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Ethical Considerations for Research on Housing-Related Health Hazards Involving Children 6 Parental Permission, Consent, and Payment Ensuring that decisions to enroll in research aretruly informed and voluntary can be a challenge in any type of research involving human participants. Research indicates that adult research participants frequently do not understand important aspects of the research. Furthermore, when research projects provide payments to participants, it raises complicated ethical issues regarding undue influence. Similar ethical issues occur when parents give permission for their children to be enrolled in research. Potential problems may be even more pronounced for research with economically and educationally disadvantaged populations, particularly those who have low literacy levels or are non-English speaking and therefore may have particular difficulty understanding important aspects of a research protocol. In addition, when research participants have limited incomes, there is particular concern that payment levels may have undue influence over their decision to enroll in the research project. This chapter analyzes the current regulatory requirements related to consent and the ethical issues regarding consent and payment in the context of housing health hazards research and offers recommendations to achieve the goals of informed, and voluntary consent. INFORMED CONSENT Free and informed consent is considered a fundamental requirement of research. It respects participants by ensuring that they do not participate in research without their knowledge and consent. Informed consent requires that the decision to participate is intentional and voluntary and that the
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Ethical Considerations for Research on Housing-Related Health Hazards Involving Children decision maker understand the nature of the research and its prospective benefits and risks. When young children are the subjects of research, they cannot give informed consent because they lack the maturity to make informed decisions; instead, their parent(s) or guardian(s) must give informed permission. In addition to parental permission, a child generally must assent to participate in the research when this is developmentally appropriate. Parental permission and the child’s assent when developmentally feasible are ethically appropriate because they show respect for children as persons. Although young children cannot be autonomous, their preferences can still be respected. In this report, “consent” is used to refer to the combination of parental permission and child assent. Parental Permission Informed permission from parents may be particularly problematic with regard to research on housing health hazards involving children. Often parents in such studies are poor, poorly educated, and members of ethnic groups that have suffered discrimination. They may have difficulties making informed decisions about their children’s enrollment in such research, particularly in light of problems that are known to occur in the research consent process. We discuss these issues in greater detail later in the chapter. The Belmont Report (National Commission, 1978; see Chapter 3) identified the three elements of informed consent as information, comprehension, and voluntariness. However, as stressed in the report of the National Bioethics Advisory Commission (2001b, p. 98), “the actual procedures emphasize disclosure requirements, and in so doing may distort the understanding of the ethical principle of respect for persons.” The federal regulations governing federally funded or conducted research involving humans outline a number of requirements for both the process of obtaining informed consent to participate in research and the substantive information that must be provided to a prospective participant.1 Researchers must allow sufficient opportunity for a prospective participant to consider the decision to participate and minimize the possibility of coercion or undue influence (45 CFR 46.116). The information must also be communicated to the potential participant in a language that is understandable to the participant; see Box 6-1 for the information that the regulations require be included in the consent process. 1 Informed consent is not required for research that is exempt from review and can be waived under certain limited conditions (see 45 CFR 46.117 (c)).
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Ethical Considerations for Research on Housing-Related Health Hazards Involving Children BOX 6-1 Required Informed Consent Information During the informed consent process, parents of potential child subjects must be provided detailed specific information about the research, including (45 CFR 46.116(a)(1)-(8)): an explanation of the purposes of the research, the expected duration of the child’s involvement, a description of procedures to be followed and identification of any experimental procedures, a description of any reasonably foreseeable risks or discomforts to the child subject, a description of any reasonably expected benefits to the child subject or others, a disclosure of appropriate alternative procedures that may be advantageous to the child subject, a description of the extent to which the confidentiality of records will be maintained, an explanation as to whether any compensation is provided or what treatments are available if injury occurs if the research involves more than minimal risk, an explanation of whom to contact for questions about the research, and a statement that enrollment is voluntary and that refusal to continue to participate will not result in a loss of benefits the child is otherwise entitled. Additional information may be required under appropriate circumstances (45 CFR 46.116(b)). Specific additional information that may be relevant to include in the consent process for housing health hazards research would include information about the risks of the hazards being studied. As discussed in Chapter 1, this information may be very relevant to a parent’s decision whether or not to enroll her or his child in the study. Furthermore, a parent may need information before the study commences on what hazards pertinent to the topic of the study are present in the housing, what hazards will continue to be present in the home after the research is completed, and how those hazards may adversely affect a child’s health. This information will help to prevent common misconceptions about housing research and reduce the likelihood that parents have a “therapeutic misconception” about the research. An additional topic that needs to be discussed during the informed consent process is whether the results of any tests conducted as part of the research protocol will be provided to parents and if so, how and when they will be provided (see Chapter 7).
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Ethical Considerations for Research on Housing-Related Health Hazards Involving Children Whether the permission of one parent is sufficient or the permission of both parents is required depends on the type of research. If the IRB [institutional review board] determines that the research involves more than minimal risk but is not expected to benefit the child subject, the regulations require that investigators secure permission from both parents. If the IRB determines that research involves no more than minimal risk or that it holds out the prospect of direct benefit to the child, the IRB may decide that the permission of one parent is sufficient. Permission from one parent is also sufficient if that parent is legally responsible for the care and custody of the child or when the other parent has died or is unknown, incompetent, or not reasonably available (Institute of Medicine, 2004, p. 104). Assent With certain exceptions, the federal regulations provide for children’s agreement or assent to be involved in research. Researchers must seek a child’s assent unless the institutional review board (IRB) determines that (1) the children to be involved (as a group or individually) are not capable of providing assent, given their age, maturity, or mental state; (2) the research has a prospect of an important direct benefit for the child that is possible only in the research context; or (3) the research involves circumstances that would allow waiver of consent for adults. Assent is obtained after the protocol has been approved and usually after the parents have decided that it is appropriate for their child to be involved. IRBs are given discretion in evaluating assent provisions in any given protocol; the federal regulations do not describe the information that must be provided to children. The report Ethical Conduct of Clinical Research Involving Children (Institute of Medicine, 2004) points out that, although the literature is limited and somewhat inconsistent, it supports a gradual expansion in children’s involvement in discussions regarding enrollment in research participation as they mature and provides some guidance. It recommends that the views of children be considered and respected both individually and as part of a family unit and that the process of assent should be developmentally appropriate given the ages and other characteristics of the children to be approached; provide opportunities for children to express and discuss their willingness or unwillingness to participate; clarify for parents and children (as appropriate) the degree of control that each will have over the participation decision; and when appropriate, describe to children and parents the kinds of information about the child that will or will not be shared with the parents (Institute of Medicine, 2004, p. 205).
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Ethical Considerations for Research on Housing-Related Health Hazards Involving Children Comprehension of Potential Participants Considerable research indicates that adult participants in research studies commonly fail to understand important aspects of research protocols (Institute of Medicine, 2004; National Bioethics Advisory Commission, 2001; Advisory Committee on Human Radiation Experiments, 1998; Wendler, 2004). Most of the empirical studies involve adults consenting to be research subjects themselves. However, evidence from more limited pediatric studies suggests that there are also misunderstandings when adults are giving permission for their children to enroll in research. The informed consent process and research on adult’s comprehension of the content of informed consent point to several areas of concern. First, IRBs place their attention on consent forms rather than on the process of providing and discussing information. Federal regulations specify what kinds of information must be provided to research participants or their representatives (see Box 6-1). IRBs typically spend considerable time revising consent forms. However, an analysis of model consent forms posted on IRB websites found that the average readability score was higher than the tenth-grade level, above the level recommended by IRBs themselves (Paasche-Orlow et al., 2003). Studies of actual research project consent forms show that many are written at the level of a college graduate (Advisory Committee on Human Radiation Experiments, 1998). There is some evidence that revisions of consent forms by IRBs lowers their readability scores (Burman et al., 2003). Simplified consent forms can improve comprehension by research participants (Coyne et al., 2003), and several studies report that parents found discussions with research staff more useful than consent forms (Flory and Emanuel, 2004). Second, adult participants in research commonly have misunderstandings about the purpose of research. Joffe and colleagues found that participants in early clinical trials usually expect that they will personally benefit from the trial, even when the primary purpose of the research study is to test safety not efficacy (Joffe et al., 2001). This tendency to view clinical research as providing a personal benefit has been termed the “therapeutic misconception” (Lidz and Applebaum, 2002). Third, adult participants may misunderstand essential features of the design of the research study (Wendler, 2004). Randomization is a frequently misunderstood concept (Kodish et al., 2004). In one study of parents who had discussed with researchers their child’s participation in leukemia clinical trials, researchers found that 50 percent of parents did not understand randomization although physicians had discussed randomization with parents in 83 percent of the discussions (Kodish et al., 2004). Although there are relatively few studies of consent in the pediatric setting, problems have been documented. For example, Tait and colleagues
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Ethical Considerations for Research on Housing-Related Health Hazards Involving Children adapted the Deaconess Informed Consent Comprehension Test to test parents’ and children’s understanding of parental permission and child assent in multiple studies, focusing mainly on research during anesthesia for surgical procedures. They found that “parents…had inadequate understanding of the elements of informed consent” and “children…have limited understanding of the elements of disclosure, particularly if they are younger and did not read the disclosure information” (Nelson and Reynolds, 2004, pp. 19-20 [citing Tait et al., 2003a, p. 606; Tait et al., 2003b, p. 609]). Individual perceptions of risk appear to affect informed consent. In research involving diabetic adolescents, several adolescents and their parents did not consider hypoglycemia that might result from study procedures to be a risk because of their confidence that they would be able to handle the situation should it occur (Nelson and Reynolds, 2004). That is, perceptions of risk may be influenced by parents’ previous experience with the disorder or condition being studied. An additional issue that may contribute to parents’ comprehension of research projects is low literacy in the United States, particularly among low-income populations, Health Literacy: A Prescription to End Confusion found that about 40 million Americans cannot read complex texts, like those typically found in research consent forms (Institute of Medicine, 2004). It reported that “the levels of informed consent documents… exceed the documented average reading levels of the majority of adults in the United States” (p. 191) and that literacy levels are lower among those who are poor, minority populations, and groups with limited English proficiency, such as recent immigrants (Institute of Medicine, 2004). These findings suggest that comprehension of written consent forms is even more challenging for the groups often targeted for housing health hazards research. Moreover, adults with limited literacy often have limited knowledge of disease management and of health-promoting behaviors. One study of the consent process for a clinical trial for childhood leukemia compared non-English-speaking Latino parents with English-speaking non-Caucasian parents from several ethnic backgrounds and English-speaking Caucasian parents. Researchers found that the physicians tended to omit key information from discussions with non-English-speaking parents, such as information about randomization and the right to withdraw from a clinical trial. Physician explanations of the clinical trial were less clear with the non-English-speaking parents. Moreover, non-English-speaking parents asked fewer questions than parents in the other groups. Despite the need for translation, total time spent did not differ among the three groups. Most important, the study found that fewer non-English-speaking parents understood key concepts, such as randomization, the difference between clinical trials and standard care, and the voluntary nature of research (Simon et al.,
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Ethical Considerations for Research on Housing-Related Health Hazards Involving Children 2003). In this study, differences might have resulted from many factors, including different amounts of information provided and social status, as well as English proficiency. There are no systematic studies of the consent process in research on housing health hazards involving children. Some findings from studies carried out in other situations, particularly studies with children recently diagnosed with leukemia (Kodish et al., 2004; Simon et al., 2003), may not be generalizable to research on housing health hazards involving healthy children. However, the Grimes case (see Chapter 3) highlighted issues specific to housing health hazards research. Among other allegations, the plaintiffs claimed that they were not fully informed of the risks, raising concerns about the consent process. As mentioned in Chapter 3, the court ruled that the consent form was not valid because “full material information was not furnished” and determined that, even though some of the housing units had been abated and the others contained lead prior to the research, the researchers needed to disclose that “some of the children might ingest dust lead particles” and “there might be some accumulation of lead in the blood of the children.” This case raised the specific issue of whether consent discussions should be broadened to include discussion of risks to children that might occur as a result of their normal living environment rather than as a result of the research interventions: for example, the risks of living in housing that contains lead paint or other health hazards. In light of these data, researchers and IRBs cannot assume that parents understand information about the research project that has been disclosed to them. To ensure that parents understand the project, researchers would need to test their comprehension. Responsible Research: A Systems Approach to Protecting Research Participants (Institute of Medicine, 2002) emphasized that informed consent should be an ongoing discussion of relevant information between investigator and participant, not a signature on a long and complex consent document. That report recommended that the informed consent process should include an “assessment of the individual’s understanding of the discussion” (p. 120). While there are several tools available to assess comprehension that have been used in research on informed consent (e.g., Deaconness Informed Consent Comprehension Test and the MacArthur Competence Assessment Tool for Clinical Research), there are no standard mechanisms for assessing comprehension in the practical context of research (Nelson and Reynolds, 2004). Interventions to Improve Comprehension Informed consent requires that researchers provide to participants (or to the parents of child subjects) information that they can comprehend. In light of the evidence that research participants frequently do not under-
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Ethical Considerations for Research on Housing-Related Health Hazards Involving Children stand important features of research, investigators need to consider what they can do to help potential child subjects and their parents better understand the research project. A recent critical review of research on interventions to improve research participants’ understanding of information concluded: Efforts to improve understanding through the use of multimedia and enhanced consent forms have had only limited success. Having a study team member or a neutral educator spend more time talking one-on-one to study participants appears to be the most effective available way of improving research participants’ understanding (Flory and Emanuel, 2004, p. 1593). Of 12 trials of multimedia interventions, only one showed a significant improvement in understanding using a computerized presentation of information. Interventions to improve consent forms also had limited success. The only rigorously designed study that showed improvements in a real consent process shortened the consent form from four to two pages, removing standard but irrelevant information on risk. Evidence for improved understanding was stronger for interventions that increased discussion between research staff and study participants. There was also evidence that a test-feedback approach increased participants’ understanding: in these studies participants were tested on their understanding and given additional information on questions they answered incorrectly. However, these studies were flawed methodologically because they may have tested memorization rather than understanding. Although this research on improving consent has been carried out with adults participating in clinical research, similar findings may hold in the setting of parents giving permission for their children to enter research studies as well. A more detailed description of some studies that showed improvement in comprehension shows the flavor of interventions that might be carried out. One study was a randomized clinical trial of an intervention to improve the consent process in a hypothetical HIV vaccine trial (Coletti et al., 2003). The study intervention involved setting the reading level at the eighth-grade level, enhancing the visual display of consent documents, making an audiotape of the consent form for low-literacy participants, having educators who are independent of the research team discuss the research with participants, and providing time and opportunity for participants to ask questions and discuss the trial. This consent intervention improved participants’ understanding of key concepts about the trial, and the effect was found for people at all educational levels and for all ethnic groups. Another study, published after the review article cited above, was a randomized trial that compared a videotape providing an overview of the informed consent process and the decision to enroll in a clinical trial with a
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Ethical Considerations for Research on Housing-Related Health Hazards Involving Children control educational videotape about the historical and regulatory aspects of human subjects protection (Wirshing et al., 2005). The videotapes were 1618 minutes long and written at a fifth-grade educational level. The informed consent videotape resulted in a small enhancement in knowledge about informed consent, in comparison with the control videotape. The National Cancer Institute (NCI) has developed a template for simplifying informed consent documents that uses a question-and-answer format.2 The form is written at an eighth-grade level, and flow charts, diagrams, calendars, and other graphics are encouraged. A cross-sectional study provides some evidence that this template is effective (Joffe et al., 2001): it found that participants in cancer clinical trials who received information following the NCI template, had a nurse present at the consent discussions, and had more time to consider participation in the clinical trials had greater understanding and fewer misconceptions about research than those who did not. Assessing the Adequacy of Informed Consent Assessing whether research participants understand the information discussed in the informed consent process has been carried out in several international clinical trials (National Bioethics Advisory Commission, 2001; Fitzgerald et al., 2002; Coletti et al., 2003; Mariner, 2003; Woodsong and Karim, 2005). Participants in developing countries are vulnerable in numerous ways, including poor education, poverty, and poor access to medical care. Thus, international clinical trials face many of the same ethical concerns that arise in research on housing health hazards with children. When research is carried out in developing nations, concerns have been raised that participants do not understand the nature of the research, the difference between research and clinical care, the voluntary nature of research, and key features of the research design, such as randomization (National Bioethics Advisory Commission, 2001; Mariner, 2003; Woodsong and Karim, 2005). Researchers in these settings have developed simple questions to test whether participants understand key elements of the research. For example, participants in an HIV vaccine trial may not comprehend that they are still at risk for HIV even if they receive the experimental vaccine. In some studies, researchers require potential participants to demonstrate that they understand crucial aspects of the trial before they are permitted to enroll in the study. Crucial items for demonstration might include 2 The template can be found at http://www.nci.nih.gov/clinicaltrials/understanding/simplification-of-informed-consent-docs/page2 [June 2005].
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Ethical Considerations for Research on Housing-Related Health Hazards Involving Children the following: (1) the research is different from clinical care; (2) interventions are determined by chance and not by what is thought best for the individual participant; (3) the effectiveness of the research intervention is unknown; (4) the research intervention has risks; and (5) the participant remains at risk for the outcome of the study (HIV infection) (National Bioethics Advisory Commission, 2001). Such assessments often are combined with enhanced discussions with participants about the research and provision of additional information to correct misunderstandings. HIV researchers in developing countries have found community advisory groups to be very helpful in identifying issues that are difficult to understand, pointing out concerns and problems that were not apparent to the researchers, and helping to develop more effective consent processes and materials (Woodsong and Karim, 2005). In the context of research on housing-related health hazards involving children, researchers could provide enhanced information on how the purpose of research is to obtain generalizable knowledge, not to benefit the child subjects directly. This approach of testing to ensure that participants understand the essential features of the research study might also be used in other research (Wendler, 2004), particularly with research on housing health hazards involving children. For example, in a lead abatement study in which lead may exist in the home, a parent needs to know that the child is at risk for elevated blood levels despite the abatement procedures, as well as basic information about the project, such as the frequency and types of tests carried out. The specific information about a housing study that a parent needs to understand will vary depending on the study. Two important questions are who decides what is essential and what criteria should be used to make that determination. The IRB is the arbiter of what information needs to be communicated to participants in a particular study. To make this judgment, the IRB should take into account the views of the community, and researchers should be required to solicit the views of the community. As discussed in Chapter 5, community representatives and advocates for child subjects and their parents may have different perceptions than researchers of what constitutes a risk or benefit and how much weight to give specific risks or potential benefits. An argument can be made for weighing several elements of consent more heavily than others. The Belmont Report suggests that the essential information should be determined using the standard of the reasonable volunteer: It may be that a standard of “the reasonable volunteer” should be proposed: the extent and nature of information should be such that persons, knowing that the procedure is neither necessary for their care nor perhaps fully understood, can decide whether they wish to participate in the fur-
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Ethical Considerations for Research on Housing-Related Health Hazards Involving Children thering of knowledge. Even when some direct benefit to them is anticipated, the participants should understand clearly the range of risk and the voluntary nature of participation [emphasis added] (National Commission, 1978, p. 5). This statement suggests that the two elements of “risk” and “voluntary choice” should have priority over the other elements of consent. Voluntariness and Undue Influence Voluntariness is an essential requirement for informed consent. According to a recent review by Nelson and Merz (2002), a voluntary act is an act of free will or personal choice that must be “done volitionally or with intent and deliberateness” and be “free from coercion and undue influence” (p. 69). Being a child, having low socioeconomic status or poor education, and having few options because of disease or social situation are characteristics that may constrain a person’s ability to make voluntary choices. Although having limited options does not necessarily make choices nonvoluntary, it might make people more vulnerable to various influences. Some actions by researchers may compromise the voluntariness of participants’ decisions to enter research projects. The probability that a researcher’s actions may be so strong as to control or determine the decision to participate depends on both the nature of the action and the vulnerability of the potential subjects. Some actions that could be readily resisted by most people might have a powerful influence on vulnerable persons. For instance, a payment level for participation that would have little influence on wealthy individuals might be difficult for a poor person to turn down: the threat to informed consent is that a person may make a decision to participate based on the payment level, without considering the risks of the research. One way to determine whether a decision is voluntary is to consider whether parents would enroll their children if the potential influence were not present. Another approach is to ask people whether the decision to enroll their children in the study was a personal choice as opposed to feeling pressure from other people to join the study (Pace and Emanuel, 2005). While both approaches seem plausible, neither has been rigorously validated. Also both have conceptual shortcomings. The criterion of whether parents would agree to enroll their children without an incentive is difficult to test empirically. It may be useful to discuss the question with community representatives, who may have a different view than researchers of whether parents would participate without an incentive. Asking parents directly whether they made the decision themselves is another option. Their response may provide useful information if they say that others influenced them. However, a negative response may not be definitive because people
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Ethical Considerations for Research on Housing-Related Health Hazards Involving Children token gift to a child as a thank you for involvement in research shows respect for them and presents no serious ethical concerns. Moreover, if families did not receive some payment for participating in research projects that require considerable time, the burden on economically disadvantaged families might be prohibitive because they cannot afford the costs of transportation, child care, and other out-of-pocket expenses. Yet if payments are too high, they may distort parents’ decisions about enrolling their children in a research project. Criticisms are strongest if the project puts children at an inappropriately high level of risk and the magnitude of payments leads parents to enroll them in the study. Hence, the concern is that too high a payment may undermine free and informed consent by leading parents to expose their children to unacceptable risks: too attractive an incentive may be an undue influence. Furthermore, how the payment is made may also result in undue inducements. For example, if payment for a long-term follow-up study is made in a lump sum and only if the subjects complete the entire study, it could constitute an undue influence to stay in the study. If, on the other hand, the money is paid weekly, the effect would not constitute an undue influence. Some commentators believe that children should never receive payment for research involvement because this may be an undue inducement and affect the voluntariness of enrollment. Similarly, they argue that parents ought not be paid to enroll their children in research. The issue of payment for participation in a research project is further complicated because of countervailing ethical guidelines. In addition to avoiding undue influence, another ethical consideration is treating different participants fairly. Payment that is trivial for some families may be substantial for economically disadvantaged families (Wendler et al., 2002). Yet to pay economically disadvantaged families less than more affluent families for participating in research is unfair because it requires similar sacrifices of time and inconvenience from both. For example, a study may involve several geographic sites. The remuneration needed to gain sufficient enrollment in a high-cost city may be significantly higher than that needed to enroll people in a rural, low-cost area. It might be unfair if the researcher offers lower payment in the area where the cost of living is lower. But if the same payment level is used for each area, the amount for those in the lower cost area might be high enough to be considered coercive and unduly encourage low-income people to enroll just for the “high” payment. A similar situation might arise in a study that enrolls participants from diverse socioeconomic backgrounds in the same area. The ongoing controversy regarding payment in research involving children is illustrated by the recent Children’s Environmental Exposure Research Study (CHEERS), which generated substantial public controversy
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Ethical Considerations for Research on Housing-Related Health Hazards Involving Children over the amount of money participant families were to receive (among other things).3 Families participating in the study were to receive a total of close to $1,000 over 2 years and a video camera. Critics charged that this was too much and would inappropriately induce low-income families to enroll their children solely for monetary purposes, without regard to the risks of the research, which they also perceived as inappropriately high. Others noted that participation in this study required the parents to collect many types of information and samples over a 2-year period. To collect urine samples, parents needed to label and save diapers and have the child subject wear a one-piece union suit with socks. To document what children ate, parents had to collect a duplicate of all the food and beverages that the child subject eats and drinks during a 24 hour period. To record the child’s activities, parents were asked to keep a diary of the child subject’s activities during a 5-day period and videotape the child’s behavior. Calculated on a per-day basis over the duration of the study, the amount to be received was $20 to $40 a day. This amount was defended as appropriate and consistent with hourly amounts research volunteers typically receive in other research projects. This example illustrates that when the level of payment is based on the length of time required by the research, a modest incentive for each activity in the study may be perceived as an undue inducement if the cumulative amount of the incentives is viewed as excessive and able to influence parents’ decisions to enroll their children in research. Practices and Policies Empirical studies show that IRB policies and practices on payments to parents and children varies considerably (Wolf et al., 2005; Weise et al., 2002). Many IRBs do not have written policies on these topics. Many allow reimbursement to parents for time and expenses related to their children’s involvement in research (e.g., child care, travel, parking, and meals). A few permit payment of “incentives” or “inducements” to parents who enroll their children in research. With respect to payments to child subjects, policies range from prohibiting to encouraging such payments. A few IRBs 3 The CHEERS study was designed to fill important data gaps in understanding how children may be exposed to pesticides (such as bug spray) and chemicals being used in households and generated substantial public controversy because of the compensation level, perception that children were being intentionally exposed to pesticides, and industry involvement. Some of this controversy seemed to be created by misinformation or incomplete information about the project. The project was initially halted pending review by an external national review panel and stopped by the Environmental Protection Agency before the review was completed (Johnson, 2005).
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Ethical Considerations for Research on Housing-Related Health Hazards Involving Children advise against monetary payments to children and offer specific alternatives (e.g., toys, gift certificates, books). Although several IRBs recommend that young children should receive smaller gifts or payments than adolescents or adults, none provides specific justification or a formula for determining an appropriate amount (Wolf et al., 2005). If local IRBs permit payments or token gifts to children, researchers who provide such payments should explain to the children the reason for the payment or gift. The payment levels allowed by IRBs vary considerably. The maximum cash amount approved by IRBs in pediatric studies ranges from $10 to $1000, with a median level of $100 (Weise et al., 2002). These data provide little guidance for researchers, however, since payment levels should vary based on the demands of the research. If the time commitment and burden is significant, one would expect a higher payment level. Payments are sometimes made in cash rather than checks on the basis of the recommendation of community groups, who point out that low-income families may not have easy access to a low-cost method for cashing a check (Jordan et al., 2000) or because they may not have a Social Security number. To reduce the perception of undue influence, many housing health hazards research studies have provided incentives in the form of goods or services rather than cash: examples include food coupons, fire extinguishers, smoke detectors, home cleaning, allergen impermeable covers, vacuum cleaners, air purifiers, and professional pest control (Eskenazi et al., 2005; Morgan et al., 2004; Rhoads et al., 1999). However, providing goods and services may not eliminate the problem of undue inducement. If the only way a low-income parent can get professional pest control in an apartment overrun by vermin is through participation in a study, that would be a very big inducement. The Office for Human Research Protections has issued some guidance to IRBs on payments, stating that “Offers that are too attractive may blind prospective subjects to the risks or impair their ability to exercise proper judgment” (U.S. Department of Health and Human Services, 1993, pp. 3-44). The guidance does not explicitly discuss payment to children or parents despite empirical evidence that IRBs have widely divergent policies regarding payment in research involving children and so address the ethical issue of undue influence in inconsistent ways. Two recent reports from The National Academies agree that payment to research participants is allowable, with certain caveats. Ethical Conduct of Clinical Research Involving Children states that agreement to enroll children in research should not be coerced or unduly influenced by psychological, financial, or other pressure (Institute of Medicine, 2004). Similarly, Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues (National Research Council, 2004) recommended that IRBs ensure that “payments to participants in…are neither so high as to
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Ethical Considerations for Research on Housing-Related Health Hazards Involving Children constitute undue inducement nor so low as to be attractive only to individuals who are socioeconomically disadvantaged. Proposed levels of and purposes for remuneration (e.g., time, inconvenience, and risk) should be scrutinized in light of the principles of justice and respect for persons” (p. 120). This conclusion highlights the potential for the same payment to have a differential influence on parents from varying socioeconomic status. As discussed above, the families of children who are the subjects in housing health hazard research are often poor, have limited education, and may not understand the purpose or description of a research study. They are more likely to be nonnative English speakers, to live in rental units, and to be at risk for deportation. Most importantly, these families often lack resources to eliminate housing hazards and usually are unable to afford safer housing. For all these reasons, incentives offered by researchers that may be acceptable under some circumstances may be an undue inducement in this context. Ethical Conduct of Clinical Research Involving Children warned that “an amount that neutralizes the burden of research participation for one family may exceed it for another and, thereby, act as an inducement” (Institute of Medicine, 2004, p. 214). To avoid unintentionally creating an undue influence for low-income participants, it has been suggested that compensation for time be set at the minimum wage level (Dickert and Grady, 1999). However, for unemployed families, this amount may be equivalent to paying the parents for enrolling their children in research (Institute of Medicine, 2004): “If such payments are proposed for studies that focus on low-income populations, IRBs should assess the potential for undue influence” (p. 214). Ethical Conduct of Clinical Research Involving Children recommended that IRBs and sponsors “adopt explicit written policies on acceptable and unacceptable types and amounts of payments related to research participation” (Institute of Medicine, 2004, p. 225). It also recommended that in addition to small gifts or payments to parents and children as gestures of appreciation, investigators may also—if they minimize the potential for undue influence—act ethically to reduce certain barriers to research participation when they (a) reimburse reasonable expenses directly related to a child’s participation in research; (b) provide reasonable, age-appropriate compensation for children based on the time involved in research that does not offer the prospect of direct benefit…(p. 226). However, it further determined that “Certain types of payments to parents…are usually if not always acceptable, for example, reimbursement for reasonable expenses that are necessary for research participation. Other payments are never appropriate in pediatric research, for example, paying parents for the use of their child in research” (p. 226) and rejected “financial encouragement for children’s participation in research based on the level of risk involved” (p. 227). While it may be morally acceptable to
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Ethical Considerations for Research on Housing-Related Health Hazards Involving Children pay adults more for high-risk work, the committee that wrote the quoted report believed that this was not acceptable for children, who cannot make decisions for themselves. The committee concluded that age-appropriate recognition could be given to children in clinical studies, but that larger payments for assumption of greater risk should not be permitted (Institute of Medicine, 2004). This committee agrees that investigators are acting ethically to reduce barriers to research enrollment if they reimburse reasonable expenses directly related to the research, provide reasonable and age-appropriate compensation for time, and offer reasonable accommodations for parent convenience, such as home visit times that address parental work schedules and family commitments. For children, the use of age-appropriate nonmonetary gestures of appreciation, such as toys and educational materials, are allowable and indeed often encouraged by IRBs and community groups. The IOM committee noted: Unfortunately, no bright line distinguishes proper and reasonable payments to parents and children from payments that are inappropriate. A mix of group or individual circumstances may determine when a particular type or level of payment crosses the line. What is excessive in one situation may not be in another, and reasonable people may sometimes differ in their judgments (Institute of Medicine, 2004, p. 214). In the context of research with families who are poor or members of minority groups, researchers need to be aware that ethical problems may arise if payments or gifts are too small as well as too large. Although small payments and token gifts avoid the potential for undue influence, they may be regarded as so low as to be exploitative. Payment for time, effort, and inconvenience is a way of paying respect to the parents and children. Tokens of appreciation are often warmly accepted, but they might be resented as a symbol of their small worth to the researcher. Many low-income, minority persons are already suspicious of research and researchers (Corbie-Smith et al., 1999; Israel et al., 2003; Minkler and Wallerstein, 2003). They may think that a token of appreciation is a way for researchers to get away with not giving anything of value back to the community. Because people have different perspectives on the line between acceptable payment and undue influence, community representatives can provide important input in determining appropriate levels of payment. They can help researchers understand how payments might influence parental decisions in the context of the particular study and study population, thereby helping to avoid payments that may constitute undue influence as well as payments that are a barrier to enrollment or are regarded as exploitative. There are no clear guidelines for establishing whether a given payment level is considered an undue influence. The payment level that would be considered an undue influence may vary from one community to another
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Ethical Considerations for Research on Housing-Related Health Hazards Involving Children given varying income levels and costs of living across geographic areas. Additional research to better understand the affect of varying payment levels on consent decisions is needed. In addition, guidance from local IRBs and community representatives on appropriate payment levels considering local circumstances would aid researchers’ efforts to design compensation plans. However, community input regarding payment can also be problematic: a community representative might try to maximize the payment. Thus, the community representatives’ desires could lead to undue inducements. There are a number of questions that IRBs may want to consider when reviewing the materials submitted by a housing health hazards researcher to determine the adequacy of the informed consent process and payment levels: Was the community involved in the informed consent process and were the community’s views considered? Were the planned payment levels discussed? What are the essential elements of the research, and were they understandably presented during the consent process? Was the difference between research and clinical care explained? Were baseline and continuing risks explained? Should moving away from the hazard be mentioned as an alternative? Are there essential aspects of the research that if not fully understood by parents should preclude enrolling their children in the study? How will the comprehension of the subjects’ parents be assessed? Is it appropriate and adequate? What are the planned payments for involvement in the research? Do they create an undue influence on parents’ decisions to enroll their children? Are the payment levels appropriate given local incomes and living expense levels? THIRD-PARTY CONSENT AND INCENTIVES Some studies of housing health hazards may require informed consent from third parties, such as other household members or landlords. The federal regulations define a research participant (“subject”) as “a living individual about whom an investigator…obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information” (45 CFR 46.102(f)). If a third party meets the regulatory definition, all the provisions of the Common Rule come into play unless the Common Rule does not apply or there are grounds for an exemption from the Common Rule. In particular, the research must obtain informed consent unless there are grounds for a waiver of informed consent. The challenge in determining when a third party becomes a research participant is that both “private” and “individually identifiable” are not easily defined
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Ethical Considerations for Research on Housing-Related Health Hazards Involving Children (National Institutes of Health, 2001).4 The Common Rule (see Chapter 3) provides some guidance by stating that information is considered private if the individual “can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record)” (§ 46.102(f)). Information that also falls outside the definition of private is information about family relationships, marital status, social networks, and occupation (National Institutes of Health, 2001). Information about a third party that is obtained from the research participant as background information about the participant is generally not considered private; rather, it is seen as contextual because it is usually unverified and is used as background information relevant to the condition or circumstances of the participants. If verification of the information about the third party is necessary, the National Institutes of Health report recommended that the third party should then be considered a research participant and informed consent should be obtained (National Institutes of Health, 2001). In housing health hazards research, there are cases when consent or permission might be necessary even if informed consent is not. For example, a landlord’s permission may be necessary to conduct pest control in a multi-unit building or to implement structural modifications to a housing unit (e.g., window replacements) as part of a study intervention. While other household residents may be present when a researcher enters the home, their permission would typically not be required if the child subject’s parent has provided permission. However, notifying them in advance or suggesting that the parent notify them when researchers will be present is warranted. Such notification shows respect for these residents by making it possible for them to minimize invasions of privacy or inconvenience. In all cases, researchers should consider their legal and ethical obligations to potential third parties; this is discussed in more detail in the next chapter. When the cooperation of third parties is necessary for the successful implementation of a research study, investigators may want to consider offering incentives to third parties. If structural modifications to a housing unit are being done, the value of the repair and potential increased property value may be sufficient incentive for landlords. If the intervention offers minimal direct benefit and the landlord’s cooperation is needed for proper access or implementation (e.g., pest control in a multi-unit building) minimal payment for time and effort is warranted. Community groups are also important third parties in many housing health hazards studies. Appropriate incentives for community groups and 4 The National Institutes of Health (NIH) document cited made recommendations to the Office of Human Research Protections (OHRP) but does not constitute NIH or OHRP policy.
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Ethical Considerations for Research on Housing-Related Health Hazards Involving Children community residents who help with recruiting or other tasks are an important feature of many study designs, but they have the potential for an ethical conflict of interest if community groups receive direct payments for recruiting subjects. In-kind arrangements, such as a commitment to hire community members to be research staff or conducting community briefings, is preferable and avoids this potential conflict of interest. COMPENSATION FOR RESEARCH-RELATED INJURIES Research-related injuries may put families at risk because they may lead to missed work time or job loss. Because many low-income families lack health insurance, such injuries are potentially catastrophic. Ethical Conduct of Clinical Research Involving Children (Institute of Medicine, 2004) urged compensation for child subjects who are injured in the course of research because children who have permanent injuries must live with them for a long period. The financial burden may be particularly severe for low-income families who participate in housing health hazard research. That report recommended that research organizations and sponsors should pay the medical and rehabilitation costs for children injured as a direct result of the research, without regard to fault. Consent and permission documents should disclose to parents (and adolescents, if appropriate) the child’s right to compensation and the mechanism for seeking such compensation. Previous national commissions have also recommended no-fault compensation for research related injures. The National Bioethics Advisory Commission (2001) pointed out that such compensation would require a national program. This committee supports that basic approach. However, the phrase “direct result of research participation” may be difficult to interpret, particularly in the context of housing health hazards involving children. A research injury usually refers to an adverse event caused by research interventions, not by the course of a disease or a pre-existing condition. For example, failure of an experimental cancer intervention is an unfortunate outcome for the child, but the growth of a cancer would not be considered a research injury. In the context of housing health hazard research, distinguishing between injuries resulting from the research and injuries resulting from the baseline risks present in the child subject’s home may prove difficult. It would be reasonable to assume that researchers should not be held accountable for injuries that result from conditions that existed in the home before the research and were not affected by the research. However, in situations in which research is designed only to partly eliminate a particular risk (e.g., partial lead abatement) and an injury results, it may be difficult to determine whether the harm resulted from the research or from the baseline risk. This complex issue warrants additional exploration and guidance.
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Ethical Considerations for Research on Housing-Related Health Hazards Involving Children CONCLUSIONS AND RECOMMENDATIONS Ethical Conduct of Clinical Research Involving Children (Institute of Medicine, 2004) made a number of recommendations to strengthen the process of obtaining parental permission and children’s assent in clinical research. Several recommendations have particular salience for research on housing health hazards in children. That report suggested “educating—not merely presenting information to—parents about issues critical to informed decision making and, as appropriate, assessing the degree to which these critical issues are understood” (p. 199). The report also suggested that for groups with low levels of literacy, investigators might use information tools that do not depend on written documents, such as simple graphics, oral explanations, and videos. This committee agrees with these recommendations on strengthening the permission process. Even more importantly, this committee emphasizes the report’s recommendation, also made by the National Bioethics Advisory Committee (2001), for protections tailored to the specific vulnerabilities of the participants in a particular research study. This targeted approach is an alternative to traditional approaches to vulnerable participants, which excluded them from research. Broad exclusion of vulnerable populations from research on housing health hazards in children may cut off research that is needed to understand and ameliorate the hazards and deleterious outcomes that such populations disproportionately encounter. Nonetheless, the characteristics of many parents of child subjects in housing health hazards research—including poor education, poverty, and lack of power relative to researchers—may result in poor comprehension or undue influence. There are several ways to improve the process. First, researchers need to talk with appropriate community representatives about the consent process, including planned payments for participation. Such consultation allows researchers to ascertain what information parents are likely to need when deciding whether to enroll their children in research. Community representatives can also suggest how to present information in a clear and understandable manner and what misunderstandings or questions parents are likely to have. In addition, community representatives can suggest what level of payment might lead to undue influence or be considered exploitative by the community. Second, after understanding the community perspectives, researchers need to consider how to respond to the concerns and suggestions raised. In many instances, researchers and community representatives can agree on how to do so. When agreement cannot be reached, community representatives should not have a formal veto over the protocol. However, researchers need to consider their perspective seriously, provide a thoughtful response, and explain to the IRB both the community’s perspective and their re-
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Ethical Considerations for Research on Housing-Related Health Hazards Involving Children sponse. Moreover, researchers should appreciate that a research project may not be feasible to carry out in the face of widespread community opposition. Third, researchers who carry out research on housing health hazards involving children need to expand their perspective on what information should be disclosed to parents of prospective child subjects. In order for parents to make informed choices, they need to understand the risks and benefits of enrolling their children in research, as well as the risks and benefits of the alternative of not doing so. Parents need to understand the key features of the protocol. In addition, parents need to understand the risks that their housing environment presents with respect to the condition and end of the study: those risks were present before the research commenced and might also be present after the conclusion of the study. Finally, what the parents understand about the research study is ethically more important than what researchers disclose. Thus, researchers who are studying housing health hazards involving children should have an appropriate means for checking that parents have understood the crucial features of the research project. Any misunderstandings or gaps in knowledge need to be corrected through additional discussions before a parent’s permission to enroll a child in the study can be accepted as ethically valid. Recommendation 6.1: 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. Informed consent should be regarded by researchers as a process that begins with a community-based discussion and concludes with an assurance that individual parents of child subjects understand the essential elements of the research. Researchers should discuss the project and aspects of the project that will be addressed in the consent form with appropriated community representatives, including the planned payment levels and the risks and benefits of the research. Their IRB submission should describe the community’s reaction and how they have responded to the community. Consent forms should be written as clearly and simply as possible while fully addressing necessary aspects of the research. Researchers and IRBs should consider approaches to improving consent that have been tried in other types of human participants’ research and test those that seem suitable for housing health hazards research. It is essential that researchers ensure that parents of child subjects understand the essential elements of the research, including baseline risks pertinent to the topic being studied and ongoing risks in the housing environment that may still be present after
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Ethical Considerations for Research on Housing-Related Health Hazards Involving Children study interventions. Researchers should have appropriate plans for ensuring that the essential elements are understood and should consider alternative ways (such as neutral educators) to educate parents about the research. The informed consent process should also include discussion with the community about any experimental tests that may be part of the research and the informed consent form should clearly state whether such test results will be available to parents. This issue is discussed in detail in the next chapter. IRBs should require that these criteria are met. Recommendation 6.2: Institutional review boards that review intervention 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 6.3: 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.
Representative terms from entire chapter: