The Ethical Issues of the STEP Study
Discuss the ethical issues surrounding the STEP Study and the reasons for its termination.
The STEP Study is the name of a clinical trial to test an experimental human immunodeficiency virus (HIV) vaccine. There were 24 cases of HIV infection among the 741 volunteers who received at least one dose of the investigational vaccine. There were 21 cases of HIV infection among the 762 volunteers who were vaccinated with a placebo. Prior to beginning this study, how would you have described the risks and benefits of the study to participants? Discuss the ethical issues surrounding this study at the beginning and at the time the decision was made to terminate the study.