Transcript Lesson #16: Ethics of an Experiment

Lesson #16:
Ethics of an Experiment
NOVEMBER 2/3, 2011
What is “Ethical”?
 Are placebo medications ethical???
 Are animal tests ethical???
 Are false surgeries (placebo surgeries)
ethical???
 What are ethics???
Question…
 In order to gain information about a new
medication or a new surgery, should other
patients be given false medication or treated
with a false surgery (didn’t actually receive
the surgery, even though they have the outer
appearance that they did)?
 Should animals be sacrificed in the name of
research in order to gain information of
bettering the lives medically of humans?
So What Are The Ethics of an Experiment?
 1. There must be approval of, and
regular review by, an Institutional
Review Board (IRB).
 2. There must be informed consent by
the subjects before the experiment
begins.
 3. All data must be kept confidential.
Institutional Review Board
 Purpose is “to protect the rights and welfare
of human subjects (including patients)
recruited to participate in research
activities”. Their purpose is not to decide if
it is a good idea.
 IRB
reviews the plan, may require changes.
Institutional Review Board
 Comprised
of members of organization, at
least one person outside of organization,
one scientist, and one nonscientist
(minimum of 5 on board).
 Reviews the consent form to
be sure subjects are informed
about nature of study and
any potential risks.
Institutional Review Board
IRB
monitors progress at least
once a year (more often if a
shorter study).
Studies with “minimal risk to
subjects” will have a shorter
review process (ex., sample
surveys).
Problems with IRB’s
 Workloads of IRB’s are very large…so what can
happen as a result?
 IRB’s may not be thorough in their review of
the plan and may miss critical information as
a result.
 IRB’s may be tempted to label study as
“minimal risk” to speed up the process.
 (Example, at Duke University Medical Center
in 1999, the government shut down their
human subject research due to inadequate
protection of the subjects…there were more
than 2000 studies going on).
Informed Consent
 Subjects must be informed in advance
about…
 Nature and purpose of the study
 Possible risks
 If it’s a survey, what kinds of questions
which will be asked
 How much time will be required
 Then they must give their consent in writing.
Informed Consent
 Who can’t give their informed consent?
 Children
under the age of 18
 Prison inmates
 Those with mental disorders
 Unconscious patients in an emergency
room with no one to speak for them gives
their “implied” consent for treatment
Problems with Informed Consent
 Problems encountered…
 Full
disclosure of better treatments or
potential hazards could be withheld in
order to gain subjects.
 Mentioning every hazard could lead to very
long consent forms…could scare off
subjects.
Confidentiality
 Need to keep the identities of the
subjects separate from the rest of
the data (i.e., in a file not with the
data).
 Can only give general summaries
about data (20% of the female
subjects did this…)
Confidentiality
 Different than
ANONYMITY
(the subjects’ names are
not known even to the
director of the study)…
someone sends in a
questionnaire and it has
no identifying
information as to its
sender. This is rarely
done.
So….
 Since placebo
medications may
actually have
medicinal value
(placebo effect),
using placebos
may actually
benefit the
patient.
 But what about placebo
surgeries? Even a real
surgery carries with it
risk…if someone is
having a surgery
without any possible
result, is that ethical?
 Remember, Ms. Eicher
just had knee surgery…
or did she??? What if
they just TOLD her she
had knee surgery??? Is
that ethical???
And…
 Many people are opposed to animal
testing when it is an animal they see as
“cute” or a “pet”, and not as
opposed when it is an animal
more often referred to as a
“pest” or “rodent”.
 So, what do you think???
Homework #14
 Pg.
180-181,
 Pg. 187,
 Pg. 191-192,
#3.44, 3.45, 3.47
#3.53
#3.61, 3.64, 3.65
Group Work (If Time)
In your groups, take a stand for
or against the use of animals in
medical research. Write at least
one paragraph stating your
group’s opinion after discussing
your side of the controversy.