public health research
In this article, the authors discuss the Maryland Court of Appeals decision in the case of Grimes v. Kennedy Krieger Institute, Inc. and its implications for the tort duty owed by researchers, in particular public health researchers, to their subjects. The Opinion resulted from two lawsuits alleging lead poisoning of children enrolled in a study conducted by the Kennedy Krieger Institute, a world renown pediatric research and treatment facility. The opinion shocked the research establishment with its scathing characterization of researchers and its apparent holding that in Maryland a parent cannot consent to the participation of a child in "nontherapeutic research or other studies in which there is any risk of injury or damage to the health of the subject." While this was the focus of much of the research community, the issue in dispute in the case was that of the scope of duty of the researchers. Hoffmann and Rothenberg describe the facts leading to the case, many of which were omitted from the Court of Appeals decision which resulted from an appeal to a motion for summary judgment, and then discuss two possible interpretations of the Court's decision as it relates to the duty of researchers. One interpretation is based on a broad view of what constitutes the research endeavor and its associated risks and would arguably not result in a change in the legal duties of researchers. The other is based on a narrow view of the research project and would lead to the disclosure of risks not traditionally required by law as they fall outside of risks resulting from participation in the research protocol. The authors assert that as a result of confusion in the Opinion regarding the definition of the research study, the Court's decision may result in a significantly broader duty than has been posed historically in the research setting. In addition to exploring the contrasting interpretations of the Court's Opinion, the authors "deconstruct" the scope of the duty as articulated by the Court and pose a series of questions as to how such a duty might be discharged and how realistic the Court's apparent expectations are regarding the duty or researchers. Finally, they discuss the implications of the Court's apparent broad based duty requirement in the context of public health studies and raise the question whether the Opinion may ultimately have negative consequences for the future of public health research in Maryland and for the compensation of injured research subjects.
6 Journal of Health Care Law & Policy 109 (2002).
Health Law and Policy | Health Services Research | Torts