Clinical & Translational Research Ethics Fellowship

Year 1, Fall

Year 1, Spring

Year 1, Fall

Year 1, Spring

Year 2, Fall

Year 2, Spring

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

• Understand the fundamental principles of the protection of human subjects, the main authoritative bodies, relevant codes, and scope of enforcement.
• Determine risk-benefit ratio of research protocols, balancing risks against potential outcomes, and critique protocols for risks to human subjects.
• Describe the elements of informed consent, including ensuring voluntariness and decision-making capacity of participants, avoiding undue influence or coercion, and providing details of the risk-benefit calculation.
• Apply the main regulatory precepts, rules, guidelines, codes, and professional standards in the conduct of clinical and translational research.
• Ensure fairness in recruiting participants and in distributing the benefits and burdens of research.
• Understand and critique special issues that arise in research with vulnerable participants and the need for additional safeguards.
• Adhere to all institutional review board (IRB) procedures and describe the principles of research documentation, validation and audit.
• Ensure appropriate levels of privacy protection throughout all phases of a study.

• Describe the basic principles and practical importance of proper study design and analytical techniques.
• Discuss the importance of data and safety monitoring plans and boards.
• Use bioinformatics ethically in clinical and translational research.

• Recognize the demographic, geographic and ethnographic features within communities and populations when designing and critiquing clinical studies.
• Summarize the principles and practices of community-engaged research, including its ethical complexities and cultural sensitivities.
• Describe cultural and social variation in standards of research integrity.

• Determine authorship using relevant standards and criteria.
• Describe the role of peer review in funding and publication.
• Avoid irresponsible practices, such as duplicate publication, redundant publication and copyright violation.

• Identify and manage conflicts of interest in research, including conflicts in financial affairs, intellectual property, employment, and industry collaboration.
• Identify and manage conflicts of interests associated with research industry collaborations.
• Identify, investigate and report misconduct in research — fabrication and falsification of data and plagiarism.

If you are currently registered for any degree-granting program in any college at MUSC, whether full-time or part-time, then you are considered a degree seeking student and thus will be taking the fellowship courses above and beyond what is required for your degree. However, several of the fellowship courses have been designated as Interprofessional Education (IPE) courses and thus may count towards your IPE curriculum requirements depending on your respective program.

Full-time and part-time tuition and fees vary by each individual academic program and college.

Part-time students pay tuition by the credit hour and have additional fees as designated by their respective college/program; and thus will be required to pay tuition and fees accordingly for the additional fellowship courses not part of your college/program curriculum. Please see Schedule of Academic Charges.

Full-time status varies by semester, college, and academic level. Most programs do not require additional tuition and fees for elective courses if enrolled as a full-time student, paying full-time tuition and fees for their program.

Students, please contact your respective program administrator or OEM administrator to confirm your enrollment status and any potential tuition and fees that may apply to you for the additional fellowship courses.

***Please note that you are NOT required to complete the fellowship curriculum prior to graduating from your degree program. Once you graduate, you may transition to the non-degree seeking status for which those rules would apply for the remainder of the fellowship.

If you are NOT currently enrolled in a degree-seeking program at MUSC, then you are considered a non-degree seeking student. This includes the following:

• All those not affiliated with MUSC.
• MUSC medical residents, fellows, and post-docs (not enrolled in a degree program).
• MUSC faculty, staff, or alumni (not enrolled in a degree program).

***Please note: if you are enrolled in the MSCR/CCR or any other degree program then you are considered a degree seeking student and thus the degree seeking rules above would apply despite your dual role as MUSC faculty/staff/trainee. After graduation you may transition to non-degree seeking status. As well, if you begin the fellowship program as a non-degree seeking student, and later enroll in a degree program at MUSC, then you will be considered a degree seeking student for that semester, and thus the rules and fees based on your respective program would apply. Your status is determine on a semester-by-semester basis.

Currently, the Provost has agreed to waive all tuition and fees for non-degree seeking students for the fellowship courses. As noted above, you will now have an official MUSC academic transcript!

A challenging, informative curriculum led by an array of talented professionals with backgrounds in health policy, law, medicine, and humanities. Very beneficial, highly recommended!

For me, the highlight of being a CTRE fellow is the interdisciplinary training. As the Coordinator of my Institutional Ethics Committee and Stem Cell Research Committee, this fellowship helped me to broaden my understanding of bioethics and ethical issues. Over the course of the fellowship, I found myself excited to participate with other fellows, shared my views, suggestions, and analyses, as well as being surrounded by a group of faculty and fellows who were passionate and truly generous with their knowledge and ideas. Due to the broad-based aspect of the fellowship, I can effectively & scientifically contribute to my work.

I participated in the CTRE fellowship as a new faculty member at MUSC in veterinary medicine with no exposure to human clinical research. I learned a lot about the ethics of clinical research and enjoyed the online format that I could flexibly schedule into my work life. Perhaps more than the enjoyment of learning ethics, I valued meeting program faculty and fellows with interests similar to mine. I highly recommend the CTRE fellowship.

I thoroughly enjoyed the CTRE course. Its format and delivery exceeded my expectations. Very thought-provoking content with a workload that was manageable while I worked full-time. A ‘must-do’ for anyone involved in human subject research.

The CTRE Fellowship Program provided me with outstanding training that will be extremely beneficial as I move forward in my career as a clinical scientist. The knowledge that I gained as part of this program helps me to feel more confident that I am conducting my research in an ethical manner. I am grateful for the opportunity to have participated in this fellowship program and would like to encourage others to participate as well. It is definitely worth the time and effort.

The Fellowship Program helped put in perspective situations we face every day as physicians and researchers. Discussion forums were invaluable to understand how each scientist approaches ethically challenging dilemmas.

While the Research Ethics program began as an opportunity to bolster my resume, it grew into much more throughout my coursework. It truly drew my attention to the world of clinical research and really made me evaluate my ethical values, research-related and otherwise.

I continue to use the concepts learned in CTRE in my bedside care as a pediatric intensivist. Recently I was fortunate enough to join the group of faculty working with Dr. Schenck on the ethics of CRISPR ... exciting stuff.