Subchapter H. EMS RESEARCH
Sec.
1021.141. Research.§ 1021.141. Research.
(a) Prior to engaging in a clinical investigation or study that relates to the provision of EMS, the principal investigator shall file with the Department a report of the planned investigation or study on a form prescribed by the Department. The principal investigator shall also file with the Department a report at the conclusion of the investigation or study and status reports as requested by the Department.
(b) A person who wants to secure from the Department or a regional EMS council and use, for research purposes, information collected by the Department or a regional EMS council through EMS PCRs, or information collected by the Department or a regional EMS council regarding patients who utilize emergency departments without being admitted to a hospital or who are admitted to a hospital through emergency departments, trauma centers or directly to special care units, shall submit the proposed research project to the Department. If the Department concludes that the proposed use of the information would serve the public interest, it may refer the proposal to the medical advisory committee of the Advisory Board or to one or more of the medical advisory committees of the regional EMS councils for review and recommendation.
(c) If access to and use of the information requested under subsection (b) is approved by the Department, the Department will release or direct the release of the information for the research project under conditions specified by the Department.
(d) A research proposal submitted under subsection (b) must include and address the following in a format specified by the Department:
(1) A specific statement of the hypothesis to be investigated and the clinical significance of the hypothesis.
(2) A specific description of the methodology to be used in the research.
(3) An estimated duration of the research.
(4) An explanation of how patient confidentiality will be protected.
(5) A letter from the principal investigator in which that person identifies himself as the principal investigator and assumes responsibility for compliance with the conditions imposed by the Department.
(6) A plan for providing the Department with progress reports, annually at a minimum, and a final report on the research.
(e) If institutional review board approval is required by law, the Department will not approve access to the requested information until it receives evidence of institutional review board approval.
(f) The Department may direct that the use of the information be terminated if the Department determines that the use of the information fails to satisfy the conditions under which the Department approved use of the information.
(g) An EMS agency or other person that intends to conduct research that would involve an EMS agency violating this part or an EMS protocol adopted or approved by the Department shall apply for an exception to the regulation or protocol under § 1021.4 (relating to exceptions).
(h) This section does not empower the Department to approve research that involves any act otherwise prohibited by law.
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