Hostname: page-component-7c8c6479df-xxrs7 Total loading time: 0 Render date: 2024-03-28T23:50:28.071Z Has data issue: false hasContentIssue false

In Defense of the Hopkins Lead Abatement Studies

Published online by Cambridge University Press:  01 January 2021

Extract

In August 2001, the Maryland Court of Appeals harshly criticized the Kennedy Krieger Institute of Johns Hopkins University for knowingly exposing poor children to lead-based paint. The court’s decision made national news, and is worth examining because it raises several very important issues for research ethics.

The research conducted by the Institute was an attempt to understand how successful different lead abatement programs were in reducing continued lead exposure to children. Previously, Julian Chisolm and Mark Farfel, of John Hopkins University, had disclosed the dangers of traditional dust-generating deleading practices. In the current study, Dr. Farfel and colleagues sought to document the longevity of various lead-based paint abatement strategies.

Type
Article
Copyright
Copyright © American Society of Law, Medicine and Ethics 2002

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Grimes v. Kennedy Krieger Institute, Inc., 782 A.2d 807 (Md. 2001).Google Scholar
The court's harsh criticisms were covered by newspapers in many cities, both locally and nationally. See, for example, Roig-Franzia, M. and Weiss, R., “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; Bor, J., “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, 17,2001, at 1B; Lewin, T., “U.S. Investigating Johns Hopkins Study of Lead Paint Hazard,” New York Times, August 24,2001, at A11; “Experiments and Ethics,” Times-Picayune (New Orleans), August 27, 2001, at Metro section; Robertson, T., “Subjects in Baltimore Rue Lead-Paint Study; Hopkins Affiliate Faces Suit, Inquiry,” Boston Globe, September 3, 2001, at A1; and Editorial, “Stiffen Medical Research Rules,” San Francisco Chronicle, August 27, 2001, at A14.Google Scholar
Farfel, R. and Chisolm, J., “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.CrossRefGoogle Scholar
Grimes v. Kennedy Krieger Institute, Inc., 782 A.2d 807, 819 (Md. 2001) (citing deposition of Mark Farfel).Google Scholar
Ryan, D., “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. See Ryan, D., “Research on Lead Hazards Is Solution, Not Problem,” Op-ed, Baltimore Sun, August 28, 2001, at 19A.Google Scholar
Grimes v. Kennedy Krieger Institute, Inc., 782 A.2d 807, 812–13, 819-24 (Md. 2001).Google Scholar
Id. at 812–13, 820-22.Google Scholar
Ryan, , “Controversy over Kennedy Krieger Research,” supra note 5.Google Scholar
Bor, J., “Kennedy Krieger Doctor Defends Lead Paint Study; Researcher Disputes High Court's Findings,” Baltimore Sun, August 18, 2001, at 1B.Google Scholar
Ryan, , “Controversy over Kennedy Krieger Research,” supra note 5.Google Scholar
Grimes v. Kennedy Krieger Institute, Inc., 782 A.2d 807, 824 (Md. 2001) (citing the Consent Form, Purpose of Study).Google Scholar
Id. at 858.Google Scholar
Id. at 816.Google Scholar
Id. at 861 (Raker, J., concurring).Google Scholar
Id. at 858.Google Scholar
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>..' href=https://scholar.google.com/scholar?q=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+.>Google Scholar
Id. at 5 (emphasis added).Google Scholar
45 C.F.R. § 46.404 (1991).CrossRefGoogle Scholar
45 C.F.R. § 46.406 (1991).CrossRefGoogle Scholar
45 C.F.R. § 46.407 (1991).CrossRefGoogle Scholar
45 C.F.R. § 46.408 (1991).Google Scholar
Grimes v. Kennedy Krieger Institute, Inc., No. 128 (Md. Oct. 11, 2001) (order denying motion for reconsideration) at 1, available at <http://www.hopkinsmedicine.org/press/2001/October/CourtofAppeals.pdf>..>Google Scholar
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 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.Google Scholar
Grimes v. Kennedy Krieger Institute, Inc., 782 A.2d 807, 815 (Md. 2001).Google Scholar
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.Google Scholar
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).Google Scholar
Brief of Amici Curiae, supra note 16, at 6 (footnotes omitted).Google Scholar
See, for example, Kaptchuk, T.J., “The Double-Blind, Randomized, Placebo-Controlled Trial: Gold Standard or Golden Calf?,” Journal of Clinical Epidemiology, 54 (2001): 541–49; Ellis, S.J. and Adams, R.F., “The Cult of the Double-Blind Placebo-Controlled Trial,” British Journal of Clinical Practice, 51 (1997): 36-39; Cleophas, T.J., Van der Meulen, J. and Kalmansohn, R.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.CrossRefGoogle Scholar
See, for example, Lurie, P. and Wolfe, S.M., “Unethical Trials of Interventions to Reduce Perinatal Transmission of Human Immunodeficiency Virus in Developing Countries,” N. Engl. J. Med., 337 (1997): 853–56; Angell, M., “The Ethics of Clinical Research in the Third World,” N. Engl. J. Med., 337 (1997): 847-49.CrossRefGoogle Scholar
45 C.F.R. § 46.405 (1991).CrossRefGoogle Scholar
45 C.F.R. § 46.406 (1991).CrossRefGoogle Scholar
45 C.F.R. § 46.407 (1991).Google Scholar
45 C.F.R. §46.102(i) (1991).CrossRefGoogle Scholar
Ryan, , “Controversy over Kennedy Krieger Research,” supra note 5. 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. 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. 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.Google Scholar
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; Weismann, D., “Lead Intoxication in Iowa Children,” Iowa Medicine, 82 (1992): 119-22; Kirchner, J.T. and Kelley, B.A., “Pediatric Lead Screening in a Suburban Family Practice Setting,” Journal of Family Practice, 32 (1991): 397-400.Google Scholar
American Academy of Pediatrics Committee on Environmental Health, “Lead Poisoning: From Screening to Primary Prevention,” Pediatrics, 92 (1993): 176–83.Google Scholar
Janofsky, J. and Starfield, B., “Assessment of Risk in Research on Children,” Journal of Pediatrics, 98 (1981): 842–46.CrossRefGoogle Scholar
See text corresponding to note 28.Google Scholar
See Ryan, , “Controversy over Kennedy Krieger Research,” supra note 5.Google Scholar
Ross, L.F., Children, Families, and Health Care Decision Making (Oxford, England: Oxford University Press, 1998): at 9698.Google Scholar
See Order Denying Motion for Reconsideration, supra note 22; Brief of Amici Curiae, supra note 16; 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>..>Google Scholar
See, Ramsey, P., The Patient as Person: Explorations in Medical Ethics (New Haven: Yale University Press, 1970): at 158; McCormick, R.A., “Proxy Consent in the Experimentation Situation,” Perspectives in Biology and Medicine, 18 (1974): 2-23; Ramsey, P., “The Enforcement of Morals: Nontherapeutic Research on Children,” Hastings Center Report, 6 (August 1976): 21-30; McCormick, R.A., “Experimentation in Children: Sharing in Sociality,” Hastings Center Report, 6 (December 1976): 41-46; Ramsey, P., “Children as Research Subjects: A Reply,” Hastings Center Report, 7 (April 1977): 40-41.Google Scholar
Ramsey, , The Patient as Person, supra note 44, at 1119.Google Scholar
McCormick, , “Proxy Consent in the Experimentation Situation,” supra note 44, at 11.Google Scholar
Ross, , supra note 42, at chapter 5, “The Child as Research Subject,” especially 7780 and 90-93.Google Scholar
See id. at 42-44. Others have argued against holding parents to a best interest of the child standard. See, for example, Goldstein, J., Freud, A. and Solnit, A., Before the Best Interests of the Child, vol. II (New York: The Free Press, 1979): at 514; Schoeman, F., “Parental Discretion and Children's Rights: Background and Implications for Medical Decision-Making,” Journal of Medicine and Philosophy, 10 (1985): 45-62.Google Scholar
Ross, , supra note 42, at chapter 3, “Constrained Parental Autonomy,” especially 4452.Google Scholar
Grimes v. Kennedy Krieger Institute, Inc., 782 A.2d 807, 814 (Md. 2001).Google Scholar
Id. at 817.Google Scholar
See, e.g., Williams, P., “Success in Spite of Failure: Why IRBs Falter in Reviewing Risks and Benefits,” IRB: A Review of Human Subjects Research, 6, no. 3 (1984): 14; Katz, J., “Do We Need Another Advisory Commission on Human Experimentation?,” Hastings Center Report, 25 (January-February 1995): 29-31. 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; Silverman, H., Hull, S.C. and Sugarman, J., “Variability among Institutional Review Boards' Decisions within the Context of a Multicenter Trial,” Critical Care Medicine, 29 (2001): 235-41.CrossRefGoogle Scholar
See, for example, Weiss, R., “U.S. Halts Research on Humans at Duke; University Can't Ensure Safety, Probers Find,” Washington Post, May 12, 1999, at A01; Hilts, P.J., “U.S. Halts Human Research at Alabama,” New York Times, National edition, January 22, 2000, at A10; Stolberg, S.G., “Gene Therapy Ordered Halted at University,” New York Times, National edition, January 22, 2000, at A1; Hilts, P.J., “Safety Concerns Halts Oklahoma Research,” New York Times, National edition, July 11, 2000, at D10; Levine, S. and Weiss, R., “Hopkins Told to Halt Trials Funded by U.S.; Death of Medical Volunteer Prompted Federal Directive,” Washington Post, July 20, 2001, at A01.Google Scholar
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 118;. Burman, W.J. et al., “Breaking the Camel's Back: Multicenter Clinical Trials and Local Institutional Review Boards,” Annals of Internal Medicine, 134 (2001): 152-57; Lemmens, T. and Thompson, A., “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.Google Scholar
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>..>Google Scholar
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>..>Google Scholar
Hellman, S. et al., Report of Johns Hopkins University External Review Committee (August 8, 2001), available at <http://www.hopkinsmedicine.org/external.pdf>..>Google Scholar
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>. 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)..+A+Johns+Hopkins+University+press+release+lists+fourteen+specific+actions.+See+Press+Release,+“Actions+Taken+to+Strengthen+Research+Oversight+at+Johns+Hopkins,”+at++(last+visited+January+30,+2002).>Google Scholar
Grimes v. Kennedy Krieger Institute, Inc., 782 A.2d 807, 858 (Md. 2001).Google Scholar
Id. at 858.Google Scholar
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>. The most recent version of the Declaration of Helsinki was published in JAMA, 284 (2000): 3043–45.CrossRef.+The+most+recent+version+of+the+Declaration+of+Helsinki+was+published+in+JAMA,+284+(2000):+3043–45.>Google Scholar
Principle 30 did not exist prior to the most recent revisions.Google Scholar
See, for example, Shapiro, H.T. and Meslin, E.M., “Ethical Issues in the Design and Conduct of Clinical Trials in Developing Countries,” N. Engl. J. Med., 345 (2001): 139–42; Lurie, and Wolfe, , supra note 31; Angell, , supra note 31.CrossRefGoogle Scholar
See, for example, Lièvre, M. et al., “Premature Discontinuation of Clinical Trial for Reasons Not Related to Efficacy, Safety, or Feasibility,” British Medical Journal, 322 (2001): 603–05; Boyd, K., “Commentary: Early Discontinuation Violates Helsinki Principles,” British Medical Journal, 322, (2001): 605-06.CrossRefGoogle Scholar
Grimes v. Kennedy Krieger Institute, Inc., 782 A.2d 807, 825, 828 (Md. 2001).Google Scholar
Id. at 825, 826–27.Google Scholar
American Academy of Pediatrics Committee on Environmental Health, supra note 38.Google Scholar