CTRE Fellowship Course Descriptions

This course is intended as a follow-up course for ETH/MCR 750 and ETH/IP 738. This course builds on the introductory CTRE core competencies addressing many of the key issues in clinical research ethics in depth. It analyzes more deeply ethical issues in such areas as data management, vulnerable populations, ethical issues in alcohol and drug abuse research, international clinical research, relations between law and research ethics, moral agency, and social determinants of health.

The course will be available online and is set up as a series of Topic Modules in specific areas of CTRE. Students will be responsible for viewing all lectures and completing all assignments for each topic module by end of the semester.

Course Objectives

As with the other components of the CTRE Fellowship Program, each weekly lesson focuses on expanding the student’s knowledge and understanding of the key competencies associated with clinical research ethics. This course is intended to enable the students to function with optimal efficiency and effectiveness during their own work in research by deepening their understanding of clinical and translational research ethics and responsibilities.

1 credit hour

This online seminar series expands the range of educational opportunities for learners who are interested in clinical and translational research ethics (CTRE). It comprises 1 to 1.5 hour-long asynchronous seminars each week with leaders from MUSC research administration and clinical/translational investigators and invited guests from other institutions, each of whom focuses on the relation of their offices and activities to CTRE. Each seminar will be followed by small group discussions online. This course may be substituted with IP 738 for fellowship credit.

The course will be available online. Students will be responsible for viewing weekly seminars and participating in the corresponding online asynchronous group forum discussions, as well as completing a Final Project based on an assignment movie on research ethics at the end of the semester.

Course Objectives

Each weekly seminar focuses on the relation of CTRE relative to the particular office, position, or research domain of the speaker. Specific objectives:

• To provide the students with a broad view and understanding of CTRE from the broadest range of relevant perspectives, from both research-related administrators and deeply engaged clinical and translational investigators.
• 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.
• To interact with faculty, staff, and students from other MUSC colleges as well as health care professionals from other institutions to learn about each other and about the values and perspectives of their respective disciplines, preparing them for future collaboration.
• To sharpen the sense of teamwork by working in small groups with other Fellows to develop case studies in Clinical Research Ethics.

1 credit hour

Emphasis will be placed on the 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. The process of assessing ethical issues in research and study will be described. The ethical considerations in collaborative research, study design and implementation, data management, data analysis, data interpretation and results presentation and publication will be described. The course will consider evolving ethical issues in clinical research including human subjects and conflict of interest. This course may be substituted with MCR 750 for fellowship credit.

The course will include a class participation system and will be available online. Students will be responsible for viewing weekly lectures and completing the short corresponding lecture quiz, participating in weekly online asynchronous group forum discussions, and completing a Final Project at the end of the semester.

Course Objectives

To familiarize students with the specific ethical issues involved in the planning, implementation and completion of research. Emphasis will be placed on conflict of interests, informed consent, protecting vulnerable populations, ethical issues in data interpretation and publication, reference citing and plagiarism, honor code, and the process for resolving ethical issues. In addition, the specific Clinical Research Ethics core competencies in the responsible conduct of clinical and translational research will be explicitly addressed.

1 credit hour

This course is intended as a follow-up course for MCR/ETH 750. Emphasis is placed on current ethical issues associated with clinical and translational research and practice. The class focuses on review of the competencies involved in the conduct of ethically responsible research. Some topics covered in MCR 750 are discussed in more detail. Additional topics associated with ethics in clinical and translational research are also be covered. A mentor guided research project on a topic in CTRE that results in a publishable manuscript may be substituted for ETH 789. A research project proposal to include the mentor’s contact information must be submitted to the Director for consideration before the start of the Spring semester ETH 789 course.

The course will be available online. Students will be responsible for viewing weekly lectures and completing the corresponding case assignment, as well as a Final case write-up and subsequent peer critique at the end of the semester.

Course Objectives

To familiarize students with the specific ethical issues involved in the planning, implementation and completion of clinical and translational research. Emphasis is placed on advanced topics in clinical research as a follow-up to MCR 750. The Clinical Research Ethics core competencies in the responsible conduct of clinical and translational research are explicitly addressed.

2 credit hours