TRAINING IN CLINICAL INVESTIGATION IN KIDNEY AND UROLOGY Release Date: October 30, 1998 PA NUMBER: PAR-99-012 P.T. National Institute of Diabetes and Digestive and Kidney Diseases Application Receipt Date: March 10, 1999 PURPOSE The Division of Kidney, Urology and Hematology (DKUH) has long been interested in stimulating more training in clinical research methods in programs related to Nephrology and Urology. At the same time, there is a dearth of clinicians that have advanced training in clinical trial methodology. The purpose of this program announcement (PA) is to encourage applications for new training programs, and to encourage Program Directors of existing Institutional Training Grants supported by DKUH to collaborate with Schools of Public Health and Departments of Epidemiology/Statistics/Biostatistics to offer didactic and practical training in clinical research methodologies. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. Potential applicants may obtain a copy of "Healthy People 2000 at http://www.crisny.org/health/us/health7.html ELIGIBILITY REQUIREMENTS For new training programs, only domestic, non-profit, private or public institutions may apply. The applicant institution must have the staff and facilities required for the proposed program. The research training program director at the institution will be responsible for the selection and appointment of trainees to receive National Research Service Award (NRSA) support and for the overall direction of the program. Racial/ethnic minority individuals, women and persons with disabilities are encouraged to apply as principal investigators. 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. Similarly, trainees may not accept NRSA support for studies which are a part of residency training leading to a medical 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. Clinical duties must be confined to those that are an integral part of the research training experience. To be appointed to a research training grant, an individual must be a citizen or a 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 must be in possession of other legal verification of such status). Individuals on temporary or student visas are not eligible. Additional information concerning trainee eligibility, appointment and payback requirements may be obtained from National Institutes of Health National Research Service Award Institutional Research Training Grants, in the NIH Guide for Grants and Contracts, Vol. 23, No. 21, June 3, 1994, or from the NIH Research Training Opportunities web site. MECHANISM OF SUPPORT Active NRSA Institutional Training Grants (T32) in Nephrology or Urology supported in DKUH are eligible for this Program Announcement. They may use one training position for didactic and practical training in clinical research methodology without prior approval of the NIDDK. If such training will incur costs in excess of current budget allowances, the Program Director must put together a supplemental budget request with complete justification for the increased costs and submit it for DKUH review and approval. Tuition and fees will be allowed up to $2,000, plus 60% of costs exceeding that amount. New applications for this program announcement should follow carefully the guidelines and instructions for NRSA Institutional Training Grant support. Necessary tuition and fees should be budgeted keeping costs within the noted guidelines for maximum allowable. RESEARCH OBJECTIVES It is widely acknowledged that there is a need to train more investigators to design and conduct well-controlled clinical studies, and to make the epidemiological assessments on which many of these studies depend. To accomplish this task, opportunities are needed to enable clinically trained individuals to obtain didactic and fieldwork training in clinical investigation and epidemiologic methods. The goal of this program announcement is to increase the number of well trained investigators who are capable of conceiving, designing, conducting, analyzing and presenting the results of clinical research in areas pertaining to Nephrology or Urology. Eligible trainees would be enrolled in, or have completed clinical training programs in nephrology or urology Institutions responding to this program announcement should have in place a formal program for training physicians in clinical research methodology. An ideal program would consist of collaboration between the respective clinical and School of Public Health departments, and would culminate in the granting of a graduate degree e.g., a MPH, DrPH or ScD. Individuals who complete the training program should be provided sufficient theoretical and applied educational experiences to be able to function as independent clinical research investigators. The following are important components of an intensive training program in clinical research: Training Environment Structured academic exposure(s) to the basic and applied sciences such that various scientific methodologies and resources used in the testing of scientific hypotheses are known. It is recognized that investigators early in their careers need to have well- developed associations with more experienced and knowledgeable investigators whose overall perspective of their fields enable them to provide guidance and consultation to the student. Normally, such individuals are present in universities and will be responsible for the student"s didactic and practical training. Course Content Course work should lead to a graduate degree with a concentration in areas related to clinical investigative methodology. The exact course mix will be determined, in part, by the student"s background and particular needs. Courses should include exposure to the following subject areas: o Research study design: Basic Statistics, Biostatistics, Epidemiology, o Analysis of experiments: Advanced Statistics, Advanced Biostatistics, o Social Sciences: Public Policy, Economics, Psychology, Sociology/Anthropology, Health Education. o Special topics in Epidemiology: clinical trial design, conduct, recruitment of subjects, implementation. o Outcomes analysis. Practicum The major intent here is to develop further a career path for nephrologist and urologists by providing "hands-on" experiences in designing and implementing clinical research, and in summarizing, analyzing and presenting data by using statistical methodologies on different sets of data. The various activities, settings and/or fieldwork experiences must be within the areas of Nephrology or Urology. Specific training in areas of statistical genetic analysis and in genetic epidemiology with application to the study of risk factors of certain diseases in Nephrology and Urology also is encouraged. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations much be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research" published in the Federal Register of March 28, 1994 (FR 59 14508- 14513) and NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994 available on the web: http://www.nih.gov/grants/guide/1994/94.03.18/index.html. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type I) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects" that was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://www.nih.gov/grants/guide/notice-files/not98-024.html Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program Staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95) and will be accepted on or before the application deadline March 10, 1999. Application kits are available at most institutional office of sponsored research, or may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301-435-0714, email: GrantsInfo@nih.gov. The program announcement title and number must by typed on line 2 of the face page of the application form and the YES box must be marked. Mail the signed, original, single-sided application, along with five exact, single-sided copies and five collated sets of appendix materials 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: Ann A. Hagan, Ph.D. Review Branch National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8886 FAX: (301) 480-3505 REVIEW CONSIDERATIONS Applications will be assigned on the basis of established Public Health Service referral guidelines. An appropriate peer review group convened in accordance with NIH peer review procedures will evaluate applications that are complete for scientific and technical merit. As part of the initial merit review, all applications will receive a written critique. Only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the NIDDK National Advisory Council. Review Criteria o Past research training record for both the program and the designated preceptors in terms of the rate at which former trainees establish independent and productive research careers, o Past research training record in terms of the success of former trainees in obtaining individual awards such as fellowships, career awards and research grants for further development, o Objectives, design and direction of the research training program, o Caliber of preceptors as researchers including successful competition for research support, o Training environment including the institutional commitment, the quality of the facilities and the availability of research support, o Recruitment and selection plans for appointees and the availability of high quality candidates, o The 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 training of health-professional postdoctorates (e.g., individuals with a Ph.D., ScD) will receive special consideration. Additional Review Considerations Minority Recruitment Plan: The NIH remains strongly committed to increasing the participation of individuals from under represented minority groups in biomedical and behavioral research. Additional information on this requirement is published in the NIH Guide for Grants and Contracts, Volume 22, Number 25, July 16, 1993 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 additional information please consult the NIH Guide for Grants and Contracts, Volume 21, Number 43, November 27, 1992. 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. Regardless of the priority score, applications with unacceptable plans will not be funded until the applicant provides a revised, acceptable plan. Staff within the awarding component of the NIDDK will judge the acceptability of the revised plan. AWARD CRITERIA Applications will compete for available funds with all other approved applications assigned to the NIDDK. The following will be considered in making funding decisions: o Quality of the proposed project as determined by peer review, o Availability of funds, o Program priority. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issue or question from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Charles H. Rodgers, Ph.D. Division of Kidney, Urologic and Hematologic Diseases National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-7717 FAX: (301) 480-3510 Email: rodgersc@extra.niddk.nih.gov Direct inquiries regarding fiscal and administrative matters to: Kim Law Grants Management Branch National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8869 Email: lawk@extra.niddk.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.849. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.


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