Curriculum on Research Experience - Research Requirements

Our research program requires that trainees achieve an understanding of certain concepts and areas of research during the course of their training. These include hypothesis development; experimental design of human animal or other experiments; and elementary statistical analysis. We find it very useful for trainees to write protocols that are submitted either to the institutional review board that regulates human research or to the animal care and use committee. We believe that it is essential that fellows understand the appropriate approach to acquisition, recording, and storage of data. For this purpose, fellows attend a course that is conducted every July by the General Clinical Research Center addressing the responsible conduct of research. Topics covered by the course include misconduct in scientific research, conflicts of interest, ethical use of humans in research, ethical use of animals in research, responsible authorship, managing scientific data, and patenting biological materials. Thus, we require that our trainees deal with issues relating to scientific integrity and the responsible conduct of research. This includes the very important issue of scientific misconduct that deals with self deception, fabrication, falsification, plagiarism, and conflicts of interest between scientists and industry.

The research experience offered by the Division of Nephrology and Hypertension is broad. Trainees may work in a laboratory, on clinical research projects, in epidemiological and outcome studies, and all are encouraged to write abstracts, manuscripts, or reports that originate from these studies. There are several funded research projects within the Division of Nephrology. These span the spectrum from basic science investigation, to translational studies, to pharmaceutical company-sponsored clinical trials.

The Division has an active research interest in the immune mechanisms of renal disease and, in particular, studies pertaining to glomerulonephritis and small vessel vasculitis. These basic investigations are funded by the National Institutes of Health. The Division has been interested in understanding the genetic makeup of patients with different types of glomerular diseases. The basic research applies to patient's blood cells, renal tissue, and combined with clinicopathologic studies, provide yet another opportunity for trainees to participate in modern day translational research. These basic studies are complimented by clinical studies that occur within the Glomerular Disease Collaborative Network. This Network, now in existence for over 15 years, has spawned a series of clinical pathological studies that have been authored or co-authored by fellows within the training program. The Glomerular Disease Collaborative Network currently has 12 active registries, 2 therapeutic pilot studies, and 2 clinical trials.

The Division is singularly capable of teaching the development, initiation, production, and analysis of clinical trials. Susan Hogan, who has a doctorate in epidemiology and her Masters of Public Health in Biostatistics, is an instructor within the Division. Her constant presence allows for an ongoing, firsthand and fully integrated approach to this issues. Susan Hogan and Dr. Romulo Colindres (MSPH in Epidemiology), in direct collaboration with the School of Public Health, have provided the framework for in-depth analysis of epidemiological issues. These included sophisticated epidemiological analyses that have allowed fellows to obtain their Masters of Public Health during the course of their residency program. This training program, in which one of the current faculty members (Dr. Abhijit Kshirsagar) has been actively involved, is a template for other trainees to follow. The Department of Epidemiology in the School of Public Health and the Division of Nephrology has been awarded a training grant through the National Institutes of Health to study renal epidemiology. Dr. Maria Ferris, Dr. Abhijit Kshirsagar and Dr. Romulo Colindres also have a Master's Degree in Public Health. Thus, trainees have an excellent opportunity within the Division and within the School of Public Health to design and conduct sophisticated epidemiologic studies.

In addition to the aforementioned clinical studies, we have created a clinical trials group within the Division. Melanie Joy, PharmD, is leading several ongoing clinical trials that make use of the surrounding dialysis clinics. Three of such studies are actively ongoing and allow the trainee an in-depth understanding of how to conduct a clinical trial concerning a pharmaceutical agent and enable them to understand the design, implementation, and analysis of such a trial in a non-biased manner. For all of these studies, the Division has a Social Research Associate position under the direction of both Dr. Joy and Susan Hogan, to interact with and to provide on-site training for the proper and responsible use of informed consent documents, including patient consent literature.

Every year during Fellows' Conference, the fellows are taught how to analyze the clinical data and to assess new therapies and the medical literature itself. Didactic sessions are provided by the Division (Susan Hogan and Dr Abhijit Kshirsagar). In fact, they receive training in what is called an "epidemiology short course" with introduction to epidemiology measurements, the use of relative risks, descriptive studies, types of epidemiological studies, analytic studies, and then statistical analysis. Additionally, the Fellows are asked to discuss in Journal Club specific articles that deal with epidemiology, case study design, and review of novel medical therapies.