First Dave died, then he got misfiled.

That is the very short version of why the Medical College of Wisconsin did not inform me for more than a month that David was enrolled without his or my consent in a medical study when he had a heart attack. His chart was misfiled in a non-urgent category and staff did not get back to it for about three weeks. College officials could not explain, though, why it took 11 days to mail the notification letter to me after it was written.

Far more importantly, that heart attack not only took Dave’s life — it also apparently took away our rights to decline to participate in a medical study. The Medical College folks are still looking into it, but believe that federal rules will not allow them to disenroll Dave entirely from the study he was dragged into when paramedics started working to revive him.

I want to thank Tom P. Aufderheide, who is heading up the study at the college, and David Clark, assistant dean of clinical research there, for meeting with me yesterday. They explained what happened in Dave’s case, apologized for the notification screw-up and said the matter was being referred to their own Institutional Review Board. They asked for my suggestions to improve the notification process, and said they would remove David from the study from the point they should have contacted me — 12 to 24 hours after he was stricken. They said they did not think the feds would allow them to erase him entirely from the study.

Now that is totally unsatisfactory. While federal regulations allow family members an opportunity to decline to have their loved one enrolled in a study, Dave may be trapped in a bureaucratic twilight zone simply because he had a heart attack.

The regulations say this:

 If obtaining informed consent is not feasible and a legally authorized representative is not reasonably available, the investigator has committed, if feasible, to attempting to contact within the therapeutic window the subject’s family member who is not a legally authorized representative, and asking whether he or she objects to the subject’s participation in the clinical investigation. The investigator will summarize efforts made to contact family members and make this information available to the IRB at the time of continuing review. (Emphasis added)

Except, said Aufderheide, there is no therapeutic window with heart attacks. Immediate intervention is needed; no one can wait 20 minutes for the family and emergency responders to wrap up their discussions about participating in study. (The college’s protocol for the study, though, does have one reference to a therapeutic window. A section discussing resuscitation techniques says that ”Several investigators have utilized this period of chest compressions as a therapeutic window…”)

I understand the need for immediate action. I can also understand the reasoning that went into the research team’s decision to wait 12 to 24 hours after someone suffers a heart attack to try to contact the family. When the college tried to contact families at the hospital right away, family members were concerned about whether their loved ones would live or die and not about some damned study.

That college’s decision to delay contact, though, seems to directly contradict the intent of the regulation, which is to allow patients the opportunity, either through their own wishes or through direction from the family, not to be enrolled in the study.

It may well be very impractical for the Medical College to seek immediate permission to enroll a heart attack patient in the study, but at some point patients and families have to have the right to remove their information entirely from the study.  The feds have to recognize that.

In America, we don’t conduct medical experiments on people without their consent. Do we?