The past decade has seen a dramatic rise in the number and diversity of biobanks in the US, from academic institutions to research institutes and hospitals. The rise of genomics and large-scale gene-environment studies have led biobanks to play an increasingly important role in biomedical research.
There are over a thousand biobanks currently operating in the US, and nearly 50 percent of these banks said, when surveyed, that the main biomolecule that they store is DNA. In total, these banks may house from tens of millions to over 50 million samples, by far the largest portion of these are being used for cancer research, which is followed by biospecimens stored for neurological diseases like Alzheimer’s as well as for research on HIV/AIDS.
Biobanks raise many privacy questions, from policies governing data sharing and security, privacy and the identifiability of genomic information, how and when to return research results and incidental findings, how governance structures function at genomic repositories, and informed consent issues caused by the multiple uses of samples by genome researchers.
Currently there are few specific guidelines and laws that govern biobanks and biorepositories. Human subject research regulations and material transfer agreements and commercialization rules fall under certain federal regulatory guidance, but none are specific to biobanks.
In some ways, the biobanking and biorepository boom has created a “Wild West” landscape that will require new and tailored regulations.
For more information please click on our new in-depth report report: Do You Know Where Your DNA Is? Genetic Privacy and Non-Forensic Biobanks which explores the various forms of biobanks in the US, their privacy limitations, the current state of regulation and the need for reform.