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date: 29 May 2020

Environmental Health Research and Ethics

Abstract and Keywords

This chapter discusses some of the key ethical issues that arise in environmental health research involving human subjects, including returning individualized research results, protecting privacy and confidentiality, research on environmental interventions, intentional exposure studies, research regulations, autonomy, beneficence, informed consent, payments to subjects, and protecting vulnerable human subjects. The chapter will discuss issues that are common to all research designs, as well as those unique to certain types of designs, such as intentional exposure studies. It will also address ethical issues that arose in two important cases, the Kennedy Krieger Institute lead abatement study, and the Children’s Environmental Exposure Research Study.

Keywords: environmental health research, research regulations, autonomy, beneficence, privacy, confidentiality, vulnerable human subjects, environmental interventions, exposure studies, public health ethics

(p. 754) Introduction

Scientific research enhances our understanding of the relationship between human health and the environment and aids in the development of interventions or policies that can improve environmental health. Environmental health research raises a number of different ethical issues, ranging from scientific integrity issues to animal and human subjects issues (Resnik, 2012; Shamoo and Resnik, 2015). This chapter will focus on some of the ethical issues that arise in environmental health research involving human participants. Common research designs for conducting environmental health research with human subjects include observational studies (e.g., prospective cohort studies, retrospective case-control studies), interventional studies (e.g., clinical trials), and intentional exposure studies (Resnik, 2012). The chapter will consider some of the ethical issues related to these study designs, as well as some that cut across different designs, such as returning individualized research results, safeguarding privacy and confidentiality, and protecting vulnerable human subjects.

Background on Ethics and Regulations

To understand the ethical issues related to environmental health research with human subjects, it will be useful to understand the ethical and legal standards that apply to research with human participants, which are embodied or reflected in federal regulations (p. 755) (e.g., HHS, 2009, 2017; EPA, 2013), international codes (e.g., ORI, 2019; WMA, 2013), government reports (National Commission, 1979), and agency guidance documents (e.g., OHRP, 2019), a number of which are referenced in the discussion below. These standards embody various ethical principles of research involving human participants, such as sound scientific design, risk minimization, reasonableness of risks, informed consent, and protection of confidentiality and privacy (Emanuel, Wendler, and Grady, 2000). They also require that an independent committee, such an institutional review board (IRB), review and oversee the research.

Cross-Cutting Issues

Returning Individualized Research Results

Environmental health researchers often collect information on participants that they may be interested in receiving, such as the results of clinical examinations or tests, environmental sampling, or genetic/genomic testing. Results may include information that is gathered as part of the study, or they may include information that investigators happen to discover (i.e., incidental findings). In some cases, this information may have a direct bearing on the participant’s health. For example, if an investigator discovers that a participant has dangerously high blood pressure, he or she could refer the participant to a physician for treatment. The investigator might even offer emergency treatment to the participant if a problem that requires emergency care is detected and the investigator has the ability to provide that care. In other cases, the information may have no direct relationship to the participant’s health and may be difficult to interpret.

Suppose, for example, that researchers are testing environmental samples collected in the home for levels of different flame retardants, but there is no established safe level for a particular retardant. Sharing information about the levels of this retardant in the home with the participant may have little value to the participant and may even lead to needless worry or confusion, especially if the participant has no way of controlling his or her exposure to this chemical (Resnik, 2012). Or suppose that investigators are testing for the presence of a chemical in the home (such as lead) for which there is an established safe level, but they are using a processing laboratory that does not have a good track record of producing accurate and reliable results. If the laboratory incorrectly determines that levels of lead in the samples are safe (false negative), then the participants might fail to take steps to prevent exposure to dangerous levels of lead in the home. If the laboratory incorrectly determines that levels of lead are unsafe (false positive), then the participants might experience needless stress or make a rash decision (such as selling their home). Thus, return of individualized results to participants presents significant ethical dilemmas for environmental health researchers, because providing this information may be beneficial or harmful (Resnik, 2012).

Two divergent views on the return of individualized research results have emerged in the literature. According to the autonomy approach, participants should receive all (p. 756) research results that they choose to receive. This approach can benefit participants and promote their ability to make autonomous choices concerning their health or life plans (Fernandez, Kodish, and Weijer, 2003; Brody et al., 2007). Proponents of this approach recommend that the consent form provide participants with information about the results they may choose to receive and when they will be available. The research proposal should include plans to provide participants with guidance on how to understand and use their results, including plans for medical referrals, if appropriate (Brody et al., 2007). To ensure that results are reliable and accurate, testing should be done in certified laboratories or using test kits that have been validated and approved for marketing (President’s Commission, 2013).

According to the harm-avoidance approach, however, participants should receive only those results that have a well-established practical value, such as information that can be used to prevent or treat disease, or to guide choices concerning reproduction or life plans (Wolf et al., 2008; Resnik, 2011). The obligation to do no harm provides the main justification for this approach, since returning results that have no established practical value may cause participants needless worry and may lead them to make unwise choices, such as selling their home because they wrongly assume that it is unsafe (Resnik, 2011). Another reason why some recommend this approach is that returning results without established practical value increases the costs of the study unnecessarily (Wolf et al., 2008). Bioethicists, scientists, and professional associations continue to debate the merits of different approaches to returning research results (President’s Commission, 2013).

An important legal ruling helped establish the legal duty to return research results relevant to preventing or treating disease. During the early 1990s, the Kennedy Krieger Institute (KKI), an affiliate of Johns Hopkins University, conducted a study funded by the US Environmental Protection Agency (EPA) and the Centers for Disease Control and Prevention (CDC) to determine whether less expensive forms of lead abatement are as effective at preventing exposures to lead in the home as full lead abatement. The investigators were interested in learning whether these less expensive forms of lead abatement can significantly reduce exposures, because full lead abatement can be expensive ($10,000 or more per home). Baltimore city leaders were concerned that landlords would abandon their homes to avoid paying the full price of lead abatement, which would have an adverse impact on the community. The study recruited families with young children who were living in homes containing lead paint on interior walls. Homes were randomly assigned to receive $1,650, $3,500, or $6,000–$7,000 worth of lead abatement. The study also included a control group consisting of homes with full lead abatement and another consisting of homes without interior lead paint. Twenty-five families participated in the study—five in each group. Investigators measured levels of lead in the children’s blood and in dust, soil, and water samples collected from the homes.

The investigators helped the landlords obtain grants to pay for lead abatement and encouraged them to rent their homes to families with young children. The study (p. 757) included plans to inform the families of dangerous lead levels, but the consent document did not warn families that children might accumulate dangerous levels of lead as a result of continuing to live in a home undergoing lead abatement. Two of the families sued the investigators and KKI, alleging that they were not informed of dangerous lead levels in a timely manner. Viola Hughes, the mother of Ericka Grimes, alleged that she was not informed that her daughter’s blood contained dangerous lead levels until nine months after these levels were detected. The court found that the investigators could be sued for negligence on the basis that they had failed to inform the parents of dangerous lead levels in a timely fashion (Grimes v. Kennedy Krieger Institute, 2001). Although the legal duty to return clinically useful research results appears to be well established, it is not clear whether researchers have a legal duty to return results that are not clinically useful.

Protecting Privacy and Confidentiality

Environmental health researchers often collect data and samples in homes or workplaces, which raises issues concerning the protection of confidentiality and privacy. For example, researchers conducting a study in the home may inadvertently observe evidence of child or elder abuse/neglect, domestic violence, or illegal activity (such as the sale or possession of illegal drugs). Although investigators have an ethical obligation to protect the confidentiality and privacy of research participants, they have legal and ethical duties to report child or elder abuse. While protecting privacy and confidentiality is important, one might argue that investigators should override this obligation in order to protect vulnerable residents of the home (such as children or frail elderly people) from harm.

Investigators should inform participants of their obligations to report suspected child or elder abuse and establish procedures for research staff to follow when evidence of abuse is discovered. Staff should also be trained in how to collect data and samples in a domestic setting without invading privacy unnecessarily. Likewise, investigators who are collecting data or samples in the workplace may observe violations of health and safety standards, worker harassment/abuse, or other problems. While protecting the employer’s confidentiality and privacy is important, investigators may override this obligation in order to protect employees from imminent harm. They should inform employers of any plans to report dangerous conditions that they happen to observe, and also establish procedures for research staff to follow (Resnik, 2012).

Protecting Vulnerable Participants

Environmental health research often includes vulnerable participants, or people who have a compromised ability to provide informed consent or protect their own interests (Levine et al. 2004). Federal research regulations include additional protections for (p. 758) specific classes of vulnerable participants, including children, fetuses, neonates, and prisoners. For example, the regulations limit the risks that children, fetuses, neonates, and prisoners can be exposed to in research that does not benefit them directly (HHS, 2009). The main rationale for special safeguards is that vulnerable subjects have a compromised ability to make autonomous choices concerning their risk exposure, due to their lack of decision-making capacity or susceptibility to coercion or undue influence, and thus need additional protection from harm (Levine et al., 2004).1 For several decades the US research regulations classified pregnant women as vulnerable subjects, but recent changes have made it clear that fetuses, not pregnant women, are vulnerable (HHS, 2017; Resnik, 2018).

A controversial environmental health research project has raised key issues concerning the protection of vulnerable participants. The Children’s Environmental Exposure Research Study (CHEERS) was a research project sponsored by the EPA, the CDC, and the Duvall County (Florida) Health Department, in which investigators planned to observe children’s in-home exposures to pesticides and other chemicals. The American Chemistry Council (ACC) also contributed money to the project. The investigators planned to recruit sixty families with children who used high levels of pesticides in their homes, as well as a control group of ten families who used a low level of pesticides or none at all. The investigators planned to visit the homes thirty times over a two-year period. During these three-hour visits, the investigators would collect soil and dust samples and blood and urine from the children. The parents would play an active role in the study by keeping a journal of their pesticide and chemical use and videotaping their children’s activities. For their efforts, the parents would receive a free video camera and $970. The investigators planned to inform the parents about safe use of pesticides and inform them of unsafe levels of pesticides (or other chemicals) detected in the home or the children’s blood or urine. The families could remain in the study even if they reduced their pesticide use, and they could withdraw at any time without penalty (Resnik and Wing, 2007).

The investigators planned to implement the study in fall of 2004, but they put the study on hold when a public controversy erupted. Critics charged that the study intentionally exposed children to pesticides, targeted low-income minority groups, offered the participants too much money, and was tainted by industry bias. The EPA terminated the study in the spring of 2005 after Senator Barbara Boxer of California threatened to derail Stephen Johnson’s nomination as EPA Administrator if the agency did not cancel it (Resnik and Wing, 2007). The charges brought by the critics lacked merit, however. First, the study was an observational study, not an intentional exposure study. The study even included a screening procedure to ensure that parents would not begin using pesticides in order to qualify for the study. After obtaining consent from the parents, the investigators would immediately visit the home to determine their level of pesticide use. If the sample analysis indicated they already used high levels of pesticides, they might qualify for enrollment in this group; if not, they might qualify for the control group.

Second, the study did not target low-income minority groups, as none of the enrollment criteria mentioned race, ethnicity, or income. The main reason for selecting Duvall (p. 759) County as the research site was that investigators already knew that many residents in the area used high levels of pesticides in the home to deal with roaches, rodents, and other pests. Third, the amount of money offered to the participants may have seemed high, but it would have been less than the federal minimum wage when one considers that the parents would contribute about 150 hours of their time to the study. Fourth, although the ACC helped support the study, it had no role in planning or implementing the project. Still, although the study was scientifically and ethically sound, the investigators could have done more to enhance its public perception by working more closely with members of the local community on recruitment, publicity, and other issues (Resnik and Wing, 2007).

One of the results of the CHEERS controversy is that the EPA adopted human research regulations that prohibit the agency from funding intentional exposure studies involving children or pregnant or nursing women (EPA, 2013). The EPA adopted these rules in response to a congressional mandate that the agency not fund pesticide experiments involving those populations (Resnik, 2007a). One might argue, however, that the EPA went too far in protecting children, fetuses, and infants from harm, because the regulations prohibit the agency from conducting or sponsoring intentional exposures studies that present no more than a minimal risk to participants.2 For example, children are often exposed to sunscreens and insect repellants in their daily lives. It would be important for promoting children’s health to have a better understanding of how these chemicals interact with children’s anatomy and physiology at exposure levels that children often encounter, yet the EPA cannot fund such research (Resnik, 2007a). The regulations also prevent the EPA from collaborating with institutions that are conducting controlled trials of medications used to prevent or treat environment-related health problems (such as asthma), because these studies involve intentional exposures (Resnik, 2007a). It is ironic that advocates for children’s health, who pressured the EPA into banning intentional exposure studies involving children or pregnant or nursing women, may have inadvertently undermined the health of these groups.

The debate over including children or pregnant or nursing women in intentional exposure studies illustrates a perennial issue related to protecting vulnerable research participants; namely, the dilemma between underprotection and overprotection (Mastroianni and Kahn, 2001). While it is important to protect vulnerable research participants from harm or exploitation, excluding them from studies may adversely impact their interests, because it may prevent researchers from conducting research that can benefit their health. For example, most drugs are prescribed to children and pregnant women on an off-label basis because these groups have been routinely excluded from clinical trials of new drugs (Resnik, 2007a; Schonfeld, 2013). Excluding children and pregnant women from drug studies can prevent researchers and clinicians from obtaining the knowledge that is needed for safe and effective prescribing. Environmental health researchers and the committees that oversee their studies need to carefully consider whether it is appropriate to include or exclude vulnerable participants, taking into account the need to protect these individuals from harm or exploitation and the potential public health benefits of inclusion.

(p. 760) Design-Related Issues

Research on Environmental Interventions

Interventional studies, such as the KKI study, attempt to determine the effectiveness of an intervention in treating, preventing, or mitigating an environmental health problem. In randomized controlled trials (RCTs), participants are randomly assigned to either the group that receives the intervention or a control group. In some cases, the control group may receive a placebo to control for bias due to the placebo effect. While RCTs in clinical medicine study the effectiveness of medical interventions (such as drugs or devices), RCTs in environmental health study the effectiveness of environmental interventions, such as lead or mold remediation, mosquito control, sanitation, or water purification (Allen, Barn, and Lanphear, 2015).

One of the key ethical issues in clinical trial design is whether patients/participants in a control group should ever receive an intervention thought to be ineffective (such as a placebo) when a therapy for the condition is known to be effective. Numerous writers have argued that it is unethical to include placebo control groups in clinical trials when a therapy is known to be effective at treating the condition under investigation, because this trial design violates the physician’s obligation to provide optimal medical care for his or her patients. Placebos may only be used when no therapy is known to be effective for a condition (Miller and Weijer, 2007). Others have argued that it can be ethical to include a placebo control group in a clinical trial when a therapy is known to be effective if the participants consent to the study and withholding therapy does not cause them significant, long-term harm (Miller and Brody, 2007). Similar issues arise when patients/participants in a clinical trial are given a therapy thought to be suboptimal when an optimal therapy is available.

In the KKI study, participants in the experimental groups lived in homes that did not receive full lead abatement, even though full lead abatement was known to be effective at preventing lead exposure. Some argued that the study was unethical because the three experimental groups did not receive full lead abatement (Spriggs, 2004). Others argued that the study was ethical because it did not impose significant risks on participants in the experimental groups and it offered them partial lead abatement, which is a significant benefit. The study also benefitted the residents of Baltimore who were living in homes containing interior lead paint because it demonstrated that partial lead abatement can be effective at preventing lead exposure (Buchanan and Miller, 2006).

An important factual issue is whether the participants in the experimental groups were already living in homes with lead paint before the study began, since it appears that some residents moved into the partially abated homes when they joined the study (Nelson, 2001). If the participants in the experimental groups were already living in homes with lead paint, then the study would impose only minimal risks on them (e.g., the risk of the blood draw), since they were already exposed to lead. However, if they (p. 761) moved into homes with lead paint in order to join the study, then this would impose more than minimal risks on participants, since the risks would include the risk of lead exposure. One could argue that the benefits of the study would not outweigh the risks if the participants were not already living in homes with lead paint.

The debate about withholding effective environmental health interventions in controlled experiments parallels, in some ways, the debate about using placebo control groups in clinical trials (Allen, Barn, and Lanphear, 2015). However, it is important to note that clinical trials are different from environmental intervention experiments, because the investigators in clinical trials are typically physicians who have ethical obligations to provide optimal care to their patient/participants, whereas the investigators in environmental intervention studies usually do not have physician-patient relationships with the participants (Resnik, 2012). Nevertheless, one might maintain that environmental health researchers are still obligated to benefit study participants and treat them fairly (Resnik, 2008).

Intentional Exposure Studies

Environmental health researchers sometimes conduct studies in which human participants are intentionally exposed to an environmental agent (such as a chemical or allergen) in order to better understand the health effects of the agent. Although animal experiments, in vitro cell and tissue studies, and human observational studies can produce useful knowledge concerning the health impacts of environmental agents, they often do not provide researchers with precise knowledge concerning human health effects and causal mechanisms. Intentional exposure studies can help close this knowledge gap (Resnik, 2007b). For example, the EPA’s National Exposure Research Laboratory conducts research that exposes human participants to air pollutants, such as ozone or diesel exhaust, in a controlled setting. The exposure takes place in a sealed chamber in which participants breathe air with a controlled dose of pollutant. The air in the chamber is safe to breathe for a limited time (Resnik, 2007b). The participants may also be asked to perform activities that involve moderate physical exertion. The investigators collect samples and data before and after the exposure and carefully monitor the participants during the study. Participants usually undergo a bronchoscopy after the exposure to allow investigators to collect tissue from the respiratory tract (Resnik, 2007b).

The main ethical issue pertaining to intentional exposure studies is whether the risks to the participants are acceptable in relation to the expected benefits (Resnik, 2007b; London et al., 2010). While investigators can take steps to minimize risks, participants may still face significant risks in some studies. For example, the main risks of the EPA’s air pollution studies are associated with breathing polluted air for a short time and the bronchoscopy. While exposure to polluted air for a short time poses a minimal risk for a healthy volunteer, a bronchoscopy can lead to respiratory irritation, mild bleeding, and, in rare cases, a pneumothorax, a condition in which gas collects around the lungs. However, these problems usually resolve themselves or can be easily treated (p. 762) (NHLBI, 2012). Proponents of intentional exposure studies argue that they yield valuable information that cannot be obtained by other means. This information can be useful in developing interventions or regulations to protect people from the harmful effects of air pollution (Resnik, 2007b).

Recent controversial intentional exposure studies included a dozen or so experiments conducted by private companies during the 1990s that exposed human participants to small quantities of pesticides (London et al., 2010). In some experiments, the investigators gave the participants a drink laced with pesticides; in others, they placed pesticides on the participants’ skin. Following exposure to the chemical, the investigators collected and analyzed the participants’ blood and urine to better understand how the body metabolizes and eliminates the chemical. The companies conducted the experiments in order to submit data to the EPA to convince the agency to increase the allowable level of pesticide residue on foods. Private companies and commercial farmers were concerned that the lower levels of allowable pesticide residues mandated by the Food Quality Protection Act of 1996 would be ineffective at controlling weeds and pests.

Critics objected to these experiments on the grounds that they benefitted the pesticide companies but not society. They also argued that the experiments were underpowered—some studies had as few as twenty-five participants—which meant that the experiments might not be able to detect statistically significant adverse effects. Moreover, some of the experiments used company employees as participants, which was potentially coercive (Lockwood, 2004; London et al., 2010). While the majority of commentators agree that most of these particular studies were flawed, some have argued that some types of human pesticide experiments would be acceptable if they meet rigorous scientific and ethical standards. Human pesticide experiments might provide government agencies or health care professionals with information they could use to protect public health (NRC, 2004; Resnik and Portier, 2005).

Conclusion

Environmental health research involving human participants raises ethical issues pertaining to such topics as returning individualized research results, safeguarding privacy and confidentiality, conducting interventional or intentional exposure studies, and protecting vulnerable participants. Environmental health researchers and oversight committees need to be aware of these issues and take appropriate measures to ensure that research meets ethical and scientific standards.

Acknowledgments

This research was supported by the Intramural Program of the National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH). It does not represent the view of the NIEHS, NIH, or US government.

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Notes:

(1.) US federal regulations have classified pregnant women as vulnerable subjects even though adult women are normally fully capable of making autonomous decisions. Pregnant women are treated as vulnerable subjects due to the vulnerability of the fetus. Regulatory revisions issued in 2017 (and intended to take effect in 2018) remove pregnant women from that classification (HHS, 2017).

(2.) US federal regulations define minimal risk as when “the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests” (HHS, 2009, 45 CFR 46.102i).