GMS 7003: Responsible Conduct of Biomedical ResearchSummer 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
5/13/08 wtm