Insights for Flourishing: To Promote Public Health, Enhance Informed Consent

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“Informed consent is rooted in the fundamental recognition —reflected in the legal presumption of competency—that adults are entitled to, accept or reject health care interventions on the basis of their own personal values and in furtherance of their own personal goals.”

–Making Health Care Decisions: The Ethical and Legal Implications of Informed Consent in Patient-Practitioner Relationship, Volume One: Report. President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. October, 1982.

We treasure our personal freedoms. Since colonial times, it’s been in our DNA to fight for our rights. To form a more perfect union amongst us, we have enshrined our rights in the Constitution.  To secure the liberty of all Americans against tyrannies that seek to trample them underfoot, we enumerate our civil rights in our statutes and laws.

And yet, through the consent of the governed and for the greater good of us all, we also recognize legitimate constraints on our individual rights.

This pandemic has severely tested our ability to achieve a proper balance between our individual right to choose freely and the government’s power to mandate what our choices must be. The resulting strain between these two competing interests has frayed the fabric of society and injured public trust. 

Among the many actions we need to take to heal these open and festering wounds, chief among them is promoting public health through enhancing informed consent.

I have several suggestions to offer in this regard. But before I do, I wish to provide some pertinent historical background; first regarding the meaning and purpose of informed consent, and then briefly, on judicial rulings underpinning public health mandates.

Informed consent is a long-standing doctrine of tort law, permitting us legal remedy for a medical injury. Specifically, an injured patient can file a civil action of negligence against a health care provider or pharmaceutical company for failure to provide relevant information about the benefits, risks, and consequences of a medical procedure or drug used on the patient.

Under the leadership of President Jimmy Carter, the 95th Congress of the United States enacted a law (PL 95-622) establishing “the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research.” Duties of this Commission included conducting a study of the ethical and legal implications of “the requirements for informed consent to participation in research projects and to otherwise undergo medical procedures.”

In 1982, the Commissioners reported their findings to the President and to the Congress in their Volume One Report.  What they wrote 40 years ago remains highly relevant today.

“The complexities of modern life make it difficult for individuals to be masters of their own fate.  Perhaps in no sphere of everyday activity is this more acute than in health care. This often-frustrating lack of control can be traced to several recent developments: the increasing reliance on advanced technology, the high degree of specialization, the consequent segmentation of care among an imposing array of health care professionals who are often strangers to the patient.”

They found the “values underlying informed consent are widely shared by people in all segments of American society.  Regardless of race, income, education, age, or gender, the vast majority of people surveyed by the Commission felt that patients have a right to information and ought to participate in decisions regarding their health care. Furthermore – despite vastly different views held by many foreign cultures and subcultures within the United States regarding the etiology of illness and the roles of healers and patients – a desire for information, therapeutic choice, and respectful communication appears to be common in all groups.”

They wrote: “Current requirements for informed consent owe much to the legal system, but the values underlying these requirements are not merely legal artifacts. Rather, they are deeply embedded in American culture and the American character; they transcend partisan ideologies and the politics of the moment. Fundamentally, informed consent is based on respect for the individual, and, in particular, for each individual’s capacity and right both to define his or her own goals and to make choices designed to achieve those goals. But in defining informed consent (and its exceptions) the law has tempered this right of self-determination with respect for other values, such as promotion of well-being in the context of an expert-layperson relationship.”

One such tempering of the right of self-determination arises when experts mandate vaccines or other public health measures as a condition of employment and unfettered participation in society.

How have the courts dealt with this tempering of our rights?

In 1905, Supreme Court Justice John Marshall Harlan wrote the majority opinion in the case of Jacobson v. Massachusetts, in which the Court upheld, by a 7 to 2 decision, the authority of states to enforce compulsory vaccination laws. Writing for the majority, Justice Harlan recognized under our Constitution, liberty is regulated by law. But any legal constraints on individual liberty must have the aim of supporting the common good. The Court found–as a function of a state’s policing power–mandating protection against an epidemic disease clearly to be in the common good. In his words, it is “of paramount necessity” and therefore constitutional.

Ironically, Dr. Anthony Fauci apparently desires public health measures to stand above judicial review. When asked by CBS News’ Kasie Hunt about U.S. District Court Judge Kathryn Kimball Mizelle recent April 18th ruling striking down mask mandates on airplanes, trains, buses and other forms of public transportation, he expressed he was “surprised and disappointed because those types of things really are the purview of the CDC.”  “This is a CDC issue, it should not have been a court issue.”

Regardless of whether Judge Mizelle’s ruling ultimately stands or is overturned, does Dr. Fauci realize the implications of what he is saying? If the courts truly have no role to play, then the Supreme Court’s rulings affirming the authority of legislative and executive branches of government to legislate and enforce public health mandates should be vacated, rendering them null and void!

So how do we navigate the treacherous ethical waters swirling between a competent adult’s fundamental right to accept or reject a medical procedure or medication and the government’s right to impose a particular health care intervention upon its citizenry?

To begin to answer that question, I will explore a suggestion offered by Dr. Fauci’s wife, Christine Grady. Dr. Grady currently serves as the Chief of the Department of Bioethics at NIH. Her conceptual and empirical research includes many topics, including “informed consent” and “international research ethics.”  (I wonder what she might have to say about the ethics of NIH supporting research in China that could accidently spawn a pandemic?)  In a wide-ranging interview with CNN’s Chief Medical Correspondent Dr. Sanjay Gupta about the government’s response to the pandemic, she said: “I think we need to think of ways to better instill in all of us the responsibility that we have to others.”

I agree with Dr. Grady. A vital way to better instill a sense of public responsibility is to develop a broader, more expansive definition of informed consent and to update the laws that permit recourse for injury.

Here are several broad areas of improvement that I recommend. I am indebted to the published work of Wendy E. Parmet, law professor and Director, Center for Health Policy and Law at Northeastern University for helping me formulate these ideas.

First, the current premise that informed consent is strictly a private matter between the patient and the physician or the pharmaceutical company doesn’t hold up when we are dealing with public health guidelines and mandates. Each citizen is now consenting to subject their body to the medical recommendations of public health officials. This means that these officials now have assumed the principal responsibility for informing us.

To maintain the public’s trust, informed consent should not be a one-time event as it is now. It ought to be an on-going process. Public health officials must do a vastly better job of providing us up-to-date information and risk assessments, warts and all, on a real-time basis. This must be done in ways that allow for greater independent review, especially when new technologies are authorized under Emergency Use.

Secondly, information provided typically has been cast from an individualistic point of view. In the case of mandates, benefits and risks to society need to be articulated and supported by evidence as well. Direct government involvement in our collective health care choices creates the additional obligation to explain–in the informed consent forms we sign–how its recommendations and mandates affect our fellow citizens, especially the most vulnerable amongst us.

Finally, tort law currently does not hold public health agencies accountable for informed consent warnings if they are found to be inadequate, incomplete, or incorrect. This is a particularly important shortcoming given the strong incentives for public health officials to extoll the virtues of their edicts while avoiding any talk about the risks or the availability of safe and effective alternative treatments.

In summary, we are deeply interdependent upon one another. As we say here at the Floriescence Institute, showing concern for the well-being of others enhances our own. Through insights and empowerment gained by a robust informed consent process–designed for the realities of the 21st century, we will “better instill in all of us the responsibility that we have to others.” 

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