The Henrietta Lacks legacy grows.

On 7 August 2013, the US Nat­ ional Institutes of Health (NIH) announced that it had reached an agreement with the descendants of Henrietta Lacks concerning NIH­funded uses of the HeLa cell line [1], which, over the past 60 years has been featured in tens of thousands of experiments all over the world, and even in outer space. The origin of these cells, although never a secret, did not become well known until the 2010 publication of Rebecca Skloot’s book The Immortal Life of Henrietta Lacks. As was the practice of the time, Henrietta Lacks was not asked for permission to use samples of her tumour for research. For several decades, her family knew noth­ ing about the HeLa cell line or its genetic tie to Henrietta Lacks—and to themselves. Henrietta Lacks’s contribution was little rec­ ognized and her family received no benefits from the widespread use of the cell line. On 11 March 2013, a team of research­ ers from The European Molecular Biology Laboratory (EMBL), led by Lars Steinmetz, published an article about the genomic characteristics of the one strain of the HeLa cell line [2]. Following current practice, they posted the whole genome sequence on­ line, intending for it to serve as a resource to help other researchers; they did not intend or expect to set off an ethical controversy. But they did. Articles in the scientific press raised questions about publishing the genome sequence of the HeLa cell line [3], because although it had mutated enor­ mously over the past 60 years, the data did provide some genomic information about Henrietta Lacks and, probabilistically, about her living descendants. As a result, Rebecca Skloot, on behalf of the Lacks family, raised concerns about their privacy. In the meantime, although the EMBL team had followed existing laws and regu­ lations in its use of the HeLa samples, it responded to the controversy. The authors wrote to the Lacks family through Rebecca Skloot, apologizing for any distress the pub­ lication had caused, removed the sequence data from the internet, and offered to work with the family to find ways to make this potentially scientifically valuable informa­ tion available while protecting the fam­ ily’s interests and acknowledging Henrietta Lacks’s crucial role. At Steinmetz’s request, we conducted a bench­side ethics consult and provided some advice to the team as it strove to deal with this situation. The 7 August agreement between the NIH and the Lacks family resulted from dis­ cussions between Francis Collins and family members. It requires that any HeLa genomic information from NIH­associated studies be deposited in NIH’s ‘database of geno­ types and phenotypes’ (dbGaP). A HeLa Genome Data Access Working Group made up of three scientists, two members of the Lacks family and one bioethicist will review requests to use the data, making recommen­ dations to the Advisory Committee to the Director, and ultimately to the NIH Director. All publications that have used the data must include a specific acknowledgement of Henrietta Lacks and her family. This compromise is a reasonable resolu­ tion to an unusually extreme example of the increasing conflict between researchers’ need for broad availability of data (and sam­ ples) and legitimate privacy and autonomy interests of the people who are the sources of biological research materials and data. Unlike most research in recent decades, until this agreement, no one ever gave any permission for Henrietta Lacks’ tumour cells to be used for research. And the source of the HeLa cells is not only identifiable, but famous. However, the agreement is not com­ pletely enforceable. The Director of the NIH only has power over the NIH and the work it funds. We hope researchers not funded by NIH will abide by the agreement, both out of respect for the Lacks family and to help build trust among millions of other research subjects, but this cannot be guaranteed. A bigger issue is the many other human samples and data sets that are broadly acces­ sible to researchers and sometimes the public. Some come with no consent, some have some consent, but few have actual and honest informed consent to be used for any purpose by any researchers or for data to be publicly available online. And although most are stripped of individual identifiers, that is cold comfort in an era of common breaches of data confidentiality and the use of other data sets to re­identify ‘anonymized’ data and samples [4]. We cannot set up new administrative committees for every set of human data or biological samples. What we can do—and must do—is to make sure that, going for­ ward, donors have knowingly made clear how they can, and cannot, be used. In addi­ tion, we must acknowledge that genomic information is no longer truly anonymous. These changes will require new under­ standings between researchers and research participants. The HeLa agreement provides a way to resolve that dilemma in an excep­ tional case; we now need to manage that conflict in common cases. One last note. Steinmetz and the EMBL group apologized to the Lacks family and took down the genomic data whilst a reso­ lution could be explored. Jay Shendure and his group agreed to hold up publication of their similar paper [5] for the same end. The NIH seriously reached out to the fam­ ily to make an agreement happen. And the Lacks family agreed. We think these acts—of consideration, patience and understanding, acknowledging and respecting the important role of research donors and participants— show an understanding of the underly­ ing interests that researchers and research participants share. That all sides could find common ground in this most extraordinary case is perhaps the best result, and lesson, of the controversy.