Informed consent: A broken contract

http://www.nature.com/news/informed-consent-a-broken-contract-1.10862?WT.ec_id=NEWS-20120626

Some customers were less than enthusiastic. Holly Dunsworth, for example, posted a comment two days later, asking: “When we agreed to the terms of service and then when some of us consented to participate in research, were we consenting to that research being used to patent genes? What's the language that covers that use of our data? I can't find it.”

The language is there, in both places. To be fair, the terms of service is a bear of a document — the kind one might quickly click past while installing software. But the consent form is compact and carefully worded, and approved by an independent review board to lay out clearly the risks and benefits of participating in research. “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,” the document reads.

It is not enough to strip out any information that would identify the donor, such as names and full health records, before the data are stored. In 2008, geneticists showed that they could easily identify individuals within pooled, anonymized data sets if they had a small amount of identified genetic information for reference (N. Homer et al. PLoS Genet 4, e1000167; 2008). And it may become possible to identify a person in a public database from other information collected during a study, such as data on ethnic background, location and medical factors unique to the study participants, or to predict a person's appearance from his or her DNA.

The opt-out model — which is used in only a few other places — troubles Misha Angrist, a genome policy analyst at Duke University, who says that it risks taking advantage of people when they are ill. “Even a routine visit to the clinic can be a vulnerable moment, and they're saying, 'Would you mind doing this for future generations, to help people just like you?'.”