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
