Wired Science

Why the US Needs Biobanking Policies

There is little argument over the potential benefit of biobanks—most scientists agree that repositories of human blood and tissues could vastly improve how well we understand, treat, and even cure debilitating diseases. But ask scientists how we should handle the ethical and legal issues surrounding their use, and you'll get a plethora of different answers.

Biobanking is wrought with debate, and it's not hard to see why. There's little question that the blood coursing through your veins today is yours, but what happens when you donate it to science? Is it still yours, and if so, do scientists need to tell you exactly what they plan to do with it, even 15 years from now? Do you have the right to remove your sample when you want to? And what, if anything, is the biobank's responsibility to you in the future?

These questions have been addressed in some countries. For instance, Estonia, Iceland, Norway, Sweden and the UK have passed laws governing how the countries' biobanks can collect, store and use human samples. And while the US Health Insurance Portability and Accountability Act and its associated Privacy Rule do regulate some aspects of confidentiality, here in the US there is no dedicated biobank legislation—despite the fact that there are more than 300 million samples already stored in various US repositories.

One issue concerns how biobanks should handle getting consent from donors to use their samples. Should they operate using what is called "blanket consent," meaning that the biobanks have the right to use samples forever as they wish, or should they have to go back to the donor every time they want to perform new tests? "There's no agreement on that," says Arthur Caplan, a bioethicist at the University of Pennsylvania Center for Bioethics.

There's also little consensus regarding the ownership of biobank tissues. If something comes out of biobank research that is patentable, for instance, who owns the rights to it—the researcher who discovers it, the one who collected the samples, the institution affiliated with the biobank, the donor, or the government? Although there are no laws here in the US, the first precedent has recently been set: Tthe US Supreme Court ruled in August that biological samples collected by former Washington University physician William Catalona belong not to him but to the university (he was hoping to bring the samples with him to Northwestern University to build a repository there).

What about a biobank's responsibility to its donors if it discovers something that could benefit them? No one really knows, but since most biobanks are built for research purposes rather than for public health, they may not have a duty to inform donors of such findings. "There are no counselors and 800 numbers—that's kind of not their thing," Caplan says.

Finally, there are privacy issues. Biobanks need to protect medical data so that donors are not discriminated against on the basis of their health or predispositions to disease. If a biobank identifies that you have a risk of developing breast cancer, "that would not be a good thing for your employability or insurance," Caplan points out. But at the same time, anonymous biobanks are not as valuable as those in which information about each donor can be traced. Caplan suggests introducing rules that anonymize data when it is collected but link it in a trusted third-party database to whomever it came from. Then in certain agreed-upon circumstances, the researchers could reconnect the identifiers with the codes, he says.

Some institutions are working to develop their own standards. For instance, the National Cancer Institute (NCI) has developed a biorepository network model for cancer research. After releasing a first draft in 2005 and opening the floor to public comment, the institute published in June its final recommendations outlining how NCI-supported biorepositories should operate with regard to informed consent and privacy protection. In addition, the International Society for Biological and Environmental Repositories has published a list of recommendations regarding the collection, storage and retrieval of human biological materials in the US.

The hope is that scientists and policymakers will eventually harmonize the current mishmash of international regulations and pass laws standardizing the operation of biobanks here in the US., Caplan says. "There is plenty of opportunity for trouble now—there is almost a moral imperative to get more consistency," he adds. But luckily, he notes, "some good efforts are under way."