Within biosample storage, a “nightmare scenario” exists that Medable and our clients discuss regularly.

Some years ago, a sponsor with tens of thousands of biosample specimens identified that they had lost the ability to link their biobank samples' documented consent for storage (and further research). The consent for these samples was taken on paper, but a system to collate and file the consent data attributed to each specimen was not implemented. When the organization couldn’t find the paper consent, they were forced to dispose of thousands of biospecimens, losing the ability to conduct valuable research and potentially millions of dollars of lost IP.

Despite the rise of digital solutions in healthcare, paper consent forms remain prevalent in today’s clinical trials. Unfortunately, paper forms present unique challenges when retaining the documentation of informed consent for centrally stored biospecimens, such as tumor samples collected during clinical trials.  

These challenges stem from limitations inherent to physical documents, such as:

  • Limited searchability: Paper forms make it difficult to track down specific details about a participant's consent for biospecimen use, often embedded in the form as an optional consent question. If researchers need to know if a participant consented to a specific biospecimen analysis, finding that information within a paper form can be time-consuming and cumbersome.
  • Risk of loss or damage: Paper forms are susceptible to physical loss, damage, or misplacement. This can lead to uncertainty about a participant's consent, especially over long periods.
  • Version control challenges: If a participant's consent preferences regarding biospecimens change over time, keeping track of these updates within paper forms can be messy and prone to errors. This can make it difficult to determine the most recent and valid consent.
  • Physical storage issues: Paper forms can also add up in expected ways, sometimes literally. some text
    • Take, for instance, a recent trial conducted by a leading Brazilian university. Here, the site would recruit 300,000 participants using a 22-page consent form. The study then applied the average number of protocol changes sites experience throughout a clinical trial. By the end, the study determined that just this site would manage 42 tons of paper. 
    • Additionally, paper forms present issues around exporting consent objects. Consent objects are electronic records linking a patient's unique identifier (ID) to their consent for sample storage, allowing for proper tracking and auditing. These consent objects do not contain any personally identifiable information (PII) about the patient, resolving potential privacy concerns. However, they still maintain crucial links back to the specific study, site, and patient, enabling efficient data management while protecting patient confidentiality. It is important to note that the consent objects, while devoid of PII, cannot be exported if the source of consent is a paper-based form stored on-site.
An example setup of a biobank database for informed consent/eConsent

At Medable, we have built in the ability for our eConsent solution, Total Consent, to easily capture consent for the storage of biosample specimens. As a robust and complete consent management solution, Total Consent solves the problems inherent in biospecimen consent storage by directly linking a consent eSignature to a sample and making this consent object easily extractable for long-term storage. This allows organizations to collect and collate biosample consents across multiple studies, enabling them to create their digital biobank. 

Sponsors gain several advantages with Total Consent over traditional paper consent forms, including:

  • Accuracy and completeness: Total Consent can be set up to ensure that all required fields are completed and that the consent information is accurate and complete before allowing the participant to sign. This reduces the risk of missing or incomplete data, which often occurs with paper forms.
  • Direct linkage: Total Consent allows for direct and permanent linkage between the participant's signature and the biospecimen sample in the database. This creates an auditable trail and eliminates the risk of mismatched or lost paperwork.
  • Version control: Total Consent systems have built-in version control capabilities, allowing for easily updating consent forms when necessary. This ensures that participants always consent to the latest approved version of the form.
  • Updated Consent:  Total Consent enables greater control for participants, who can modify or update their consent preferences over time.
  • Accessibility: Total Consent can be accessed and completed remotely, increasing convenience for participants and reducing the need for in-person visits.
  • Data integration: Total Consent data can be easily integrated with electronic health records (EHRs) and other research databases, streamlining data management and clinical research processes.
  • Site and study team efficiency: Electronic processes can be more efficient than manual paper-based methods, reducing administrative burdens and costs associated with printing, distributing, and storing physical forms. This is especially important in labor-intensive scenarios such as re-consenting or consenting to changes in protocol.

Sleep soundly with eConsent

As clinical trials continue their focus on rarer diseases and disease subtypes, biospecimen storage and their consent will remain critical to clinical research. Organizations should strongly consider eConsent technology, like Total Consent, to avoid a potential nightmare scenario and unlock the full potential of biospecimen research while maintaining the highest standards of regulatory compliance and ethical conduct.