Hastings Center Report

Knowing what's in store.

In April, at a conference on caring for persons with advanced heart failure, I attended a presentation on the use of expensive new technologies like the implantable cardioverter defibrillator (ICD), which when implanted into the chest or abdomen can detect abnormal heart rhythms and shock the heart back into normal rhythm. Clinicians were concerned about the quality of the ICD informed consent process; some patients who had the devices apparently did not realize that ICDs save lives by administering a powerful jolt of electricity, and they were totally unprepared for the experience when the ICD went off. Conference attendees suggested a project to develop patient education materials.

Giving patients information in a form they can use is a good idea, but a more basic problem also deserves attention: the inadequacy of the available information. This is a perennial problem in health care. A new drug or device must undergo clinical trials before it is approved, but the trials can include only carefully selected people, treated under a strict protocol. In other words, the trials provide ICDs in circumstances quite unlike those that prevail in routine care, and they largely exclude the kinds of people who will eventually be candidates for them.

We don't need information about every possible user in every possible setting before we give anyone access to ICDs. Nevertheless, once they are in routine use, we could and should develop information on what happens to the patients who get them. Yet we don't have the infrastructure in place to do this.

When I've raised this point over the years, in various contexts, I've emphasized that we need to understand a technology's benefits, harms, and costs in actual use to make ethical decisions about allocating scarce resources to it. In April, I found myself thinking more about ethical obligations to the patients considering the technology. A patient's right to be treated only if he gives informed consent is a central ethical value in medicine. To be informed enough to consent, however, a patient should not only know that the device worked in a clinical trial but also have some idea of what its effects will be on everyday quality of life for someone like him. Is this ethical value upheld by merely giving patients whatever information is available? Isn't there at least some societal ethical responsibility to ensure that the information available is adequate? I think so.

As changes in health care like integrated delivery systems and electronic medical records make it easier and cheaper to collect data on patient experiences with devices like ICDs, we are finally beginning to develop the infrastructure we need. Ironically, these efforts are running into obstacles related to the ethical requirements of medical research. The requirements serve an important ethical goal: protecting the subjects of medical research from being used to promote the social good without their consent. However, importing these requirements unchanged from the context of medical research into that of managing and improving ongoing clinical care threatens the fulfillment of other important ethical goals. At the conference, I suddenly saw that among these other goals is the development of the information needed to give real substance to the clinical consent process. [End Page c2]