1
Introduction

Everyone wants children to have the opportunity to grow up healthy. And people think of homes as special places where children grow, develop, and thrive—where parents, guardians, and extended family teach children values and nurture their futures. Yet some homes have hazards that present serious health risks to children.

Hazards in housing have long been associated with infectious and chronic diseases, injuries, and even death. By the mid-nineteenth century, with the growth in urban populations and overcrowded tenements, the connection between health and housing was clearly recognized (see Duffy, 1990; Atkins, 1947). Overcrowding, impure drinking water, faulty sanitation, and poor construction allowed the transmission of tuberculosis, diphtheria, cholera, and other communicable diseases in crowded tenements (American Public Health Association, 1938). The sanitarian or public health movement emphasized adequate lighting, ventilation, and sewage and waste disposal. After World War II, however, public health efforts were largely divorced from housing codes and regulations as housing policy shifted toward code enforcement and provision of affordable housing (National Research Council, 2000).

Today, the connection between housing conditions and health has reemerged as an important issue, with the identification of new and often subtler hazards in homes, such as exposure to lead, pesticides, indoor allergens, molds, indoor air pollutants, as well as unintentional injuries in the home (Matte and Jacobs, 2000; Krieger and Higgins, 2002). Young children are uniquely susceptible to these hazards because they spend the majority of their time in the home (Wiley et al., 1991) and because normal



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Ethical Considerations for Research on Housing-Related Health Hazards Involving Children 1 Introduction Everyone wants children to have the opportunity to grow up healthy. And people think of homes as special places where children grow, develop, and thrive—where parents, guardians, and extended family teach children values and nurture their futures. Yet some homes have hazards that present serious health risks to children. Hazards in housing have long been associated with infectious and chronic diseases, injuries, and even death. By the mid-nineteenth century, with the growth in urban populations and overcrowded tenements, the connection between health and housing was clearly recognized (see Duffy, 1990; Atkins, 1947). Overcrowding, impure drinking water, faulty sanitation, and poor construction allowed the transmission of tuberculosis, diphtheria, cholera, and other communicable diseases in crowded tenements (American Public Health Association, 1938). The sanitarian or public health movement emphasized adequate lighting, ventilation, and sewage and waste disposal. After World War II, however, public health efforts were largely divorced from housing codes and regulations as housing policy shifted toward code enforcement and provision of affordable housing (National Research Council, 2000). Today, the connection between housing conditions and health has reemerged as an important issue, with the identification of new and often subtler hazards in homes, such as exposure to lead, pesticides, indoor allergens, molds, indoor air pollutants, as well as unintentional injuries in the home (Matte and Jacobs, 2000; Krieger and Higgins, 2002). Young children are uniquely susceptible to these hazards because they spend the majority of their time in the home (Wiley et al., 1991) and because normal

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Ethical Considerations for Research on Housing-Related Health Hazards Involving Children exploratory behaviors increase their likelihood of exposure (Bearer, 1995). In addition, the effects of exposure may be magnified by their smaller size and developmental immaturity (Bearer, 1995). Among children, those in minority and low-income households are at greatest risk for health hazards in the home because of the generally poorer quality of their housing. Homes occupied by African Americans and low-income residents are 1.7 and 2.2 times more likely, respectively, to have a severe physical problem than other homes (Krieger and Higgins, 2002, citing American Housing Survey data). Children in low-income families are more likely to live in overcrowded households. Fatal residential injuries occur more frequently among African American children (Nagaraja et al., 2005). Evidence suggests that the higher prevalence of asthma and asthma morbidity among children in low-income families is at least partly attributable to housing conditions (Rauh, Chew, and Garfinkel, 2002; Huss et al., 1994). Lead poisoning is concentrated among poor, black children in older, poorly maintained homes in inner cities (Cummins and Jackson, 2001). In agricultural communities, particularly among the children of migrant farm workers, pesticide exposure is common (Bradman et al., 2005). ISSUES IN RESEARCH WITH CHILDREN Research with children inevitably raises ethical concerns. First, unlike adults, children cannot directly avoid or mitigate the risks of research because of their lack of experience and lack of control of their environment. Second, young children cannot provide informed consent on their own behalf: their parents or guardians must give permission for them to be enrolled in research. Exposing humans to research risks to which they have not consented always calls for close ethical scrutiny. The goal of research by definition is the advancement of generalizable knowledge. As such, research interventions primarily benefit society as a whole, or future generations of children, not necessarily the children enrolled in the research and exposed to any risks that may be associated with the research. The federal regulations that govern research with children recognize that children have unique vulnerabilities; the regulations are accordingly designed to provide special protections. Although additional guidance is needed on some aspects of these regulations (discussed in this report), the current regulatory framework provides a solid framework for conducting ethical research with children. However, the particular characteristics of housing health hazards research introduce ethical issues not fully addressed by the current regulations: those additional issues are the focus of this report. Although some of the same characteristics are present in other types of research, and the additional protections proposed could apply in these cases, the focus of this report is specifically on housing health hazards research.

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Ethical Considerations for Research on Housing-Related Health Hazards Involving Children HOUSING HEALTH HAZARDS RESEARCH Research can identify hazards in homes, characterize the sources and pathways of exposure and mechanisms of adverse health effects, and evaluate interventions to ameliorate or eliminate these risks. Research has led to improved screening for some risk factors, regulatory changes to reduce risks, and more effective interventions to reduce known hazards. For example, early epidemiological research led to requirements for window guards, which led to a significant reduction in childhood injuries from falls through windows. Research identified lead-based paint as a cause of lead poisoning in children; other studies showed that early lead abatement techniques para-doxically increased lead poisoning because they caused lead contamination of house dust, which is then ingested by children. Recent studies have been designed to determine effective strategies for mitigating known environmental risks for asthma and other housing health hazards. Research now under way is aimed at identifying the exposure and adverse effects of pesticides and other chemicals introduced into the home through human activity (e.g., building materials, furnishings, and consumer products). The promise of improved health from research on housing health hazards involving children has not always been fulfilled. Housing codes may not be upgraded or enforced, regulations may be more significant for public than for private housing, and low-income families often face an inadequate supply of affordable housing that meets code and safety standards. In light of the continued problem of lack of affordable decent housing despite years of research showing the risks to children, community advocates may believe that additional research is unlikely to lead to improved housing for children who live in hazardous housing. In the experience of researchers working with community advisory boards, some community representatives (Krieger et al., 2002a) believe with due cause that the promise of the benefits of research has been deferred too long, and they may be cynical about the value of further research in their communities. Some advocates may believe that, rather than more research about housing health hazards, what is needed is greater political and social commitment to provide the resources or regulatory oversight needed to ensure safe and affordable housing for all children. Other advocates for better housing for children support additional research that may support housing reforms by providing more compelling evidence of how housing hazards impair children’s health and how those hazards can be ameliorated. Housing health hazards research involving children raises particular ethical challenges because it is usually conducted in homes.1 A home setting 1   In some cases, research is conducted in vacant housing.

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Ethical Considerations for Research on Housing-Related Health Hazards Involving Children is very different from a clinic setting in that a range of household risks (not covered by the research) may often be present and need to be considered. The researchers’ relationship with children and their parents may be more complicated, and there may be conflicts in their roles and ethical obligations that are not always present (or as evident) in clinic-based research. Furthermore, research in homes may uncover personal information which may not be revealed in a clinical setting. In some cases, this information may involve third parties. In addition, because children in low-income families are more likely to live in poor-quality housing and therefore are at increased risk for many housing health hazards, and to generate the necessary knowledge to understand and ameliorate these risks, such research often involves economically and educationally disadvantaged children. There are a number of ethical concerns about targeting such children for research. They are more likely to experience a range of vulnerabilities, such as poor access to health care and poor-quality schools. Their families are also more likely to be members of minority groups that historically have suffered and may continue to suffer discrimination. These multiple vulnerabilities raise concerns about both the exposure to any risks of research and to barriers to free and informed consent. Moreover, the relative lack of social, economic, and political power by low-income parents in relation to researchers may affect the voluntary nature of informed consent, at the same time that payments for participation may unduly influence parents’ decision to allow their children to be enrolled in research. Furthermore, increased risk for housing health hazards of children in low-income families is due, in large part, to social circumstances. Poverty limits their parents’ access to affordable, decent-quality housing and ability to pay for improvements that can ameliorate housing hazards. Moving to better quality housing, which would reduce many housing health hazards, is usually not a feasible option. Researchers conducting housing health hazard research face many challenges. When researchers enter a home, even with the permission of the parents, there is an invasion of privacy. Although researchers were invited in the home to carry out only specific research interventions, they may be in a unique position to identify and help ameliorate hazards beyond those that are the focus of the study. If they do not act, an opportunity to prevent harm may be lost. However, if researchers do not point out any health hazards, parents may infer that there are none in their homes. (In some cases, researchers may have a legal obligation to report observations in the home.) Entering homes to conduct research also raises concerns about the potential effects on third parties, including other residents in the home.

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Ethical Considerations for Research on Housing-Related Health Hazards Involving Children DIFFERENT ASSESSMENTS OF RISKS AND BENEFITS Assessing the risks and potential benefits of research always depends on value judgments about the salience and significance of the risks and benefits. Researchers may reach different conclusions about the risks and benefits of research than do the parents of potential subjects or other people in the community. Researchers may regard the physical risks of the research they carry out in the home as minimal because it does not involve any invasive medical procedures. However, community leaders and parents of child subjects may take a broader view of risks associated with the research. They may be concerned about baseline risks of the health hazard being studied, as well as any additional risk from any interventions by the researchers as part of the study. They may also be concerned about the risks that persist after the research interventions are carried out and the study is completed. In an intervention study, parents and others may regard a “usual care” case control as unacceptable (Israel et al., 2003; Minkler and Wallerstein, 2003; Krieger et al., 2002b). These perceptions of risk may be associated with expectations or hopes that the risk will be eliminated, rather than just studied or partially abated. Community representatives may want researchers to reduce the adverse effects of existing housing hazards, even though the researchers’ actions have not caused or worsened those hazards. Broadly, some community advocates may see research more as a means to obtain direct benefits of improved housing rather than as a means to gain generalizable knowledge about a health hazard and its remediation. But the views of community representatives are not monolithic or static. Krieger and colleagues (2002b) describe how one community advisory board changed its views over time: at the onset of a project, the community board insisted that the research project provide direct benefits to all children; subsequently, the board decided to support study designs that included a control group, believing that rigorous research was a powerful tool to mobilize support for improvements in housing. There may also be disagreements over assessment of the potential benefits of the research. Low-income parents may perceive payments for research participation or equipment used in the study (such as equipment to clean homes) as an important benefit of the study. However, focusing on the tangible benefits of participation may constitute an undue inducement and thereby compromise the personal weighing of potential risks and benefits that is part of the informed consent process. As noted above, some community advocates may be more interested in the potential immediate benefit to their community than in the potential benefits to society. For housing health hazards research, the mechanisms to translate effective interventions into benefits for those affected are more limited than for

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Ethical Considerations for Research on Housing-Related Health Hazards Involving Children biomedical research. In biomedical research, the health insurance and health care systems offer some assurance that effective new tests or therapies will be available to all those who could benefit from them. However, in the context of housing health hazards research, there is a much more limited infrastructure and fewer available public resources to bring the benefits of research to all those who may need them. There are often questions about whether housing interventions shown to be efficacious in research studies will be widely disseminated and implemented. In turn, these questions may affect people’s assessment of the benefits of housing health hazards research. GRIMES V. KENNEDY KRIEGER: AN ILLUSTRATIVE CASE In 2001 the Maryland Court of Appeals ruling in the case of Grimes v. Kennedy Krieger dramatized the ethical dilemmas in research on housing health hazards involving children and became the impetus for this study. Briefly, that study compared three different levels of partial lead abatement in inner-city Baltimore with two control groups. The control groups were living in housing built after 1978, which presumably contained no lead-based paint, or in housing from which the lead had been earlier abated. Blood samples were taken from enrolled children to measure blood lead levels, and dust samples were taken in the homes. Two parents in this study sued the researchers and the research institution after their children developed elevated lead levels while enrolled in the study. The legal proceedings were complicated, and the case was ultimately settled out of court. However, the court’s rulings prior to settlement raised numerous ethical issues that prompted concern in the research community. The court appeared to endorse more stringent criteria for allowable research (applicable in the state of Maryland) than is permitted under the federal regulations: it declared that parents may not consent to their children’s enrollment in “nontherapeutic research” that does not offer the prospect of direct benefit. The court suggested that researchers have a legal duty that can be the basis of a negligence action and declared that the informed consent form in this case was not valid because it failed to include essential information related to baseline risks in the home. The court also discussed additional issues, such as the acceptable level of risk for children in research on housing health hazards; discordant perceptions of risk and benefit among families, investigators, and institutional review boards (IRBs); problems with informed consent in vulnerable populations; research oversight; and reporting of results from research tests to families. Both our charge and our deliberations led us away from the particulars of the case. Because the ruling turned on a motion for summary judgment and the case was settled out of court, there was no court testimony on such

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Ethical Considerations for Research on Housing-Related Health Hazards Involving Children crucial issues as what the researchers told parents about the study and what parents understood. Also, there was no cross-examination of witnesses and no opportunity for the jury to assess the credibility of witnesses. However, the committee considered closely the ethical issues raised by this case. For instance, as we deliberated, we realized that the crucial issue regarding consent was not what information was contained in consent forms, but rather what the parents understood about the study and the hazards present in the home before and after the study. The court ruling challenged researchers, sponsors, and IRBs to rethink important ethical issues concerning research on housing health hazards involving children. The decision suggests stricter standards for limiting the risk to children enrolled in research, calls attention to the need to better protect vulnerable persons, questions the adequacy of IRB review, and calls for broader informed consent discussions. THE COMMITTEE’S STUDY The issues raised by the Maryland Court of Appeals decision provided the impetus for the Department of Housing and Urban Development, the Centers for Disease Control and Prevention, and the Environmental Protection Agency to request that the National Academies, through the National Research Council and the Institute of Medicine (IOM), establish a committee to review research challenges and ethical issues in the design and conduct of housing health hazards research. The Board on Children, Youth, and Families convened the Committee on Ethical Issues in Housing-Related Health Hazard Research Involving Children, Youth, and Families to undertake the following tasks: review and synthesize existing approaches to conducting research to identify safe and effective methods for controlling environmental and structural hazards to children’s health in housing, and compare and contrast them to approaches for conducting research to identify safe and effective biomedical therapies for children; identify the defining characteristics of “therapeutic” vs. “nontherapeutic” studies for controlling housing-related health hazards as compared to biomedical treatments; characterize the research challenges that come up during the planning and conduct of housing-related health-hazard research and contrast them with those of biomedical research; review and synthesize the ethical issues that are intrinsic to the design and conduct of housing-related health hazard research on children and families and contrast them to those of biomedical research; discuss the ethical obligations of researchers to inform child sub-

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Ethical Considerations for Research on Housing-Related Health Hazards Involving Children jects, their parents or guardians, and appropriate others of data collected during a study, including a consideration of how to balance issues such as timely provision of information versus assuring relevance of the data, and making certain that information is provided in a way that is easily understood by recipients of the information; and identify approaches to deciding when and how researchers should intervene in a housing-related health hazard study to protect child subjects from harm or treat conditions identified during the course of the study. The committee was also asked to consider the legal and ethical issues raised in Grimes v. Kennedy Krieger and address the full range of issues relevant to the ethical conduct of housing health hazard research with children, including determining whose responsibility it is to determine when a proposed project is considered ethical; whether there is a need for a specific institutional review process for housing research, and how ongoing oversight of such studies should occur, and whether there is a need only for guidance or for the issuance of specific regulations governing this field of research. The committee met five times over the course of nearly two years. The committee heard from the primary federal agencies who conduct research on the intersection of housing and health, as well as the perspectives of several national groups that work on this subject. The committee commissioned several papers on topics relevant to its charge, including the legal context of Grimes v. Kennedy Krieger, ethical underpinnings of children’s research, informed consent, and lessons from the behavioral and social sciences. The committee also requested presentations by researchers who conduct housing health hazards research; scholars from bioethics, law, and social sciences who have studied issues pertinent to the committee’s charge; representatives of the communities in which research has taken place; and parents of research subjects. Building on Other National Academies’ Reports This committee undertook its charge in the context of an extensive body of work on research with vulnerable people. Such research is challenging because of an inherent ethical dilemma: research with vulnerable people, targeted to the very conditions that cause them to have disproportionately adverse health (or other) outcomes, may provide benefits to the population from which the participants are drawn, but such research may also inadvertently cause harm or carry risks of harm for people who are already disadvantaged. The ethical and scientific challenge is to carry out research on housing health hazards that ultimately will lead to improvements in the health of children, while assuring that vulnerable children enrolled in that

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Ethical Considerations for Research on Housing-Related Health Hazards Involving Children research do not face inappropriate risks relative to the prospective benefits of the research and that their parents or guardians are truly informed about the research. A number of National Academies committees have considered issues related to the design and conduct of research involving humans. The work of this committee builds on the work of several prior committees, particularly the recent report, Ethical Conduct of Clinical Research Involving Children (Institute of Medicine, 2004), which addressed the challenges associated with conducting clinical research with children and reviewed the ethical and legal standards for conducting it. The IOM report thoroughly reviews the history of children’s research and the relevant federal regulations governing research involving children, and it makes several recommendations aimed at improving application of the relevant federal regulations. It discusses the regulations in significantly greater detail than this report and can serve as a valuable resource for readers interested in a more detailed description of the regulations. This committee carefully analyzed the reasoning of the IOM committee and the recommendations it made. We also considered how that reasoning and recommendations would apply in the particular case of research on housing health hazards involving children. We paid special attention to the IOM committee’s deliberations about the crucial issues of assessment of the benefits and risks of research and informed permission from parents and assent from children in research. A topic that is particularly important for housing health hazards research is the interpretation of such key regulatory terms as “minor increase over minimal risk” and “disorder or condition.” As detailed in Chapter 8, we deliberated at length regarding the IOM committee’s recommendations related to research that defines disorder or condition based on social characteristics. Although we agree with the committee’s analysis of the issues, we came to a somewhat different conclusion about how to proceed. The IOM committee also made a number of recommendations about the process of parental permission and children’s assent. That committee recommended that these processes “are sensitive to educational, cultural and other differences among families.” Our committee carried out further analyses of the consent process and the need to take into account the circumstances of research on housing health hazards involving children that may complicate the consent process. As detailed in Chapter 6, we concluded that the previous committee’s basic recommendations about the permission and assent processes are appropriate for housing health hazards research. Yet another issue that the previous committee considered was payments to children in research. The committee pointed out that payments to adult research participants raise concerns regarding undue inducement and that payments to either children or their parents raise further concerns. The

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Ethical Considerations for Research on Housing-Related Health Hazards Involving Children IOM committee distinguished several types of payment, including reimbursement for expenses, gestures for appreciation, and payment for time involved in research that does not offer the prospect of direct benefit. This committee extended the deliberations of the IOM committee because additional ethical concerns about payment arise when the children enrolled in research are from low-income families and have other vulnerabilities as well, as detailed in Chapter 6. With respect to IRB review of protocols for clinical research involving children and adolescents, the previous committee recommended that IRBs have adequate expertise in child health care and research. The committee also recommended that, when it is relevant to the study being reviewed, IRBs consult with other child health experts, parents, children, adolescents, and community representatives who can provide relevant family or community perspectives. This committee concluded that the issue of adequate expertise and information is even more pertinent for the review of research on housing health hazards involving children than for other types of research with children. In housing health hazards research, it is even more important for IRBs to understand family and community perspectives because researchers enter children’s homes and because of the many vulnerabilities of children enrolled in such research. As did the earlier IOM committee that produced Responsible Research (Institute of Medicine, 2003), the more recent committee recommended that research organizations and sponsors pay the medical and rehabilitation costs for children injured as a direct result of the research, without regard to fault. Another National Academies report, Protecting Participants and Facilitating Social and Behavioral Sciences Research (National Research Council, 2003), examined how the structure and function of IRBs relate to behavioral, social, and economic sciences. That report particularly addressed issues related to informed consent, data confidentiality, and procedures related to minimal risk research. It includes several recommendations that are highly pertinent to the topic of this report, including that the Office for Human Research Protections develop detailed guidance for IRBs and researchers on (1) appropriate consent procedures for different types of populations—including language minorities and vulnerable groups, such as undocumented immigrants—studied in social, behavioral, and economic sciences research; and (2) when it is and is not necessary to obtain consent from third parties about whom participants are asked to provide information. All of these previous reports contributed significantly to this committee’s work, and they are referred to throughout this report.

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Ethical Considerations for Research on Housing-Related Health Hazards Involving Children Report Structure Chapters 2-4 provide context for housing health hazards research. Chapter 2 describes the connection between housing and health, with emphasis on the particular housing health hazards more commonly experienced among low-income, minority populations. Chapter 3 analyzes the issues raised by Grimes v. Kennedy Krieger and how federal regulations have dealt with these issues and details the protections afforded by the current regulations. Chapter 4 analyzes in more detail how housing health hazards research is different than traditional biomedical research and the unique ethical issues raised by these differences. Chapters 5-8 present and discuss the committee’s recommendations to ensure that housing health hazards research is designed and conducted so that it is consistent with the ethical principles of respect for persons, beneficence, and justice. Chapter 5 explores how community involvement contributes to ethical research and lays out the range of possible approaches. Chapter 6 analyzes how the ethical issues raised when research targets primarily economically and educationally disadvantaged populations can be addressed through an informed consent process that embraces community input and emphasizes essential features of the research. Chapter 7 describes the ethical obligations of researchers, including the need to consider innovative research designs, how to handle test results, obligations to potential third parties, and the need to develop anticipatory plans to respond to risks observed in the home. The final chapter presents recommendations for a system of research oversight that acknowledges the roles of research institutions and their IRBs and research sponsors in addition to those of researchers, including the need for guidance on various aspects of the applicable federal regulations.