(A)
Policy statement
This policy describes the rights and
responsibilities of university faculty, staff and students in the collection,
use, retention and maintenance of research data and the standards of practice
required for the conduct of scholarship and research at the university of
Toledo. It is intended to complement, but be independent of existing university
policies, sponsoring agency policies, and federal regulations governing certain
aspects of the conduct of research including, but not limited to human
subjects, animal subjects, radiation, biosafety, conflict-of-interest, and
hazardous materials. A separate university policy on misconduct, which is
mandated by federal regulations, describes how the university handles issues of
research misconduct (see rule 3364-70-21 of the Administrative Code). The
university complies with all applicable laws and regulations governing aspects
of the conduct of research and other scholarly activities.
(B)
Scope
Scientific inquiry, scholarly
contributions, creativity, and academic accomplishment can take many forms and
may vary among disciplines. The issues addressed by this policy are essential
to all research and scholarship and describes rights and responsibilities of
the faculty, staff and students in authorship and publication, responsible
conduct of research training, and in the collection, use, retention, and
maintenance of data, produced as a result of the research enterprise of the
university.
(C)
Definitions
(1)
Corresponding author is the author who is responsible
for communicating with the publisher during the peer review and editorial
process and for ensuring that all authors have reviewed and have access to the
submitted or edited manuscript(s) and /or responses to reviewers. This
individual is responsible for completing the administrative requirements of the
publisher. In the event that there is more than one corresponding author, the
corresponding authors share the responsibilities equally under this
policy.
(2)
Research director (RD) is any individual who is a
dissertation or thesis advisor, laboratory director or research program
director. The principal investigator on any grant/contract or sponsored project
is the RD for the research or project(s) supported by that
grant/contract.
(3)
Trainee is any individual in training. Trainees may
include, but are not be limited to, undergraduate and graduate students,
postdoctoral fellows, research associates or fellows, residents, and junior
colleagues.
(4)
Unit head is the immediate responsible administrator,
generally a department chair, program director, center director, or
dean.
(5)
Research data is any information that has been
collected, observed or generated, as well as any other primary records that are
necessary for the reconstruction and evaluation of reported results of research
and the events and processes leading to those results, regardless of the form
of the media on which they may be recorded.
(6)
Electronic
communications such as email and associated attachments transmitted, received
or used in the course of university business, such as research projects, are
considered to be public records, as stated in rule 3364-65-07 of the
Administrative Code (electronic communication), regardless of whether the
communication was sent or received on a public or privately owned personnel
computer or messaging system.
(7)
Research means a
systematic investigation, including research development, testing and
evaluation, designed to develop or contribute to generalizable knowledge.
Scholarship is defined as the practice of advancing, preserving, and
disseminating knowledge and thought through study, reflection, and engagement
that extends beyond traditional instructional activities. Research and
scholarship are used interchangeably in this document.
(8)
Sponsored
projects include activities originated or conducted by university faculty or
staff supported wholly or in part by external restricted funds awarded to the
university. Definitions of activities are found in rule 3364-70-23 of the
Administrative Code (facilities and administration costs). Such activities
include: sponsored instruction and training, organized research and other
sponsored activities.
(D)
Responsible
conduct of research (RCR)
It is the responsibility of the RD to
ensure that all applicable research team members are informed of sponsor RCR
training requirements and that requirements have been met. It is also RD's
responsibility to provide appropriate mentoring of trainees under their
direction through discussions of RCR and through oversight of the research
project. RCR topics related to the research project may include:
(1)
Conflicts of
interest (personal, professional, and financial).
(2)
Policies
regarding the use of human subjects in research.
(3)
Policies
regarding the use of animals in research.
(4)
Laboratory
safety, biohazard management, chemical safety, and polices regarding the use of
radioisotopes and radiation sources and controlled substances in
research.
(5)
The responsibilities and relationships of mentors and
mentees.
(6)
Collaborative research.
(7)
The peer review
process.
(8)
Data acquisition and laboratory tools; management,
sharing and ownership of data and research tools.
(9)
Research
misconduct and policies for handling research misconduct.
(10)
Authorship and
publication.
(11)
Science and engineering in society which may include:
responsibilities to the community and society; ethical issues in research; and
the environmental and societal impacts of scientific research.
(12)
Export
control.
(13)
Compliance with terms and conditions contained within
agreements related to research activity such as federal awards, sponsored
project agreements, material transfer agreements, and confidentiality
agreements.
(E)
University responsibilities
(1)
The
responsibilities of the university in research activities include, but are not
limited to:
(a)
Ensuring compliance with the terms of sponsored project
agreements;
(b)
Monitoring and regulating the appropriate use of
animals, human subjects, recombinant DNA, biological agents, radioactive
materials, and the like;
(c)
Protecting the rights of faculty, staff, and students,
including, but not limited to, their rights to access to data from research in
which they participated for their programs of study;
(d)
Securing the
intellectual property rights of the university; and
(e)
Facilitating the
investigation of charges, such as scientific misconduct or conflict of
interest.
(F)
Research
data
(1)
Ownership
University ownership and stewardship of
research data for projects conducted by university faculty, staff, and students
through the use of university facilities and resources, is based on state law
(section 3345.14 of the Revised Code), federal regulation (section 215.53 of
OMB Circular), and sound management principles.
(2)
Collection and
retention
(a)
The university must retain research data in sufficient
detail and for an adequate period of time to enable appropriate responses to
questions about accuracy, authenticity, primacy, and compliance with laws,
regulations and sponsor requirements governing the conduct of the
research.
(b)
The RD is responsible for the collection, management,
and retention of research data. The RD should adopt an orderly system of data
organization and should communicate the chosen system to all members of a
research group and to applicable administrative personnel, where appropriate.
Particularly for long-term projects, the RD should prepare for preservation of
research data in the case of fire, natural disaster, or any other
emergency.
(c)
Research data should be archived for a minimum of five
years after the final project closeout, with original primary data retained
wherever possible. In addition, any of the following circumstances may justify
longer periods of retention:
(i)
Terms and conditions of a sponsored project
agreement;
(ii)
As long as may be necessary to protect intellectual
property resulting from the work. Research data used to support a patent or
copyright application must be archived for a minimum of twenty years or such
other time as required by the office of research and sponsored programs
(ORSP);
(iii)
If any charges regarding the research arise, such as
allegations of scientific misconduct or conflict of interest, data must be
retained for a minimum of seven years as required by federal regulation, until
such charges are fully resolved, or as required by applicable rule 3364-70-21
of the Administrative Code; and
(iv)
If a student is
participating in the research, research data must be retained until the degree
is awarded, or until it is clear that the student has abandoned the
work.
(d)
Beyond the period of retention specified here, the
destruction of research records is at the discretion of the RD. Records will
normally be retained in the unit where they are produced. Research records must
be retained in university facilities unless pursuant to paragraph (F)(5)(d) of
this rule. For additional information regarding specific records retention
procedures see the university of Toledo's general records retention schedule
(managed by the university archives).
(3)
Data
security
(a)
The collection, retention, and sharing of research data that
incorporates individually-identifiable protected health information (PHI) must
comply with all applicable Health Insurance Portability and Accountability Act
(HIPAA) policies and processes, including security standards.
(b)
Research data
that incorporates personally identifiable or sensitive elements (such as social
security numbers), or proprietary university information or trade secrets or
includes controlled unclassified information or export controlled information,
must have adequate security protections and be treated as "restricted data." It
is the responsibility of the RD to properly identify the classification of the
data and to provide appropriate protections, as well as any additional data
security that may be specifically required under the terms of a sponsored
program or data use agreement (such those in the federal information security
management act or the food and drug administration's electronic records
regulations).
(c)
It is the responsibility of the RD to immediately
report any suspected or proven disclosure or exposure of personal information
or other restricted data in the custody of the RD, co-investigator(s), research
staff or students, which is stored in a university computer, system, or data
network resource to the office of the chief information officer. (See rule
3364-65-10 of the Administrative Code (technology incident response
policy)).
(d)
The RD is responsible for assuring compliance with any
agreed-upon restrictions from sponsors (including publication and sharing with
non-U.S. citizen collaborators and/or students) when using data that is
controlled under federal international traffic in arms regulations or export
administration regulations.
(4)
Access
(a)
Trainees or other
research contributors or collaborators (referred to as researchers) may be
granted access to research data by a RD for academic or research purposes in
connection with a course of study or degree program or in their capacity as
employees.
(i)
Researchers given access to research data from any source
are subject to all university rules, state and federal laws, and contractual
obligations relevant to the research data.
(ii)
Research
directors who give researchers access to research data must inform them in
writing, where appropriate, of any limitations or restrictions, including but
not limited to export controls, on the use or dissemination of the
data.
(iii)
Researchers must retain access to research data
resulting from research projects they themselves have initiated, and to data
acquired by processes for which they were primarily
responsible.
(iv)
Researchers previously given access to research data in
connection with a course of study, degree program, or contract may be denied
such access by the RD or other responsible university official for reasonable
cause.
(v)
Concerns or disputes concerning access to research data
will be handled according to the procedures described in this paragraph.
(a)
If a dispute
arises concerning a researcher's access to data, an initial effort to resolve
the dispute will be made by the student's director or department chair (in the
case of students) or the unit head (for other researchers) of the relevant
unit(s) involved, following stated grievance procedures for the program or
academic unit(s).
(b)
Subsequent appeals will be referred to the following
entities in order: the relevant college associate dean for research, or other
qualified faculty administrator appointed by the dean first; and the office of
research and sponsored programs under the direction of the vice president for
research. Appeals for students will be referred to the college of graduate
studies.
(b)
To ensure needed
and appropriate access as, for example, to facilitate a response to an
allegation of research misconduct, the university has the option to take
custody of the primary data and research records and electronic communication
(e.g. emails) in a manner specified in rule 3364-70-21 of the Administrative
Code.
(5)
Transfer of data from the university
(a)
In general, when
the RD or co-investigators involved in research projects at the university of
Toledo leave the university, they may take copies of research data for projects
on which they have worked.
(b)
As required by
academic practice, the use of such data (for example, to conduct additional
research, or for presentation or publication) is dependent on agreement with
the RD, or as may be formally agreed-upon beforehand by the RD and other
co-investigators in a data use agreement.
(c)
In all cases, the
RD must retain the primary research data at the university unless specifically
authorized pursuant to paragraph (F)(5) (d) in this rule.
(d)
If a RD leaves
the university or a project is moved to another institution, the primary
research data may be transferred with the approval of the dean of the college
employing the RD, the vice president for research, and with written agreement
from the new institution. At a minimum, such written agreement must
include:
(i)
Adoption by the new institution of all custodial
responsibilities for the data, including acceptance of all university and
federal security requirements for restricted data that is
transferred;
(ii)
Formal recognition by the new institution of the
university of Toledo's continued ownership of the data; and
(iii)
Guaranteed
access by the university of Toledo to the primary data, should such access
become necessary.
(G)
Publication and
authorship
(1)
Publication and presentation of research
The RD should ensure that procedures
for resolving detailed concerns, such as the timing of presentations or
publications, order of authorship, and privilege of presenting results at
meetings, be discussed with research team members to the extent feasible at the
beginning and throughout the research activities as needed and as part of
on-boarding new members to the research group or project. The RD (or
corresponding author) has the right and responsibility to ensure that research
is accurately reported to the scientific and academic community, as well as to
select the vehicle for the initial publication or presentation of research data
and results, including poster or conference presentations.
(a)
Authorship
disputes should be addressed through the relevant academic units and through
procedures established by the provost's office.
(b)
In the event that
an allegation of fabrication, falsification, plagiarism, or a deliberate
violation of regulations exists in addition to the authorship dispute, the
chair, dean, provost, or their designees must immediately consult with the vice
president for research or the university research integrity officer regarding
the allegation(s). Allegations of research misconduct will be reviewed under
rule 3364-70-21 of the Administrative Code.
Replaces: 3364-70-02
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