The Paperless Lab: Database Systems for the Life Sciences

Date: September 27, 1999Laboratory Database Systems The collective mantra of the scientific community seems to be "Data! Data! Data!" New high-throughput devices generate mountains of data in a matter of minutes. Without some way to manage this information, a researcher can be quickly mired in "information overload." Laboratory database software systems provide a convenient way to centralize, archive, and secure data generated by many sources. These systems can reduce clutter, speed communication, and serve as a direct link to ongoing projects for all parties involved in the investigation. A centralized information management system can make a laboratory run smoother in at least two ways. First, as data comes in, it can be read by the principal investigator (PI) without his leaving the office. The PI can quickly modify research plans based on the results and not waste time pursuing deadends. Internet access can allow the PI attending meetings to keep abreast of ongoing projects without needing to adjust sleep patterns to the lab's time zone. Second, use of a centralized database makes data generated by past lab members easier to access and understand avoiding the usual confusion that ensues when trying to piece together results from long-departed colleagues. Departing researchers leave behind a wealth of notes and samples, which are rarely organized in a standard way, rendering them essentially useless as a resource for future research. But it is often necessary for these old studies to be resurrected during parallel studies or when new ideas spring forth. When recorded in a laboratory database, notes are preserved in a pristine, easy-to-access form. There is no need to reinvent the wheel by repeating experiments to revisualize faded results. A recent bill passed by President Clinton included a provision that could expand the Freedom of Information Act (FOIA) to include any materials associated with publicly funded studies, potentially including lab notebooks, E-mail, diaries, and phone logs. Ostensibly, this could open new paths of communication between scientists and the public, but the potential for harm is not easy to dismiss. Patients may refuse to participate in studies for fear of their health records falling into the wrong hands, and unscrupulous investigators could "scoop" competitors, rendering years of effort worthless. This unprecedented access also opens investigators to potential harassment by groups opposed to certain research projects. One of the driving forces behind this legislation appears to be the growing frustration by the public concerning recent fraud and scientific misconduct cases. Through increased scrutiny of all aspects of research, the public hopes to increase scientists' accountability. But most scientists involved in pure research consider the notebook a reference work and are reluctant to have it presented as a legal document. Multiple projects requiring a series of steps are carried out at the same time, making the production of a chronological record that is also a concise reference nearly impossible to achieve. More often, a separate looseleaf notebook is kept for each study where results and calculations to be used for presentations and publications are stored. A March 20, 1997 decision by the FDA allowed information recorded as electronic notes and data to be considered legally binding when accompanied by password protection and an electronic signature. The adoption of a standardized database system may fend off some of the more insidious aspects of this hypervigilance. Most basic research labs are notoriously insecure. A locked door only serves to keep out honest people or temporarily deter a determined thief. Large labs have so much traffic that an intruder can easily pass through unnoticed. One area of intense concern is data security, as highlighted by recent espionage cases. No medium appears to be safe, be it paper or electronic. The problem even plagued Leonardo DaVinci, who took to writing his notes backward, requiring a mirror to decipher. Electronic databases offer a distinct security advantage; sophisticated encryption methods make them nearly impossible to breach for all but the most determined hacker. Voice and fingerprint technology allows data to be specifically tagged and accessed by the researcher or privileged individuals. Electronic lab notebooks (ELNs) are often mistakenly referred to as Laboratory Information Management Systems (LIMS) but actually represent an evolutionary step up from most LIMS in that they can store a wider variety of data such as notes, photos, video, and audio--any file that can be captured by Windows is fair game. ELNs also offer encryption and verification modules to prevent corruption and unauthorized access. Avatar Consulting and Mantra Software Corp. offer products specifically tailored to biotech applications. Avatar's 32-bit LABTrack program offers features such as sample login, sample tracking, instrument interfacing, data export/import, custom reports and queries, and built-in audit control. It can store images, text, spreadsheets, chromatograms--you name it, even video and audio recordings. Data is tagged with the date and user ID as it is entered and cannot be deleted (only lined-out), showing the complete history of work performed on a project. Lined-out data can be excluded from reports, allowing researchers to omit irrelevant data from analysis. The electronic signature module is designed for FDA compliance to ensure legality and database record tracking. Fingerprint and voiceprint modules are in the works for users wanting increased security and flexibility. The intuitive software requires no dedicated system administrator, reducing operational cost. Avatar offers on-site training for all of its software products. Mantra Software's 32-bit hierarchical NuGenesis™ Scientific Data Management System software has a number of distinct configurations to help centralize, access, and manipulate data. The system may be configured with either an ISAM engine using Microsoft Access or by an SQL engine for an Oracle client/server. With both, data can be saved from any Windows 95, 98, or 2000 source by using the UNIFY client application's "print to database" command, creating a common format in a central database. As data is saved to the database, it is marked with a "metadata" tag, then compressed and encrypted, saving disk space and ensuring security. Using the Vision client application, tags can be filtered by name, ID number, date/time, or any Boolean, numeric, or wild-card options. Text within individual fields may be searched. Since the data--be it images or text--is vector-scalable, it is preserved in its original state without corruption or degradation. Reports and documents can be quickly prepared and archived for future reference using the Archive client application. The Archive client application is designed especially for high-throughput analytical labs that need to comply with FDA and regulatory issues such as GLP/GMP procedures. Data security is ensured via log-on and "fail-safe" protocols. What will the lab notebook of the future be like? Perhaps it will be a small, splash-proof palm PC or wristwatch that the researcher can carry easily throughout the day. Investigator-specific voice software will allow the researcher to simply access protocols, speak notes, and make calculations without the need for carrying around paper and pen. Data and notes will be automatically transferred to the appropriate project folder in a voice-encrypted database, keeping sensitive information out of view of unscrupulous eyes. The power and convenience of today's PC allows researchers to store, retrieve, and manipulate information in new and exciting ways. The ability to archive data in pristine form allows past data to be easily searchable for future projects while simplifying analysis and report generation. The availability of low-priced, time-saving programs to meet these needs now gives the modern lab an opportunity to increase efficiency and save a few trees in the process. Laboratory Database Systems Grant Meisenholder can be contacted at gmeisenholder@the-scientist.com.

The Paperless Lab: Database Systems for the Life Sciences

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