NICHD INSTITUTIONAL TRAINING IN EPIDEMIOLOGY AND CLINICAL TRIALS FOR OBSTETRICIANS AND GYNECOLOGISTS Release Date: May 12, 2000 RFA: HD-00-014 National Institute of Child Health and Human Development (http://www.nichd.nih.gov) Letter of Intent Receipt Date: June 12, 2000 Application Receipt Date: July 24, 2000 PURPOSE The National Institute of Child Health and Human Development (NICHD) invites applications for National Research Service Award (NRSA) Institutional Training Grants to establish programs of postdoctoral research training in epidemiology and clinical trial methodology for obstetricians and gynecologists with a research interest in contraception and reproductive health. The purpose of this Request for Applications (RFA) is to develop a cadre of academic obstetricians and gynecologists trained in epidemiologic and clinical research in contraception and other areas of reproductive health. 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 Healthy People 2010 at http://www.health.gov/healthypeople. APPLICANT ELIGIBILITY REQUIREMENTS Only domestic, non-profit, private or public institutions may apply for grants to support research training programs. Applications will be accepted only from schools of medicine or osteopathy, and schools of public health. 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. The research training program director at the institution will be responsible for the selection and appointment of trainees to receive NRSA support and for the overall direction of the program. The applicant must have access to a training environment with ongoing clinical trials, preferably including multi-institutional trials of new contraceptives. Ideally, the applicant organization serves as a coordinating center that provides these clinical trials with ongoing biostatistical, epidemiologic, and research design expertise. TRAINEE ELIGIBILITY REQUIREMENTS Positions on NRSA Institutional Training 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. Similarly, trainees may not accept NRSA support for studies that are part of residency training leading to certification in a medical or dental specialty or subspecialty, except when the residency program credits a period of full-time, postdoctoral research training toward board certification and the trainee intends to pursue a research career. 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 in clinical areas 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 training 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 obstetrics and gynecology in an ACGME-approved residency program. Citizenship: To be appointed to a training position supported by an NRSA research training grant, an individual must be a citizen or non-citizen national of the United States, or have been lawfully admitted for permanent residence (i.e., in possession of a currently valid Alien Registration Receipt Card I-551, or be in possession of other legal verification of such status). Non-citizen nationals are generally persons born in outlying possessions of the United States (e.g., American Samoa). Individuals on temporary or student visas are not eligible. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) Institutional National Research Service Award (NRSA) Institutional Training Grant mechanism (T32). The provisions of this mechanism are detailed in the NIH announcement for NRSA Institutional Research Training Grants, published in the NIH Guide for Grants and Contracts, May 16, 1997, and available at: http://grants.nih.gov/grants/guide/notice-files/not97-007.html. All provisions of the T32 award described in the announcement apply to grants made under this initiative, except as noted in this RFA. Only postdoctoral level training is supported under this RFA. Institutional NRSA research training grants may be made for periods up to five years and are renewable. Awards within an approved competitive segment normally are made in 12-month increments, with support for additional years based on satisfactory progress and the continued availability of funds. Trainee appointments are normally made in 12-month increments. No trainee may be appointed for less than nine months during the initial period of appointment, except with the prior approval of the NICHD or when health-professional students are appointed to approved, short-term research training positions. No individual trainee may receive more than three years of aggregate NRSA support at the postdoctoral level, including any combination of support from institutional training grants and individual fellowship awards. Any extension of the total duration of trainee support requires approval by the Director of the NICHD. Requests for extension must be made in writing by the trainee, endorsed by the director of the training program and the appropriate institutional official, and addressed to the Director, NICHD. The request must include a sound justification for an extension of the statutory limits on the period of support. FUNDS AVAILABLE The NICHD intends to commit approximately $600,000 in total costs [direct plus Facilities and Administrative (F&A) costs] in FY 2001 to fund up to three new and/or competing continuation institutional training grants in response to this RFA. 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 competing continuation applications will be accepted and/or if this RFA will be reissued. RESEARCH OBJECTIVES Background There is currently a dearth of training opportunities for obstetricians and gynecologists in epidemiologic research and clinical trials methodology. This is partly responsible for the insufficient number of investigator-initiated NIH grants in this area. The U.S. Congress has noted the absence of such training opportunities and has directed NICHD to address the shortage. In addition, the Institute of Medicine (IOM), in the publication Strengthening Research in Academic OB/GYN Departments, outlined the need for NICHD to target training support to expand the number of research training opportunities for obstetricians and gynecologists. In another publication, Careers in Clinical Research, the IOM recommended that NIH support expansion or replication of model programs that have a proven track record in preparing successful clinical investigators. Experience gathered from such programs has informed the development of this RFA. In the area of contraception and related areas of reproductive health, there are very few clinicians with significant skills in epidemiologic research and clinical trials methodology. Many of the most qualified researchers are approaching retirement and there is a need to develop a new cadre of independent investigators in these fields. The objective of this program is to produce a well-qualified cadre of academic obstetricians and gynecologists who are capable of successfully competing for NIH and foundation research support for epidemiologic and clinical research in contraception and reproductive health. It is anticipated that many of the trainees will be encouraged to pursue further training in epidemiologic and clinical research via individual research career development awards (K-series mechanisms) and eventually develop the experience and expertise necessary to direct large, multicenter epidemiologic studies or clinical trials. Scope of Training The emphasis of this postdoctoral research training program is on the training of obstetricians and gynecologists in the basics of epidemiology and biostatistics, including clinical epidemiology, reproductive epidemiology, and clinical trials methodology. Master’s level coursework in epidemiology and clinical trials methodology must be an integral part of the program. At least one mentored independent research study in the area of contraception or reproductive health, including the design, conduct and analysis of an epidemiologic study or clinical trial, must be undertaken by each trainee. The program must be a cooperative effort between (1) a department of epidemiology, biostatistics or community medicine (or the equivalent) in a school of public health or a school of medicine and (2) a department of obstetrics and gynecology in a school of medicine or osteopathy. The program director may be in either department, but evidence of significant cooperation between the two departments must be presented in the application. The training program will provide each trainee with a minimum of 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 qualified mentors experienced in the conduct of epidemiologic studies and clinical trials. Each trainee should have both an epidemiologic/methodologic mentor from the department of epidemiology or biostatistics (or equivalent), and a clinical mentor from the department of obstetrics and gynecology. The research mentors must have participated as Principal Investigators in funded, peer-reviewed research programs in the areas of contraception or reproductive health. Plans must also 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. The training program may be integrated into the last year of a residency program in obstetrics and gynecology or integrated into a fellowship program in reproductive endocrinology and infertility. Because separate funding exists for research training in maternal/fetal medicine and gynecologic oncology, this program is confined to trainees in general obstetrics and gynecology or reproductive endocrinology and infertility. The training program should include, but not be limited to, instruction in the following areas: (1) epidemiology, (2) biostatistics, (3) clinical epidemiology, (4) reproductive epidemiology, (5) clinical trials design and conduct, (6) data management and analysis, (7) bioethics and the responsible conduct of research, (8) preparation for individual career development research grants or independent research grants. 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 minority groups under- represented nationally in the biomedical and behavioral sciences. The following groups have been identified as under-represented 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. 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 two years. It also has been shown that individuals who have been supported by individual postdoctoral fellowships 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 trainees to apply for individual postdoctoral fellowships or mentored research career development awards (K awards). During the review of training grants applications, for existing programs, peer reviewers will examine the training record of the program 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. 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 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 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 pursuant to the Pregnancy Discrimination Act [42 USC 2000 e(k)]. Trainees also may 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 also must submit a Payback Agreement (PHS Form 6031) upon return from a leave of absence. Stipends National Research Service Awards provide funds, in the form of stipends, to postdoctoral 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. 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. Current postdoctoral stipend levels effective for FY 2000 are as follows: Years of Relevant Experience Annual Amount less than 1 $26,916 greater than or equal to 1 but less than 2 28,416 greater than or equal to 2 but less than 3 33,516 greater than or equal to 3 but less than 4 35,232 greater than or equal to 4 but less than 5 36,936 greater than or equal to 5 but less than 6 38,628 greater than or equal to 6 but less than 7 40,332 greater than or equal to 7 42,300 No departure from the established stipend schedule may be negotiated by the institution with the trainee. The stipend for each additional full year of stipend 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 following conditions are met: Stipend Supplementation. Supplementation or additional support to offset the cost of living may be provided by the grantee institution. Supplementation does not require any additional effort from the trainee. Federal funds may not be used for supplementation unless specifically authorized under the terms of both the program from which such supplemental funds are to be received and the program whose funds are to be supplemented. Under no circumstances may PHS funds be used for supplementation. Compensation. An institution may provide additional funds to a trainee in the form of compensation (as salary and/or tuition remission) for services such as teaching or serving as a research assistant. A trainee may receive compensation for services as a research assistant or in some other position on a Federal research grant, including an NIH research grant. However, compensated services should occur on a limited, part-time basis apart from the normal research training activities, which require a minimum of 40 hours per week. In addition, compensation may not be paid from a research grant supporting research that is part of the research training experience. 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. Refer to the NRSA Guidelines (http://grants.nih.gov/grants/guide/notice-files/not97-007.html) for additional information on compensation. Educational Loans or GI Bill. An individual may make use of Federal educational loan funds and assistance under the Veterans Readjustment Benefits Act (GI Bill). Such funds are not considered supplementation or compensation. Concurrent Awards. Support from an NRSA may not be held concurrently with another federally sponsored fellowship or similar Federal award that provides a stipend or otherwise duplicates provisions of the NRSA. Tuition, Fees, and Health Insurance Tuition, for purposes of the NRSA, is defined as the cumulative amount of tuition, all fees, and self-only or family medical insurance, and are allowable trainee costs only if such charges are required of all individuals in a similar training status at the institution, regardless of their source of support. Tuition at the postdoctoral level is limited to that required for specific courses in support of the approved research training program. On an annual basis, for each trainee, the training grant will cover 100 percent of the first $3,000 of the combined cost of tuition, fees, and health insurance and 60 percent of any amount above $3,000. Institutions are instructed to request the full amount of these costs in competing applications. Noncompeting awards will reimburse tuition, fees, and health insurance costs in the amount paid in the previous award year, unless there is a change in the scope of the award or the number of trainees to be supported. 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 considering the type of opportunities for training available, how these opportunities differ from 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. Institutional costs of up to $2,500 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. Under exceptional circumstances, which can include providing accommodations for a trainee with disabilities, it is possible to request institutional costs above the standard rate. Requests for additional costs must be explained in detail and carefully justified in the application. Consultation with the NICHD program staff contact listed under INQUIRIES, below, in advance of such requests is strongly advised. A facilities and administrative (F & A) allowance (indirect costs) based on eight percent of total allowable direct costs (excluding amounts for tuition, fees, health insurance, and equipment) may be requested. Applications from State and local government agencies may request full F & A cost reimbursement (see NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps/). Payback Provisions Payback provisions, specified in the NIH Revitalization Act of 1993, state that 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. Consult the NRSA Guidelines (http://grants.nih.gov/grants/guide/notice-files/not97-007.html) for complete information on payback provisions. URLs IN NIH GRANT APPLICATIONS AND APPENDICES All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes a descriptive title of the proposed training program, the name, address, and telephone number of the Program Director, 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 June 12, 2000 to Dr. H. Trent MacKay at the address listed under INQUIRIES, below. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants. It contains special instructions for Institutional National Research Service Awards (T32). These forms are available at most institutional offices of sponsored research, on the Internet at http://grants.nih.gov/grants/forms.htm, and from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 710-0267, E-mail: GrantsInfo@nih.gov. Applicants must observe the 25-page limit on the narrative section. 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. Predoctoral and short-term research training positions may not be requested in responses to this RFA. The RFA label available in the PHS 398 (rev. 4/98) application form must be stapled to the bottom of the face page of the application and must display the RFA number HD-00-014. A sample RFA label is available at http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. Please note this is in the pdf format. 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. 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 should be sent to: L. R. Stanford, Ph.D. Director, Division of Scientific Review National Institute of Child Health and Human Development 6100 Executive Blvd., Room 5E03, MSC 7510 Bethesda, MD 20892-7510 Rockville, MD 20852 (for express/courier service) Telephone: 301-496-9254 Applications must be received by July 24, 2000. 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. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the CSR and for responsiveness by NICHD. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to this 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 receive a written critique and may undergo a process in which only those applications deemed to have the highest scientific merit will be discussed, assigned a priority score, and 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 awards, further training appointments, and similar accomplishments. Evidence of a productive scientific career can include a record of successful competition for research grants in the design and conduct of epidemiologic studies or clinical trials, 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. o Caliber of preceptors as researchers with expertise in contraception, reproductive health, biostatistics, epidemiology, and clinical trials, including successful competition for research support. o The institutional training environment, including the level of institutional commitment, quality of the facilities, availability of appropriate courses, and availability of research support, including access to a variety of clinical trials and epidemiologic studies in the areas of contraception and/or reproductive health. o Recruitment and selection plans for trainees and the availability of high quality candidates. o Record of the research training program in retaining health-professional postdoctoral trainees for at least two years in research training or other research activities. o When appropriate, the concomitant research training of health-professional postdoctorates (i.e., individuals with the M.D., D.O., D.D.S., etc.) with basic science postdoctorates (i.e., individuals with a Ph.D., etc.) or linkages with basic science departments. o Commitment to the objectives, design, and direction of a research training program responsive to this RFA. Additional Review Considerations Minority Recruitment Plan: The NIH remains committed to increasing the participation of individuals from under-represented minority groups in biomedical and behavioral research. As first announced in 1989, all competing applications for institutional NRSA research training grants must include a specific plan to recruit and retain under-represented minorities in the training program. In addition, all competing continuation applications also must include a report on the recruitment and retention of under-represented minorities during the previous award period. If an application is received without a plan, or without a report on the previous award period, the application will be considered incomplete and will be returned to the applicant without review. Additional information on this requirement was published in the NIH Guide for Grants and Contracts, Volume 22, Number 25, July 16, 1993 (http://grants.nih.gov/grants/guide/notice-files/not93-188.html). As indicated above, competing continuation applications must include a detailed account of experiences in recruiting individuals from under- represented groups during the previous award period. Information must be included on successful and unsuccessful recruitment strategies. The report should provide information on the racial/ethnic distribution of: o students or postdoctorates who applied for admission or positions within the department(s) relative to the training grant, o students or postdoctorates who were offered admission to or a position within the department(s), o students actually enrolled in the academic program relevant to the training grant, o students or postdoctorates who were appointed to the research training grant. For those trainees who were appointed to the grant, the report should include information about the duration of research training and whether those trainees have finished their training in good standing. After the overall educational and technical merit of an application has been assessed, peer reviewers will examine and evaluate the minority recruitment plan and any record of recruitment and retention. For competing continuation applications, the reviewers will examine and evaluate the record of the program in recruiting and retaining under-represented minority trainees during the previous award period. The panel also will consider whether the experience in recruitment during the previous award period has been incorporated into the formulation of the recruitment plan for the next award period. The findings of the review group will be included in an administrative note in the summary statement. If the minority recruitment plan or the record of recruitment and retention of minorities is judged to be unacceptable, funding will be withheld until a revised plan that addresses the deficiencies is received. Staff within the NICHD, with guidance from the National Advisory Child Health and Human Development Council, will determine whether amended plans and reports submitted after the initial review are acceptable. Training in the Responsible Conduct of Research: Every 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 (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 may be returned to the applicant without review. o Although the NIH does not establish specific curricula or formal requirements, all programs are encouraged strongly to consider instruction in the following areas: conflict of interest, responsible authorship, policies for handling misconduct, policies regarding the use of human and animal subjects, and data management. Within the context of training in scientific integrity, it is also beneficial to discuss the mutual responsibilities of the institution and the 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 non- competing applications. The NIH encourages institutions to provide instruction in the responsible conduct of research to all graduate students and postdoctorates in a training program or department, regardless of the source of support. The NICHD scientific review group 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 quality 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 in the summary statement. Regardless of the priority score, applications with unacceptable plans will not be funded until a revised, acceptable plan is provided by the applicant. The acceptability of the revised plan will be judged by NICHD staff. Following initial review, applications are reviewed by the National Advisory Child Health and Human Development Council. The council will consider, in addition to the assessment of the scientific and educational merit of the research training grant application, the scientific review group"s 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. SCHEDULE Letter of Intent Receipt Date: June 12, 2000 Application Receipt Date: July 24, 2000 Peer Review Date: November 2000 Council Review: January 2001 Earliest Anticipated Start Date: May 1, 2001 AWARD CRITERIA Applications for this program will compete for available funds with other T32 applications received and reviewed by the NICHD. The following will be considered when making funding decisions: o Responsiveness to the purpose of this announcement, o Quality of the proposed training program, as determined by peer review, o Availability of funds. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Consultation with NICHD staff is strongly encouraged, especially during the planning phase of the application process. Direct inquiries regarding programmatic issues to: H. Trent MacKay, M.D., M.P.H. Contraception and Reproductive Health Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Suite 8B13, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 435-6988 FAX: (301) 480-1972 E-mail: mackayt@mail.nih.gov Direct inquiries regarding fiscal matters to: Michael Loewe Grants Management Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Suite 8A17, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 435-7008 FAX: (301) 402-0915 E-mail: ml70m@nih.gov AUTHORITY AND REGULATIONS 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. This program also is described under the following numbers in the Catalog of Federal Domestic Assistance: 93.121, 93.172, 93.173, 93.272, 93.278, 93.282, 93.306, 93.361, 93.398, 93.821, 93.837-93.839, 93.846-93.849, 93.853-93.856, 93.859, 93.862-93.868, 93.871, 93.880, 93.894, and 93.929. PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the nonuse 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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