must comply with all UF policies and procedures*(see below) as well
as all applicable federal*, state, and local laws regarding the protection
of human subjects in research, including, but not limited to the following:
IRB approval prior to involving any human subjects (including their
data or tissue) in research studies.
that only qualified personnel conduct the study according to the approved
Protocol, and in compliance with each individual's scope of practice.
the rights and welfare of each research subject, and that the subject's
rights and welfare must take precedence over the goals and requirements
of the research.
no changes in the approved Protocol or Informed Consent Form without
prior Institutional Review Board (IRB) approval, except in an emergency,
if necessary to safeguard the well-being of human subjects.
that anyone obtaining informed consent has read the protocol and has
sufficient knowledge of all information provided in the informed consent
legally effective informed consent from human subjects or their legally
responsible representative before any research-related screening or
intervention commences and using only the currently approved, stamped
Informed Consent Form, when applicable.
each subject enrolled in the study a copy of the IRB-approved informed
consent document at the time of the consent, unless the IRB has specifically
waived this requirement.
specified otherwise, all signed informed consents and other research
related documents (including but not limited to paperwork submitted
to and approved by the IRB) should be retained throughout the study
and for an additional three years after the study is completed/closed
with the IRB.
reporting any injuries or unanticipated problems to the IRB in writing
within 5 working days of occurrence or discovery of occurrence.
progress of approved research to the appropriate IRB, as often as
and in the manner prescribed by the IRB on the basis of risks to subjects,
but not less than once per year. This includes submitting a closure
report to the IRB once the research is completed.
investigator training as required by the Institutional Review Board.
investigators will advise the IRB and the appropriate officials of
this Institution and other institutions of the intent to admit human
subjects who are involved in research protocols. When such admission
is planned or a frequent occurrence, those institutions must possess
an applicable OHRP-approved Assurance prior to involvement of such
persons as human subjects in those research protocols.
conducting research involving products regulated by the Food and Drug
Administration (FDA), the investigator will comply with all applicable
FDA regulations and fulfill all investigator responsibilities (or
investigator-sponsor responsibilities, where appropriate), including
those described at:
to conduct or direct this research personally, as when on sabbatical,
leave, or vacation, to: (1) arrange for a co-investigator to assume
research related responsibilities in the researcher's absence, and
(2) to notify the IRB in writing of this change prior to the absence.
event that employment with the university is discontinued, to do one
of the following with each approved/active study prior to leaving
the university: (1) transfer the study to a new principal investigator
or (2) close the project. These changes must be sent in writing to
the IRB by submitting either a formal revision or a Continuing Review/Study
closure report. This notification must be submitted in advance (prior
to the termination of employment).
investigator will seek to obtain research credit for, or use data
from, patient interventions that constitute the provision of emergency
medical care without prior IRB approval. A physician may provide emergency
medical care to a patient without prior IRB review and approval, to
the extent permitted by law (see Section 116[f]). However, such activities
will not be counted as research nor the data used in support of research.
the IRB may determine if research is exempt from Federal regulations
(investigators may not make the final determination of exemption).
All investigators should review and be familiar with:
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