Field Epidemiology Training Program: Case Study: Research Ethics
Short-course Zidovudine Compared to What? A Trial to Prevent Mother-to-Infant HIV Transmission is a classroom-based interactive case study that addresses ethical and scientific issues in research. The research example used in this case study is a randomized controlled trial of zidovudine to prevent mother-to-child transmission of HIV in developing countries after its effectiveness had been established in developed countries. The case study focuses on ethical issues, particularly the appropriateness and selection of a comparison (placebo) group, the review process, and informed consent.
After completing this case study, the participant should be able to:
- Discuss the principle of equipoise and its relevance in designating an appropriate comparison group in a randomized controlled trial (RCT)
- Describe the role of an Institutional Review Board
- List the required elements of informed consent and discuss key considerations in using informed consent in developing countries
- Describe the ethical rationale for conducting an interim analysis of a clinical trial
The case study is intended to be used in the classroom, with students reading text and responding to questions under the facilitation of an instructor. The instructor should provoke discussion and exchange of ideas among participants.
Instructor and participant versions are available. The participant’s version includes all text and questions and space for answers. The instructor's version includes all of the text and questions, plus teaching points and responses for each question.