Running head: INFORMED CONSENT

Informed Consent
Maryanna Sarkissian
Health, Happiness, and Human Rights
Dr. Neiworth
Portland State University
November 2, 2015

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Abstract

Informed consent is essential and you should not proceed with a human research subject
without obtaining it first. Consent is generally seen as an essential ethical requirement in clinical
research. Scientists frequently complain that the current system for regulating research is too
troublesome, with long, tedious consent forms that don't result in better protection for research
participants. Receiving informed consent and understanding what it remains is an ongoing issue
that the community has to struggle with every day. People have the right to choose whether or
not they want to participate in a research project after hearing about what it is and the risks it
possesses.

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Informed Consent

According to M D Kirby, informed consent is that consent that is obtained after the
patient has been sufficiently instructed about the ration or risk and benefit involved in the
procedure as compared to alternative procedures or no treatment at all (1983). There are
individuals and doctors that overlook the importance of informed consent from their clientele on
a constant daily basis. Informed consent is essential and you should not proceed with a human
research subject without obtaining it first.
Informed consent is generally seen as an essential ethical requirement in clinical research,
as can be seen from a concise glance at research guidelines and regulations. At its simplest,
informed consent constituted the giving of permission to act. It requires that participation is
freely given, or withheld, by a competent person, based on an adequate understanding of relevant
information related to that decision. Informed consent is most often supported by appeal to the
idea of respect for an individuals autonomy (Sim & Dawson, 2012).
Henrietta Lacks was an African-American woman who died of cervical cancer on
October 4, 1951. Cells were initially taken from her body without her knowledge and were used
to form the HeLa cell line, which to this day is used significantly in medical research since that
time. The genetic revolution exploded almost immediately following her death. Lacks case
ended up generating ethical and legal debates all over the world around the rights that Henrietta
possessed over her tissue and genetic material. Lacks had not given any sort of informed consent
to her doctors when her tissue was taken from her body during surgery. Years later, her family is
still struggling to gain recognition and justice for what was essentially taken from their mother
before she had passed (Skloot, 2010).

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There is a large controversy among the people that debated whether or not Henrietta
Lacks actually had any consent over the tissue that was removed from her body during surgery.
The first main issue is one of consent from Henrietta Lacks to run and publish the genome of
cells derived from her body. As Skloot made very clear throughout the entirety of her book, no
such consent was ever taken nor was there every any effort put into receiving it. And, since
Lacks died a long time ago, it cannot be attained. Lots of people, including Skloot, pointed out
that consent was neither required nor was it commonly acquired in the 1950s when Lacks was
sick. Even though informed consent wasnt very common back in Henriettas day, it is simply
unethical to take without asking.
Serious problems with receiving informed consent may arise when individuals need an
explanation of what is to happen on a more common language. Many times what you will
actually see happen is an individual agree to something that they essentially have no
understanding about. Personnel must collect informed consent from individuals in a way that is
sure to make sense to them. That may include having to use a more common language, giving
examples, and providing an explanation as to what is to follow.
There may commonly be a situation that contains an individual who is incompetent.
Such situations make it difficult to receive informed consent but do not make it legal to proceed
without it in any sort of way. As the Declaration of Helsinki states: Clinical research on a
human being cannot be undertaken without his free consent after he has been fully informed; if
he is legally incompetent, the consent of the legal guardian should be procured. For example, if
there is an unconscious patient that has been admitted into the hospital and is incapable of giving
any sort of informed consent to the doctors at hand, the doctors may then move to the patients
guardians and family members to receive their permission to proceed.

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Scientists frequently complain that the current system for regulating research is too
troublesome, with long, tedious consent forms that don't result in better protection for research
participants. Now, leading ethicists say that some studies on humans may not require patient
consent at all (Shuchman, 2014). According to the federal Office for Human Research
Protections, people have the right to choose whether or not they want to participate in a research
project after hearing about it.
Nancy Kass compared investigators conducting studies of approved, standard
treatments, where the risks to patients are very small, to doctors taking a patient's blood pressure.
Doctors don't specifically inform patients about why they're checking blood pressure or ask
permission to do it, she said; they make "an assumption based on experience, that patients don't
mind, that they understand it's not harmful and it's in their best interest." Certain research to
improve clinical care "fits into that same context," she said (Shuchman, 2014). So, after such
discussion, where does this situation put Henrietta? Was the event of doctors taking part of her
tissue during surgery without consent not harmful and in everyones best interest? It cannot be
that simple. There was never any permission given to the doctors to be able to take a part of her
body and perform extensive research on.
This is an ongoing issue that the community has to struggle with every day. Questions
arise without end and strain the human research projects. Receiving informed consent is a
definite extended and detailed task. Many choose to skip the overall process of informed consent
because they believe it is not important enough and their research is essentially harmless. This
should never be the case. Why risk everything you have accomplished as a human researcher by
avoiding to ask permission from your subjects in order to save a bit of time, or save you the

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trouble of finding someone who does agree with your terms and risks of research? Informed
consent is real. It is something that you cannot run around without crossing. It is only most
ethical to believe it comes first.

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References

Skloot, R. (2010). The immortal life of Henrietta Lacks. New York: Crown.
Kirby, M. (1983). Informed consent: What does it mean? Journal of Medical Ethics, 69-75.
Sim, J., & Dawson, A. (n.d.). Informed Consent and Cluster-Randomized Trials. Am J
Public Health American Journal of Public Health, 480-485.
Shuchman, M. (2014). Is informed consent in research sometimes optional? Canadian Medical
Association Journal, 495-495.