GMS 7003:  Responsible Conduct of Biomedical Research

Summer 2008

 

Class meets at 8:30-10:00 a.m. in LG-100 A/B, except as noted below

 

Date   Topic Reading Faculty
Mon, May 12,
LG-110 A/B
L Introduction to RCR & Ethical Decision-Making   Wayne T. McCormack, Ph.D., Course Director
Wed, May 14,
LG-110 A/B
L History of Research Ethics Chapter 1
& Chapter 2
William L. Allen, J.D., M.Div.
Associate Professor, Community Health & Family Medicine;  Director, Program in Bioethics, Law and Medical Professionalism (PDF)
Fri, May 16, G301, HPNP TBL Rules of the Road & Research Misconduct Chapter 1
& Chapter 2

Drs. Allen & McCormack

Wed, May 21,
LG-110 A/B
L IRB & Clinical Trials Chapter 3 Ammon B. Peck, Ph.D.
Professor, Dept. of Pathology, Immunology & Laboratory Medicine
Fri, May 23,
LG-110 A/B
TBL Protection of Human Subjects Chapter 3 Drs. Peck & McCormack
Wed, May 28,
LG-110 A/B
L IACUC & Animal Research Chapter 4 William C. Buhi, Ph.D.
Chair, UF Institutional Animal Care & Use Committee (IACUC)
Fri, May 30,
LG-110 A/B
TBL Welfare of Laboratory Animals
Instructions (PDF)   Bad ACUP (PDF)
Chapter 4 Drs. Buhi & McCormack
Wed, June 4, LG-101A (Auditorium) L Conflicts of Interest & Data Management Practices Chapter 5
& Chapter 6
William L. Allen, J.D., M.Div.
Associate Professor, Community Health & Family Medicine;  Director, Program in Bioethics, Law and Medical Professionalism
Fri, June 6,
LG-110 A/B
TBL Conflicts of Interest & Data Management Practices Chapter 5
& Chapter 6
Drs. Allen & McCormack
Wed, June 11, LG-101A (Auditorium) L Mentor & Trainee Responsibilities and Collaborative Research Chapter 7
& Chapter 8
Colin Sumners, Ph.D.
Professor, Physiology & Functional Genomics
Fri, June 13,
LG-110 A/B
TBL Mentor & Trainee Responsibilities and Collaborative Research Chapter 7
& Chapter 8
Dr. Sumners
Wed, June 18,
LG-110 A/B
L Authorship & Publication and Peer Review Chapter 9
& Chapter 10
Catherine Ketcham, Ph.D.
Assistant in Pathology; Managing Editor, Laboratory Investigation
Fri, June 20,
LG-110 A/B
TBL Authorship & Publication and Peer Review Chapter 9
& Chapter 10
Drs. Ketcham & McCormack

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.  Grading for students registered for credit will be based on attendance to lectures, and both individual and group assessments during team-based learning sessions.  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:  
        8:30 - Individual Readiness Assurance Test
        8:45 - Group Readiness Assurance Test
        9:00 - 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.
        9:45 - Large Group Discussion of Case Studies
        10:00 - 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.  

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


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