<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".08" citation="COMAR 10.52.01.08" title_num="10" subtitle_num="52" chapter_num="01" heading="Research.">
  <paragraph num="A.">
    <text>An individual researcher or institution shall apply for and receive approval from the Department before starting research in collaboration with an OADPO program.</text>
  </paragraph>
  <paragraph num="B.">
    <text>The Department shall:</text>
    <paragraph num="(1)">
      <text>Review each request; and</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Approve or disapprove the proposed research based on whether the proposed research:</text>
      <paragraph num="(a)">
        <text>Advances scientific knowledge or practice related to opioid-associated disease prevention and outreach;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Has approaches, aims, and methods that will allow the researcher to perform descriptive analyses or test hypotheses;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Has one or more investigators who have training and experience with the approaches and methods;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Will impede or interfere with the operations of the OADPO program;</text>
      </paragraph>
      <paragraph num="(e)">
        <text>Is approved by the Department’s Institutional Review Board to ensure that the research will be conducted according to established ethical guidelines for research in the field of opioid-associated disease prevention and outreach; and</text>
      </paragraph>
      <paragraph num="(f)">
        <text>Will keep any data used for the research confidential as required by:</text>
        <paragraph num="(i)">
          <text>Health-General Article, §24-906(B), Annotated Code of Maryland;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>42 U.S.C. §290dd-2; and</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>42 CFR Part 2.</text>
        </paragraph>
      </paragraph>
    </paragraph>
  </paragraph>
</regulation>