Grimes v. Kennedy Krieger Institute, Inc., 782 A.2d 807 (Md.2001).
2.
The court's harsh criticisms were covered by newspapers in many cities, both locally and nationally. See, for example, Roig-FranziaM.WeissR., “Maryland Appeals Court Slams Researchers; Participants in Study on Lead Paint Weren't Informed of Risks, Judge Says,”Washington Post, August 21, 2001, at B01;.
3.
BorJ., “Lead Paint Lawsuits to Go to Trial; Kennedy Krieger Accused of Putting Children in Danger; Research Deemed Risky; Appeals Court Finds Doctors Failed to Warn of Hazards,”Baltimore Sun, August 17, 2001, at 1B;.
4.
LewinT., “U.S. Investigating Johns Hopkins Study of Lead Paint Hazard,”New York Times, August 24, 2001, at A11.
5.
“Experiments and Ethics,”Times-Picayune (New Orleans), August 27, 2001, at Metro section;.
6.
RobertsonT., “Subjects in Baltimore Rue Lead-Paint Study; Hopkins Affiliate Faces Suit, Inquiry,”Boston Globe, September 3, 2001, at A1.
7.
and Editorial, “Stiffen Medical Research Rules,”San Francisco Chronicle, August 27, 2001, at A14.
8.
FarfelR.ChisolmJ., “Health and Environmental Outcomes of Traditional and Modified Practices for Abatement of Residential Lead-Based Paint,”American Journal of Public Health, 80 (1990): 1240–45.
9.
Grimes v. Kennedy Krieger Institute, Inc., 782 A.2d 807, 819 (Md.2001) (citing deposition of Mark Farfel).
10.
RyanD., “Controversy over Kennedy Krieger Research,” e-mail to the Children's Environmental Health Network list-serv (August 28, 2001) (on file with author). Don Ryan is the executive director of the Alliance to End Childhood Lead Poisoning, an advocacy group based in Washington, D.C. An editorial offering some of the facts and opinions detailed on the list-serv was published in the Baltimore Sun on that same day.
11.
See RyanD., “Research on Lead Hazards Is Solution, Not Problem,” Op-ed, Baltimore Sun, August 28, 2001, at 19A.
12.
Grimes v. Kennedy Krieger Institute, Inc., 782 A.2d 807, 812–13, 819–24 (Md.2001).
13.
Id. at 812–13, 820–22.
14.
Ryan, “Controversy over Kennedy Krieger Research,”supra note 5.
15.
BorJ., “Kennedy Krieger Doctor Defends Lead Paint Study; Researcher Disputes High Court's Findings,”Baltimore Sun, August 18, 2001, at 1B.
16.
Ryan, “Controversy over Kennedy Krieger Research,”supra note 5.
17.
Grimes v. Kennedy Krieger Institute, Inc., 782 A.2d 807, 824 (Md.2001) (citing the Consent Form, Purpose of Study).
18.
Id. at 858.
19.
Id. at 816.
20.
Id. at 861 (Raker, J., concurring).
21.
Id. at 858.
22.
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 at 1, Grimesv. Kennedy Krieger Institute, Inc., 782 A.2d 807 (Md. 2001) (No. 128), available at <http://www.hopkinsmedicine.org/press/2001/SEPTEMBER/briefs.htm>.
A Lexis-Nexis search of general news and major U.S. and international newspapers, using the key words “Kennedy Krieger,” “lead paint,” or “lead poisoning,” found that the initial story was covered by newspapers in many cities, including Boston, San Francisco, New York, and New Orleans. In contrast, the same Lexis-Nexis search found that only the Washington Post
32.
the Baltimore Sun, both local papers, covered the court's October 11, 2001 decision to deny reconsideration despite the fact that the case raises major issues for pediatric research generally.
33.
Grimes v. Kennedy Krieger Institute, Inc., 782 A.2d 807, 815 (Md.2001).
34.
This is not meant to say that all of the children were necessarily better off in terms of lead exposure than they would have been had they lived elsewhere or just not participated. Although most low-income rental properties in Baltimore at the time were old and heavily leaded, and steps to control lead hazards were almost exclusively in response to already poisoned children, some families might have moved into other homes with lower lead exposure, albeit unintentionally. In addition, it is not clear whether families who chose to move into these abated homes and participate in the research were better or worse off than those who moved into these homes but refused to participate. The former were encouraged to stay in their homes; the latter would not have been, and thus, unwittingly, they might have moved to homes with less lead hazards.
35.
Grimes v. Kennedy Krieger Institute, Inc., 782 A.2d 807, 814 (Md.2001) (citing a letter dated May 11, 1992 from the Johns Hopkins University Joint Committee on Clinical Investigation to Dr. Farfel).
36.
Brief of Amici Curiae, supra note 16, at 6 (footnotes omitted).
37.
See, for example, KaptchukT.J., “The Double-Blind, Randomized, Placebo-Controlled Trial: Gold Standard or Golden Calf?,”Journal of Clinical Epidemiology, 54 (2001): 541–49;.
38.
EllisS.J.AdamsR.F., “The Cult of the Double-Blind Placebo-Controlled Trial,”British Journal of Clinical Practice, 51 (1997): 36–39;.
39.
CleophasT.J.Van der MeulenJ.KalmansohnR.B., “Phase III Trials: Specific Problems Associated with the Use of a Placebo Control Group,”International Journal of Clinical Pharmacology and Therapeutics, 35 (1997): 47–50.
40.
See, for example, LurieP.WolfeS.M., “Unethical Trials of Interventions to Reduce Perinatal Transmission of Human Immunodeficiency Virus in Developing Countries,”N. Engl. J. Med., 337 (1997): 853–56;.
41.
AngellM., “The Ethics of Clinical Research in the Third World,”N. Engl. J. Med., 337 (1997): 847–49.
42.
45 C.F.R. § 46.405 (1991).
43.
45 C.F.R. § 46.406 (1991).
44.
45 C.F.R. § 46.407 (1991).
45.
45 C.F.R. §46.102(i) (1991).
46.
Ryan, “Controversy over Kennedy Krieger Research,”supra note 5
47.
One problem with this argument is the ambiguity of the definition of “minimal risk.” A study involves minimal risk when “the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.” 45 C.F.R. § 46.102 (1991). Whereas the National Commission defined “minimal risk” with respect to the daily life of the healthy child, the federal regulations do not specify by whose daily life the risk is to be judged
48.
See National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Research Involving Children: Report and Recommendations, DHEW Pub. No. (OS) 78–006 (Washington, D.C.: U.S. Gov't Printing Office, 1977): At xx
49.
As such, the regulations allow the probability and magnitude of harm to be defined against what the particular child in question encounters in his daily life. Since poor children are frequently exposed to lead hazards, the research by the Kennedy Krieger Institute could be classified as minimal risk. Even if one used a more stringent notion of minimal risk, the issue is whether the research itself involved more than minimal risk. The research was a study of nature and entailed collecting lead data from the homes and blood of children. The methods used in the study itself did not expose the children to more than minimal risk, even if their environment did.
50.
See, for example, Anonymous, “State Activities for Prevention of Lead Poisoning Among Children — United States, 1992,” MMWR (Morbidity & Mortality Weekly Report), 42 (1993): 165, 171–72;.
51.
WeismannD., “Lead Intoxication in Iowa Children,”Iowa Medicine, 82 (1992): 119–22;.
52.
KirchnerJ.T.KelleyB.A., “Pediatric Lead Screening in a Suburban Family Practice Setting,”Journal of Family Practice, 32 (1991): 397–400.
53.
American Academy of Pediatrics Committee on Environmental Health, “Lead Poisoning: From Screening to Primary Prevention,”Pediatrics, 92 (1993): 176–83.
54.
JanofskyJ.StarfieldB., “Assessment of Risk in Research on Children,”Journal of Pediatrics, 98 (1981): 842–46.
55.
See text corresponding to note 28.
56.
See Ryan, “Controversy over Kennedy Krieger Research,”supra note 5.
57.
RossL.F., Children, Families, and Health Care Decision Making (Oxford, England: Oxford University Press, 1998): at 96–98.
58.
See Order Denying Motion for Reconsideration, supra note 22.
59.
Brief of Amici Curiae, supra note 16.
60.
Brief of the University of Maryland Baltimore as Amicus Curiae in Support of 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/UMbrief.htm>.
61.
See, RamseyP., The Patient as Person: Explorations in Medical Ethics (New Haven: Yale University Press, 1970): at 1–58;.
62.
McCormickR.A., “Proxy Consent in the Experimentation Situation,”Perspectives in Biology and Medicine, 18 (1974): 2–23;.
63.
RamseyP., “The Enforcement of Morals: Nontherapeutic Research on Children,”Hastings Center Report, 6 (August 1976): 21–30;.
64.
McCormickR.A., “Experimentation in Children: Sharing in Sociality,”Hastings Center Report, 6 (December 1976): 41–46;.
65.
RamseyP., “Children as Research Subjects: A Reply,”Hastings Center Report, 7 (April 1977): 40–41.
66.
Ramsey, The Patient as Person, supra note 44, at 11–19.
67.
McCormick, “Proxy Consent in the Experimentation Situation,”supra note 44, at 11.
68.
Ross, supra note 42, at chapter 5,
69.
“The Child as Research Subject,” especially 77–80 and 90–93.
70.
See id. at 42–44
71.
Others have argued against holding parents to a best interest of the child standard. See, for example, GoldsteinJ.FreudA.SolnitA., Before the Best Interests of the Child, vol. II (New York: The Free Press, 1979): at 5–14;.
72.
SchoemanF., “Parental Discretion and Children's Rights: Background and Implications for Medical Decision-Making,”Journal of Medicine and Philosophy, 10 (1985): 45–62.
73.
Ross, supra note 42, at chapter 3
74.
“Constrained Parental Autonomy,” especially44–52.
75.
Grimes v. Kennedy Krieger Institute, Inc., 782 A.2d 807, 814 (Md.2001).
76.
Id. at 817.
77.
See, e.g., WilliamsP., “Success in Spite of Failure: Why IRBs Falter in Reviewing Risks and Benefits,”IRB: A Review of Human Subjects Research, 6, no. 3 (1984): 1–4;.
78.
KatzJ., “Do We Need Another Advisory Commission on Human Experimentation?,”Hastings Center Report, 25 (January–February 1995): 29–31.
79.
Advisory Committee on Human Radiation Experimentation, Final Report: Advisory Committee on Human Radiation Experiments (Washington, D.C.: U.S. Gov't Printing Office, 1995): at 816–28;.
80.
SilvermanH.HullS.C.SugarmanJ., “Variability among Institutional Review Boards' Decisions within the Context of a Multicenter Trial,”Critical Care Medicine, 29 (2001): 235–41.
81.
See, for example, WeissR., “U.S. Halts Research on Humans at Duke; University Can't Ensure Safety, Probers Find,”Washington Post, May 12, 1999, at A01;.
82.
HiltsP.J., “U.S. Halts Human Research at Alabama,”New York Times, National edition, January 22, 2000, at A10;.
83.
StolbergS.G., “Gene Therapy Ordered Halted at University,”New York Times, National edition, January 22, 2000, at A1;.
84.
HiltsP.J., “Safety Concerns Halts Oklahoma Research,”New York Times, National edition, July 11, 2000, at D10;.
85.
LevineS.WeissR., “Hopkins Told to Halt Trials Funded by U.S.; Death of Medical Volunteer Prompted Federal Directive,”Washington Post, July 20, 2001, at A01.
86.
See, for example, Office of the Inspector General, Department of Health and Human Services, Institutional Review Boards: The Emergence of Independent Boards, OEI-01-97-00192 (Washington, D.C.: U.S. Gov't Printing Office, 1998): at 1–18;.
87.
BurmanW.J., “Breaking the Camel's Back: Multicenter Clinical Trials and Local Institutional Review Boards,”Annals of Internal Medicine, 134 (2001): 152–57;.
88.
LemmensT.ThompsonA., “Noninstitutional Commercial Review Boards in North America: A Critical Appraisal and Comparison with IRBs,”IRB: Ethics and Human Research, 23, no. 2 (2001): 1–12.
89.
National Bioethics Advisory Commission, Ethical and Policy Issues in Research Involving Human Participants, vol. I of Report and Recommendations of the National Bioethics Advisory Commission (Bethesda: National Bioethics Advisory Commission, 2001), available at <http://bioethics.georgetown.edu/nbac/human/overvol1.html>.
90.
Office of Human Research Protections, Letter to Johns Hopkins University, “Re: Human Subjects Protections under Multiple Project Assurance (MPA) M-1011,” dated July 19, 2001, available at <http://ohrp.osophs.dhhs.gov/detrm_letrs/jul01a.pdf>.
The corrective actions were enumerated in a letter from Johns Hopkins University to the Office of Human Research Protections. See Johns Hopkins University, Letter to Office of Human Research Protections, “Re: Human Subjects Protections under Multiple Project Assurance (MPA) M-1011,” dated July 21, 2001, available at <http://www.hopkinsmedicine.org/press/2001/JULY/ActionPlanLetter.htm>
93.
A Johns Hopkins University press release lists fourteen specific actions. See Press Release, “Actions Taken to Strengthen Research Oversight at Johns Hopkins,” at <http://www.hopkinsmedicine.org/press/2001/AUGUST/actionplan.htm> (last visited January 30, 2002).
94.
Grimes v. Kennedy Krieger Institute, Inc., 782 A.2d 807, 858 (Md.2001).
95.
Id. at 858.
96.
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): Principle 30, available at <http://www.wma.net/e/policy/17c.pdf>.
97.
The most recent version of the Declaration of Helsinki was published in JAMA, 284 (2000): 3043–45.
98.
Principle 30 did not exist prior to the most recent revisions.
99.
See, for example, ShapiroH.T.MeslinE.M., “Ethical Issues in the Design and Conduct of Clinical Trials in Developing Countries,”N. Engl. J. Med., 345 (2001): 139–42.
100.
LurieWolfe, supra note 31.
101.
Angell, supra note 31.
102.
See, for example, LièvreM., “Premature Discontinuation of Clinical Trial for Reasons Not Related to Efficacy, Safety, or Feasibility,”British Medical Journal, 322 (2001): 603–05;.
103.
BoydK., “Commentary: Early Discontinuation Violates Helsinki Principles,”British Medical Journal, 322, (2001): 605–06.
104.
Grimes v. Kennedy Krieger Institute, Inc., 782 A.2d 807, 825, 828 (Md.2001).
105.
Id. at 825, 826–27.
106.
American Academy of Pediatrics Committee on Environmental Health, supra note 38.
