Informed consent is theorized to be the ongoing process of communication between the participant and the study team in which a participant, after thoroughly being educated about all aspects of the research project that are relevant to the participant’s decision to participate, voluntarily confirms their willingness to do so (Mayo Clinic 2016). According to the U.S. Department of Human Service’s Food and Drug Administration’s code of federal regulations, all aspects of the research project includes, but is not limited to, duration, identification of experimental procedures, foreseeable risks or discomforts, benefits to the subject or others, disclosure of appropriate alternative procedures, etc. (21 C.F.R. § 50.25 2016). The term ‘informed consent’ first appeared in a legal ruling on a lawsuit involving a patient who awoke paralyzed after a procedure after never being informed that such a risk existed, and has since expanded to include research trials, pharmaceutical trials, and medical procedures in its purview (Salgo vs. Leland Stanford Jr. University Board of Trustees 1957). In modern times, informed consent is a branch of bioethics that serves as the baseline standard in determining if a research study or medical procedure is ethical. Varying government institutions serve as the governing body, regulating and standardizing what is required for a patient to receive full knowledge and give complete consent. Ultimately, these institutional review boards are the primary means through which the caveats of informed consent are elucidated.
The push for informed consent in the medical field began gaining traction during the early twentieth century, but did not gain wide-spread prominence until around 1972. At this point, medical philosophy gradually focused on the physician’s or researcher’s obligation to disclose information to patients, emphasizing the quality of the patient’s understanding of the treatment and their right to refuse biomedical care (Grace et. all 2016). Currently, informed consent is viewed as a preliminary consultation, where a patient signs a lengthy form acknowledging their understanding of the procedure.
The debate surrounding the role and the efficacy of informed consent has centered on the role of ‘valid’ consent, with a capacitated, informed and voluntary individual agreeing to a procedure. It is generally agreed that protection, autonomy, prevention of abusive conduct, trust, self-ownership, non-domination and personal integrity form the pillars for a complete, unbiased role of informed consent, however the nuances of this bioethical dilemma often prove challenging to defining its role and purpose (Stanford Encyclopedia of Philosophy 2011).
Overall, informed consent can seem cut and dry – the patient was informed or not. However, in order to best understand why informed consent is the basis of robust debate, it is good to do case-studies to explore the limits of informed consent. One example of this is non-lying deceit, when a medical professional purposely prompts a false impression, which is not always mal-intentioned. A dire diagnosis or medically over-complicating an explanation are examples of this. Another extension of non-lying deceit lies in the idea that a patient can be fully-informed of their condition or treatment, which is not rationally nor logistically feasible. A patient needs many years of medical school and practical experience to fully understand the historical context and the rationale material to a decision. (To address this, the reasonable person standard is used to mandate the disclosure of whatever details a rational patient would find imperative (Stanford Encyclopedia of Philosophy 2011)). The role of informed consent can additionally be debated when emergency medical intervention is necessitated, but consent cannot be obtained (for reasons due to unconsciousness, impairment (due to dementia, stroke, developmental disorders, traumatic brain injury, intoxication, etc) or even an inability to be prompt in specifying preferences in time. In these cases, often ‘presumed consent’ is used to justify intervention. This standard can also be applied to such contexts as organ donation, unless opposition has been explicitly stated.
Therefore, bioethicists seeking justification for necessitating informed consent need to justify not only the relatively non-controversial core, but also the weaker and more dubious edge of highly specific, nuanced situations. One belief is that the core is founded from a natural right, where the edge is an extension of this right into institutionalized customs. A violation of the core values of informed consent demands extensive investigation, but oven violations on the edge are easily outweighed by competing values, often the progression of science (Grace et. all 2016).
One of the fundamental tenants of the informed consent debate is the application of ready to consent individuals, or populations whose best option is participation in a clinical trial without alternative options (Fisher 2007). Often, pharmaceutical companies capitalize on the socioeconomic conditions of disadvantaged populations around the world to find human subjects. This mass recruitment of individuals can often be traced to differences in race, gender and class, and many of these populations lack alternatives to participating in clinical trials for medical, financial or emotional reasons. Federal regulation 45 CFR 46.111(b) addresses this issue, affirming that individuals likely to be vulnerable to coercion or undue influence require additional safeguards to be included in studies (Mayo Clinic 2016). Yet, oftentimes a patient has decided to receive treatment before being informed, consenting by default due to lack of options otherwise.
Additionally, human subject research is an exceptionally controversial issue whose governing body is still dynamic. One classical example of ethical dilemmas of informed consent in human experimentation is the Study of Prisoners and Guards conducted at Stanford University (the Stanford Prison Experiment), where test subjects signed informed consent forms, yet fully informed consent was impossible because the researcher could not fully predict the outcome of the experiment. This study, approved by the appropriate internal review boards, adhered to the informed consent standards of the time, but it was widely recognized that they needed to be updated to reflect this new, unforeseen caveat in informed consent. Another example is the case of Henrietta Lacks, a cancer patient whose tissue cells have since formed a major component of medical research. Yet, these cells were harvested and used without her, nor her families consent, questioning the value of medical research in the face of personal opinion.
Informed consent relates to the politics of health through its interactions with institutions to govern and monitor its application to the biomedical sciences. There is an expectation that the governing boards act in a moral, unbiased manner, uniformly applying their best interpretation of the scientific and moral facts onto the situation requiring informed consent. Yet, these institutions are inherently political. They either are governmental organizations, where individual politics can usurp scientific fact, or biomedical institutional organizations, where the needs of the company might be placed above the best interests of the patient.
References:
Grace, Sandra, Narelle Patton, Ev Innes, and Lynette Stockhousen. “Ethical experiential learning in medical, nursing and allied health education: A narrative review.” Nurse Education Today 21 (December 24, 2016): 22-33. Accessed January 22, 2017. doi:j.nedt.2016.12.024.
Henrietta’s Tumor. Performed by Rebecca Skloot. Radiolab. Accessed January 22, 2017. http://www.radiolab.org/story/91716-henriettas-tumor/.
“Informed Consent.” Stanford Encyclopedia of Philosophy. September 20, 2011. Accessed January 20, 2017, https://plato.stanford.edu/entries/informed-consent/#StaReq.
“Informed Consent and the Research Subject.” Mayo Clinic Institutional Review Board. June 28, 2016. Accessed January 20, 2017, http://www.mayo.edu/research/documents/50-informed-consent-and-assessment-of-capacity-to-consent-to-research/doc-20180876?_ga=1.62189870.341842255.1481505812
Jill A. Fisher, “Ready-to-Recruit’ or ‘Ready to Consent’ Populations? Informed Consent and the Limits of Subject Autonomy,” in Qualitative Inquiry 13 (2007). Pp. 875-894.
McLeod, S. A., “Zimbardo – Stanford Prison Experiment” (2016). Accessed Janurary 22, 2017, www.simplypsychology.org/zimbardo.htm
“Protection of Human Subjects, 21 C.F.R. § 50.25.” Food and Drug Administration, U.S. Department of Health and Human Services. Accessed 22 January, 2017, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=50.25
Salgo vs. Leland Stanford Jr. University Board of Trustees (1957). 154 California Civil Case Number 17045. First District, Division One. Oct. 22, 1957.
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