Informed consent is a process by which a physician or scientific researcher is required to advise each patient not only of the patient’s rights, but also of the risks and benefits of any procedure, treatment, or research study. Although the concept of informed consent seems straightforward, its application varies from place to place. As a result, the informed consent process has gradually been reduced to a legal formality that does not truly serve the interests of patients or research subjects.

Ethicists Review Informed Consent Policy vs. Practice

During the 1970s, ethicists in the United States began to examine the practice of informed consent. More than 30 years had passed since the policies suggested in the Nuremberg Code, and yet not one international organization (including the United Nations) had incorporated the Code into law.

Furthermore, research abuses continued despite a heightened awareness of the ethics behind informed consent, as well as the adoption of international codes such as the Declaration of Helsinki (1964) and national guidelines such as the Belmont Report (1979). Faced with a discrepancy between policy and practice, ethicists focused on what factors most influenced the informed consent process.

Informed Consent is Reduced to a Legal Doctrine

The results were startling. As medicine advanced, and the amount of money allocated to clinical research grew astronomically, informed consent slowly moved from the international stage to local jurisdictions. According to Sfikas, court decisions and state laws have been more influential in establishing the criteria for informed consent than national guidelines or international ethical codes.

Although courts of law might seem to be the best place to resolve informed consent problems, the reality is far different. As Fry-Revere (2007) observed, courts are inherently undemocratic because they are bound by precedent, allied with conservative interests, and obliged to uphold the letter of the law. Courts are not intended to invent rights not specified under law. As a consequence, “informed consent has developed from a valuable form of evidence to a near meaningless formality.”

The state of Louisiana is a case in point.

Louisiana Wrestles With Informed Consent

In 1975, Louisiana adopted the Uniform Consent Law of 1975 (La. R.S. 40:1299.40) in order to simplify informed consent forms and minimize legal disputes. The statute specified that consent was presumed to be valid if a physician advised a patient of all known risks of a procedure, including“the loss of function of an organ or limb.”

On the surface, the statute was a pragmatic approach to a difficult problem. In 1989, however, the Louisiana Supreme Court considered a malpractice case, Hondroulis v. Schumacher (553 So. 2d 398) According to the lawsuit, the plaintiff underwent back surgery and unexpectedly lost bladder use following the procedure. The Supreme Court decided that telling patients they could lose “function of an organ” was too vague. Instead, physicians were directed to specify the exact organ at risk.

In response, Louisiana physicians began expanding informed consent forms to include as many theoretical risks associated with any given procedure, regardless of whether the risk was practical or not. Palmisano (1995) claimed that some amended forms listed more than 100 risks for any procedure.

In 1990, the Louisiana legislature tried again to resolve the problem by creating a Medical Disclosure Panel. The Panel was authorized to define all risks that a physician was required to disclose for any procedure, treatment, or research study in order to comply with current law. Unfortunately, none of the risks enumerated by the Panel are legally binding in any state other than Louisiana.

Individual States Refuse to Obey International or National Laws

The problem is larger than one state. Not only does the U.S. government routinely override state laws and practices (Whitlock v. Duke Univ., et al. 1987), but individual states often decline to adopt policy decisions made in other states — sometimes even going so far as to exempt themselves from international law, as well as national policy.

In 1997, a West Virginia federal court reviewed a case involving the over-prescription of narcotic drugs by a physician (Hoover v. West Virginia Dep’t of Health and Human Services). The plaintiff cited the Declaration of Helsinki (1964) as legal grounds for suing the physician. The court declared that the plaintiff could not sue under international law as the Declaration of Helsinki was a nonbinding document and had no “force of law” in the United States.

In 2002, a Connecticut court considered a malpractice case, Acheff v. Hartford Hospital. The plaintiff argued that the Belmont Report (1979), which set limits for acceptable medical care, provided grounds for a lawsuit against the hospital. The court, however, ruled that the Belmont Report was “unfairly prejudicial” in expressing acceptable standards of care and thus should be disregarded.

In 1995, an Ohio court reviewed a lawsuit brought against an institution and its research investigators (In re: Cincinnati Radiation Litigation). The plaintiff alleged that the investigators had performed radiation experiments on patients without their consent. Although Ohio law at that time did not provide a cause of action against the institution, the court ruled that the plaintiff could sue under the Nuremberg Code, as the “Code is part of the law of humanity.”

Protection or Meaningless Formality?

In the cases referenced above, several states made rulings of law based on differing interpretations of international and national law. In all instances, states decided what laws they would obey as well as what guidelines they could ignore. As a result, the principle of informed consent has been reduced from a protective process to a legal obstacle to be overcome on an individual basis.

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