ETH 738 Seminar Series in Clinical and Translational Research Ethics
Course Placement: Fall 2015
Credit: 1 Credit Hours
Instructors: Dr. Andrea D. Boan (Course Director) firstname.lastname@example.org
Fellow in Clinical Research Ethics; Faculty, staff, and registered students of MUSC; instructor permission
This seminar series expands the range of educational opportunities for students who are interested in clinical research ethics (CRE). It comprises hour-long meetings 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 CRE. It is part of a fellowship program that leads to a Certificate in Clinical Research Ethics. This course is available both in classroom and online. Students who are on campus and are taking the course for academic credit are expected to attend the classroom seminar; all others are encouraged to attend if on campus or participate online.
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:
- 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 via online discussions with forum group.
- The class is divided into small groups to work collaboratively in developing a case study
Major content areas:
The content areas encompass the full range of core competencies within CRE. A partial 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.
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. Grading is 100% based on quality and timely completion of online assignments and forum discussions.
The faculty of the MUSC College of Graduate Studies endorse the campus Honor Code and expect students to be familiar with and abide by its provisions. The Honor Code policy applies to all tests, written assignments, clinical behavior, clinical logs, medical record entries, and verbal and electronic communication. The Honor Code document can be viewed in the Student Handbook.
Plagiarism is a form of academic misconduct and is the use of another person’s words or ideas without providing credit to that person. It is the theft of another person’s words or ideas to give the impression that you created them. These words and ideas may be from a variety of sources including printed works, speeches, presentations, and/or Internet sites and documents. Appropriate and complete referencing of words and ideas obtained from others is a requirement in ALL courses. If a work is anonymous, as may be the case with some Internet documents, it still must be fully referenced.
Accommodation for disabilities:
Section 504 of the Rehabilitation Act of and the Americans with Disabilities Act of 1990 requires MUSC to provide academic adjustments or accommodations for students with documented disabilities. Students seeking academic adjustments or accommodations must self-identify with the Associate Dean for Academics in the College of Graduate Studies. The Disability Accommodation Request form may be found in the Office of Student services. After consulting with the Associate Dean for Academics, students are encouraged to meet with instructors to discuss their needs and, if applicable, any clinical safety concerns related to their disabilities.
ETH 738: Seminar Series in Clinical and Translational Research Ethics
Fall Semester, 2015
CTRE Program Introduction
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. Daniel Lackland, Director, MSCR
Academic Freedom, Tenure
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. Herman Blake, MUSC Humanities Scholar in Residence
The humanities in research
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)
* The scheduled speakers are subject to change.