In 2009, TIME Magazine named the National Cancer Institute’s effort to develop a national biobank housing tissue samples, tumor samples, DNA and blood one of the “Top 10 Ideas Changing the World Right Now.” A 2010 report from the Tufts Center for the Study of Drug Development summarizing a survey of drug companies noted that half of all clinical trials now collect DNA from participants to help find biomarkers that correlate with a drug’s effectiveness or safety. As noted in the TIME article, however, the challenge in developing biobanks is to maintain the privacy of the genetic data and to ensure that people are comfortable with sharing their DNA.
Currently, no comprehensive regulatory scheme exists for the collection and use of biospecimens and the laws that do apply, which vary among states and federal agencies, are confusing and sometimes conflicting. For example, regulations governing federally-funded research permit identifiable biospecimens to be used, in certain circumstances, for future unspecified research with the general consent of the individual. In contrast, the HIPAA Privacy Rule requires that authorizations for use of identifiable biospecimens be study-specific, though interpretation and application of this requirement have varied widely. Further, some states, such as Alaska and Texas, have enacted or have considered laws that give individuals exclusive rights to their own DNA samples, and it is unclear how these laws affect consent for research use of biospecimens.