|March 25, 2013|
By Michelle Huckaby Lewis, MD, JD
The op-ed by Rebecca Skloot about genetic sequencing performed on a cell line of HeLa cells that long ago originated from Henrietta Lacks raises important issues about genomic and genetic research, the responsibilities of researchers, and the importance of maintaining public trust in the research enterprise. In this case, the cells of a known, deceased individual were sequenced without consent and temporarily made available to the public on line.
A more probable, and potentially more worrisome, scenario for most individuals might involve the release of an individual’s de-identified blood sample to researchers. Generally speaking, the use of de-identified samples for research does not require consent under current regulations. The concern is that since a blood sample contains the individual’s DNA, and the individual’s genetic sequence is unique to that individual, the de-identified sample could be re-identified and linked back to the individual who was the source of the sample and its related information.
It is important to note that although this scenario is possible, it is not likely since the researcher would have to have independent information about the individual’s genetic sequence information and the identity of the individual in order for the re-linking to occur. As has been shown recently in the scientific literature, this scenario is possible, but for most of us, at the present time, researchers would not have independent access to genetic information linked to our identities. However, in the future, access to this type of information might be more readily accessible.
Nevertheless, the possibility of this scenario highlights the need for the development of robust privacy protections that would serve to build, rather than undermine, public trust in genomic research. One proposal has included strict prohibitions against attempts by researchers to re-identify de-identified blood or tissue samples. To be effective, these prohibitions must be coupled with penalties for violation. Another important safeguard would be to delineate strict criteria with respect to what types of entities are allowed access to the sequence information and how the information may be used.
Genomic research presents novel ethical and legal challenges. There are many more questions that need to be addressed, but this example highlights the need for continued oversight of genomic and genetic research.
Michelle Huckaby Lewis, MD, JD, is a pediatrician and an attorney with training in bioethics and health services research. She joined the Berman Institute of Bioethics and the Genetics and Public Policy Center in 2010. Her overall goal is to use her interdisciplinary training to inform the debate about the development of policies related to genetics research. Her current research focuses primarily on the retention and use of residual newborn screening blood samples. In addition, she is involved in the development of a website to provide clinical information about specific cystic fibrosis mutations on a publicly available web site.