PHIL 335 Lecture Notes - Lecture 6: Syphilis, Randomized Controlled Trial, Nuremberg Code
3 Jun 2018
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Unit 6
1.
What lessons have been (or should be) learned from past abuses of research participants?
We have learned that any experiment that is being conducted with unwilling, captive, human
subjects against their will and meaning without informed consent is unethical and is morally
unacceptable. Also learned is that scientists conducting these kinds of trials on humans can be
criminally charged after the implementation of the Nuremberg Code (since replaced with the
Declaration of Helsinki), the Nuremberg Code was established in order to protect humans
participating in research and also to prevent the recurrence of tragedies such as the 20 Nazi
surgeons who undertook experiments on concentration camp prisoners since World War 2.
It has also been learned that harm against humans participating in research occurs in wealthy
places where we would least expect it such as medical schools, military teaching hospitals and
industry.
1. What is a research ethics board, and what are its core functions?
A research ethics board (REB) is a group of experts whose primary role is to examine and
evaluate submitted protocol from scientists who are planning to conduct a trial. The ethics board
is responsible to ensure that the patient’s right to informed consent is protected including the
risks, benefits and expectations of both the researcher and participants of the trial.
The REB are to determine that the risks of participating in a study are less than the benefit of the
knowledge that is to be gained from the study. For instance, are the side effects of the drug worse
than the bit of information will be gained? The REB is looking to see that there will be a
significant knowledge gain as to not pose the participants to unethical conditions. By doing this
they fulfill another role they play which is to determine if the scientific research is worthwhile.
And last the REB is to ensure that the research protocol is designed in such a way that it
promotes the increase in knowledge that they are looking for.
The REB does not want to risk the health of a participant by having them involved in a study that
isn’t structured well enough to answer the research question that the researcher intends to answer
after the trial has been completed.
There are 2 important questions that the REB must be able to answer about the proposed study
before it is given approval:
• Is the proposed research question scientifically important?
• Will the design of the study allow for the research question to be answered?
If these questions are not able to be found in the proposed protocol the REB has the right to
refuse approval for further research.
find more resources at oneclass.com
find more resources at oneclass.com
1. What is a randomized, controlled, clinical trial (RCT)? What does it mean to say
that an RCT is “active controlled”?
An RCT is a study in which participants are randomized (by code via computer) and divided into
2 groups after informed consent has been obtained. The first group is the experimental group
who will receive the new drug. The second group is the control group who will receive standard
treatment (a drug that is already on the market). But if there is not an approved standard
treatment, then a placebo will be given. A placebo is a sugar pill that has no biologically active
ingredients.
An “active- controlled” clinical trial on the other hand is a clinical trial in which 2 drugs are
compared against each other.
The reasons that scientists want to compare the two drugs is so at the end of the study they can
decide which of the two are better for treatment, which one has less side effects and which one is
more cost effective. The participants in both groups are compared on those standards and are
assessed for the best outcomes and the most beneficial drug is then chosen as the best drug and is
then known as the standard treatment.
1. What is “clinical equipoise,” and why does it matter to research ethics?
Clinical equipoise refers to the existence of an honest, professional disagreement among expert
clinicians about the preferred treatment for a condition. Clinical equipoise is at its most concrete
when the REB can’t decide which of the preferred treatments will be the most beneficial.
The inability of the clinicians to determine this leads to an ethical foundation that studies should
be based on in order to proceed. This means that the REB has deemed the study safe and
therefore ethical so that humans can participate in the study if they consent to do so.
If the REB already knows that the experimental drug is better or worse than the standard frug
then it is an unethical study because it is ethically and morally wrong to involve humans in
clinical trials that may involve risk to their health.
If there is a lack of clinical equipoise then the REB will be unable to fill their responsibility of
answering the two most important questions they must ask when a proposal is introduced to them
which are:
• Is the proposed research question scientifically important?
• Will the study as designed be able to answer the research question?
\ Clinical equipoise is important in research because a well-designed study one cannot
exist since there will be no question to answer. It prevents participants from being exposed to
unnecessary risk.
find more resources at oneclass.com
find more resources at oneclass.com
Document Summary
We have learned that any experiment that is being conducted with unwilling, captive, human subjects against their will and meaning without informed consent is unethical and is morally unacceptable. Also learned is that scientists conducting these kinds of trials on humans can be criminally charged after the implementation of the nuremberg code (since replaced with the. A research ethics board (reb) is a group of experts whose primary role is to examine and evaluate submitted protocol from scientists who are planning to conduct a trial. The ethics board is responsible to ensure that the patient"s right to informed consent is protected including the risks, benefits and expectations of both the researcher and participants of the trial. The reb are to determine that the risks of participating in a study are less than the benefit of the knowledge that is to be gained from the study.
