Academic journal article The Hastings Center Report

Informed Consent from the Doctor?

Academic journal article The Hastings Center Report

Informed Consent from the Doctor?

Article excerpt

Dan is at the hospital bedside of his 13-year-old son, Rob, who was admitted the previous night with severe breathing difficulties. Rob is heavily sedated but conscious. Dan has been told that his son may have cancer; tests done during the night showed that he has very elevated white blood cell counts.

The next morning, Rob's oncologist RS talks with Dan. He confirms that Rob has cancer--acute lymphoblastic leukemia. He says the disease is curable, but that treatment needs to start immediately since the boy's white blood cell count is "50 times higher than it should be." RS also explains that Rob is eligible for a Phase III clinical trial:

Dan: You do anything you need to do to fix him! I don't care.

RS: I know you don't care--

D: Whatever you gotta do to fix my son, do it!

RS: I know. I--

D: (Interrupts) You don't have to tell me all the lingo. Just fix him!

RS: I know. But I do need to tell you. (Laughs) And I know you're not gonna completely understand this because--

D: (Interrupts) Whatever you need to do, do it!

RS: Well, and that's what we will do.

D: Yeah, I'll sign anything you want. Just let me drive my son home.

RS persists despite frequent interruptions from Dan. He discusses the clinical trial and its four "arms," how one of these is the standard therapy, how Rob would be randomized to one of the arms, that participation in the study is voluntary, that Rob can be withdrawn from the study if he has too many side effects. He explains that the research study is not strictly speaking experimental; it will provide Rob with the "best known" treatment for childhood leukemia.

Dan is frustrated and concerned that all this discussion is delaying his son's treatment. He says, "I just wish you could give the order and we could get this thing started."

RS responds, "The bottom line is, if you feel uncomfortable with the study we can give him standard therapy."

Dan: "That's your decision! I'm an electrician, I can wire your house, but I couldn't.... it's your call. You're the doctor."

Ultimately, Dan signs the consent form to authorize his son's participation in the research study. The gesture is perfunctory. "Whatever you think is best for my son, I'll do it. I'll sign anything!" Is this informed consent?

Did RS respond appropriately to Dan's insistence that he didn't need "all the lingo" about the clinical trial? That he, the doctor, should make the right decision for his son? Should proxy decisionmakers like Dan be encouraged to regard themselves as qualified decision makers? Or should their stated preference for another potential proxy--the child's doctor--be honored? To what extent should the ethical appropriateness of these and other possible responses be evaluated against the clinical urgency to treat? Or the doctor's conviction that the best known treatment for the patient is the clinical trial?

commentary

by Steven Joffe

I once helped care for an eleven-year-old boy with acute myeloid leukemia, a highly lethal malignancy. He was eligible for a randomized trial comparing intensified chemotherapy to standard chemotherapy. Despite numerous discussions, his psychologically paralyzed single father was unable to decide whether to permit his enrollment. Ultimately, we decided unilaterally to give the child standard-dose chemotherapy outside the trial.

Whose approach was preferable--ours or RS's? Are there other options? Finally, should we reproach these fathers for their unwillingness or inability to own the enrollment decision?

The current U.S. regulatory scheme views valid consent (or proxy permission) as "informed opting-in." IRBs may waive consent for certain minimal risk studies, but randomized trials for childhood leukemia do not qualify. Thus, Rob should not have been entered in the trial.

The decision to exclude patients like Rob, however, has costs. …

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