RESEARCH CURRICULUM FOR TWO-YEAR CLINICAL NEPHROLOGY FELLOWS
The Research Curriculum for two year Clinical Nephrology Fellows at UT Southwestern is designed to provide trainees with a meaningful experience in clinical research. The curriculum consists of: 1) individual mentoring by clinical faculty actively involved in clinical research; 2) formal didactic training in patient-oriented research techniques; 3) clinical research projects tailored to interests and aptitude of the trainee; 3) Institutional (NIH-sponsored K30 Clinical Research Curriculum Award (Dr. Robert Toto)and General Clinical Research Center; Divisional (2000 square ft dedicated clinic lab and office space) and Faculty (NIH-sponsored K24 Mentoring Research Award - Dr. Toto) infrastructural support for a broad spectrum of clinical research activities; 4) integration into the clinical training program. The goal is for each trainee to participate in design, conduct, presentation and ultimately publication of a completed clinical research project by the conclusion of their fellowship.
I. Mentoring
A. General: We strongly believe that mentoring trainees in clinic research is essential. Trainees will be assigned mentors for clinical research at the beginning of their fellowship. Mentors will meet with the fellows during the first month of fellowship to discuss key aspects of the curriculum including design, objectives, goals and expectations. A calendar for the development and execution of a research project will be outlined during this initial meeting and completed during the first quarter of the Fellowship. Fellows will meet with mentors periodically (e.g., quarterly) thereafter to review progress, trouble shoot problems and analyze data. Mentors, together with the trainee, will complete a progress report that will be copied to the Director for review.
B. Role of Mentors: Mentors will provide leadership to fellows including intellectual and scholarly guidance for the conduct of human research. Each mentor will be responsible for assisting trainees throughout their training. The responsibilities include project assignment and development, tracking progress, assigning literature review, approaches to critical review of the literature and assistance in oral presentations and written presentations of their work. Mentors may carry up to 2 clinical fellows per year.
C. Current Faculty: Nephrology faculty actively involved in clinical research include: Dr. Robert Toto-Director of Patient-Oriented Research in Nephrology, Dr. Susan Hedayati (VAMC). Dr. Miguel Vasquez, Dr. Devasmita Dev (VAMC), Dr. Ramesh Saxena, and Dr. Khashayar Sakhaee.
II. Didactic
Lectures on Key Areas in Clinical Research: Trainees will attend lectures in clinical research methodology during their two years of training. These lectures are designed to provide trainees with a background in clinical research methodologies including ethics in human research, role of the General Clinical Research Center, IRB and Federal regulations, clinical research design, informed consent, clinical epidemiology and public health, basic biostatistics and scholarly and professional writing. The didactic curriculum is intended to be taken in conjunction with clinical training, therefore accessible to trainees who also have clinical responsibilities. This is accomplished by scheduling attendance during less demanding rotations (e.g., consult services).
III. Projects
A. Assignment of projects: Trainees will be assigned projects by mentors. However, project assignments will be decided on an individual basis and effort will be made to accommodate specific interests of the trainee. Mentors will provide appropriate guidance and direction to insure maximum likelihood of each fellow achieving a meaningful experience in clinical research. Project assignments will be reviewed by the Director of patient-oriented research for each trainee.
B. Available Resources:
1. Patient: Patient material for clinical research is abundant. Our clinic population includes more than 13,000 patients with progressing (pre-ESRD) chronic renal disease. Our ESRD population exceeds 2,500 hemodialysis and 300 peritoneal dialysis patients and more than 1500 renal transplant patients. In addition, we have access to more than 500 patients with renal stone disease. These patient populations are in accessible computerized databases on and off campus. Also, the inpatient consult, dialysis and transplant services at Parkland Hospital, VA Medical Center, and Methodist Hospital are active with census ranging from 15-50 per hospital at any given time. Each hospital has an acute hemodialysis unit supporting several intensive care units.
2. Infrastructure: The Nephrology Division has 2000 square feet of space
dedicated to clinical research on the UTSW campus. Also, the Nephrology Division has several active protocols ongoing in our General Clinical Research Center (GCRC). The center has 12 inpatient beds and 3000 square feet of outpatient clinic and office space as well as biostatistical support. Dr. Khashayar Sakhaee, a member of the Nephrology Division, is Director of the GCRC and is very active clinical research. Computer terminals are available for literature search, data analysis and manuscript development.
3. Funding: Funding for specific projects will be the responsibility of the mentor. Trainees are not expected to write research grants to obtain funding for projects. Nevertheless, with guidance trainees may submit such grants.
C. Scope of Research: Areas of clinical research suitable for our curriculum include those already ongoing in our Division: 1) mechanisms of renal diseases (e.g., conducted in the General Clinical Research Center; 2) case-control studies; 3) health services research; 4) retrospective studies (e.g., risk factors for progression of renal diseases); 5) epidemiologic and statistical analyses; 6) literature reviews and meta-analyses, 7) clinical trials; and 8) case series.
IV. Presentations
A. Oral: Trainees will be required to present the results of their research during the final quarter of their 2-year fellowship to the Nephrology Division trainees and faculty members. Trainees who are selected to present abstracts at scientific meetings will receive travel stipends for such activities.
B. Written: Trainees will be expected to produce a manuscript from their research project. Manuscripts will be submitted for publication to appropriate journals. Mentors will assist in this process.
V. Quality Control
A clinical research committee consisting of the clinical faculty mentors meets on a regular basis to identify appropriate research projects, review progress of trainees, and make recommendations for improvements and modifications in the program.
VI. Integration
It is recognized that time and manpower constraints during a 2-year clinical fellowship do not allow in-depth training in clinical research. For these reasons we have structured our program with mentors for each trainee to tailor the research experience in order to provide the trainee with a meaningful experience in clinical research within our 2- year curriculum. “Protected time” to conduct clinical research projects is limited, nevertheless, supervision by faculty ensures feasibility of completion of projects during the 2-year training period.
VII. Implementation and Specifics
Clinically meaningful research can range from writing a case-report or review article to cross-sectional analysis of already collected clinical data, written up as an ASN abstract or original research manuscript. The outcome should be an abstract or manuscript that is submitted for publication. Given that there is limited protected time for research during your 2-year clinical fellowship, we recommend the following in order to accomplish this:
A. Cross-sectional or secondary analysis of already collected data: If you are interested in a particular area of clinical research, identify a clinical question and a mentor in the Division of Nephrology by the end of your first 6 mo of fellowship and decide on a project.
a. Remember that the project has to be completed in a year in order to leave you another 6 mo time-period for preparation and submission of an abstract or manuscript.
b. The project has to be approved to assure it is feasible.
B. Case-Report or Review Article: Use your first year of clinical fellowship to identify an unusual clinical case that can be written up into a case-report, or identify a subject to write a review article.
a. You need to also identify a mentor to be the senior author on the paper (perhaps the attending who staffed the case with you or someone who is doing research or has written on the subject).
C. At the end of your first year of clinical fellowship, an appointment should be made with Dr. Hedayati so as to review the chosen subject matter and mentor.
a. If by the end of your first year you have not identified a subject and mentor, you will be assigned a subject and a mentor in order to help you accomplish this requirement by the time you graduate.
D. Written documentation of the project and mentor should be sent to Dr. Hedayati by the end of your first year of fellowship. If you decide to pursue a cross-sectional or retrospective clinical research project, you need to communicate this by the end of the first 6 mo of fellowship. A written form for this purpose is given below.
E. By the end of your second year, email me a copy of the finished product.
Updated November 21, 2007 Created by Megan Johnson
