Grimes v. Kennedy Krieger Institute, Inc.
Court of Appeals of Maryland
782 A.2d 807 (2001)
The Kennedy Krieger Institute (defendant) ran a non-therapeutic study testing whether partial lead-paint abatement in rental homes would still expose low-income, minority children to dangerous lead levels, recruiting families with nominal compensation ($5-15) and consent forms that never clearly explained the study involved exposing children to lead and testing their blood for contamination; the study's institutional review board approved the protocols despite this gap. After discovering lead "hot spots" in participant Viola Hughes's home, Kennedy Krieger tested her daughter Erica Grimes's (plaintiffs) blood, finding significant lead contamination, and notified Hughes only after already detecting the hot spots; Hughes and Grimes then withdrew from the study and moved out, later suing for failure to timely warn them that lead exposure was contemplated by the study design, and the trial court granted Kennedy Krieger summary judgment, finding no legal duty to warn, prompting the appeal.
Whether human subjects participating in a non-therapeutic research study must be provided with all material information, including foreseeable risks of harm, in order to give valid informed consent.