On Informed Consent

The first point of the Nuremberg Code, carefully articulated by the judges overseeing the Nuremberg Trials, focuses on the necessity of voluntary and informed consent.i It carefully states what is required for a person to give truly voluntary consent. The part that will be the basis for this paper focuses on disclosure of information. The part states:
“…before acceptance of an affirmative decision by the experimental subject there should be made known to him the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonably to be expected; and the effects upon his health or person which may possibly come from his participation in the experiment…”ii

It shows that for a potential participant to give their truly voluntary consent, any information that may affect the decision to enter the research experiment must be disclosed by the researcher and fully understood by the subject. Failure by the researcher to comply with disclosure, or failure by the potential participant to understand what is outlined, delegitimizes the enrollment of that participant. This paper will argue that the most important provision in the ethical recruitment of patients to clinical research trials and other forms of research is their understanding of any information that will affect their decision to participate; and that only when they are giving truly informed consent, are they giving their truly voluntary consent. I will do this by presenting the idea of disclosure of information as the most important requirement for consent; showing that without an informed decision, the consent to enter into research is not truly voluntary. I will prove this by presenting two arguments; the first is that for a patient to give a truly informed decision, they must be sufficiently educated by the physician or researcher, such that there is no lack of understanding regarding the method, the hazards, the duration, and the nature of the experiment. The second is that if there are any benefits for the patient or the physician, such that it might coerce the physician to want to enroll the patient, or coerce the patient into accepting the invitation to enroll, they must be disclosed.
This paper will also refute the counterargument that because patients lack the medical expertise, their decision will never be totally informed, but can still be voluntary.
Informed consent, in the context of this paper comes to mean a patients understanding of their risks, potential benefits, procedures, and alternatives to the study in question.iii Informed consent is qualified when the medical investigator informs the patient of the goals, the hazards, and the nature of the study. Participation is defined as the invitation to enroll in an experimental study.iv Voluntary consent is defined in this paper as the choice to enroll in a study based on the explanation of information qualified for informed consent.v Voluntary consent is free from any coercion, fraud, and deception.vi
The Nuremberg Code, and subsequent revisions by localized Ethics Committees, have already emphasized the need for patients to be fully informed of the dangers, hazards, et al, of participation. However, when the patient is presented with information, they are being bombarded with information mixed between both legal and medical jargon. Such forms of disclosure, while providing the necessary information required for participation, is set in language mostly incomprehensible to the layperson. Franz J. Ingelfinger argues that when information in such a manner is presented, it satisfies the requirements of the doctor, ethicist, and lawyer, but does not sufficiently clarify the goals, hazards and nature of the study to the potential participant.vii The patient may have given their consent, but they do not truly understand what they have consented to. If the patient does not fully understand the particulars of the study, their participation should be disqualified.
Robert J. Levine argues that disclosure is determined by one of three points, 1) general medical practice or opinion, 2) the requirements of a “reasonable person”, and 3) the idiosyncratic judgment of the individual.viii
Levine believes that there is already a shift from the first point to the second.ix In the context of this paper, the first determinant of disclosure can be disqualified because it allows only as much disclosure as the medical investigator feels is necessary.x This paternalistic approach removes the autonomy of the person by forcing a form of control over the patient, and thus invalidates the consent from being truly voluntary.xi
The second determinant of disclosure, the requirements of a “reasonable person”, is argued to be imperative to participation by Veatch.xii If the patient does not want to understand the goals, hazards, and nature of the study, even if they are able and willing to participate, they should not be accepted.xiii This point can be taken a step further, and related back to Ingelfingers’ argument about the language of disclosure.xiv Though the person may be disclosed the information, they do not have sufficient understanding of the study to make a reasonable decision and should not be accepted for participation.xv Moreover, unless the person has been presented information in both the terminology required for legal and medical understanding, and in an abridged manner, they cannot make a fully informed decision.
Benjamin Freedman disagrees and adopts the third determinant of disclosure, the idiosyncratic judgment of the individual.xvi He argues that a person can choose to accept less information than what a “reasonable person” would insist on.xvii Levine acknowledges that this may be the decision most respectful of autonomy, but the argument can be refuted.xviii
For example, if a patient with breast cancer walks into the office of a medical investigator who also happens to be leading the field of nano-biotechnology and says, “I don’t want to lose my breast from a mastectomy, what else can I do?” The medical investigator might say he has a new technology he is working on that can send nanoparticles under her skin and kill the cancer without chance of coming back, but the experiment is strictly in the experimental stages. The patient, trusting the investigator might say, “Don’t tell me anymore…sign me up and call me when you are ready to initiate the procedure. I trust you, Doc.”
The aforementioned scenario shows the idiosyncratic judgment of the individual, but is clearly an ill-informed decision, and made solely on the trust of her physician to do the right thing.xix The medical investigator might have had alternative methods he could have tried before telling the patient of his experimental study, but did not disclose them because he wanted to sign up as many people for his study as possible.xx On the medical investigators part, it exhibits a subtle form of coercion and deception. Although the judgment was ultimately up to the patient, the decision was not sufficiently informed, so it could not be truly voluntary. The patient is not informed of any possible hazards, like whether or not it might leave her breast deformed, or if it will guarantee she become cancer-free. She would not be disclosed that information or have full a understanding of the study, and would not have been presented information that might affect her decision to participate.
This scenario proves that there lies greater importance in the need for fully-informed consent over truly voluntary consent. Truly voluntary consent in the aforementioned scenario would have left the patients’ care entirely in the hands of the medical investigators.xxi Her volunteerism would have prevented her from understanding of the risks.
If a patient cannot give truly voluntary consent unless they give fully informed consent, it raises the question of what fully informed consent is, and how can one be fully informed. Freedman argues that a patient can never give truly informed consent.xxii In his paper, A Moral Theory of Informed Consent, he argues that there ‘is no end to “fully informed consent”’.xxiii If we were to truly practice it, then medical investigators would be required to explain every minute detail of every procedure conducted.xxiv Explanations of anatomy would be necessary for the simplest of procedures, like catheter insertion, or needle-injection.xxv He questions, how much do we have to explain to ensure fully informed consent is qualified? If the patient is being enrolled in a drug trial, must the molecular structure of the drug be explained? Must the melting point of the catheter be told to the patient before insertion so the patient is confident it will not melt if it reaches his body temperature while inside him? He recognizes these arguments as reductio ad absurdum, and explains that the idea of “fully informed consent” itself is a reductio ad absurdum, since all information relevant to the study and procedure can never be given.xxvi
Freedman argues that in order for a patient to be capable of giving fully informed consent, they would have to undertake the same education that the medical investigator has.xxvii At the very least, to ensure fully informed consent has been given, only medical students and life science graduate students ought to be accepted as research subjects.xxviii
For these reasons, Freedman disputes the idea. Rather, Freedman pledges that as much information as is required be given to the patient, should be given.xxix He argues for enough information so that legal obligations are met. He says, “the patient must be informed so that he will know what he is getting into, what he may expect from the procedure, what his likely alternatives are – in short, what the procedure will mean, so that a reasonable decision on the matter be made.”xxx
The premise of Freedman’s proposal agrees with the points outlined in the Nuremberg Code, but he then goes on to say, “The proper test of whether a piece of information needs to be given is, then, whether the physician, knowing what he does about the patient/subject, feels that the patient/subject would want to know this before making up his mind.”xxxi He qualifies this with an example of a doctor, aware of the risk of impotence in a procedure, choosing to inform his patient of this information because the man takes pride in his sexual prowess, not simply because it is a risk.xxxii
Further in the article, Freedman says “It…is not unusual for a patient to give his doctor carte blanche to perform any medical procedure which the physician deems proper in order to effect a cure. He is telling the doctor to act as his agent in choosing which procedure to follow.”xxxiii
Freedman’s arguments can be refuted by simply extrapolating the situation. If all discretion has been left to the medical investigator, the patient is simply a yes-man, given discretion only to say yes or no based on possibly uninformed consent. If the medical investigator follows the school of thought that scientific progress must not be hindered by ethics and human rights, then the patient, who would be unaware of this information, would be subjected to only possible uninformed consent, or partially-informed consent.
The question of legality is covered in Freedman’s argument, but the question of integrity is not. For example, let us say a medical investigator is given voluntary consent and has enrolled their patient in a study. Now let us assume that notions A,B,C, and D need to be covered to give full disclosure of the goals, hazards, and nature of the study, but only covered A,B, and C, because based on the limited interactions with the patient (interactions that are always when the patient is under physical duress or is ill), he decided D was information unimportant to the patient. Assuming D was a qualifying factor in the patients participation, and it manifested itself during the study, the patient may decide to leave. The risk of experiencing D is not worth the experience of A,B, and C. In this scenario, the medical investigator loses his integrity with the patient, and the patient loses confidence in the medical investigator, citing deception and coercion into the study.
The patient was not disclosed all the information necessary to make an informed decision. Ingelfinger argues that when patients are approached for an invitation to a research study, they are ‘Incapacitated, frightened, and often unduly hopeful’ and that many patients are ‘unable to exercise genuinely free choice when an authority figure in a white coat amiably requests their consent to research’.xxxiv Ingelfinger and Henry Beecher conclude that while education of patients is necessary for them to give their informed consent, if they are not, their ‘only real protection remains the conscience and compassion of the investigator and his or her peers.’xxxv

If there are any benefits for the patient or the physician, such that it might coerce the physician to want to enroll the patient, or coerce the patient into accepting the invitation to enroll, they must be disclosed. Meaning, if the pharmaceutical corporation funding the study is paying the medical investigator $500 for every enrollee, with an enrollment cap of 200 patients, there becomes the question of integrity of the medical investigator. Is it ethical for the investigator to take money for enrolling someone in a study? Let us look at the analogy of an auctioneer. If an auctioneer is selling items that are not on display, and whose sales are dependent only on his description, there might be deception on his part to describe the items as something grander than what actually materializes, or less functional than they turn out to be, if he is being paid per item sold. If the auctioneer is being paid per item, he has incentive to get rid of the items without describing the item as it really is. In a similar manner, the medical investigator is capable of deceiving, even slightly, if it means there is incentive behind his signing up a patient. The patient, in that case, cannot give a fully-informed consent to enroll, and will likely give consent involuntarily based on Ingelfingers premonition that a less educated person might become incapacitated and frightened by not taking the medical investigators advice.xxxvi The advice and explanation of the goals, hazards, and nature of the study, being entirely at the discretion of the medical investigator, comes back to the first determination of disclosure proposed by Robert J. Levine; it comes back to general medical practice or opinion.xxxvii
We could look at the flip side as well, and examine when the patient is the one with financial incentive. If the patient needs money, they might forego the entire of the goals, hazards, and nature of the study, not basing their decision on the expectations of a “reasonable person”.xxxviii They would instead have accepted Levine’s third determinant of disclosure, the idiosyncratic judgment of the individual.xxxix The choice is no longer based on informed consent, but on monetary need.xl In both cases, there is coercion, and in both cases, full disclosure of the goals, hazards, and nature of the study is not explained to the patient in a manner in which they can understand and in which they can decide whether the factors laid out for them are deciding factors in their decision to participate.
Because the patient has been coerced to enroll in the study, and because the decision to enroll or not enroll was not based on informed consent, the decision cannot be voluntary.
To summarize, the Nuremberg Code outlined after World War II outlined guidelines for patients, with its first point, the point of emphasis, being on voluntary and informed consent. From the arguments presented, including the need for education of patients, the need for disclosure of any benefits that may be attained by the patient or medical investigator, and the counterargument that explanation and “informed” is entirely up to the discretion of the medical investigator because the patient can never be totally “informed”, we learn that voluntary consent does not preclude one from being informed, but being informed precludes that the decision will be voluntary. Based on the arguments and information presented for the thinkers, Franz J. Ingelfinger, Benjamin Freedman, and Robert J. Levine, there exists a healthy dialogue on the ethics of enrollment of patients into clinical trials and other experimental studies by medical investigators. Therefore, from the body presented, one can say the most important provision in the ethical recruitment of patients to clinical research studies is their understanding of any information that will affect their decision to participate.