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Pediatric Research Regulations under Legal Scrutiny: Grimes Narrows Their Interpretation

Published online by Cambridge University Press:  01 January 2021

Loretta M. Kopelman
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Extract

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
Copyright © American Society of Law, Medicine and Ethics 2002

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References

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
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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
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See Brief of Amici Curiae Association of American Medical Colleges, Association of American Universities, Johns Hopkins University, and University of Maryland Medical System Corporation in Support of Appellee's Motion for Reconsideration, Grimes v. Kennedy Krieger Institute, Inc., 782 A.2d 807 (Md. 2001) (No. 128), available at <http://www.hopkinsmedicine.org/press/2001/SEPTEMBER/briefs.htm>. This will also be shown below.. This will also be shown below.' href=https://scholar.google.com/scholar?q=See+Brief+of+Amici+Curiae+Association+of+American+Medical+Colleges,+Association+of+American+Universities,+Johns+Hopkins+University,+and+University+of+Maryland+Medical+System+Corporation+in+Support+of+Appellee's+Motion+for+Reconsideration,+Grimes+v.+Kennedy+Krieger+Institute,+Inc.,+782+A.2d+807+(Md.+2001)+(No.+128),+available+at+.+This+will+also+be+shown+below.>Google Scholar
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The National Commission took a protectionist stance regarding many vulnerable groups, including children. As a result, it became harder to do research with children and fewer therapies were available for them. Levine, R.J., Ethics and the Regulation of Clinical Research, 2nd ed. (New Haven: Yale University Press, 1986). The wisdom of this policy was directly challenged when its consequences became apparent; namely, children could not gain access to many investigational new drugs and the quest for evidence-based pediatric medical care was severely hampered. Kopelman, L.M., “Children as Research Subjects: A Dilemma,” Journal of Medicine and Philosophy, 25, no. 6 (2001): 745–64.Google Scholar
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The best interest of the child standard does not mandate that one always do what is literally best or ideal for the child. That would be an impossible duty for parents or investigators. Rather, it requires that some reasonable or minimal threshold duty of care must be met. For fuller discussion, see Kopelman, , supra note 16, at 745–64.Google Scholar
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See id. at 833. I am aware that the inconsistencies among the Nuremberg Code, 45 C.F.R. § 46, Grimes, and the other policies considered are not strictly speaking relevant to the court's inquiry about whether researchers owed a duty of care to subjects. It does not matter for the court's purposes if they are consistent. It is important, however, for other purposes to reconcile Grimes and 45 C.F.R. § 46, as I discuss below.Google Scholar
For example, to learn if children are developmentally delayed because they have ingested lead, they must be compared to normal children. But to establish normal ranges, investigators need to collect data from healthy children. These studies, however, would be non-therapeutic since these children are healthy. Yet non-therapeutic research cannot be guaranteed to be risk-free. Children might be harmed from unforeseen violations of confidentiality or accidental exposure to pathogens in a clinical setting.Google Scholar
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In proposing this reconciliation, I have assumed that the understandings of “minimal risk” in the Grimes holding and 45 C.F.R. § 46 are similar. But this is an assumption worth considering in its own right, as is the assumption that “benefit” and “therapy” can be used interchangeably in this context.Google Scholar