MENTORED MEDICAL STUDENT CLINICAL RESEARCH PROGRAM Release Date: December 22, 1999 PA NUMBER: PAR-00-035 National Center for Research Resources Application Receipt Date: February 15, 2000 PURPOSE Patient-oriented clinical research is an essential component for translation of basic scientific knowledge into new avenues of clinical diagnosis and treatment. The Mentored Medical Student Clinical Research Program is intended to serve as a catalyst for medical students to introduce them to the potential of a career in patient-oriented research. The institutional General Clinical Research Center (GCRC) is a focal point for exposure of medical students to both didactic training and the clinical practice of patient-oriented research, and provides the necessary infrastructure to provide case examples of the design, methodology, and analysis of clinical trials. In a mentored one-year program of study usually conducted between their third and fourth year of medical school, medical students will be engaged in a variety of clinical activities within the institutional GCRC. These activities may range from supervised participation in clinical trials, didactic coursework related to patient-oriented research, or acquisition of laboratory skills that can be applied to patient-oriented clinical research efforts. 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. This PA, Mentored Medical Student Clinical Research Program, is related to the priority area of human resource development. Potential applicants may obtain a copy of "Healthy People 2000" at http://odphp.osophs.dhhs.gov/pubs/hp2000. ELIGIBILITY Institution: Applications must be submitted by the lead mentor on behalf of the medical student. If there is more than one mentor for a medical student, a lead mentor must be identified. The lead mentor will be the principal investigator for the grant award and must be affiliated with the GCRC at the institution at which the medical student is receiving his/her medical education. A medical student is eligible to participate in the Mentored Medical Student Clinical Research Program if he/she is currently enrolled in medical education courses at an accredited medical school that is affiliated with an institutional GCRC. A maximum of three applications may be submitted per institution. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply, as medical students who desire training in patient- oriented research or as the mentor for a medical student. Both medical students and mentors must be citizens or noncitizen nationals of the United States, or must have been lawfully admitted to the United States for permanent residence (i.e., in possession of a currently valid Alien Registration Receipt Card I-551, or other legal verification of such status). Noncitizen nationals are generally persons born in outlying possessions of the United States (i.e., American Samoa and Swains Island). Individuals on temporary visas are not eligible. Medical students cannot receive concurrent support from any other PHS award while being supported by the Mentored Medical Student Clinical Research Program. A medical student is not eligible for participation in this program if he/she is a current or former principal investigator on NIH research project (R01), FIRST Award (R29), sub-project of program project (P01) or center grants (P50), and the equivalent. Medical students who are former principal investigators of NIH Small Grants (R03) or Exploratory/Developmental Grants (R21) remain eligible. There are no restrictions on the category of grant support held by the mentor; it is required, however, that the mentor has peer-reviewed funding support from some source. It is also expected that the mentor(s) will allot 3-5% percent effort to supervise the medical student during his/her year of research on the GCRC. MECHANISM OF SUPPORT This PA will use the National Institutes of Health (NIH) R25 (Education Projects) mechanism. The project period for an application submitted in response to this PA may not exceed one year. Awards are not renewable. RESEARCH OBJECTIVES A. Background: In many developing and emerging fields of patient-oriented research, scientists must function within interdisciplinary teams rather than as isolated investigators. Preparing junior clinicians for this new type of research environment will require education and career development experiences in highly inter-disciplinary and collaborative clinical research settings that are integrated within a specialized curriculum. The institutional GCRC provides both educational and career development experience, and typically involves patient-oriented investigators from an array of disciplines. The GCRC environment provides concerted leadership and dedicated time of interdisciplinary faculty in order to sustain effective interactions. Furthermore, for medical students lacking any prior research training, these experiences may need to be augmented by additional course work beyond that which is offered in their medical education training or by exposure to basic laboratory techniques that are pertinent to patient- oriented research. B. Program: The award provides support to the medical student via his/her lead mentor, where the lead mentor serves as the principal investigator. Percent effort by the medical student is 100% for this award. The mentor(s) are expected to allot up to 3-5% effort to supervise the medical student on the GCRC, and will supervise, coordinate and evaluate the research program during the year that the medical student will spend on the GCRC. This program should provide opportunities for both didactic and patient-oriented collaborative research training experiences for the medical student. It should also demonstrate to the medical student the research and communication skills necessary to conduct patient-oriented research in an inter- disciplinary and collaborative team research setting on the GCRC. C. Environment: The participating institution must be affiliated with a GCRC and have well-established research programs and faculty qualified in curriculum development. The research environment should be team-oriented and highly collaborative with a strong potential for a dynamic two-way exchange of information and ideas within and across diverse and disparate disciplines of clinical research. Finally, the institution must demonstrate a commitment to provide sustained leadership and dedicated faculty time to the development and implementation of research protocols, and commitment to the development of junior investigators at all levels of training into productive, independent investigators. D. Curriculum: A specialized curriculum, not otherwise available at the institutional medical school, must be developed by the medical student and his/her mentor. Activities should provide a broad exposure to diverse aspects of patient-oriented research. These may include, but are not limited to: 1) exposure to current protocols on the GCRC, with supervised participation in selected clinical trials; 2) didactic education, either through an institutional course curriculum, attendance at clinical rounds or seminars sponsored by the GCRC, or participation in data analysis or clinical trial protocol design; and 3) acquisition of basic science skills that are relevant to patient-oriented research by supervised training in a laboratory, processing of clinical samples for selected protocols, and exposure to methodologies and instrumentation that represent the interdisciplinary contribution of the basic sciences to translational research on the GCRC. E. Mentor(s): The lead mentor must be involved in active participation at the institutional GCRC. The student may spend time with mentors not affiliated with the GCRC (e.g., to learn a technique in a basic science laboratory that is relevant to patient-oriented research), but at least 75% of the medical student's time should be committed to participation in activities directly linked to patient-oriented research on the GCRC. F. Evaluation: A plan must be provided for progress and outcome evaluation of the program of study. SPECIAL REQUIREMENTS A. Allowable costs: 1. Medical student support: The medical student under this program may be provided a stipend of up to $20,000 per year commensurate with the institution's full-time salary for persons of equivalent qualifications, experience and rank. These costs should be budgeted for in the "other expenses" category. The institution may supplement the NIH contribution to the student's stipend up to a level that is consistent with the institution's salary scale. Institutional supplementation must not require extra duties or responsibilities that would interfere with the purpose of the award. Note: Fringe benefits for the medical student will be an allowable cost only if he/she will be an employee of the recipient organization during the period of support. 2. Salary for mentor(s): Salary support plus associated fringe benefits will be awarded to the mentor(s) at a level commensurate with the 3-5% effort that is stated in the grant application. 3. Other expenses: Up to $4,000 in direct costs per medical student will be provided to support travel and other research-related expenses that are directly related to activities of the medical student. Expenses for equipment and salary support for technical personnel are not allowed. 4. Tuition support: Up to $5,000 in direct costs will be provided for tuition costs for course work that is necessary for the continuing education of the medical student in patient-oriented research. Justification for such course work must be provided in the application for this award. 5. Ancillary personnel support: Salary for secretarial and administrative assistance, etc., is not allowed. 6. Facilities and Administrative costs: These costs, which were formerly called indirect costs, will be reimbursed at 8 percent of modified total direct costs. B. Special Leave: Leave to another institution of an appointee, including a foreign laboratory, may be permitted if directly related to the purpose of the award. Only local, institutional approval is required if such leave does not exceed 3 months. For longer periods, prior written approval from NCRR is required. To obtain prior approval, the medical student must submit a letter to the NCRR describing the plan, countersigned by his or her medical school institutional official, the Program Director of the institutional GCRC, and the lead mentor. A copy of a letter or other evidence from the institution where the leave is to be taken must be submitted to assure that satisfactory arrangements have been made. Support from the award will continue during such leave. NCRR Program staff should be contacted prior to submitting the request for leave. C. Termination: If a medical student plans to terminate an award prior to the 12-month project period, the mentor must notify NCRR in writing at the earliest possible time so that appropriate instructions can be given for termination. D. Change of institution: The Mentored Medical Student Clinical Research Program award can not be transferred from one institution to another. E. Change of mentor: If the GCRC lead mentor moves to another institution or resigns from his/her mentoring position, award support may be continued provided that the GCRC Program Director has submitted a written request on behalf of the medical student for a change of mentor. During this interim period, the GCRC Program Director or Associate Program Director should request that he/she be named temporary Principal Investigator for the grant. The request must describe the reasons for the change of mentor, and be countersigned by the appropriate institutional business official prior to submission to program staff at the NCRR. A biographical sketch of the proposed new lead mentor must also be provided, and include a listing of active grant support and of participation in clinical protocol(s) on the institutional GCRC. The information provided must establish that the specific aims of the original peer-reviewed research program to be conducted under the direction of the new mentor will remain unchanged, and that the new mentor has the appropriate research and administrative expertise to lead the program of study. NCRR program staff will review the proposed plan of study to ensure that it remains within the scope of the original peer-reviewed research application. If the proposed plan of study does not satisfy this requirement and no resolution of study plan deficiencies can be made with the NCRR program staff, the award may be terminated. F. Progress Reports: A final progress report is required upon termination of an award. This report should include a summary of the accomplishments and a description of the research and progress of each medical student. G. Evaluation: In carrying out its stewardship of human resource related programs, the NCRR may request information essential to an assessment of the effectiveness of this program. Accordingly, recipients are hereby notified, that they may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program. 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 must 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" which have been published in the Federal register of March 28, 1994 (FR 59 14508-14513), and in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994 available on the web at the following URL address: https://grants.nih.gov/grants/guide/notice-files/not94-100.html Investigators may obtain copies from these sources or from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. 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 NIH, unless there are clear and compelling 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 was published in the NIH GUIDE FOR GRANTS AND CONTRACTS, March 6, 1998, and is available at the following URL address: https://grants.nih.gov/grants/guide/notice-files/not98-024.html APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (revised 4/98). Application kits are available at most institutional offices of sponsored research 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, Email: grantsinfo@nih.gov. Application forms and instructions are also available on the internet at: https://grants.nih.gov/grants/funding/phs398/forms_toc.html. The title and number of the program announcement must be typed on line 2 of the face page of the application form and the YES box must be marked. The completed original application and three legible copies must be sent to or delivered 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) An additional two copies with all accompanying materials are to be sent to: David Wilde, M.D., Ph.D. National Center for Research Resources Rockledge I, Room 6030 6705 Rockledge Drive MSC 7965 Bethesda, MD 20892-7965 (zip code 20817 for express/courier service). The information summarized below must be provided in this application: o A letter of recommendation from the proposed mentor(s), including a table of trainees, a table of current grant support, a description of the training environment of the medical student, a curriculum vitae, and an assessment of the applicant's potential as a biomedical researcher; o A letter from the Dean of the applicant's medical school, endorsing the application; o Two letters of reference from persons other than the research mentor(s) and dean; o An Education and Career Development Plan for the medical student; o Justification for the proposed time commitment of ancillary support staff (e.g., GCRC staff involved in the planning or conduct of a clinical trial); o Core Curriculum, to include a research plan and any scheduled coursework; o Provisions for training of the medical student on the protection of human subjects and vertebrate animals in clinical research; o Plans for training in ethical conduct of research; o Budget. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the Center for Scientific Review (CSR) for responsiveness in two areas by NCRR. Incomplete and/or non-responsive applications will be returned to the applicant without review. Applications that are complete and responsive to the PA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the Office of Review, NCRR, in accordance with the standard NIH peer-review procedures. As part of the initial merit review, all applications will receive a written critique and 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 Research Resources Council (NARRC). Review Criteria The review criteria that will be applied to the application are: o Appropriateness and adequacy of the proposed curriculum for the educational and research career development objectives of the proposed R25 educational program; o Appropriateness and adequacy of the funded research activities, resources, facilities and mentors affiliated with the program; o Adequacy of the percent commitment of the mentor and faculty; AWARD CRITERIA The following will be considered in making decisions: quality of the proposed project as determined by peer review, availability of funds, and program priority. The earliest possible award date is July 1, 2000. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: David Wilde, M.D., Ph.D. General Clinical Research Centers Program National Center for Research Resources One Rockledge Centre, Room 6030 6705 Rockledge Drive, MSC 7965 Bethesda, MD 20892-7965 Telephone: (301) 435-0790 FAX: (301) 480-3661 Email: dw171w@nih.gov For inquiries about fiscal matters, please contact: Ms. Mary Niemiec Section Grants Management Officer Office of Grants Management National Center for Research Resources 6705 Rockledge Drive, MSC 7965 Bethesda, MD 20892-7965 Telephone: (301) 435-0844 FAX: (301) 480-3777 Email: MaryN@ncrr.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.333. 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, 42 USC 241 and 285) and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. 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 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.
Return to NIH Guide Main Index
Office of Extramural Research (OER) |
National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892 |
Department of Health and Human Services (HHS) |
||||||||
Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files. |