The United States’ Precision Medicine Initiative is among one of the many public and privately-owned programs that support biobanks in the US, which collect blood, cells, DNA and other biological samples from patients for research purposes. While biobank activity has intensified over the last several decades, a recent essay published in PLOS Biology suggests that the ethical and legal issues surrounding patient consent for sample and health information collection has yet to be standardized.
“Those most involved in the research—that is, those involved with the collection of samples and the establishment and administration of biobanks—appear to be operating under the belief that the issues associated with the law and public opinion are either settled or manageable within existing frameworks,” write Timothy Caulfield and Blake Murdoch, both health law researchers at the University of Alberta.
The researchers say that governments and industry have invested billions in the creation and maintenance of large biobanks housing samples collected from hundreds of thousands of donors. While their usefulness in research is undeniable, these biobanks could be at risk of losing it all if the consent process used at the time of collection was inadequate, prompting donors to take legal action.
Many factors prevent the use of traditional consent models for biobank donors, including the number of patients and researchers involved in the study, and the long duration of such efforts. However, the emergence of the idea of biorights and questions concerning patient privacy will likely only exacerbate the issue of patient consent.
Patient advocates for biorights believe that they should have a right to control how their research samples are used and receive some benefit as a result of their contribution, whether that be health-related or financial in nature. The case of Henrietta Lacks, a women whose cancer cells were used to generate the HeLa cell line that is still in use by research labs today, is a particularly poignant example of the importance of patient consent. Over 60 years after Lacks’ sample was collected, her family now seeks financial compensation from Johns Hopkins University, the medical center where she was treated for an aggressive form of cervical cancer.
Caulfield and Murdoch do admit that efforts are being made to standardize consent, however those changes do not always satisfy all stakeholders in the process. For example, European regulations maintain that “consent must be ‘specific and informed’”, however critics say that biobanks may be unable to fulfill this requirement because they do not know what the risks and benefits might be.
“The international research community has built a massive and diverse research infrastructure on a foundation that has the potential to collapse, in bits or altogether,” said Caulfield and Murdoch. “This issue would benefit from more explicit recognition of the vast disconnect between the current practices and the realities of the law, research ethics and public perceptions.”