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6 Parental Permission, Consent, and Payment
Pages 99-123

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From page 99...
... 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.
From page 100...
... 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.
From page 101...
... . 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.
From page 102...
... 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.
From page 103...
... . Simplified consent forms can improve comprehension by research participants (Coyne et al., 2003)
From page 104...
... . These findings suggest that comprehension of written consent forms is even more challenging for the groups often targeted for housing health hazards research.
From page 105...
... 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)
From page 106...
... 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.
From page 107...
... 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)
From page 108...
... 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.
From page 109...
... Voluntariness and Undue Influence Voluntariness is an essential requirement for informed consent. According to a recent review by Nelson and Merz (2002)
From page 110...
... Emanuel argues that such problems should be addressed directly; reducing payments to participants in a study will not address them. However, as discussed throughout this report, there is particular sensitivity regarding the acceptable level of risk in housing health hazards research.
From page 111...
... The perception of undue influence may be as important as the question of whether the concerns are really displaced concerns about other ethical issues. Rather than saying the undue inducements are not a problem in research on housing health hazards in children, it
From page 112...
... ; · incentive payments beyond those listed above: such payments may raise ethical concerns about undue inducements that undermine the voluntariness of the consent process. Payments to children involved in research and their families remains a controversial issue (Wendler et al., 2002; American Academy of Pediatrics, 1995)
From page 113...
... 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)
From page 114...
... 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)
From page 115...
... 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)
From page 116...
... . 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.
From page 117...
... 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.
From page 118...
... 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?
From page 119...
... . In housing health hazards research, there are cases when consent or permission might be necessary even if informed consent is not.
From page 120...
... 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.
From page 121...
... 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.
From page 122...
... 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
From page 123...
... Recommendation 6.2: Institutional review boards that review interven tion or longitudinal cohort studies on housing health hazards involving children should require that the informed consent process reflects ap propriate 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)


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