<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".04" citation="COMAR 30.03.05.04" title_num="30" subtitle_num="03" chapter_num="05" heading="Research Supplemental Protocol.">
  <paragraph num="A.">
    <text>The EMS Board may approve a research supplemental protocol upon the recommendation of the Executive Director of MIEMSS with the approval of the:</text>
    <paragraph num="(1)">
      <text>EMS operational medical director and EMS operational program where the research will be conducted; and</text>
    </paragraph>
    <paragraph num="(2)">
      <text>MIEMSS Institutional Review Board.</text>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>An individual seeking to conduct research that would require a supplement to the protocols shall:</text>
    <paragraph num="(1)">
      <text>Submit the proposed research project and the proposed research protocol, including provisions for the expiration of the research supplemental protocol, to the:</text>
      <paragraph num="(a)">
        <text>State EMS Medical Director,</text>
      </paragraph>
      <paragraph num="(b)">
        <text>EMS operational program where the research is to be conducted,</text>
      </paragraph>
      <paragraph num="(c)">
        <text>EMS operational program medical director for the EMS operational program where the research is to be conducted, and</text>
      </paragraph>
      <paragraph num="(d)">
        <text>MIEMSS Institutional Review Board; and</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>Provide further information and meet certain requirements as determined by the MIEMSS Institutional Review Board.</text>
    </paragraph>
  </paragraph>
  <paragraph num="C.">
    <text>The MIEMSS Institutional Review Board shall suspend or terminate approval of a research supplemental protocol that is not:</text>
    <paragraph num="(1)">
      <text>Conducted in accordance with requirements of this regulation; or</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Determined to be associated with unexpected serious harm to research subjects.</text>
    </paragraph>
  </paragraph>
  <paragraph num="D.">
    <text>Upon suspension or termination of approval of a research supplemental protocol by the MIEMSS Institutional Review Board, the Executive Director shall immediately suspend or terminate the research supplemental protocol. The suspension shall be effective pending action by the EMS Board.</text>
  </paragraph>
</regulation>