Long Trail for Extra Tissue Samples

By Matt Fisher, General Counsel, Carium
Twitter: @matt_r_fisher
Twitter: @cariumcares
Host of Healthcare de Jure#HCdeJure

In healthcare, many layers always exist around seemingly each and every issue. The ongoing utilization of extra blood from newborn heel stick samples provides the latest example. The concerns raised go to privacy and informed consent as the primary issues. The heel stick provides a good way to dive into when good services results in unexpected consequences.

Newborn Heel Stick

What is the newborn heel stick? The heel stick is a test conducted on a newborn within 24 to 48 hours after birth. A blood sample is obtained from the newborn by pricking the heel and squeezing blood onto a sample sheet. The purpose of the heel stick is to enable screening for rare medical conditions that can be effectively treated if found early and treatment initiated quickly.

Once the heel stick is conducted and the blood sample taken, the sample is used for the testing. Further, testing is mandated in most states around the country, so it is not even optional. Requiring testing is not necessarily bad because it does help to catch serious conditions that can be treated.

Leftover Samples

However, the full amount of the sample is also often not used in the testing. Since the whole sample isn’t used, the sample is retained. Leftover blood samples are not an uncommon occurrence and constitute leftover bodily materials or tissue samples. When bodily materials are leftover, the leftovers are most often viewed as abandoned by the patient. Once a sample is considered abandoned, then the sample can be used for almost any purpose or even sold.

The law is slowly being changed in some places, but for the most part, once a sample has been taken, it can be retained and then used for additional purposes. The additional purposes do not need to relate to the test or other reasons that it was taken from the patient. All of the additional utilization will almost always occur without the knowledge of the individual whose sample is being used.

How are the retained samples being used? According to a recent report, uses include research, sale to third parties for various purposes, and law enforcement to help with investigations. Arguably, parents may not want blood samples taken from their newborn to be used for any of these purposes and very likely not retained for years on end.

What About Informed Consent?

Before most medical procedures, it is necessary to provide informed consent to the patient. Informed consent is intended to let patients know about the potential benefits and risks of a procedure as well as what will happen during the procedure. In the instance of taking a blood sample or a sample of any bodily material, the question would be should the patient be told about the potential for retaining samples and further use?

In the instance of retaining samples, the answer (at least currently and for the most part), there is not a clear or even mandated requirement to provide any notification about ongoing use. Not requiring informed consent an outgrowth of the now infamous example of Henrietta Lacks. An all too brief of the Henrietta Lacks issue is that Henrietta Lacks was a patient in the early 1950s who was part of an underserved patient population and needed treatment for cancer. As part of her treatment, samples of Ms. Lacks’ cells were obtained and added to a sample collection. The cells reacted differently than any other cells previously collected. Given the unique nature of the cells, the cells were retained and used for many different research purposes. In fact, the cells are still being used. As has received more attention over time, the cells were used without consent and questions have arisen over all of the financial implications that arose.

All of that too short background is to say that informed consent is not currently required when it comes to retaining heel stick samples and using them for additional purposes. Further, the use will happen absent a change in informed consent requirements or laws addressing retention of bodily materials samples obtained in various settings.

The Privacy Issues

Not knowing the full scope of how leftover samples are utilized raises privacy issues on top of the opaqueness around how long samples are retained and where they are going. What are the privacy issues? For a non-exhaustive list, it can include having information included in a law enforcement repository, potential for use in research, and likely potential for genetic sequencing (this seems more likely given the ready availability of such tools and the falling cost of doing it).

Provision of samples to law enforcement may be most concerning given recent developments and the unknowns around how law enforcement could take advantage of the information. If an individual’s bodily sample is a law enforcement database, how would it be used? It could be compared to samples taken from a crime scene, which could lead to unexpected connections when looking for suspects. Depending on the community that the individual comes from, there could be a real likelihood of profiling in the future. If an individual is included in a database of potential matches from the start of their life, the long-term ramifications would be untested. The unknowns are concerning.

On the research side, as the brief summary about Henrietta Lacks’ cells touched upon, there is an erosion of personal privacy as more people could know genetic secrets about the individual. There is also the possibility of combining the information with new information in the future which results in a connection back to the individual. That is not such a remote possibility anymore with all of the differing databases that can be connected to result in individual identification even from supposedly de-identified data. If all of that occurs without an individual even knowing that the sample exists, what does it say about the concept of privacy? That is a question to ponder, debate, and hopefully begin to consider means for addressing.

Change Could be Coming

Some states are beginning to change laws around retention of newborn samples and others may be considering changes. The changes would likely focus on how long such samples are retained as well as who may be able to access those retained samples. Change is happening slowly, but that pace can be accelerated when more information is provided about the practices along with spotlights shining on the issue. Discussion and awareness are where change starts. The benefit of the newborn heel stick is not being questioned, just what happens with the samples.

This article was originally published on The Pulse blog and is republished here with permission.