In Grimes v. Kennedy Krieger Institute , the Maryland Court of Appeals (Maryland’s highest court) considered whether it is possible for investigators or research entities to have a special relationship with subjects, thereby creating a duty of care that could, if breached, give rise to an action in negligence. The research under review, the Lead Abatement and Repair & Maintenance Study, was conducted from 1993 to 1996 by investigators at the Kennedy Krieger Institute (KKI), an affiliate of Johns Hopkins University.
After briefly discussing the case at the center of this ruling, I consider how ambiguities within the federal research regulations at 45 C.F.R. § 46 contribute to disagreements among reasonable and informed people of good will about what studies should be approved. I argue that Grimes may be understood as placing restrictions on how these regulations may be interpreted and used.
Type Article Information Journal of Law, Medicine & Ethics , Volume 30 , Issue 1 , Spring 2002 , pp. 38 - 49 Copyright © American Society of Law, Medicine and Ethics 2002Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)
Grimes v. Kennedy Krieger Institute, Inc. 782 A.2d 807 (Md. 2001 ). This decision reversed the trial court's order of summary judgment for the Kennedy Krieger Institute (KKI). The court was asked to decide if KKI would win as a matter of law even if the facts as presented by the plaintiffs Grimes and Higgins were true. It does not take a stand on whether the facts are true since this would only be relevant at trial, not for a summary judgment motion. The case began when parents sued the investigators and KKI for allegedly inducing them to keep their children in houses having lead while promising that their homes would be cleaned, repaired, and made safe; these parents alleged this was not done and their children were harmed. The Court of Appeals ruled that KKI may have owed a duty of care to the plaintiffs, which the trier of fact would have to determine at trial. The Court of Appeals not only reversed the trial court's ruling that there was no such duty as a matter of law, but also condemned the study as unethical.Google Scholar
The account of the study is based upon the Clinical Investigation Consent Form; the Quality Assurance Project Plan for the Kennedy-Krieger Institute Lead-Based Paint Abatement and Repair Maintenance Study (draft) to the U.S. Environmental Protection Agency, Office of Pollution, Prevention and Toxins, dated June 22, 1992; KKI's “Lead-Based Paint Study Fact Sheet”; and the Grimes ruling. Unfortunately, as far as I am able to ascertain, neither the protocol nor the results have been released. I was unable to find out whether this study gained IRB approval under 45 C.F.R. § 46.404,45 C.F.R. § 46.405,45 C.F.R. § 46.406, or 45 C.F.R. § 46.407 of the federal regulations.Google Scholar
See id. The authors also write that earlier research showed that all “three tiers of intervention reduced lead dust by approximately 80% from that found in untreated properties, that is the overwhelming majority of affordable rental housing stock then available in Baltimore's low-income, high risk neighborhood.” Another document says that systematic studies have not been done. See Kennedy Krieger Institute, Quality Assurance Project Plan for the Kennedy-Krieger Institute Lead-Based Paint Abatement and Repair & Maintenance Study (draft), dated June 22, 1992 , at 1 (on file with author).Google Scholar
See Grimes v. Kennedy Krieger Institute, Inc., 782 A.2d 807, 820 (Md. 2001 ).Google Scholar See id. at 821 .Google Scholar See id. at 818, 826, 829 .Google Scholar See id. at 832 .Google Scholar See id. at 818 .Google ScholarSee id. at 834 . I wish to thank John Davis for helping me with this and other points on the law in this paper.Google Scholar