Evolving Total Consent: Introducing Digitally-Enabled Biosample Consent Storage

Within biosample storage, a “nightmare scenario” often discussed by Medable and our clients involves the loss of consent documentation for stored biosamples. Several years ago, a sponsor overseeing tens of thousands of biosample specimens discovered they could no longer link their biobank samples to the documented consent for storage and further research. Consent for these samples had been collected on paper, but the sponsor failed to implement a system to collate and file the consent data for each specimen. When they could not locate the paper consents, they were forced to dispose of thousands of biospecimens, resulting in the loss of valuable research opportunities and potentially millions of dollars in intellectual property.

Despite the rise of digital solutions in healthcare, paper consent forms are still common in today’s clinical trials. Unfortunately, these paper forms pose significant challenges in retaining the documentation of informed consent for centrally stored biospecimens, such as tumor samples collected during clinical trials. This highlights the urgent need for robust digital solutions to ensure the secure and efficient management of consent documentation, safeguarding valuable research resources and enhancing the integrity of clinical studies.