This post was inspired by some questions from @doulahattie. She’s reading The Immortal Life of Henrietta Lacks by Rebecca Skloot and had this question (paraphrasing):

I read that when you leave human tissue in a hospital or doctor’s office it doesn’t belong to you anymore…and anyone can sell it–is this true? Is this also case with blood left over from newborn screening? Can parents opt out of the research?

A very interesting and complicated question! Here are my thoughts…

Caveat: All the information in this post comes from the internet and what I learned in law school–I know just enough to be dangerous–not enough to claim any expertise.

My Property Law casebook had a memorable section titled “Body Parts.” I thought “It’s illegal to sell your kidney for profit” was going to be the extent of it, but science is amazing and now there have been lawsuits grappling with who has rights and responsibilities in relation to sperm, embryos, blood, cells and DNA.

The basic rule is this — most body products, once they leave your body, aren’t yours anymore and you don’t have control over what happens to them. The states and federal government have some laws in place that control what can be done with body parts and tissues–safe handling, privacy, etc. And the law of informed consent applies, but in a lot of ways we’re in a new frontier and we haven’t figured out what all the rules should be yet.

So what does this have to do with Newborn Screening?

Newborn screening is a public health service–it’s a blood test that new babies get in the hospital to identify a range of serious genetic disorders and diseases that can show up in babies who look perfectly healthy on the outside. Virtually every baby in the US gets the heel prick test, leading to the prevention of thousands of illnesses and premature deaths.

You can learn more about your state’s newborn screening program at: www.BabysFirstTest.org 

Here is the part that freaks some people out - some states don’t throw the leftover blood samples out – they store them and make the samples available for [approved] research.

Newborn Screening is about protecting the well-being of the individual baby first and foremost–but it didn’t take long for doctors and researchers involved in newborn screening to recognize that there is significant scientific value to those little drops of blood -

• They provide a nearly complete representation of the population.
• They can be integrated with existing public health data.
• Because they consist of whole blood samples, they also contain a very wide range of biomarkers, including DNA, RNA, proteins, metabolites, and evidence of exposures to environmental or infectious agents.

Many states make residual blood spots available for research, with varying requirements. Here are a few examples of how leftover newborn screening blood spots have been used:

• to identify PCB hazards for children born near Love Canal in New York
• to determine mercury levels in newborns in Minnesota
• to develop additional laboratory screening methods for sickle cell diseases
• to search for new disease markers for childhood leukemia

No question, the responsible use of newborn blood spots in research is good for science, the public, and especially sick kids and their families.

“If they only asked, I would have said yes”

Image via Wikipedia

So newborn screening and research are generally great, BUT some states have gotten their newborn screening programs into a mess by using newborn screening samples for research without:

1.  informing parents
2. having clear guidelines and explanations about how the babies’ privacy will be protected, and
3. giving parents the informed choice to opt out. 

When parents find out after the fact that their child’s blood may be being used in research, they often feel violated. The cautionary tales are Texas and Minnesota, where millions of newborn blood spots are being destroyed essentially because medical professionals did not obtain informed consent from parents.

In those millions of blood spots that have been destroyed there was much to learn about the health of our communities and our babies. I wish the courts had required researchers and hospitals to go back and and ask for informed consent from all of those parents. Alas.

We need respect and dialogue

Researchers must have enough respect for members of the public to have a conversation with them about what is happening. Consent conveys respect by asking questions and inviting participation. It permits the expression of diverse beliefs, values, and preferences.

–From Challenges and Opportunities in Using Residual Newborn Screening Samples for Translational Research: Workshop Summary (this is a fascinating read–for free!)

That pretty much sums it up. There should be a big, transparent and ongoing conversation about what sort of research is worthy of our newborn’s blood spots and any privacy concerns. Ideally parents should be able to choose what sort of research they consent to, and if the blood spots are kept for more than 18 years, the newborn should one day have a say too!

What parents should know right now.

www.BabysFirstTest.org can tell you the rough outlines of what your state does with blood spots and where to get more information. Currently, in every state that holds blood spots for research parents DO have the right to opt out of research–it just isn’t publicized. Don’t opt out of the newborn screening itself, but if you’re uncomfortable with research as your state handles it, you can request that the blood spots be destroyed or returned to you after they’ve been tested for your child.

Are you comfortable with research performed on newborn screening blood spots? Why or Why not? When do you think research on blood spots is ok?

Worth Reading

• Taking the Least of You by Rebecca Skloot
• Genetics and Paranoia: Will Newborns be Saved? by Mary Ellen Mannix at James’s Project
• Challenges and Opportunities in Using Residual Newborn Screening Samples for Translational Research: Workshop Summary