Government Intervention in Biomedical Research

Author: Sylvia Kniest

Time: 1 class period
Copy worksheets and “glossary of Clinical Trials” for student groups
Materials: Worksheets and “glossary of Clinical Trials”


Now that students have an understanding of the history of biomedical research and clinical trials, they will participate in a lesson where they will attempt to correct the ethical violations that were made in previous clinical trials such as the Tuskegee Syphilis Study. In this lesson, students will role play members of the Federal Drug Administration in which they will devise a list of protocols to ensure that future clinical trials will protect the rights and health of human subjects. This activity will allow students to understand how the government plays a pivotal role in sustaining healthy citizens.

Students will be able to:
1. Explain the role of government in protecting the rights of citizens.

National Standards For Civics and Government
V-B What are the rights of citizens?
V-E How can citizens take part in civic life?

Teacher Background
Copy “Glossary of Clinical Trials” from: http://clinicaltrials.gov/ct/info/glossary#protocols

Resource Websites
http://clinicaltrials.gov/ct/info/glossary “Glossary of Clinical Trials”



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.

2. 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.

3. 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.

4. .Each group will share their guidelines with the rest of the class. Conclude the discussion by asking:
- Which government agencies will enforce these guidelines?

5. 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 important, etc


Embedded Assessment
Students will be assessed on their contributions to the group’s guidelines for clinical trials.

PULSE is a project of the Community Outreach and Education Program of the Southwest Environmental Health Sciences Center and is funded by:

NIH/NCRR award #16260-01A1
The Community Outreach and Education Program is part of the Southwest Environmental Health Sciences Center: an NIEHS Award


Supported by NIEHS grant # ES06694

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