Ethics in Clinical Research, E-Module Versus Traditional Online Lecture, a Randomized Study

Abstract

In a biostatistics course on clinical trials, one important topic is human research ethics. In this study, an E-Learning module (e-module) was developed to train students in human research ethics. This interactive e-module provides an overview of the ethical perspectives of conducting clinical research, historical events, Nuremberg Code, three principles of the Belmont Report, and eight ethical requirements to conduct clinical research. Students in a clinical trials course were randomized to the e-module or traditional online lecture and then took a knowledge-based quiz and an optional satisfaction survey. Students indicated that they preferred learning from an e-module and would like additional e-modules added to the course. We found students randomized to the e-module did not perform as well on the knowledge-based quiz compared to those assigned to the traditional online format, however, e-module students were not given a copy of the slides. When the study was repeated in a second cohort, and both groups were given a copy of the slides, the two groups performed similarly on the knowledge-based quiz. This indicates that additional resources, such as the slides, are helpful when implementing an e-module as part of a biostatistics course.

Keywords

• Biostatistics
• Clinical trials
• E-learning