Another aspect of genes and ownership has arisen with the publication of the HeLa genome.
In case you're unfamiliar with the story, Henrietta Lacks was a woman who lived in the US and died of cervical cancer in 1951. Before her death, some of her cells were taken from her, and unlike almost every other set of human cells they kept multiplying, to the point where people are still using them today. They've been instrumental in a hugely wide range of biomedical research.
A few years ago Rebecca Skloot, a science journalist, tracked down the Lacks family, and told their and Henrietta's story in one of the most well-received and read books of 2010, The Immortal Life of Henrietta Lacks. Lacks' story has multiple layers: the cells were taken from her without her knowledge or consent; she was an African-American woman; she was poor. The US has a long and troubled history around medicine, consent, poverty, and race. There's far too much to summarize here, so I would just encourage you to read the book.
Fast forward to this past March, and we have yet another chapter of Henrietta Lacks and consent. A German team sequenced the HeLa genes and published their data. When the Lacks family learned of this, they felt that yet again their consent had been unsought in working with their family's cells.
Fast forward again to last week, when Francis Collins, the director of the NIH, met with the Lacks family and, after explaining the various ways in which publishing the genome would benefit medical research, obtained their consent for a limited publication of the genetic data. The data will be available, but only by application, to prevent it from being completely public.
It is, obviously, good that Collins was willing to meet with the Lacks family, and that the family was willing to meet with Collins. Ignoring the family's wishes would be unconscionable given the history of denied consent surrounding the HeLa cells. It's worth noting, though, that this is the beginning of a discussion about genes, ownership, and consent, and not the end.
The way the situation was handled has been presented as a precedent, but if so it's an extremely limited one. For one thing it's completely unclear what would have happened had the family not given consent at all, and insisted that the genome data remain private. Even if the NIH had agreed to that, they don't have the force of law, only funding. I don't know the law well enough to say if the family could have launched a lawsuit in the US to stop publication of the data, but they certainly wouldn't have the resources to launch similar challenges in every country with labs in possession of HeLa cells and the capacity to sequence them.
Hopefully tissue samples at stake in the future will be from consenting donors, but this brings up another issue. As Michael Eisen asked, if the donor consented, does their family still have the right to withhold their consent to the genome being published later on the basis that the data affects them as well? Rebecca Skloot seems to think so, judging by the New York Times editorial she wrote about the HeLa genome publication.
The issue of gene ownership isn't going to go away. The capacity to sequence someone's genome is steadily coming down in price, and the data processing power to analyse the sequence (and identify who it came from, even if it's "anonymous") is becoming ever more widely available.
If we're going to address this we need a framework with two qualities: the force of law, and international scope.
Force of law is needed because the cheaper it is to acquire genomic data the less effective large organizations like the NIH will be at setting policy. Someone biohacking in their garage is presumably a lot less concerned with being on a NIH blacklist than a large university lab. The only way to realistically enforce a gene policy in a world where individuals can acquire the means to sequence and process genomes is to give those who feel they've been wronged an avenue for legal redress.
International scope is needed because research ties stretch across borders, and information doesn't even notice them. What good is a guarantee from the Canadian government that an unconsenting individual's genome will be protected if groups in the US or Germany can publish it with impunity?
Beyond these requirements are a whole host of discussions around access and consent. The question "who owns your genes?" may not have one answer. Even if I do have ultimate control over any tissues in my body, what about the genetic information itself? Generally information about my body isn't protected. (Doctors are bound by confidentiality, but if a journalist somehow found out about my heart condition, for example, the law wouldn't stop them from publishing it). And speaking of tissue, every day I shed small amounts of skin and hair everywhere I go, not to mention the chunks I might leave on the floor of a barber shop. Does that abandonment of tissue imply that someone else can pick it up and sequence any DNA they find in it?
There's a lot to discuss, and unfortunately the discussion that has come about from the HeLa genome has so far been somehwhat muddled. We already saw that Skloot seemed to be confusing the issue about whether the consent of the Lacks family was needed because Henrietta's consent was never obtained (a situation specific to the HeLa cells) or whether it was needed because HeLa DNA contains information about her descendants as well (a situation that would apply to all genome sequences).
Collins' interview contained an answer that I found even more worrisome:
Why not ban all research on tissues from unconsenting donors?Collins seems to be saying that banning research on tissue from unconsenting donors wouldn't be worth it because it would slow research down. But this in and of itself isn't a good argument. If continuing to use tissue from unconsenting donors wasn't any faster than banning it, it wouldn't be an ethical dilemma: banning the research would be the best thing to do from all angles. Collins doesn't show any indication that he's grappling with the balance between collective good and individual harm.
The goal of medical research is public benefit, to try to make discoveries that are going to help people. And although the use of archived specimens is limiting in certain ways, [those tissues still offer] an incredible trove of material. If you shut off access to them, you would undoubtedly slow research right now, in terms of diseases such as cancer. The trade-off would not justify that extreme position.
And perhaps he doesn't have to. He is, after all, not the medical world's Ethics Czar; he's the head of the NIH. Someone needs to be talking about this, though; preferably a lot of someones. And if the public doesn't have the framework to do so now, then we in the science communication community have a mission ahead of us.