Hayden's piece hits close to home because in her second paragraph she quotes MT's own Holly Dunsworth who left a comment on the 23andMe blog post announcing the patent application. Holly said that she didn't believe she'd agreed to the possibility that one of her genes could be patented when she signed her consent for their genetic services. (She's aghast that genes can be patented, and is against it -- that makes it unanimous here at MT.) But Hayden points out that "the language is there" in the consent forms. Well, that may be so if you're a lawyer and it occurs to you that "If 23andMe develops intellectual property and/or commercializes products or services, directly or indirectly, based on the results of this study, you will not receive any compensation" means that if they find something they want to patent in your genome, they will and it's theirs.
The non-legal crowd isn't as likely to have read it that way, and didn't realize they were signing on to the possibility that the company might patent one of their genes, without sharing any of the profit, and without explicitly broaching this sensitive ethical issue with participants. It's more than a bit disingenuous of 23andMe to claim to be open and free with knowledge on the one hand, engaging customers because of this open access policy and on the other hand committed to constraining that freedom when there's profit to be made -- by them!
But beyond what this means about 23andMe, this does point out one of the problematic issues having to do with informed consent, and that is that when what can be done with the materials a subject or donor consented to give a researcher or company access to can change as technologies change or as findings accumulate, "informed consent" is in fact not that. 23andMe's consent asks their customers to agree essentially to blanket use of their genetic data. It's an open-ended consent, as many researchers and institutions prefer these days, seeking permission to do anything with the sample in perpetuity. Some consent agreements, though, impose specific time or usage limits instead. Given how quickly technology changes however, these limiting agreements may well be used less and less as genetic research goes forward. You can be pretty sure that once researchers get their hands on your samples they aren't going to want to give them up.
Another approach is George Church's no-consent-at-all model for the Personal Genome Project. When people sign on to the project he requests that participants allow all their biomedical data to be freely accessible online, along with their whole genome sequence. The idea is that because researchers can't predict what they'll find, or what new technologies will come along, science will best progress if participants allow anything at all be done with their data and their biomedical information now and in the future.
Of course this kind of consent can't be properly 'informed' in any serious sense, relative to being what is fair to call a blank check for the researchers. They know this, of course, and any benefits that do happen to become possible will likely go to them. Researchers don't get to set all the limits, though. Any consent for a study using federal funding must allow research participants to be free to remove their samples and data from a study. And, Hayden says that several US states, including California where 23andMe is based, are considering laws to constrain what can be done with a person's DNA.
However, genetic data are different from, say, demographic data because even anonymized, no names attached, it's possible to identify individuals if reference genetic data are available, and identifying ethnicity is often trivial. Not to mention that no genome is an island, so if you are genotyped, that tells you a lot about your parents as well as your siblings. So, if you consent to genotyping or whole genome sequencing but your parents don't, that can be a problem. And of course once a sequence is published or summarized in statistical data, it is no longer removable.
Who is informed consent for, though? Who is it designed to protect? It stems from Nuremberg Trial protections that were the result of the Nazi experiments in World War II. They were indeed for protecting human subjects. Human subjects protections have evolved over the years however, and now while still nominally for protection of, well, human subjects, there's a whole lot of CYA going on, as universities and companies try to avoid the kinds of legal difficulties that researchers such as those working with the Havasupai in Arizona got into not long ago (a case we blogged about here).
Indeed, Hayden quotes Mishra Angrist, genome policy analyst at Duke University, and participant in the Personal Genome Project saying, “Institutions use informed consent to mitigate their own liability and to tell research participants about all the things they cannot have, and all the ways they can't be involved. It borders on farcical.”
The interests of researchers and subjects don't always coincide, of course. It is only human to expect those with their hands on the data to be tempted, and at least occasionally to yield to the temptation, to seek private gain from the samples, beyond their salaries and job status. Also, researchers generally and naturally want to be allowed to do whatever they want with their hard-earned samples, while subjects often want constraints -- if they even understand the study.
Many researchers say that the obvious solution is a broad consent document that gives researchers free rein with the data. But many non-scientists think participants should be able to control how their data are used, says lawyer Tim Caulfield of the University of Alberta in Calgary, Canada, who has surveyed patients about this idea. “There's an emerging consensus within the research community about the need to adopt things like broad consent, but that hasn't translated out to the legal community or to the public,” he says.And then there's 23andMe, which gives their customers access to all their own data. Until they don't.