Study Responsibility & IRB Paperwork
Principal Investigator (PI) is the fully responsible for
the conduct of all aspects of his/her IRB approved protocol.
Due to the significance of this responsibility, IRB-01 will
only accept protocol paperwork that has been signed by the
PI. This assures us that the PI is aware of the conduct
of his/her protocol. Paperwork signed by a Co-Principal
Investigator (Co-PI) or sub-Investigator (sub-I) will not
be accepted, processed, or reviewed and will be returned
to the sender/PI.
PIs can sometimes be unavailable for a significant length
of time (e.g. travel, medical reasons, etc.) and might not
be available to oversee their protocol and/or sign protocol
related paperwork. In these events, the PI must obtain a
"temporary PI" to oversee the conduct of the protocol
in the PI's absence and to sign any protocol related paperwork.
This temporary transfer must be written, protocol specific,
for specific and limited time frame, and signed by both
the PI and the temporary PI. The temporary PI must already
be listed as a co- or sub- investigator on the protocol
(otherwise a protocol revision will be necessary). The transfer
should be obtained prior to the PI's absence, and should
be submitted to the IRB (1) when first obtained and (2)
with any subsequent submissions that the temporary PI signs.
You should use our Temporary
Transfer of Study Responsibility Form.
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.
Continuing Review: apply for renewal of your IRB approved projects prior to the expiration date. If your project expires, you may not do any of the following:
(1) enroll or screen any new subjects, (2) perform any study interventions, unless the IRB finds that it
is in the best interest of individual subjects to continue participating in research interventions or interactions, (3) collect, use, or report any data, and/or (4) receive any study funding.
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, Informed Consent
Form or other IRB approved study related documents without prior Institutional Review Board (IRB) approval,
except in an emergency when it is necessary to safeguard the
well-being of human subjects.
If applicable, only a qualified clinician may be responsible for study-related healthcare decisions.
that anyone obtaining informed consent has read the protocol
and has sufficient knowledge of all information provided
in the informed consent document.
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 a minimum of three additional
years after the study is completed/closed with the
IRB (check with the IRB and/or your sponsor regarding how long your records need to be retained).
reporting any serious & unexpected adverse events, unanticipated
problems involving risks to subjects and/or others, or
any changes made to eliminate apparent immediate hazards
to subjects to the IRB in writing within 5 working days
of occurrence or discovery of occurrence.
reporting any interim reports (for example, Data Safety
and Monitoring Board reports) or other events that require
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 or terminated.
investigator training as required by the Institutional
RESEARCH RECORDS must be retained after completion of the research. Researchers must comply with the longest
the IRB may determine if research is exempt from Federal
regulations (investigators may not make the final determination
- If the project involves VA patients, facilities, staff, or resources, you must obtain approval from the VA Research & Development (R&D) Committee before initiating the research at the VA.
- Other committees: you are responsible for obtaining approval from all appropriate offices related to the conduct of your research project (e.g. billing compliance, radiation review, biosafety review, etc).
applicable standard according to current institutional policies. UF & Shands researchers must retain research records for a
minimum of three years or longer depending if any of the following are involved: HIPAA, medical treatment, patents, or
contractual language with a sponsor. For research involving the VA records must be retained indefinitely until VA
regulations establish a shorter retention period. Lastly, research data is the property of the institution and you must comply
with all institutional requirements before destroying, copying, or transferring any research data. Additional information is available at: http://irb.ufl.edu/irb01/data.html (item number 4).
You are responsible for notifying all parties about the approval of your research projects, including your co-Investigators and supervisor.
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
Reporting the emergency use of an approved test article to the IRB within 5 working days.
Submitting paperwork in accordance with IRB Submission Acceptability Standards.
unavailable 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.
the 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).
research 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.
All investigators should review and be familiar with:
affiliation with UF, Shands, or NF/SG VAMC ends
to leaving UF/Shands/VA, the PI must either (1) revise their
protocol to name a new PI or (2) close their study by submitting
a Study Closure Report.
the event the PI fails to do either, responsibility for
the study defaults to the PI's supervisor (department chair,
dean, etc.). The supervisor is responsible for the conduct
of the study and must either name a new PI and renew or
close the study once approval expires.