<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".08" citation="COMAR 10.25.11.08" title_num="10" subtitle_num="25" chapter_num="11" heading="Suspension or Termination of IRB Approval.">
  <paragraph num="A.">
    <text>The Commission shall require an applicant to file periodic progress reports concerning any aspect of the use of data released under this chapter.</text>
  </paragraph>
  <paragraph num="B.">
    <text>The Commission may:</text>
    <paragraph num="(1)">
      <text>Investigate use made of data released under this chapter; and</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Require an applicant to provide information necessary to assist the Commission in its investigation.</text>
    </paragraph>
  </paragraph>
  <paragraph num="C.">
    <text>The Commission may delegate the function listed in §B of this regulation to the IRB.</text>
  </paragraph>
  <paragraph num="D.">
    <text>If an applicant fails to make use of the data in accordance with IRB requirements, including IRB data security and confidentiality requirements, the Commission, at the recommendation of the IRB or on its own motion, may:</text>
    <paragraph num="(1)">
      <text>Immediately suspend or terminate its approval of the data release; and</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Require the applicant to:</text>
      <paragraph num="(a)">
        <text>Return to the Commission, or</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Destroy previously released data.</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="E.">
    <text>The applicant is entitled to a post-suspension or termination hearing in front of the IRB to show cause why the suspension or termination should be rescinded. Following the hearing, the IRB shall make a recommendation to the Commission concerning reinstatement of the applicant's use of the information.</text>
  </paragraph>
</regulation>