Grimes v. Kennedy Krieger Institute, Inc.

Brief Fact Summary. The circuit court granted summary judgment to the Kennedy Krieger Institute, Inc. (KKI) (Defendant).  Parents (Plaintiff) of the children subject to the research study conducted by Defendant appealed, arguing that Defendant owed a duty of care based on the nature of its relationship with the Plaintiff and the children participating in the study.

Synopsis of Rule of Law. Under Maryland law, informed consent agreements in nontherapeutic research projects can constitute contracts and can constitute special relationships giving rise to duties, which could result in negligence actions if breached.

Facts. The Kennedy Krieger Institute (KKI) (Defendant), a prestigious research institute associated with Johns Hopkins University, created a nontherapeutic research program which required particular classes of homes to have only partial lead paint abatement modifications completed.  In at least some instances, including this case, the institute arranged for the landlords to receive public funding by way of loans or grants to aid in the modifications.  The research institute then encouraged, and sometimes required, that the landlords rent the properties to families with young children.  Children were encouraged to live in the houses where the possibility of lead dust was known to the researchers to be likely, so that lead dust content of their blood could be compared with the level of lead dust in the houses at periodic intervals over a period of two years.  In order for the study to be complete, the continuing presence of the children was required in the participating houses.  The purpose of the research was to determine how effective different degrees of lead paint abatement procedures were.  The researchers acknowledged that lead paint was particularly hazardous to children and that lead dust often remained or returned to abated houses over time.  The Institutional Review Board (IRB) overseeing this research abandoned its responsibility to review the potential safety and health hazard impact of this nontherapeutic study, and instead advised the institute to recast the study with the purpose of obscuring those dangers.  The research study was sponsored jointly by the Environmental Protection Agency (EPA) and the Maryland Department of Housing and Community Development.  This action against Defendant was brought by parents (Plaintiff) of children with elevated blood levels of lead.  Defendant moved for summary judgment on the basis that no contract existed between Defendant and the plaintiffs, and there was inherently no duty owed to a research subject by a researcher.  The circuit court granted Defendant’s motion.  The parents (Plaintiff) of the children in the study appealed, arguing that Defendant owed a duty of care based on the nature of its relationship with the Plaintiffs and the children participating in the study based on a contract between the parties, the voluntary assumption by Defendant, a special relationship between the parties, and federal regulation.

Issue. Under Maryland law, can informed consent agreements in nontherapeutic research projects can constitute contracts and can the agreements constitute special relationships giving rise to duties, which could result in negligence actions if breached?

Held. (Cathell, J.)  Yes.  Under Maryland law, informed consent agreements in nontherapeutic research projects can constitute contracts and can constitute special relationships giving rise to duties, which could result in negligence actions if breached.  The very nature of nontherapeutic scientific research on human subjects can create special relationships which give rise to duties.  Researchers have no right to place children in potentially hazardous living situations for nontherapeutic studies such as the one at issue here.  Furthermore, parents, whether enticed improperly with food stamps, money or other items, have no more right to intentionally and unnecessarily place children in potentially hazardous nontherapeutic research settings.  IRBs are not designed to be objective, as they are generally internal boards tied as much to the success of a research project regarding its ethical implications.  This is evident in this case, where the IRB did not ensure the safety of the children in the study, but encouraged researchers to misrepresent the research as therapeutic in nature.  Special relationships are generally created between researchers and their human subjects.  Finally, government regulations can create duties on the part of researchers toward human subjects out of which special relationships may arise.  Special relationships are to be determined on a case-by-case basis.  The circuit court erred in granting Defendant’s motions for summary judgment.  Reversed.

Concurrence. (Raker, J.)  The majority correctly found that a special relationship existed between the parties giving rise to an action in tor, but went too far when it decided the duty of care was breached in this case.

Discussion. The court in Grimes denied a motion for reconsideration in this case.  Judge Raker dissented, arguing that the majority’s discussion of the ability of a parent or guardian to give consent for a minor child to participate in a nontherapeutic research study in the opinion was a statement of public policy, best left to the Legislature.