MRM Insights: Privacy and Confidentiality in Human Stem Cell Research – Finding the Right Balance
Mr. Michael Beauvais
Every month, in MRM Insights, a member of the MRM Network is writing about stem cells and regenerative medicine from a different perspective. This month, Michael Beauvais, Research Assistant at the Centre of Genomics and Policy and member of the MRM Ethics Committee, discusses privacy and confidentiality in human stem cell research.
Privacy and Confidentiality in Human Stem Cell Research: Finding the Right Balance
As a society that is increasingly relying on a data-driven economy (in which data-intensive research plays a central part), risks to individual privacy are on the rise. Yet, the only way to completely eliminate privacy concerns is to abstain from collecting and/or using any personal information.
Doing this, however, endangers the ability to carry out socially useful activities, such as public health management during a pandemic. A draconian approach to the minimization of personal information also greatly reduces insights that can be drawn from research. Rather than being at either end of an extreme of using a maximal or minimal amount of personal data, the overarching issue can be thought of as a question of striking a proportionate balance between benefits and risks.
As a scarce resource, there is a general ethical imperative, or obligation, to maximize the use of stem cell lines. A central way in which this ethical obligation can be met is through the wide sharing of cell lines. Broad sharing is also key to ensuring the scientific validity of research by permitting reproducibility. Against this background, however, there are other ethical issues. One central one is respect for persons and non-maleficence. That is, researchers must minimize risks to cell line donors. One such risk is of informational (or privacy) harms. In this MRM Insight, I am going to discuss some considerations related to donor privacy when it comes to cell lines.
Privacy and identifiability: key concepts
Privacy, broadly understood, concerns the contextual rules that govern the flow of personal information. Depending on the type of information at issue, the relational context in which it was generated, the expectations of the individual(s) to whom the data relates, etc., the rules will differ. Not all information implicates privacy, either. Only “personal” information does. For information to be “personal”, it must identify an individual. This exists on a continuum from direct identifiers (e.g., your name) to indirect identifiers (e.g., genomic sequence traces).
For stem cell research, the type of cells is also relevant for determining the information that could be linked back to an individual donor. In the case of induced pluripotent stem cells (iPSC), they can retain a significant amount of the genetic data of the donor. For donors who have rare diseases, their genetic sequence alone may be a powerful identifier, even if it is indirect one. All that is necessary to make information “personal” is something that distinguishes an individual from the rest of the population. On the other hand, for human embryonic stem cells (hESC), there is no unique, donor-specific genetic data because the cell lines were derived from an embryo only, such that the genetic information is from the two gamete contributors. In such a case, though, probabilistic insights could still be drawn about the gamete contributors from this data.
Protecting donor privacy
Where working with iPSCs or hESCs, protecting the personal information of donors of stem cell lines is a concern that spans the duration of the cell lines’ derivation and use. The International Society for Stem Cell Research (ISSCR) in its 2016 guidelines, for example, specify that researchers who are deriving the cell line should have a privacy management plan in place. This may include the coding of certain personal information (i.e., replacing direct identifiers with a code) and keeping the key with a trusted third party. These measures should be communicated to donors as part of the consent process. Given the richness of other data sets with which donor information may be linked and the sophistication of re-identification techniques, it should also be mentioned in consent documents that there is no way to guarantee that privacy can be absolutely protected. Similarly, the Tri-Council Policy Statement (TCPS2) mandates that human pluripotent stem cell lines be anonymized (i.e., have all identifying information irreversibly removed) or coded in most circumstances. Moreover, researchers who make cell lines available to other researchers must ensure that the lines are either anonymized or coded. This process strikes a balance between the ethical duty to share and to respect participants.
Conclusion
Privacy issues are apt to tire even the most patient of researchers and ethicists. Questions of identifiability can be fiercely (and frustratingly) complex, due to the contextual nature of the query. It is ultimately a question to made with a given donor, a specific research project, the type of cell line, and the foreseen ways in which cell lines may be shared. The existence of personal information in a research project should not per se prevent it from happening. Rather, it is always a question of proportionately minimizing the risks the research poses to donors and participants.