As an academic or industry scientist, no matter how large or small your research group is, the legal implications of your everyday work may be one of the furthest things from your mind. In the short term, you’ve got experiments to plan, funding to apply for, budgets to manage, and data to analyse.
But, while you’re focused on your “to-do” list for the week, there are long-term legal repercussions for everything you do. For instance, the experimental results and analyses you perform and record today can have far-reaching implications for intellectual property (IP) protection and future patent disputes over the timing of discovery. With the most recent events of former Harvard President Claudine Gay’s resignation around allegations of plagiarism, it is imperative to discuss the legal expectations in the scientific world, whether it is in R&D, clinical trials, or drug discovery.
Digitalising lab operations and implementing a defined Digital Lab Strategy has become a key step in “future-proofing” labs against legal complications, data loss, accidental or purposeful plagiarism, and procedural inefficiencies. While operating without digitalisation in a laboratory may not intrinsically lead to legal problems, there are several potential challenges and risks that can arise. These difficulties aren’t limited to paper-based record keeping but include inflexible digital platforms that aren’t tailored to the lab environment.
Paper-based records are more vulnerable to physical theft or unauthorised access than digital data. Failure to adequately protect sensitive information can result in legal consequences, especially if there are ISO or other regulations in place, such as GDPR or HIPAA, that mandate the protection of personal or sensitive data.
Alternatively, some labs may use a combination of digital tools that aren’t tailored to the laboratory environment. While these can be useful, some may not offer the security to keep sensitive data safe or protect against cyberattacks. Unpredictable events, such as natural disasters, may lead to data loss if data is stored in a paper format or digitally on a local network.
Inaccurate or incomplete manual records may lead to regulatory compliance issues. Audits and inspections by regulatory bodies are common in highly regulated environments and may be more challenging without organised and easily accessible digital records. Paper lab notebooks are not fully traceable and present challenges with linking data to specific instruments or equipment. Even digital platforms that some researchers use to record lab operations, such as OneNote, may not comply with 21 CFR Part 11 regulations, which lay out criteria for electronic records and signatures.
Paper-based record-keeping can create problems with retrieving, analysing, and interpreting data. Digital tools not tailored to the laboratory environment can make managing data, from creation to archival, slower and more error-prone. Without digital tools that are made for the data-heavy lab environment, research groups cannot demonstrate data integrity and traceability, which could pose compliance issues.
The regulatory environment is constantly changing. When using paper or piecemeal software tools, it can be difficult to generate timely and accurate reports required for compliance or to keep up with the ever-changing regulatory requirements. Flexible, customisable, and searchable digital lab platforms can help with this, particularly if bulk changes need to be made across multiple reports or notebook entries.
Establishing and maintaining collaborations using paper-based notebook entries requires manual, time-consuming, and inefficient tasks. First, paper notebooks aren’t easily searchable, making finding specific entries or data difficult. Once found, entries must be scanned or copied to transmit electronically to a collaborator. Lack of efficient communication channels can lead to misunderstandings or delays in decision-making. With digital lab platforms, sharing and controlling entry permissions is as easy as a Google Doc.
Using paper lab notebooks can lead to IP problems due to the inherent risks of loss, damage, or unauthorised access. Paper records may be easily misplaced or damaged, resulting in the permanent loss of crucial experimental data, which can impact the claims made in patent applications or scientific publications.
Additionally, the lack of version control in paper notebooks may make establishing the timeline of discoveries challenging, potentially leading to disputes over priority and ownership of intellectual property. Embracing electronic lab notebooks with secure access controls and data backup features can mitigate these risks and provide a more robust framework for protecting valuable intellectual property.
Laboratories need to assess their specific needs and regulatory requirements and determine how much digitalisation can address the legal challenges discussed above. Implementing an appropriate digital lab platform can help mitigate risks and enhance overall efficiency and compliance in laboratory operations.
To learn more about eLabNext and how our digital lab platform can help protect you from future legal trouble, read our report, “The Legal Implications of an Un-Digitized Lab,” or book a personal demo today.
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