Biosample Tracking: A Consenting Dilemma

By Sonia Fischer, Customer Integrations Manager

Biosample collection is an inevitable part of most clinical trials. Whether it be for a current study or future applications, site teams will draw blood or fluids, collect genetic samples, and gather other materials. If there are leftover samples, oftentimes sponsors will request to keep them for any possible future use as well. However, without a clear plan for how the sample will be used in the future, the practice could create issues down the road.

Under today’s regulations, patients must specifically agree to how their specimens will be used in the current trial – and beyond. If they don’t, it could lead to serious privacy violations. This issue was made famous by the story of Henrietta Lacks, an African-American woman whose cancer cells and medical records led to the first human cell line in medical research – without her knowledge or consent.

Since then, regulators have introduced rules requiring donors to give clear consent for how sponsors and sites can use their specimens which requires a level of granularity and traceability in consent forms that can’t be accomplished with traditional paper-based processes. Learn how sponsors should be tracking every sample back to the source so as to not risk violating compliance issues.