over the course of the year is at least 75%. NIH policy permits supplementation of salary from non-Federal sources. Supplementation from other Federal funds is not allowed unless explicitly authorized by the program from which the funds are derived and the NHLBI. Under certain circumstances and with prior NHLBI approval, other NIH funds may be used for supplementary salary support if derived from a grant for which the awardee applied after receipt of the K01 award. Mentor's Salary - Salary support may be requested for the primary mentor up to a level commensurate with 5% effort. If the mentor is at a different institution than the applicant institution, arrangements for the transfer of funds for the mentor's salary and, if necessary, for research expenses should be formalized in a contract or written agreement with the mentor's institution and included as part of the application. The mentor's salary support is considered as separate and distinct from funds requested for the candidate's salary or research and development support. The percent effort may exceed 5% for selected periods of time, provided the total effort for the budget period (12 months) does not exceed 5%. If the mentor's salary is requested as a consortium cost, the subcontracting grantee is only allowed to request Facilities and Administrative Costs based on 8% of total allowable direct costs. The mentor=s salary should not be included in the research and development costs. Research and Development Costs - A maximum of $30,000 per year may be requested for research project requirements and related support, (e.g., technical personnel costs, supplies, equipment, candidate travel, telephone charges, publication costs, and tuition for necessary courses). Facilities and Administrative Costs - Funds will be provided for the reimbursement of facilities and administrative costs at a rate of 8% of the total direct costs of each award, exclusive of tuition, fees, and expenditures for equipment. Concurrent Applications NHLBI Mentored Minority Faculty Development Award applications may not be submitted or awarded concurrently with other NIH applications, such as the Independent Scientist Award, Mentored Clinical Scientist Development Award, Academic Award, Research Project Grant, or Mentored Patient-Oriented Research Career Development Award. Subsequent Applications for NIH Research Support During the later years of the NHLBI Mentored Minority Faculty Development Award (K01), incumbents are encouraged to apply for independent research support (e.g., R01, etc.). K01 recipients who are successful in obtaining subsequent NIH research grant support may not receive salary support from the research grant for the duration of the K01 award except under certain circumstances and with prior NHLBI approval. After the conclusion or termination of the K01 award, salary support should transfer to the research grant. K01 recipients who apply for subsequent research grant support are encouraged to include salary and all other research needs in the research grant application for the period following completion of the K01. Alternatively, recipients of research grant awards may terminate the K01 prior to the start of the research grant. Training in the Responsible Conduct of Research (RCR): Candidates must describe plans to receive instruction in the responsible conduct of research. The Public Health Service policy on RCR (http://ori.hhs.gov/policies/RCR_Policy.shtml#rcr) describes nine core instructional areas that comprise RCR: data acquisition, management, sharing, and ownership; mentor/trainee responsibilities; publication practices and responsible authorship; peer review; collaborative science; human subjects; research involving animals; research misconduct; and conflict of interest and commitment. Plans for RCR training must describe the proposed subject matter, format, frequency and duration of instruction. This description should be about one paragraph long and include an explicit statement that the candidate has taken or will take the course, and when. No award will be made if an application lacks this component. See the NIH website http://www.nih.gov/sigs/bioethics for resources and information on this topic. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: programmatic, review and financial or grants management issues: o Direct your questions about programmatic issues to: Lorraine M. Silsbee, M.H.S. Division of Epidemiology and Clinical Applications (responding for all NHLBI programmatic Divisions) National Heart, Lung, and Blood Institute 6701 Rockledge Drive, MSC 7934 Bethesda, MD 20892-7934 Telephone: (301) 435-0709 FAX: (301) 480-1667 Email: silsbeeL@nhlbi.nih.gov o Direct your questions about review issues to: Anne Clark, Ph.D. Chief, Review Branch Division of Extramural Affairs National Heart, Lung, and Blood Institute Two Rockledge Center, Room 7214 6701 Rockledge Drive, MSC 7924 Bethesda, MD 20892-7924 Bethesda, MD 20817 (for express mail) Telephone: (301) 435-0270 FAX: (301) 480-0730 Email: clarka@nhlbi.nih.gov o Direct your questions about financial or grants management matters to: Ms. Marsha D. Mathis Grants Management Specialist Division of Extramural Affairs National Heart, Lung, and Blood Institute National Institutes of Health 6701 Rockledge Drive, Room 7158, MSC 7926 Bethesda, MD 20892-7926 Telephone: (301) 435-0170 FAX: (301) 480-3310 Email: mathism@nhlbi.nih.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o A descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NHLBI staff to estimate the potential review workload and plan for the review. The letter of intent is to be sent to Dr. Anne Clark at the address listed under WHERE TO SEND INQUIRIES by May 22, 2003. 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. Refer to K section. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov. USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title (NHLBI MENTORED MINORITY FACULTY DEVELOPMENT AWARD) and number (HL-03-011) must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application and three 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) All grant applications submitted to the Center For Scientific Review (CSR) must come via United States Postal Service or a recognized delivery/courier service. Individuals may not personally deliver packages to the building on Rockledge Drive. For further information please see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html. At the time of submission, two additional copies of the application and all five collated sets of the appendix material must be sent to Dr. Anne Clark at the address listed under WHERE TO SEND INQUIRIES. APPLICATION PROCESSING: Applications must be received by June 23, 2003. If an application is received after that date, it will be returned to the applicant without review. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. 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. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to an RFA, it is to be prepared as a NEW application. That is the application for the RFA must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes. While the investigator may still benefit from the previous review, the RFA application is not to state explicitly how. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NHLBI. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by a Special Emphasis Panel in the Division of Extramural Affairs, NHLBI, in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Receive a written critique o Undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed and assigned a priority score o Receive a second level review by the National Heart, Lung, and Blood Advisory Council. REVIEW CRITERIA The following criteria will be considered when assessing the merits of the proposed NHLBI Mentored Minority Faculty Development Award Program: o Candidate -- The candidate's overall competence as demonstrated by previous training and research performance, potential for a career as an independent researcher, and commitment toward pursuit of an academic research career. o Career Development Plan -- The quality of the research career development plan, based on the candidate's past research experience, training, and career goals as demonstrated by such things as research experience, attendance at scientific meetings, and participation in journal clubs and research seminars. o Research Project -- Scientific merit of the proposed research project and its appropriateness as a vehicle for developing the candidate's research skills. o Mentor(s) -- The mentor's accomplishments in the scientific research area(s) proposed, experience and record in training investigators, and commitment for the duration of a candidate's research development. A curriculum vitae with relevant publications and a list of current and pending research support must be included for all mentors. Mentors should also include a list of current and past research trainees (not more than the last 10 years) with information on their current positions. This information should be provided for the co- mentor, if relevant and for the members of the Advisory Committee. o Environment -- The applicant institution's ability to provide adequate facilities, resources, and opportunities necessary for the candidate's training, and the institutional commitment to the candidate. If the mentor=s institution is different from the applicant institution, the quality and extent of interaction of the faculty in the basic and clinical sciences, and the quality of the research and research training programs. o Institutional Commitment -- The institution=s commitment to the development of the candidate. ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: 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 on 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. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the section on 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. o BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research and career development activities. Training in the Responsible Conduct of Research: Every predoctoral and postdoctoral NRSA trainee supported by an institutional research training grant must receive instruction in the responsible conduct of research. (For more information on this provision, see the NIH Guide for Grants and Contracts, Volume 21, Number 43, November 27, 1992, see http://grants.nih.gov/grants/guide/notice-files/not92-236.html. Applications must include a description of a program to provide formal or informal instruction in scientific integrity or the responsible conduct of research. Applications without plans for instruction in the responsible conduct of research will be considered incomplete and will be returned to the applicant without review. o Although the NIH does not establish specific curricula or formal requirements, all programs are encouraged to consider instruction in the following areas: conflict of interest, responsible authorship, policies for handling misconduct, data management, data sharing, and policies regarding the use of human and animal subjects. Within the context of training in scientific integrity, it is also beneficial to discuss the relationship and the specific responsibilities of the institution and the graduate students or postdoctorates appointed to the program. o Plans must address the subject matter of the instruction, the format of the instruction, the degree of faculty participation, trainee attendance, and the frequency of instruction. o The rationale for the proposed plan of instruction must be provided. o Program reports on the type of instruction provided, topics covered, and other relevant information, such as attendance by trainees and faculty participation, must be included in future competing continuation and noncompeting applications. The NIH encourages institutions to provide instruction in the responsible conduct of research to all graduate students, postdoctorates, and research staff regardless of their source of support. NIH initial review groups will assess the applicant's plans on the basis of the appropriateness of topics, format, amount and nature of faculty participation, and the frequency and duration of instruction. The plan will be discussed after the overall determination of merit, so that the review panel's evaluation of the plan will not be a factor in the determination of the priority score. Plans will be judged as acceptable or unacceptable. The acceptability of the plan will be described in an administrative note on the summary statement. Regardless of the priority score, applications with unacceptable plans will not be funded until the applicant provides a revised, acceptable plan. Staff within the NIH awarding component will judge the acceptability of the revised plan. Following initial review, the NHLB Advisory Council provides a second level review. The Council will consider the assessment of the scientific and educational merit of the research training grant application as well the plan for instruction in the responsible conduct of research. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: May 22, 2003 Application Receipt Date: June 23, 2003 Peer Review Date: October/November 2003 Council Review: February 2004 Earliest Anticipated Start Date: April 1, 2004 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific and career development merit (as determined by peer review) o Availability of funds o Programmatic priorities. REQUIRED FEDERAL CITATIONS HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. 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, NIH Guide for Grants and Contracts, June 12, 1998: 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 "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (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. 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. 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 RFA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance No. 93.233, 93.837, 93.838, and 93.839 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. 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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