Day-to-day record keeping the lab notebook
Why keep daily records?
• To establish good work practices
• To teach the people in your lab
• To meet contractual requirements
• To avoid fraud
• To defend patents
• To allow work to be reproduced by others
• To facilitate preparation of formal reports, presentations and papers
• To validate your research
• To serve as a source for assigning credit to lab members
In this stage of an investigation, reseachers have to be extremely clear, both to themselves and to others, about the methods being used to gather and analyze data. Other scientists will be judging not only the validity of the data but also the validity and accuracy of the methods used to derive those data. The development of new methods can be a controversial process, as scientists seek to determine whether a given method can serve as a reliable source of new information. If someone is not forthcoming about the procedures used to derive a new result, the validation of that result by others will be hampered. From: On Being a Scientist: Responsible Conduct of Research, National Academy of Sciences, 1995. |
Tracking and storing information
Notebooks should err on the side of completeness. Someone from outside your lab should be able to read what was done without your verbal interpretation.
Lab notebooks are designed to be used for:
• Gathering information
- Rationale (Why was this done?)
- Detailed methods (Exactly and precisely what was done?)
- Details on processing raw data
- All scientific data both positive and negative
• Forming hypotheses
- (What ideas are you forming? Who originated the idea?)
• Designing experiments
• Observing results
- Both positive and negative results should be recorded
• Recording the use and locations of materials
- Lists of specimens and reagents
- Information about Instrument s
• Permanently affixing extrinsic data such as charts and pictures
• Teaching tools for grad students, postdocs, and technicians in how to:
• Analyze data
• Construct new theories
• Retrace their steps to identify errors
Meeting contractual requirements
Both explicit and implicit obligations to keep detailed records for:
• Grants
• Contracts
• Patent applications
• NIH, e.g., has the legal right to audit and examine records relevant to any research grant award
Whenever research is done with third party funding, there will be additional obligations placed on the investigator or institution. The Principal Investigator will bear the responsibility for complying with the requirements for data gathering, storage, and protection.
US patent law currently follows a first to conceive or “first to invent” framework. Documentation to support the date of discovery or invention is especially critical for this type of framework. The technology industry is currently lobbying for overhauling the U.S. patent laws related to “first to invent”. It wants to shift to the “first to file” method used in most other countries. See: “ Senators offer sweeping patent system changes ” from an August 2006 News.com report.
Avoiding fraud
Lab directors are responsible for lab integrity. Progress of activities in the laboratory can be followed and documented via accurate laboratory notebooks.
Periodic checks of raw data in lab notebooks can help:
• Uncover and correct carelessness
• Uncover and correct outright fraud
• Safeguard against fraud
• Defending patents
“ Research fraud needn't happen at all ” is the name of a February 2002 article from the APA's Monitor on Psychology. The article points out that though research fraud is rare; there exists the perception that it is more common. Each case that comes to light does damage to the credibility of researchers. By carefully supervising your lab you can avoid one of these damaging situations.
See the following articles for other examples of research integrity in the news:
• Faked Research Results on the Rise? Wired News, July 10, 2005
• Truth and Consequences , Science Magazine, December 2006
Good practices for laboratory notebooks
• Permanently bound book (not spiral)
• Pages should be consecutively numbered
• Dated entries
• Signed entries
• Record entries chronologically
• Recorded in English
• Each entry should stand on it's own
• Organize material with sections and headings
• If a page is left blank draw a line through it
• Identify material sources (e.g. manufacturer, lot number, expiration date)
• Identify and describe reagents and specimens
• Include instrument serial numbers and calibration dates
• Explain nonstandard abbreviations
• Use permanent ink – don't remove pages or obliterate original entries
• Use glue to permanently attach graphs computer printouts etc. to the notebook (sign & date)
• Outline new experiments, include objectives & rationale
• Include periodic factual summaries of findings
• Enter observations immediately
• Summarize discussions from lab meetings and ideas made by others citing the person's name
Who owns the data?
This is an important question to answer before you begin gathering data. It would seem that the one who conducts the research would own the data but that is almost never the case. The one who funds the research is usually the owner. This gets complicated when funding comes from more than one source and careful attention to the obligations of any grants or contracts is paramount.
Grant or Contract? With government funding, it is important to distinguish between grants and contracts. Under grants, researchers must carry out the research as planned and submit reports, but control of the data remains with the institution that received the funds (see below). Contracts require the researcher to deliver a product or service, which is then usually owned and controlled by the government. if your research is supported with government funds, make sure you know whether you are working under a grant or a contract. The difference is significant and could determine who has the right to publish and use your results. ORI: Introduction to the Responsible Conduct of Research: Nicholas H. Steneck, Illustrations by David Zinn. |
Address ownership issues for each of the following parties:
• The PI and co-PIs, especially in collaborative projects
• All involved in the lab
• The institution
• The funding agency
• Research subjects and entities
Accessibility to data can be arranged for non-owners.
• The Bayh-Dole Act (Public Law: 96-517) specifies that universities, small businesses and non-profit institutions are to have access to any data they generate using federal funds. This provides them incentive to continue their research.
• Some researchers are allowed to take data with them when they change institutions. This is not always the case and should be agreed upon ahead of time.
When is a witness warranted?
• When you think you have conceived an invention
• When an idea may have intellectual property value
• When the idea is put into actual practice
A witness must be someone who is not involved in your work but one who has enough scientific understanding to explain your idea. The date of the witnesses' signature becomes the date of invention.
Where and how long should you keep laboratory notebooks?
• Lab notebooks “in progress” – kept at the bench
- Fireproof files could be used for extra protection
• Completed lab notebooks – kept in central repository
- A check out system should be implements
- Original notebooks normally stay at the institution where the data was generated
- There may be an occasion for a departing investigator to take primary data or unique reagents with them. Arrangements need to be made for their safe-keeping and for their availability to appropriate others.
• Generally kept for at least 5 years after the study ends.
• For patented items – generally keep for the life of the patent plus six years
These are general guidelines. You should, however, always check with your institution for policies on data storage and ownership. Also check on regulations related to grants, contracts and patents.
What is the best way to assure the physical quality of records?
- Printed records
- Write in ink
- Use acid-free paper
- Store at 21 degrees C at about 50% humidity
- Electronic records
- CD-ROMs and DVDs have a 200 year shelf life
- Stored in the dark
- Stored at 25 degrees C and 40% relative humidity
- Floppy Disks only last about 3 years