ETH 738 SEMINAR SERIES IN CLINICAL AND TRANSLATIONAL RESEARCH ETHICS
Tuesdays: 12:00 – 1:00 PM Ashley River Tower 7033
Course Placement: Fall & Spring 2014-2015
Credit: 2 Semester Hours
Prerequisites: Faculty, staff, and registered students of MUSC; instructor permission
Course Description: The IP 738/ETH 738 seminar series is designed for students who are interested in clinical and translational research ethics (CTRE). It comprises hour-long meetings at noon each week with leaders from MUSC research administration and clinical/translational investigators, each of whom focuses on the relation of their offices and activities to CTRE. It is part of a fellowship program that leads to a Certificate in Clinical Research Ethics. The seminar series is available in classroom and, for students who are not on campus, online. Students who are on campus and are taking the course for academic credit are expected to attend the classroom seminar. Questions should be directed to Dr. Andrea Boan, course director.
Course Objectives: Each weekly seminar focuses on the relation of CRE relative to the particular office, position, or research domain of the speaker.
1. To provide the students with a broad view and understanding of CRE from the broadest range of relevant perspectives, from both research-related administrators and deeply engaged clinical and translational investigators.
2. To enable the participants to function with optimal efficiency and effectiveness during their own work in research by deepening their understanding of research ethics and responsibilities from a wide variety of viewpoints.
3. To interact with faculty, staff, and students from other MUSC colleges to learn about each other and about the values and perspectives of their respective disciplines, preparing them for future collaboration.
4. To sharpen the sense of teamwork by working in small groups with other Fellows to develop case studies in Clinical Research Ethics.
Two major learning activities are:
1. The seminars begin with 5-10 minute presentations by the speakers, in which they describe the relation of their position to CRE. Relevant cases from the speakers’ own experience or from the literature may be discussed. Each student is expected to participate actively by leading the discussion.
2. The last one or two sessions each semester are spent in small groups developing case studies in Clinical Research Ethics. The class is divided into groups that work collaboratively in developing their cases.
Major content areas:
The content areas encompass the full range of core competencies within CRE. A non-exhaustive list includes conflicts of interest, such as those relating to recruitment of subjects and relations with industry; publication issues, such as authorship, collaboration, plagiarism, duplicate publication, and peer review; research misconduct, including falsification and fabrication of data; protection of human subjects in research including the role of IRBs and the concepts of vulnerability and coercion. Many other areas of CRE will be covered.
Class Time & Location: Tuesdays, 12:00 – 1:00 pm, Ashley River Tower 7033
Andrea D. Boan, PhD, course director firstname.lastname@example.org
Evaluation of Students: To obtain credit for this course, students must complete all exercises for each session, as posted in Moodle, within one week after the session is posted. Late completion results in loss of 5 percentage points on the grading scale.
Those required to attend class:
50% Attendance and required class participation.
50% Quality and timely completion of online assignments.
Those participating online:
100% Quality and timely completion of online assignments.
ETH 738 Seminar Series in Clinical and Translational Research Ethics
Wednesdays: 12:00 – 1:00 PM Ashley River Tower 7033
(The scheduled speakers are subject to change)
Dr. Daniel Lackland, Director, MSCR Program
Introduction and research misconduct
Dr. Susan Sonne, Clinical & Translational Research Center and Chair, IRB 2
Informed consent for research
Dr. Kathryn Magruder, Director, MUSC Office of Research Integrity
Dr. Robert Sade, Director, SCTR Clinical Research Ethics Core
Honesty and integrity in research
Dr. Gail Stuart, Dean, College of Nursing
Nursing Psychiatry Research
Dr. Herman Blake, MUSC Humanities Scholar in Residence
The humanities in research
Dr. Susan Newman, SCTR Director, Community Engagement Program
Dr. Jihad Obeid, Interim Director, SCTR Institute Biomedical Informatics
Dr. Daniel Wueste, Director, Clemson University’s Rutland Institute for Ethics
Rutland Institute for Ethics
Dr. Etta Pisano, Vice President for Medical Affairs and Dean, College of Medicine
Research relations with industry
Dr. Daynna Wolff, Director, Cytogenetics, Pathology Department
Dr. Mark Sothmann, Vice President for Academic Affairs and Provost
Conflicts of interest and of obligation
Ms. Lisa Kindy, Esq., Director, Clinical Risk Management, University Counsel
Research risk management
Dr. Raymond Anton, Director, Center for Drug and Alcohol Programs
Drug and alcohol research
Planning Case Analyses—Small Groups (Dr. Edward Krug)
Case Analyses (Dr. Edward Krug)