GMS 7003:  Responsible Conduct of Biomedical Research

Spring 2014

 

The course will meet on Tuesdays at 3:30-5:30 pm
Sessions 3-11 will be in the team-based learning (TBL) format.

 

 

Date Room

Topic

Reading

Faculty

Jan 7 R2-265 Course Intro & Ethical Decision-Making Pre-Test - Wayne T. McCormack, Ph.D.
Jan 14 R2-265 Introduction to RCR, Ethical Decision-Making, & TBL Forward, Preface, Parts I-IV, Chapter 1 Wayne T. McCormack, Ph.D.
Jan 21   No Class
Jan 28 R5-265 Research Misconduct Chapter 2

William L. Allen, J.D., M.Div.

Feb 4   No Class    
Feb 11 R2-265 Welfare of Laboratory Animals Chapter 4 William Buhi, Ph.D., IACUC Chair
Feb 18 R2-265 Protection of Human Subjects Chapter 3 Ammon B. Peck, Ph.D.
Feb 25   No Class
Mar 4   UF Spring Break-No Class
Mar 11 R2-265

Data Management Practices

Chapter 6 William L. Allen, J.D., M.Div.
Mar 18
R2-265

Conflicts of Interest

Chapter 5 William L. Allen, J.D., M.Div.
Mar 25 R2-265 Mentor & Trainee Responsibilities Chapter 7 Colin Sumners, Ph.D.
Apr 1
R2-265 Collaborative Research Chapter 8 Colin Sumners, Ph.D.
Apr 8 R2-265

Authorship

Chapter 9 Bruce Goldberger, Ph.D.
Apr 15 R2-265

Peer Review

Chapter 10, Part V Bruce Goldberger, Ph.D.
Apr 22 R2-265 Ethical Decision-Making Post-Test - Wayne T. McCormack, Ph.D.


       Course Director:    Wayne T. McCormack, Ph.D.  
                                       e-mail:    mccormac@pathology.ufl.edu
                                       phone:    273-9042
                                       office:     D6-18B

This course is required for all IDP students.  It is designed to introduce key issues in the responsible conduct of research (RCR), 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.  

This course is open to graduate students in other graduate programs, and postdoctoral fellows and junior faculty members who must complete RCR training to fulfill fellowship or training grant requirements are also welcome to participate.  Please contact Dr. McCormack for more information.

Attendance:  Unexcused absences will lower your grade as described below.  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) features case studies, text-box inserts, discussion questions, and electronic and printed resources.  The text is available on-line (Table of Contents, and see links above for specific reading assignments), as a PDF document, and in print format from the Government Printing Office on-line bookstore

Lectures:  PowerPoint presentations and/or videotaped lectures are available on-line at the StudyCore course web site.  Log in using your Gatorlink username and password.  Click on "Documents" to see folders for each session.  Click on the folder to see contents (arrow head will point down). 

Grading:  Letter grade (90, A; 85, A-; 80, B+; 75, B; 70, B-; 65, C+; 60, C; 55, C-; 50, D).  On a 100 point scale, grading for students registered for credit will be based on both individual and team assessments during team-based learning sessions (90 points total; relative weighting to be determined by student vote) and completion of the ethical decision-making pre-test and post-test (5 points each).  Unexcused absences will result in a score of 0 and will lower your grade (see Make-Up Assignments below). 

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.

Ethical Decision-Making Pre-Test and Post-Test:  The purpose of RCR training is not only to familiarize you with the rules, regulations, and professional practices that define the responsible conduct of research, but to help you assess your own behavior in your research practices.  The ethical decision-making (EDM) test will be used at the beginning and end of the course to give you opportunities to think about the complexity of situations that arise in biomedical research, and provide you with confidential feedback about your decision-making skills in the domains of data management, study conduct, professional practices, and business practices, as well as social-behavioral responses to ethical problems.  Simply taking each test earns 5 points each toward your final grade.  The EDM measures will be coded, and the results will not be tabulated until after completion of the course, thus the results will be anonymous to the faculty members and will have no impact on your grade.  You will have an opportunity to obtain your coded individual results from a staff person in order to provide you with a self-assessment of your decision-making skills at the end of the course. 

Reading Assignments:  Please read the assigned chapters and view the on-line lectures 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. 

Preparation for 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 assignments before each team-based learning session are to:
1.  view the relevant PowerPoint and/or videotaped lecture (links at course web site)
2.  read the assigned chapter of "ORI Introduction to the Responsible Conduct of Research" (links above and at course web site)
3.  familiarize yourself with the main points of the assigned chapter, and
4.  think about how you would answer the case study and discussion questions in the assigned chapter.  
    Session schedule:  
        3:00 - Individual Readiness Assurance Test
        3:15 - Team Readiness Assurance Test
        3:30 - Team Application Exercise - Team discussion of case studies and questions
        4:30 - 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).  Team Readiness Assurance Tests will consist of the same questions as the Individual Readiness Assurance Test, and team 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.  

Evaluation:  The EDM assessments used during this course will also be used to evaluate the effectiveness of the training program.  Students will be invited to complete a second EDM post-test 6 months after the course ends, and participation will be voluntary.  Students' identities and other personal information will not be attached to any data collected, and the data will only be presented in aggregate form, thereby assuring student confidentiality.  You may choose not to have your assessments used for research purposes. 

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://casr.ou.edu/
        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/
Ethical Decision-Making Test References:
        Mumford, MD, et al. 2006. Validation of ethical decision-making measures: Evidence for a new set of measures. Ethics Behav. 16:319-345.
        Antes, AL, et al. 2010. Evaluating the effects that existing instruction on responsible conduct of research has on ethical decision making. Acad Med. 85:519-26.


Bioethics and Responsible Conduct of Research - Web Links


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