Your assignment this week will
be to take on the character of a Human Subjects Review Committee (HSRC),
deliberate about three biomedical human subjects experiments,
and decide whether you will approve them to be done or not.
You will be divided into
two groups, each group will deliberate separately about the experiments,
come to a conclusion about each experiment, and issue a report
to
the class on each of its three decisions.
All three of these experiments
you will be examining are real experiments that have actually been
done in the past or are being done now. (Of course, as we know from the
Tuskegee Study, just because a study
has been done doesn't mean it should have
been done.) For
each proposed experiment your committee can make one of three determinations:
1. Approve
the study as it is presented.
2. Approve the study but only
with certain conditions (list the conditions, and explain why they are
necessary).
3. Reject the study.
The first
experiment about which you will deliberate is Edward Jenner’s famous
smallpox vaccine experiment in 1796, about which there has been much
debate
and discussion.
The second and
third experiments
are current studies regarding the health effects of pesticide
exposure on fetuses,
infants, and young children.
I. Your
first job as an HSRC will be to review what your ethical standards
will be for evaluating
all
these proposed
trials.
To do this you
will 1) Review
the Nuremberg Code, 2) read
the WHO/CIOMS International Ethical Guidelines
for Biomedical Research
Involving Human Subjects, 3) read
the Universal
Declaration of Human Rights (UDHR), and 4) Review
the Belmont Report.
These
documents may require some
discussion in your group
to make
sure you understand
the major
provisions.
II. Your second
charge, to be begun at least by Friday,
will be to
discuss the
merits
of Edward Jenner’s
proposed smallpox vaccine
experiment. Your primary
sources of information
for this will be 1) Kerns,
Jenner
On Trial (for
informational background
about smallpox, Jenner,
the experiment itself,
etc),
2) Jenner’s Ethics
Committee Application Form,
and 3) Jenner’s
Informed Consent Form.
Your Committee will need to come
to its decision about this trial by Saturday night or Sunday
morning so that a report can
be written and issued to the classroom by Sunday evening.
If you finish
these first two above
tasks before Sunday
you can
go ahead and get
an early start
on the
next task.
III. Your
third charge will be to discuss
the merits
of the two
pesticide
trials.
Your primary
sources
of information
about these
trials will
be the two articles
above, both published in Environmental
Health
Perspectives,
a peer reviewed
journal published
by the National
Institute of
Environmental
Health Sciences,
one of the US National
Institutes of Health
(NIH). You may,
if you wish, read
only the short
abstract at the beginning
of these
two
studies, and
the few
paragraphs on “Methods.” It
may be helpful
to read the entire
articles,
but it is not required.
Your
committee can
begin discussing
these two trials
any time but
the decisions will
need
to be made and
the reports
posted by
Tuesday evening.
Wednesday
will be for more general
discussions
about
the trials
and the ERC process.