Ethical Considerations for Research on Housing-Related Health Hazards Involving Children (2005) / Chapter Skim
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3 Grimes v. Kennedy Krieger Institute: Revisiting the Ethical Issues
3 Grimes v. Kennedy Krieger Institute: Revisiting the Ethical Issues
Pages 41-61
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From page 41... ...
This chapter provides a brief summary of Grimes v. Kennedy Krieger Institute with a focus on the core ethical issues raised by the court's opinion; presents the reasoning reflected in the current federal regulations in light of issues raised by the court's opinion; and introduces the current federal regulations governing research involving human participants ("subjects")
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From page 42... ...
Kennedy Krieger Institute has become a key case in the recent history of concern about ethical issues in research. The federal government began overseeing research that involves human participants in 1974, creating a framework for independent review of research protocols and requiring informed consent from participants to assure that research would be conducted in an ethically responsible manner.
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in Baltimore, Maryland, to compare and evaluate the effectiveness of low-cost lead control measures (Johns Hopkins University, 2001) by the Kennedy Krieger Institute of John Hopkins University.
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In doing so, the court was not indicating that the plaintiffs would win at trial, only that there was enough evidence on the specific issue of a duty of care owed by the researchers to subjects for the case to go to trial. The ruling harshly criticized the design of the study and the research oversight process and raised legal and ethical issues related to the exploitation of vulnerable populations, institutional review and oversight of research, and the informed consent process.
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. 2The informed consent document stated that the Kennedy Krieger Institute would provide specific blood lead results and contract families to discuss a summary of the environmental results and possible steps to reduce any risks of exposure.
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From page 46... ...
that reviewed and approved the Kennedy Krieger Institute repair and maintenance study, regarding suggestions made to the researchers about amending the protocol so that it would comply with federal regulations and therefore qualify for federal funding. Although the Kennedy Krieger Institute initially presented the study to its IRB as having no prospect of direct benefit, the IRB recommended changing the category of research to providing a prospect of direct benefit, thereby lowering the criteria for review.
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From page 47... ...
Informed Consent The court examined at length the adequacy of the forms provided to parents to provide consent for their children to participate in the research. It seriously questioned whether or not the Kennedy Krieger Institute had provided sufficient information to the mothers about the study design and goals and the risks to their children associated with enrolling in the study so as to obtain truly free and informed consent.
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The legal decision related to "nontherapeutic" research and the court's clarification reflect the perspective that children should not be enrolled in a study with more than minimal risk that does not offer the prospect of direct benefit to the individual child because children are unable to consent for themselves and parents cannot consent on their child's behalf because they are bound to make decisions that are in the best interest of the child. The court concluded that "[I]
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From page 49... ...
Research Involving Children focused on the "Ramsey-McCormick debate," in which two eminent bioethics scholars, Paul Ramsey and Richard McCormick, took fundamentally different views on the ethics of research with children that did not offer any prospect of benefit to the child. Key elements of the debate, similar to those raised in the Kennedy Krieger case, include the authority of parents to consent to enroll their children in research and the core question of whether or not it is ethically permissible to allow children to be enrolled in research that offers no prospect of individual direct benefit ("nontherapeutic" research)
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McCormick, on the other side, argued that parental consent for children to enroll in nontherapeutic research may be morally valid, at least for research that poses only a minimal risk of harm to individual subjects. He contended that children, like all people, have a moral obligation to help fellow human beings when there is little risk to themselves.
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Finally, it rejected Ramsey's argument that children should not participate in research that he termed nontherapeutic, pointing out that Ramsey "neglects discussion of the low level of risk involved in most research involving children" (National Commission, 1977, p.
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Several years later, in 1991, 17 federal agencies and departments adopted the DHHS general human research protection regulations. These regulations, Subpart A of 45 CFR 46, or the "Common Rule," contain the basic requirements that must be met for a research protocol involving humans to qualify for federal funding from most federal agencies or departments.4 In 1983, several years after the release of Research Involving Children, DHHS became the first agency to adopt the National Commission's recommendations designed to address the unique issues when involving children in research.
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. Several provisions of the Common Rule are important to understand as context for housing health hazards research involving children.6 The Common Rule establishes several general requirements for all research involving human participants to be approved.
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. Additional Protections for Research Involving Children: Subpart D Regulatory provisions that provide specific protections for child subjects in research were formally adopted by DHHS in 1983 as Subpart D.7 Subpart D specifies three categories of research that can be approved by local IRBs: · research that does not involve greater than minimal risk (45 CFR 46.404 or "Section 404")
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: research that presents a greater than minor increase over minimal risk with no prospect of direct benefit, but has the potential to provide knowledge to understand or ameliorate the health condition; see Box 3-2 for the regulatory language for research involving children permitted under Section 406. Such projects may not be approved by a local IRB; they must be reviewed by a national panel and approved by the Secretary of DHHS.
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adequate provisions are made for soliciting the assent of the children and permission of their parents or guardians, as set forth in 46.408. Section 46.406 Research involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subject's disorder or condition.
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KRIEGER INSTITUTE 57 (b) the intervention or procedure presents experiences to subjects that are rea sonably commensurate with those inherent in their actual or expected medical, dental, psychological, social, or educational situations; (c)
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Best Interests of the Child One of the ethical issues in research involving children cited in Grimes v. Kennedy Krieger Institute is what is in the best interests of the child.
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Under the Common Rule (see above) , the researcher's duty of beneficence requires that the risks of research
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Kennedy Krieger Institute questioned whether parents should be allowed to enroll their children in research that does not offer a prospect of direct benefit, the committee concludes that it is reasonable to defer such decisions to parents, provided that they are fully informed about the risks and benefits involved, that they understand the essential features of the study, that the level of risk is acceptable, and that payments do not represent an undue inducement. Later chapters of this report outline strategies for ensuring that the risks and benefits of research are truly understood by the parents of potential child subjects in research and that payments are reasonable.
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Kennedy Krieger Institute, however, provides a useful context in which to consider the particular issues raised in housing health hazards research and highlights the particular sensitivities that occur when conducting research with socially and economically disadvantaged populations. Subsequent chapters of this report address many of the issues discussed in the court's decision.
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