Laboratory Notebook

FEATURE ARTICLE

The Laboratory Notebook ALOKANANDA SENGUPTA Laboratory Notebooks have served a unique purpose in the evolution of science. A Laboratory Notebook is usually not perfect, but the closer it tends to perfection, the better will it serve its purpose. EXPERIMENTS and efforts of scientists in the laboratory lead to scientific inventions. So, much of the time spent in the laboratory has to be devoted to experimental, theoretical and analytical work. But, unless properly recorded for later use and reflection, the experimental work could become a mess. The laboratory notebook is a basic tool for recording details of any experimental work, whether it is basic research, product development or engineering design. A detailed laboratory notebook is the best and most direct evidence of the work performed. The three most important reasons for keeping an accurate and complete record of experimental work are: • Intellectual Property Rights Protection – The laboratory notebook is a base document upon which a scientist’s Intellectual Property Rights may be protected. Exact details and dates of conception, experimental observations and results, and chronological record of a scientist’s work are an essential part of the written record. This is an essential piece of evidence for patent applications. • Scientific Repeatability – The laboratory notebook contains the only first hand record of the work performed and results obtained. Based on the content of a laboratory notebook another scientist should be able to repeat the work performed, using only the notebook as a guide. Reproducibility – even many years later – is crucial because the project notebook should be viewed as a legal document to help verify scientific findings and to support possible commercialization of work viz. – scale-up studies, technology transfer etc • Project Accountability – Financing parties and funding bodies need to have assurances that their investments are being effectively and wisely utilized. Therefore keeping accurate, complete, authentic and reliable records of research data is essential for the scientific integrity of the staff as well as the institute. The laboratory notebook should help provide and prove: • A chronological record of all the work done • The work details • The dates of conception • Diligence in reducing the invention to practice • Details regarding structure and operation

In December 1994, the United States Government passed a Bill on the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) of the General Agreement on Tariff and Trade (GATT). This Bill provided from 1st January 1996 onwards, foreign countries including India a level playing ground while applying for US Patent. For the first time, evidence of inventive acts that took place outside the USA could be used to establish the date of an invention. To take advantage of the US Patent laws the Government of India has established guidelines for maintenance of laboratory notebooks. All the laboratories in India, including the CSIR Laboratories, follow these general guidelines. Throughout the world, Institutes and Laboratories adopt the general guidelines laid down by their governments to suit their requirements. Maintaining the Laboratory Notebook The laboratory notebook is sometimes also called a technical notebook, journal, or experimental notebook. The methods of maintaining legally defensible laboratory notebooks are almost universal. In case of graduate, undergraduate and school students, the guidelines laid down by the institute, in which the work is done, are followed. The notebook should be bound, so that pages cannot be removed and replaced, never loose leaf, and the pages numbered consecutively, preferably by a printer. The pages may be plain, bordered, lined or with grid. The first page of the notebook should list the name of the principal investigator, the names of the other investigators, the title of the study and the date the study began. The goal of the study and the problems the study attempts to address may also be indicated. If more than one notebook is used for a project, they should be serially numbered. All entries should be in non-erasable ink. “White-outs” are not allowed. Erasures should not be made in the notebook. If an entry was made in error, it should be crossed out; taking care to make sure it remains legible. While writing the date, the use of only numerals can cause confusion. It is best to follow the procedure of writing the date, three-alphabet abbreviation of the month, and the year. Proof of the date of an invention is often crucial, especially if there is a need to establish patentability in view of an existing publication or, if there is a dispute as to which of two different inventors is the first to invent. This is the case particularly when filing patents in countries like the United States, where patent laws provide that the ‘first to invent’ is granted a patent rather than the ‘first to file’. Again, it is often necessary to prove whether a publication published less than one year before filing date of a patent application is applicable as prior art against the application. If the applicant can prove that he or she invented the invention before the publication date, then the publication can be removed as a bar to patentability. Depending on how the notebook is designed, the back pages may or may not be used. If not used all blank spaces may be voided by a corner-to-corner line. Every bit of every page must be filled and legible, either with information or with a mark that voids the section. The language used in the laboratory notebook should be objective and factual. The past tense (for example, ‘was heated’) should be used to describe experiments that were actually performed.

When recording an experiment, it is important to include enough information, so that the experiment will be reproducible. These include information relating to the equipment that was used, time, condition and method of experiment. It is advisable to record all the entries in the table of contents as one goes along. It is preferable to include multiple levels in a table of contents – that is – to indicate where a new study starts and also to include subheadings for specific parts of a study, method, sets of data etc. Two or more pages may be required for the table of contents. All abbreviations and acronyms must be defined the first time they appear in the laboratory notebook. Notebooks should be made contemporary with ideas and experiments. It is important to include ideas and not just data in the notebook, since the notebook is to serve for corroborations of the conception of the invention. Conception is an idea. An idea concerning what the invention is, what problem it addresses, and how it is different from what was done earlier should be entered in the laboratory notebook. Comments should be objective and accurate and derogatory comments about work of others should be avoided. It is often useful to record what occurred at laboratory group meetings, especially if suggestions concerning the invention were made. This will be helpful in documenting conception and inventorship. Entries made by any person other than the person to whom the notebook belongs must be dated and signed by the person making the entry. Data that is generated may be incorporated in the notebook by photocopying and stapling into the notebook. Data that cannot be stapled into the notebook should be maintained in an orderly manner and its location should be cross- referenced in the notebook. An independent witness, i.e. someone who understands the technology but will not be named as a co-inventor of the invention, should sign and date each of entry after a statement like: “Read and understood by …”. The witness should preferably sign the entries on a contemporaneous or fairly contemporaneous basis, but entries can also be reviewed, signed and dated on a weekly or monthly basis. No changes should be made to an entry after witnessing of a page. If changes must be made, the witness should rewitness the entry by signing and dating next to the correction. Dr Huang of the California Institute of Technology (CIT) sued the CIT for not including his name as inventor of CIT’s automatic DNA sequencing patents. The court found that his Laboratory Notebook was insufficient because they were not witnessed or reliably dated. Only in those instances where Dr Huang’s Laboratory Notebooks were corroborated by independent evidence were they considered as persuasive. Archiving and Categorization Notebooks are permanent records of a research project, and are stored securely for years and sometimes centuries. Laboratory notebooks that relate to inventions on which patents are granted must be preserved for the life of the patent plus six years. Laboratory notebooks are categorized by levels of use and include: i. A working laboratory notebook – one that is in current use. ii. An active laboratory notebook – one that is complete but is required for reference. iii. An inactive laboratory notebook – one that is complete and currently not required for quick reference.

Most institutes permit the investigators to make copies of the primary data in the laboratory notebook for his or her own use, but laboratory notebooks are not permitted to be removed from the laboratory. Laboratory notebooks of eminent scientists and Nobel laureates are preserved carefully and studied for centuries. Recently the recovery of Enrico Fermi’s first laboratory notebook (March – April 1934) generated considerable renewed interest in the conceptual understanding of neutron induced artificial radioactivity. The Oregon State University has made all of Linus Pauling’s notebooks available on the Internet. Leonardo Da Vinci’s (1452-1519) Notebooks are carefully preserved in several libraries of Europe. Laboratory Notebooks of the Future The increasing use of computers in research indicates that very soon we may use electronic laboratory notebooks (e-laboratory notebooks). The viability of collecting laboratory data and information within a fully electronic environment is being studied. As software is increasingly being used in research, the number of computer-assisted discovery programs will also increase, making the use of the e-laboratory notebook inevitable. For a scientist, using a Laboratory Notebook to record ideas, inventions, experiments, records, observations and all work details is a vital process. It is essential because: • The research endeavour is funded by a funding body who expect their money to be well utilised. If the funding body is government, then it is the taxpayers’ money to which the scientist owes the debt of performing productive and responsible science. • Scientists have a responsibility to science. Confidence in the reproducibility of the results is fundamental to anyone intending to build upon the earlier results of others. Science is built on trust and the trust is most inspired when the original data exists for review. • Scientists have a personal responsibility to the laboratory in which they are trained and/or work; not only to the mentor and/or current laboratory colleagues, but also to those who will follow and may wish to build upon the earlier experiments. ----------------------------------Mrs Alokananda Sengupta is a Scientist with the PME Cell, North East Institute of Science & Technology (NEIST), CSIR, Jorhat-785006, Assam; Email: [email protected]; [email protected]