MSCR 789: Advanced Ethical Issues in Clinical Research

Course Placement:

Completion of MCR 750; Student in MSCR or Graduate Studies, Fellow in Clinical Research Ethics, or instructor permission

This course is intended as a follow-up for MCR 750. Emphasis will be placed on current ethical issues associated with clinical research and practice. The class will focus on review of the competencies involved in the conduct of ethically responsible research. some topics covered in MCR 750 will be covered in more detail. Additional topics associated with ethics in clinical research will also be covered

To familiarize students with the specific ethical issues involved in the planning, implementation and completion of clinical research.  Emphasis will be placed on advanced topics in clinical research as a follow-up to MCR 750. The competencies involved with the conduct of ethically responsible research with be presented and discussed including: understanding the rationale for human subject protection; understanding the mission and function of the IRB; understanding the processes and procedures of the IRB; knowledge of the preparation of an IRB application for submission; understanding the regulatory issues and requirements (State, Federal and Institutional) related to clinical and translational research; understanding and compliance with ethical issues involved in the recruitment of research participants including vulnerable populations; understanding the informed consent process; and understanding the ethical and professional issues involved in clinical and translational research.

1. Lectures, seminars, discussions, panels
2. Assigned references
3. Participation in case discussions in the classroom or online

1. The student will be able to identify ethical issues associated with the practice and conduct of clinical and translational research.

2. The student will be able to identify the process for dealing with ethical violations.

3. The student will have the knowledge to incorporate ethical considerations in all aspects of research and academics.

General Topics Include:

• Mentoring and collaboration
• Academia-industry collaboration
• Controversies in clinical equipoise
• Issues in global health research and genetic research
• Intellectual Property
• Ethical issues in genetic research
• Cloning and stem cell research
• Authorship in publication of research
• Data Safety and Monitoring Boards
• Privacy and confidentiality issues in research
• Compensation for research-related injury
• Deception in research
• Therapeutic misconception
• Use of animals in research

Professor Daniel Lackland  Lackland@musc.edu

Professor Robert M. Sade   sader@musc.edu

Professor Susan Sonne      sonnesc@musc.edu

Professor Perry Halushka    halushpv@musc.edu

Robert Donato, Esq.            donator@musc.edu

Professor Jihad Obeid         jobeid@musc.edu

Professor John Arthur          arthurj@musc.edu

Professor Lisa Kindy, Esq    kindylz@musc.edu

Professor Ronald Acierno    acierno@musc.edu

Professor Pamela Williams  wilpame@musc.edu

Partial listing of student responsibilities

1. Reading – Assigned References Required text: Responsible Conduct of Research, Second Edition
   Adil E. Shamoo and David B. Resnik
   ISBN13: 9780195368246ISBN10: 019536824X Paperback, 440 pages
   Jan 2009
2. Participation in case presentation

Grading:

25%...Case write-up
25%...Case write-up
25%...Completion of web-based certification
25%...Class Participation

Case Review – 3 cases will be presented regarding potential plagiarism, authorship eligibility and data interpretation.  The cases will be reviewed and assessed for possible ethics policy infractions or inappropriate date/authorship interpretation.  A short written opinion for each case will be submitted.