The ethics of informed consent

The Department of Health (DOH) recently announced that it will only inform vaccine recipients of the brand of COVID-19 vaccine at the vaccination center. It assured us, however, that consent will “ALWAYS be a prerequisite to vaccination[.]” The DOH fundamentally misunderstands the meaning of “informed consent.”

To start with, why should there even be a need for consent? The answer may not be as simple as it seems. In a survey by the UK National Health Service, 88 percent of over 1,000 participants perceived consent as a legal prerequisite to treatment, while 46 percent believed that the purpose of consent was simply to protect hospitals from suit. Further, 68 percent thought that consent was not an expression of their own interest, but a delegation of control to the doctor.

Clearly, consent, even when given, is not always understood. After all, what “informs” consent? Is it the conduct of the medical practitioner informing the patient? Or perhaps it alludes less to the doctor’s behavior than to the patient’s state of mind?

Traditionally, we would not have even bothered with these questions. In the days of yore, doctors were not bound to share information about prognosis. The Hippocratic promise, after all, is not to the patient, but to “Apollo and Aesculapius to follow that system of regimen which according to [their] ability and judgment [they] consider for the benefit of [their] patients.” Under the traditional Hippocratic paradigm, it was the doctor who was the autonomous subject, and the patient his object. The medical approach, stated simply, was paternalistic.

But with the growing respect for patient autonomy, the focus has shifted away from the doctor’s authority and toward the patient’s rights—and with it, a paradigmatic shift in the doctor-patient relationship from Hippocratic to Partnership. The patient is now no longer a means toward a medically identified end, but is a decision-maker in his or her own right. The Partnership Model, far from being an indictment of medical expertise, recognizes that scientific answers and personal choice are two separate spheres of decision-making. When consulting with your doctor, this new approach recognizes two specialists in their respective fields: the medical expert and the personal expert (i.e. you). The doctor may have the expertise to identify the risks involved in treatment, but it is the patient who is best placed to decide which risks are worth taking. He alone can make certain decisions about his own body, his own life, the pains he deems worthy of enduring and, in the end, the risks he is prepared to take, and the hopes he is prepared to surrender.

The DOH notion of consent is terribly wanting. It is not enough to tell the patient what vaccine he is getting right before he gets it. Informed consent requires that patients be given sufficient information to make that choice in the first place. How much information may depend on the circumstances, but what is certain is that a sufficient amount of information does not necessarily mean all of it. Like the Terms and Conditions of Facebook, the longer the T&C is the more likely “my eyes glaze over.” The threat of no information is just as real as that of too much information. Information overload may paralyze rather than promote informed choice. To borrow from the UK Supreme Court in Montgomery v. Lanarkshire (2017), obtaining consent is neither bureaucratic nor blunt but personalized and precise. Information should not only be contributed but also communicated. Not simply conferred, but comprehended.

In its attempt to salvage “brand agnosticism” from the objections of medical ethicists, the DOH claims that consent remains “a prerequisite to vaccination”—that potential vaccine recipients will still have the option to decide whether or not they will authorize the vaccines’ inoculation. But by leaving patients clueless up to the 11th hour, the DOH has effectively preempted choice. By the point in time patients are informed, they would have already patiently waited for their appointment date, taken time from their work schedules, commuted to the center, queued in their lines, and in so doing subjected themselves to COVID-19 exposure at a time when community quarantine measures continue to be imposed. What is more, patients are forced to make that choice under circumstances of vulnerability and uncertainty as to whether they will ever get another shot at a vaccine. Last but not least, there is the walk of shame that awaits them if they so opt not to receive the vaccine only recently revealed.

Securing informed consent is about respecting individual choice. Yet “brand agnosticism” questionably portrays that choice as binary, as if it were a simple yes or no. When it comes to difficult, intimate questions of what we inject into our bodies, consent is more than a one-off event. It is a process, and processes take time. The vaccine we receive is not the product of a single decision, but a series of decisions, discussions, and tos-and-fros in between. The DOH assumes that this choice is easy.

Under the weight of these considerations, the odds are not even. This is no 50/50 choice, but one skewed in favor of a particular choice. The DOH attempts to adopt the framework of consent, but in truth manipulates the situation to coerce consent. And from the lens of medical ethics, duressed consent is deprived consent.

If the country truly seeks to (re)instill vaccine confidence among the Filipino people in the wake of the hesitance inherited from the Dengvaxia debacle, we must foster genuine consent through a community informed.

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Raphael A. Pangalangan teaches law and bioethics at the UP College of Medicine and legal theory at the UP College of Law. He is the associate dean of Jindal Global Law School and a Justice Fellow for Centerlaw Philippines.