Informed Consent and Malformed Consent

In a free society, each person decides how best to use his or her own physical body.  Government must respect the rights of people to make knowing, voluntary decisions about how to dispose of their own body tissues and organs.  Those rights to bodily integrity find protection through informed consent requirements.  Unfortunately, some recent trends and events in law and public policy suggest that safeguards offered by informed consent are being subtly eroded in certain ways.  The premises underlying this piecemeal movement away from informed consent in human tissue and organ donation could pave the way for an affirmative "duty to donate," to the detriment of human liberty itself.  The importance of informed consent needs to be reasserted.

For most of us, it's self-evident that medical professionals must obtain the informed consent of persons before their organs or other physical body parts may be removed for transplant or experimentation. Individual humans have rights and responsibilities vested in their own respective bodies.  Only where human liberty prevails do we have the space to make the moral choice of giving up part of our own bodies for the well being of others.

Contrast the human liberty to donate one's physical body for beneficent medical purposes with the notion of an affirmative obligation or "duty to donate" one's body.  Of course, the very idea of a "duty to donate" is incoherent.  No human can ever act freely while under coercion.  If humans were to have an affirmative obligation to furnish their own physical bodies to others, we could hardly claim to call our individual bodies our own.  Rather, human bodily control would be a temporary responsibility delegated each of us by a governing power.  But such a scenario is highly improbable so long as society takes informed consent seriously.

Troubling court rulings

However, some recent trial court rulings from across the country suggest that concerns underlying informed consent are taking a backseat to larger medical and social purposes.

Just last month, in a case called Adams v. King County, a Seattle trial judge dismissed a lawsuit brought by the family of a man whose organs were taken from his body and transferred from the hospital to a medical research institute for use in experiments.  Jesse Smith had consented to being an organ donor when he renewed his state driver's license.  But upon his death, Smith's organs were not delivered to living patients for transplantation.  Instead, his brain, liver and spleen were sent by the King County Medical Examiner to the Stanley Medical Research Institute in Baltimore.  Smith's brain was used in a schizophrenia study. 

Smith never consented to the donation of his body parts for any purposes other than organ transplantation.  His family didn't even learn about the ultimate fate of Smith's body until a 2005 investigation by a local television news station uncovered it. The family of Smith was offered no recourse in a court of law for the experimental use of his body without informed consent.  The trial judge ruled that Smith's status as an organ donor negated any further consent requirements.  While an appeal is pending, Washington State's Department of Licensing claims it will re-examine its donation procedures.  As it now stands in Washington State, the necessity of informed consent in an unknown range of instances appears to depend on bureaucratic decision-making, rather than protections of constitutional or common law. 

Meanwhile, the closely watched case of Catalona v. Washington University concerns informed consent procedures and human tissues donated by living patients.  Dr. William Catalona and a handful of tissue donors filed a civil action against Washington University in St. Louis, Missouri.  The donors initially sought to turn their respective tissues over for further research by Catalona, who had left the employ of the University.  Both Catalona and the donors asserted that the tissue samples were donated to him, not the University. The informed consent form did identify a right of withdrawal.  But the Senior U.S. District Court judge sided with the University.  The judge ruled that because the tissue donors were not in possession of the tissues, Washington University was their presumptive owner.  He also ruled the University could use the donated tissues for purposes other than those expressly contemplated in the informed consent form.  The import of the informed consent forms, opined the judge, was that the donors were not obligated to donate future samples.  The decision has been appealed and is now pending before the Eight Circuit Court of Appeals.  

The trial court rulings in both the Adams and Catalona cases imply a crucial background assumption: human donors do not retain residual ownership of their own bodies and body parts without a clear expression to the contrary.  Instead, both trial court rulings all but imply a default rule that all uncertainties about a prospective donor's intent and all ambiguities arising under informed consent forms should be construed in favor of donation.

Presumed consent and the slippery slope

Add to this mix the concept of organ donation systems operating on a "presumed consent" basis.  Some jurisdictions have contemplated the idea of requiring citizens to donate their bodies' organs unless they explicitly express their intent to "opt out" upon renewal of their drivers' licenses.  For instance, both the American Medical Association and the U.S. Department of Health & Human Services' Advisory Committee on Organ Transplantation have considered "presumed consent" systems for organ donation in the last few years.  A number of European countries already presume all persons are organ donors unless they specifically opt out.  

Any change to a "presumed consent" system for organ donation diminishes the deliberate choice of the individual to donate.  Where "presumed consent" prevails, organ donation is not primarily a charitable choice but is instead a default expectation.  More importantly, in a "presumed consent" setting, the burden is placed upon individual persons to commit an act of un-charity just to keep their own body's tissues and organs. 

From a baseline expectation of bodily tissue and organ donation it is but a short step to require non-donating persons to provide adequate justification for refusing to donate their own body parts.  Imposition of a "duty to donate" is then but a shorter step still. 

Living Patients

It is difficult enough to steer an ethical course consistent with informed consent in light of modern civilization's praiseworthy but persistent pursuit of pain palliation and health enhancement.  Outside of the donative context, consider the ethical conundrums offered by medical experiments on unconscious living patients who themselves could benefit from a successful new procedure, along with the rest of human kind.  Such conundrums are raised by the new, five-year Resuscitation Outcomes Consortium (ROC) project.  Several U.S. agencies are funding the project to the tune of $50 million, with medical experiments conducted at medical centers throughout the country.  Nearly 21,000 people are expected to be involved in experiments to improve care for pre-hospital trauma and cardiac-arrest patients.  Ascertaining where the best interests of a patient part ways with the advancement of medical knowledge for others can make for a tough call.

At what point could we be treating individual patients as a means for medical advancement rather than as ends in and of themselves? 

The notion of a "duty to donate" may be especially tempting in difficult situations.  Suppose we face an abundance of patients with strong chances for long and healthy lives facing shortages of vital organs and tissues.  Can we so easily ignore the hope offered by the bodies of recently deceased persons who had previously expressed unwillingness to donate their bodies?

The situation becomes more disconcerting still in light of modern utilitarian theories about human personhood and human value.  Too many bioethicists have rejected the bright-line, equality of life standard that had been a mainstay of western civilization.  In its place, they have instead adopted a line-blurring quality of life standard. 

Under a quality-of-life criterion, for instance, committees of government-select "experts" can be tasked with determining whether an individual human is truly a "person" through individualized determinations involving such individual's cognitive function, life expectancy, physical mobility.  Utilitarian ethical standards can readily be employed to justify the demand that persons who have just passed from life or who are on the brink of "non-personhood" status be harvested for their tissues and organs, in order to give to those persons who have greater prospects for longer and more fruitful lives.  During the debate over Terry Schiavo's life, one bioethicist even suggested Schiavo be euthanized  so that her organs might be harvested and given to persons with urgent medical need.  Utilitarian ethics can readily legitimize such a revolting use of life-and-death powers.

The logic and moral imperatives underlying informed consent need to be reasserted.  We can all insist on legislative measures that require organ and body part donors wishes be respected.  It should be reemphasized that donors only donate for what they actually and expressly consent to.  We can also demand that our legislators resist "presumed consent" or "opt out" donation systems and oppose any administrative regulations that achieve the same result.  In addition, we can require that experimental forms of treatment only be allowed on un-consenting persons where preliminary research both suggests the benefits of such treatments over existing practices and where those new treatments have been shown to be void of any downsides. 

Moreover, lawyers and judges should be mindful of the connections between informed consent, voluntary donation and human liberty. Regardless of how cases such as Adams and Catalona are ultimately decided through appellate courts, superseding legislation can be enacted to strengthen informed consent for future cases.  Such legislation can make clear that the law favors the intent of prospective donors and won't take license in the absence of such intent.

Questionable readings of informed consent forms by courts, presumed consent systems for organ donation and the like might not strike us as immediately troublesome.  Taken in isolation, it would sound alarmist to identify such developments as threats to essential human liberty. But the underlying rationales for such informed consent-eroding measures should give us grave concern.  The logical premises that most readily explain uninformed or presumed consent as necessary for public health easily and logically lend themselves to a "duty to donate" and unduly subordinate the good of individual persons to government-backed experts' determinations about the good of the whole.  In a nation founded on the consent of the governed, the governed need to remember the importance of their informed consent in medical decision-making. 

Seth Cooper is an attorney in Washington State.