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Smith Smith

Prof. Smith

Biomedical Ethics

30 June 2017

Informed Consent: Who Is Informed

Informed consent is the process by which a patient is provided adequate information and

education about all aspects of their health care along with the ability to participate in choices and

make a apprise decision regarding their care. It is the legal right of the patient to direct what

happens to them and the ethical duty of the doctor to involve the patient in their care. My final

paper analyzes informed consent and its perilous deception. I shall present three main points

against informed consent by arguing the complexity of the information given to the patient, the

decision-making process, and lastly patient competency.

To begin, there are four important pieces of information that the physician must tell a

patient to ensure they are informed; the nature of the procedure, the risks of the procedure, the

alternatives to the proposed procedureincluding the option of no treatment, and the expected

benefits of the proposed treatment. Adequate disclosure has a different meaning to every

physician and patient and not every patient will fully understand the information being given.

Lack of understanding, information overload, manipulation and even peer pressure can also lead

to patients not understanding the extent of their decision.

It is presumed that when a patient signs their consent form, they are legally stating they

fully understand everything that is stated in the consent form. Nonetheless, it would be difficult

to evaluate a patients comprehension since there is no guidelines to measure the level of

understanding that a patient has about the information they are consenting to. One must believe
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since there are not any guidelines to test comprehension, then it can also be presumed that there

is a degree of misunderstanding that occurs. In the article "Ethical Issues with Informed

Consent, it states

Many individuals sign the consent form without being fully aware of

what they are signing. For example, a study conducted by Paul S. Appelbaum

et al. (1982)[1] found that research subjects systematically misrepresent

the risk/benefits ratio of participating in research. They report that this is

due to a failure to understand the research methodology. This study found

that 69% of the participants failed to understand the meaning of randomization.

This type of misunderstanding increases with patients who have limited English

proficiency. (p.3)

Who should be responsible to ensure that a patient understands what they are signing? As

with all relationships, whether romantic, social, or physician-patient there is a responsibility that

each person must have to secure a trusting rapport. In a physician-patient relationship, a patient

must uphold to their responsibility of understanding their healthcare. They must be able to

communicate their concerns, voice misunderstanding, and educate themselves. If the counter-

argument in removing informed consent is the fear of taking away a patients autonomy; than a

patient, placing their understanding in the hands of the physician implies that informed consent is

ineffective. The informed consent, rocky foundation, is built on the concept of a patient,

understanding the nature of a treatment or procedure in order to consent to it.

Secondly, the decision-making process. Corrigan writes There are a number of

contributions from medical sociology that draw attention to the complexities of decision-making,

and render the medical encounter problematic by discussing the ways in which patients are often
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dependent on medical expertise and advice. As stated previously informed consent essentially

relies on the physician-patient relationship. A doctor cannot coerce, persuade, or direct a patient

into a treatment, a test, or a procedure; even if they feel it is best. Patients generally assume that

the doctor is acting exclusively in the patients best interests. Corrigan further found in a study

that 38 per cent of patients who had consented to participate in clinical trials stated that their

motivation for doing so was to comply with the doctors request.

The need to secure a patients fully-informed consent prior to medical intervention for

treatment or research purposes is increasingly heralded as an ethical panacea counteracting the

potential danger of paternalistic and autocratic practices. (Corrigan, 2003). Informed consent

allows a patient-centered care perspective that recognizes care that is responsive to the patients

preferences, needs, and values. One can debate that it forces physicians to put patients wants and

needs above their own, including not expecting patients to blindly just do what the doctor says.

Should doctors be allowed to weigh in their opinion when informing their patients of

treatment? Yes, they should. There are many different factors that we consider before making an

informed decision. Many times, these factors are over-whelming and we generally consult with

others to ensure we are making the right decision. One of the important steps in becoming a

doctor is taking the Hippocratic Oath and one of the promises within that oath is first, do no

harm. We have grown up in a society where we trust our doctors. Long before informed consent

took shape between 1914-1970s we trusted a physicians opinion. If there is skepticism with one

physician, we can obtain a second opinion from another physician. If we removed the doctors

standpoint from informed consent, then patients would not receive the care they need. They

would be so overwhelmed with no reassurance from their physician, that it may delay their care.
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Finally, who determines patient competency. According to the article Information

Disclosure, Truth-Telling, and Informed Consent, a health-care professional will determine

patient competency if they refuse medical treatment. They will then ask the following questions:

does the patient understand his or her medical condition? Does the patient understand the

treatment options and the consequences of his or her decision? Are the patient's reasons for

refusal rational? If not rational, are the reasons based on religious beliefs, which must be

respected in accordance with the First Amendment?

Competence is practically the ability to render decisions about medical interventions.

Most patients are considered competent, except for cases of developmentally disabled, dementia,

and being underage. There are less clear-cut situations of incompetence such as a patient under

the influence of a prescribed medication or a patient overwhelmed by pain or fear. How can a

physician measure a patients competence based on their brief intermittent interactions? The

answer is they cant. Competence isnt black or white. Physicians are not spending an abundant

amount of time with their patients to build the physician-patient relationship. At times, it does

take for a patient to refuse or demand answers to have a medical professional question their

capability to make informed decisions.

In closing, whos to say a patient is competent? Whos to say that the patient received

adequate disclosure information? Whos to say the patient fully understands the information? Is

the patient voluntarily consenting to treatment? If a signature on a dotted line ensures that all

these questions are answered, then informed consent has fulfilled its purpose. However, there is

no way to test informed consent to ensure it is achieving its end goal. There is no way to test the

complexity of the information that is given to the patient and establish patient understanding. We

cannot exclude the physicians voice in the decision-making process, nor can a physician
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thoroughly evaluate a patient competency. Every physician has a different perspective of

informed consent, as well as every patient. In many cases, informed consent causes more harm

than good. It frightens and confuses the patient and forces them to make decisions that they

would rather leave for the doctor. Theres even the possibility of an erosion of trust between the

doctor and the patient. In worst scenarios of mistrust there are lawsuits.

Perhaps improving the physicianpatient relationship is key to adjusting informed

consent concepts. This relationship is important for the delivery of high-quality care in the

diagnosis and treatment of disease. The doctorpatient relationship forms one of the foundations

of contemporary medical ethics.

Works Cited

Corrigan, Oonagh. "Empty ethics: the problem with informed consent." Sociology of Health &

Illness 25.3 (2003): 768-92. Web. 14 May 2017.

<https://pdfs.semanticscholar.org/d235/05ee82cda083c7c7bad9ea7ab5d5467b1fd9.pdf>.

Escobedo, Crisol, Javier Guerrero, Gilbert Lujan,, Abril Ramirez, and Diana Serrano. "Ethical

Issues with Informed Consent." E-Zine Journal: Youth Scientists and the Ethics of

Current Science Bioethics.1 (Fall 2007): 1-8. Web. 15 May 2017.

<http://cstep.cs.utep.edu/research/ezine/Ezine-EthicalIssueswithInformedConsent.pdf>.

"Information Disclosure, Truth-Telling, and Informed Consent." Bioethics for Students: How Do

We Know Whats Right? Ed. Steven G. Post. Vol. 1. New York: Macmillan Reference

USA, 1999. Opposing Viewpoints in Context. Web. 16 May 2017.

http://link.galegroup.com/apps/doc/EJ3012001020/OVIC?u=sunysuffolk&xid=df2e76a7

Vaughn, Lewis. Bioethics: principles, issues, and cases. 2nd ed. New York: Oxford U Press,

2013. Print.