<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".04" citation="COMAR 10.25.11.04" title_num="10" subtitle_num="25" chapter_num="11" heading="IRB Review of Applications.">
  <paragraph num="A.">
    <text>The IRB shall review all applications submitted pursuant to this chapter.</text>
  </paragraph>
  <paragraph num="B.">
    <text>The IRB shall recommend:</text>
    <paragraph num="(1)">
      <text>Approval, disapproval, or termination; or</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Modifications in research or security to secure approval.</text>
    </paragraph>
  </paragraph>
  <paragraph num="C.">
    <text>The IRB shall meet as necessary in order to provide timely responses to requests for information.</text>
  </paragraph>
  <paragraph num="D.">
    <text>Requests for information within the scope of this chapter shall include a description of the:</text>
    <paragraph num="(1)">
      <text>Research use to be made of the information;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Intent, if any, to present or publish the findings;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Nature of the requested information;</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Safeguards and procedures that the applicant will take to protect the identity of the data; and</text>
    </paragraph>
    <paragraph num="(5)">
      <text>A description of any potential risks or benefits.</text>
    </paragraph>
  </paragraph>
  <paragraph num="E.">
    <text>Upon receipt of an application within the scope of this chapter, the Commission shall immediately forward the request and all supporting documentation to the IRB for a recommendation.</text>
  </paragraph>
  <paragraph num="F.">
    <text>The IRB shall require an applicant to provide any:</text>
    <paragraph num="(1)">
      <text>Documentation necessary to satisfy itself that the security of the released data will be preserved; and</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Information necessary to assist the IRB in making a decision on an application.</text>
    </paragraph>
  </paragraph>
  <paragraph num="G.">
    <text>The IRB shall make a timely recommendation concerning release of the requested information.</text>
  </paragraph>
  <paragraph num="H.">
    <text>An IRB recommendation shall be made on the basis of a majority of the full IRB membership.</text>
  </paragraph>
  <paragraph num="I.">
    <text>If the IRB denies an application, the IRB shall inform the applicant promptly in writing of the reasons for denial.</text>
  </paragraph>
  <paragraph num="J.">
    <text>Deliberations.</text>
    <paragraph num="(1)">
      <text>In conducting its deliberations, the IRB shall be mindful of conflicts of interest and the appearance of conflict.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>IRB members with an actual or apparent conflict concerning a particular application shall recuse themselves from deliberating and voting upon that application.</text>
    </paragraph>
  </paragraph>
</regulation>