Uninformed Consent

by jeeg 12. February 2013 22:40

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.

Erika Check Hayden, The Last Word on Nothing

 

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