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Safeguarding the Rights of the Study Participant

Author: Catharine Niuzzo Honaman



Time: 2-3 classes
Preparation
Time:
1 hour to read lesson and to make copies of the “Questions to Consider in Writing an Informed Consent Document”
Materials: Copies of the “Questions to Consider in Writing an Informed Consent Document” for each group and
use of the computer lab

 


Abstract
Students learned what an informed consent document was in the lesson entitled “Two Specific Documents”. Now they will apply that knowledge along with what they have learned about the issues surrounding teens using tanning booths and the known detrimental effects of such activities on a person’s health from their government, biology, and/or physics classes to writing an informed consent document that could be used in an actual study.

Purpose – This is an apply lesson. Students will write an informed consent document that ties into the theme of the final project. The informed consent document will be for people involved in a clinical trial designed to study the negative and possible positive health effects of using tanning booths.

Objectives
Students will be able to:
1. Write a paper that follows all the conventions of proper English;
2. Create a paper that incorporates the required sections of an informed consent document such as would be used in a real clinical trial;
3. Synthesize information and concepts learned in the government and physics/biology classes to simulate an authentic informed consent document.

National English Education Standards
Standard #6
Students apply knowledge of language structure, language conventions (e.g., spelling and punctuation), media techniques, figurative language, and genre to create, critique, and discuss print and non-print texts.

Standard #7
Students conduct research on issues and interests by generating ideas and questions, and by posing problems. They gather, evaluate, and synthesize data from a variety of sources to communicate their discoveries in ways that suit their purpose and audience.

Teacher Background
An understanding of the clinical trial process is necessary.
A helpful site is http://www.research.umn.edu/consent/sitemapmed/sitemap_med.html


Resource Websites

http://www.research.umn.edu/consent/sitemapmed/sitemap_med.html (Explains about informed consent documents and is used in this Explain Lesson)
http://humansubjects.stanford.edu/medical/SUSampCons.html (the Stanford Sample Consent Form)

 

 

Activity
1. Students will probably work best in small groups of two or three for this assignment, though a highly motivated student wishing to work on his or her own is also an option. Each group will need a copy of the Questions to Consider in Writing an Informed Consent Document, which is based on the work the students did in the Explain Lesson.

2. Using the Questions to Consider in Writing an Informed Consent Document, the students need to go through each part of the informed consent document composing what is appropriate in a clinical trial designed to study the negative and possible positive health effects of using tanning booths. The students have learned about the mock Senate Committee hearing that will be the central activity of the final project in their government class. This informed consent document would be for a study that would have been done prior to this Senate Committee hearing and supplies data for the hearing. It could also be for a study that is proposed during the hearing because more data is deemed necessary before the government can determine if legislation is needed to regulate the tanning booth industry.

3. Before the students begin writing their documents let them know that their informed consent documents will be assessed on how well they used proper English mechanics (spelling, punctuation, grammar, usage) and how thoroughly they covered all the necessary parts of a real informed consent document. Groups should exchange papers when their rough drafts are completed to peer edit each other’s work before the final copies are written. Each group needs a copy of the Firefighter Smoke Exposure and Medical Surveillance Study Subject’s Consent Form (found at the end of the Explain lesson) and the Stanford Sample Consent Form (found at http://humansubjects.stanford.edu/medical/SUSampCons.html).

Closure
If time permits have a short class discussion with the students in which they talk about the most difficult writing sections of the informed consent document assignment.

Homework
None

Embedded Assessment
The informed consent document will be used as the measure for student learning for this lesson. It needs to follow the conventions of proper English usage and contain all the sections of an actual informed consent document. Student learning should also be gauged by how engaged each student was with this assignment.

 


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


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

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Supported by NIEHS grant # ES06694


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Last update: November 10, 2009
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