NICHD INSTITUTIONAL TRAINING FOR PEDIATRICIANS Release Date: May 16, 2002 RFA: HD-02-019 National Institute of Child Health and Human Development (NICHD) ( Letter of Intent Receipt Date: July 17, 2002 Application Receipt Date: August 16, 2002 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Program Objectives o Mechanism of Support o Funds Available o Eligible Institutions o Eligible Training Program Directors o Eligible Trainees o Special Program Considerations o Stipend Supplementation, Compensation, and Other Income o Service Payback o Trainee Reporting Requirements o Leave 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 National Institute of Child Health and Human Development (NICHD) invites applications for Institutional National Research Service Awards (NRSA) to establish programs of postdoctoral pediatrics research training in basic science or clinical research. The NICHD will award these Institutional Training Grants to eligible institutions to develop or enhance research training opportunities for individuals, selected by the institution, who are training for careers in pediatrics research. The purpose of this NRSA program is to help ensure that a diverse and highly trained workforce of pediatricians is available to assume leadership roles related to the Nation"s biomedical and behavioral research agenda in areas of child health. This initiative responds to language in The Children"s Health Act of 2000 recommending support for the expansion or initiation of programs to train new investigators in pediatrics. The Institutional Training Grant is a mechanism for the postdoctoral training of physicians who may have extensive clinical training, but limited research experience. Such individuals would benefit from a period during which there is protection from clinical and teaching responsibilities for further development of knowledge and skills. The goal is to provide an environment in which trainees can acquire the skills necessary to carry out scientific investigation. This environment should provide the time, expertise, and guidance to enable trainees to gain critical knowledge of an area of research. For those embarking on basic science research, courses in molecular biology techniques should be an integral part of the training and may be a part of a research degree program. For those interested in clinical research, courses in epidemiology, ethics, and biostatistics should be an integral part of the training. In addition, trainees should develop skills in writing and should be instructed in the preparation of manuscripts and grant applications. Research training positions should last at least nine months and must not exceed three years. In most cases, postdoctoral trainees should agree to engage in at least two years of research, research training, or comparable activities beginning at the time of appointment because the duration of training has been shown to be strongly correlated with successful post-training research activity. PROGRAM OBJECTIVES Background The NICHD Institutional Training Grant for Pediatricians provides pediatric research institutions with the funds to recruit and train qualified physician investigators. The primary objective of the program is to promote the development of a diverse and highly trained workforce of pediatrician scientists to assume leadership roles related to the Nation"s biomedical and behavioral research efforts in the area of child health. Established investigators will serve as mentors for physicians who are within the training period described in this RFA. There is currently a shortage of such training opportunities for pediatricians who intend to pursue research careers. The U.S. Congress has noted the absence of such training opportunities and has, in the Children"s Health Act of 2000, recommended that the NICHD support the expansion of existing programs or initiation of new programs to train new investigators in pediatrics. The ultimate objective of this program is to produce a well-qualified cadre of academic pediatricians who will be capable of successfully competing for NIH support. Training Grant Program Directors, therefore, should limit appointments to individuals who are committed to a career in research and plan to remain on the training grant or in some other type of research training experience for a minimum of two years. It is anticipated that many of the trainees will be encouraged to pursue further training in basic science or clinical research via individual research career development awards (K-series mechanisms). During the review of applications, peer reviewers will examine the training record of the department to determine the average duration of training appointments for trainees and whether there is a record of transition to independent support mechanisms. Scope of Training Institutional research training grants (T32) are a desirable mechanism for the postdoctoral training of physicians who may have extensive clinical training, but have limited research experience. For such individuals, the training may be a part of a research degree program. Master"s level coursework in, but not limited to, areas such as epidemiology and clinical trials methodology may be an integral part of the program. Established investigators from basic science departments may be included as mentors to supply expertise and resources, provided the emphasis remains on research that has some relevance to clinical pediatrics and is consistent with the goals of the program. Applications should describe the basic science department"s contribution to the research training experience. Although mentors from collaborating departments may provide expertise and resources, the emphasis should remain on research relevant to child health. Multidisciplinary studies are encouraged although the research of the applicant department may focus on a single theme. The training program will provide each trainee with two years of full-time postdoctoral research training, including didactic instruction, mentoring, and supervised research experience. Plans must be presented for each trainee to be guided by a qualified mentor. The mentor should be recognized as an accomplished investigator and have a track record of success in training independent investigators. The training program may be integrated into the last year of a residency program in pediatrics or integrated into a fellowship program in a subspecialty area of pediatrics. The application should provide details about how a curriculum will be developed and what it will include. Appropriate topics to be addressed include, but are not limited to, human subjects protection, research ethics, clinical trial methodologies, biostatistics, genetics, cellular and molecular biology, and state-of-the-art laboratory technologies such as genomics, proteomics, and bioinformatics. MECHANISM OF SUPPORT This RFA will use the NIH Institutional Training Grant (T32) award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. Future unsolicited, competing continuation applications based on this project will compete with all investigator- initiated applications and will be reviewed according to the customary peer review procedures. The anticipated award date is May 2003. FUNDS AVAILABLE The NICHD intends to commit approximately $1.2 million in total costs [Direct plus Facilities and Administrative (F&A) costs] in FY 2003 to fund up to six new institutional training grants in response to this RFA. In general, at least three, and no more than five, postdoctoral trainees per year may be proposed for training. Smaller departments may request two trainees for the first year of the grant. New trainee appointments can be made by the department as those originally appointed complete their training. Each trainee may receive two years of support with a possibility of extending for a third year. Although the financial plans of the NICHD 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 meritorious applications. At this time, it is not known if this RFA will be reissued. ELIGIBILE INSTITUTIONS Only domestic, non-profit, private or public institutions may apply for grants to support research training programs. The applicant institution must have a strong research program in the area(s)proposed for research training and must have the requisite staff and facilities to carry out the proposed program. ELIGIBLE TRAINING PROGRAM DIRECTORS Training programs with a focus on subspecialty areas generally considered to have inadequate numbers of trainees (such as pediatric endocrinology) are encouraged to apply. 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. Trainees appointed to the 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 in pediatrics. The applicant must have access to a training environment with ongoing basic or clinical research and/or clinical trials, preferably including several subspecialty areas of pediatrics. The applicant organization may be a professional organization that will serve as a coordinating center for a training program implemented through collaborations with qualified academic pediatric departments. The Principal Investigator must be the Chairperson of the Department of Pediatrics or the Chief of the Pediatric Service. When the applicant is a professional organization, the Principal Investigator is the key person directing the organization or an individual in charge of research development. The Program Director may be the department head or another individual in the Department of Pediatrics involved in residency or fellowship training. ELIGIBLE TRAINEES Positions on NRSA institutional grants may not be used for study leading to the M.D., D.D.S., or other clinical, health-professional degrees except when those studies are a part of a formal combined research degree program, such as the M.D./Ph.D. It is permissible and encouraged for clinicians to engage in NRSA-supported full-time, postdoctoral research when that experience is creditable toward certification by a clinical specialty or subspecialty board. Pediatric residents may interrupt their studies to engage in an extended period of full-time research training before completing their clinical training. 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. The trainees appointed under this program must hold, as of the beginning date of the NRSA appointment, an M.D. or D.O. degree from an accredited domestic or foreign institution and have completed, or be within one year of completing, postgraduate clinical training in pediatrics in an ABP-approved residency program. To be appointed to a training position supported by an NRSA research training grant, an individual must be a citizen or noncitizen 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). Noncitizen 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. SPECIAL PROGRAM CONSIDERATIONS The primary objective of the NRSA program is to prepare qualified individuals for careers that significantly impact the Nation"s research agenda. Within the framework of the program"s longstanding commitment to excellence and projected need for investigators in particular areas of research, attention must be given to recruiting individuals from racial or ethnic groups underrepresented in the biomedical and behavioral sciences. The following groups have been identified as underrepresented in biomedical and behavioral research nationally: African Americans, Hispanic Americans, Native Americans, Alaskan Natives, and Pacific Islanders. Use of the term "minority" in this announcement will refer to these groups. Other considerations relate to the duration of training and the transition of trainees to individual support mechanisms. Studies have shown that the length of the appointment to a training grant for postdoctoral trainees with health-professional degrees strongly correlates with subsequent application for and receipt of independent NIH research support. Training grant program directors, therefore, should limit appointments to individuals who are committed to a career in research and plan to remain on the training grant or in some other type of research experience for a minimum of 2 years. It has also been shown that individuals who have been supported by an individual postdoctoral fellowship are more likely to subsequently apply for and receive NIH research support than are individuals who have received support only from a research training grant. Therefore, program directors should encourage postdoctoral trainees who have proceeded beyond the didactic part of their training to apply for individual postdoctoral fellowships or mentored career development awards (K awards). During the review of training grants applications, peer reviewers will examine the training record to determine the average duration of training appointments for health-professional postdoctoral trainees and whether there is a record of transition to individual support mechanisms. Past studies have shown that health professional trainees, who train in combined programs with post-doctoral researchers with an intensive research background, are more likely to apply for and receive research grant support. Programs located in clinical departments that focus on research training for individuals with an M.D. or other health-professional degrees should consider developing ties to basic science departments or modifying their program to include individuals with research doctoral degrees when such changes are consistent with the goals of the program. Applications should describe the basic science department"s contribution to the research training experience and also indicate if both health professional trainees and trainees with research doctorates are included in the training program. Individual Training Plans Plans also must be presented for the means by which individual trainee needs and goals will be developed and addressed. Plans for ongoing program evaluation and mechanisms to improve course content, mentoring, and supervised research experiences must be included. Trainees should have a period of research training and career development consistent with his or her previous research and clinical experience. For a trainee with limited experience in a given field of research, a phased program, including a period of didactic training followed by a period of mentored research experience, may be the most effective means of attaining independence. A trainee with previous research experience and training may not require extensive additional didactic preparation, and a shorter program that focuses on mentored research experience may be most appropriate. The didactic and research components of both phases must develop new knowledge and research skills in scientific areas relevant to the career goals of the trainee. ALLOWABLE COSTS Stipends: National Research Service Awards provide funds, in the form of stipends, to physician trainees. A stipend is provided as a subsistence allowance to help trainees defray living expenses during the research training experience. It is not provided as a condition of employment with either the Federal Government or the awardee institution. Stipends must be paid to all trainees at the levels approved by the Secretary of the Department of Health and Human Services. Stipend levels are adjusted occasionally, and current stipend levels are available on the NIH website at: The current annual stipend for postdoctoral trainees is determined by the number of FULL years of relevant postdoctoral experience at the time of appointment. Relevant experience may include research experience (including industrial), teaching, internship, residency, clinical duties, or other time spent in full-time studies in a health-related field following the date of the qualifying doctoral degree. Stipend levels for Fiscal Year 2003 and beyond may change. Consult the NIH website above for the future announcements of stipend levels. Postdoctoral stipends for awards made with FY 2002 funds are as follows: Years of Postdoctoral Experience Annual Amount 0 $ 31,092 1 $ 32,820 2 $ 38,712 3 $ 40,692 4 $ 42,648 5 $ 44,616 6 $ 46,584 7 or more $ 48,852 Tuition, Fees, and Health Insurance: The NIH will offset the combined cost of tuition, fees, and health insurance (either self-only or family, as appropriate) at the following rate: 100 percent of all costs up to $3,000 and 60 percent of costs above $3,000. Costs associated with tuition, fees, and health insurance are allowable only if they are required for all individuals in a similar research training status at the institution regardless of the source of support. A full description of the tuition policy is contained within the NRSA Policy Guidelines on the NIH website at: Other Trainee Costs: Trainee travel, including attendance at scientific meetings that the institution determines to be necessary to the individual"s research training, is an allowable trainee expense. In addition, support for travel to a research training experience away from the institution may be permitted. Research training experiences away from the parent institution must be justified and should consider the type of opportunities for training available, the manner in which these opportunities differ from and complement those offered at the parent institution, and the relationship of the proposed experience to the trainee"s career stage and goals. This type of research training requires prior approval from the NICHD. Letters requesting such training may be submitted to the NICHD at any time during the award period. Under exceptional circumstances, which may include providing accommodations for a trainee with disabilities, it is possible to request institutional costs above the standard rate. Requests for additional trainee costs must be explained in detail and carefully justified in the application. Consultation with NICHD program staff in advance of such requests is strongly advised. Training Related Expenses: Institutional costs of $3850 per 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. Facilities and Administrative Costs: A Facilities and Administrative (F & A) allowance (indirect cost allowance) based on eight percent of total allowable direct costs (this excludes amounts for tuition, fees, health insurance, and equipment) may be requested. See NRSA Policy Guidelines on the NIH Website at: STIPEND SUPPLEMENTATION, COMPENSATION, AND OTHER INCOME No departure from the established stipend schedule may be negotiated by the institution with the trainee. For postdoctoral trainees, the stipend for each additional full year of research training support is the next level in the stipend structure and does not change in the middle of an appointment. The grantee institution is allowed to provide funds to an individual in addition to the stipends paid by the NIH. Such additional amounts may be either in the form of augmented stipends (supplementation) or in the form of compensation, such as salary or tuition remission for services such as teaching or serving as a laboratory assistant, provided the conditions described below are met. Under no circumstances may the conditions of stipend supplementation or the services provided for compensation interfere with, detract from, or prolong the trainee"s approved NRSA training program. For complete information on Stipend Supplementation, Compensation, Educational Loans, G.I. Bill, Concurrent Awards, and Tax Liability, see the current announcement for NRSA Institutional Research Training Grants (T32), available on the Internet at SERVICE PAYBACK 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. The applicable guidelines for the payback provision are presented in the current Institutional Research Training Grant announcement at TRAINEE REPORTING REQUIREMENTS The institution must submit a completed Statement of Appointment (PHS Form 2271) for each trainee appointed or reappointed to the training grant at the beginning of the appointment period. Additionally, a completed Payback Agreement (PHS Form 6031) must be submitted for each trainee in their first 12 months of postdoctoral support. Within 30 days of the end of the total support period for each trainee, the institution must submit a Termination Notice (PHS Form 416-7). Failure to submit the required forms in a timely, complete, and accurate manner may result in an expenditure disallowance or a delay in any continuation funding for the award. LEAVE In general, trainees may receive stipends during the normal periods of vacation and holidays observed by individuals in comparable training 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 research training and is not considered to be a vacation or holiday. Trainees may receive stipends for up to 15 calendar days of sick leave per year. Sick leave may be used for the medical conditions related to pregnancy and childbirth. Trainees may also receive stipends for up to 30 calendar days of parental leave per year for the adoption or the birth of a child when those in comparable training 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 training experience longer than specified here must seek approval from the NICHD for an unpaid leave of absence. At the beginning of a leave of absence, the trainee must submit a Termination Notice (PHS Form 416-7) and upon return from the leave of absence, the trainee must be formally reappointed to the grant by submitting an updated Statement of Appointment (PHS Form 2271). Trainees within the first 12 months of postdoctoral support must also submit a Payback Agreement (PHS Form 6031) upon return from a leave of absence. 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: scientific/research, peer review, and financial or grants management issues: o Direct your questions about scientific/research issues to: Karen K. Winer, M.D. Endocrinology, Nutrition and Growth Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Suite 4B11, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 435-6877 FAX: (301) 480-9791 Email: o Direct your questions about peer review issues to: Robert H. Stretch, Ph.D. Acting Director, Division of Scientific Review National Institute of Child Health and Human Development 6100 Executive Blvd., Room 5B01, MSC 7510 Bethesda, MD 20892-7510 Rockville, MD 20852 (for express/courier service) Telephone: (301)496-1485 FAX: (301)402-4104 Email: o Direct your questions about financial or grants management matters to: Mary E. Daley Grants Management Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Suite 8A17, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-1305 FAX: (301) 402-0915 Email: LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes a descriptive title of the proposed program, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the 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 NICHD staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to: Karen K. Winer, M.D. Endocrinology, Nutrition and Growth Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Suite 4B11, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 435-6877 FAX: (301) 480-9791 Email: 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 in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: SUPPLEMENTAL INSTRUCTIONS: The special instructions for Institutional National Research Service Awards (T32) presented in the PHS 398 must be followed, including all components and page limits. Applicants may request up to five years of support through the T32 mechanism. The applicant should justify the number of full-time postdoctoral training positions requested. Tuition, fees, health insurance, and trainee travel, and other expenses are to be included in "training related expenses." 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 and number 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: 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) At the time of submission, two additional copies of the application must be sent to: Robert H. Stretch, Ph.D. Acting Director, Division of Scientific Review National Institute of Child Health and Human Development 6100 Executive Blvd., Room 5B01, MSC 7510 Bethesda, MD 20892-7510 Rockville, MD 20852 (for express/courier service) APPLICATION PROCESSING: Applications must be received by the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an Introduction addressing the previous critique. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and for responsiveness to this RFA by NICHD. 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 an appropriate peer review group convened by the NICHD 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 Advisory Child Health and Human Development Council. REVIEW CRITERIA o Past research training record of both the program and the designated preceptors as determined by the success of former trainees in seeking further career development and in establishing productive scientific careers. Evidence of further career development can include receipt of fellowships, career development awards, further training appointments, and similar accomplishments. Evidence of a productive scientific career can include a record of successful competition for research grants, receipt of special honors, a record of publications, receipt of patents, promotion to scientific positions, and any other measure of success consistent with the nature and duration of the training received. o Objectives, design, and direction of the research training program and plans for implementation. o Caliber of well-funded, established investigators who can act as mentors to the trainees. The ongoing research at the institution should not be narrowly defined and should encompass several subspecialty areas of pediatrics. In addition, areas of expertise may include molecular biology techniques, biostatistics, epidemiology, and clinical trials. o The institutional training environment, including institutional commitment to the program, quality of the facilities, availability of appropriate courses, and availability of research support. o Recruitment and selection plans for trainees and the availability of a pool of high quality candidates. o The probability that this training experience will contribute notably to the scientific development of trainees. o Likelihood that the postdoctoral trainees will continue their research training or other research activities for at least two years. Record of the research training program (or similar programs at the institution) in retaining health-professional postdoctoral trainees in research training or other research activities. ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: o PROTECTIONS: The adequacy of the proposed protection for humans, animals, or the environment, to the extent they may be adversely affected by the project proposed in the application. o INCLUSION: 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 included in the section on Federal Citations, below) o BUDGET: The reasonableness of the proposed budget and the requested period of support. OTHER REVIEW CONSIDERATIONS (1) Minority Recruitment Plan The plan will be discussed after the overall determination of merit. The review panel"s evaluation will not be a factor in the determination of the priority score, but 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. NICHD staff, with guidance from the National Advisory Child Health and Human Development Council, will determine whether amended plans are acceptable. (2) Plans for Training in the Responsible Conduct of Research 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. NICHD staff will judge the acceptability of the revised plan. The National Advisory Child Health and Human Development Council will consider, in addition to the reviewers" assessment of the scientific and educational merit of the application, the comments on the recruitment of individuals from under-represented minority groups into the research training program and the plan for instruction in the responsible conduct of research. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: July 17, 2002 Application Receipt Date: August 16, 2002 Peer Review Date: October/November 2002 Council Review: January 2003 Earliest Anticipated Start Date: May 1, 2003 AWARD CRITERIA Criteria that will be used to make award decisions include: o Responsiveness to the purpose of this RFA, o Quality of the proposed training program, as determined by peer review, o Availability of funds. REQUIRED FEDERAL CITATIONS INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 ( files/NOT-OD-02-001.html), a complete copy of the updated Guidelines is available at 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 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 HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at and at Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see It is the responsibility of the applicant to provide the official NIH identifier(s)for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at 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 AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance No. 93.865, Research for Mothers and Children, and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are administered under NIH grants policies described at NRSA Institutional Research Training Grants are made under the authority of Section 487 of the Public Health Service Act as amended (42 USC 288). Title 42 of the Code of Federal Regulations, Part 66, is applicable to this program. 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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