informed consent: the human right to medical choice

Running head: INFORMED CONSENT: THE HUMAN RIGHT TO MEDICAL CHOICE

LSTD 5653 Ethics and Leadership Final Paper

Shadraconis, Sophon

University of Oklahoma

July 31, 2010

Informed Consent: The Human Right to Medical Choice 2

Informed Consent: The Human Right to Medical Choice

Moral dilemmas can and do arise every day making ethical leadership difficult; the

subject of human medical testing is not exempt from this. According to the United Nations

Universal Declaration of Human Rights, human life has an inherent worth that needs to be

respected and all people deserve to be treated with dignity. Leaders have a duty to ensure that

their followers are receiving these basic human rights. It is problematic when basic human rights

are infringed upon for the purpose of medical research or narrow public policy ideology. There

are several ethical factors to consider when conducting studies or developing public health

policy; the decisions made by leaders and different conceptions of morality can have a

significant impact on obtaining informed consent. It is possible that some medical advances are

impossible to achieve without the use of human subjects. However, every person has the right to

provided with the nature or purpose of a treatment or study, as well as information regarding

medications, treatment, potential results, and potential hazards prior to participating and

providing what would be considered informed consent. Individuals are being robbed of their

dignity and their humanity is devalued when they are not provided with this minimum amount of

information. This paper explores some of the unethical leadership decisions and various views

of morality that are involved with the concept of informed consent in the Tuskegee syphilis

study.

Background

The “Tuskegee Syphilis Study” is a historic, unethical experiment that took place from

1932-1972 in the United States. For the study, public health officials recruited local African

American men with syphilis from Tuskegee, Alabama to observe the effects of syphilis on the


African American male. In exchange for their cooperation with the researchers, the Alabama

State Board of Health required that everyone in the study found to have syphilis would have to

be treated, not necessarily curing them but rendering them non-infectious (Fourtner, Fourtner &

Herreid, 2008). Neither the men with syphilis nor the control group were informed of the true

objective of the study. The original study, which was supposed to only last approximately nine

months, eventually became a lifelong observation the men with mandatory autopsies, to prove

that untreated syphilis affected African Americans differently than those with European descent

(Fourtner, Fourtner & Herreid, 2008). Early on in the study, the men were observed and not

provided treatment for their disease; partially due to the expense and also because the available

treatment of the day did not guarantee results and took years to administer. However, after the

first ten years of the study penicillin was discovered to be an effective treatment for the disease

yet, the men were never provided with treatment. In total, the men of the Tuskegee study were

observed for forty years. In fact, the administrators went to great lengths to prevent the men

from obtaining treatment even going so far as to write the draft board to have them excluded

from treatment (Thomas & Quinn, 1991). It was only after the story of the untreated men hit

major media outlets across the nation did the experiment come to an end.

Because of the incident in Tuskegee, the United States Department of Health, Education,

and Welfare published what is known as the Belmont Report, which provides ethical guidelines

for treatment of human subjects in medical testing. The report set forth three main principles:

beneficence, respect for subjects, and justice (Sieber, 2009). These three principles are not only

important when it comes to the treatment of subjects in conventional testing, but they are pivotal

when expanding the view of human testing to include drug trials, public policies, and

government mandated procedures. One question that arises is, is it ever ethical to perform tests


on humans without informed consent? In the Tuskegee study, it is questionable whether the men

would have participated if they had more information about the nature of the study. In this case,

it can be argued that the motivation of researchers was not for the good of the patients but rather,

for self-serving ends.

Beneficence

The principle of beneficence is that research should “maximize good outcomes for

science, humanity and the individual research participant, while avoiding or minimizing

unnecessary risk, harm or wrong” (Sieber, 2009, p. 109). The principle of beneficence forms the

moral basis of the experiment. All studies are likely to contain inherent risks; however, any

unnecessary risks should be reviewed and actions should be taken to either mitigate risks or

minimize their impact. Human subjects should never be exploited for additional information or

used solely to gather more subjects. The leaders of a study must clearly establish what the

ethical guidelines will be when performing a study. This includes ensuring that there is a valid

purpose for the design and procedures used in a study.

The officials conducting the Tuskegee study did not minimize unnecessary risk or harm

to the participants. Most notably, this can be seen because the men in the study who had syphilis

were never treated for their disease even when an effective treatment was discovered. The

researchers clearly violated their moral duty to the men and the concept of maximizing good

outcome for each individual research participant. Viewing the principle of beneficence from the

perspective of Kantian ethics, everyone participating within the study (not just the leaders) had a

duty to “do the right thing” despite the consequences. Under Kantian ethics, the morality of an

action is dependent on a person’s intention rather than the ultimate end result (Ciulla, 2003). He


held the idea that none are exempt from moral laws and leaders should act on strongly held

beliefs and duties, even if these were not necessarily in their personal best interest. Since there

was no intention to treat the men in the study, it is accurate to say that under Kantian terms they

were unethical and immoral.

The concept of maximizing good for each individual participant can be seen as a

utilitarian approach to research; that is, maximizing happiness for the participants. John Stuart

Mill, a proponent of utilitarianism, argued that it is the intention of an act which determines the

morality of the agent, not the outcome (Ciulla, 2003). Therefore, it is possible for an action to be

moral despite the original intention of the agent. By applying Mill’s standard it can be also

concluded that the researchers were immoral (in agreement with Kant) because they never

intended to provide treatment to the men. In fact, they were fully intent on following participants

to their death so they could perform an autopsy for their research. In addition, even if the

researchers felt they were morally justified in continuing their observation of the men for forty

years, the act of not treating the men had additional repercussions such as potentially increasing

the syphilis rate in the area by allowing the men to remain infectious. Because syphilis can be

easily passed during its first and second stages, this creates an additional risk to the community

(Peate, 2007). The men could have easily infected their wives or sexual partners thus increasing

the potential for the disease to be passed on to newborn children.

The participants were never informed that they had the disease and were robbed of their

option to pursue treatment when it was available. By preventing the men from getting treatment,

the researchers failed to maximize good outcomes and did everything possible to ensure a

negative outcome. In the philosophical context of both Kant and Mill, it can be said that both

believed that people were not tools to be used as a means to an end. However, the individuals in


this study were merely tools for the overzealous researchers that wanted to prove their theory.

Because the men were never informed that they had syphilis, they never had the opportunity to

evaluate their options for treatment. In addition, since the men were never informed of the true

nature of the study, they never had the opportunity to truly consider the risks involved with the

study and make an informed decision.

Respect

The principle of respect forms the basis of how human subjects should be treated

throughout all stages of a study and also includes the protection of identities, autonomy, and

confidentiality of information obtained during research. Information about the study should be

explained to the potential subjects in a friendly, easy to understand manner that is as free of legal

or technical jargon as much as possible. Subjects will rarely be in a position to fully understand

the technical or medical terms and this may cause embarrassment or undue stress potentially

causing them to agree to something they normally would not do. As a simple matter of respect,

the voluntary informed consent should be reviewed and explained to the participants to ensure

reasonable understanding of both possible benefits and potential risks. It is of the utmost

importance to treat the subject with respect and dignity throughout the entire research process.

Voluntary informed consent is a right, not a privilege, concession or formality. If a

subject does not understand what they are agreeing to, it is difficult to argue that they are able to

provide informed consent. It is possible that individuals who are fully informed of the potential

hazards of a study are not as likely to participate as their counterparts; however, this is another

compulsory aspect of ethical requirements in responsible science and study. In the case of the

Tuskegee study Dr. Clark, a senior Public Health Service (PHS) official and the original director


of the study, wrote to a colleague, “these negroes are very ignorant and easily influenced by

things that would be of minor significance in a more intelligent group” (Center for Ethics and

Humanities, 2003). This statement clearly indicates that the leaders did not have respect for the

subjects in the Tuskegee study considering that, no objections arose from the other leaders

questioning the methods and deception being employed. These private opinions and

communications between the leadership provided justification for their concealment of the true

aims of the study. Leaders such as, Dr. Clark and Dr. Vonderlehr, clearly knew that the men

may have objected to participation if they were informed of the true motives of the study.

The leaders of the Tuskegee syphilis study abused their power and authority. Power is

the ability to “influence a target person’s behavior” (Ciulla, 2003, p. 4). Dr. Clark and Dr.

Vonderlehr clearly had formal authority derived from their positions as directing officials of the

study and the PHS. This authority allowed them to make the decision that the study would be a

long term observational study that provided no treatment, even though there was an agreement

with the Alabama State Board of Health that treatment would be provided (Fourtner, Fourtner &

Herreid, 2008). In addition, because they were both doctors they also possessed expert power

over the subjects, influence over others that is derived from task-relevant or technical (Ciulla,

2003). With expert power, “the target person complies because he or she believes the agent has

special knowledge about the best way to do something” (Ciulla, 2003, p. 4). Since none of the

men ever received regular medical care, each of these sources of power and authority separately,

were enough for the participants to fully trust that being cared for properly. The men believed

what they were told, with good reason, and did not have any idea that the spinal tap they received

was not actually treatment for their ailments. These continued violations throughout the study


shows that the leaders did not treat the men with respect and clearly violated this ethical

principle.

Justice

The principle of justice forms the procedural basis of a study ensuring that all procedures

are followed and participants are not exploited. Eleanor Roosevelt felt that, “People need to live

according to fundamental rights of human dignity, equality, and justice without discrimination”

(Ciulla, 2003, p. 257). This is fitting statement when reviewing how the procedures are created

and followed in a study. Participants in any study should feel safe that any information given

during the process will remain anonymous. In addition, participants should not feel as if they

can be retaliated against for the information that they provide. Participants should not feel

pressured or rushed; the decision of whether or not to participate should be of their own free will

and accord.

Rawls states that “precepts of justice are derivative from the one end of attaining the

greatest net balance of satisfactions” (Ciulla, 2003, p. 155). This can be seen as an argument of

risk versus reward. To serve the greatest good of society, advantages must be distributed

between the greatest advantaged and the least advantaged in a society. Rawls’ also felt that the

basis of societal order, such as laws and rules that govern institutions, should be established

under a “veil of ignorance” to prevent any tainting of the social contract of that society that

would influence opportunity for the least advantaged. When creating a study, the rules that form

the procedure should be similar to these concepts outlined by Rawls. This concept is cohesive

with the other principles as well since the requirement of operating under the “veil of ignorance”


does not allow for bargaining power based on position in society (in this case, the leaders of the

study) to negatively impact the opportunities of the least advantaged.

The men in the study were part of the least advantaged in society not having access to

regular medical care and little educational opportunity. Knowing that they were disadvantaged,

the researchers exploited the men, formulating false materials and therapies to further the

motives of the researchers. For example, to study for signs of neurosyphilis, the researchers

needed to conduct a spinal tap on the men. To gain “consent” from the men for a spinal tap, Dr.

Volderlehr sent a letter to the men calling it a “special free treatment,” and emphasized that it

was their “last chance” to receive a free examination and treatment (Center for Ethics and

Humanities, 2003). This emphasis on the time constraint is likely to have rushed the participants

into agreeing to the “treatment” before they could obtain any additional information about the

procedure. To gain the greatest net balance of satisfactions, the men would have needed to know

what the purpose of the treatment was and its potential for improving their health. However, the

spinal tap was never intended to treat but was in fact, an elaborate scheme to solicit consent as

well as obtain further research goals. It must be emphasized that this consent was not informed

consent, the men were once again robbed of their fundamental rights of “human dignity,

equality, and justice without discrimination” because, they were unaware of the true intent of the

“treatment” and that there was no possibility of it assisting them personally (Ciulla, 2003, p.

257). It could have and should have been explained to the men that the procedure was to look

for signs of neurosyphilis or further disease but instead, Dr. Volderlehr and the other researchers

falsely portrayed it as a treatment.

Violating rights and perpetuating injustice can create a culture of distrust. Although

some have inappropriately made the term culture synonymous with race, the concept of culture


encompasses much more (Perusek, 2007). Culture consists of shared “values (how the world

should be), beliefs (how the world is), and customs (how one conducts oneself under the

guidance of a particular set of values and beliefs) (Ciulla, 2003, p. 245). Viewing it on a micro

live, it is plausible to say that then men of Tuskegee did have their own culture, much like there

are many sub-cultures throughout the United States today. The area developed its own unique

culture through the interaction of the people and the shared values, beliefs, and customs of the

people who lived in the area. Culture can have a significant impact on how leaders operate

because it can place a constraint on their actions and influence the choices they make.

It has been argued that leadership is the “art of exploiting cultures” (Ciulla, 2003, p. 253).

There is no doubt that leaders of the Tuskegee study utilized local culture to their advantage and

to influence the men. For example, rather than informing the men they had syphilis, it was

referred to as “bad blood,” a local term used to describe ailments such as anemia, fatigue, and

syphilis (Centers for Disease Control and Prevention, 2009). In addition, Eunice Rivers, the

African American PHS nurse assigned to monitor the men was an essential factor in gaining the

trust and cooperation of the men (Fourtner, Fourtner & Herreid, 2008). It can be hypothesized

that the men felt more comfortable because there was the presence of an African American as the

chief on-site assistant, who was from their area and monitoring them. Rivers acted as the

primary contact person organizing medical examinations with the PHS physicians, providing

transportation, reassurance, and developed trusting relationships with the men and their families

(Thomas & Quinn, 1991). Although the study was not kept secret from the medical community

and numerous papers were written by the PHS team, “virtually no member of the non-medical

public in Macon County, Alabama, much less the men who were the actual subjects, knew that

this study was being conducted” (Center for Ethics and Humanities, 2005). Researchers


assumed that “uneducated people simply could not understand science and medical research” and

this was their rationalization for not disclosing the nature of the study to the men (Center for

Ethics and Humanities, 2005).

Analysis of Leadership

There are many differing opinions of how leaders should act and what their duty is to

their followers. For example, Confucius felt that leaders should work for what is best for their

followers while being fair, truthful, and generous (Ciulla, 2003). In turn, followers should

support leaders that are attempting to work for the benefit of all with loyalty, diligence, and

proper conduct (Ciulla, 2003). Greenleaf proposed that leaders should act as servants to their

followers, helping them to attain a healthier, wiser, and freer existence (Ciulla, 2003). Another

view of leadership promoted by Burns was that leaders act as sources of information so their

followers could make informed decisions (Ciulla, 2003). The leaders of the Tuskegee study did

not demonstrate quality leadership or decision making skills by any of these standards.

Leaders should be fair, truthful, and generous. The officials at PHS created the illusion

of being truthful, generous, and fair to the test subjects. Leaders in the community such as

pastors, community elders, and plantation owners were enlisted to encourage participation under

the guise of access to health care in a period when it was extremely limited (Thomas & Quinn,

1991). The men in the study were enticed with the promise of free medical treatment and money

for burial (Fourtner, Fourtner & Herreid, 2008). PHS leaders utilized many strategies to keep the

subjects involved in the study and continue to participate in annual checks ups. For example,

according the Center for Ethics and Humanities (2005) they provided a special certificate

offering praise to the surviving participants for their involvement 25 years after the study was


undertaken. In addition, the participants were given “pink medicine” (aspirin) as part of their

treatment (Centers for Disease Control and Prevention, 2009). All of this was done in the guise

of helping the men but in reality, it was only done to bring as many of them as possible to

autopsy.

Leaders should act as servants first seeking to meet the needs of their followers. The

leaders of this study acted in a self-serving manner and were only interested in their study, not

the men that were being treated. The men were seen as a means to an end and were essentially

treated as lab rats. They were not provided the means to live a healthier or freer life but rather,

they were imprisoned to living in sickness with a life-long, easily treatable illness. In addition,

participants were allowed to do harm to their loved ones through the spread of an infectious

disease. Available treatment was denied to the men and this lapse in judgment did much harm to

the men.

Leaders should provide followers with as much information as possible so their followers

can make informed decisions. The leadership at PHS intentionally withheld information because

they felt that full disclosure would have inhibited their ability to maintain test subjects (Center

for Ethics and Humanities, 2005). It is only when people are properly informed can they make a

conscious choice between alternatives. In this case, it would have resulted in true informed

consent, not “consent” that was appropriated under false pretense. Leaders should assist their

followers in transcending everyday wants to “experience higher levels of moral development”

(Ciulla, 2003, p. 228). However, the leaders of the study substituted their desires for the good of

the patient causing suffering. Unfortunately, their actions have long term effects causing strife

within the community sowing seeds of distrust (Thomas & Quinn, 1991). Based on the

standards of the day, the leaders of the Tuskegee study such as Dr. Clark and Dr. Vonderleher,


were seen to be progressive or liberal on racial matters (Center for Ethics and Humanities, 2005).

However, the determination to continue the observation without treatment brings that idea into

question.

It can be argued that the members of the PHS staff began to suffer from groupthink.

“The doctors convinced themselves that the syphilis in the Tuskegee men was too far along to be

effectively treated by penicillin and that the men might actually suffer severe complications from

such therapy” (Fourtner, Fourtner & Herreid, 2008). However, of all the early leaders of the

study Dr. Vonderlehr’s influence seems to be the most overarching and he appears to

demonstrate charismatic leadership. He was praised for his ability and “flair for framing letters

to negroes” (Center for Ethics and Humanities, 2005). Dr. Vonderlehr began as the deputy

director of the program and developed the early deceptive practices of the study (Center for

Ethics and Humanities, 2005). In addition, he complained about the expense of treatment and

lobbied for the extension of the study. Dr. Vonderlehr eventually became the director of the PHS

Venereal Disease Division, controlled the funds for the study, and developed the policies that

guided the study (Fourtner, Fourtner & Herreid, 2008). Because he had control of the funds for

the study, he decided to continued with the observation of the men without providing treatment,

even after the American Heart Association challenged the scientific validity of the project as well

as expressed doubt and criticism of the procedures (Fourtner, Fourtner & Herreid, 2008). This is

reminiscent of the moral implications in the story of the “Ring of Gyges” where a good shepherd

allowed his baser emotions to take control of his actions when he found a ring that granted him

invisibility (Ciulla, 2003). His actions were allowed to go unchecked and none of the staff

questioned the decision to observe the men without treatment, even though they were aware of

the damage that syphilis could cause if left untreated long term.


Dr. Vonderlehr’s influence pervaded all aspects of the study. The men in the study

continued to trust officials at PHS and believed that they were actually receiving treatment and

care for their illness. Even Rivers felt that the men were better off, not seeing them as victims of

an unethical study, because they were receiving routine medical examinations and aspirin

(Fourtner, Fourtner & Herreid, 2008). In fact, she continued to gather the men for the

examinations even after she retired from nursing in 1965 (Center for Ethics and Humanities,

2005). Through the deliberate controlling and withholding of information they created a false

sense of security and community for the men in the study. Vonderlehr’s ideas, enthusiastic

belief, and rhetorical persuasiveness made him a charismatic leader. He was able to distort the

perceptions of others PHS members about the validity of the study and the importance of

bringing the men to autopsy. Members supported his efforts even though doubts arose in other

areas of the scientific and medical community. Through his charisma and effective

communication skills, he was able to not only obstruct informed consent from the men in the

study, but also convinced other members of PHS that what they were doing was ethical. It is

interesting to think that he was able to convince himself as well, considering originally a

proponent of mass syphilis treatment programs in the African American community (Center for

Ethics and Humanities, 2005). In fact, they were so convinced that when mass penicillin became

available, they continued their observation of the men with no consideration to treatment.

Conclusion

The principles of the Belmont Report can be seen as a secular ethical foundation that

maintains the dignity of all human beings, a system that Kant argued needed to be in place for a

functional society (Ciulla, 2003). These principles form the foundation for informed consent.


When the opportunity for informed consent is not provided, it results in a violation of the basic

social construct, that of trust. It is through mutual trust that societies agree on what is socially

and morally acceptable, and what laws they will operate and function in society. There is a basic

framework of trust in Western society. For example, we trust policemen to enforce the laws and

that we will be treated with dignity and equality in the eyes of the law. When we begin to

engage in actions that violate these inherent trusts such as, removing or denying informed

consent it damages the social framework of peace and justice. It is important to never stand for

the destruction of this concept and allow the social framework to recede into the background; if it

is permitted it allows personal agendas to rule, potentially having terrifying or objectionable

consequences. This was the case in the Tuskegee study. The researchers essentially used human

beings as lab animals observing how long it took syphilis to kill a person.

The distrust and resistance to public health programs may today be a direct result of

historical actions. There are still some groups that distrust public health officials and

government efforts to reduce the spread of disease because of the Tuskegee study (Thomas &

Quinn, 1991). The potential ramifications are endless; families and friends may continue to pass

down oral traditions and stories harboring the seeds of distrust. Foregoing informed consent

destroys the credibility of government and those who are actually attempting to help society.

This is counterproductive to the aims of developed and advanced nations. Vulnerable

populations such as the uneducated, poor, and illiterate should not be subjected to any less

respect and dignity that would be provided to the learned classes. Robbing these individuals of

informed consent does exactly this; it strips them of their dignity while simultaneously denying

them any sense of respect as a human being. What was particularly unconscionable in the

Tuskegee case was that the men were incentivized with what was called medical care. Because


of poor decisions made in the past, leaders may be constrained in their future actions to address

public health concerns.

Human beings are not computers; we cannot run trials of deliberately withholding

medication if it is detrimental to their health. Unlike simulations, there is no way in which we

can reset the control group and start over. The consequences are real and the price is death when

there is a willful obstruction of happiness and human potential. It may be seen as “just informed

consent” however, when leaders feel that they can easily overcome public resistance and get

away with such deplorable actions, the gravity of their actions will escalate. This could possibly

create an atmosphere that is ripe for eugenic experimentation and more controlling behavior such

as, returning to mandatory sterilization in the United States (Reilly, 1987). When a society

allows for the violation basic human rights, it is just the beginning, sowing the seeds for personal

infringement. Like Jim Jones and the Peoples Temple, charismatic leaders will demand more

power, exercising increased control over the actions of their followers. A fully functional,

conscious society cannot exist like this; members of society must be able to formulate personal

opinions and be provided with all of the facts so they can make an informed decision. Therefore,

it is never ever ethical to perform tests on humans without informed consent.


References

Ciulla, J. (2003). The ethics of leadership. Belmont, CA: Wadsworth Cenage Learning

Centers for Disease Control and Prevention (2009). U.S. Public Health Service syphilis study at

Tuskegee. Retrieved on July 25, 2010 from http://www.cdc.gov/tuskegee/timeline.htm.

Center for Ethics and Humanities (2005). Faces of Tuskegee. Retrieved on July 25, 2010 from

https://www.msu.edu/course/hm/546/tuskegee.htm.

Department of Health, Education, and Welfare (1979). The Belmont Report: Ethical principles

and guidelines for the protection of human subjects of research. Retrieved November 1,

2009, from http://www.mri.edu.eg/mri/The%20Belmont%20Report.pdf

Fourtner, A. W., Fourtner, C. R., & Herreid, C. F. (2008). “Bad blood:” A case study of the

Tuskegee syphilis project. Retrieved on July 25, 2010, from

http://ublib.buffalo.edu/libraries/projects/cases/blood.htm.

Peate, I. (2007). Syphilis: Clinical presentation, diagnosis and treatment. Nursing Standard,

22(10), 48-55. Retrieved from Academic Search Premier database.

Perusek, D. (2007). Grounding cultural relativism. Anthropological Quarterly, 80(3), 821-836.

Retrieved from MasterFILE Premier database.

Reilly, P. R. (1987). Involuntary sterilization in the United States: A surgical solution [Electronic

version]. The Quarterly Review of Biology, 62(2), 153-170. Retrieved from JSTOR

database.

Sieber, J. E. (2009). Planning ethically responsible research. In L. Bickman & D. J. Rog (Eds.),

The Sage Handbook of Applied Research Methods (2nd ed.) (pp.106-146). Thousand

Oaks, CA: SAGE Publications.


Thomas, S. B., & Quinn, S. C. (1991). The Tuskegee syphilis study, 1932 to 1972: Implications

for HIV education and AIDS risk education programs in the black community. American

Journal of Public Health, 81(11), 1498-1505. doi: 10.2105/AJPH.81.11.1498.

informed consent: the human right to medical choice

Documents