GUIDELINES FOR KEEPING LABORATORY NOTEBOOKS
This paper highlights a few of the most important procedures to keep in mind when recording
research data: it is not meant to be exhaustive; nor does it address every situation which
might arise. Good judgement must prevail in producing an accurate, reliable and coherent
record of experimentation. It is worth noting that proper verification and transparency in
research is becoming increasingly important in supporting the validity of results and proving
inventorship.
Why maintain detailed laboratory notebooks?
A well-maintained and properly documented laboratory notebook establishes a permanent
record of research protocols and results which can be referred to in the future, most
commonly in the preparation of scientific papers and reports. Additionally, it can be an
invaluable source of information for a variety of purposes, including determination of claims
of discovery where new inventions are concerned; demonstration of adherence to standards of
good practice, and of academic and ethical integrity; and compliance with contractual
provisions permitting sponsors to audit work carried out in pursuit of sponsored research.
1.
Determination of claims of discoveries
Laboratory notebooks provide important documentary evidence of the conception and
reduction to practice of an invention. In the US ‘invention’ comprises both elements:
‘conception’, the formulation of the complete means for solving a problem in such a
way that one of ordinary skill in the art could practice the invention without unduly
exercising extensive research or experimentation; and ‘reduction to practice’, the
making and testing of the invention, and determining that it will work for its intended
purpose. Generally a sketch and a brief written description are sufficient to establish
‘conception’. ‘Reduction to practice’, however, can be ‘constructive’ (by filing a
patent) or ‘actual’ by the construction and successful testing of a prototype of the
invention. In either case it requires convincing, corroborating evidence of diligence (i.e.
constant progress from the conception of an invention). A well-maintained laboratory
notebook can provide such evidence if the need arises.
2.
First to Invent: practice in the US
Unlike the practice in the UK and Europe, whereby a patent is awarded based on the
first to file a patent application citing the new technology, US patent law requires that
inventors satisfy its ‘first to invent’ criteria. This system relies heavily upon the
production of clear, convincing, documentary evidence to support the precise timing of
an invention and/or its reduction to practice. Properly maintained laboratory notebooks
are critically important to this process. A detailed description of the research
undertaken during the course of the project, which can be relied upon and referred to at
a later stage to establish the date of an invention, is essential if it is deemed appropriate
and desirable to seek patent protection in both the US and the UK.
3.
Verification or reproduction of important procedures
A successful laboratory notebook allows for ready verification of quality and integrity
of research data and enables another investigator to reproduce the procedure which has
been documented and get the same result. Entries which are fragmentary, or so difficult
to follow that they can be interpreted only by the author, are of little practical use.
Student laboratory notebooks should permit the supervisor to identify what step, or
steps, in a procedure might introduce discrepancies, and to advise on potential
solutions.
4.
Support for publications; defence against claims of scientific misconduct
Laboratory notebooks supply the necessary background data and evidence for scientific
publications, and can be used to defend against claims of scientific misconduct. Even if
a patent application is not filed on the subject-matter of a research project, it may still
be necessary to establish when and where an invention occurred (e.g. in any patent
infringement litigation).
5.
Adherence to Good Laboratory Practice
Laboratory notebooks can be used to demonstrate compliance with appropriate health
and safety regulations and conformity with other good practice guidelines. Special
attention should be paid to recording the use of potentially hazardous substances and
proper adherence to Standard Operating Procedures for routine methods and use of
items of equipment.
6.
Compliance with sponsored-research audit requirements
If research is being undertaken with the benefit of third-party funding there are often
additional obligations placed on the institution, or investigator, to provide an adequate
record of work done during the course of the project. Similarly, research councils, or
other government agencies may impose regulatory requirements for certain types of
records to be retained by the institution (e.g. research records relating to clinical or
public health studies should be retained for twenty (20) years to provide scope for
follow-up if necessary).
Retention of laboratory notebooks following their completion
Once a laboratory notebook has either been completed or the researcher has left the
Department, the notebook should ideally be retained for a minimum of six years, ideally
longer if possible. This is aimed to ensure that full details of the research in question can be
accessed in the future to provide evidence in support of an invention, a publication or
adherence to appropriate procedures. If a laboratory notebook contains details of an invention
which has been patented, Isis Innovation should be consulted before the notebook is disposed
of, regardless of the time period which has lapsed. In this way Isis Innovation can provide
evidence of the University’s claim to a piece of IP, should this become necessary.
Practical suggestions for keeping a laboratory notebook:
• Pages should be bound and numbered sequentially. Loose-leaf notebooks should
be avoided and permanent bindings used to avoid any suggestion that pages
might have been removed or inserted. Laboratory notebooks in a series should
also be numbered sequentially.
• There should be at least two copies of every notebook: one for the researcher and
one for the University. In principle, the University (through the relevant
department) should retain the original version of all laboratory notebooks, but if
this is not practical, the copy retained by the University should be a certified
copy.
• Dates should be recorded unambiguously (i.e. 8 July 2002 not 8/7/02 or 7/8/02)
to avoid confusion arising if the dates are written in the UK and read in the US.
• Corrections should be clearly visible and struck through with a single line.
Irreversible substances (such as Tipp-ex) should not be used.
• Entries (made in indelible ink and not pencil) should be consistent and
continuous. Spaces and other anomalies should be clearly explained in the text.
• Ideas should be recorded contemporaneously to the extent possible.
• Entries should be signed and dated promptly and absences for a period of time
noted appropriately.
• Entries should be witnessed and corroborated regularly by a scientist who is not
working on the same project, but who is competent to understand the work.
• Ideas should be expressed in a clear narrative style. Each individual entry should
be intelligible to another investigator without specific explanation.
• Investigators working together on a joint project should each maintain a separate
record of the research project.
• Electronic notes should be avoided. However, if such notes are taken hard copies
of the entries should be printed out regularly, signed, dated and affixed to
consecutive pages of a bound notebook.
• All labels, gels and diagrams should be permanently affixed in the notebook.
Temporary measures such as staples or paperclips should not be used.
• Entries should never be changed or added to at a later date.
Useful Sources of Information
Research Council Guidelines
Biotechnology and Biological Sciences Research Council guidelines on good scientific
practice
www.bbsrc.ac.uk/funding/overview/good_practice.pdf
Engineering and Physical Sciences Research Council guide to good practice in research
http://www.epsrc.ac.uk/researchfunding/infoforgrantholders/guidetogoodpracticeinscienceandengineeringresea
rch.htm
Economic and Social Research Council rules for safe guarding good scientific practice
http://www.esrcsocietytoday.ac.uk/ESRCInfoCentre/opportunities/research%5Fethics%5Fframework
Medical Research Council guidelines on good research/clinical practice and scientific
misconduct
www.mrc.ac.uk/prn/index/funding/funding-terms_and_conditions/fundingterms_and_conditions_masterprint.htm
Patent Offices
UK Patent Office – www.patent.gov.uk
Advice on IP from the UK government - www.intellectual-property.gov.uk
European Patent Office - www.european-patent-office.org
World Intellectual Property Organisation - www.wipo.int
US Patent and Trademark Office - www.uspto.gov
Miscellaneous
British Technology Group guidelines on laboratory notebooks
http://www.btgplc.com/newsevents/news.cfm#labnotebook
Reprint of a Nature Biotechnology article on laboratory record keeping
www.wiggin.com/pubs/articles_template.asp?ID=102187242000
Kanare, Howard M: Writing the Laboratory Notebook. Washington D.C.: American
Chemical Society, 1985. ISBN0 8412 0933 2