Taking Notes: Lab Notebooks in the Private Sector

One of my to-do tasks includes making some revisions to a standard operating procedure draft document for lab notebook policies for our division. I'm a member of an "executive lab notebook committee" or as I fondly like to call my assignment, the stinking albatross that hangs around my neck. The confluence of discovery scientists and attorneys is an uneasy one, and acting as an intermediary between the two factions can get pretty stinky in that dead-avian pendant way.

I have no one to blame but myself for landing in this role. I made the grievous error of telling my boss about my prior experiences with the legal importance of lab notebooks. As an employee at another company. my lab notebooks were subpoenaed for a patent infringement case brought against my then-employer. The prosecuting company went after a number of pharmas and biotech for using a biochemical assay for which said company held the patent. Later, my notebooks were used for due diligence by two or three larger companies looking to partner with my employer on the research project I supported. In both the patent infringement (1) and due diligence cases, the details and dates of my notebooks were scrutinized intently.

Lab notebooks have been addressed before on Science Blogs by Sandy, Bora and most notably by Janet - here and here.

Largely, the emphasis in these articles, with the exception of Sandy's, by my SciBlings was lab notebook record keeping in the graduate school/post-doctoral environment with an emphasis of acknowledging work, documenting procedures and leaving a paper trail of ideas.

From Janet's article, "What good are lab notebooks?":

The permanent record of what you observed and how you set up the conditions to observe it is not only useful in attempts to reproduce particular findings, but is also, as some commenters noted, a legal document that can be requested (or subpoenaed) by funding agencies that, among other things, have an interest in ensuring that the research they fund is actually conducted and that important results are communicated to the community of science (via journal articles, for example) and possibly even the broader public.

Janet accurately describes the legal implications of lab notebooks as they pertain to funding agencies, but in the pharma and biotech milieu, the stakes become extremely high because of intellectual property issues. Setting a date of conception for an idea or a result can make or break a patent claim. Lab notebooks in the private sector not only contain the methods and records of research, but they also are seriously legal documents.

Guidelines for what goes into a lab notebook in the private sector can be strict and Byzantine in complexity. Accurate dates and witnessing by a second and even a third party are critical. So are appropriate conclusions. The researcher must take care in summarizing results. For example, stating that "Huh. A few of the rats died. Maybe this compound is toxic." is not a good thing to write into a lab notebook. It's speculative and its implication can have all kinds of nasty ramifications.

My albatross is particularly pungent because of the diversity of groups in our big division. Legally capturing the massive amount of data and results generated by a high-throughput screening department is a challenge. Lab notebook policies for other groups, like mine, are more straightforward. But all must be consistent and kosher with the attorneys.

Then there's the paperless electronic lab notebook. Don't ask. I'd have to kill you after I told you anyway.

Young researchers coming from grad school and post-docs into the world of pharma/biotech find that lab notebooks here are sharp-fanged, bureaucratically constipated beasts, and a bit different than those notebooks of their halcyon (2) university years. They are not a journal for stream-of-consciousness scientific yammering, but must be able to stand up to a court case. Having experienced this, I can assure you that's pretty scary.

So what good is a lab notebook? In the private sector, a well-documented lab notebook can be worth millions of dollars.

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(1) The outcome was that my then-employer offered a piece of the pie potentially generated by revenues if the clinical candidate we discovered using their patented procedures goes to market. The prosecuting company was satisfied with that. But sometimes companies jump through all sorts of hoops to avoid such issues by subtle changes in gene sequence, cell lines etc- all of which are patentable. What is allowed by the US Patent office is ridiculous in my opinion and hinders research in both the public and private sector. But that's the subject of another screed. Plus I might just be speaking out of two sides of my mouth since I have a patent application for an idea!

(2) I might just be using this adjective in a sarcastic manner...or not.