Part II: Informed Consent and Human Rights

Part II: Informed Consent and Human Rights

May 3, 2022

Joy Stepinski, MSN

You may ask yourself why informed consent is so important. Across history, people have been subjected to experimentation without their knowledge. Self-determination is the basic human right of freedom to choose. Without preserving this sacred right, the choice of one’s own medical decisions will be in jeopardy. As stated by the American Nurses Association Code of Ethics for Nurses (2015),

Patients have the moral and legal right to determine what will be done with and to their own person; to be given accurate, complete, and understandable information in a manner that facilitates an informed decision; and to be assisted with weighing the benefits, burdens, and available options in their treatment, including the choice of no treatment. (p. 2)

Throughout the twentieth century, the act of human experimentation occurred time and again. In 1932, a well-known research study took place called the Syphilis Study at Tuskegee through the United States Public Health Service (USPHS). The disease of syphilis is thought to be spread through sexual contact, conceivably leading to blindness; deafness; bone, teeth, and central nervous system deterioration; heart disease; and/or death (Keller, 2017). During this time, 600 Alabama black men were involved, 399 diagnosed with syphilis and 201 showing no signs of disease (CDC, 2021).

The length of the study took place over 40 years to determine the effects of untreated syphilis (Heller, 2017). Informed consent was not obtained and the men were informed that they were treated for “bad blood” (CDC, 2021) without disclosure of having the disease. The men were offered free transportation to appointments, hot lunches, free treatment apart from the syphilis-related remedies, and free burial in exchange for their participation. Although half of the syphilis subjects were given an arsenic-mercury treatment, the other half were never offered therapy. Penicillin became available as a cure, yet the medicine was never made available to the men.

As a result of the study, seven men died directly from syphilis and another 154 from heart failure (Keller, 2017). Not until 1973 did the Department of Health and Human Services advise the USPHS to provide treatment for any remaining survivors. Medical and health benefits were then given to the families. That same year, a class-action lawsuit was filed and settled out of court for $10 billion dollars. A formal apology was given by the U.S. President in 1997.

Henrietta Lacks is another woman whose family faced a great ethical conflict. She died from cervical cancer at the age of 31 in 1951. Shortly after she was diagnosed with the disease, her physician at Johns Hopkins took a cell sample, which was subsequently cloned and used for research. Her cell line still exists today. Several ethical issues arose surrounding these cells. First, there was no informed consent. Neither the patient nor the family knew that the cells were being used for research. In fact, the family had no knowledge until 1973 and therefore was never informed of their usage. There was no privacy. The HeLa cell line was named using two letters of the patient’s first name and two letters from her last name. Throughout the decades, HeLa cells have been involved with all sorts of research advances, including the development of the polio vaccine and Parkinson’s medications, cloning, in vitro fertilization, and the effect of toxins (Scott, 2022). Furthermore, the ownership of the cells was actually never established. Johns Hopkins never patented the cells, yet the family received no financial incentive. Perhaps even more surprising, tissue samples can still be used today without the consent of the patient. For more information about this stunning story, a book was written entitled The Immortal Life of Henrietta Lacks by Rebecca Skloot.

Several court cases uphold the importance of informed consent. One occurred in 1914, Schloendorff v. New York Hospital, which took place in the Court of Appeals of the State of New York. The plaintiff was seen by New York Hospital in 1908 for a stomach disorder. She remained in the hospital for several weeks where her physician believed that she had a fibroid tumor, only confirmed by surgery. The patient declined surgical treatment; however, was brought to the operating room anyways and the surgery proceeded without her consent (Schloendorff v New York Hospital, 1914). The judge ruled that “every human being of adult years and sound mind has a right to determine what will be done with his own body. (Rock & Hoebeke, 2014, p. 189)”

Perhaps the most well-known example within this past century occurred in the concentration camps of Germany, which led to the landmark Nuremberg Code. Following tribunals related to human experimentation atrocities, the code was adopted. The key elements included that any experiment must have the voluntary consent of the human subject; be for the benefit of society instead of a random purpose; avoid physical and mental suffering; be averted if death or severe disability could occur; allow the participant to bring the experiment to an end; and permit the scientist to terminate the research if any injury, disability, or death was anticipated (Ghoo, 2011).

These examples may evoke emotion, yet they serve as a reminder of the precious right of self-determination and the freedom to make decisions about one’s own body. Learning the components of informed consent is vital to advocate for yourself. The healthcare provider should inform you that you can participate in the decision-making process, provide you with information about the treatment, share alternative therapies, disclose all the risks and benefits, review any uncertainties surrounding your decision, and ask you to convey your understanding of the information. The decision is ultimately yours. Your health depends on this!

References:

Centers for Disease Control and Prevention. (2021). The Tuskegee timeline. https://www.cdc.gov/tuskegee/timeline.htm

Code of Ethics for Nurses with interpretive statements. (2015). American Nurses Association. https://www.nursingworld.org/coe-view-only

Ghoo, R. B. (2011). The Nuremburg Code – A critique. Perspectives in Clinical Research, 2(2), 72 – 76. doi:10.4103/2229-3485.80371

Heller, J. (2017). AP was there: Black men untreated in Tuskegee Syphilis Study. AP News. https://apnews.com/article/business-science-health-race-and-ethnicity-syphilis-e9dd07eaa4e74052878a68132cd3803a

Rock, M. J., & Hoebeke, R. (2014). Informed consent: whose duty to inform?. Medsurg Nursing, 23(3), 189.

Schloendorff v. New York Hospital, 211 N.Y. 125, 105 N.E. 92 (N.Y. 1914) (1914).

Scott, G. (2022). Henrietta Lacks, the ethics of consent. The Researcher’s Gateway. https://researchersgateway.com/henrietta-lacks-ethics/