NHLBI MINORITY INSTITUTIONAL RESEARCH TRAINING PROGRAM (T32) RELEASE DATE: March 14, 2003 RFA: HL-03-013 (see continuation RFA-HL-04-027) 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 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 Minority Institutional Research Training Program is a Ruth L. Kirschstein National Research Service Award Program intended to support training of graduate and health professional students and individuals in postdoctoral training at minority schools having the potential to develop meritorious training programs in cardiovascular, pulmonary, hematologic, and sleep disorders. Graduate and health professional students and individuals in postdoctoral training in minority schools need further opportunities to develop biomedical and behavioral research skills. The NHLBI Minority Institutional Research Training Program is designed to attract students in their developmental stages; to increase their awareness of cardiovascular, pulmonary, hematologic, and sleep disorders research; and to encourage them to pursue research career opportunities in these areas. RESEARCH OBJECTIVES Although the number of underrepresented minority individuals (Blacks, Hispanics, Native Americans) pursuing advanced degrees in the biomedical and behavioral sciences increased over the past 20 years, their representation in these fields remains below their representation in the U.S. population (National Research Council, Survey of Earned Doctorates, 2000). There are existing programs at the NIH that are designed to increase the number of minorities in biomedical and behavioral research. These include the Minority Biomedical Research Support Program, the Minority Access to Research Careers Program, and the Research Supplements for Underrepresented Minorities Program. Even though these programs appear successful in meeting their specific objectives and career development goals, more needs to be done to attract minorities to biomedical and behavioral research careers. The NHLBI Minority Institutional Research Training Program makes research training grant awards in cardiovascular, pulmonary, hematologic, and sleep disorders research to minority schools to enable qualified graduate and health professional students and individuals in postdoctoral training to participate in research programs. It is expected to attract students in their developmental stages, increase their awareness of these diseases, and to encourage them to pursue career opportunities in research related to the mission of the National Heart, Lung, and Blood Institute (NHLBI). MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) Ruth L. Kirschstein Institutional National Research Service Award (NSRA) mechanism (T32). Responsibility for the planning, direction, and execution of the proposed training program will be solely that of the applicant. The total project period for an application submitted in response to this RFA may not exceed five years. Funds will be provided on an annual basis to develop and maintain a stable research training experience for qualified students. Successful applicants may compete for a second or subsequent awards of up to five years' duration upon completion of the initial grant period. Funding beyond the first year of the grant is contingent upon satisfactory progress during the preceding year and availability of funds. 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 $250,000 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. Two new awards are anticipated. Facilities and Administrative Costs will be awarded based on 8% of total direct costs exclusive of tuition, and fees. 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 The Institution must be a domestic college or university with student enrollment drawn substantially from minority ethnic groups (including African Americans/Blacks, Hispanics, American Indians, Alaska Natives, and non-Asian Pacific Islanders). It must have the ongoing staff and facilities required for the proposed program. The program director at the minority school will be responsible for the selection and appointment of students and the overall direction of the program. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as program directors. Foreign institutions are not eligible to apply. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS/PROGRAM DIRECTORS Any individual with the skills, knowledge, and resources necessary to organize and implement a high quality research training program is invited to work with their institution as the director of the research training program in order 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. The research training program director at the institution will be responsible for the selection and appointment of trainees to the NRSA research training grant and for the overall direction, management, and administration of the program. SPECIAL REQUIREMENTS Research Center The minority institution must identify and collaborate with a research center (medical school or comparable institution) that has strong, well-established cardiovascular, pulmonary, hematologic, or sleep disorders research and research training programs. Cooperation and collaboration between institutions is needed to provide each trainee with a mentor who is recognized as an accomplished investigator in cardiovascular, pulmonary, hematologic or sleep disorders research and who will assist the advisor at the minority institution with the trainee's development and research plan. Plans for summer training as well as academic year training should be developed by the student and advisor at the trainee's home institution in collaboration with the mentor at the research center. It is expected that both advisor and mentor will guide the trainee through the initial training period and continue this interaction throughout the award. The development of strong mentoring relationships is essential to the success of the trainees and the program. The minority institution will identify and complete arrangements with an established cardiovascular, pulmonary, hematologic, or sleep disorders research center(s) before submitting an application. Arrangements between the participating institutions for the recruitment of trainees and joint selection of trainers for the provision of training, and for ongoing cooperation and collaboration between the institutions in the implementation of the program, should be clearly outlined in the application. Trainees Trainees appointed to the training program must have the opportunity to carry out supervised biomedical or behavioral research with the primary objective of developing or extending their research skills and knowledge in preparation for a research career. A trainee must be a citizen or non-citizen national of the United States or must have been lawfully admitted for permanent residence (i.e., in possession of a currently valid Alien Registration Receipt Card I-551, or some other legal verification of such status). Non-citizen nationals are generally persons born in outlying possessions of the United States (e.g., American Samoa and Swains Island). Individuals on temporary or student visas are not eligible. Trainees can fall into one of the following categories: Predoctoral Trainees. Predoctoral trainees must have received a baccalaureate degree by the beginning date of their NRSA appointment, and must be training at the postbaccalaureate level and enrolled in a program leading to a Ph.D. in science or in an equivalent research doctoral degree program. Health- professional students, graduate students in the quantitative sciences, or individuals in postgraduate clinical training who wish to interrupt their studies for a year or more to engage in full-time research training before completing their formal training programs are also eligible. Postdoctoral Trainees. Postdoctoral trainees must have received, as of the beginning date of the NRSA appointment, a Ph.D., M.D., D.D.S., or comparable doctoral degree from an accredited domestic or foreign institution. Eligible doctoral degrees include, but are not limited to, the following: D.M.D., D.C., D.O., D.V.M., O.D., D.P.M., Sc.D., Eng. D., Dr. P. H., D.N.Sc., Pharm.D., N. D. (Doctor of Naturopathy), D.S.W., and Psy.D. Documentation by an authorized official of the degree-granting institution certifying all degree requirements have been met prior to the beginning date of training is acceptable. Short-Term Health Professional Trainees. To be eligible for short-term predoctoral research training positions, students must be enrolled and in good standing and must have completed at least one quarter in a program leading to a clinical doctorate or a masters or doctorate in a quantitative science such as physics, mathematics, or engineering prior to participating in the program. Individuals already matriculated in a formal research degree program in the health sciences, or those holding a research doctorate or master's degree or a combined health-professional/research doctorate normally are not eligible for short-term training positions. Within schools of pharmacy, only individuals who are candidates for the Pharm.D. degree are eligible for short-term positions. Positions on NRSA institutional grants may not be used for study leading to the M.D., D.D.S., or other clinical, health-professional training except when those studies are a part of a formal combined research degree program, such as the M.D./Ph.D. Similarly, trainees may not accept NRSA support for clinical training that is a part of residency training leading to clinical certification in a medical or dental specialty or subspecialty. It is permissible and encouraged, however, for clinicians to engage in NRSA supported full-time, postdoctoral research training even when that experience is creditable toward certification by a clinical specialty or subspecialty board. Trainees are required to pursue their research training on a full-time basis, devoting at least 40 hours per week to the program. Within the 40 hours per week training period, research trainees who are also training as clinicians must devote their time to the proposed research training and must confine clinical duties to those that are an integral part of the research training experience. Provisions Of The Award o The trainees may be appointed for 9 - 12 months at any time during the course of the budget period. Students must be enrolled on a full-time basis. A strong interest in a cardiovascular, pulmonary, hematologic, or sleep disorder research career must be evident. Short-term training positions for health professional students are allowed under this program. Predoctoral trainees appointed to the grant may receive support for up to five years. Postdoctoral trainees appointed to the grant may receive support for up to three years. o A written commitment to the training plan signed by the intended faculty mentors at the research center, the department(s) involved and countersigned by both institutional officials, must be part of the application. The trainee and his or her faculty advisor at the minority institution will jointly select a faculty mentor at the research center. o Procedures for annual evaluation of the program should include plans to measure the impact of the program on the individual students and plans to measure the trainees' progress. The evaluation procedures should also describe plans to monitor the future career course of individual trainees, to evaluate the effectiveness of the overall program, and assess the impact of the training program on the institution. It should also include plans for assessing the effectiveness of the mentoring relationship and the training plan. Funds may be requested for: A. Stipends - The current stipend level for graduate and health professional student trainees at all levels of experience is $18,156 per year. Current stipend levels for postdoctoral trainees are available at http://grants.nih.gov/training/nrsa.htm. B. Tuition, Fees, and Health Insurance - The combined cost of tuition, fees, and health insurance (either self-only or family as appropriate) will be offset at the following rate: 100% of all costs up to $3,000 and 60% of costs above $3,000 per trainee. Costs associated with tuition and fees are allowable only if they are required for specific courses in support of the research training experience supported by the training grant. A full description of the tuition policy is contained within the NRSA Policy Guidelines on the NIH website at: http://grants.nih.gov/grants/policy/nihgps_2001/part_iib_3.htm C. Trainee Travel Costs - The institution may request funds to cover the costs of trainees, travel, including attendance at scientific meetings, that are necessary to the individual's training. The maximum allowable per student per year is $1,400. D. Training-related Expenses - Institutional costs of $2,200 a year per predoctoral trainee and $3,850 a year per postdoctoral trainee may be requested to defray the costs of other research training related expenses, such as staff salaries, consultant costs, equipment, research supplies, and staff travel. E. Facilities and Administrative Costs - The Notice of Grant Award will provide facilities and administrative costs based on 8% of total direct costs, exclusive of tuition, and fees. F. Short-Term Training - Applicants who wish to include a request for short- term research training positions should identify short-term positions separately within the "stipends" and "training related expenses" categories on the budget page. Under "stipends," short-term positions should be listed in the "other" category. Tuition, fees, health insurance, and trainee travel, and other expenses are to be included in "training related expenses." Within each section of the program plan, a separate description of the short-term training should be included. The applicant should address the relationship of the proposed short-term training to the regular research training and provide assurance that the short-term program will not detract from the regular program. Applicants must observe the 25-page limit on the narrative section. Payback Agreement - As specified in the NIH Revitalization Act of 1993, NRSA recipients incur a service payback obligation only during their first 12 months of postdoctoral support. Additionally, the NIH Revitalization Act of 1993 specifies that the second and subsequent years of postdoctoral NRSA training will serve to pay back a postdoctoral service payback obligation. Accordingly, the following guidelines apply: o Predoctoral trainees are not required to sign the payback agreement and do not incur a service payback obligation. o Postdoctoral trainees in the first 12 months of postdoctoral NRSA support must sign the payback agreement form (PHS form 6031) before initiating an appointment. Postdoctoral trainees in their first 12 months of support will incur a period of service payback obligation equal to the period of support. o Postdoctoral trainees in the 13th and subsequent months of NRSA postdoctoral support are not required to sign the payback agreement form and will not incur a service payback obligation. o The 13th and subsequent months of postdoctoral NRSA support are considered acceptable payback service for prior postdoctoral support. For example, postdoctoral trainees who continue under that award for 2 years have fulfilled the obligation incurred during the first 12 months of support by the end of the second year. Simple guidelines for completing the payback requirement are available at http://www.nhlbi.nih.gov/funding/policies/t32/payback.htm. Service payback obligations can also be paid back by conducting health-related research or teaching averaging more than 20 hours per week of a full work year after terminating NRSA support. o Recipients with service obligations must begin to provide service on a continuous basis within two years of termination of NRSA support. The period for undertaking payback service may be delayed for such reasons as temporary disability, completion of residency requirements, or completion of the requirements for a graduate degree. Requests for an extension must be made in writing to the NIH specifying the need for additional time and the length of the required extension. o Recipients of NRSA support are responsible for informing the NIH of changes in status or address. o For individuals who fail to fulfill their obligation through service, the United States is entitled to recover the total amount of NRSA funds paid to the individual for the obligated period plus interest at a rate determined by the Secretary of the Treasury. Financial payback must be completed within three years beginning on the date the United States becomes entitled to recover such amount. o Under certain conditions, the Secretary, U.S. Department of Health and Human Services (or those delegated this authority) may extend the period for starting service or repayment, permit breaks in service, or in rare cases in which service or financial repayment would constitute an extreme hardship, may waive or suspend the payback obligation of an individual. o Officials at the awardee institution have the responsibility of explaining the terms of the payback requirements to all prospective training candidates before appointment to the training grant. Additionally, all trainees recruited into the training program must be provided with information related to the career options that might be available when they complete the program. The relationship of the positions available and the training provided must also be discussed along with the applicability of these positions to any outstanding service payback obligation. A Statement of Appointment form (PHS 2271, rev. 5/01) must be submitted at the start of each trainee appointment and reappointment. This form is available at the following URL address: http://grants.nih.gov/training/phs2271.pdf. Postdoctoral individuals supported under this program are required to sign an NRSA Payback Agreement and all appointed trainees are required to submit an NRSA Termination Notice. Training in the Responsible Conduct of Research (RCR): The application must include a description of plans to provide 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. 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: Sandra Colombini Hatch, M.D. Division of Lung Diseases (responding for all NHLBI programmatic Divisions) National Heart, Lung, and Blood Institute National Institutes of Health 6701 Rockledge Drive, MSC 7952 Bethesda, Maryland 20892-7952 Telephone: (301) 435-0222 FAX: (301) 480-3557 Email: HatchS@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: Beckie Chamberlin Grants Management Specialist National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Room 7144, MSC 7926 Bethesda, Maryland 20892-7926 Telephone: (301) 435-0174 FAX: (301) 480-1948 Email: chamberr@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 T 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 MINORITY INSTITUTIONAL RESEARCH TRAINING PROGRAM) and number (HL-03- 013) 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/labels.pdf. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the Checklist, and three signed photocopies, in one package to: Center For Scientific Review National Institutes Of Health 6701 Rockledge Drive, 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 in the evaluation of the proposed NHLBI Minority Institutional Research Training Program: o Design of the proposed training program; o Qualifications, dedication, and previous training record of the program director and all participating faculty, particularly with regard to prior experience with similar programs; o Adequacy of facilities, environment, and resources for the proposed research training, both at the minority institution and the collaborating research center; o Adequacy of the cooperative arrangements between the minority institution and the collaborating research center; o Recruitment and selection plans for trainees, and the availability of high quality candidates; o Methods for retaining promising students in the program and methods for tracking students; o Commitment of the relevant faculty and the two institutions to the goals of the training program; and o Procedures for evaluation of the effectiveness of the program and impact of the program on the trainees involved. 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. 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, NHLBI Advisory Council provides a second level of 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 training 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. 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. 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 Section 487 of the Public Health Service Act as amended (42 USC 288) and administered under NIH grants policies described at http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 66. 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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