1. Introduce the lesson by telling the students that they are to play the
role of a member of the Food and Drug Administration, which has completed
a study on ethical problems of using human subjects in clinical trials.
Their task is to develop a list of guidelines for conducting
biomedical research on human subjects. The purpose is
to provide a list of protocols to
ensure that future studies protect the rights and health of human subjects.
Assign students to groups of four. Hand out one worksheet, “Citizens
and Rights in Medical Research” and one copy of “Glossary of
Clinical Trials” from http://clinicaltrials.gov/ct/info/glossary to each group.
.Each group will share their guidelines with the rest
of the class.
Conclude the discussion by asking:
- Which government agencies will enforce these guidelines?
If time allows, students may want to collaborate as a
class to rank the guidelines that
they have in common. (1) Which protocol is the most