PERCSS
Program for the Ethical and Responsible Conduct of Science and Scholarship
DATA
MANAGEMENT: KEEPING A
MANAGEMENT: KEEPING A
RESEARCH NOTEBOOK, FILES
AND RELATED ISSUES
AND RELATED ISSUES
Good record keeping promotes
t bilit d i t it i h accountability and integrity in research
Necessary for data analysis, publication, collaboration, peer review among
others.
Necessary to support intellectual ecessa y to suppo t te ectua property claims.
Can defend you against false allegations Can defend you against false allegations of research misconduct.
Good record keeping,
contin ed
continued…
Important for the care of human subjects.
necessary for members of your group or any other researcher to be able to o a y ot e esea c e to be ab e to duplicate your work, when needed. Required by NIH and other granting Required by NIH and other granting institutions to meet policies and
standards for the conduct of good standards for the conduct of good
The lab notebook O e ie
The lab notebook: Overview
It is a record of both physical and mental activity.
Good records are complete, accurate and understandable to others.
a d u de sta dab e to ot e s
Each member of the research team is responsible for his/her records
responsible for his/her records.
The PI has the final responsibility for the laboratory records
the laboratory records.
C ie’s Notebook
Curie’s Notebook
P of X’s Notebook
Prof. X’s Notebook
Ca. 2000
Wh t i
L b N t b k?
What is a Lab Notebook?
Complete record of procedures,
reagents, data, and thoughts to pass
t th h
on to other researchers
Why experiments were initiated, how performed,
and results comments and results, comments
Place to compile data/charts/photos/ideas Place of clues, to troubleshoot problems, p Place to observe whole picture and think Legal document, to prove patents
T pe and Fo mat
Type and Format…
Ultimately dictated by your PI Ultimately dictated by your PI
Typeyp Advantagesg Drawbacks
Bound book
(stitched) No lost sheetsProof against Fraud Entered as doneNo logical order Duplicate “Bound”
Book (yellow sheets) Double record. Easy copies Diff. To Read.Not true duplicate Loose Leaf Order by expts Lost sheets
Loose Leaf (folders/notebooks) Order by expts Easy recording Lost sheets Authenticity prob. Computerp Easy to read Lost data
(ELN)
y
Easy calculations Authenticity prob
Physical Characteristics of a
Good Notebook
Good Notebook…
Large >= 8.5x11 at least
Bound (stitched) pages to ensure integrity Numbered pages
Numbered pages
Number the book Name
Dates PI
White gridded
Acid free paper (30 years)
PI
Book No.
p p ( y )
What pen is best? Roller tip in this test:
P epa ing a Ne Lab Notebook
Preparing a New Lab Notebook
Create a table of contents in the first 2 pages
List experiments by: Title
Title Date
Lab Book Number/Page Number Lab Book Number/Page Number
For Every Experiment, Record:
Start Date: on all pages
Title
Why: Brief statement of purpose, rationale
Why: Brief statement of purpose, rationale
How: Description/protocol with ref to origin Calculations, concentrations, dilutions, etc., Include sketches, diagrams
Include sketches, diagrams
What Happened:
All (protocol changes; on floor, kicked)
Taped/stabled in Information
Taped/stabled in Information
Data
Associated information: Samples, storage
l ti D t Fil Di k I
location, Data Files, Disks, Images
What It means: Interpretation (and comments)
What’s Next
Attaching mate ials
Computer generated data
Attaching materials
Computer generated data Photographic data
Printed graphs (make as you go) Datasheet templates
Product labels
Who provided plasmids, etc. Who provided plasmids, etc.
Notes (or pasted copies) of discussions, conversations, emails, readings related to exp’t design or goals
Archive locations of plasmids probes etc Archive locations of plasmids, probes, etc.
X-rays and other large items may be kept in a
Referencing attached data and
samples
samples
Name Expt/Dates Book#/page# Name Expt/Dat e Book#/pa g Name Expt/Dates Book#/page# es ge# 14 Label Notebooks, Boxes with Lab Book Book#/Page#Also eco d
Also record…
Discussions with others (time, names, issues). Good for future credit.
issues). Good for future credit.
Correspondence with colleagues (phone calls e-mails)
calls, e mails).
Names of individuals who have played any role in your research Technicians any role in your research. Technicians in core laboratories are also important
Date Title Times Data Data Calculations Interpretation Future studies
Taken from the online Linus Pauling Research Notebooks, http://osulibrary.orst.edu/specialcollections/rnb/index.html16
F eq entl Fo gotten Info
Frequently Forgotten Info…
Serum lot number Antibody titer
Oth l i l d
Growth medium used Buffer pH
C l l ti Other people involved
Centrifuge model, speed, temp Calculations Initial # cells Age/passage culture speed, temp Incubation time # washes Age/passage culture % Gel
Growth stage Bact. Tube size and type
Unexpected delays
g
The impo tance of timing
The importance of timing…
Always record, update, review…
Record as you go
Input paper towel and post-it info ASAP! Input paper towel and post-it info ASAP! At the LATEST, insert data the next day! Do a weekly checkup
1 hour to review
Make sure everything is attached securely, all
summaries written future directions written summaries written, future directions written, record in table of contents
Retractions have been associated with untimely record keeping
record keeping
If o make a mistake
If you make a mistake…
They should be marked through with a single line and a full explanation of the error provided.
Never obliterate mistakes with ink or e e ob te ate sta es t o cover them with corrective fluid.
To a casual observer these actions may To a casual observer these actions may suggest improper reasons.
Characteristics Helpful for Filing a
P t t
Patent
Patents on intellectual property are awarded not by the first to p p y y file, but “first to invent” – first to record!
Sign and date each entry
H i d d i i d d h
Have an independent witness sign and date each entry Witness cannot be co-inventor and must understand data
Do not change entries (make a new entry and cross-reference t i t )
to prior entry) Use past tense
Never remove original pages or attachments
R d ll di i / ti /id l t t th j t Record all discussions/meetings/ideas relevant to the project Record as much detail as possible
http://www.invention-protection.com/ip/publications/docs/A_Primer_On_Lab_Notebooks.html http://www uspto gov/web/offices/pac/doc/general/
http://www.uspto.gov/web/offices/pac/doc/general/
Paper vs. Electronic Lab
Notebook:
Paper notebooks have limited capacity Paper notebooks have limited capacity
Raw data is massive
Data capture is archaic
R i t t l b t d
Raw printouts can no longer be stored
Data formats are restricted
2-D gels, photomicrographs
R d k i i t di
Record-keeping is tedious
Repetitive protocols lost, require manual entries
Searching is difficult
Context of work is often lost
No connection to other people, projects, labs
Data Flow in the Laboratoryy
D t Lab Automation & Robotics Chromatography Data Systems Data Analysis Equipment Interfacing Data Warehousing Electronic Laboratory Notebooks Laboratory I t t Laboratory Information Management S t (LIMS) Mi iData Instruments Systems (LIMS) MiningData Acquisition Information Processing Knowledge Management
22
Collabo ati e ELN
Collaborative ELN
research clinician specialist nurse scientist data encoder lab technician writer lab manager statistician writerDemands for ELN:
21 CFR pa t 11*
21 CFR part 11*
FDA rule initiated August 1997
Sets standards for electronic submission Electronic records
Thoroughly validated Automatic audit trails Results can be recreated
Electronic signatures Unique identity Unique identity Linked to e-record No grandfather clause 24
*Code of Federal regulations Title 21, Part 11, Electronic Signatures
Software for ELN
Software for ELN
How long to keep notebooks
and eco ds?
and records?
NIH policy mandates 3 years after the
end of the project (grant funding period) p j (g g p )
FDA policy mandates 10 years after use
P t t li d t 23 ft
Patent policy mandates 23 years after
issue of the patent.
The organization with the longest policy
has priority p y
Who owns notebooks and
data?
data?
When NIH awards a research grant to a university, any and all data collected as part of that funded project are owned by the grantee institution.
Data books of all investigators (PI,
postdocs, grad students, technicians)
postdocs, g ad stude ts, tec c a s)
Who owns notebooks and
data?
data?
The principal investigator is the steward.
If the PI resigns or moves to another institution:st tut o
Equipment and all data belong to the initial
institution.
Permission can be obtained to transfer the
award, equipment and data.q p
Resea ch data do not incl de
Research data do not include:
Preliminary analyses Drafts of papers
Drafts of papers
Plans for future research Peer reviews
Peer reviews
Physical objects (samples, tapes) Trade secrets or commercial
Applicabilit of
les
Applicability of rules
Data produced with Federal support that are cited publicly and officially.
Data collected by institutions of higher education, hospitals, and non-profit institutions
l d l l
Does not apply to state and local govt
Does not apply to commercial organizations
Applies to new and competing awards made after the effective date of the amendment (11/8/1999)
P blic Access to Data
Public Access to Data
The Office of Management and Budget (OMB) revised the regulations regarding public access to experimental data in
1999
The public can obtain access to
experimental data through the Freedom experimental data through the Freedom of Information Act (FOIA)
What happens if the PI
ef ses to compl ?
refuses to comply?
This is view as a material failure to comply with the terms of the award NIH would initiate appropriate
enforcement action e o ce e t act o
This could include withholding future support to the institution
support to the institution
Consequences of Research
Mi
d t
Misconduct
Debarment from eligibility to receive Federal f d
funds
Prohibition from service on advisory
committees, peer review committees, or as committees, peer review committees, or as consultants
Certification of information sources that is forwarded by the institution
forwarded by the institution
Certification of data by the institution Supervision by the institution
Supervision by the institution
Submission of a correction or retraction of a published article
Best practice principles for
leade s of esea ch g o ps
leaders of research groups:
Set standards and provide examples of good record keeping practices for the group
Provide tools for good record keepingo de too s o good eco d eep g Provide training for the group and
review records review records
Clarify data and research ownership and access rights
access rights
Institutional Best Practice
P inciples WUSTL
Principles: WUSTL
“It is the policy of WUSTL to publish
research results and to foster the use of University inventions, discoveries and and other works for the common good ”
other works for the common good. Intellectual Property Policy
With care and attention to our
o k e sho ld a oid
work we should avoid…
RETRACTION
“We wish to retract our report (Science 2004;
303 371) i hi h d h β N
303, 371) in which we reported that β -N-acetylglucosamine-serine can be
bi th ti ll i t d t d fi d it i biosynthetically incorporated at a defined site in myoglobin in E. coli. …
RETRACTION
RETRACTION…
Regrettably through no fault of the authors Regrettably, through no fault of the authors, the lab notebooks are no longer available to replicate the original experimental conditions replicate the original experimental conditions, and we are unable to introduce this amino acid into myoglobin with the information and
into myoglobin with the information and reagents currently in hand…”
Z Zhang et al UT at Austin Z. Zhang et al., UT at Austin.
Notebook Ethics
Notebook Ethics
"Many people say that it is the intellect which makes a great scientist. They are wrong: it is character." -- Albert
Einstein
Resea ch Integ it
Research Integrity
h Off f h d f
The NIH Office of Research Integrity defines misconduct in science as:
“Fabrication, falsification, plagiarism, or other ab cat o , a s cat o , p ag a s , o ot e
practices that seriously deviate from those that are commonly accepted within the scientific
community. This does not include honest error or
h t diff i i t t ti j d t
honest differences in interpretations or judgments of data.” (Federal Register 54:32446-32451, Aug 8, 1989)
“Th i t it f h d d
“The integrity of research depends on
accurate, detailed, organized, complete, and accessible data” Office of Research Integrity
Tips to P ese e Data Integ it
Tips to Preserve Data Integrity
Never, ever, remove a pagee e , e e , e o e a page Fill consecutive pages
Cross out unused parts of pagesp p g
Record all info as accurately as possible.
Do NOT omit any result, no matter how odd. Cross out mistakes lightly (might need to recover)
l bl Write legibly
Put a full date (international date problems…) with month spelled out
with month spelled out.
Mo e Helpf l Tips
More Helpful Tips
The institution owns “your” notebook
The institution owns your notebook
Do NOT remove your notebook from the lab
( l thi i t bl l b ti )
(unless this is an acceptable lab practice) You may get permission to take copies at graduation but do not take original pages graduation, but do not take original pages Do NOT read another person’s notebook
without permission (even the PI won’t look at without permission (even the PI won t look at advanced researcher’s notebooks secretly).
Data manip lation
Data manipulation
“Data may be excluded from the “Data may be excluded from the
i l l l if h
i l l l if h
experimental results only if you have experimental results only if you have
a sound reason to do so!” a sound reason to do so!”
Mother Nature Mother Nature
misleading presentation of
d t f
d t
t
data from data management
errors
errors
Number of animals vs. number ofdeterminations
Non-standard normalization
Not showing entire gel
Varying exposures of imagesAs photographed As photographed Brightness Brightness--Contrast Contrast Adjustment Adjustment 44
As photographed As photographed
Erasing Erasing
The Journal of Cell Biology: The Journal of Cell Biology: The Journal of Cell Biology: The Journal of Cell Biology:
•• revokes the acceptance of about 1% of its revokes the acceptance of about 1% of its papers due to inappropriate image
papers due to inappropriate image papers due to inappropriate image papers due to inappropriate image manipulation
manipulation
•• 25% of accepted papers have at least 1 figure 25% of accepted papers have at least 1 figure pp p pp p gg with undocumented manipulation
with undocumented manipulation
“If you misrepresent your data you are deceiving “If you misrepresent your data you are deceiving
people.” people.”
Rossner, M. (2006). The Scientist
Rossner, M. (2006). The Scientist 2020:24:24--25.25.
What can I do?
Nature, instructions to authors (2006)
What can I do?
• List all image acquisition and processing tools and software
• Document key image-gathering setting and y g g g g manipulations in the Supplemental materials
• Clearly demarcate borders between images collected at different times
different times
• Avoid use of touch up tools or deliberately obscuring parts of an image
bl l f l d h • Processing is acceptable only if applied across the
entire image
• Be prepared to deliver the original, unprocessed images p p g , p g to the editor
Slide so ces
•
Gail P Taylor PhD and AngelinaSlide sources:
Gail P. Taylor PhD and Angelina Hoefle, UT San Antonio
•
Carmen S Dence MS Washington•
Carmen S. Dence MS, WashingtonUniversity
Ed d K PhD M di l C ll
Ed d K PhD M di l C ll
••
Edward Krug PhD Medical College Edward Krug PhD Medical Collegeof South Carolina of South Carolina
•
Douglas Perry PhD,Acknowledgements and
Refe ences
References
Kathy Barker, At the Bench: A laboratory Navigator. Cold Spring Harbor Laboratory press. 1998.y p
Guidelines for Keeping a Laboratory Record. David Caprette, Rice University. http://www.ruf.rice.edu/~bioslabs/tools/notebook/notebook.html Guidelines for Keeping a Laboratory Notebook. Colin Purrington, Swarthmore Univ
Swarthmore Univ.
http://www.swarthmore.edu/NatSci/cpurrin1/notebookadvice.htm
Laboratory Record Keeping. Todd E. Garabedian, Nature Biotechnology v. 15 (August 1997) pp.799-800
http://biotech about com/gi/dynamic/offsite htm http://biotech.about.com/gi/dynamic/offsite.htm
Office of Research Integrity, U.S. Dept. of Health and Human Services http://www.unh.edu/rcr/
Responsible Conduct of Research Online Study Guide. Julie Si U i it f N H hi
Simpson, University of New Hampshire http://www.unh.edu/rcr/
Francis L. Macrina, Scientific Integrity: An Introductory Text with Cases. ASM Press. 2000.
Academic Research Record keeping: Best Practices for Individuals Academic Research Record-keeping: Best Practices for Individuals, Group Leaders and Institutions. Academic Med. 81, 42-47; 2006,
