Critical Analysis of a Literary Work and Personal Position
The importance of medical research can never be understated as far as safeguarding the health and wealth of the human race is concerned. This is especially considering that health has a bearing on the wealth creation capacity of individuals. Needless to say, there has been a proliferation of ailments, some of which have proved extremely difficult to treat. This has triggered a flurry of studies and medical research and experiments, all in an effort to come up with a comprehensive understanding of the varied aspects of the ailments including the symptoms, causes, risk factors, and especially the most appropriate and effective treatments and prevention measures for the ailments. Needless to say, the medical research has largely involved the use of animals before the medications or interventions can be tested on human beings. This, however, does not negate the fact that human subjects have also been increasingly used in such research studies.
Nevertheless, the use of human subjects introduces a number of ethical issues. This is especially with regard to informed consent, confidentiality of the particulars of the subjects and especially with regard to the outcomes of the research. Informed consent refers to the process by which a patient that is fully informed would take part in the varied choices pertaining to his or her healthcare. It is based on the ethical and legal right pertaining to the fact that patient has to direct the things that happen to his or her body, as well as the ethical duty that the physician has to allow for the involvement of the patient in his or her healthcare. Informed concept is, essentially, a crucial component of the research process, in which case it entails going beyond obtaining the patient’s signature on a form. It is always imperative that the investigators, researchers and physicians educate the potential subjects on all aspects pertaining to the research so as to ensure that they come up with a truly informed decision pertaining to whether they would like to take part in the research or not. It is imperative that their informed consent is given voluntarily without coercion and has to be based on a clear comprehension of all aspects pertaining to the participation, as well as the manner in which the results pertaining to the experiments in which they participate will be used.
Patient privacy, on the other hand, revolves around the capacity of a patient or subject having control pertaining to the extent, circumstances and timing of sharing himself or herself intellectually, physically, and behaviorally with other people (Plomer, 2005). It underlines the right of an individual to restrict access by other people to certain aspects or elements of their person that may include identifying information, thoughts, as well as information that is incorporated in their bodily fluids and tissues. This has a close relationship to confidentiality, which revolves around the process of safeguarding the privacy of an individual. It pertaining to the manner in which information that a patient has disclosed to a physician or researcher in a relationship of trust is treated, with the expectation that such information will not be disclosed to unauthorized parties without permission (Plomer, 2005). Scholars have noted that the necessity of safeguarding the privacy of personal information is usually weighed against the necessity of sharing the information that incorporates the potential to benefit the public good. The development of innovative and new medical treatments necessitates that information is shared from DNA sequencing, repositories and databanks, quality assurance efforts, as well as public health measures (Plomer, 2005). It is imperative that researchers have a clear comprehension of the manner in which the competing values would be viewed, as well as the manner in which the goals of the researchers can be balanced against the competing needs. It is imperative that the type of health information that is collected is balanced against the magnitude of harm that would occur in instances where unauthorized disclosure of the information occurs (Plomer, 2005).
While there have been numerous cases involving the violation of informed consent requirement, patient privacy and confidentiality, none has been more popular than the case of Henrietta Lacks. Indeed, these are the ethical issues around which Rebecca Skloot’s book “The Immortal Life of Henrietta Lacks” published in 2010 revolves.
Summary of the book
The book outlines the story of, Henrietta Lacks, a young black woman who was diagnosed with cervical cancer on January 29th 1951. Henrietta was taken to John Hopkins Hospital, which was the only hospital closest to her home that treated blacks. At this time, it was generally believed that noninvasive cervical cancer was not fatal unlike the invasive type. However, Richard TeLinde, a cancer expert in the Hopkins at the time disagreed and stated that the noninvasive type was simply the formative stages of the invasive type, in which case it should be treated just as seriously. TeLinde was infamous for using human subjects in experiments without their knowledge or consent. He had been trying to develop living samples derived from normal cervical tissue, as well as from living samples of both invasive and noninvasive cervical cancer so as to compare them. He got in touch with George Gey, the head of research on tissue culture in Hopkins, who was determined to develop the first immortal human cells that would be continually dividing and constantly replenish themselves without dying. When Gey got the supply of cervical cancer tissue from TeLinde from the women in Hopkins, he got a chance to try growing living samples from the tissue. The tissues delivered were for the women that visited Hopkins including Henrietta. However, what separated Henrietta Lacks’ cells from those of other women is that they were not simply surviving but also growing with a mythological intensity. Her cells and tissues, therefore, formed the foundation of tissue culture. Indeed, the tissues have been replicated and cloned under the pseudonym HeLa cells, taking up the first two letters of Henrietta Lacks (Skloot, 2010). Underlining the intense replication and reproduction is the fact that almost every tissue culture lab in the world incorporates some HeLa cells. Of particular concern, however, is the fact that neither Lacks nor her family were informed about the use of the cells in the experiments or even had their consent sought. In fact, the family came to know about the use of the cells about in 1973 when researchers came looking for them asking for their cells to be used in studies (Skloot, 2010). Indeed, scientists investigating HeLa started using Henrietta’s husband and children in experiments and research without obtaining informed consent (Skloot, 2010). Ironically, as much as the HeLa cell line formed the basis for a significant number of medical advances such as chemotherapy, polio vaccines, gene mapping, cancer drug tamoxifen, in vitro fertilization, as well as treatment for diseases such as Parkinson’s disease, leukemia and influenza, her family has been living in poverty and has not benefited much from her cells. Skloots notes that one of Henrietta Lacks’ sons is living in the streets as a homeless man, while her daughter who tries to obtain knowledge about the mother that she never knew cannot even afford health insurance (Skloot, 2010). Even more appalling is the fact that the DNA information of Henrietta Lacks has been published and given to other companies without the consent of the family. This is a direct affront on the privacy of the family and the right to have their personal information kept private and only used within the direction of the family (Skloot, 2010).
Needless to say, the story outlined in the book touch immensely on research ethics. This is especially with regard to informed consent. It is worth noting that, all factors held constant, Dr. Gey and Dr. TeLinde undertook this research without following the due procedure pertaining to informed consent. This is especially considering that they used to subject their patients to experiments without the patients’ knowledge or even without obtaining the informed consent from the patient (Skloot, 2013). This trend was continued about 20 years after the death of Henrietta Lacks, when scientists started contacting the family and even subjected them to further experiments without their informed consent (Skloot, 2013).
An informed consent that is ethically valid for research must incorporate a number of components or meet some conditions. First, it is imperative that the informed consent incorporates disclosure where the potential participant is informed as fully as the researchers possibly can about the nature, as well as the purpose of the research, procedures that would be used, expected benefits to both the society and the participant, not to mention any foreseeable stresses, risks, discomforts and alternatives to the participation of the patient in the research. This disclosure should also incorporate a statement outlining the procedures that have been put in place to safeguard the anonymity and confidentiality of the participant, as well as any available medical treatment or compensation in case of research related injuries. Second, informed consent must incorporate understanding where the participant has clear comprehension of the things that have been explained and is provided with a chance to ask any questions he or she has and have them answered. This underlines the fact that the document pertaining to informed consent must avoid technical jargon and be written in the simplest layman’s language. Third, the informed consent must incorporate voluntariness, where the participant voluntarily makes the decision to participate in the research without any coercion on the side of the investigators or researchers. It is worth noting that such participants should also not be offered any promises of benefits that would be unlikely to result from their participation. Fourth, informed consent must incorporate competence where the participant is sufficiently competent to give his or her competence. In instances where the participant is not sufficiently competent as a result of an emergency, disease or mental status, it would be imperative that the investigators get the informed consent of a designated surrogate who would only provide the consent if the participation is in the best interests of the patient.
Needless to say, the researchers involved in this case did no fulfill any of the conditions stipulated. Not only did they not inform Henrietta Lacks or her relatives of the fact that her cells would be used in the experiment, but the investigators continued hiding the fact even after her death. Indeed, it’s not surprising that her family was surprised to be approached by scientists twenty years after Henrietta’s death. These scientists proceeded to involve them in research without seeking their informed consent either.
On the same note, it is worth noting that the privacy of the patient’s information was not protected. This would be evident from the manner in which the cells have been replicated, reproduced and sold to numerous companies and laboratories around the world. This information was released some years ago by a certain newspaper either deliberately or by mistake. While the information was later taken off the company’s website, it had already been downloaded by 15 people, which means that such information could be in unauthorized hands already (Skloot, 2013). Researchers had insinuated that the cells have undergone so much change over time that they could not accurately tell or reveal anything about the Lacks. However, Skloot, in an opinion column at the New York Times noted that such claims are far from accurate as scientists have used a certain public website, uploaded the HeLa’s genome and obtained a report that is full of Henrietta Lacks personal information, as well as that of her family (Skloot, 2013). This only means that the personal information of great grandchildren of Henrietta stands at risk of falling into the wrong hands, which is not desirable. It is worth noting, however, that the use of the pseudonym HeLa was an effort to cover the identity of the person from whom the tissues had been derived. Indeed, Gey had tried to give other names when asked about the source of the HeLa cells. While the motive for this may be unclear, the efforts were clearly not sufficient to protect the information.
Nevertheless, while these issues are pertinent, it is worth noting that the research was done at a time when laws pertaining to informed consent or even patient privacy laws were yet to be as comprehensive as they are today. Indeed, it was not uncommon for physicians to undertake research or experiments on their patients without the patient’s consent or even knowledge.
While there may be differing opinions as to the importance of obtaining an informed consent in the case of Henrietta or any other human subjects, I hold the opinion that informed consent should be a requirement for any research involving human subjects.
First, informed consent guards against the exploitation of the subjects or even their coercion to take part in a research that they were unwilling to take part in, to start with. The basis of informed consent remains that the individual or potential subject will have varied aspects pertaining to the research in which his participation is being sought explained to him or her in a simple language that allows for full comprehension of all the elements. It allows them to ask questions and seek answers to any issues that are unclear to them before or even in the course of the research. This means that there is little chance that they would be exploited as was the case for the Lacks, who were shoved between laboratories and scientists and experiments without informed consent. It is understandable that they became extremely skeptical about any individuals that called to enquire about Henrietta’s cells that they initially do not even want to be associated with the research by Sckloot.
Moreover, the informed consent requirement would allow for the safeguarding of the confidentiality and privacy of the personal information of the human subjects that participate in the research. The case of Henrietta Lacks presents extreme complexity especially with regard to the importance of sharing such information among scientists without seeking the consent of the owner of such tissues. Of course, it is well acknowledged that sharing such information among the experts in the medical research field has been extremely crucial to the entire world as far as the advances in medicine are concerned (Miller, 2012). However, it is imperative that one acknowledges that there were certain risks to which the subjects or their descendants were exposed. For example, personal information pertaining to such health matters may be used to discriminate against the descendants of Henrietta Lacks in cases of employment opportunities.
In addition, it would allow for the trickle down of the benefits that would result from the research to the subjects. It is well acknowledged that informed consents would not incorporate benefits that the subjects would reap from their participation in the research. However, informed consent allows the human subjects to have relative control over the manner in which their tissues are used or even the experiments to which they are subjected. It is highly regrettable that despite the fact that Henrietta Lacks’ cells are used by almost every individual that has taken any medicine stronger than aspirin, yet her family and descendants can barely afford to pay their way through life (Miller, 2012). The industry that is set upon HeLa cells is undoubtedly a multi-billion dollar one, yet the descendants of the person whose cells set its foundation cannot even afford health insurance. Informed consent would, therefore, have allowed the family to patent the cells, in which case they would at least have had a semblance of benefits from the same.
However, some scholars have argued for limited protection of the privacy of the information derived from such research especially in instances where there is bound to be immense benefit to the public good (Miller, 2012). Indeed, there have been opinions to the effect that not only were no laws flouted in failing to get an informed consent from the patient but also that such a consent would have restricted the immense benefits that have been derived from the cells. Of course, it would be inaccurate to ignore the immense contribution that the HeLa cells have made to the medical world (Miller, 2012). The argument would not revolve around limiting their use in enhancing the medical field, rather it revolves around the treatment of the human subjects not as tools and instruments in the lab but as human beings who have their own feelings and thoughts as to what should happen to any part of their body that is used in the advancement of science.
In conclusion, the use of human subjects in medical research introduces varied controversies especially with regard to informed consent and the privacy of personal information of the subjects. This is the case for Henrietta Lacks, a black woman whose cancerous tissues were obtained without her knowledge or consent and used in developing the current multi-billion industry cell tissue industry. Her cells have been widely circulated around the world in almost every cell tissue lab. Ironically, her family still lives in abject poverty unable to afford the basic amenities including healthcare insurance. In addition, the privacy of her health information has been violated with some scientists allowing for access of her genome by the public.
While there may be differing opinions, enforcement of informed consent would be imperative in every research involving human subjects. This would protect the human subjects from exploitation, ensure that their privacy is protected and ensure that they reap the maximum benefits from the research.
Skloot, R (2013). The Immortal Life of Henrietta Lacks, the Sequel. The New York Times Sunday Review. Retrieved from HYPERLINK “http://www.nytimes.com/2013/03/24/opinion/sunday/the-immortal-life-of-henrietta-lacks-the-sequel.html?pagewanted=all&_r=0” http://www.nytimes.com/2013/03/24/opinion/sunday/the-immortal-life-of-henrietta-lacks-the-sequel.html?pagewanted=all&_r=0
Skloot, R. (2010). The immortal life of Henrietta Lacks. New York: Crown Publishers.
Plomer, A. (2005). The law and ethics of medical research: International bioethics and human rights. London: Cavendish.
Miller, T. (2012). Ethics in qualitative research. London: SAGE.