Good Record Keeping: Procedures for Academic Laboratory Settings
1. The Need for Proper Laboratory Record Keeping
The need for complete and accurate recording of ideas and data has never been more important. In the industrial setting good laboratory record keeping has always been necessary in order to preserve intellectual property rights, such as patents and know-how. As universities continue to seek out more collaborations with industrial scientists, academic laboratories will have to bring their record keeping up to industrial standards. Also, due to the increased scrutiny of the academic laboratory by the taxpayer, as witnessed by more concerns with "scientific misconduct," "financial disclosure," and "conflict of interest," proper recording of laboratory activity is even more important.
Today's graduate students must be prepared for a career path that will permit them to move easily between academia and various industrial settings. In order to be good employees, graduates must have proper laboratory record keeping skills. Acquisition of the skills must become an automatic part of the graduate curriculum
As the research enterprise grows more interdisciplinary and collaborative within the university itself, many people may be reviewing the results of one research technician. The days of the single investigator/single laboratory technician are probably over. The collaborative nature of research indicates that we must keep our data in a way that we can share it with others.
2. Rules for Record Keeping
2.1 Entry Format
Investigators, students and technicians should use bound laboratory notebooks that open in a book format with left and right pages, and to which extra pages cannot be added. If successive notebooks are used, the volumes should be numbered sequentially. All entries should be in ink or other indelible, permanent medium. Data should be entered on every page, and if a page is left blank or a space within a page is left blank a line should be drawn through it. Corrections should be made in ink. Drawing one or two lines through an erroneous entry is sufficient. Never erase material from a notebook. Also, pages or portions of a page must not be removed from a notebook for any reason.
Each and every activity relating to the investigation should be recorded. It is best to begin the description in a narrative form, describing what research is planned, then describing the circumstances under which the research was conducted (materials and methods), the actual findings under the circumstances (data), and how these findings relate to the variables of the investigation (tentative conclusions). Each entry must be dated and signed by the person performing the task.
Subsequent entries should be made on the line immediately following the previous entry's date and signature. All unused lines on the prior page must be crossed out if one starts a new page for a new entry.
All photographs, sketches, charts, graphs and other supporting materials, if any, must be permanently affixed with glue to the page. They should not be stapled or paper clipped, which appear to be temporary insertions.
Lapses between entries should be explained by making an entry, such as, "Working on other activities" or "Annual leave," followed by signing and dating the explanation. The notebook should be viewed as a diary of laboratory activity and scientific exploration (thinking) and, therefore, should contain narrative descriptions, as appropriate.
The individual making the entries must have another technically knowledgeable person read and corroborate the notebook entries. Preferably, this corroboration should occur at least once every two weeks while research is in progress and after a significant portion of the project is completed. This corroboration should occur naturally as part of a review with the principal investigator or others in the research team. In industry, a laboratory will generally have "notebook witnessing day" every week, at which time the various investigators will exchange notebooks, read them, sign them, date them, and return them to the originating investigator.
The corroborator must write, sign and date the following statement after the most recent entry: "On this date I read and understood all of the entries in this notebook from the entry dated ___ on page ___, to and including the most recent entry immediately above. Signed ___ and dated ___." Note that many investigators avoid writing this lengthy statement by purchasing prelabeled, standard laboratory notebooks that have prenumbered sections which read: "Performed by: ___, on ___ date" and "Read and Understood by ___, on ____date." Almost every scientific products distributor has this variety of laboratory notebook for sale. Also, an inexpensive stamp can be used to add these phrases to the bottom of each page of a standard laboratory notebook.
Note that the corroborator is often not a co-inventor, especially if the laboratory has a routine exchange of laboratory notebooks. However, once it becomes apparent that the research has led to a new discovery or potential invention, it is best to make a specific notebook entry that succinctly describes the discovery or invention. The inventor should sign and date the notebook entry and immediately thereafter have a colleague who is not involved in any way with the investigation, but who is capable of understanding the concept, read and corroborate the entry by writing, signing and dating the corroborative statement specified above. All employees, appointees and affiliates of the University of Florida are required to disclose all inventions to the University of Florida's Office of Technology Licensing (see the University's Patent Policy).
2.3 Laboratory Notebook Use, Supervision, and Retention
Each technician or graduate student should have his or her own laboratory notebook, which is maintained under the supervision of the principal investigator. If each of the research projects are voluminous enough, an individual may have a different notebook for each of the different projects. The principal investigator should appropriately cross-reference his or her notebook(s) to the support person's notebook, and, if used, to a facility logbook.
The University of Florida owns all laboratory notebooks and work products of its employees, appointees, and affiliates. This ownership is required by both state and federal law (for example, as part of a federal research grant). Depending on the nature of the work product and the inventions contained therein, faculty who leave the University are permitted to copy their laboratory notebooks and take the copies with them, even when they are required to maintain the confidentiality of the data contained within the notebooks.
Graduate students working under research grants or contracts will be either employees, appointees, or affiliates of the University of Florida. However, a graduate student "owns" his or her graduate dissertation, and, therefore, a student should not be permitted to work on a research contract (as contrasted with a grant) to fulfill his or her dissertation requirements because of the conflict between the student "owning" the dissertation and the University "owning" the work product.
Depending on the nature and type of data, laboratory notebooks and other records should be retained for extended periods of time. Important laboratory records should be kept in a fireproof, locked safe. The Intellectual Property Agreement of the University of Florida, which is signed by all employees, appointees, and affiliates of the University, requires that such individuals protect and assign to the University any rights in work products, and actual or perspective patents, trademarks or copyrights on such work products. Invention disclosures must be submitted to the Office of Technology Licensing, 3rd floor Walker Hall, PO Box 115500, Gainesville, FL 32611. For a complete discussion of the invention disclosure requirements, see the Patent Policy of the University of Florida.
2.4 Record Keeping of Computer-Generated Data
In this era of computer-assisted research, many pieces of data are collected, stored, and analyzed by computer. The difficulty with such storage systems is that many people can often access the data. Thus, it is hard to prove that the data was not added to, deleted from, or in some way tampered with. In order to have computer-generated data withstand legal scrutiny (for example, in order to defend oneself against an allegation of scientific misconduct or to show that the data behind a patent was valid) one has to print out the data from the computer, bind the printed data, and sign and date each page as described above. Corroboration is also required. Small segments of data can, of course, be printed out and permanently affixed in a standard laboratory notebook, but for large volumes of data the only recourse is to print them out and bind them. Hopefully, better encryption methods will allow researchers to rely on the integrity of their computer-stored data. But for now, the courts only recognize a written printout that has been properly signed and dated and corroborated by a witness, as described above.
3. Records Can Win or Lose Patents
(This section is copied in part from "Record Keeping," Research Corporation Technologies, 1990, reprinted with permission.)
Disputes sometimes arise over who first made an invention. This issue is usually decided on the written evidence kept by the parties to the dispute. U.S. patent practice places a premium on witnessed records when two or more parties claim the same invention. The date the idea occurred, called "conception," and the date it was put into actual practice, called "reduction to practice," are vital.
But for the lack of witnessed notebooks describing his device, the man known as the inventor of the telephone would have been a talented mechanic named Daniel Drawbaugh. Although Drawbaugh was able to testify that he had talked over a crude telephone long before Alexander Graham Bell filed a patent application in 1875, Drawbaugh had not a scrap of paper dating and describing the invention. The Supreme Court rejected Drawbaugh's claim of prior inventorship in 1888 by a narrow margin of four votes to three. Similar disputes have raged over who invented the automobile, the electric light and the laser and, in all of them, records or the lack thereof played a deciding role.
The U.S. Patent and Trademark Office conducts proceedings, called interference proceedings, to determine who is the first inventor when this is in dispute. Because the first inventor must be able to prove his or her case by means of appropriate evidence, it is important to have good records of conception and reduction to practice, corroborated by witnesses other than inventors. Equally important to the U.S. Patent Office in such proceedings is the diligence shown by a contending inventor. Diligence refers to work done between the conception and reduction to practice stages of invention. A contending inventor must show work was diligently undertaken on the invention, i.e., the invention was not abandoned. This is why it is important to explain lapses in the laboratory records (e.g., "Working on other projects" or "Annual leave"). Diligence must be documented on a day-by-day basis and witnessed by a knowledgeable third party.
Proper record keeping is important for research. It is best for a laboratory to incorporate the rules described in this handout into their standard operating procedures. "Notebook witnessing day" should be a routine part of the review of the research process by the principal investigator. Also, all new technicians and graduate students should be issued their own laboratory notebook, with instructions on how to record in them.
These rules can be summarized as:
Record all laboratory information in a bound notebook, and use indelible ink. Each page of the notebook should be used. If blank spaces must be left, a line should be drawn diagonally through the blank space, and the line signed and dated. Everything must be permanently recorded. State your hypothesis, materials and methods, data and conclusions. All labels and other materials must be permanently glued into the laboratory notebook.
Each entry must be signed and dated by the person doing the work. Legal rules of evidence apply. (There are no other rules except "legal" ones.) Your reputation, career and inventions rest on your written documentation.
Corroborate all entries by an additional, knowledgeable party (e.g., the Principal Investigator) who reads, co-signs and dates all entries.
Original entries should never be erased. If a mistake is made, draw a single or double line through the mistake and sign and date the correction.
Review and retain all records. Records should be safely retained as long as necessary. For example, invention records should be retained for a minimum of 30 years. Review is important to analyze research progress, evaluate the laboratory technician's or graduate student's performance, discover trends in the data, and spark the imagination of invention.
Data generated or stored on a computer must be printed out, permanently bound, signed and dated, and corroborated.
Further information, updates, and permission to reprint this or download it may be obtained from the Office of Technology Transfer, 3rd Floor Walker Hall, 392-8929.