See what I did there?!
The subject of illegal aliens is a hot topic around here (in southern California). ELNs, aliens, similar sounds…. Okay, sorry for that.
So… Let’s look at the LEGAL ISSUES INVOLVED WITH ELNs.
I want to begin with a little bit of a rant. I use Microsoft Onenote, it’s free (in the sense that I already have Office). What is the difference between writing in a composition notebook and writing in Onenote? I have been told on multiple occasions to write it in a composition book for ‘legal purposes’ or ‘because a grant requires it’. What makes a composition notebook and ink so secure. I am a computer nerd and I know computer files can be changed - but so can composition notebooks!
ELN software now looks for solutions with electronic signatures and other ’security’ technology that feigns to make your electronic record of research indisputable in a court of law. Let’s face it though - just like a composition notebook wirtten in ink, electronic notebooks will always be subject to forgery. And when a researcher testifies of what’s in his/her record that’s about as good as it gets.

Okay, back to the LAW - I keep getting sidetracked in editorial comments.
37 CFR - Patent Submission Rules – electronic records acceptable as long as they comply with appropriate format requirements
Recent rulings (Sept 2004) confirmed that electronic records will be accorded the same weight as paper records in interference cases
Federal Rules of Evidence – Business Records Exemption Fed. R. Evid. 803(6)
– Records of regularly conducted activity. A memorandum, report, record, or
data compilation, in any form, of acts, events, conditions, opinions, or
diagnoses, made at or near the time by, or from information transmitted by, a
person with knowledge, if kept in the course of a regularly conducted business
activity, and if it was the regular practice of that business activity to make the
memorandum, report, record, or data compilation, all as shown by the testimony
of the custodian or other qualified witness, unless the source of information or
the method or circumstances of preparation indicate lack of trustworthiness. The
term “business” as used in this paragraph includes business, institution,
association, profession, occupation, and calling of every kind, whether or not
conducted for profit.
The Federal Rules of Evidence state that
– If data are stored in a computer or similar device, any printout or other output readable by sight, shown to reflect the data accurately, is an “original”. Fed. R. Evid. 1001(3).
An accurate printout of computer data always satisfies the best evidence rule.
There are no test cases yet (and may never be).
Re Scott T Jolley – Fed. Cir. 2002
Emails were used when Dow granted patent interference for Lubrizol based on prior art.
Why may there never be test cases?
Very few patent interferences or litigation arise each year.
95% of cases are settled pre-trial.
The 5% left over are unlikely to come down to ELN or Paper notebook evidence.
THINGS TO NOTE
USER AUTHENTICATION / 3RD PARTY TIME STAMPS - These are expensive ’solutions’ to making sure your electronic notebook is ‘legal’. (eg. SAFE compliant Smart Card). A GREAT solution to truly making your research notebooks bulletproof to the lawyers. But really, when someone argues I should have something like that if I want to replace my composition book - my reply would be ‘is there some 3rd party time stamp in my composition book that I’m missing?’
RECORD MANAGEMENT - There should be a clear distinction between record authoring and record storage/archiving. Current ‘best practice’ suggests PDF is appropriate for long term archiving. WHY? In a larger organization the author wants to be sure his record has not been edited by others handling/storing the record.
MY OPINION (again)
I’m all for better security, better time stamps, etc. But what is the difference, right now, between paper and electronic? Why stop progress by saying no to a simple ELN using Onenote or another program!? I don’t think there are grants that stipulate - have a composition notebook written in ink. Why should it be - paper notebook for one dollar or ‘certified’ ELN software for 10s of thousands of dollars. Scientists don’t know (or usually care) about the wild/crazy laws, so they just stick with the old school, or pay lots of money to feel secure. Well, I say go ahead and use cheap solutions like Onenote - it’s much better than a composition notebook (which, let’s face it, people rarely look at) and as far as I can tell it’s just as ‘legal’! If you’re really worried, email a backup to someone every week
IRONY
The majority of data in a paper notebook now is originally electronic!
Some lawyers don’t want their clients to have electronic records because it provides too easy of access to all their clients raw data which leaves them exposed to reanalysis and new findings! So basically, as opposed to paper notebooks (which nobody would ever use or read), electronic notebooks/records can easily be search and utilized - well that would be horrible!
LETS NOT MAKE THIS TOO COMPLICATED - LEGALLY THERE’S NOT MUCH DIFFERENCE BETWEEN RECORDING WITH A PEN AND PAPER OR ELECTRONICALLY.