So this morning I donated blood.
Before going through the usual 36 questions about my travel habits, medications, and sexual history, the Red Cross staff handed me a ten-or-twelve-page pamphlet with information about blood donations and asked me to verbally confirm that I’d read and understood it.
Did I read every word in that pamphlet? No. I wanted to get to the iodine swab and the needle and get on with my day. I glazed over at least a third of it. I used the usual heuristics: I’ve donated blood six or seven times before without exploding. There probably isn’t any information in this pamphlet that would make me change my mind. Haven’t heard of any blood-bank scandals lately.
Somewhere in those ten or twelve pages were a few bullet points that explained that the Red Cross sometimes uses blood donations not for transfusions, but for research purposes. (Like this project, I guess.)
I made a point of reading those items, because I was interested, but now, two and a half hours later, I doubt I’d score 100% on a quiz about them. Did they specify whether they share specimens with biobanks outside the Red Cross umbrella? With for-profit corporations? Couldn’t really tell you.
In this week’s Chronicle of Higher Education, I wrote about an unusual effort to test tissue donors’ understanding of their donations, two months after the fact. It’s an unusual context: a large-scale genetic study that requires tissues to be procured from people within several hours after they’ve died. The donors — the deceased subjects’ next of kin — are given a short window of time to decide whether to donate a deceased loved one’s tissues to a major genetic study. When approached two months later, at least 40 percent of them didn’t recall that the genetic study wouldn’t be returning any personalized genetic information about their families’ health. (The vast majority said that they wanted such information.)
These donors weren’t deceived. All of them had signed informed-consent forms that stated in black and white that no personalized information would be returned. But only some of the donors had had conversations about that topic with the tissue procurers. (Those who did were two and a half times more likely to recall the information correctly.)
When does that kind of imperfect memory matter? In tissue and organ donations — and in all sorts of other biomedical research — informed-consent documents are inevitably going to be long and complex. Interventions are complicated, protocols are complicated, risks are complicated. Even for something like a simple blood donation, you need to talk about potential bruising, anemia, dizziness, the remote risk of infection . . . it’s a long list.
If tissue donors and research participants allow their eyes to glaze over some of those details, and sign the forms without actually absorbing them — well, sometimes that behavior is probably more or less benign. I don’t blame the Red Cross for not being more aggressive about force-feeding me its warnings and disclosures.
But in some contexts, the stakes are higher.
A nontrivial proportion of participants in biomedical research don’t fully absorb what they’ve signed up for. They overestimate the odds that an investigational treatment will benefit them, and they underestimate the potential risks.
How dark a shadow does this cast over medical science? Should the participants’ incomprehension be chalked up to ordinary weaknesses of memory and cognition? Or does it point to more serious problems with the ethics of typical informed-consent practices?
Two addenda to the Chronicle story:
1. You can watch Laura Siminoff describe her research on the informed-consent processes in the GTEx study on this NIH Webcast from May 20, beginning at around 1:45.
2. Here is a systematic review of interventions to improve research participants’ absorption of key information. (One of the best methods appears to be the old-fashioned, low-tech, one-on-one conversation.)