Ethical Considerations for Research on Housing-Related Health Hazards Involving Children (2005) / Chapter Skim
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Executive Summary
Executive Summary
Pages 1-12
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From page 1... ...
However, some housing health hazards -- such as lead poisoning, asthma, and fatal injuries -- occur at disproportionately high rates in the poor-quality homes of children in low-income families. Research on housing health hazards involving children is necessary to understand how hazards affect health and to develop interventions that can ameliorate or eliminate them.
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Broadly, our charge was to review and synthesize existing approaches to conducting housing health hazards research involving children and the challenges and ethical issues that arise in conducting that research and to identify approaches to ensuring the ethical conduct of that research. NATURE OF THE RESEARCH The current regulatory framework that governs research involving human participants (referred to in the regulations as "subjects")
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From page 3... ...
Similarly, at least two other features of some housing health hazards research raise general ethical issues, especially as they interact with the ones just noted: · Economic and educational disadvantage and limited literacy among low-income parents may place them at a disadvantage in the informed consent process. · Financial or other material incentives may present undue influences for parents in the decision to allow their children to participate in a research project.
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The committee identifies the community as an additional component of the system in the context of housing health hazards research. Community involvement in research on housing health hazards with children has been shown to make research more responsive to community needs, identify risks that researchers had not appreciated, improve informed consent, increase study enrollment, enhance data validity and quality, build trust for research, and help translate research into public policy.
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6.2) 6.1 require ensure should need who undue consent studies enable should for should to understand parties and informed Recommendations Researchers third (Recommendation Sponsors funding (Recommendation Compensation potential (Recommendation The longitudinal input subjects research (Recommendations of undue therapeutic misunderstandings implications constitute for other and may and payment likelihood procedures of Implications Ethical Increased misconception research Amount inducement Continued with educationally groups and ES-1 conducted TABLE Characteristics Often economically disadvantaged
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7 or and all from necessary understand studies which advice community in benefit the intervention economically with for groups parents direct have include 6.2) designs of that research and intervention they involving process guidance should the 8.3)
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Researchers have several other areas of responsibility with regard to ethical housing health hazards research: innovative research designs, anticipatory response plans, and consideration of the effect of their research on third parties. Innovative research designs are important because of the ethical issues and difficulties of doing randomized control trials for housing health hazards.
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Researchers designing intervention studies on housing health hazards involving children should consider using innovative designs in which all subjects receive a prospect of direct benefit. (Recommendation 7.1)
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(Recommendation 5.2) Institutional review boards that review intervention studies or longitu dinal cohort studies on housing health hazards involving children should require that the informed consent process reflects appropriate community input and includes plans to ensure that parents of child subjects understand the essential elements of the research.
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From page 11... ...
The committee concludes that these additional protections are critical to establishing consistent conditions for researchers and IRBs when designing and overseeing housing health hazards research. Subpart D provides a solid foundation for research involving children, but key terms -- such as "minimal risk," "minor increase over minimal risk," and "disorder or condition" -- which are vital in determining whether research involving children is allowable and the standards that must be applied, are interpreted in widely varying ways.
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From page 12... ...
Implementing the committee's recommendations for housing health hazards research involving children can provide needed protection for child subjects and affected communities and researchers, ensure that the rights of child subjects are protected, and allow valuable research to proceed that is intended to benefit children living in poor-quality housing. Critical steps include adoption of Subpart D by all federal agencies and clarification of key terms in Subpart D and efforts by researchers, IRBs, and sponsors to ensure appropriate community involvement and thorough understanding by parents of key elements of the research.
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Key Terms
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