Scientific Record Keeping do and don't issues to conduct good ...

Scientific Record Keeping
do and don’t issues to
conduct good science
Carmen S. Dence, MS

Good record keeping (GRK)
promotes accountability and
integrity in research
• GRK is necessary for data analysis,
publication, collaboration, peer review
among others.
• GRK is necessary to support intellectual
property claims.
• Can defend you against false allegations
of research misconduct.

Continue…
• GRK is important for the care of human
subjects.
• GRK is necessary for members of your
group or any other researcher to be able to
duplicate your work, when needed.
• GRK is required by NIH and other granting
institutions to meet policies and standards
for the conduct of good science

Data Authenticity and Integrity
• Authentic data represent the true results of
work and observations.
• Carelessness, self-deception, deliberate
misrepresentation will cause authenticity to
be lost .
• Integrity is dependent on results being
collected using well-chosen scientific
methods carried out in the proper manner.

What is really a lab book?
• Is a record of both physical and mental
activity.
• Good records are complete, accurate and
understandable to others.
• Each member of the research team is
responsible for his/her records.
• The PI has the final responsibility for the
laboratory records.

Laboratory Notebooks
• Who did it.
• What you did.
• When you did it.
• What project the research was part of.
• How you did it (methodology).
• What materials were used.
• Findings.
• Your interpretation.
• The next step.

Laboratory Notebooks
• Bound, serially numbered pages
• All entries should be dated
• Permanent ink
• Table of contents- First few pages
• Include the actual data, such as
photographs, negatives, autoradiograms
and printouts

Data in Laboratory Notebooks
• Original data should be included.
• Photographs, negatives and similar can be
glued or taped.
• Other materials can be inserted in plastic
sleeves (including CD or DVD).
• Oversize material and magnetic media
should be stored, with the location and
coding scheme included in the lab book.

Electronic Record Keeping
• ELN – Electronic Laboratory Notebook
Database software
Generic electronic notebooks
Scientific electronic notebooks
• CENSA – Collaborative Electronic
Notebook Systems Association

The loose-leaf notebook
• The use of a ring-binder and loose-leaf
sheets in acceptable for many academic
investigators.
Can be used as a supplement to bound NB
Loose sheets should be dated and added to
the binder in chronological order, to meet
standards of good science and assure
research integrity.

Every lab book must include
• Subject matter.
• Experimental details.
• Sketches, diagrams.
• Control conditions.
• Test results and their explanations.
Conclusions should be short and supported
by the factual data.

It is desirable to record…
• Discussions with others (time, names,
issues). Good for future credit.
• Correspondence with colleagues (phone
calls, e-mails).
• Names of individuals who have played
any role in your research. Technicians in
core laboratories are specially important

So…you made 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
cover them with corrective fluid.
• To a casual observer these actions may
suggest improper reasons.

How long to keep
notebooks?
• NIH policy mandates 3 years after the end
of the project (grant funding period).
• FDA policy mandates 10 years after use.
• Patent policy mandates 23 years after
issue of the patent.

How long to keep notebooks?
• The organization with the longest policy
has priority.
• State law when present, usually overrides
federal laws.

Who owns the notebooks and
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) are
the property of the institution.

Who owns the notebooks and
data?
• The principal investigator is the steward.
• If the PI resigns or moves to another
institution:
Equipment and all data belong to the initial
institution.
Permission can be obtained to transfer the
award, equipment and data.

Applicability
• Data produced with Federal support that are cited
publicly and officially.
• Data collected by institutions of higher education,
hospitals, and non-profit institutions
Does not apply to commercial organizations.
Does not apply to state and local governments
• Applies to new and competing awards made after
the effective date of the amendment (11/8/1999)

Research Data
• Recorded, factual material commonly
accepted in the scientific community as
necessary to validate research findings.
• Published
Peer-reviewed scientific or technical journal.
Cited by a Federal agency publicly and
officially.

Research Data Do Not Include:
• Preliminary analyses
• Drafts of papers
• Plans for future research
• Peer reviews
• Physical objects (samples, tapes)
• Trade secrets or commercial information

Record Keeping in
Clinical Research
Clinical data carries additional
responsibility:
• Patient privacy and confidentiality.
• Civil and criminal penalties associated with
violations of the Privacy Act.
•The PI of the study has ultimate responsibility
for all clinical research records.

Witnessing Data
• Less common in the academic world.
• A funding agency may require it for
contract work such as clinical testing.
• Bridging basic and applied research may
require it.
• Witnessing of data is necessary if the work
may lead to a patentable discovery or
invention.

Witnessing Data
• The witness must be able to understand
the work.
• The witness must not be a co-inventor.
• Co-inventors are not allowed to
corroborate each other’s work.
• Another worker in the same lab could sign,
assuming he/she understood the work but
was not involved with it.

Public Access to Data
• The Office of Management and Budget
(OMB) revised the regulations regarding
public access to experimental data in 1999
Circular A-110 included the revisions.
The public can obtain access to experimental
data through the Freedom of Information Act
(FOIA).

FOIA Request Must Include:
• Specific regulation or order citing the data
• Publication cited
• Grant number
• Description of the data being sought
• A statement that the data are being
requested under the amendment to
Circular A-110

What happens if the PI refuses
to comply with the request?
• This would be viewed as a material failure
to comply with the terms and conditions of
the award.
• NIH would initiate appropriate enforcement
action.
This could include withholding future support
to the institution.

Best Practice Principles for
Leaders of Research Groups
• Set standards for record-keeping practices
in their group.
•Provide/assure training for group members
•Emphasize the benefits of GRK and the
problems with poor practices.
•Provide examples of GRK practices.
•Clarify data and research record ownership
and access rights.

Best Practice Principles for
Leaders of Research Groups
• Perform periodic reviews of the
records of members of your group.
•Delegate, as needed, oversight and
training duties for group records to
senior members.
•Provide the tools for GRK.
•Require adherence to GRK by group
members.

Best Practice Principles for
Leaders of Research Groups
• Promote communication of research
information within the group.
•Have a plan to assure the transmission
of important research information from
departing group members.
•Update records standards as needed.

Best Practice Principles for
Department/School Level
• “It is the policy of WU-STL to publish
research results and to foster the use of
University inventions, discoveries and
other works for the common good..” An
18-page document is available:
•Intellectual Property Policy:
www.wustl.edu/policies/intelprop.html

With care and attention to
our work, we should avoid
RETRACTION
“We wish to retract our report (Science 2004;
303, 371) in which we reported that β-Nacetylglucosamine-serine
can be
biosynthetically incorporated at a defined site in
myoglobin in E. coli.

RETRACTION…
Regrettably, through no fault of the authors,
the lab notebooks are no longer available to
replicate the original experimental conditions,
and we are unable to introduce this amino acid
into myoglobin with the information and
reagents currently in hand…”
Z. Zhang eta l., UT at Austin.
Science 2009; 326, 1187.

Sources of Information
• Guidelines for Scientific Record Keeping in
the Intramural Research Program at the
NIH.
• Scientific Record Keeping. Alan L. Goldin
• Academic Research Record-keeping: Best
Practices for Individuals, Group Leaders
and Institutions. Academic Med. 2006;81,
42-47.
• Scientific Record Keeping. Francis L.
Macrina. Chapter 11, pp231-256.

Additional Sources of Information
• Responsible Conduct of Research
Education Consortium (RCREC) Web Site
• Office of Management & Budget Circular A-
100 (section 36)
• NIH Working Group Report on Research
Tools
• Kanare HM. 1985. Writing the Laboratory
Notebook, ACS, Washington, D.C.