Two Specific Documents

Author: Catharine Niuzzo Honaman

Time: 3-4 classes
2 hours to read lesson and to read background information
Materials: Computer lab


Now that the students understand the place of clearly delineated ethical standards in medical research, it is time for them to examine actual informed consent documents created by researchers to educate study participants about the clinical trials in which they are involved. After establishing the significance of informed consent, students will then look at legislation that is designed to protect people from unethical medical testing practices. Students will also look at the place and purpose of position papers in governmental hearings. Scientists use both of these documents to communicate to specific audiences what is happening in their research. This is the Explain Lesson. Students will examine two types of documents that scientists use to communicate specific information to specialized audiences.

Students will be able to:
1. Read and analyze the essential parts of two specific types of documents, the informed consent document and the position paper, used by scientists to communicate information about their research to two different kinds of audiences: to participants in a clinical study with the informed consent document and to a government body with the position paper;
2. Draw connections between legislation created to protect the public from unethical medical testing and practices and the protections found in informed consent documents.

National English Education Standards
Standard #3
Students apply a wide range of strategies to comprehend, interpret, evaluate, and appreciate texts. They draw on their prior experience, their interactions with other readers and writers, their knowledge of word meanings and of other texts, their identification strategies, and their understanding of textual features (e.g., sound-letter correspondence, sentence structure, context, and graphics)

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.

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

Resource Websites
http://history.cit.nih.gov/history/Prot_for_Human_Subjects.html (Timeline of Laws Related to the Protection of Human Subjects)
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)
Consult http://thomas.loc.gov/home/lawsmade.bysec/considbycomm.html#pubhrngs to read about how the public hearings are conducted.



The Informed Consent Document
1. Begin the lesson by asking the students to pretend that they have volunteered to participate in a clinical trial for a new medicine or a new medical treatment technique. Have them create a list of questions about the experiment that they would have for the researchers. In other words, what have they signed up for? What practical questions should be answered? For example, one would want to know how long the clinical trial is going to last. Give the students about ten minutes to generate their lists and then have a class discussion in which the students share their questions. Students should add questions onto their lists that others have thought of but have not occurred to them.

2. The next step is to look at an actual informed consent document and an actual set of guidelines. The students should break into groups of three. Each group needs a copy of the Firefighter Smoke Exposure and Medical Surveillance Study Subject’s Consent Form (found at the end of this lesson) and the Stanford Sample Consent Form (found at http://humansubjects.stanford.edu/medical/SUSampCons.html). Have the students examine both of these documents, making a list of each of the parts that needs to be incorporated into an informed consent document with a brief description of what each part should contain. This will probably take 30 to 45 minutes.

3. When the students have completed their lists have the class as a whole establish what is necessary to create a complete informed consent document. Have the group correct/amend their own lists using a different color pen from the original work to help them see what they have overlooked. Use an overhead projector or some other large format so the class as a whole can see what each group is contributing. Ask each group to go up to the projector or board to write in a section of the informed consent document, going in order of how these sections should appear in a real ICD (informed consent document).

4. Finally have the students look at the legislation, which has been enacted to protect participants in clinical trials from unethical medical practices. Download this information from http://history.cit.nih.gov/history/Prot_for_Human_Subjects.html (Timeline of Laws Related to the Protection of Human Subjects). Ask them if they think that these laws are sufficient or does additional legislation need to be enacted?

5. All of the activities in #1, #2, #3, and #4 should take two to three class periods.
The Position Paper

6. On the last day of the lesson the students are going to shift gears a little bit. With your class consult http://thomas.loc.gov/home/lawsmade.bysec/considbycomm.html#pubhrngs to read about how the public hearings are conducted. This website states that:

So far as practicable, committees require that witnesses who appear before it file a written statement of their proposed testimony in advance of their appearance and limit their oral presentations to a brief summary of their arguments. In the case of a witness appearing in a nongovernmental capacity, a written statement of proposed testimony shall include a curriculum vitae and a disclosure of certain federal grants and contracts.

7. Ask the students to state in their own words what this tells you about the requirements of the position paper. They should see that they will be writing a formal paper that describes the arguments which will be made before the Congressional committee for the final project of this unit. In other words, they will be writing a persuasive paper. What elements create an effective persuasive paper? Clear arguments, abundant facts to support the arguments, and well-chosen vocabulary that bolsters the strength of one’s side of the issue are all essential elements of an effective persuasive paper.

8. The format of an expository theme would fit these requirements well. Go over this format with your students, highlighting the necessary elements: a focused introduction, body paragraphs that begin with a clear topic sentence and supporting sentences with specific data, ending with a conclusion that reviews all the arguments and leaves the reader with something to ponder.

9. The students do not yet know about the requirements for the final project, as these will be given out in the explanation part of the government class. Also, they do not yet know that the class will be divided into eight different kinds of groups that range from various types of lobbyists to government representatives to scientists. As all of that will be assigned later on after the classes which will teach the students about the formation of government policy; your task now is to give the students guidelines in writing a persuasive paper that will prepare them to skillfully participate in the final project. Another factor to take into consideration is that the final project will basically be dealing with the dangers of too much UVA and UVB exposure. The students will be researching the scientific concepts that back up their arguments in their physics and/or biology classes. Each member of the government task force will argue for support for their position on the usage of tanning beds. Therefore, students need to address the benefits or dangers of using tanning booths in the areas of short and long-term health concerns, impact on personal liberty, and the feasibility of implementation. In your class discussion, please guide your students to these three points.

10. Lastly, the matter of audience needs to be considered. Discuss with your class that the audience for the position paper will be government bureaucrats and politicians. Ask them what kind of tone will be necessary in the paper. Make a list of those features that would give a paper a more formal tone. What features would make professional people take a paper seriously? Such features would include the avoidance of slang or informal language, the inclusion of technical terms appropriate to the subject, precise descriptions, more complex sentence structures, always presenting ideas as supported by numerous facts and scientific studies, and avoidance of the first person and personal opinion.

11. Briefly review with the class what they learned about finding reliable sources of information. Also remind them of the importance of documenting where they find their information. You may wish to review good note-taking practices and the necessity of giving credit to a source for its ideas and information. A position paper will only be as believable as the proof that backs up its arguments. So it is essential to have strong arguments and substantial facts and studies to illustrate each point from respected sources. Inform the students that they should have a minimum of three arguments in their papers, preferably one economic, one environmental, and one concerning environmental health issues for human beings.


Embedded Assessment
Student engagement with this lesson can be assessed on how well the students participate in the various class discussions and how actively they contribute to the group work. Look at how accurately they analyzed the requirements for the informed consent document. Did they have all the necessary parts? Were they able to establish all the necessary areas of concern a participant in a clinical study would specifically want/need to know? Finally, were the students able to correlate the protections outlined in the various pieces of legislation with the provisions found in the informed consent document? Did they thoughtfully draw conclusions and ask questions about how well the informed consent document safeguards the rights of study participants?


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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