Where's the Line?

Photo Credit: Fotos Gov/Ba

A study conducted in 2008 and 2009 showed that many scientists in the research community were fuzzy on the relationship between citizens’ rights and research to help the public. While some might say this uncertainty is acceptable given the fact that states have discrepancies between their newborn screening processes, we do not want to leave the health and constitutional rights of our children of people who aren’t really sure where to draw the line. The purpose of the study was to evaluate the views of newborn screening advisory committees on the current process and proposed reforms. The study identified problem areas with the current NBS process.

The study began by assembling a team of committees in charge of monitoring the newborn screening process in their states and advising their state legislators. The committees were taken from four states in the Mountain States region of the country (Arizona, Colorado, Montana, New Mexico, Nevada, Texas, Utah, and Wyoming), but the individual states were kept anonymous. The group met for one to two hours four times between November 2008 and June 2009. The groups were composed of lab coordinators, geneticists, pediatricians, community directors, and newborn screening staff. The groups were asked to give their opinions of the storage of dried blood spots (DBSs), the role of parents in the screening process, and the role of advisory committees in the process of newborn screening. Their responses were recorded and analyzed.

The study brought up several concerns that committees had with the process of newborn screening. It was decided that parents need to be more informed about the screening. The current process of educating parents usually consists of a stack of pamphlets that never get read. One participant was quoted saying, “People don't even know that newborn screening happens, and I know after having children, when you get stacks [of pamphlets] this high before you walk out the door, nobody reads it, so there's got to be a different mechanism.” The results indicated that parent education is one of the areas that needs to be reformed in the newborn screening process. Many participants were concerned about where it would leave them if parents were to receive more participation in the screening process. Several participants expressed concern with giving parents the option to deny researchers the right to their child’s DNA. They argued that if parents were more informed about the secondary research done afterwards, they may not want their child to even be screened at all. This would leave many children untested for many dangerous and preventable diseases.

Some, but not all, participants expressed concerns with the secondary use of the samples. One participant said, “I think it depends in part on the type of research that you're doing," and "I can see using the samples for sort of public health, seeing as they're part of the public health system already.” This brings up the issue of the intentions of research, which can become murky very quickly. If the research is for the greater good, is the current process of newborn screening a means to an end that should be overlooked because of its contribution to the future of science? Another participant argues that only the necessary tests should be performed on the samples without consent, regardless of the intent or goals of the research. This participant said, “And there's also the [question], ‘Why do you have me run screening; is it to do research, or was it because you wanted to screen for whatever disorder a child might have and help that child in that family?’” This participant has reservations about conducting any secondary research, taking into account the families of newborns being tested.

Another major issue that came out of this research was the ownership of the samples. Participants were unclear about whether the state, the health department, or patients had rights to the samples. Several participants felt that the samples belonged to the state because they were the ones regulating the screening. Others felt that the health department owned the samples, partly because they could properly organize and regulate the samples. Still other participants felt that the samples belonged to the families of the participants, citing the precedent that medical records can only be released to family.

Obviously, even those involved directly in the field and in charge of making life-changing decisions for newborns are confused about where the line is concerning newborn screening. Some areas, such as the education of parents, can be cleared up easier than others, such as the ownership of the samples, which might require legislation.


Works Cited

Title: Concerns of Newborn Blood Screening Advisory Committee Members Regarding Storage and Use of Residual Newborn Screening Blood Spots

Erin W. Rothwell, PhD, Rebecca A. Anderson, RN, BS, Matthew J. Burbank, PhD, Aaron J. Goldenberg, PhD, MPH, Michelle Huckaby Lewis, MD, JD, Louisa A. Stark, PhD, Bob Wong, PhD, and Jeffrey R. Botkin, MD, MPH