Maryland Few cases directly address state treatment of research with children and adolescents. Perhaps the most compelling and recent case is that described in the “case example” above, which highlights the facts of a recent Maryland case, Grimes v. Kennedy Krieger Institute, Inc. 49. In its decision on this case, the Court of Appeals of Maryland (the states highest court) decided that a “legal duty normally exists between researcher and subject,” by virtue of the “special relationship” between them and arising out of contract law (the “contract” being the informed consent and permission form signed by the parents, who received compensation for their childs participation) 50. Finding that a duty could exist, the case was remanded to the trial court for a factual determination whether a duty did in fact exist in this case, whether that duty was breached, and if such breach was the proximate cause of damages (standard requirements of action in negligence) 51. Of particular note was the courts decision to go beyond the issue of negligence to find that, under state law, parental authority to permit their children to participate in research does not extend to nontherapeutic research that carries with it the risk of harm to the health of the child 52.14 In so deciding, the court referenced the history of abuse in research: from Nazi experiments (e.g., typhus experiments with concentration camp inmates) to the Tuskegee study (syphilis studies) and the Jewish Chronic Disease Hospital Study (cancer study without consent) 53. The court was particularly troubled by the economically disadvantaged condition of the children and families in this case 54. As the court stated: The determination of whether a duty exists under Maryland law is the ultimate function of various policy considerations as adopted by the Legislature, or, if it has not spoken, as it has not in respect to this situation, by Maryland courts. We do not feel that it serves proper public policy concerns to permit children to be placed in situations of potential harm, during nontherapeutic procedures, even if parents, or other surrogates, consent 55. That is, the court interpreted Maryland law as not allowing parental consent (permission) for greater than minimal risk, “nontherapeutic” research in the first instance (e.g., when a “reasonable parent” would not allow such) 56. Similarly, research was found to be impermissible without valid informed consent 57. The merits of this decision are beyond the scope of this paper. However, its ramifications are important for future researchers in Maryland and to the extent that it has received national scrutiny across the country. The case has received much press, especially in research, research subject advocate, and legal circles, which quite likely will translate to related case and state law developments 58. It will be interesting to see if other courts, in Maryland and beyond, follow the appellate courts lead and further delineate those conditions under which research with children, including at-risk, sick, or healthy children, is permissible 59. It will also be interesting to see how states respond to challenges to define “risk,” ”therapeutic,” and “nontherapeutic,” as well as the limits of “assent” and parental “permission” in relation to research with youth. As noted in the preceding sections, state legislatures and executive agencies have, to date, had little to say about research in general and even less about research with children and adolescents. This case might serve to create ferment in state legislative bodies and within child-serving agencies to craft policies, guidelines, and even statutes to address research issues. Of note, however, is the fact that as of this writing (August 2003), the Maryland legislature has not passed legislation specifically responding to concerns raised by the Grimes decision. After the initial Court of Appeals decision, many believed that Johns Hopkins University and the University of Maryland would push for legislation to address the extent or limits of parental authority to permit research with their children, and a legislative committee hearing was scheduled to talk about what was seen as the crippling effect of the decision on research involving children. However, after a subsequent clarification by the court in its denial of the Kennedy Krieger Institutes motion for reconsideration (in which it clarified its intent as to the meaning of “any risk” as per the bounds of parental authority), the universities backed off, deciding that the ruling would not dramatically alter their respective research portfolios 60. The legislative committee hearing was conducted in October 2001, but its focus shifted from the Grimes case to the “regulatory gap” created by the limits of federal regulation and the unregulated status of non-federally funded, non-FDA research. To address this, a bill was enacted in 2002 61. Interestingly, however, no further legislative attention has been paid to the issues in the Grimes case itself
Posted on: Sat, 02 Nov 2013 06:11:51 +0000
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