Hribal 1

Mikayla Hribal

Lori Bedell

CAS 137H 001

7 November 2022

From Ignorance to Informed Consent: The Shift in Medical Ethics

It is no secret that patients dread the sight of the piles of paperwork required when

preparing for a medical procedure. While it can be a pain, those papers ensure that patients

understand exactly what will happen and why. This confirms the obtainment of informed

consent, which can loosely be defined as a person voluntarily agreeing to an operation or

research study with full knowledge of the procedure, risks, and effects (Manti & Licari). In other

words, it protects individuals from unknowingly participating in that which they would not

normally consent to, preventing health professionals from taking advantage of them. Although

this is regulated today, in the past, it was regarded as a suggestion for doctors, allowing them to

omit certain details of an operation or manipulate patients into agreeing to a study. This is

depicted by America’s extensive history of unjust research studies and medical procedures

performed on vulnerable groups. Despite the precedents that supported informed consent in the

early 1900s, inconvenience and racial biases deterred health professionals from pursuing these

guidelines. However, due to the push for individual liberties and the rise of the civil rights

movement, the violations of the medical community were made visible, resulting in a demand for

formal regulation of informed consent.

BACKGROUND

This idea of informed consent has slowly been established throughout history. This originated

with the Hippocratic Oath that all doctors recite to “do no harm,” which first formulated the
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practice of devoting their life to protecting patients (“Encyclopedia of Bioethics”). In the last

century, a part of this protection has developed to include the term consent, ensuring that patients

were willing to undergo a proposed procedure. In the U.S., this notion of consent was still in its

infancy when the case Pratt v. Davis (1906) came to the attention of the Supreme Court. The

appellee, Parmelia Davis, was an epileptic woman. She was informed that surgery on her uterus

was necessary to alleviate her seizures, but the doctor later admitted to "calmly deceiving the

woman” and withholding information to obtain her agreement. It was found clear that she did not

consent to a full hysterectomy, a removal of all reproductive organs (“Pratt v. Davis”). The

decision set the precedent that no one could “violate without permission the bodily integrity of

his patient” (Bazzano et al.). Other cases, such as Schloendorff v. Society of the New York

Hospital (1914), echoed this decision and formally introduced the term “consent” into legal

terminology, stating that a medical procedure done “without his patient’s consent commits an

assault” (“Schloendorff v. Society of the New York”).

Decades later, this notion of consent was confirmed internationally in response to the

horrors that occurred in the WWII concentration camps. These studies included inhumane

experimentation on multiple “undesirable” groups with the forcible infection of prisoners to

study diseases, most of which led to death (“Nazi Medical Experiments”). In response to these

atrocities, the Nuremburg Military Tribunal created what is now known as the Nuremberg Code

to regulate human experimentation. It asserts that “the voluntary consent of the human subject…

without the intervention of any element” is crucial (“Nuremburg Code”). It firmly grounded the

need for consent in international law and provided a set of ethics on which research should be

conducted.

RESISTANCE TO CONSENT
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With these policies came opposition due to some issues with obtaining consent and the effect it

could have on results. One of these concerns originates from the Hawthorne effect, which is

when a subject’s awareness of being a part of a study impacts how they behave (Rebers et al.).

For example, if researchers are testing a depression treatment, a patient could be placed in the

control group, which is not given the drug. They may feel disappointment that they did not

receive the treatment they signed up to test. This is called “resentful demoralization,” which is

when a person, randomly assigned to the control group, is dissatisfied, influencing their behavior

and the results of the study, especially when dealing with mental health trials (Rebers et al.).

However, regulations were updated in the 1990s to accommodate these concerns so that

informed consent could be waived only for control groups. The group receiving treatment would

still require consent (Manti & Licari).

Another common argument is that informing the patient of the trial or procedure may

cause unnecessary confusion if the patient is exceptionally ill or has a mental disorder. In the

previously mentioned case “Pratt v. Davis,” the doctor knew that Mrs. Davis was epileptic and

occasionally seen as “insane.” So, when he told her vague details of the surgery, he knew “she

did not realize the full aspect of” what he was saying (“Pratt v. Davis”). Often, this mentality is a

way to cut corners, but in cases of extremely ill patients, it may be better to allow them to focus

on recovering instead of confusing them with every medical detail. This sometimes falls under

the category of emergency treatment and research where no consent can be obtained due to a

life-or-death scenario (Rebers et al.). Others also argue that full informed consent cannot be

achieved with certain, uneducated groups. Especially before the rise of science education, the

average person would not be able to understand the research study or treatment they were given.

Thus, doctors found it easier to gloss over some of the truth in order to put it into simpler terms.
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UNJUST STUDIES

Though many of these concerns with obtaining consent are legitimate, they do not justify the

inhumane studies that were conducted as a result. Many of which targeted vulnerable minority

groups that were discriminated against by the medical community, due to the sense of white

superiority constructed from supposed scientific studies supporting racism. Thus, many turned a

blind eye when these so-called lesser peoples were exploited in unjust studies.

One story of medical injustice is that of Henrietta Lacks. She was an African American

woman who was diagnosed with aggressive cervical cancer. At the time, there were few

hospitals that would treat African Americans, so her only option was to go to John Hopkin’s

public hospital ward for treatment. Since it was a free, public part of the hospital, many

researchers took samples from unknowing patients, claiming that their samples were a form of

payment for their free treatment. Unbeknownst to Henrietta or her family, when she went in for

surgery, a doctor kept a sample of her tumor for study, and it was found to be endlessly dividing,

essentially “immortal.” These cells were then sold and sent all over the world for research

purposes. This continued long after her death and still without any consent from her family

(Skloot).

Another long-standing example of medical discrimination is the Tuskegee Syphilis

Study. Before most standards in research were established, scientists wanted to study the full

effects of syphilis from infection to death. They observed 411 African American men with

syphilis and 200 without it from 1933 to 1972. During this time, none of the infected individuals

received any treatment. In fact, local doctors and hospitals were instructed to refuse medical

treatment if these subjects were to request it. The research team went as far as to remove any

drafted men from the military so that they could maintain their test subjects. Meanwhile, the
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individuals in the study were told they were receiving treatments for their conditions, while they

were actually receiving a useless placebo injection. This experiment continued despite the

establishment of the Nuremburg Code in 1947 and the development of penicillin to treat syphilis.

In the end, 128 patients died from syphilis, and 59 of their immediate family members were

infected (McVean).

REASONS

Although there is no excuse for the atrocities committed during this time, many of the reasons

they occurred were because of the underlying bias in the medical community. Especially

throughout the enslavement of African Americans and during segregation, they were seen as the

lesser race. This was readily confirmed with “scientific racism,” where doctors would claim

other races, particularly African Americans, to be a different species “uniquely fit for

enslavement,” claiming they possessed lesser brain function and increased strength (McVean).

This reinforced society’s trampling of an entire race and dehumanized them to the point where

they were not given respect or rights. This type of thinking takes decades to reverse, as seen

through Jim Crow laws and the segregation that occurred after the end of slavery. The same

holds true for the scientific community and its treatment of African Americans. The idea of

needing consent from someone barely considered human would seem ridiculous to a white,

privileged doctor. Thus, many of these studies lacking informed consent targeted the vulnerable

black community.

With these social biases also came a political motivation. The government did not want to

regulate the scientific community because it had benefitted them throughout the Cold War.

Particularly after the launch of Sputnik in 1957, the intense scientific rivalry between the Soviet

Union and America began (Plumer). With this came an increase in government spending on
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scientific research and STEM education. They most notably championed their push for scientific

discovery as “a bastion of scientific freedom” against the communist reign (Finkbeiner). This

created a connection between the scientific and political communities. Though medicine and its

corresponding research were not directly tied to the Cold War, they still fell under the

government’s pursuit of free discovery, and some of these studies could impact the war through

the health of soldiers or biological warfare. Therefore, they would not want to attempt to regulate

research or informed consent for fear of restricting their progress throughout the Cold War.

MOVEMENTS FOR CHANGE

With these social issues came a wave of pushback against different forms of oppression, bringing

attention to the injustices in the medical fields. Especially during the 1960s and 70s, there was a

shift in how people perceived their freedoms and challenged the social norms of the time.

One of these key movements was the civil rights movement. African Americans have

suffered injustices throughout American history in many ways, and as a result, there developed

the need to rise up and fight against oppression. One of the first successes in gaining recognition

came with the case of Brown v. Board of Education, which ended segregation in public schools.

Similar to the response to earlier cases of informed consent, these court rulings were widely

ignored by society, with segregation still widespread. Nevertheless, the civil rights movement

pressed on, using groups such as the NAACP to organize peaceful protests to gain the attention

of the government and society, highlighting the inequalities the black community faced. Despite

strong resistance and many hardships, the Civil Rights Act of 1964 was signed by President

Johnson, which prevented discrimination based on race, religion, or sex and established the

Equal Employment Opportunity Commission to oversee this (“Civil Rights Movement

Timeline”). This was a major victory for the civil rights movement because not only did it
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establish a law, but it also created a commission to oversee and enforce the implementation of

that law. With these legal advancements, it slowly began to influence how society treated the

black community.

Through this platform of reform and change for African Americans, other groups such as

Hispanics, the LGBT community, and the women’s rights movement used this momentum to

promote their own freedom from oppression, creating a societal shift towards supporting liberty

for all (“The 1970s”). Most notable was the emerging feminism that changed how women’s roles

were viewed in the workplace and within a family. Slowly, they fought to gain the equal

opportunity that men have, as women began to protest for fairer wages and access to traditionally

male-only jobs. This shift also brought attention to the protection of women’s rights, specifically

with the creation of legislation allowing the prosecution of rapists and the case of Roe v. Wade to

protect women’s reproductive rights. As the ideas of consent and “my body, my choice” finally

began to emerge within the general population, it paved the way for a similar type of reform on

informed consent within the medical community.

Through this shift to a more modern and critical perspective, it also developed a distrust

in the government, largely from the anti-war movement of the Vietnam Era. With the publication

of the Pentagon Papers, exposing the deception of the public throughout the Vietnam War,

people were furious and protested against both the war and government control (“The 1970s”).

This distrust began to bleed into other issues, digging up additional offenses that the government

has attempted to hide, such as the lack of regulation within the scientific community.

THE SOCIAL AND POLITICAL RESPONSE

Due to the social advancements in equality and consent, paired with a distrust in the government,

people began to uncover the unjust studies from the earlier 20th century, which cultivated protests
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and forced scientific practices to change. One of these revealing moments came when a

whistleblower, Peter Buxtun, exposed the Tuskegee Study to the New York Times. This resulted

in a “mass public outrage” when the public discovered how the government has kept yet another

secret hidden and forfeited the rights and lives of African American men in the pursuit of

science, despite having numerous opportunities over the years to shut down the study. The

NAACP initiated a lawsuit that ended with ten million dollars to pay for the medical treatments

of the surviving patients and their family members, who at this point only numbered to be

seventy-four (McVean).

After these revelations, protests began to emerge for stricter regulation of informed

consent and the scientific community. The government responded with the passage of the

National Research Act of 1974, which created a commission to oversee research conduct. After

years of deliberation, the commission developed and published the Belmont Report in 1979,

which listed three essential points in obtaining informed consent: “information, comprehension,

and voluntariness” (Bazzano et al.). This forced researchers and physicians to inform the patient

of all the necessary details on the study or procedure and confirm that they fully understand what

it means, ensuring that anyone uneducated on the matter is not being taken advantage of. After

knowing the risks and possible outcomes, the patient can voluntarily decide for themselves if

they wish to proceed. Due to the establishment of these standardized procedures for informed

consent, it was then easier to enforce them on a national level.

THE MODERN FIGHT

Despite these efforts, there are still unfolding stories of injustice within the scientific field. One

of these stories is that of HeLa cells. As mentioned before, these cells were unknowingly taken

from Henrietta Lacks and became a prominent cell line utilized in research. However, her family
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did not even know of this until 1973, and their protests were widely ignored (Zimmer). Even

still, scientists barely knew her name, often calling her Helen Lane by mistake. The truth was not

fully uncovered until 2010, nearly 60 years after Henrietta’s death, by Rebecca Skloot through

her book, The Immortal Life of Henrietta Lacks, which brought to light the injustices endured by

Henrietta and the Lacks family. As this story spread, so did a new wave of protests against the

biases of the medical community, and after a few years of debate and collaboration with the

Lacks’ family, the NIH established an agreement that access to Henrietta’s genes would be

regulated by a committee, including two members of the Lacks family (Zimmer). While their

family is proud that Henrietta’s cells are advancing medicine, it is still an issue that companies

make thousands from HeLa cells while the Lacks family does not even have proper health

insurance. Their lawsuit against Thermo Fisher Scientific, a large company selling HeLa

products, is an attempt to rectify the financial injustices suffered by their family, but it is

currently unresolved. Their attorney, Ben Crump, who also represented George Floyd and

Breonna Taylor’s families, commented that this is “indicative of the Black struggle for equality

and respect,” and if Henrietta were not black, what differences would there be in this case,

calling attention to the underlying discrimination in society (LeMoult).

As this question persists, so does the debate on the enforcement of the consent procedure

and the underlying biases that still persist today. Under current regulations, an institutional

review board (IRB) enforces the regulations set by the government and must approve that the

study is necessary and humane; it can also waive consent under certain guidelines (Manti &

Licari). However, it has been found that the number of African Americans enrolled in studies not

requiring consent is twenty-nine percent, which is disproportionately high compared to their

overall percent of the population, which is thirteen (Swetlitz). This high percentage is juxtaposed
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by the wariness of most African Americans towards participating in these studies due to past

grievances such as the Tuskegee study. If there was consent for these studies, it begs the question

if the percent of African Americans involved would drastically decline. This highlights the

implicit biases that scientists have with using African Americans in studies, and they have yet to

be fully addressed.

In addition to these racial issues, other controversies over consent have branched out into

different topics that are still under debate today. These include issues such as using children in

research when there is a conflict between parent and child consent and being able to protect those

with disabilities or conditions that prevent them from consenting (Nijhawan). It can also become

a conflict with respecting religious and personal objections when it interferes with public health,

such as with the COVID-19 vaccine. Though these are a few current examples, many more

ethical debates are occurring around the world and across scientific disciplines.

CONCLUSION

Though consent was established as a guideline in the early 1900s, it has often been overlooked

by the medical and scientific communities due to inconvenience and racial bias. This perspective

has shifted due to many movements for change that protested in favor of consent and equal

treatment, which has led to an enforced regulation of informed consent in the science

field. Though the discussions on consent and medical ethics are far from over, it is important to

first reflect on the atrocities that occurred in the past. To remember the individuals and groups

that have been wronged in order to make this right. Society is now tasked with correcting these

injustices and must work to develop a new system to protect the rights that every individual

deserves, so that those mistakes are never committed again. That is what learning and developing

as a society means, and that is what we are called to do. To remember. To learn. To protect.
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