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Suggested Citation:"Executive Summary." National Research Council and Institute of Medicine. 2005. Ethical Considerations for Research on Housing-Related Health Hazards Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/11450.
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Executive Summary

A home is considered a place where children grow and flourish. However, homes may also contain hazards that can cause physical illness, compromise children’s growth and development, and lower school performance. These hazards are particularly serious for young children because they spend significant amounts of time in their homes, because their normal exploratory behaviors increase the likelihood of exposure to hazards, and because the effect of exposure may be particularly harmful because of their small size and developmental immaturity.

Many health hazards in homes—such as mold, radon, tobacco smoke, and household chemicals—occur in housing at all economic levels. 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. Such research, typically conducted in children’s homes, has contributed significantly to knowledge about the risks of health hazards in homes. Some research is directed toward generalizable knowledge and offers no direct benefit to the children who are enrolled in it, such as studies of how exposure to environmental hazards in homes affects health. This kind of research has resulted in the design of interventions to address hazards, such as window guards that have significantly reduced childhood injuries from falls through windows. Other research has evaluated interventions to ameliorate or eliminate the risks of exposure and harm. This kind of research may offer the prospect of direct benefit to the children who are enrolled in the

Suggested Citation:"Executive Summary." National Research Council and Institute of Medicine. 2005. Ethical Considerations for Research on Housing-Related Health Hazards Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/11450.
×

studies. Research both identified lead-based paint as a cause of lead poisoning among children and showed that the abatement techniques previously used actually increased lead poisoning because they caused lead contamination of house dust, which children ingest. Research on housing health hazards has led to changes in public policy, such as improved screening for risk factors and regulatory changes to reduce risks.

Housing health hazards research focuses on a risk factor that is not a physical susceptibility to disease, but rather results from environmental conditions that generally exist in poor-quality housing. Many of those conditions could be improved by better quality housing, but there is a lack of decent affordable housing for children in low-income families. Research is often conducted with children in low-income families because they experience the greatest risk and because they have the most to gain from such research.

The 2001 case of Grimes v. Kennedy Krieger Institute highlighted uncertainties and conflicts involving several issues integral to research on housing health hazards. Although the case was eventually settled out of court, the ruling of the Maryland Court of Appeals raised important issues involving the adequacy of informed consent, parents’ perceptions of risk, duties of researchers to child subjects and their parents, the role of institutional review boards (IRBs), and the authority of parents to provide permission for their children to participate in research that is not intended to provide direct benefit for their children.

The issues posed by that case led the Department of Housing and Urban Development, the Centers for Disease Control and Prevention, and the Environmental Protection Agency to request a study from the National Academies on ethical issues related to housing health hazards research. The Committee on Ethical Issues in Housing Related Health Hazard Research Involving Children, Youth, and Families was formed in response to that request, under the Board on Children, Youth, and Families of the National Academies’ National Research Council and Institute of Medicine. 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”) that is conducted or funded by certain agencies of the federal government is based on the fundamental ethical principles of respect for person, beneficence, and

Suggested Citation:"Executive Summary." National Research Council and Institute of Medicine. 2005. Ethical Considerations for Research on Housing-Related Health Hazards Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/11450.
×

justice. Subpart A (of 45 CFR 46) provides various protections related to informed consent, level of allowable risk, and IRB approval. If the research receives funding from the Department of Health and Human Services (DHHS) or certain other federal agencies, Subpart D provides additional protections for research involving children. Oversight is the responsibility of the Office for Human Research Protections (OHRP) in DHHS, with input from the Secretary’s Advisory Committee on Human Research Protections (SACHRP).

Because housing health hazards research is conducted in homes, some ethical issues arise that are not as common in biomedical and other types of research.

  • Research conducted in homes intrudes on the privacy of all residents and reveals many things about the residents that would not otherwise be apparent or shared.

  • The research is almost always based in the community and frequently involves community concerns about the safety and quality of local housing.

  • Because some hazards occur disproportionately among children in low-income families who live in poor-quality housing, they are more likely to be candidates for housing health hazards research, and disproportionate enrollment of children in low-income families may raise questions about targeting or inequitable selection of subjects.

  • The residents of poor-quality housing in low-income communities often face a range of housing health hazards and may be concerned about hazards other than the one being studied or may mistakenly believe that research designed to test an intervention may actually eliminate the hazard.

  • Parents of potential subjects and community residents may be concerned about the housing risks that persist after the research interventions and the study are completed.

Some of these issues may also affect other types of research conducted in homes. 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.

Suggested Citation:"Executive Summary." National Research Council and Institute of Medicine. 2005. Ethical Considerations for Research on Housing-Related Health Hazards Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/11450.
×

A SYSTEMS APPROACH

The report Responsible Conduct of Research (Institute of Medicine, 2004) argued that a systems approach is necessary to ensure that the ethics and science of human participants research are of high quality. A systems approach involves responsibilities for researchers, oversight bodies such as IRBs, the OHRP, and research sponsors. This committee concurs with a systems approach and recommends additional responsibilities for each system component: researchers, in designing and implementing studies; research institutions and IRBs, in approving and overseeing research; and the federal government and sponsors of research, in funding research.

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. Community involvement allows researchers to understand the views of the community in which research studies are conducted and to respond to those perspectives so that the risks of a research project are minimized and appropriate in light of the anticipated benefits of research, as required by the federal regulations.

Table ES-1 provides an overview of a systems approach, summarizing key characteristics of housing health hazards research, the ethical issues raised by those characteristics, and the committee’s recommendations.

RESPONSIBILITIES OF RESEARCHERS

Community involvement is a key element for conducting in an ethical manner housing health hazards research that involves children in their homes. Community involvement can contribute to the ethical conduct of this research, ensuring that parents understand key features of the research and that compensation is appropriate. With community involvement researchers in turn can present their findings to key local officials to support evidence-based policies aimed at ameliorating housing-related health hazards.

The consent process for research participants in any scientific study should be both informed and freely given without coercion or undue influence. One critical component of the consent process for research involving children is ensuring that parents or other caregivers are aware of and do not misunderstand essential features of the research study. When the parents of child subjects are economically and educationally disadvantaged, particular attention must be paid to potential sources of undue influence as identified

Suggested Citation:"Executive Summary." National Research Council and Institute of Medicine. 2005. Ethical Considerations for Research on Housing-Related Health Hazards Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/11450.
×

TABLE ES-1 Housing Health Hazards Research: Characteristics, Ethical Implications, and Recommendations

Characteristics

Ethical Implications

Recommendations

Conducted with children

Children are vulnerable and unable to provide informed consent

All funders should at a minimum adopt the protections of Subpart D

(Recommendation 8.1)

 

 

OHRP should issue guidance on key terms used in Subpart D

(Recommendation 8.2)

 

 

Communities should be involved in design and implementation of research projects

(Recommendations 5.1 and 5.2)

Conducted in the home

There is a breach of privacy

Researchers need to develop anticipatory plans to assess and respond to observed risks and behaviors and educate their staffs

(Recommendations 7.3 and 7.4)

 

Researchers are likely to observe risks not related to research questions

 

 

Researchers need to recognize obligations to third parties affected by their research

(Recommendation 7.2)

Conducted in the community

Research procedures and findings affect the entire community

Communities should be involved in design and implementation of research projects

(Recommendations 5.1 and 5.2)

 

Differences in priorities between researchers and community members

Researchers need to respond to community concerns (Recommendation 5.1)

Suggested Citation:"Executive Summary." National Research Council and Institute of Medicine. 2005. Ethical Considerations for Research on Housing-Related Health Hazards Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/11450.
×

Characteristics

Ethical Implications

Recommendations

 

 

Researchers need to recognize obligations to third parties who are affected by their research

(Recommendation 7.2)

 

 

Sponsors should require and provide adequate funding to enable community involvement

(Recommendation 5.3)

Often conducted with economically and educationally disadvantaged groups

Increased likelihood for therapeutic misconception and other misunderstandings of research procedures and implications

Compensation should be reasonable and avoid potential for undue influence

(Recommendation 6.2)

 

Amount of payment may constitute undue inducement

The informed consent process for intervention or longitudinal studies should include community input and should ensure that parents of child subjects understand essential features of the research

(Recommendations 6.1 and 6.2)

Suggested Citation:"Executive Summary." National Research Council and Institute of Medicine. 2005. Ethical Considerations for Research on Housing-Related Health Hazards Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/11450.
×

 

 

OHRP should issue guidance with advice from SACHRP on research involving economically and educationally disadvantaged groups

(Recommendation 8.3)

Presence of multiple health hazards in homes of child subjects

Research may address only one aspect of problems in the home

The informed consent process for intervention or longitudinal studies should include community input and should ensure that parents understand essential features of the research

(Recommendations 6.1 and 6.2)

 

 

Researchers who design intervention studies should consider innovative designs in which all subjects have the prospect of direct benefit

(Recommendation 7.1)

Lack of IRB expertise and experience in housing health hazards research

Potential for inadequate review and oversight of research

IRBs need to ensure that they have the necessary expertise

(Recommendation 8.4)

Suggested Citation:"Executive Summary." National Research Council and Institute of Medicine. 2005. Ethical Considerations for Research on Housing-Related Health Hazards Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/11450.
×

in the relevant regulations. To ensure that consent is truly informed, researchers must ensure that parents of child subjects:

  • understand the risks present in the home pertinent to the topic being studied;

  • understand ongoing risks in the housing environment that may persist after completion of study interventions;

  • understand the essential elements of the research including whether and when test results will be provided to them and the risks and benefits presented by the research project itself.

Researchers should obtain the assent of children to participate in the research as appropriate to their age and developmental status.

The issue of appropriate compensation for children involved in research and their families is an important issue in all research with children, but it is a particular concern with low-income families. Payments should be structured to compensate parents for their time and expenses, and they may include modest incentives or gifts of appreciation. Excessive payments constitute an undue inducement that could lead parents to agree to a greater level of risk than they would otherwise.

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. Community residents often object to randomized trials because of the lack of benefits provided to the comparison group in such research, particularly because virtually all children involved in the research will live in conditions that may pose health risks. Innovative study designs that offer a benefit to both the research and comparison groups, without compromising the integrity of the research, can alleviate some of the ethical concerns. In addition, child subjects should be recruited from potentially affected groups at all income levels whenever feasible.

Because researchers enter families’ homes, privacy is compromised: they observe behavior and hear conversations that would otherwise be private. They may observe behaviors or situations that are not related to the research project but that pose a risk or danger to either research subjects or other residents. Researchers should anticipate and define their legal and ethical obligations to both subjects and others. They need to anticipate risks and have plans for dealing with them and inform their staffs of those plans.

When children in a home are at risk of imminent and serious harm, researchers and their staffs are ethically obligated to respond to dangerous

Suggested Citation:"Executive Summary." National Research Council and Institute of Medicine. 2005. Ethical Considerations for Research on Housing-Related Health Hazards Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/11450.
×

circumstances by discussing these concerns with the family and, if needed, notifying appropriate authorities as required by law or good practice. In cases that pose less serious threats, researchers should respond to observed problems in ways that respect the values and needs of the children’s household, respond to community norms, and reflect their own ethical obligations.

Finally, researchers need to consider situations that may require them to obtain permission, provide notification, or act to reduce risks to third parties, such as other residents in the housing, landlords, or neighbors.

Researchers carrying out research on housing health hazards involving children should describe in their protocols and IRB submissions how they have involved and will continue to involve the affected community in the research project, justify the lack of such involvement, and report how they have responded to any community concerns. (Recommendation 5.1)

Researchers who carry out intervention studies or longitudinal cohort studies on housing health hazards with children should implement a process of informed parental decision making by discussing the planned consent process with community representatives, considering their input, and ensuring that parents of child subjects understand the essential elements of the research. (Recommendation 6.1)

Payment for participating in research on housing health hazards involving children should reimburse (1) reasonable expenses directly related to participation; (2) reasonable, age-appropriate compensation to children for time spent in research that does not offer the prospect of direct benefit; and (3) reasonable compensation to parents for time spent in research. Such compensation may be in addition to token gifts to parents and children as gestures of appreciation. Such payments must avoid the potential for undue influence. (Recommendation 6.3)

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)

Researchers carrying out research on housing health hazards involving children should discuss in their protocols and IRB submissions their legal and ethical obligations to potential third parties affected by their research. (Recommendation 7.2)

Researchers designing research on housing health hazards to children need to anticipate the risks and behaviors that may be observed in the

Suggested Citation:"Executive Summary." National Research Council and Institute of Medicine. 2005. Ethical Considerations for Research on Housing-Related Health Hazards Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/11450.
×

home, including observations that are not part of the research protocol, develop anticipatory plans that specify how to assess and respond to risks when they are identified, and educate staffs about the plan. (Recommendation 7.3)

RESPONSIBILITIES OF RESEARCH INSTITUTIONS AND IRBS

Research institutions have an obligation to ensure that the research they conduct is done in an ethical manner and in compliance with applicable statutes and regulations. Those institutions and their oversight bodies, such as IRBs, need to have the necessary expertise to provide complete and adequate review and oversight of research on housing health hazards to children.

Subpart D specifies three types of research involving children that can be approved by an IRB: (1) research involving minimal risk (Section 404); (2) research involving a greater than minimal risk with the prospect of direct benefit to subjects (Section 405); and (3) research involving a minor increase over minimal risk with no prospect of direct benefit to the subjects (Section 406). Section 406 research may be approved by an IRB only if the research shows promise of providing information necessary to understand or ameliorate the “disorder or condition” of the children who are subjects in the research.

Disadvantaged children who reside in poor-quality housing stand to gain the most from such research because they are most at risk from many housing health hazards, yet they are also at increased risk for harm from housing health hazards because of their disadvantages.

Institutional review boards should require appropriate community involvement in housing health hazards research involving children and require that investigators’ protocols are responsive to any community concerns. (Recommendation 5.2)

Institutional review boards that review intervention studies or longitudinal 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. (Recommendation 6.2)

Institutional review boards that review housing health hazards research should examine researchers’ plans for responding to risks observed in the home and require that they be appropriate in the context of the research and the affected community. (Recommendation 7.4)

Suggested Citation:"Executive Summary." National Research Council and Institute of Medicine. 2005. Ethical Considerations for Research on Housing-Related Health Hazards Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/11450.
×

Institutional review boards that review housing health hazards research involving children should ensure that those boards have the necessary expertise to conduct a complete and adequate review, including expertise on research involving children and community perspectives. (Recommendation 8.4)

RESPONSIBILITIES OF THE FEDERAL GOVERNMENT AND RESEARCH SPONSORS

Subpart D of the federal regulations governing research that involves children provides specific protections and a solid ethical foundation for the conduct of this research. The primary agencies that sponsor such research include the Department of Housing and Urban Development (HUD), the Environmental Protection Agency (EPA), and the Department of Health and Human Services (DHHS), including the Centers for Disease Control and Prevention (CDC), and the National Institutes of Health (NIH). Of them, only DHHS has adopted Subpart D. 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. The committee concludes that consistent definitions are critical to providing oversight to IRBs.

In Subpart A of the federal regulations, economically and educationally disadvantaged people are identified as a vulnerable group that warrants particular consideration, specifically in the context of informed consent and justice. However, unlike other designated vulnerable people—children, pregnant women, and prisoners—no specific regulations are provided for applying additional protections for this group. Guidance on how to implement special protections for this vulnerable group are needed to help researchers and IRBs develop appropriate protocols and assure that their rights and welfare are protected.

All federal agencies—including the U.S. Department of Housing and Urban Development and the Environmental Protection Agency—private foundations, and other funders of research on housing health hazards involving children should at a minimum adopt the current regulatory framework in Subpart D of 45 CFR 46. (Recommendation 8.1)

Suggested Citation:"Executive Summary." National Research Council and Institute of Medicine. 2005. Ethical Considerations for Research on Housing-Related Health Hazards Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/11450.
×

The Office of Human Research Protections should issue guidance to institutional review boards on how to interpret the key regulatory terms—“minimal risk,” “minor increase over minimal risk,” “disorder or condition,” “reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social, or educational situations,” and “vital importance”—in the context of housing health hazard research. (Recommendation 8.2)

The Secretary’s Advisory Committee on Human Research Protections should develop guidelines for research with economically and educationally disadvantaged participants for use by the Office for Human Research Protections use in issuing guidance for researchers and institutional review boards. (Recommendation 8.3)

Community involvement in research and continued evaluation of the outcomes of this involvement will be advanced if funders require it as part of the research they fund. Meaningful community involvement requires adequate time and resources, including resources to reimburse the expenses of researchers and community residents or to compensate them for the time required; such expenses are not typically included in research grants.

Federal agencies (e.g., HUD, EPA, NIH, CDC), private foundations, and other funders of research on housing health hazards involving children should require researchers to have appropriate community involvement in the research. Funders should provide adequate funding to involve affected communities and should sponsor research to evaluate the outcomes of community involvement. (Recommendation 5.3)

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. To do this successfully will require the commitment of researchers, IRBs, OHRP, sponsors, and representatives of the communities where this research will be carried out. A partnership among all these parties will help develop the scientific basis for public policies that will reduce or eliminate the housing hazards that threaten children’s health.

Suggested Citation:"Executive Summary." National Research Council and Institute of Medicine. 2005. Ethical Considerations for Research on Housing-Related Health Hazards Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/11450.
×
Page 1
Suggested Citation:"Executive Summary." National Research Council and Institute of Medicine. 2005. Ethical Considerations for Research on Housing-Related Health Hazards Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/11450.
×
Page 2
Suggested Citation:"Executive Summary." National Research Council and Institute of Medicine. 2005. Ethical Considerations for Research on Housing-Related Health Hazards Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/11450.
×
Page 3
Suggested Citation:"Executive Summary." National Research Council and Institute of Medicine. 2005. Ethical Considerations for Research on Housing-Related Health Hazards Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/11450.
×
Page 4
Suggested Citation:"Executive Summary." National Research Council and Institute of Medicine. 2005. Ethical Considerations for Research on Housing-Related Health Hazards Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/11450.
×
Page 5
Suggested Citation:"Executive Summary." National Research Council and Institute of Medicine. 2005. Ethical Considerations for Research on Housing-Related Health Hazards Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/11450.
×
Page 6
Suggested Citation:"Executive Summary." National Research Council and Institute of Medicine. 2005. Ethical Considerations for Research on Housing-Related Health Hazards Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/11450.
×
Page 7
Suggested Citation:"Executive Summary." National Research Council and Institute of Medicine. 2005. Ethical Considerations for Research on Housing-Related Health Hazards Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/11450.
×
Page 8
Suggested Citation:"Executive Summary." National Research Council and Institute of Medicine. 2005. Ethical Considerations for Research on Housing-Related Health Hazards Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/11450.
×
Page 9
Suggested Citation:"Executive Summary." National Research Council and Institute of Medicine. 2005. Ethical Considerations for Research on Housing-Related Health Hazards Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/11450.
×
Page 10
Suggested Citation:"Executive Summary." National Research Council and Institute of Medicine. 2005. Ethical Considerations for Research on Housing-Related Health Hazards Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/11450.
×
Page 11
Suggested Citation:"Executive Summary." National Research Council and Institute of Medicine. 2005. Ethical Considerations for Research on Housing-Related Health Hazards Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/11450.
×
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Ethical Considerations for Research on Housing-Related Health Hazards Involving Children explores the ethical issues posed when conducting research designed to identify, understand, or ameliorate housing-related health hazards among children. Such research involves children as subjects and is conducted in the home and in communities. It is often conducted with children in low-income families given the disproportionate prevalence of housing-related conditions such as lead poisoning, asthma, and fatal injuries among these children. This book emphasizes five key elements to address the particular ethical concerns raised by these characteristics: involving the affected community in the research and responding to their concerns; ensuring that parents understand the essential elements of the research; adopting uniform federal guidelines for such research by all sponsors (Subpart D of 45 CFR 46); providing guidance on key terms in the regulations; and viewing research oversight as a system with important roles for researchers, IRBs and their research institutions, sponsors and regulators of research, and the community.

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