Over on Privacy Lives, Melissa Ngo blogs about an issue I’ve discussed a number of times on this blog: the collection, storage, and use/misuse of newborns’ blood samples. Melissa points us to a discussion on Minnesota Public Radio:
… On Tuesday, parents, doctors and researchers urged state lawmakers to reject proposed restrictions on Minnesota’s Newborn Screening program — changes that could keep other parents from such lifesaving results.
Amendments in two Senate bills would require the Minnesota Department of Health to promptly destroy the blood samples that are collected from newborns to identify rare medical disorders that aren’t obvious at birth.
“Our genetic information is ours … until there is consent for the use of our genetic information, no research should happen.”
Currently, the agency stores the blood samples indefinitely so they can be used for quality control tests or disease research. The new rules would allow parents to give their written permission to store the material up to a maximum of two years.
Read more on MPR. It’s probably one of the more balanced discussions of the issue that I’ve seen in a while.
Some of the issue comes down to transparency and consent. Why is so that very hard for governments and researchers to embrace? That if you explain what you want to do, explain how it will benefit the individual or others, and then ask for consent, many will consent? It’s always seemed to me that government simply doesn’t trust its own citizenry and takes a “we know best” attitude that justifies them riding roughshod over crucial consent and ethical issues.
The issue is that it’s axiomatic in public health research that when consent is required, some percentage of individuals will opt out and then you no longer have a complete sample set, so there is the risk of statistical bias in the results. In other words, the results will not truly reflect the underlying pattern being studied. This is a serious problem since it affects the reliability of the research.
As someone who taught research design and data analysis for a decade, I’m aware of the issue/concerns. The concern, however, does not justify ignoring a patient’s right to control who has access to their information – particularly when there have been outrageous failures in protecting both the privacy and security of such data.
I think we also need to examine the subset of those who would not opt-in to see if they’re randomly distributed or if there really would be some selection bias or factor that could confound interpretation of available data. If their main reason for not opting in is data security or privacy, is it because they have some unusual or stigmatizing condition that they are worried about or is it more randomly distributed across all conditions, etc. If the latter, then the argument against respecting patient privacy rights falls by the wayside.
then presumably you are familiar with the Common Rule.
Yes. And that it applies to federal agencies. This is a state-level issue, is it not?