<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".10" citation="COMAR 10.25.11.10" title_num="10" subtitle_num="25" chapter_num="11" heading="IRB Records.">
  <paragraph num="A.">
    <text>The IRB shall maintain the following records:</text>
    <paragraph num="(1)">
      <text>Minutes of all IRB meetings describing:</text>
      <paragraph num="(a)">
        <text>Time and date of the meetings;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Members present;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Actions taken;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Votes on the actions including the number:</text>
        <paragraph num="(i)">
          <text>Voting for;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Voting against; and</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Abstaining;</text>
        </paragraph>
      </paragraph>
      <paragraph num="(e)">
        <text>The basis for requiring changes in or disapproving research; and</text>
      </paragraph>
      <paragraph num="(f)">
        <text>A discussion of controverted issues and their resolution;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>Minutes which shall include:</text>
      <paragraph num="(a)">
        <text>Copies of all applications, supporting documentation, related correspondence, and progress reports;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Records of continuing review activities;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>A list of IRB members and current curriculum vitae sufficient to demonstrate the IRB members' areas of expertise and current employment or consultant relationships and board memberships; and</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Any written procedures or bylaws adopted by the IRB.</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>The IRB shall adhere to the record retention guidelines applicable to the Commission.</text>
  </paragraph>
</regulation>