Suppose your research group has been collecting data for 2 years when an associate convinces the team to investigate an additional hypothesis. The hypothesis strikes everyone as intriguing, and you collectively decide to add ten new questions to a survey instrument you have people filling out online. A few months later you, a first-year graduate student, wake up in the middle of the night and realize that the group never asked the Institutional Review Board (IRB) to approve the new questions. You even have reason to believe that the Principal Investigator (PI) is aware of the situation and has decided to do nothing. What should you do? We will return to this question at the end of the chapter. First we must lay out the reasons that the informed consent of research subjects is so important.

Introduction

Researchers enroll tens of thousands of people in experiments each year. In many cases, the participants benefit profoundly from the experience. In some cases, though, some participants are harmed. How do we minimize the risks to each individual, ensure that moral rights are protected, and maximize overall well-being?

The question directs attention to one of the most important issues in research ethics because unspeakable crimes have been committed in the name of science. The Nazi doctor Josef Mengele, for example, conducted experiments on twins in which he injected dye into the eyes of brown-eyed patients to determine whether he could transform them into blue eyes (Robert Jay Lifton, The Nazi Doctors: Medical Killing And The Psychology Of Genocide. Basic Books, 1986). He forcibly distended the rectums of adolescents, without anesthesia, and excised tissue samples from their kidneys and prostates. When experiments were concluded, the subjects were killed by injections to the heart. The justification Mengele gave for his research was that he was trying to discover basic scientific knowledge about physiological processes in order to assist in the medical treatment of wounded German soldiers. But could such awful experiments ever be justified by appeals to their potential consequences? No reasonable observer would answer such a question affirmatively.