I got a letter from the Medical College of Wisconsin Wednesday, a month after my husband died from a heart attack.

The purpose of the letter, it said, ”is to inform you that Mr. Doege participated in an out-of-hospital study with the Milwaukee County paramedics.”

This was the first I’d heard about any study. David never regained consciousness after his Oct. 19 heart attack and could not have volunteered.

“In emergent situation, it is not possible for us to obtain informed consent from the participant in this research,” the letter said. “Therefore, prior to the start of this study, the Milwaukee community was notified of the specifics of the research through the local media such as the Milwaukee Journal Sentinel.”

It turns out that if David did not want to participate in this study he should have notified the Medical College as far back as November 2007, more than a year before he had his heart attack, when the Medical College published a notice in the newspaper.

Doesn’t make much sense, does it? Any process that is so offensive to common sense is probably a bad process. And the idea that a medical institution can enroll you in a study just because you cannot say ‘no’ is a very scary concept.

I am trying to say ‘no,’ but the Medical College of Wisconsin may not allow me to do so. I have requested that David be removed from the study, but it is not clear at all that MCW will respect my request. 

There are a couple of reasons I’m trying to say no. Dave and I agreed that the involuntary enrollment process was problematic, at the very least. We actually discussed it one day after something about it was in the newspaper.

The Medical College also simply did not give me a reason to support the study or David’s inclusion in it. Its letter essentially said “Yeah, we did some stuff with your husband and we’re finally getting around to telling you.”

The letter itself did not give the first clue as to what the study was about (I assume that is because the lack of detail makes the mail merge so much easier). It instead said I should check out a web site, or call or write. I opened the letter on Wednesday evening, the start of the Thanksgiving weekend. I obviously have Internet access, so at least could immediately get an idea what the study involved and did not have to spend four days wondering what the hell they had done to my husband and whether he suffered because of it.

I read about the study on the web site and I read the federal regulations, to which the letter also referred me, that control what must be done if researchers want to do a study without the informed consent of its subjects.

And yesterday I called the Medical College to request that it remove David completely from its study.

I may be too late. The MCW representative I talked to said David was already IN the study and the only thing left to object to was his continuing involvment, which won’t happen anyway since he died.

That’s not how it is supposed to work, though. The regulations cited in the MCW’s own letter, as I pointed out to the Medical College guy, include this requirement:

The conditions imposed by the federal regulations are, on a practical level, impossible to meet. Is it believable that Medical College personnel did not know this from the beginning of the study or do we simply have here a little wink and a nod at the regs so the researchers get to do what they want to do anyway?

Here is what the college’s own protocol for the study says:

When a subject has been enrolled, paramedics will call the research personnel via cell phone. Paramedic base operations will also call research personnel to alert them to subject enrollment. Research personnel will go to the receiving hospital to attempt contact with the subject’s LAR (legally authorized representative) or family as appropriate to inform them of subject’s enrollment into the study.

Whoopsie. Didn’t happen, at least that last part.

Another section says:

The Research Team will provide information about the emergency research study to the patient or their representative at the earliest feasible opportunity after administration of the intervention. (emphasis added)

And here, just for laughs, is one more:

In the event the subject is not competent to participate in the process, written informed consent will be acquired by the research team from a family member or the individual with durable power of attorney, (LAR), for healthcare decision-making. The informed consent process will be conducted by trained members of the research team and will begin during the first three days of the patient’s hospital stay. (emphasis added)

David was in the hospital for six days. Members of his family were there for hours and hours each day. I know of no effort by the Medical College to contact any of us.

When I told Mr. Medical College during our phone conversation that I did not want David in the study, he  asked me if I had power of attorney to make that decision for David. When I referred again to the family consent portion of the regulations, he snapped, ”I was just asking!”

The college learned that David died Oct. 25 when it contacted the hospital on Nov. 10, according to Mr. Medical College. The college, he said, sent its letter to me that day.

But, but, but … the letter was dated the 10th, but it was postmarked the 21st, meaning that it sat around for 11 days before someone got off his or her lazy ass and put it in the mail.

Our conversation did not end well. Mr. MCW’s voice, while not rising to the shout level, got a lot louder than an everyday conversation level as he insisted David was already in the study and SO THERE!  When I said I wanted David’s privacy respected, he demanded to know what definition of privacy I was using. 

 I told him again that I did not want David’s data included in the study. I told him I wanted the college to remove it. I told him I wanted the Medical College’s confirmation that it had done so in writing.

He took my contact number and said someone would be in touch to let me know if my request would be granted. The notification might be in writing or it might not be, he said.

So far, I haven’t heard anything. Maybe our fine medical researchers will wait another month or so to let me know what is going on.

And I’m left here wondering why we’ve given so much power to medical reasearchers. They are involuntarily enrolling people who are at their most vulnerable into medical studies on the absurd premise that it is a reasonable to require people to opt out a year or more in advance, even though they have no idea they will become eligible to participate.

The information needed to opt out is in an ad in a newspaper that most people do not get. And what if someone is visiting from out of town and weren’t around when the ads ran? Too bad for them, I guess.

Those who do opt out of the study can wear wristbands telling medical personnel that very thing. How many wristbands might one end up wearing if one opts out of all such non-consent studies?  

I understand the need for medical research. I also understand the abuses that have occurred disguised as medical research. The power to conduct studies on people incapable of either objecting or agreeing to participate invites abuse. 

The disregard of protocols in conducting the research is abuse. There have been larger abuses, surely, but the failure to inform and involve families in the manner promised is an abuse.

And as for the Medical College of Wisconsin, the answer is still “no.”

That is, if I have anything to say about it.