The bill was sprung on the Icelandic community “as lightning from the clear sky,” says Einar Arnason, a population geneticist and evolutionary biologist at the University of Iceland. Arnason is also vice chairman of Mannvernd, the Association of Icelanders for Ethics in Science and Medicine, which was formed to oppose the bill. While the act was passed by the Icelandic parliament in December 1998, Mannvernd is challenging its constitutionality and counting among its allies the Icelandic Medical Association and a substantial fraction of the nation’s physicians.DeCODE’s critics have attacked it on several ethical fronts, charging it with misleading the Icelandic public; playing on Icelandic patriotism and national self-interest, when the company is incorporated in Delaware and backed almost exclusively by U.S. investors; and, as Harvard University geneticist Richard Lewontin wrote in the New York Times, converting “the health and genetic status of the entire population into a tool for the profit of a single enterprise.”
The specific criticisms are threefold: first, that deCODE will have exclusive rights to the data in the health-records database, while other scientists, even Icelandic ones, will have to buy their way in; second, that the company may not be able to adequately protect the privacy of individuals whose records go into the database; and third, and most controversial, that the deCODE database works on the basis of “presumed consent” rather than “informed consent.” In other words, rather than asking individuals beforehand whether they would like to participate, deCODE has a right to the records of anyone who doesn’t “opt out” by filling out a form and sending it in to the proper authorities.
The deCODE imbroglio has almost single-handedly rendered the ethics issue a primary focus in the emerging field of population genomics. As medical ethicists like Stanford law professor Henry Greely point out, genetics research grew up with family studies, in which the families involved have an obvious incentive to participate. “They want to find something to help themselves, their kids, their grandkids,” he says. “They’re not worried about who makes money, and they end up with really close relationships with the geneticists.” Now that the research is moving into entire populations, says Greely, “Researchers don’t have any contact with anything but ones and zeroes or perhaps a little bit of extracted DNA.” Issues such as whether or not participants should be told about findings that relate directly to their own health, and even whether they should benefit financially, have to be worked out carefully in advance.
If nothing else, the ongoing deCODE controversy has the other players in population genomics trumpeting their ethics policies-and how they differ from deCODE’s. UmanGenomics, for instance, was founded in 1999 to market the genetic information from a 15-year-old bank of biological samples taken from the bulk of the population of the county of Vterbotten in northern Sweden. Sune Rosell, a former Karolinska Institute pharmacologist and now president of UmanGenomics, explains that three levels of informed consent are involved in the endeavor, from the individual level (an informed consent form is signed before anyone donates blood samples) to a societal level (all projects have to be approved by a regional ethics council) and a community level (representatives from the county are on the company board). In addition, says Rosell, while the company is privately owned, 51 percent of the shares are held by the county and the local University of Umea.
In Britain, the Wellcome Trust and the governmental Medical Research Council are planning to create the U.K. Population Biomedical Collection to link DNA samples, medical records and lifestyle details from 500,000 volunteers. The project has been approved for funding, but the only significant work so far, says project leader Tom Meade, who also directs the Medical Research Council’s epidemiology and medical-care unit, has been “a great deal of public consultation” on “all the issues of reassuring people about confidentiality and getting informed consent. And making sure people understand what this is all about.”