# Health - General (GHG)

## Title 13. Miscellaneous Health Care Programs

### Subtitle 20. Human Subject Research

#### Section 13-2001

(a) In this subtitle the following words have the meanings indicated.

(b) "Federal regulations on the protection of human subjects" means:

  (1) Title 45, Part 46 of the Code of Federal Regulations, and any subsequent revision of those regulations; and

  (2) 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.

(c) "Human subject" has the meaning stated in the federal regulations on the protection of human subjects.

(d) "Institutional review board" has the meaning stated in the federal regulations on the protection of human subjects.

(e) "Research" has the meaning stated in the federal regulations on the protection of human subjects.

#### Section 13-2002

(a) 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.

(b) 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.

#### Section 13-2003

(a) 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.

(b) 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.

(c) The minutes of a meeting of an institutional review board are not public records under Title 4 of the General Provisions Article.

#### Section 13-2004

(a) 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.

(b) In exercising the authority granted under subsection (a) of this section, the Office of the Attorney General may not:

  (1) Duplicate the investigatory, compliance, or enforcement action undertaken by an agency of the federal government; or

  (2) Bring an action under subsection (a) of this section if an agency of the federal government has determined that an investigation is not warranted.

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Md. Code Ann., Health-Gen. (as displayed at mgaleg.maryland.gov, October 16, 2026)