Originally posted March 26, 2013

By Debra Mathews, PhD, MA

Rebecca Skloot’s recent OpEd in the New York Times, regarding the completion and (brief) posting of the whole genome sequence from the HeLa cell line, derived from Henrietta Lacks in 1951, highlights ethics and policy issues both specific and generalizable. As Skloot has pointed out elsewhere, the concern about whether the researchers who carried out the sequencing of HeLa had sought and received consent from the Lacks family is very specific to this cell line and this family and their history with the medical and research communities. At the same time, the general question of consent for whole genome sequencing of human tissue samples is an ongoing and critical debate. What is less in debate now is whether researchers can promise research participants anonymity: we can’t.

As my Berman Institute colleague, Michelle Huckaby Lewis, alluded to, the research community has been presented with evidence over the past five years, that various kinds of identification of “de-identified” data is possible; most recently, researchers in Boston were able to go from de-identified whole genome sequence data to names and whole families, using publicly available online resources. While this particular case involves a very well characterized set of samples (from individuals who were thoroughly consented), and therefore we may argue that it is not generalizable, the fact is that going forward, it is very unlikely that there will be less information available about each of us on the internet.

Clearly, as Michelle has pointed out, we need to think carefully about how best to protect individuals’ privacy. We also need to move forward on the issue of whether research on “de-identified” samples and data is human subjects research.

It is clear that genetic research, and in particular large scale sequencing to study complex diseases like diabetes and heart disease, will require that many, many people are willing to provide samples to be sequenced and to have those sequences shared with other researchers. Convincing many people to share these samples and data will require that they trust the researchers and the research community.

Situations like the one that the Lacks family has been living do not help the cause of trust. Appropriate informed consent and strong privacy protections certainly move us in the right direction.

We should also consider a further step: engaging individuals in the research process, so that they become true participants, rather than subjects. Research models wherein individuals can modify their consent over time, receive information about ongoing and proposed research with their samples and data, and receive individual research results keeps the individual at the center of the research enterprise and gives them meaningful control over what happens to their samples and data (whether they choose to exercise that control is up to them).

These models also offer the opportunity to enhance the usefulness of tissue and data repositories with updated medical information about the individuals from whom they were derived, and they foster trust. It’s a win-win.

Debra JH Mathews, PhD, MA, is the Assistant Director for Science Programs for the Berman Institute of Bioethics at Johns Hopkins University. Her research interests focus on the intersection of science, public policy and society. Dr Mathews’ most recent publication, ‘Access to Stem Cells and Data: Persons, Property Rights and Scientific Progress’, published in Science can be accessed here (free abstract) and here (open access full text).

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