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CAROLINA UNIVERSITY
POLICY ON THE CUSTODY, RETENTION, TRANSFER AND ACCESS TO RESEARCH
DATA AND RECORDS
Approved by the Research Ethics Oversight Committee
October 25, 2001
and in revised form June 27, 2002.
Approved after further revisions by the Faculty Senate Governance
Committee Dec 11, 2002
And by the Faculty Senate January 28, 2003
PURPOSE
The
preparation and retention of accurate and appropriate records are
essential components of a credible research endeavor. East Carolina
University, its faculty, its staff, and its students have a common
interest and a shared responsibility to assure that research data
and records are recorded appropriately, archived for a reasonable
length of time, and available for review by scholars and others
under appropriate circumstances. Original research records are also
essential to protect intellectual property rights, to answer ongoing
questions regarding the management of a research program, and to
address questions that may arise regarding the propriety of research
conduct and methods. This policy defines the nature of research
data and its associated records. It also describes the importance
of good data and record keeping for obtaining and defending intellectual
property rights, and the procedures to be used for the custody,
retention, access, and transfer of research data and records.
This policy shall apply to all faculty, staff, and students of
East Carolina University who are involved in the design, conduct,
and/or reporting of research at or under the auspices of East Carolina
University, regardless of source of funding.
DEFINITION OF RESEARCH DATA AND RECORDS
Research data and records refers to recorded information, regardless
of its form or the media on which it may be recorded, which is necessary
for the reconstruction and evaluation of the reported results of
a research project. Research data and records include more than
just primary data (e.g., raw numbers generated by a measuring instrument;
audiotapes or transcripts of survey interviews). They also include
documentation or citation of a) the experimental methods for data
collection, and b) the methods used for data processing and interpretation.
In practice, they include, but are not limited to, the material
contained in laboratory notebooks or other media such as computer
disks and machine printouts. The term does not include the intellectual
property generated by a research project; administrative information,
such as financial data; or the tangible products of research, e.g.,
tissue banks, specialized tools or chemicals produced by the project.
(Ownership and disposition of intellectual property or the tangible
products of research are covered by other ECU policies.)
INTELLECTUAL PROPERTY ISSUES INVOLVING RESEARCH DATA AND
RECORDS
Retention of maximum intellectual property rights places additional
importance on the preparation and retention of research data and
records. Documented research records are important in determining
priority of research data, such as identifying who first conceived
an invention or in defending against patent infringement. In order
to protect the rights of investigators and the University to the
intellectual property generated by their research programs, university
technology transfer managers recommend specific record keeping and
retention practices such as the use of bound laboratory notebooks.
Maintaining good data records is recommended for all university
laboratories, but is essential for any patentable or licensable
research activity. Responsible faculty should be aware of and follow,
as closely as possible, the record-keeping recommendations described
in Addendum B. Section II of the OPERATIONAL PROCEDURES FOR IMPLEMENTATION
OF FACULTY MANUAL PART VII, SECTION II (Regarding Inventions, Patents,
and Technology Transfer) Approved October 22, 1999. (See: http://www.research2.ecu.edu/ott/operating.html
)
The data management approaches above will also help defend an investigator
and his/her work if there is an allegation of misconduct regarding
this research.
CUSTODY OF RESEARCH DATA AND RECORDS
By tradition, and for practical reasons, custody of original research
data and records shall be with the senior investigator of a project,
usually a faculty member. This senior investigator (the responsible
investigator) shall insure the integrity, preservation and security
of the original research data and records. Expenses of data and
record preservation and security are allowable costs to sponsored
programs. As an aid to scholars and other appropriate individuals
who may wish to review the research data and records, they should
be appropriately organized and labeled to allow the identification
of specific information within the records by someone who was not
involved with the original project.
In situations where the designated ECU Integrity Officer has received
an substantive allegation of research misconduct pursuant to ECU
policy (Faculty Manual Part VII Section VI) or when patent litigation
is imminent, the University may take immediate and preemptory custody
of the original research data and records relating to the allegation
or the patent. In this circumstance the University shall provide
needed copies of data and records to the investigator that will
allow active research projects to continue.
In multi-institutional studies, contractual agreements often stipulate
that the home institution of the primary study director shall have
custody of original primary data from all participating institutions.
In situations where ECU is not the site of the home institution
and will need to transfer the original data to the institution of
the study director, ECU shall retain a true copy of all data and
records generated for the multi-institutional study.
Senior members of research teams have obligations to discuss the
responsibilities of data management and retention with other members
of the research team and to directly oversee the data and record
management of the technicians, post-doctoral fellow, students, and
others working under their direct supervision.
ACCESS TO RESEARCH DATA AND RECORDS
The University has the right of access to and to make copies of
the data and records for all research performed at the University
or under University auspices provided such access to the records
shall be for reasonable cause, at reasonable times and after reasonable
notice (except in cases of misconduct allegations, see below). For
example, the University Medical Center Institutional Review Board
and the Brody School of Medicine Compliance Office acting for the
University may review records and study data of projects that use
human subjects to assure compliance with human subjects protection
regulations. In cases involving an allegation of research misconduct,
the University Integrity Officer or his designee may request immediate,
preemptory access and custody of original research records. When
such records contain confidential information about human participants
in research, the Vice Chancellor shall institute appropriate procedures
to assure that participant confidentiality is maintained while the
research records are in his custody.
Extramural sponsors providing support for East Carolina University
or appropriate governmental officials also have the right to review
the data and records resulting from that extramural support. In
addition, investigators, co-investigators, students, visiting researchers,
and students who are or were an integral part of a research project
team have the right to review all records and data which are part
of that project, or which support publications for which they are
named authors. Similarly, investigators, co-investigators, students,
visiting researchers, and students have a right to a copy of data
that they personally generated or substantially analyzed unless
prohibited by law, regulation, or contractual agreements. The responsible
investigator in addition has the right to distribute to other scholars
or individuals copies of any part the research records in his custody
per the general practices of his/her field of study unless prohibited
by law, regulation, or contractual agreements.
RETENTION OF RESEARCH DATA AND RECORDS
Research data and records, including the primary experimental results,
should be retained for a sufficient period to allow evaluation and
repetition by others of published results emanating from those data.
In general, three years from the first publication date of the research
results is specified as the minimum period of retention for research
published in peer-reviewed journals. For sponsored research that
is not published, the minimum retention period is three years from
the date of the issuance of the final report to the research sponsor,
unless the sponsor specifies a longer retention period. However,
if an investigation, legal action or an official inquiry concerning
a research project is underway, all data and records related to
the project must be retained and made accessible until all issues
are resolved. In addition, the records should be kept for as long
as may be required to protect any patents or other intellectual
property resulting from this work. If a research project is not
funded with external or designated internal funds (e.g., an internal
university grant), the above retention policy shall apply to these
research data and records only when the project results in a publication;
its data is used to support a grant or contract application; or
it involves the use of animal or human subjects.
TRANSFER OF RESEARCH DATA AND RECORDS THAT SUPPORT UNIVERSITY
PATENTS OR WERE FUNDED BY FEDERAL GRANTS & CONTRACTS
Pursuant to federal regulations (OMB Circular A-110, section 53)
and the need of the University to protect its patent rights, original
research data and records that support university patents or were
funded by federal grants and contracts must remain in the custody
of the University for the required retention period as discussed
above. In the event the responsible investigator transfers to another
institution or leaves the University for any reason, the responsible
investigator shall transfer custody of these original research data
and records to the University. Exceptions to this policy are discussed
at the end of this section. The responsible investigator, however,
may make a copy of the data and research records at University expense
for his/her personal use at a new institution unless prohibited
by law, regulations or contractual agreements. Before his/her departure,
the responsible investigator shall transfer custody of the original
research data and records to his/her department chair or supervisor
as required by this policy. These records shall be retained in the
University Archives of Joyner Library pursuant to the retention
paragraph above. These data and records shall be organized in a
format to permit reasonable identification of specific experiments
and data by individuals not involved with the original research.
These research data and records shall be used by the University
only for patent litigation, misconduct inquires and investigations,
or for other purposes required by federal regulations for US government
funded research.
Exceptions:
1) Currently Active Federal Grants and Contracts: If the responsible
federal agency allows the transfer of an active grant or contract
to the new institution of the principle investigator, and the new
institution accepts the administrative responsibility for the federal
award, the original research data and records may be transferred
to the new institution upon the request of that institution. The
University, however, shall retain a true copy, made at University
expense, of all research records produced while the research project
was active and under ECU jurisdiction.
2) Faculty Request for Transfer of Original Records: Per OMB Circular
A-110 section 53c, a faculty member may request authorization from
the responsible federal agency to substitute true copies of the
research data and records in the University Archives in place of
the originals. If so authorized, the investigator may then transfer
his/her original data and records to the new institution.
3) Multi-Institutional Federal Grants and Contracts: If such federal
awards designate a specific institution as the depository of original
data and records for a multi-institutional project, the University
shall comply with this requirement. However, the University shall
retain a true copy of the original records produced at University
expense.
TRANSFER OF OTHER RESEARCH DATA AND RECORDS
In the event the responsible investigator transfers to another institution
or leaves the University for any reason, the responsible investigator
shall provide a true copy at University expense of his/her research
data and records that have been retained less than three years in
the investigator’s possession per the retention paragraph
above. Before his/her departure, the responsible investigator shall
provide these true copies of the research data and records to his/her
department chair or supervisor. These data and records shall be
organized in a format to permit reasonable identification of specific
experiments by individuals not involved with the original research.
These research data and records shall be used by the University
only for misconduct inquires and investigations and patent litigations.
RESOLUTION OF DISPUTES INVOLVING RESEARCH DATA AND RECORDS
The Vice Chancellor for Research, Economic Development, and Community
Engagement or his designee shall arbitrate all disputes involving
research data ownership, retention, and access. Whenever possible,
the Vice Chancellor or his designee shall first attempt to mediate
a resolution to the dispute acceptable to all parties. When the
dispute involves faculty from the School of Medicine or the College
of Arts and Sciences, the Vice Chancellor or his designee shall
consult with the designated Associate Deans for Research in those
units. This paragraph does not apply to situations involving allegations
of research misconduct. Other University policies shall apply in
those situations.
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