➤ Establishing sufficient confidence that
electronic records fully comply with these requirements, and the lack of any case history, have been critical factors that have seriously influenced decisions to replace a paper lab notebook with an ELN. Unfortunately, we are unlikely to see a suitable body of case law for a great many years. Some organisations have chosen to adopt a hybrid solution, using an ELN front-end tool to author records, and then preserving the resulting records on paper. This gives the benefits of paper records (for the lawyers), while providing the scientists with the benefit of new tools. However, the use of multiple systems for patent evidence creation and preservation can expose an organisation to increased risk because of the need to manage ‘duplicate’ systems. Furthermore, amendments to the Federal Rules of Civil Procedure in 2006 set out changes to the e-discovery process that specifically enables a court to permit access to ‘electronically stored information’. As a consequence, paper records in a hybrid system have no specific value. Patent reform legislation, in the form of
the Leahy Smith America Invents Act 2011, will change the US system from first-to- invent to first-to-file in March 2013. It is very tempting to view this change as an opportunity to relax some of the procedural requirements of ELNs used in research laboratories. However, there are clauses in the act that would suggest it wise not to make such an assumption. It is likely that patent interferences and interfering patent actions will continue for many years for patents and applications filed after March 2013. There are specific circumstances described in the America Invents Act that, for example, require proof of inventive activities to remove prior art for joint research activities, or preserve the right to an interference if the application contains, or contained at any time a claim to an invention filed before March 2013. Until the act becomes effective, and there is clarification about the implications of the new legislation, there is no reason to either change in-house procedures for keeping laboratory notebooks, or any reasons for vendors to revise the procedures and workflows in their ELN products.
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From the vendors’ perspective, legal
compliance of records within an ELN puts demands on the workflow and the long- term preservation of electronic records. Workflow is usually addressed by providing an electronic signature workflow based on email or other messaging systems, alerting signatories to their need to witness and sign experimental records. Long-term preservation is typically addressed by rendering the experiment record in an appropriate format, typically PDF or PDF/A, both of which are ISO standards. This typically addresses concerns about data integrity and data authenticity. Data integrity, in a general sense, means that data cannot be created, changed, or deleted without authorisation. Put simply, data integrity is the assurance that data is consistent, correct, and accessible. Data
ELN contains sufficient information to support the conclusions of the experiment and to allow the experiment to be repeated, but eliminates the need to manage disparate proprietary data within the ELN system. A records management policy, therefore, becomes essential in order to specify what is to be kept, for how long, where it will be stored, how it is managed, and how and when it will be deleted. Despite a lot of the early concerns and
the lack of case law, there is a growing level of confidence that ELNs are ‘legally compliant’, although the onus is on the use to adopt suitable policies and procedures. Most major pharmaceutical companies are now fully ‘electronic’ and paper is no longer being used for archival purposes. Furthermore, the transition from paper to
‘from ThE vEndors’ pErspEcTivE, LEgAL compLiAncE of rEcords wiThin An ELn pUTs dEmAnds on ThE workfLow’
authenticity is the term used to reinforce the integrity of electronic data by authenticating authorship by means of electronic signatures and time stamping. Generally speaking, electronic signatures are considered admissible in evidence to assure the integrity and authenticity of electronic records. The long-term preservation of electronic
records raises both a business and a technology issue. The business issue is ‘what records do we keep?’ Since an experiment write-up will cross reference sources of data that have been acquired and processed during the experiment, and used to derive conclusions, the big question is where should this data be stored: should it be included in the ELN system, or stored in a different data repository and linked from the ELN? There’s no simple answer, but best practice points to separate repositories, with appropriate metadata, and a robust and integrated management process to maintain integrity of the repositories. The experiment record in the ELN can include appropriate graphical representation of the data – basically the electronic equivalent of traditional cutting and pasting of graphical instrument output into a paper lab notebook. In this way, the
digital in almost all walks of life means that we are not alone, and that the solutions to the problems we see in the laboratory world are already being addressed in other domains. Furthermore, legislation typically does not distinguish between the medium (paper or electronic), but concentrates on the content. After all there may be a lack of case law associated with ELNs, but there are plenty of examples in civil and criminal law where electronic records have been used as evidence. All of this should mean that, with a well-implemented ELN, good policies and procedures, and good laboratory ‘citizens’, even lawyers can relax. So the momentum for the change to
electronic lab notebooks increases. Early doubts are being progressively dispelled. Businesses stand to gain through improved access to data and information, ease of sharing and collaboration, and more productive and efficient workflows. Whether you are a scientist, a business manager or a lawyer, it’s win, win, win!
● John Trigg is an independent informatics consultant:
john.trigg@
phasefour-informatics.com
Using E Lns
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