Law on Human Subjects Research
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
the ethical conduct of research to all research conducted in
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;
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.
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.
about compliance with the principal federal regulations on the
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:
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.