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.
But it does not follow they are free, in identical circumstances, to make martyrs of their children before they have reached the age of full and legal discretion when they can make that choice for themselves.
View Full Point of LawIssue. 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.)Â 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.