<?xml version='1.0' encoding='utf-8'?>
<subtitle article="ghg" title_number="13" subtitle_number="20" title_name="Miscellaneous Health Care Programs" subtitle_name="Human Subject Research">
  <section article="ghg" article_name="Health - General" number="13-2001" title_number="13" title_name="Miscellaneous Health Care Programs" subtitle_number="20" subtitle_name="Human Subject Research">
    <level label="a">
      <text>In this subtitle the following words have the meanings indicated.</text>
    </level>
    <level label="b">
      <text>“Federal regulations on the protection of human subjects” means:</text>
      <level label="1">
        <text>Title 45, Part 46 of the Code of Federal Regulations, and any subsequent revision of those regulations; and</text>
      </level>
      <level label="2">
        <text>With respect to research that is subject to the jurisdiction of the federal Food and Drug Administration, Title 21, Parts 50 and 56 of the Code of Federal Regulations, and any subsequent revision of those regulations.</text>
      </level>
    </level>
    <level label="c">
      <text>“Human subject” has the meaning stated in the federal regulations on the protection of human subjects.</text>
    </level>
    <level label="d">
      <text>“Institutional review board” has the meaning stated in the federal regulations on the protection of human subjects.</text>
    </level>
    <level label="e">
      <text>“Research” has the meaning stated in the federal regulations on the protection of human subjects.</text>
    </level>
  </section>
  <section article="ghg" article_name="Health - General" number="13-2002" title_number="13" title_name="Miscellaneous Health Care Programs" subtitle_number="20" subtitle_name="Human Subject Research">
    <level label="a">
      <text>A person may not conduct research using a human subject unless the person conducts the research in accordance with the federal regulations on the protection of human subjects.</text>
    </level>
    <level label="b">
      <text>Notwithstanding any provision in the federal regulations on the protection of human subjects that limits the applicability of the federal regulations to certain research, subsection (a) of this section applies to all research using a human subject.</text>
    </level>
  </section>
  <section article="ghg" article_name="Health - General" number="13-2003" title_number="13" title_name="Miscellaneous Health Care Programs" subtitle_number="20" subtitle_name="Human Subject Research">
    <level label="a">
      <text>An institutional review board shall make the final minutes of a meeting available for inspection within 30 days of receipt of a request for the minutes from any person.</text>
    </level>
    <level label="b">
      <text>Prior to making the minutes of a meeting available for inspection under subsection (a) of this section, an institutional review board may redact confidential or privileged information.</text>
    </level>
    <level label="c">
      <text>The minutes of a meeting of an institutional review board are not public records under Title 4 of the General Provisions Article.</text>
    </level>
  </section>
  <section article="ghg" article_name="Health - General" number="13-2004" title_number="13" title_name="Miscellaneous Health Care Programs" subtitle_number="20" subtitle_name="Human Subject Research">
    <level label="a">
      <text>The Office of the Attorney General may seek appropriate injunctive or other relief to prevent the conduct of human subject research in violation of the federal regulations on the protection of human subjects or this subtitle.</text>
    </level>
    <level label="b">
      <text>In exercising the authority granted under subsection (a) of this section, the Office of the Attorney General may not:</text>
      <level label="1">
        <text>Duplicate the investigatory, compliance, or enforcement action undertaken by an agency of the federal government; or</text>
      </level>
      <level label="2">
        <text>Bring an action under subsection (a) of this section if an agency of the federal government has determined that an investigation is not warranted.</text>
      </level>
    </level>
  </section>
</subtitle>