Uninformed consent

baby writing
“I understand that my tissues, fluids, cells and other specimens….”

Last year, after years of writing about research studies, I agreed to become a research subject myself.

I agreed to allow a local medical center to use my tissue, health records, fluids, cells, and other “specimens” for research. Not only that – I also allowed the researchers to use the same types of information and specimens from my newborn daughter.

The only catch: I have no memory of allowing this to happen.

I agreed to all of this either right before, or right after, my daughter was born. I arrived at a local hospital in labor on a Saturday afternoon; two hours later, she arrived into this world.

Some time that afternoon or evening, I signed a document agreeing to the hospital’s terms of service. I authorized the hospital to use my “medical information, photographs, and/or video in any form” for purposes “including patient safety and education.” I agreed “that my medical information and tissue, fluids, cells and other specimens” collected during my treatment and care could be “used and shared with researchers.”

I signed two copies of this document: one for me, and one for my daughter.

By doing so, I agreed to let the medical center enroll us in research, commercialize products based on findings made with our “specimens,” and share data about us with unspecified “other researchers.”

In other words, I gave informed consent for the research.

But in reality, I must have signed this document some time in the chaotic, painful hours before my daughter’s birth – I’ll spare you the details, gentle reader, but she arrived too quickly for an epidural – or sometime after she arrived, as I was basking in the glow of relief and joy.

At no point, I’ll confess, was I able to calmly read through the document, consider its implications, and make a truly informed decision about enrolling myself and my baby in research. I wasn’t able to ask what kinds of research might be done on our “specimens,” or who would have access to the data arising from that research.

I might have been able to do so in the weeks and months before the birth. I received all of my prenatal care through the same institution where I delivered my baby, so there was time for someone to discuss the possibility of research with me before my baby’s arrival.

But I don’t remember ever seeing this document until a month or so after my daughter was born, when I was finally able to sort through the piles of paperwork that accompanied us home from the hospital.

Even if I had possessed the presence of mind to wade through pages of legalese between contractions, it’s not clear to me that I really had a choice in the matter. The consent to research is embedded in a general terms of service document through which I also gave the hospital permission to treat me, and through which I promised to pay for my treatment.

If I hadn’t agreed to the research terms, and had declined to sign the overall document, what would I have done next?

Leave the hospital and go have my baby in the streets of San Francisco?

I know plenty of women who have given birth under non-ideal circumstances, including one who had her baby in the back of a New York City taxicab. But given the scarcity of cabs here, that probably wasn’t an option for me.

What’s more, the hospital didn’t even legally have to tell me that it might conduct research on my cells, as long as researchers take some minimal steps to try to make sure no one else can ever tell that the cells came from my body.

But here’s the problem: it’s becoming increasingly clear that it may never be possible to protect the identity of people who donate certain types of data.

This matters not just for mothers and babies, but for anyone who has ever been treated in a hospital.

I’ll explain why it does in my next post.


Photo courtesy Alex Couros/flickr.

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9 thoughts on “Uninformed consent

  1. In most hospitals, you can scratch out the information that you do not consent to. You should also be able to revoke consent, although as far as I know, each hospital has a different setup for how you’d do that.

    The problem is, of course, what you note: this kind of information is often deeply embedded in a document, which is shifty and cause for concern. Ideally, consent forms should be a single page or two document, no more, and be limited to what you are being seen for.

  2. This is so outrageous. I’m glad you are writing about this.

    I have on occasion tried to get the informed consent forms ahead of time, like several days before the procedure, and they were VERY reluctant to let me see them when I wasn’t two minutes and counting from anesthesia.

    You could try to get them early and cross out the offending parts. But we shouldn’t be having to come into conflict right before we go in for care. There’s an implicit threat in that situation that if you upset people you won’t get the best care. It’s coercive.

    HIPPA basically means that almost any institution can see your medical records but you and your family will have to go to some trouble to see them.

  3. As someone who has consented a lot of people in the last few years, I’m more than appalled that you would have been consented in this way. Aside from opening themselves up to a lawsuit (or ten), it’s just so amazingly unethical to consent someone in any position of pain or discomfort. I’m so sorry this happened. And I hope you get a head on a spike at the end of this.

  4. This strikes me as being coercive, given that this provision was buried in legalese which you could not have ably reviewed during the frenetic circumstances of your child’s birth. That situation would make it easy for you to overturn in a court of law, if it came to that. Whatever trust you may have had in the medical system is trumped by the hospital’s actions. Whoever came up with this “consent” form at that hospital should rethink their process.

  5. I’ve done minimal work that required an IRB review, but even though the most danger my work posed to subjects was a paper cut in filling out an anonymous questionnaire, I had to provide an explanation of the research I was doing to all subjects in acquiring their consent, and I had to make sure there was no possibility that they felt coerced.

    Surely, IRB reviews for medical stuff isn’t less protective?

    Does the consent form you were given contain the IRB information?

    (IRB=Institutional Review Board)

  6. Thanks for all of your comments, everyone (and hi, Ted!).

    It does seem shocking that this happens when there is a well-defined process in place for getting informed consent for research studies. They key thing about my situation was that I was being treated in a hospital. Researchers don’t legally have to get informed consent from patients to conduct studies on materials that are collected from the patients during their clinical care – as long as researchers strip the data of identifying information, such as the patient’s name.

    So in a way it’s shocking that the hospital did notify me about the research at all, albeit not in a way that gave me any real choice in the matter.

  7. Thank you for this. I can’t tell you how it rankles me to have to sign “routine” forms for informed consent or even for privacy, seemingly without any option. As you point out, what would I do — not have the treatment? Leave and find another provider who wouldn’t require the same? It’s a joke, meant more to cover someone’s legal behind than protect the patient.

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