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.
2.
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.
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).
5.
See Grimes v. Kennedy Krieger Institute, Inc., 782 A.2d 807, 820 (Md. 2001).
6.
See id. at 821.
7.
See id. at 818, 826, 829.
8.
See id. at 832.
9.
See id. at 818.
10.
See id. at 834. I wish to thank John Davis for helping me with this and other points on the law in this paper.
11.
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.
12.
Kennedy Krieger Institute, Lead Paint Abatement and Repair & Maintenance Study Clinical Investigation Consent Form (August 10, 1992): 1.
13.
Id.
14.
See Grimes v. Kennedy Krieger Institute, Inc.782 A.2d 807, 821 (Md. 2001).
15.
See Brief of Amici Curiae, supra note 11.
16.
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. LevineR.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.
17.
KopelmanL.M., “Children as Research Subjects: A Dilemma,”Journal of Medicine and Philosophy, 25, no. 6 (2001): 745–64.
18.
See Brief of Amici Curiae, supra note 11.
19.
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.
20.
See Grimes v. Kennedy Krieger Institute, Inc.782 A.2d 807, 833 (Md. 2001). I wish to thank John Davis for help in clarifying the legal points in this section.
21.
See id. at 853.
22.
See id. at 841–52. The Nuremberg Code, which forbids research without consent from subjects, is very different from the courts' holding and the federal regulations
23.
See Kopelman, supra note 16.
24.
See Grimes v. Kennedy Krieger Institute, Inc.782 A.2d 807, 850 (Md. 2001).
25.
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.
26.
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.
This framework is used by the World Medical Organization in its Declaration of Helsinki (2000). World Medical Association, Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects, rev. ed. (Edinburgh: 52nd World Medical Association General Assembly, October 2000), available at <http://www.wma.net/e/policy/17c.pdf>.
29.
See Levine, supra note 16.
30.
KopelmanL.M., “Children/Ill. Health Care and Research,” in ReichW.T., ed., Encyclopedia of Bioethics, rev. ed., vol. 1 (New York: Simon & Schuster MacMillan, 1995): 357–68.
31.
See 45 C.F.R. § 46 (1991) and Additional Protections for Children Involved as Subjects in Research, 48 Fed. Reg. 9,814–9,820 (March 8, 1983).
32.
See also Council for International Organizations of Medical Science (CIOMS), International Ethical Guidelines for Biomedical Research Involving Human Subjects (Geneva: CIOMS, 1993);.
33.
Kopelman, supra note 16. This should be called a “harm-benefit” analysis or a “risk of harm-potential benefit” analysis. The name of this approach has been criticized because it suggests we compare actual benefits with potential harms, when what we are really comparing are potential benefits with potential harms.
34.
“Nuremberg Code,”Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10, vol. 2 (Washington, D.C.: U.S. Government Printing Office, 1949): 181–82.
35.
Declaration of Helsinki, supra note 26, CIOMS, supra note 29.
36.
C.F.R. § 46. I wish to thank John Davis, David Resnik, and Kenneth De Ville for clarifying these points.
37.
See Brief of Amici Curiae, supra note 11, at 3, 3–4, and 4, respectively.
38.
See Brief of Amici Curiae, supra note 11, at 6.
39.
Order Denying Motion for Reconsideration, supra note 25, at 2.
40.
See Kennedy Krieger Institute, supra note 3.
41.
45 C.F.R. § 46.102i (1991).
42.
The terms “absolute” and “relative” are part of the literature and not of my choosing.
43.
KopelmanL.M., “Estimating Risk in Human Research,”Clinical Research, 29 (1981): 1–8.
44.
Id. As noted earlier, Grimes asserts that some of the investigators may have had a role in placing some children in higher risk environments.
45.
National Bioethics Advisory Commission, Ethical and Policy Issues in Research Involving Human Participants, vol. 1 of Report and Recommendations of the National Bioethics Advisory Commission (Bethesda: National Bioethics Advisory Commission, 2001): At Recommendation 4.2, available at <http://bioethics.georgetown.edu/nbac/human/overvol1.html>.
46.
See also Regulatory Understanding of Minimal Risk: Meeting Before the Human Subjects Subcommittee of the National Bioethics Advisory Commission (Virginia, January 8, 1998) (testimony of Gary Ellis) available at <http://bioethics.georgetown.edu/nbac/transcripts/jan898/regulato.txt>.
47.
See Grimes v. Kennedy Krieger Institute, Inc.782 A.2d 807, 849 (Md. 2001).
48.
Levine recounts that the National Commission rejected the therapeutic-non-therapeutic distinction in favor of determining whether or not “[t]he relation of potential harms and benefits is ‘at least as favorable to the subjects as that presented by any …’ available options.” Levine,
49.
supra note 16, at 9. This language may be found in the 45 C.F.R. § 46.405 (1991) requirements (see Table 1). See Additional Protections for Children Involved as Subjects in Research,
50.
supra note 29. One aspect of the lead abatement study might well have gained approval under 45 C.F.R. § 46.405, namely, the testing of Succimer against a placebo to determine if it is effective in treating lead poisoning (assuming, among other things, there was clinical equipoise at the beginning of the study).
51.
See Kennedy Krieger Institute, supra note 3.
52.
See Grimes v. Kennedy Krieger Institute, Inc.782 A.2d 807, 852–53 (Md. 2001).
53.
MillerP.B.WeijerC., “Moral Solutions in Assessing Research Risk,”IRB: A Review of Human Subject Research, 22, no. 5 (2000): 7–10.
54.
JanofskyJ.StarfieldB., “Assessment of Risk and Research on Children,”Journal of Pediatrics, 98 (1981): 842–46.
55.
LascariA.D., Editorial: “Risk of Research in Children,”Journal of Pediatrics, 98 (1981): 759–60.
56.
See National Bioethics Advisory Commission, supra note 39.
57.
See Grimes v. Kennedy Krieger Institute, Inc.782A.2d 807, 848 (Md. 2001).
58.
See id. at 814 & n.5.
59.
Id. at 848.
60.
National Institutes of Health, Report of the Human Growth Hormone Protocol Review Committee (October 2, 1992) (unpublished, on file with author).
61.
See Kopelman, supra note 16.
62.
See MillerWeijer, supra note 44.
63.
See Grimes v. Kennedy Krieger Institute, Inc.782 A.2d 807, 811 (Md. 2001).
64.
See Kennedy Krieger Institute, supra note 3.
65.
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.
