(A)
Policy
statement
The university of Toledo ("UT") assumes
responsibility for safeguarding the rights and welfare of human subjects
involved in all research activities conducted by its faculty, community based
faculty, staff, registered students, and registered volunteers. Research
involving human subjects will be conducted only in accordance with this policy,
including the following activities conducted for research purposes:
(1)
interaction or intervention with living individuals,
(2)use of human biological specimens from living individuals,
or
(3)review of data that can identify a living individual
(directly or in combination with other data) and that is not publicly
available.
UT has a federal wide assurance
("Assurance") on file with the United States department of health and human
services ("HHS") office for human research protections ("OHRP"). This assurance
sets forth the university's promise that UT research will be guided by the
ethical principles of the Belmont report of 1979 and conducted in compliance
with applicable laws, regulations and standards of local, state, and federal
government agencies (such as 45 C.F.R. 46, 45 C.F.R. parts 160 and 164, and 21
C.F.R. parts 50 and 56) concerning the protection of human subjects. The
assurance between the government and university covers university faculty,
community based faculty, staff, registered students, and registered volunteers
who are engaged in human subject research. The institutional review board
("IRB") maintains written procedures for the protection of human research
subjects.
(B)
Purpose of
policy
This policy enumerates the specific
requirements for the performance of human research at UT in order to protect
the rights and welfare of human subjects and assure that human research
activities conform to the ethical codes of conduct for human experimentation,
federal and state statutes, HHS and food and drug administration ("FDA")
regulations, policies and guidelines; and applicable UT policies and
procedures.
(C)
Scope
This policy applies to all UT related
research involving human subjects.
(D)
Definitions
(1)
The IRB is an
administrative body established to protect the rights and welfare of human
research subjects recruited to participate in research activities conducted
under the auspices of the institution with which it is
affiliated.
(2)
"Research" means a systematic investigation, including
research development, testing, and evaluation, designed to develop or
contribute to generalizable knowledge (
45 C.F.R.
46.102(l) ).
(3)
"Human subject"
means a living individual about whom an investigator (whether professional or
student) conducting research (a) obtains information or biospecimens through
intervention or interaction with the individual, and uses, studies, or analyzes
the information or biospecimens; or (b) obtains, uses, studies, analyzes, or
generates identifiable private information or identifiable biospecimens (
45 C.F.R.
46.102(e)(1)
).
(4)
"Clinical trial" means a research study in which one or
more human subjects are prospectively assigned to one or more interventions
(which may include placebo or other control) to evaluate the effects of the
interventions on biomedical or behavioral health-related outcomes (
45 C.F.R.
46.102(b) ).
(5)
"Study personnel"
includes, but is not limited to, the principal investigator, co-investigators,
study coordinators, research collaborators and all other individuals
interacting with subjects for research purposes. The term is not intended to
apply to individuals who provide primarily technical support or who are purely
advisory, with no direct access to the data (e.g., control over its collection
or analysis) or to the study participants or their private information, unless
they are in a position to influence the study's results.
(6)
Human research
protection program ("HRPP")" describes the UT program that provides support to
UT IRBs, provides educational activities, serves as a resource for faculty,
staff and student researchers, recommends and implements policies and
regulations for the protection of human subjects in research, and ensures
compliance with relevant laws, regulations, and ethical standards while
addressing the needs and concerns of investigators who conduct research with
human subjects. Compliance of clinical trials conducted by UT study personnel
is also addressed in rule
3364-70-28 of the Administrative
Code (internal auditing of clinical research policy).
(7)
"UT-related
research" means research carried out on or off campus (including other states
or countries) by university faculty, students, or other employees, and any
studies conducted by any investigator using university facilities and/or
university patients as subjects, including patient records or
surveys.
(E)
The HRPP provides support to activities including but
not limited to the following:
(1)
All UT IRBs (e.g., biomedical, biomedical cancer, and
social behavioral and educational). IRB members are appointed by the vice
president for research. The university may enter into agreements with external
institutional review boards, which may be authorized to review selected
university research.
(a)
All UT-related research involving human subjects must
be reviewed and approved by the appropriate UT IRB or a UT-authorized external
IRB prior to beginning the research, and at intervals specified by the
reviewing IRB. It is a violation of federal regulations, the university
assurance and university policy to commence any research covered by this policy
without prior institutional review board approval, or to continue research
beyond the specified approval dates.
(b)
UT biomedical IRB
and biomedical cancer IRB may approve clinical research performed at
UT-affiliated practice sites or sites where the university is formally
authorized to review research. A list of these sites is available from the HRPP
office.
(c)
Approval from non-UT IRBs can replace approval from the
university institutional review board when a formal authorization agreement is
in place.
(d)
Any research involving fresh samples of umbilical cord
blood for research must be reviewed and approved by the UT IRB prior to the
start of such study. If samples are to be obtained from another institution, a
copy of that institution's IRB approval must be submitted to the UTIRB for
review before UT IRB approval may be granted.
(e)
Research covered
by this policy that has been approved by an IRB may be subject to further
appropriate review and approval or disapproval by officials of the institution.
However, those officials may not approve the research if it has not been
approved by an IRB.
(2)
Study personnel:
The UT IRB must review and approval all study personnel and their proposed role
in the research prior to their participation in any research with human subject
activity. The vice president for research must approve any exceptions to the
below criteria regarding the eligibility of an individual to serve as the
principal investigator of an IRB study.
(a)
Only university
salaried faculty, appropriately qualified salaried/contract university
personnel or duly appointed community based clinical or research faculty may be
a principal investigator on a UT IRB study. All students including graduate
students conducting research must have a UT salaried faculty or appropriately
qualified salaried/contracted university employee named as the principal
investigator on their application. The principal investigator must be in a
position to provide human subject protections guidance, provide direct,
personal, day-to-day oversight of activities and personnel associated with the
institutional review board study, and guide the student in compliance with
university research policies and IRB procedures.
(b)
Research training
is required for all study personnel interacting or intervening with human
subjects. For non-UT personnel, the principal investigator is responsible for
providing written assurance to the university, of the non-university
personnel's qualifications and expertise to serve in the proposed role in UT
research.
(c)
In compliance with rule
3364-70-01
of the Administrative Code (financial conflict of interest policy for sponsored
programs), all study personnel must apprise the IRB of any financial or other
interest (including, but not limited to, consulting agreements) that they, or
any member of their family, have in a sponsoring company or any financial
interest in the technology being studied. All study personnel must disclose
potential conflict-of-interests at the time of IRB application and as any new
potential interests arise.
(3)
The UT IRBs have
the authority to determine the appropriate course of action with respect to
study deviations and adverse events depending on the degree of risk to subjects
or affected individuals and previous deviations by the
investigator.
(4)
The vice president for research is the institutional
official ("IO"). The IO, or his/her designee, is responsible for communicating
reports to the relevant federal agencies as required.
(5)
No compensation
to individuals who refer subjects for research studies (i.e., "finder's fees)
is allowed, except in rare circumstances requiring prior approval of the IRB.
The principal investigator must justify to the IRB the reason(s) for offering
such remuneration by including a separate statement with the study application.
If compensation is approved by the IRB, it must not be contingent upon the
subject's acceptance into the study, agreement to participate, or completion of
the study, and the subject must be informed in the consent form that the
referring professional received compensation for his or her time and
effort.
(6)
Principal investigator responsibilities in research
involving human subjects:
(a)
Acknowledge and accept their responsibility for
protecting the rights and welfare of human research subjects and for complying
with all applicable federal regulations, as well as UT policies regarding
research with human subjects. It is the responsibility of each investigator to
know and understand those regulations and policies prior to initiating any such
research.
(b)
The principal investigator of an applicable
IRB-approved investigator initiated clinical trial is responsible for following
HHS (
45 C.F.R.
46.116(h) ) and FDA ( 42
C.F.R. 11 ) regulations which require study information to be posted on
clinicaltrials.gov. Studies only defined as a clinical trial by HHS regulations
may use a docket folder at
http://www.regulations.gov(docket ID: HHS-OPHS-2018-0021).
(c)
Principal
investigators will not make the final determination of the category of IRB
review (i.e. exempt, expedited or full board) for research involving human
subjects. The UT IRB or HRPP staff may make an exempt determination after
review of the proposed research study. When UT researchers are involved in
collaborative research, a UT IRB may accept an exempt determination from
different IRB.
(d)
Provide a copy of the UT IRB-approved informed consent
document (signed by the individual explaining the study and obtaining consent
from the subject) to each subject at the time of consent unless the IRB has
specifically waived this requirement. All signed consent documents must remain
confidential and must be retained in a confidential manner approved by the UT
IRB.
(e)
Promptly report all proposed changes in previously
approved human subject research activities to the UT IRB. The proposed changes
may not be initiated without UT IRB review and approval, except where necessary
to eliminate apparent immediate hazards to the subjects in which case the IRB
must be notified within ten working days.
(f)
Report progress
of approved research to the UT IRB and submit this report for continuing review
or progress report as often as and in the manner prescribed by the IRB on the
basis of risks to subjects and in accordance with federal regulations. HRPP
staff may review progress reports.
(g)
Promptly report
to the UT IRB, and any other agency required by regulation or contract, any
unanticipated problems involving human research subjects in compliance with UT
IRB procedures.
(h)
Promptly report to the UT IRB, and any other agency
required by regulation or contract, any deviations, violations or participant
non-compliance from the UT IRB-approved study in compliance with UT IRB
procedures.
(i)
No principal investigator or any member of his/her
research team will seek to obtain research credit for, or use data from,
patient interventions that constitute the provision of emergency medical care
without prior UT IRB approval. A physician may provide emergency medical care
to a patient without prior UT IRB review and approval to the extent permitted
by law. However, such activities may not be used for research nor the data used
in support of research.
(j)
Advise the UT IRB, research and sponsored programs
office, and the appropriate officials of other institutions of the intent to
admit human subjects into another institution (e.g., into another hospital) for
research purposes. When such admissions are a planned part of HHS-supported
research, those institutions must possess an applicable human research federal
wide assurance ("FWA") prior to involvement of such persons as human subjects
in those research studies at those institutions.
(k)
Provide accurate
and complete information to the IRB for determination of compliance with HHS
and FDA regulations, and HIPAA privacy rules. Principal investigators will
adhere to rules and regulations applicable to their research at all
times.
(l)
Submit final reports within thirty days following the
expiration date of UT IRB approval or completion of data collection, analysis
and cessation of all study activity (whichever comes first). If no expiration
date is indicated, submit final reports within thirty days following the
completion of data collection, analysis and cessation of all study activity.
The UT IRB may withhold approval of subsequent research applications from an
investigator who has not submitted a final report from previous research.
(7)
All individually identifiable protected health
information, as defined by the HIPAA privacy rule, must be removed or redacted
from medical records and research records prior to such records being removed
from the university for research purposes. This does not limit the ability of
sponsors and their research monitors to review or copy medical or research
records as necessary to monitor the research, however, such copied materials
must be stripped of protected health information prior to leaving the
university.
An exception to this redaction policy
can be approved by the IRB if the consent and HIPAA authorization clearly
explain the scope of the disclosure and the subject agrees to such disclosure.
The principal investigator is responsible for ensuring compliance with
subject's authorization.
(8)
Ohio law forbids
experimental use or sale of any products of aborted human conception (section
2929.14 of the Revised Code).
This statute extends to the use of cell lines originally derived from aborted
fetal tissue received from any location.
(9)
Approval for
research use of autopsy or cadaveric material is not within the scope of human
subjects' research.