Question (1a). Describe a historical event that has shaped current guidelines and
regulations for the ethical conduct of epidemiologic research with human subjects.
Question (1b). Describe the key principles, guidelines, and regulations governing research
with human subjects and relate them to the Tuskegee experiment and the Guatemalan
Please use three ref including GORDIS LEON. EPIDEMIOLOGY 5TH ED. (This is the
text book given by the school). No cover sheet or heading needed. Please indicate ref.
separate for each question. If possible include one online website.
Over the years, research has contributed largely to the improvement of the medical field.
It is through the researches that new forms of medication have been implemented. It is also
through these researches that some disease causing microorganisms have been suppressed.
However, researches have also had their fair share of controversy. This is in relation to the ethics
and the manner in which medical researches are done. Ethical issues have particularly in the
recent past being a source of controversy (Gordis, 2013). This is because most researchers are
said to have crossed the ethical line and violated the rights of their human subjects. The focus of
this discussion is on one of the events that has shaped the ethical conduct of epidemiological
research. The discussion will also look at some of the principles that have continually guided
research where human subjects are in use.
1 a. The Disaster in Thalidomide
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Thalidomide was a drug that was prescribed for expectant women in Europe in the
sixties. The drug was to aid women who were pregnant to deal with pregnancy associated
sickness. The drug had not been tested on its safety. The resulting effect is that all children
whose mothers had administered the drug suffered from irreversible medical defects (Ann,
2013). This was a result of the exposure to the drugs which contained harmful substances to the
unborn children. It was this disaster that would prompt a need for the medical field to self-
regulate itself. One of the requirements was that in conducting any medical research, safety
measures must be considered. This means that before any drug can be rolled out for use as a
prescription, it must be tested to check the side effects. In cases where the side effects are found
to be very severe, then such a drug should be completely done away with.
The conference which was held in Helsinki in 1964 would lead to a declaration which
defined fundamental changes that required implementation in the field of research. World
Medical Association was the main organizers of the conference. The aim was to address the
rising cases of unethical behavior in the field. Although there have been several amendments
made to the declaration since 1964, it still remains the guiding principle internationally for
epidemiological researches. Some of the sharp focuses of the conference include the need for all
human subjects involved in research to give consent. The consent should not only be free but
informed (Gordis, 2013). Therefore, a participant in a research must fully understand the nature
of the research. In case of any side effects or negative implications, the participant should be
informed beforehand. Free consent means that there ought not to be any form of coercion or
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enticement. Instead, a participant should accept to participate independently and without any
1b Key Principles
There are certain key principles that are used to guide the medical field. The first
principle is in regard to the issue of consent. As aforementioned, any participant must give an
informed and free consent before taking part. The participant should not be forced, enticed or
coerced to participate (Ann, 2013). Further, there should be a true representation of the facts.
This means that the participant should be well aware of what to expect including both the
positive and negative implication emanating from the research.
The other principle is the need to first consider testing in the lab before conducting the researches
on human subjects. Sometimes, some of the researches can be fatal due to the chemicals in use.
In some cases, the tests and researches done can fail. When this happens use of human subjects
will be fatal. As was the case the Thalidomide disaster, failure to carry out tests may lead to very
It is also important that ethics are applied when conducting the tests. The impact of
researches should not be life-changing. For example, a participant in a research should not be
subjected to any research that is likely to maim or disable any part of his body. For example
researches for ovarian and cervical cancers should not entail the destruction or removal of these
organs. A healthy woman should not, after participating in the research be unable to give birth.
These are some of the professional and ethical issues that the Helsinki Declaration addresses
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Research conducted in medical fields cannot be underestimated. It contributes a great
deal to helping to bring improvements. On the other side however, crucial issues that must be
taken into consideration including the wellbeing of the participants in these researches. More
often, the rights of these people have been grossly violated leading to loss of lives and permanent
disabilities in some cases. It is important that as medical researches are conducted, fair
consideration is given to all human subjects who participate. This will help to ensure that the
interests of the human subjects are not compromised. Focus should not be just on obtaining the
results but also the well-being of those participating.
Ann, A. (2013). Essentials of epidemiology in public health. Boston: University of Boston Press.
Gordis, L. (2013). Epidemiology. New York: Blackwell.
Rothman, K. (2012). Epidemiology: an introduction. California: Oxford University Press.