Transcript Document
Scientific Record
Keeping
Alan L. Goldin, M.D./Ph.D.
Laboratory Notebooks
Bound, serially numbered pages
All entries should be dated
Permanent ink
Table of contents
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
Laboratory Notebook Requirements
Can be More Detailed
Data book paper should be acid-free
Bindings should be sewn or glued
Plastic
comb, wire spiral, or ring binders are
considered unacceptable
Data books may be inventoried
Master
data book log
This policy applies in industry
Policies in Industry
Only bound laboratory notebooks are
acceptable
Entries must be countersigned weekly or
more often
The rules are stricter because the
notebooks may be used as evidence to
gain patent protection
Electronic Record Keeping
ELN – Electronic Laboratory Notebook
Database
software
Generic electronic notebooks
Scientific electronic notebooks
CENSA – Collaborative Electronic
Notebook Systems Association
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 usually overrides federal laws
Virginia
mandates that data by state agencies
must be retained for 5 years
Investigators in Virginia at state-supported
universities must follow that policy
Who owns the notebooks &
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
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)
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
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 has
moved?
Research grants are award to institutions,
not individuals
The FOIA office will send the request to
the institution
Both the FOIA office and the institution will
try to locate the PI and fulfill the request
for data
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
What if the data are in an abstract
cited in a Federal regulation?
If the abstract is based on preliminary
analyses, then the data would be excluded
If the abstract is not based on preliminary
analyses and is cited by a Federal agency
in a regulation, then the data may be
accessible
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