Kaitlyn Grubbs

Miss Burke

Honors English 11

22 May 2016

Annotated Bibliography: Informed Consent

Bioethics, Committee on. Informed Consent, Parental Permission, and Assent in Pediatric

Practice. Pediatrics, American Academy of Pediatrics, 1 Feb. 1995,

pediatrics.aappublications.org/content/95/2/314.short. Accessed 17 May 2017.

In relation to informed consent, but more specifically in application to pediatric practice,

there have been questions raised on limitations. Through a re-analysis of informed

consent, the very important limitations are being reevaluated. In order to revise

procedures for receiving informed consent, there are two major concepts that must be

taken into consideration. Parental permission and patient assent must be observed by a

very careful eye to ensure that there is no confusion between families and those in the

medical field. Parental permission is required, especially for minors, in order for the

correct and best decision to be made. Minors are not mature enough in order to make all

of their own medical decisions, such a surgeries. It is understood that physicians have the

obligation to receive parental consent for any planned medical interventions. This is not

only the ethical thing to do, but has become a law for physicians in the United States.

Patient assent is very different from consent, but they are very similar to each other. For a
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patient to give assent they must be old enough to understand what is being proposed and

be willing to take part in it. Though they can have an understanding of what will happen,

the patient is too young to make their own decision. Patient assent is not always required,

as it would not be a developmentally appropriate time for the child. There are also cases

where physicians can obtain informed consent directly from the patients. In a case where

the minor is emancipated or have reached a level of maturity where they have adequate

decision-making skills, they can give informed consent. Consent can also be received

directly from a minor when in a scenario that it is permitted by law

Blanchard, Jennifer. AMA Journal of Medical Ethics. Who Decides, Patient or Family?, 2007,

journalofethics.ama-assn.org/2007/08/ccas3-0708.html. Accessed 16 May 2017.

There seems to be a lot of controversy over who gives consent in various medical

situations. Provided by Jennifer Blanchard, MD, there is an example of a tricky situation

over who gives the consent for Mrs. Odundo, a fictional character. Mrs. Odundo is a 55

year old woman with esophageal cancer and a mass, probably advances carcinoma, with

very limited treatment options. Surgery was ruled out as it was decided as unable to cure

her. Her husband has a conversation with the doctor and states that hes spoken with his

wife in the past and that she wants everything possible to be done to her despite the small

chance of a cure. As the story continues, there is major conflict between Mr. and Mrs.

Odundo and their children as they decide how to treat her cancer. Blanchard offers

commentary on the situation after the story. In order to the doctors to be allowed to
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perform any type of operation, they must first make sure that the patient understands their

illness and treatment options. Before the patient, or those speaking for the patient, can

make the informed decision for treatment, the physician must make any possible

complications known. Despite how horrible the situation may be, the physician should

remain hopeful and emphasize how they will continue to work on the patients behalf

despite the decision that is made. When it is unsure if consent is given, physicians should

postpone any surgeries in this scenario. The patient or those speaking for them must make

the consent very clear or else the physician could run into a legal problem. Regardless, it

is ultimately the decision of the patient once everything has been covered. Physicians

cannot perform any sort of operation or other treatments without consent directly from

the patient. In cases where the patient cannot make their own decision, the physician must

receive informed consent from the patients family.

Code of Medical Ethics. Chicago, IL, American Medical Association, 2007.

The Code of Medical Ethics provides the standards for informed consent, decisions for

adult patients who lack capacity, decisions for minors, among others. To begin, it

explicitly states that informed consent is fundamental in both ethics and law. Physicians

are unable to deny information about treatments when patients ask questions. In order for

a patient to give informed consent they have to understand their condition and treatment

options in depth. When the physician and patient engage in successful communication, it

fosters trust with their professional relationship. Consent must always be given by the
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patient except in certain instances. The patient can have a surrogate, this would happen

when the patient lacks decision-making capacity, they could also decline to participate in

the decision making process. As part of the physicians job, they must first assess the

patients ability to understand relevant medical information and the implications of

treatment alternatives and to make an independent, voluntary decision. To clarify, a

physician should not try to pressure the patient into make any particular decision, as it is

up to the patient only. However, a physician can offer advice and answer questions in

order to help make the decision-making process easier. The physician must also present

relevant information accurately and sensitively. In doing this, the patient will be able to

understand what is happening to them. When this happens, the physician should give the

patient their diagnosis when a conclusion is found alone with the nature and purpose of

recommended interventions and any information, positive or negative, about their

options. After a decision is made, the physician must document it in a medical record

with written consent included in the record. In scenarios where a decision must be made

urgently and no one is there to make the decision for the patient, physicians may initiate

treatment without informed consent. When doing this, they must inform the

patient/surrogate as early as possible and receive consent for ongoing treatment.

Ethical Principles for Medical Research Involving Human Subjects. World Medical

Association Declaration of Helsinki: Ethical Principles for Medical Research Involving

Human Subjects ; Edinburgh 2000, Canary Publications, Guildford, 2000, pp. 373374.
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The Ethical Principles for Medical Research Involving Human Subjects, developed by

the World Medical Association Declaration of Helsinki, was developed as a means to

provide a safe experience for those taking part in testing. There are no limits to what kind

of testing or research is being performed when taking into account the safety of a human

subject. This article offers guidance to physicians and participants in testing that involves

human subjects. It outlines and promotes how physicians can keep the environment safe

for their participants. Without question, there should never be a time where the physician

or subject is wondering if there is a safety risk. An important statement in the article is

that they, the physician, should look at the wellbeing of the participants as opposed to

what people the physicians are interested in running tests on. To clarify, a person should

be chosen if their body will be able to withstand any types of tests as opposed to seeking

out terminally ill patients that could be put at risk. There is also a great emphasis on

respecting all human beings and making sure to protect their rights and health along the

way. Unlike how it was for Henrietta Lacks, for example, race, nationality, and similar

cases should not play a part in deciding if rights should be protected. Throughout medical

research, a physician is required to protect the life, health, privacy, and dignity of the

human subject who is participating. Any subject who is participating should also be able

to opt out of testing if they feel unsafe. It is required that, contained within a research

protocol is, a statement of medical considerations in included. By providing this, there

can be research done on the actual testing to ensure that it is safe for any of the

participating subjects. Throughout research, it is also required that research is conducted

by a scientifically qualified persons under the supervision of a clinically competent

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medical person. This will ensure the safety of patients along with verifying that the

research follows all of the standards for medical ethics.

Skloot, Rebecca. The Immortal Life of Henrietta Lacks. New York, Broadway Books, 2017.

Throughout the book there was a constant argument over if it was ethical to obtain and

perform experiments on a black womans immortal cell line. In order to obtain these

immortal cells, the doctor scraped the cancer cells on the patients cervix. The patient was

unaware of what the doctors were doing and had just assumed that they were only trying

to help her, never suspecting that they had stolen her cancer cells and would be using

them in research. Doctors secretly found vaccinations such as the polio and smallpox

vaccines. Also, various experiments were performed on the cells such as exposing them

to radiation. The breakthroughs made by doctors were public to the entire world, but the

family of Henrietta Lacks was left in the dark. The immortal cell line made millions of

dollars without the familys knowledge. There was even a market for buying and selling

vials of the immortal cells. The book covers the emotions felt by the family as they

struggle to understand why experiments were performed without any consent by Lacks or

her family. Research is conducted to discover if any consent was given by Lacks without

her family knowing. During this time period, there were no laws forbidding the

experiments or protecting the family. In addition, these experiments were considered to

be acceptable since Lacks was receiving her cancer treatments at no cost. It seemed to be

as though using her cells was a form of payment for the treatment. Even though it seemed
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as if the exchange was not a fair trade, nobody attempted to put an end to it. Many years

later, all the way up until the 2000s, the Lacks family is still outraged that they received

no compensation from the cell line.