In a momentous decision, the Wisconsin Supreme Court affirmed the lower court’s judgment in finding the physician liable for failing to disclose the availability of the ultrasound procedure.
Another area where informed consent is under renewed scrutiny is in research. Doctors in practice are increasingly participating as coinvestigators in industry-sponsored drug trials, and should be familiar with what is expected in the research context.
Augmented rules regarding informed consent govern all clinical research, with patient safety and free meaningful choice being paramount considerations. Federal and state regulations, implemented and monitored by institutional review boards, serve to enforce compliance and safeguard the safety of experimental subjects.
Still, as predicted nearly 50 years ago by Dr. Henry K. Beecher, “In any precise sense, statements regarding consent are meaningless unless one knows how fully the patient was informed of all risks, and if these are not known, that fact should also be made clear. A far more dependable safeguard than consent is the presence of a truly responsible investigator” (N. Engl. J. Med. 1966;274:1354-60).
Scandals in human research led by or in collaboration with U.S. investigators in foreign countries have been in the news. Global clinical trials are supposed to be carried out in compliance with the Nuremberg Code and the Declaration of Helsinki, but there may be occasional lapses or disregard for such international laws. A recent example is the trial using the antibiotic trovafloxacin, administered orally, versus FDA-approved parenteral ceftriaxone, during a meningitis outbreak in Nigeria (N. Engl. J. Med. 2009;360:2050-3).
Finally, the politics of abortion and first amendment rights have managed to insinuate themselves into the informed consent debate. Can states mandate disclosure in the name of securing meaningful informed consent, e.g., requiring physicians to provide information that might encourage a woman to reconsider her decision to have an abortion?
In 1992, the U.S. Supreme Court decided that this passes constitutional muster, because it did not place an undue burden on the woman. However, the Fourth Circuit Appellate Court recently ruled unconstitutional a North Carolina statute called Display of Real-Time View Requirement. The statute requires physicians to display ultrasound images of the unborn child to a mother contemplating an abortion, which the court ruled violated the First Amendment’s prohibition on state-compelled speech (N. Engl. J. Med. 2015;372:1285-7).
Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at siang@hawaii.edu.