Rochester Clinical Research Curriculum

Curriculum

The curriculum of the RCRC consists of coursework, a practical skills workshop series, a clinical research seminar series, clinical site field visits and a mentored research experience. Full-time students can complete the coursework in one year, with the research experience continuing into a second year. Part-time students can complete all components of the program in two years.

Beginning in July of Year I, trainees will complete a series of "field trips" to various sites of clinical research at the University of Rochester Medical Center. The purpose of the field trips is for participants to gain an understanding of what forms clinical research can take and potentially for them to identify mentors and research projects. Representative sites include:

Institutional Review Board

Clinical Research Center

Heart Research Follow-Up Program

Clinical Trials Coordination Center

Vaccine Trials Center

Aab Institute for Biological Sciences

Smoking Cessation Research

Mentored Research Experience

Trainees are required to complete a research project, usually in their clinical field of interest. Trainee research projects should include methodologies appropriate to public health and/or population research (e.g. epidemiology, biostatistics, survey research, economics, policy analysis, systems analysis or operations research), and apply skills and methods acquired by the student in the required coursework.

Trainees must develop and work with a Research Advisory Committee including at least one Department of Community and Preventive Medicine faculty member:

1. Establish a Research Advisory Committee.
2. The student should work with his Research Advisory Committee to define a research topic and methodological approach. The student should not proceed with preparation of the research proposal until the Research Committee has signed off on the topic and approach as satisfactory to the Committee.
3. The student must prepare a written proposal, including purpose, hypothesis, literature review, methodology and analytic approach, and study significance and limitations. This proposal should be appropriate to meet the requirements of the Human Subjects Review Board for permission to enroll human subjects, if necessary. It should also contain a thorough review of the relevant literature, and a complete description and justification of the methodological approach chosen for the project.
4. Following the written proposal, the student will present his or her project proposal in a seminar for Department of Community and Preventive Medicine students and faculty. This seminar should take place prior to data collection, analysis and reporting. A seminar presenting the project to faculty in a clinical department cannot be substituted for this seminar requirement.
5. The paper describing the research project must be the work of the RCRC trainee. This means the student must be the principal author of the paper; must have researched the literature, conducted all data analyses, formulated the results and written all sections of the paper. If there are other investigators involved in the research, the trainee will need to choose a subsection of a larger project for purposes of the RCRC.
6. Throughout the conduct of the research, the student should maintain contact with his Research Committee. For purposes of completing the program, the Research Committee members must be satisfied that the paper is of sufficient quality to be accepted for publication in a peer-reviewed journal.
7. Practical Skills Workshop Series

The Practical Skills Workshops begin in July of Year I with an Introduction to Clinical Research. Thomas Pearson, MD, MPH, PhD, Principal Investigator of the Rochester Clinical Research Curriculum Award, will provide an overview and introduction to what the various types of clinical research are including patient-oriented research, epidemiology, behavioral sciences and health services research. An emphasis will be placed on current research at UR.

The second workshop in the series, Introduction to Medical Informatics, will be in August of Year I. This workshop will orient the trainee to computer and communication resources available at the UR. Trainees will receive an overview of UR computer systems, telecommunications network, intranet, Internet, Miner library resources. This workshop will be lead by Julia Sollenberger, Director of Miner Library and Will DiGrazio of the Clinical Research Center.

In the fall semester of Year I, trainees will take Ethics in Research (IND 501). This course covers a broad range of topics and issues related to professional standards of conduct, including: ethical presentations of scientific information, fraud, responsible reviewing of grants, sexual harassment, ethical mentoring, Federal and University policies on scientific misconduct, statistics and ethics, ethical publishing, sharing reagents, laboratory record keeping, relations with industry, human experimentation, copyrights and authorship, and animal experimentation.

In spring of Year I, the Workshop in Scientific Communication will be offered. This workshop will address the principle elements of scientific presentation and communication such as: abstract preparation, poster development, Power Point instruction, manuscript review and critique, oral presentations, and working with the media/public relations.

An Advanced Research Informatics workshop will be offered in summer of Year II. The workshop will expand upon the information presented in the Introduction to Research Informatics in year I. It will go more in-depth into use of the Internet and the "virtual research center". It will also cover areas such as: data protection and security and its legal, technical and ethical implications; methods of masking data and preventing identification by inference; overview of clinical data systems including rules of operation; clinical data repositories and how to construct queries into them; methods of data sharing across institutions; database technologies used to bring together disparate data elements in disparate databases; and collaborative tools for research, publication and sharing of data.

In the fall semester of Year II the Workshop in Technology Transfer/Working with Industry will be offered. This workshop series will provide an introduction to types and sources of research funding, including the UR SMART system. It will also address legal issues in clinical research, copyright, patenting, licensure and other intellectual property issues, as well as program management and marketing by industry.

Practical Skills in Grant Writing (PM 438) is offered in the spring semester of Year II. This course is intended to provide practical skills related to procuring external support for research. The course content includes a variety of didactic lectures on grant-related topics, discussion sessions with the opportunity to examine grants that others have written, examination of tools and resources available to assist in grant writing, and the opportunity to write a grant for support of the student's own research project and have it critiqued. At the end of the course, the enrollee should be able to write a research grant.

Clinical Research Seminar Series

A weekly seminar series of clinical research presentations will be given by UR researchers, distinguished outside speakers, as well as RCRC trainees. These will be interspersed with presentations on clinical research technologies.

The seminar series is designed to bring together mentors and trainees from diverse fields and disciplines incorporating techniques used in clinical and basic science research. It will also be an opportunity for trainees to gain exposure to a wide variety of role models both from within the UR as well as outside of it. Additionally, trainees will have an opportunity to present their work to their peers and colleagues, to identify ideas and methods which might enhance their work and in the process stimulate cross-discplinary approaches.

Required Coursework

Introduction to Biostatistics
Principles of Epidemiology
Clinical Evaluation and Outcomes Research
Social and Behavioral Medicine
Medical Decision and Cost Effectiveness Research
Introduction to SAS for Windows
Design of Clinical Trials

Additional Coursework Needed to Receive the MPH degree in Clinical Investigation

Introduction to the US Health Care System
Public Health and the Environment
Management and Evaluation of Health Services Organization
+ 1 Elective Course