Medical advancements would be impossible without the use of biospecimens. Over the decades, scientists have used the tissue of patients to experiment, which has contributed to a large body of scientific knowledge that humanity has access to nowadays. However, as the ethics and policy issues surrounding research started to gain the attention of the public, the morality of various studies was questioned. The following paper focuses on the story of an Afro-American woman from Baltimore, which has become the catalyst for regulatory changes in the United States and worldwide. The purpose of the paper is to examine how the case of Henrietta Lacks demonstrates the nuanced nature of informed consent, particularly in regard to biospecimen research.
The Immortal Life of Henrietta Lacks by Rebecca Skloot tells the story of Henrietta, a mother of five who suffered from cancer and never consented to her cells being used for research. Racial segregation had led to African-Americans being unable to be treated at most facilities, which prompted Henrietta to go to Johns Hopkins Hospital. There, she was diagnosed with cervical cancer, and her doctor performed a standard procedure of removing the samples of her tissue without any consent from the patient. As her cells began to multiply rapidly, the cell line HeLa developed, leading to its widespread use in research after Dr. Gey distributed HeLa cells to a broader community of prominent scholars. A series of world-changing discoveries have been made thanks partially to HeLa cells. The case of Henrietta Lacks serves as a cautionary tale on the importance of informed consent in medical practice and scientific research.
The notion of informed consent and the ambiguity behind it is not new. Considering the recent progress in genetic modification and molecular biology, it is evident that the issue of patient autonomy is at the forefront of scholarly discussions. According to Jenks, Skloot’s work raises important questions on whether “patient consent is required in research and how much control donors ought to have over their genetic information” (4). Researchers face the ultimate challenge of making substantial contributions to science while navigating the ethical implications of their studies, which involve the safe and ethical collection, use, and disposal of samples. Until recently, the scientific community believed that since individuals such as Henrietta received free treatment, “it was fair to use them as research subjects as a form of payment” (Skloot 80). The issues described in the book by Skloot are ultimately rooted in “legal concepts of property rights, ownership, and invention” (Beskow 397). Although researchers of the last barely concerned themselves with the ethics behind their experiments, such issues are especially relevant to modern scholars.
Informed consent is exceptionally hard to define due to a number of factors. Firstly, there is no reliable framework to assess whether someone fully understood the possible implications or comprehended the entirety of the issues involved. Research suggests that patients might understand neither the study they take part in nor “their rights as participants despite having signed a consent form” (Kadam 108). Furthermore, informed consent might not even always be possible. There are specific contexts in which “the nature of the information is such that the patient’s understanding and capacity for decision-making are overwhelmed, making informed consent impossible” (Bester et al. 871). Although there are certain structured tools to determine the capacity of informed consent, it is virtually impossible to be fully confident that a person has indeed consented to anything.
The nature of biospecimen research makes it especially challenging to apply the concept of informed consent. No consent form can offer the patient entirely accurate information regarding the potential use of their tissues in studies. Robertson and Loe indicate that this is due to the fact “the aims, methods and results of future biospecimen research are often unknowable when a sample is drawn” (para. 5). Thus, even if informed consent regulations were to be adopted in the first half of the 20th century, it is likely that Henrietta would have signed the consent form. After all, the hospital would have asked her to merely “sign another form generally referring to potential “research” on her specimen” (Robertson and Loe para. 5). In its traditional sense, informed consent does little to provide patients or study participants with the accurate and comprehensive data regarding the potential use of their cells.
The definition of informed consent is a work in progress. Informed consent is a set of principles and procedures to ensure individuals have the ability to make fully informed, voluntary decisions regarding their participation in research or certain aspects of their medical care. Beskow argues that information must be provided “in a manner and language understandable to the person, and under conditions that are free from coercion or undue influence” (397). Despite that, the regulatory guidelines related to informed consent can not be applied successfully in scenarios involving biospecimen research. It is evident that Henrietta’s case, arguably more than any other one associated with biospecimen use, is a highly nuanced one. On the one hand, it teaches the importance of consent. On the other hand, Henrietta’s story demonstrates that informed consent is mostly a privacy guarantee. It is often impossible to inform individuals of all the future possibilities of their tissue being utilized for research. However, the principle of informed consent should imply that the information provided to patients is as specific as possible yet acknowledges the vagueness of potential use.
In conclusion, it is evident that the concept of informed consent is of great importance to modern and future research. The story of HeLa cells demonstrates the highly nuanced nature of personal consent, especially in cases that involve the use of biospecimens. The aspects of information provision continue to change to fit the needs of modern research. Despite that, applying the principle of informed consent in biospecimen research remains a challenge. For the sake of patients, it is crucial for regulators and scholars to acknowledge that informed consent in its traditional sense is not always possible.
Works Cited
Beskow, Laura M. “Lessons from HeLa Cells: The Ethics and Policy of Biospecimens.” Annual Review of Genomics and Human Genetics, vol. 17, 2016, pp. 395-417.
Bester, Johan, et al. “The Limits of Informed Consent for an Overwhelmed Patient: Clinicians’ Role in Protecting Patients and Preventing Overwhelm.” AMA Journal of Ethics, vol. 18, no. 9, 2016, pp. 869-886.
Jenks, Susan. “Patient Consent: Defining Control of Genetic Information.” Journal of the National Cancer Institute, vol. 109, no. 8, 2017, pp. 4–7.
Kadam, Rashmi A. “Informed Consent Process: A Step Further Towards Making It Meaningful!” Perspectives in Clinical Research, vol. 8, no. 3, 2017, pp. 107-112. Web.
Robertson, Christopher, and Jonathan D. Loe. “Learning the Wrong Lesson on Privacy from Henrietta Lacks.” The Washington Post, 2016.
Skloot, Rebecca. The Immortal Life of Henrietta Lacks. Grown Publishing Group, 2010.