GMS 7003:  Responsible Conduct of Biomedical Research

All dates & times are tentative.

Course Director:    Wayne T. McCormack, Ph.D.  
                                e-mail:   mccormac@pathology.ufl.edu
                                phone:  392-7413
                                office:    R1-102

This course is required for all IDP students.  It is designed to introduce key issues in the responsible conduct of research, following the research process from inception to planning, conducting, reporting, and reviewing biomedical research.  The course seeks to provide a practical overview of the rules, regulations, and professional practices that define the responsible conduct of research.  The coverage is not exhaustive and leaves room for continued reading and discussion with the student's mentor, in the laboratory and classroom, at professional meetings, and in any other setting where researchers gather to discuss their work.  

Attendance:  Unexcused absences will lower your grade as described below.  Be sure to sign the attendance sheet.  If you will miss any sessions due to professional travel, please contact Dr. McCormack for instructions about a make-up assignment.  

Textbook:  The textbook "ORI Introduction to the Responsible Conduct of Research" by Nicholas H. Steneck (Department of Health & Human Services) is available in an HTML version (2006).  This publication features case studies, text-box inserts, discussion questions, and electronic and printed resources.  The text is also available as a PDF document, and in print format from the Government Printing Office on-line bookstore.

Grading:  Letter grade (90, A; 80, B+; 70, B; 65, C+; 60, C; 55, D).  Grading for students registered for credit will be based on attendance to lectures, and both individual and group assessments during team-based learning sessions (relative weighting to be determined by student vote).  To get credit for attendance at lectures, you must sign the attendance sheets.  Unexcused absences will lower your grade. 

Academic Honesty:  Please do not seek material from students from previous years for this course.  Doing so constitutes academic dishonesty, and will result in automatic failure for this course.

Reading Assignments:  Please read the chapters before each session.  Each team-based learning (TBL) session begins with a quiz (readiness assurance test) about the reading material content, which you will take individually and counts toward your grade.  Assigned readings associated with each seminar include case scenarios and discussion questions dealing with the relevant ethical issues.  Please think about how you would answer these questions before each team-based learning session. 

Friday Team-Based Learning Sessions:  Small groups will be set up using the Team-Based Learning format.  Team assignments will be posted on the door, and you will work with the same team for the duration of the course.  Your assignment before each team-based learning session is to attend the preceding lecture, read the assigned chapters of "ORI Introduction to the Responsible Conduct of Research", familiarize yourself with the main points of the chapter(s), and think about how you would answer the case study and discussion questions.  
    Session schedule:  
        3:30 - Individual Readiness Assurance Test
        3:45 - Group Readiness Assurance Test
        4:00 - Small Group Discussion of Case Studies and Discussion Questions
                     Case studies and discussion questions are in the textbook and copied on the web pages linked above.  Handouts will also be provided.
        4:45 - Large Group Discussion of Case Studies
        5:00 - Adjourn
Readiness Assurance Tests will consist of 10 multiple-choice questions based on the assigned reading and seminar content (closed book).  Individual Readiness Assurance Tests must be completed individually, and answers will be recorded on bubble sheets along with your last name and UFID number (please bring a pencil or a blue or black pen to class).  Group Readiness Assurance Tests will consist of the same questions as the Individual Readiness Assurance Test, and group answers will be recorded on scratch-off cards that will be provided.  

Make-Up Assignments:  If you miss a session due to illness or professional travel, please contact me as soon as possible (preferably in advance for travel).  Please submit via e-mail, preferably in advance of your trip or within a week if absent due to illness, brief written answers to each of the discussion questions and case study questions in the assigned chapter for reading.  Links to the case studies are in the right margin of the introduction page for each chapter (labeled either "Short Case" or "Case Study").  Discussion questions may be found at the "Questions" link in the left margin.  I don't expect you to write extensively on each question, but enough to demonstrate that you have read the material and have thought about the issues in the context of responsible conduct of research.  

Acknowledgements:  Some course materials are adapted from the following sources.
        "Responsible Conduct of Research Training: Better Ethics through Sensemaking", Michael D. Mumford, Shane Connelly, Lynn D. Devenport, Ryan P. Brown,
            Stephen T. Murphy, Jason H. Hill, Alison L. Antes, & Ethan P. Waples. Center for Applied Social Research, University of Oklahoma.  http://www.ou-research.com/
        Online Research Ethics Course, Practical Ethics Center, University of Montana.  http://ori.dhhs.gov/education/products/montana_round1/research_ethics.html
        Online Ethics Center for Engineering and Science, Case Western Reserve University.  http://onlineethics.org/

Bioethics and Responsible Conduct of Research - Web Links

11/17/08  wtm