Lack of consent for research on infants’ blood samples
A recent story out of Texas describes how, since 2002, the state has been keeping the blood samples from infants’ routine heel prick tests, without consent from parents. By law, the heel pricks are required by the state for all newborn infants to test for a number of birth defects. Prior to 2002, the blood was kept for a period of time, then destroyed. The “de-identified” samples are now kept indefinitely, without parental consent, for medical research of all kinds.
Here is the story, from the Austin American Statesman:
Texans unknowingly donate children’s blood to research
Since 1965, Texas law has required the screening of newborns for birth defects, and the state now checks for 27 different health conditions — ranging from a gene that can cause severe mental disability to sickle cell anemia. In 2002, the state health department’s Birth Defects Epidemiology and Surveillance Branch asked that the blood be stored for research rather than discarded; the department’s leadership agreed. It contracted with Texas A&M [University’s School of Rural Public Health] in 2006 to store the samples because the agency did not have room to keep them indefinitely, according to a Nov. 15, 2006, health department memo.
The agency says in the memo that it did not need to change state law to store the blood samples because “the agency’s position has been that health-related research that uses these bloodspots is consistent with this agency’s overall mission.” The same memo says the department considers the blood samples to be “state records,” which state law allows agencies to store indefinitely.
There are a couple of important issues that this story highlights:
1. According to the story, the state does not have to inform parents about how the blood samples might be used. Parents, “if they are aware of the tests”, can opt out for “religious reasons”. It’s not clear from the story whether parents might actually be unaware that the initial battery of tests are even done on their own children (as consent is not sought) or whether they might be unaware of the fact that the samples will be used for future research and kept indefinitely. Either way, “opt out” options are almost always problematic in most contexts, but especially in this case, as it seems parents might be unaware of the testing, the use and storage of the samples or their right to opt out in the first place.
2. There is a difference, which is poorly understood by many people, between two basic and fundamentally important concepts: de-identified data and anonymized data. With anonymized data, the link between the biological sample (the data) and the patient is broken. Therefore the sample can’t be traced back to a particular person. However, with de-identified samples, while they aren’t labeled with any kind of obviously identifying information — like a name or SIN number — the samples can certainly be traced back to their respective donors. The fact that, according to this story, these are “de-identified” samples then leads to two questions. Do researchers who have access to these samples then have an ethical obligation to go back and contact those who provided the sample if they find, say, important or even devastating health information or if they want further information? Wouldn’t contact like this be much more easily received by those who unwittingly provided the samples if instead, there had been an original consent to use their infants’ blood for research in the first place?
3. If we think a little more about the first two issues here, we come to the third, perhaps most obvious issue. These are de-identified samples, collected for routine, mandated tests that can be traced back to the infants from whom they were taken, being used in all sorts of health research (i.e. whatever the state deems to be important and viable, as the state considers the samples to be their “state records” and not either personal health information or biological material owned by the individual). Why not just simply and clearly inform parents that these tests are being done as per state health regulations and then provide them with an opportunity to consent to allow the state to keep the samples indefinitely for research purposes? By informing parents up front, it would actually facilitate the goals and aims of keeping traceable samples indefinitely for research purposes — people would be far more receptive to possible future contact from researchers if they actually knew about and had consented to provide the samples in the first place.