Laboratory Notebooks Chronicle A Scientist's Progress

WHAT'S WHAT: Old Dominion's Kerry Kilburn found a notebook to be useful in explaining to a grad student how to analyze data she collected. Confirming experimental evidence is much like re-creating a prizewinning cheesecake: Both are much easier when a written record of the process is followed. While laboratory notebooks often contain detailed "recipes" for experiments, these diaries have several other functions, as well. "Scientists maintain notebooks to refer to previous experimental procedures and data-it allows for reproducing protocols and results without reinventing the wheel," says Steven Lazar, senior patent counsel at Genetics Institute Inc. in Cambridge, Mass. Notebooks also are crucial to establish intellectual-property ownership. "Documents provide proof of progress, invention, and having met an objective," notes Joseph O. Falkinham, III, a professor of biology at Virginia Polytechnic Institute and State University in Blacksburg. "There is also a new scrutiny in science. Any statement must be backed up by data in notebooks, including statements in research grants and proposals, as well as publications." It was probably inevitable, in light of the ever-increasing role of computers in the lab, that electronic notebooks would emerge as a powerful way for scientists to record their activities. James D. Myers, a project leader at the environmental molecular sciences laboratory at Pacific Northwest National Laboratory (PNNL) in Richland, Wash., points out that the comprehensiveness that an electronic notebook can offer isn't a new idea. "Leonardo DaVinci's notebook contained all of the ideas, data, calculations, and graphs that he had. He didn't keep notes on paper [and] data on a floppy drive, do analysis in one program and make graphs in another, and write papers somewhere else. Electronic notebooks will allow such a reintegration of data, notes, and data processing." Myers heads the Collaborative Laboratory program at PNNL, which is developing technology and practices to allow scientific research and education to be conducted over the Internet. Electronic notebooks are part of the project. "Our work is making electronic notebooks easily sharable across the Internet in a secure manner and providing means to add images, spectra, molecular models, and data files into the notebook," he says. PNNL is part of the Collaborative Electronic Notebook Systems Association (CENSA, http://www.censa.org), a Woburn, Mass.-based consortium of chemical and pharmaceutical companies and software vendors that is jump-starting use of electronic notebooks. A major focus of CENSA, Myers says, is to make electronic notebooks legal documents that can be used to issue patents or Food and Drug Administration approvals. Digital timestamps and "biometric" signatures that recognize handwriting are two features of electronic notebooks that are important in establishing claims of discovery. PERMANENT RECORD: W. Scott Stornetta's company offers a system that certifies electronically recorded data. Some scientists fear that electronic notebooks can be easily altered. But W. Scott Stornetta, CEO of Surety Technologies Inc. in Florham, N.J., says just the opposite is true. The company markets a "digital notary system" (DNS) electronic notebook. "Researchers don't have to bother certifying records. They can just turn on a workstation, and everything that flows through gets certified," he says. Each day's work, or a particular experiment, is dated and sealed. Still, some researchers are reluctant to part with the comfort of a good, old-fashioned, paper notebook. Ralph R. Meyer, a professor of biological sciences at the University of Cincinnati, has testified as an expert witness in several trials in which lab notebook evidence was pivotal. He says: "Whatever the type of storage system, it can go down and not recover the data. I back everything up three times, don't keep data only on computer, and print hard copies of data and paste them into a real notebook." -R.L. In general, academic scientists tend to be less concerned than their industrial counterparts with secrecy and ownership matters. "Academic scientists are far less rigorous in notebook keeping. I've seen several different ways that they keep notebooks," comments Ralph P. Meyer, a professor of biological science at the University of Cincinnati. Choosing the right notebook to use for record-keeping entails balancing flexibility with clearly establishing who did precisely what and when. Bound notebooks, from which pages cannot be removed, are restrictive, Meyer contends. "When you do many kinds of experiments, it can be hard to know where to find things," he says. Another type of notebook used in academia includes sheets of carbon paper after each page, so that one copy can remain in the notebook and the other can be removed. Meyer, who works on DNA polymerases, uses loose-leaf binders, so that he can easily add data sheets and reorganize locations of different experimental write-ups. "This makes it easier to write manuscripts, but there is the danger that you can pull out data and lose it," he notes. For Kerry S. Kilburn, a professor of biological sciences at Old Dominion University in Norfolk, Va., a loose-leaf notebook is a must for her research in the mountains of West Virginia, where she traps small mammals to study their ecology and anatomy. "Field notes are kept on 100 percent rag, loose-leaf paper. A loose-leaf is important, because the notes are archived along with the specimens-they are part of the official record and are critically important for future researchers," she explains. Field note pages are sequentially numbered and labeled with the collection locality or research site. In addition, the pages are dated and the collector's name recorded. But many industrial scientists would be aghast at a method of record-keeping in which a page could literally fly away with a passing breeze. At companies, notebooks typically are duplicated, witnessed, and kept under lock and key. "The notebooks which Genetics Institute distributes are official, numbered laboratory notebooks, with numbered pages, and they are not spiral or loose-leaf, because pages from such notebooks can be torn out," says Lazar. Each page or experiment must be signed, dated, and witnessed as soon as possible after completion, he adds. "The witness signing is key, because it provides corroboration from someone who understands and works in the field," explains W. Dennis Drehkoff, a patent attorney with Banner and Witcoff Ltd. in Chicago who gives seminars on keeping laboratory notebooks. Companies vary, though, in the degree of caution. At Kemp Biotechnologies Inc. in Frederick, Md., which does contract cell culture work, "all lab notes are entered in hardbound notebooks using pen, and all notebooks remain in the lab at all times," reports director of research Marjorie Young. But at Polyprobe Inc. in Bala Cynwyd, Pa., which markets a signal amplification technology, scientists keep three copies of each notebook. "One hard copy is a printout/worksheet, one copy is the original worksheet on disk, and the third copy contains the actual data recorded in completing the experiment, such as electronic images of gels, phosphorimager data, and spectra," says president Thor W. Nilsen. "All the electronic data are downloaded off-site nightly." And at Genetronics Inc. in San Diego, a manufacturer of electroporation equipment, researchers record experimental data in spiral notebooks and ideas and information for inventions in a bound notebook, reports Dietmar P. Rabussay, vice president for research and development. A notebook should include data; background information such as safety instructions; objectives; lists of materials and methods used; and, of course, results and conclusions (A.J.S. Rayl, The Scientist, Nov. 11, 1991, page 18). "Notebooks have to have raw data," advises Falkinham. "If you have to use a paper towel or a cuff of a sleeve, put it in your notebook. Write data while it is fresh. You can look it over later from a different perspective." He also suggests using a standard format for each experiment so that details are not excluded, recording different projects in different notebooks, and keeping duplicates, especially if an electronic notebook is used. Because a laboratory notebook is so much a part of doing science, many professors instill in their students the value of keeping an accurate, readable record. "I require students to follow a certain protocol for each experiment, including raw data results and their analysis, such as graphs or tables," says Meyer. Patricia Kreke, an assistant professor of chemistry at Mount St. Mary's College in Emmitsburg, Md., considers keeping a lab notebook an integral part of the undergraduate experience. "Students write a prelab outline-which is what most scientists do in preparing for an experiment-then write everything as it is done in lab, as well as everything that doesn't happen in the lab as expected. I grade the notebooks by whether the experiments can be reproduced," she says. Ensuring the permanence of scientific records is crucial when questions of intellectual property arise. "When two or more companies file for patents on similar or overlapping inventions, they may be called upon to prove who was the first to invent," says Lazar. And that proof often leads to lab notebooks. Patent law states that a notebook be kept on file for 23 years-three years past the 20-year life of a patent. "But legally there is no requirement to keep a notebook of research. It is a [United States Patent and Trademark Office] rule," adds Drehkoff. Notebooks are proving crucial, for example, in an on-going patent dispute between Promega Corp. of Madison, Wis., and Hoffmann-LaRoche Inc. of Nutley, N.J., concerning use of Taq DNA polymerase. This enzyme, from a hot springs bacterium, is used in the polymerase chain reaction (PCR) process. Hoffmann-LaRoche sued Promega in 1992, alleging that Promega infringed its patent infringement by selling the enzyme, which was patented in 1987 by Hoffmann-LaRoche (R. Finn, The Scientist, Oct. 14, 1996, page 1), for PCR. SIGNED, SEALED, DELIVERED: Patent attorney W. Dennis Drehkoff notes that having a witness sign a notebook provides crucial corroboration. The patent is being contested, however, because of laboratory notebook evidence showing that the enzyme was actually discovered and described by John M. Trela, an associate professor of biological sciences at the University of Cincinnati (A. Chien et al., Journal of Bacteriology, 127:1550-7, 1976). Promega was marketing that enzyme, and the preexistence of the Chien paper may negate the patent. The notebooks and several master's theses provide even more information than is in the key publication. Relates Meyer, an expert witness for Promega: "We look to see whether or not the information in a patent is supported by data in the notebooks. We look for flaws in data and experimental technique, and how experiments were done." Scientists from Promega and the former Cetus Corp., where PCR was invented, have had to use old notebooks to repeat experiments to see if the two enzymes are the same. Outcome of the contest is pending. Validation of results and protecting intellectual property are two obvious uses of laboratory notebooks. A third use is when one scientist takes over a project from another. Old Dominion's Kilburn learned the value of a well-kept notebook in this situation. She had spent a summer recording data on 200 mouse skeletons while visiting a colleague's lab. After the summer, the data were left to be analyzed by a graduate student. "The extremely good records I kept were valuable for quickly filling the graduate student in on the methods, the data, and the analyses I'd completed to that point," she recalls. Kreke agrees that a lab notebook is vital to research. "I've made the mistake [of thinking] of a lab notebook as a personal record of what happened. But it is an important part of doing science." Ricki Lewis, a freelance science writer based in Scotia, N.Y., is the author of several biology textbooks. She can be reached online at 76715.3517@compuserve.com.

Laboratory Notebooks Chronicle A Scientist's Progress

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