Activity
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.
Closure
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.
Homework
None |
