Despite being the most specific individual identifier we currently know of, federal regulators still don’t consider DNA to be individually identifiable material. To be fair, the federal Office for Human Research Protections has said it will reconsider the notion of “identifiability” every 4 years, with whole genome sequencing likely to be one of the first technologies it reviews (FR Vol. 82, No. 12; page 7169, aka the Preamble to the Revised Common Rule).
In the interim, however, IRBs and others will continue to struggle with the idea of what’s identifiable, what’s not, what’s an appropriate future use of genetic material, and how much should subjects be told now about what might be done in the future with genetic material they donate today, since we can’t predict what technologies might be available in the future.
Take, for example, commercial DNA testing company’s 23andMe’s recent licensing of a drug it developed using its customers’ DNA, recently reported in NewScientist. This deal, involving a drug for a potential treatment for inflammatory diseases, is with a Spanish company. The report indicates about 80 percent of 23andMe’s customers agree to allow their data to be used for research, and the company’s terms of service specify customers will not be compensated for any research or commercial products stemming from their samples. But, as one commenter notes, do they know just how much money the company may make from the products? These are the kinds of questions IRB reviewers must consider as well.
Click on the link above to read the full story.