Maryland Law on Human Subjects Research

In its 2002 Session, the General Assembly passed House Bill 917, "Human Subject Research – Institutional Review Boards." This important bill, strongly supported by the Attorney General's Office, applies the federal regulations on the ethical conduct of research to all research conducted in Maryland, regardless of funding source; requires institutional review boards to make their minutes (after redaction of any confidential or privileged information) available to any person upon request; and empowers the Attorney General to seek injunctive or other judicial relief to prevent unlawfully conducted human subject research. The new law took effect on October 1, 2002, and is now codified in Title 13, Subtitle 20 of the Health-General Article.

The Attorney General provided the Governor with a bill review letter that discusses two issues of statutory construction. Our Office also sent a letter to Dr. Greg Koski, then head of the federal Office for Human Research Protections, describing House Bill 917 and the manner in which we intend to coordinate any investigatory activity with federal authorities.

Information about compliance with the principal federal regulations on the protection of human subjects, codified at 45 C.F.R. Part 46, may be found at the Web site of the Office for Human Research Protections: http://www.hhs.gov/ohrp. Information about compliance with the Food and Drug Administration's regulations on the protection of human subjects, codified at 21 C.F.R. Parts 50 and 56, may be found at the following Web site: http://www.fda.gov/oc/ohrt/irbs/default.htm.

Maryland law on human subjects research also includes a very important court decision about pediatric research. The case, called Grimes v. Kennedy Krieger Institute, was decided by the Court of Appeals (Maryland's highest court) in 2001. Any investigator planning to conduct pediatric research in Maryland should be aware of the Court's discussion of parental authority and not simply assume that parents may always give permission for their children to become research subjects. More broadly, the case is of interest because of its holding about the legal duty of investigators to subjects and its criticism of IRBs. Click here for a copy of the court opinion. Also available here is a PowerPoint slide show that summarizes the key aspects of the case.