The story of the Immortal Life of Henrietta Lacks is about the ethical conduct of research, specifically informed consent. The origins of informed consent date back to the early twentieth century, even though numerous situations arose prior to the twentieth century indicating the need for informed consent. Before legislation was put into place requiring informed consent for medical procedures and research on human subjects, courts heard a plethora of battery cases involving doctors that had failed to disclose the risks and benefits of medical procedures performed on patients; those procedures later caused additional health issues for the patients. After one such case in 1957, Salgo v. Leland Stanford Jr. University Board of Trustees, the court determined that it is the ethical and professional duty of doctors to present the risks, benefits, and alternative treatments of medical procedures to patients so that the patient can make an informed decision about undergoing the procedure or treatment.
United States courts have also heard cases that implicated the lack of informed consent in medical research. Courts determined that experimentation on human subjects was important to the advancement of science and medicine but acknowledged the need for informed consent following the Fortner v. Koch case in 1935. However, it was not until around the beginning of World War II that widespread research on human subjects began in the US, even though this type of research was happening around the world.
An infamous example of this research arose out of World War II when Nazi doctors performed experiments on prisoners who had not given consent. These doctors performed extensive, horrific medical treatments on the prisoners, including injection with infectious diseases, mutilation, and forceful consumption of poison. After the war ended, these physicians were tried and convicted during the Nuremburg Trials. From those trials arose the Nuremberg Code, which laid the foundation for what is now legally required when conducting research involving human subjects.
Today, institutions performing research on human subjects (such as universities) must undergo a process whereby an Institutional Review Board (IRB) reviews the proposed research. Researchers must clearly define through the submission of a research protocol the population to be studied, including the number of people, the research methods, the risks and benefits of the research, how they will obtain informed consent, recruitment materials, surveys or focus group questions, and what they hope to learn from the research. A team of highly trained and IRB-certified board members with research expertise review the protocol against federal regulations. It is the responsibility of the IRB to ensure researchers are proposing and using ethical procedures when conducting research on human subjects. Researchers may not conduct any of their research procedures until their protocols are thoroughly reviewed and approved by the IRB.
Personally, I'm not surprised by the main issues and legislation surrounding the collection and use of human tissue samples. I work with human subjects in my research appointment. That said, when I first started out as a graduate student and had to learn about human subject’s research and the IRB process, I became fascinated by the history that led to these important regulations and now fully understand why these regulations are in place. Participating in research studies helps with the “common good”; that is the advancement of scientific knowledge. I feel much safer knowing that there are laws in place to protect me if I choose to participate as a human subject.
For more information on the history of informed consent, read "The History of Informed Consent Requirement in United States Federal Policy."
https://dash.harvard.edu/bitstream/handle/1/8852197/Wandler.pdf?sequence=1
Wednesday, February 17, 2016
In the Afterword, Skloot summarizes the main issues and legislation surrounding the collection and use of human tissue samples currently. Were you surprised by this? Why or why not?
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