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The preparation and retention of appropriate records is an essential component
of a research endeavor. These endeavors include all aspects of university
research which are obtained and tested through the scientific method.
The University, its faculty and its trainees have a common interest and
a shared responsibility to assure that research is appropriately recorded,
archived for a reasonable length of time, and available for review under
appropriate circumstances. Original research records are essential to
protect intellectual property rights, to answer ongoing questions regarding
management of a research program, and to address possible questions that
may arise regarding the propriety of research conduct.
Research records include (but are not limited to) material contained in
research notes, laboratory notebooks and in other media such as computer
disks and machine printouts. Research materials or products generated
by the research may also become archived research records.
Faculty, or the responsible investigators, have the obligation to insure
that, for all aspects of their research program, sufficient records are
kept to document the experimental methods and accuracy of data collection
as well as the methods and accuracy of data interpretation. This policy
does not create an obligation to retain the research records of an unfunded
project unless it results in publication or involves the use of animals
or human subjects. Research records should be archived for a minimum of
five years after final reporting or publication of a project. The records
archived should be the originals whenever possible. In addition, the records
should be kept for as long as may be required to protect any patents resulting
from this work or required by an external funding source. If any questions
regarding the research are raised during the five year retention period,
the records should be kept until such questions are fully resolved. In
the event an investigator leaves the University for any reason, he/she
must notify his/her supervisor of the designated custodian and location
of research records covered by this policy.
The University has the right of access to the supporting records for all
research at the University or supported by University-sponsored funds
provided such access to the records shall be for reasonable cause, at
reasonable times and after reasonable notice. The University's right of
access to the data shall continue regardless of the location of the responsible
investigator. Information or data that would violate the confidentiality
of sources or subjects involved in the research should not be disclosed.
Extramural sponsors providing support for research at Duke University
may also have the right to review the data and records resulting from
that extramural support. Co-investigators and trainees who are an integral
part of a research project have the right to review all records and data
which are part of that project.
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