Unit 3: Human Subjects Research
Medical research typically begins in a test tube or petri dish, moves on to animal testing, and eventually ends in experiments with people. But even after a new drug, therapy, or procedure has been thoroughly tested in people, no one can accurately predict how that treatment will work in any given individual. Every use of a drug or treatment is, in some sense, an experiment.
This unit introduces students to the issues associated with human subjects research. What are the protections that are afforded to individuals who volunteer to participate in clinical trials of new drugs and therapies? How do those who agree to participate learn about experiments? What are the obligations of researchers to the subjects of their experiments? What are the rights of individuals who participate in experiments? Why were these protections put into place?
Most experiments are thoughtfully designed and most researchers are motivated by a desire to do good. But, during the past century, some serious abuses of subjects have taken place. How did this happen? What can be done to prevent this from happening again? What should be done, even now, to compensate those who were injured in studies? What is proper punishment or censure for unethical researchers? What should contemporary researchers do about data obtained improperly or unethically? How does a society ensure that future abuses will not occur?
Experimentation has important positive outcomes. But often what makes the news and guides policymakers are the experiments where something went terribly wrong. Today, more people than ever are participating in clinical trials. This unit introduces students to the concept of informed consent. Whether they become researchers, participate in studies for their own benefit or to help advance medical research, or merely make use of medical treatments, they should be aware of the ethical issues involved in research with living beings.