The global clinical trials enterprise is growing worldwide. However, many parts of the world, especially low- and middle-income countries (LMICs), lack sufficient clinical trial capacity, meaning sponsors encounter difficulties or avoid establishing trial sites in those countries. Ethical review of interventional clinical research is a core component of institutional, regional, and national clinical trial capacity. This course will provide learners with a foundational understanding of key scientific and ethical issues in the design and review of clinical trials to enable them to critically analyze applications for clinical trials in their local region.
Language: English
Course information
Overview: The global clinical trials enterprise is growing worldwide. However, many parts of the world, especially low- and middle-income countries (LMICs), lack sufficient clinical trial capacity, meaning sponsors encounter difficulties or avoid establishing trial sites in those countries. Ethical review of interventional clinical research is a core component of institutional, regional, and national clinical trial capacity. Stating ethical principles or an ethical framework is relatively simple, but the application of ethical principles to real-life, challenging assessments of risk, benefit, and burden, in the context of culture, community, privacy, confidentiality, and current knowledge is complex and challenging.
This course will provide learners with a foundational understanding of key scientific and ethical issues in the design and review of clinical trials to enable them to critically analyze applications for clinical trials in their local region. This course is tailored to research ethics committee members, chairs, administrative staff, and others who review clinical trial protocols. The course will also benefit regulators, investigators, study staff, care providers, and others involved in clinical trials.
Course duration: Approximately four and half hours.
Certificates: A Certificate of Achievement will be available to participants who score at least 80% of the total points available on the quiz. Participants who receive a Certificate of Achievement can also download an Open Badge for this course. Click here to learn how.
Acknowledgments: This course was developed by the Multi-Regional Clinical Trials Center (MRCT Center) of Brigham & Women’s Hospital and Harvard. We would like to thank our expert review group for sharing their time and expertise in the review of this course: Dr. Aamir Jafarey (Centre of Biomedical Ethics and Culture, Sindh Institute of Urology and Transplantation, Pakistan), Dr. Roli Mathur (Indian Council of Medical Research Bioethics Unit, India), Ms. Winfred Nazziwa (Uganda National Council for Science & Technology, Uganda), Ms. Ana Palmero (World Health Organization, Argentina), and Ms. Lealem Wagaw (Salale University, Ethiopia).
What you'll learn
- Describe the critical role research ethics committees (RECs) play in protecting human research participants enrolled in clinical research
- Understand the basic product development process for drugs, vaccines, and medical devices
- Identify key ethical issues associated with different phases of clinical research and different elements of study design
- Apply the core principles of research ethics to assess a proposed research study
Who this course is for
- This course is tailored to research ethics committee members, chairs, administrative staff, and others who review clinical trial protocols. The course will also benefit regulators, investigators, study staff, care providers, and others involved in clinical trials.
Enroll me for this course
Certificate Requirements
- Gain a Record of Achievement by earning at least 80% of the maximum number of points from all graded assignments.
- Gain an Open Badge by completing the course.