English Essay Assignment!!! For Aristotle only!!!

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20 May 2013

Rebecca Skloot’s Obtained Consent in Medical Research and ‘Free Choice’ Consent

Each year in the United States, around 2.3 million patients sign consent forms in order to participate in government and industry-sponsored clinical trials, with many more participating in research at academic health centers and hospitals (Cohn & Larson 273). The Federal Policy for the Protection of Human Subjects, also known as the Common Rule, requires informed consent for all human-subject research. But, in reality, this does not happen because a huge number of tissue research are not federally funded, and the research is also never considered research on humans since researchers never get to meet donors firsthand (Skloot 231). Henrietta Lacks gifted the world the first ever immortal human cells, yet she never gave consent to have her cells removed and used for research, and neither did she benefit from the widespread use of the unique cells. Today, consent is necessary in order for personal data to be used in medical research, unless a person is dead, or researchers are all healthcare professional or the data collected do not identify the person (Singleton & Wadsworth 255). However, consent in medical research though important, should not be equated to giving a choice to a potential research subject or tissue donor because consent is simply the carrying out of formalities meant to protect researchers and adhere to laws governing medical research and clinical trials. Therefore, although obtained consent is crucial in medical research, it is not a one fit all solution; emphasis should be to support free choice among patients, potential donors and subjects, rather than simply fulfill the formalities of obtaining consent.

In their research paper Confidentiality and Consent in Medical Research: Consent for the use of Personal Medical Data in Research Peter Singleton and Michael Wadsworth define consent as “. . . a person's expression of agreement with a proposed action” (256). Thus, in gaining consent, a person does not willfully make a choice to the course of action; rather they are guided and directed towards the choice. In fact, Singleton and Wadsworth observe that even the manner in which a person is approached influences their decision, meaning that the ‘consent’ gained though indicating agreement with the choices offered is not really a choice made freely. Singleton and Wadsworth, in arguing for the need for choice, state that consent implies “. . . compliance rather than consent—a lack of objection rather than a positive choice” (256). Therefore, when a patient complies with a request made by a doctor or medical professional, they do agree with them, but it does not necessarily mean that the choice to do so is positive, or it is a decision made willfully. Therefore, informed consent is not similar to free choice, and this is what medical research ought to promote, because in doing so, fundamental misunderstandings in the use, of tissue or medical findings from patients may not cause heartache to subjects and their families.

Henrietta Lacks’ cells were first introduced to the world when she went to hospital to get treatment for cancer. Before the surgery, Henrietta had ‘given consent’ to doctors at Johns Hopkins Hospital, “. . . to perform any operative procedures and under any anaesthetic either local or general that they may deem necessary in the proper surgical care and treatment of cervical cancer” (27). Thus, the consent that Henrietta had given was the treatment of cervical cancer. However, even after “. . . two dime-sized pieces of tissue” were removed from Henrietta’s cervix, she was not informed, yet she was alive. When the same pieces of tissue were found to be valuable to medical research, by virtue of being the first ever immortal human cells, neither Henrietta nor her family was informed of this feat, yet the same cells were distributed to scientists all over the world. In fact, when it was found that the cells proliferated at an amazing rate, and they could not run out, they were sold to scientists “. . . for ten dollars plus Air Express fees” (Skloot 73). Thus, when consent was given by Henrietta Lacks to her doctors to get treated for cervical cancer, she complied rather than gave consent. She did not object, but the act of signing was also not a positive choice, she was guided into signing the consent form, because in order for her to get treated by undergoing surgery, she had to sign the consent form.

Apart from the guiding and directing nature that informed consent adopts, it is also a premise that often takes the assumption that adequate information has been offered, and thus subjects can make informed choices by giving consent. This implies that all relevant information has been offered and therefore the consent given is based on understanding this information. However, this approach has a fallacy because individuals have different definitions of how much information is adequate. In the past, compliance including the retention of tissue has often been presumed and is the reason information is not usually offered, meaning that questions cannot be asked to agree with or dissent to such a decision (Singleton & Wadsworth 256). Thus, in such a case, it would be assumed that consent was gained, with such an action, but in reality this is not so because choice was not offered and adequate information was not availed. Onora O'Neill in the paper Some Limits of Informed Consent argues that genuine consent can only be possible if tissue donor, research subjects and patients are offered “. . . accurate and relevant information and providing user friendly ways for them to extend this amount . . . consent is apparent where patients can control the amount of information they receive, and what they allow to be done” (6). This implies that since information can be wide and this can hamper understanding by subjects, then it should be offered in such a manner as to ensure that subjects are able to understand it easily, and also have the ability to control it. Thus, in order for subjects, patients and tissue donors to have free choice in informed consent, they should be free to “. . . determine how far they will be informed, and. . . remain free to rescind their initial choice. Where these standards are met, there are reasonable assurances that nobody is coerced or deceived” (O'Neill 6). Thus, free choice equals adequate information, based on the subject, tissue donor or patient’s understanding and not the medical professional who dispenses information quickly in order to gain consent, devoid of free choice.

When Henrietta Lacks started getting treatment for cervical cancer, she hoped that one day she would be able to get back to her family and possible have more children. However, what she was not informed was that the treatment that involved radiation would leave her infertile. In fact, Skloot points out that had Henrietta been offered adequate information when she gave consent for treatment, “. . . she would not have gone through with treatment” (38). Thus, Henrietta was denied the choice to make an informed decision based on all facts. However, it could be argued that by giving consent to get treated for cervical cancer, then it was implied that Henrietta had agreed to all effects therein. But this argument does not wash since Telinde, a doctor at Johns Hopkins, where Henrietta got treated for cancer had written extensively on the effect of hysterectomy on women. He stated:

The psychic effect of hysterectomy, especially on the young, is considerable, and it should not be done without a thorough understanding on the part of the patient [who is] entitled to a simple explanation of the facts [including] loss of the reproductive function. … It is well to present the facts to such an individual and give her ample time to digest them (Skloot 38).

Thus, Rebecca Skloot shows that informed consent in this case was not genuine. It was not based on free choice, because the information provided was not adequate, and thus the patient was guided and she simply complied with the condition of getting treatment for her illness, which meant ‘giving consent’ devoid of free choice and will.

Finally, today informed consent is often seen as the key to respecting patient autonomy. O'Neill in Some limits of Informed Consent points out that informed consent is a premise that is highly esteemed because it is equated to:

Liberty (positive or negative) . . . dignity, integrity, individuality, independence, responsibility and self knowledge . . . self assertion . . . critical reflection . . . freedom from obligation . . . absence of external causation . . . and knowledge of one's own interests (5).

However, the truth is that informed consent is above and beyond patient autonomy, it is an act that is carried out in the medical world to show and demonstrate to the patient, tissue donor, or research subject that he/she has not been coerced or deceived (O'Neill 5). Thus, if this is the case, then it goes without saying that a choice made by the patient should by borne of free choice and free will. So, when asking for consent, medical practitioners ought to do so in a manner that will offer patients free will to make an informed choice. O’Neill argues that for this to happen, consent ought to be viewed as a propositional attitude, and it should neither be too vague as to fail legitimate action, nor too detailed as to undermine the idea of informed consent (5). Therefore, in order for informed consent to gain legitimacy, free choice should be the guiding principle, as it will demonstrate understanding and create trust in the medical field.

Rebecca Skloot in The Immortal Life of Henrietta Lacks states that Henrietta was often denied adequate information on her ailment, treatment plan and use of harvested tissue. This was not done illegally, based on the laws of the time when it was ethical for doctors to carry out research and experiment on subjects without them really knowing about it (100). However, the manner in which it was done does not capture the spirit of informed consent as it ought to be. This is because while Henrietta was informed, the information offered was too vague; for instance she was not informed that she would never have children, and at the same time she was not asked for assent over the use of her tissue. Thus, free choice was denied to Henrietta.

Informed consent at its most basic definition talks of “. . . a person's expression of agreement with a proposed action” (Singleton & Wadsworth 255). Therefore, it focuses on how a person agrees or does not agree with an action, it does not give an allowance of free choice on the part of the subject or patient. Thus, the focus on informed consent is to simply adhere to regulations governing medical research, without regards to understanding on the part of the patient. In their research paper Improving Participant Comprehension in the Informed Consent Process Elizabeth Cohn and Elaine Larson point out that “. . . despite increased regulatory scrutiny . . . increased attention by institutional review boards to the consent process, no detectable improvement in comprehension of informed consent is evident, even in more recent studies” (279). Thus, informed consent seems to be centered on the medical profession, and does not focus on the patients, tissue donor or subjects, yet without input from them, advances in medical science would stall. Cohn and Larson thus state that”

A successful consent process must at a minimum include the use of various communication modes—written, verbal, asking the participant to repeat what he or she understands—and is likely to require one-to-one interaction with someone knowledgeable about the study, such as a consent educator (279).

Rebecca Skloot offers insights on what informed consent entails, and when juxtaposed with informed consent, based on free choice, it is clear that Henrietta Lacks was coerced, ergo denied free choice and ‘informed consent’. So, in conclusion, informed consent takes many forms, but the best form would be one that embraces ‘free choice’ and does not guide, nor coerce patients, research subjects or tissue donors towards consenting for the sake of it, rather it should be consent borne of free will.

Works Cited

Cohn, Elizabeth, and Elaine Larson. "Improving Participant Comprehension in the Informed

Consent Process." Journal of Nursing Scholarship 39.3 (2007): 273-280. 20 May 2013. Web.

O'Neill, Onora. "Some limits of Informed Consent." Journal of Medical Ethics 29.1 (2003): 4-7.

20 May 2013. Web.

Singleton, Peter, and Michael Wadsworth. "Confidentiality and Consent in Medical Research:

Consent for the Use of Personal Medical Data in Research." BMJ: British Medical Journal 333.7561 (2006): 255. 20 May 2013. Web.

Skloot, Rebecca. The Immortal Life of Henrietta Lacks. New York: Crown, 2010. Print.