GMS 7003: Responsible Conduct of Biomedical ResearchSpring 2010 |
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| Date | Room | Topic | Reading | Faculty |
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Thu, Jan 7
|
LG-101A |
Introduction to RCR & Ethical Decision-Making | Wayne T. McCormack, Ph.D., Course Director | |
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Thu, Jan 14
|
LG-101A |
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 |
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Tue, Jan 19 3:30-5:00 |
G103 HPNP |
TBL: Rules of the Road & Research Misconduct | Chapter
1 & Chapter 2 |
Drs. Allen & McCormack |
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Thu, Jan 21
|
LG-101A |
Career
Development Seminar: |
Peter W. Stacpoole, Ph.D., M.D.
Director, Clinical and Translational Science Institute, Associate Dean,
Clinical Research and Training, UF College of Medicine Sponsored by the COM Graduate Student Organization (GSO) |
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Thu, Jan 28 |
LG-101A |
IRB & Clinical Trials | Chapter 3 | Ammon B. Peck, Ph.D., Professor, Dept. of Pathology, Immunology & Laboratory Medicine |
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Tue, Feb 2 3:30-5:00 |
G103 HPNP |
TBL: Protection of Human Subjects | Chapter 3 | Drs. Peck & McCormack |
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Thu, Feb 4 |
LG-101A |
Research Seminar: TBA | TBA | |
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Thu, Feb 4 |
LG-101A |
Research
Seminar Review Session (Attendance required for first-year students) |
Richard C. Condit, Ph.D. | |
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Thu, Feb 11 |
LG-101A |
IACUC & Animal Research | Chapter 4 | William C. Buhi, Ph.D., Chair, UF Institutional Animal Care & Use Committee (IACUC) |
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Tue, Feb 16 3:30-5:00 |
G103 HPNP |
TBL: Welfare of Laboratory Animals | Chapter 4 | Drs. Buhi & McCormack |
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Thu, Feb 18 |
LG-101A |
Career
Development Seminar: Experiences and Opportunities in Medical Writing for Biomedical Scientists |
Rebecca K. Davis, Ph.D.
Student Outreach Chair for the American Medical Writers' Association (AMWA), Florida Chapter Sponsored by the COM Graduate Student Organization (GSO) |
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Thu, Feb 25 |
LG-101A |
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 |
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Tue, Mar 2 |
G103 HPNP |
TBL: Conflicts of Interest & Data Management Practices | Chapter
5 & Chapter 6 |
Drs. Allen & McCormack |
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Thu, Mar 4 |
LG-101A |
Research Seminar: Nanotechnology for Cancer Therapy: Lessons Learned from NCI's Nanotechnology Characterization Lab |
Scott McNeil,. Ph.D., Director, Nanotechnology Characterization
Laboratory, National Cancer Institute, Frederick, MD |
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Thu, Mar 4 |
LG-101A |
Research
Seminar Review Session (Attendance required for first-year students) |
Richard C. Condit, Ph.D. | |
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Thu, Mar 11 |
No class - UF Spring Break Week |
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Thu, Mar 18 |
LG-101A |
Career
Development Seminar: |
Edward Niles, Ph.D., Project Officer, Biomedical
Advanced Research and Development Authority (BARDA),
US Dept. of Health and Human Services, Washington, DC Sponsored by the COM Graduate Student Organization (GSO) |
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Thu, Mar 25 |
LG-101A |
Research Seminar: TBA |
Jeffrey
A. Bluestone, Ph.D., AW and Mary Clausen Distinguished Professor
of Medicine, Pathology, Microbiology and Immunology, Director, UCSF
Diabetes Center and The Immune Tolerance Network
Hosted by the students of the Immunology &
Microbiology Advanced Program |
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Thu, Mar 25 |
LG-101A |
Research
Seminar Review Session |
Richard C. Condit, Ph.D. | |
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Thu, Apr 1 |
LG-101A |
Mentor & Trainee Responsibilities and Collaborative Research |
Chapter
7 & Chapter 8 |
Colin Sumners, Ph.D. Professor, Physiology & Functional Genomics |
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Tue, Apr 6 |
G103 HPNP |
TBL: Mentor & Trainee Responsibilities and Collaborative Research |
Chapter
7 & Chapter 8 |
Dr. Sumners & McCormack |
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Thu, Apr 8 |
LG-101A |
Authorship & Publication and Peer Review |
Chapter
9 & Chapter 10 |
TBA |
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Tue, Apr 13 |
G103 HPNP |
TBL: Authorship & Publication and Peer Review |
Chapter
9 & Chapter 10 |
Drs. TBA & McCormack |
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Thu, Apr 15 |
LG-101A |
Career
Development Seminar: |
Jodi
Gentry, M.A. Director, UF Human Resource Services |
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| Tue, Apr 20 | HPNP Auditorium | COM Research Day Medical Guild Graduate Student Research Competition |
Course Director:
Wayne T. McCormack, Ph.D.
e-mail: mccormac@pathology.ufl.edu
phone: 273-8603
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 or illness, please contact Dr. McCormack and see below 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.
Powerpoint presentations from lectures will be posted at the MedInfo Courses web site for this course <https://medinfo.ufl.edu/courses/php/content.php?courseid=63> (login using Gatorlink username and password).
Grading: Letter grade (90, A; 85, A-; 80, B+; 75, B; 70, B-; 65, C+; 60, C; 55, C-; 50, 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 assigned 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, as your team will be discussing similar scenarios in some detail.
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 - Group Activity Exercise - Team
discussion of case studies and questions
4:45 - Class 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 used in the TBL sessions 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
11/16/09 wtm