Since the human genome can be sequenced faster and deeper than before — and for a lot less money — whole-genome sequencing is poised to explode both in the clinic and outside, but there are few ethical recommendations that guide this field. To fill that void, a group of bioethicists and genomic scientists convened to draw up ethical recommendations for some key issues in genomic research.
"You have high-profile people like Craig Venter, obviously, doing it and Jim Watson, but increasingly it seems like this is going to be a more frequently used research methodology," says Timothy Caulfield, the director of the University of Alberta's Health Law Institute and the lead author on the consensus statement that was published in PLoS Biology. "At a minimum, I hope that we can stimulate discussion about what needs to be done. At best, I hope that we are giving actually guidance on how to resolve issues and what's needed to do this work ethically," he says. "This is controversial research. You want to make sure you get this right."
The main theme is to get consent and be candid with study participants. Since any genomic or related clinical information gathered may be studied again later, Caulfield and his colleagues recommend that the consent process includes a discussion of potential future uses of the data, in as much detail as possible. Though participants have the right to withdraw their consent at any time, the feasibility and practicality of this right may be limited if the data is released, either among researchers or to the public. In that case, Caulfield and his colleagues encourage researchers to disclose the data release policy and how it affects the ability to withdraw from the project to the study participants during the consent process.
"The ethos emerging now is open access," says Caulfield, who adds that once data is publicly available, researchers lose control over it. "We came up with this idea that is in the middle, that whatever kind of access policy or release policy is proposed, it has to be justifiable scientifically, ethically."
As in other documents that provide ethical guidelines, absolutes — as in what defines 'scientifically justifiable' — might be hard to pin down. "There are these vague terms balancing interests. It's really hard, other than on a case-by-case basis," says Caulfield. That's where the ethics committees and IRBs come in with their informed judgment, he says.