(f) Submit a timeline indicating the proposed duration of the study.
(g) Describe the proposed data to be submitted to this state during the study.
Generally, data submission is required quarterly.
(h) If the medical control authority designs the study to develop or contribute to
generalizable knowledge, the medical control authority shall also submit documentation
of Institutional Review Board approval, exemption, or not regulated status for the study.
(3) A medical control authority that intends to establish a protocol involving skills,
techniques, procedures, or equipment that is not included in this state’s approved
curriculum and is not consistent with either the level of licensure or scope of practice,
involves human subject research under 45 CFR part 46, or intends to publish the human
subject research, shall require a special study if it complies with all of the following:
(a) Provide any available studies or supporting documentation indicating the
practice has been studied. Published studies supporting the safety or efficacy of its
application within the emergency setting must also be submitted.
(b) Submit initial and refresher education requirements and provide an educational
outline to be implemented to instruct the emergency medical services personnel in the
new skill, technique, procedure, or equipment, as well as verification of competency that
will be utilized. Refresher education requirements must include frequency and content of
refresher to maintain proficiency in skill, technique, procedure, or equipment.
(c) Identify life support agencies involved, their licensure level, the number of
emergency medical services personnel to be trained, and their respective licensure levels.
(d) If providing mutual aid outside its medical control authority region, the medical
control authority shall have a written agreement with another medical control authority to
continue to utilize its protocols.
(e) Identify the quality review process that will be implemented.
(f) Submit protocols that will be included in the special study.
(g) Identify data parameters to be collected and the quality review process that will
be implemented. The medical control authority shall submit quarterly reports, and upon
completion of the study, submit a final report to the department.
(h) Obtain and submit an institutional review board approval or an institutional
review board official exemption. If the medical control authority used a randomized
study, include the consent form, method of institutional review board approval, and
institutional review board approval letter.
(4) A special study may be terminated by the department, with the advice of the
quality assurance task force, for any of the following reasons:
(a) The special study jeopardizes the health, safety, or welfare of the citizens of this
state.
(b) There is evidence of failure to follow study parameters.
(c) There is evidence of failure to submit reports.
(d) The medical control authority or medical director requests termination.
(e) There is not sufficient data to support continuation.
(5) A special study may be considered complete when outcomes have been met, the
timeline has been completed, or the study has been terminated by the department with the
advice of the quality assurance task force. A final report must be submitted to the
department by the medical control authority when the study is complete, unless the study
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