EVOLUTION OF ELECTRONIC LABORATORY NOTEBOOKS - Collaborative Computational Technologies for Biomedical Research - page 305

as the United States they serve a secondary purpose, that is, to claim the prior-
ity date for an invention to support the fi rst - to - invent principle on which a
patent is granted.
Prior to 1998 a U.S. patent could only be awarded to inventions that occurred
within the United States, but in that year the United States adopted legislation
that removed this discrimination [6]. In order to be awarded a patent it was
still necessary to prove fi rst invention, and this required the keeping of U.S.-
style laboratory notebooks that met USPTO standards. Scientists outside the
United States were not used to keeping paper laboratory notebooks. This
provided the drive to ELNs. Over the next decade ELN applications evolved
and the technical and legal issues that impeded their acceptance have been
overcome.

19.2 EARLY ELN S

A pioneer in the fi eld of ELNs was Richard Lysakowski, the founder of
CENSA [7]. CENSA was ahead of its time and was unable eventually to con-
tribute to the growth of ELNs, but it did provide the fi rst defi nition of an ELN:
“An electronic notebook is a system to create, store, retrieve and share fully
electronic records in ways that meet all legal, regulatory, technical and scien-
tifi c requirements.” Subsequently this defi nition was adopted by Bristol Myers
Squibb (BMS), a founding member of the organization.
Initially, the focus of ELN development centered on IP protection. Progress
was slow but eventually electronic technology was employed to produce
robust and secure electronic notebook records. The crucial components for
gaining a U.S. patent are:

￿ Conception — record the idea behind the invention.
￿ Reduction to practice— carry out the invention.
￿ Diligence — execute the invention in a timely manner.
￿ Corroboration — prove that the work was done and when it was done.

Critical to the process is time stamping of the records and all changes to a
record. The timestamp must be verifi able, for example, by making it a standard
operating practice to reset the clock against a public resource such as the
National Institute for Standards and Technology (NIST) [8]. An additional,
and safe, practice is to back up the electronic records frequently and retain
the backups. A combination of auditing, time stamping, calibration of the
timestamps, and availability of extensive backups provides a chain of custody
that supports the authenticity of the ELN record.
Important to this process is the fact that electronic records are never origi-
nal records and are always copies. It is, therefore, important to demonstrate a
chain of custody for the record that shows that it has not been tampered with.
Furthermore, it is likely that the person who made the original record may not
be available to defend its authenticity. Legally this makes the record hearsay,