The vision of exposure science articulated in the preceding chapters requires broad public support for gathering information on human and environmental exposures. That support involves understanding the aims of exposure science and a perspective that exposure science is integral to decision-making, including developing mitigation and prevention strategies that advance societal goals and objectives. If support is to weather the inevitable challenges, it is critical that researchers and stakeholders share values of and expectations for exposure science. In addition, appropriate safeguards and definable ethical standards to protect volunteers who give their time for exposure research are needed. Those considerations illustrate that the long-term success of human and environmental exposure science requires that attention be focused on the ethical and societal issues raised by modern research practice.
Although human exposure studies typically present only minor risks to research volunteers, several studies have sparked controversy. For example, the Children’s Environment Exposure Research Study (CHEERS), a proposed study that was intended to examine how children may be exposed to pesticides and other household chemicals generated considerable mass-media interest and contributed to fears that children would be placed at increased risk. The concerns prompted the U.S. Environmental Protection Agency to cancel its plans for the study (Resnik and Wing 2007). Reactions to the proposed study resulted in raising the bar for the conduct of observational exposure studies and led to the publication of Scientific and Ethical Approaches for Observational Exposure Studies (EPA 2008), which provides guidance for conducting observational studies. The CHEERS study, together with other controversial studies, highlight a number of ethical and societal issues that need to be navigated successfully to achieve the committee’s vision for human and environmental exposure science.
In this chapter, the committee addresses considerations related to the promotion of public trust in exposure science. Although none of the issues dis-
cussed is peculiar to exposure science, how they present themselves can pose special challenges for observational studies. That is particularly true of ethical issues associated with ubiquitous technologies—new personal and environmental monitoring tools—whose use and availability are expected to become more prevalent. As technologies evolve our capacity to detect chemicals and other stressors at increasingly lower levels is outpacing our capacity to interpret what the findings mean for health, subclinical effects, or even for elucidating potential exposure reduction strategies, creating scientific and ethical challenges for society.
Exposure-science research may involve observational studies of humans and the environments in which they live. The ability to conduct exposure studies in all populations, particularly among the most vulnerable (for example, the elderly, children, and the infirm) is critical to understanding and preventing harmful exposures and risks in society. As with all research involving human subjects, it is vital that measures be implemented at the beginning of a study to protect the rights and welfare of participants (volunteers). In cases that lack such protections, research subjects may be needlessly placed at increased risk, which can threaten not only their well being but the long-term success of human and environmental exposure-science research.
All exposure-science research involving human subjects must be reviewed and approved by an appropriate institutional review board (IRB) and be consistent with national ethics standards. Many of the ethical considerations that should guide the conduct of observational exposure studies are discussed in the recent EPA report Scientific and Ethical Approaches for Observational Exposure Studies, which provides well-defined and documented procedures for conducting exposure-related research. That report describes two primary elements for human-subject protections: review by an impartial IRB and informed consent of research subjects.
High standards of ethical conduct in human-subjects research are enforced by multiple oversight committees or review boards, which examine both scientific and ethical details of the proposed research. IRBs include appropriate medical and scientific experts who are not directly involved in the conduct of the research and who do not have any personal interests in the study. They also have members outside the scientific community. In deciding whether a research study is acceptable, IRB members are asked to consider whether or not the foreseeable risks to participants are appropriately minimized and acceptable in light of the potential benefits to participants and to society.
The process of seeking informed consent of participants is a second key element of ethical conduct in research. Informed consent ensures that subjects give their voluntary and informed consent to be participants in a research study.
In addition to consenting to participate in a study, participants can consent on whether or not they want their results (Morello-Frosch et al. 2009). (Additional discussion is found in the section, Returning Research Results.) Researchers conducting observational exposure studies are expected to seek permission from research subjects who must be informed about the goals of the research, the specific procedures involved, and the potential benefits of and risks posed by participation. That kind of communication does not end when a research subject signs a permission form or otherwise indicates his or her willingness to participate. As a study progresses and new findings are discovered, investigators are expected to communicate to research subjects any changes that have been made in the study protocol. It is through such regular communication that consent to participate is reaffirmed. If an important risk is detected, the investigators are also obliged to report it to the participants and the funding agency involved.
Typically, observational studies that do not involve efforts to mitigate human exposures present minor risks to the people who participate as research subjects. However, in addition to minor burdens associated with the collection of exposure data, without full communication such studies may also increase participants’ exposure in unintended ways, for example, by promoting an unwarranted sense of protection to subjects through their wearing of exposure-monitoring devices. Observational studies can also present risks related to the unintended disclosure of private information; for example, release of medical records might impair a person’s ability to obtain employment. To address those possible risks, investigators should strive to ensure that data are protected and that research subjects understand any potential risks associated with their participation.
The committee acknowledges in addition to observational exposure studies, there are intentional dosing studies that can involve potential increases in harmful exposures. For example, a study conducted in London, England, had asthmatic volunteers walk routes with low and high exposures to air pollution (McCreanor et al. 2007). In another study, men suffering from congestive heart failure were exposed to high concentrations of diesel exhaust, which has been linked to an increased risk of a coronary event (Mills et al. 2007). Such studies raise additional ethical considerations (see NRC 2004); but these studies fall outside the scope of this committee’s charge.
It is critical that scientists conducting research with human subjects not have conflicts of interest that may impair their ability to conduct the research ethically. Financial relationships with industry sponsors of research should be disclosed to IRBs and other research-oversight boards, such as university committees on conflict of interest. Sources of research funding should be disclosed to potential volunteers when they are approached to participate in a study, as should any financial relationships of the investigators with commercial entities that may be affected by the outcome of the research. Such disclosures can promote public trust by increasing transparency and giving study volunteers the opportunity to assess the full array of potential benefits and risks associated with their participation in the research.
Public trust must be promoted to foster support for exposure-science research. Mass-media coverage of higher-visibility studies has at times mischaracterized key aspects of study design, reinforcing distrust of regulatory agencies and fueling concerns about the identification of human and environmental stressors. To maintain public confidence in the integrity of exposure science, innovative forms of public engagement are required. They should foster public understanding of the purpose, benefits, and limitations of human and environmental exposure-science research and its potential contributions to public health.
Engaging the public through education may be needed to improve understanding of how exposure-science studies have made great strides in identifying and reducing harmful exposures. Examples are described in earlier chapters and in a recently published series of exposure-science digests (Graham 2010). These and other exposure-science studies have contributed to greater understanding of the health effects of hazardous environments and have helped to reduce the likelihood of future adverse exposures.
Exposure scientists should engage members of the public in identifying and addressing relevant health concerns. To advance that goal, it is critical that members of the public be able to access information from human and environmental exposure studies. Although exposure studies are often intended to serve as the basis of regulatory policy, the data that they produce may have relevance for other purposes. In particular, members of the public may find results of exposure studies useful in addressing local environmental conditions—for example, in modifying local planning or zoning ordinances or blocking construction of new facilities on the basis of data showing that the community will be burdened by increased exposure to environmental stressors. Exposure information may also help members of the public in making personal choices about their environments, including their behaviors, diet, housing, employment, or the purchase of personal products, and can be used by community organizations and individuals to provide input to decisionmakers.
Exposure science can help communities to identify and address differential, cumulative, and emergent exposures. Community members can be among the first to identify an exposure of concern. Once the design of a community-based exposure study begins, community members may be found to have a wealth of information about the exposures of potential concern. Communities are all too often the “subjects of” health studies and have little input into the problems to be studied. Recognizing potential community knowledge and adopting a spirit of openness in disseminating exposure-related data are pivotal for building trust. Correspondingly, conducting exposure studies in the absence of
community input or failing to maintain communication with affected communities may greatly diminish public confidence in exposure science and reinforce distrust of scientists engaged in this work (NRC 1989; 1996). Engaging members of differentially affected communities is critical for increasing public trust and improving stakeholder participation in exposure science. Federal and private funding agencies have been providing increased support for community-engaged exposure studies, recognizing that this contributes to improving study results through better recruitment and retention of study participants and through dissemination of study results to diverse public audiences (Brown et al. 2012).
Open discussion is necessary if community members are to have input into problem formulation and ultimately to benefit from research findings. The groundwork for such discussion lies in effective multidirectional communication among all stakeholders, including members of affected communities, scientists, public-health agencies, and policy-makers (Chess et al. 1988; NRC 1989, 1996; Lundgren and McMakin 2009). Effective communication underlies all stages of research, from identifying the stakeholders who should be at the table to understanding how research findings can best be shared with community members. Outreach and engagement not only provide the vehicle for disseminating the results of exposure studies but provide the opportunity for researchers to listen to community members so that they can identify preferred approaches and formats for dissemination. Such information may assist communities in developing new public-health interventions, environmental policies, or community-development initiatives to reduce harmful exposures.
A trend in public-health research is the engagement of affected communities and populations through the use of community-based participatory research (CBPR). Members of differentially burdened and exposed communities have turned to CBPR as an approach to communicate their environmental-health concerns to scientists and promote collaborative research. As part of CBPR, community-based organizations use their grassroots activism and resources, “expert local knowledge”, and university partners to develop a framework for studying differential health effects at the local level (Wilson et al. 2008; Baron and Wilson 2011). Critical to this approach is an effort to put scientific knowledge into practice by dissolving traditional boundaries between knowledge and action. CBPR acknowledges the community as a unit of identity and builds on community strengths and resources to facilitate more equitable partnerships that involve power-sharing and community empowerment (Israel et al. 1998).
Many community-based environmental justice and health organizations exist across the United States, for example, West Harlem Environmental Action, in New York City; Concerned Citizens of Tillery, North Carolina; Alternatives for Community and Environment, based in Boston, Massachusetts; and the Environmental Health Coalition, in San Diego. Many of these organizations have
engaged in community-driven research to obtain locally relevant exposure data on a variety of environmental health issues, including air pollution in metropolitan areas, housing stock, burden of pollution from industries, locally unwanted land uses, transportation issues, and industrial animal production (Shepard et al. 2002). Using CBPR, they and other organizations have leveraged their local knowledge in collaboration with university partners to develop a framework for addressing environmental health and justice issues at the local level (Wilson et al. 2008). Using that approach, community-based organizations have become more involved in creating research agendas that advance the goals of differentially affected communities (see for example, Box 6-1 which describes the role of CBPR in reducing adverse exposures and advancing the health of the community of Spartansburg, SC).
The city of Spartanburg is in northwestern South Carolina and has a population of 40,000, about 50% black and 50% white (EPA 2003, 2006). This former “textile town” has undergone a transformation with its revitalized downtown and a concentration of international business firms within the city limits (EPA 2003, 2006; Fleming 2004). However, the Arkwright and Forest Park neighborhoods, just beyond the city’s downtown, are two predominantly black neighborhoods with a combined population of almost 5,000 residents that has not benefited from the revitalization efforts (EPA 2003, 2006; Fleming 2004). The closing of local mills and plants and the lack of zoning regulations and land-use controls (EPA 2003, 2006; Fleming 2004; Habisreutinger and Gunderson 2006) left the population poor (25% in poverty) and underemployed (10% unemployment) (EPA 2003, 2006).
The two neighborhoods are affected by environmental exposures. For example, the residents were exposed to a 40-acre International Mineral and Chemicals (IMC) fertilizer plant (a Superfund site); the Arkwright dump, a 30-acre former municipal landfill (a Superfund site); the Rhodia chemical plant (in operation); the Mt. Vernon textile mill (in operation); and six brownfields (EPA 2003, 2006; Fleming 2004; Habisreutinger and Gunderson 2006; ReGenesis 2008). About 4,700 people lived within 1 mile of the IMC site and 200 within 0.25 mile of the landfill (EPA 2003, 2006; Fleming 2004; ReGenesis 2008). Those exposures have been associated with a high rate of cancer—particularly bone, colon, and lung cancer—and high rates of respiratory illnesses, adult and infant mortality, miscarriages, and birth defects (EPA 2003, 2006; ReGenesis 2008). In addition, neighborhood residents had a poor transportation infrastructure, inadequate sewer and water services, lack of access to medical care, public-safety issues, few economic opportunities, and declining property values (EPA 2003, 2006).
In 1997, Harold Mitchell, a resident concerned about the environmental contamination in his community, began organizing community meetings to discuss environmental justice and health issues (EPA 2003, 2006; Fleming 2004; ReGenesis 2008). The meetings empowered local residents and motivated efforts by the government and industry to clean up the contaminated Superfund sites and brownfields. This community-driven collaboration became known as the “ReGenesis Project”. ReGenesis built an environmental-justice partnership with the city of Spartanburg, the county, the EPA Region 4 Office of Environmental Justice, the Department of Health and Environmental Control, the Spartanburg Housing Authority, the county’s Community and Economic Development Department, local industry, and the University of South Carolina to address environmental effects on local health and adopt strategies to revitalize the Arkwright and Forest Park neighborhoods (EPA 2003, 2006).
With help from EPA Region 4, in 2000 ReGenesis was designated a national demonstration project of the Federal Interagency Working Group on Environmental Justice, giving it access to financial resources, technical experts, and information (EPA 2003, 2006). With that designation, new funding was made available, and local, state, and federal agencies began to understand that action was needed in the Arkwright and Forest Park neighborhoods to improve public health (EPA 2003, 2006). Spartanburg County was awarded additional funding through EPA’s Brownfield Initiative to perform site assessments of the brownfields (EPA 2003, 2006; Habisreutinger and Gunderson 2006; ReGenesis 2008). The brownfields assessment found contamination and led to government agencies’ providing additional funding to clean up the sites for redevelopment (EPA 2003, 2006; Habisreutinger and Gunderson 2006; ReGenesis 2008). The success of ReGenesis in working with its collaborative partners for assessment, cleanup, and redevelopment of brownfields and other industrial sites also led to additional efforts to improve the health-promoting infrastructure of the Arkwright and Forest Park neighborhoods.
The CBPR approach allows the research process to increase a community’s ability to study differential and cumulative exposures, address environmental justice and health issues, and increase engagement of minority-group and low-income stakeholders (Minkler et al. 2006; Wilson et al. 2008; Baron and Wilson 2011). For example, CBPR was used to obtain community-generated dietary consumption data for subsistence anglers in the East River of New York. These data, together with fish tissue contaminant concentration data were used by EPA in calculating risk estimates for exposures to contaminants in fish (for example, cadmium, mercury, and dioxins) consumed by the local, ethnic populations, when no appropriate dietary assessment data were previously available for this high-risk group (Corburn 2002). Members of the community were essential for collecting this consumption data given the cultural and language barriers of
the anglers. Similarly CBPR has been used to help assess farmworkers’ pesticide exposures and associated health effects (Acury et al. 2001); a particularly difficult population to study given their transience and changing occupational status, language barriers, and questions regarding immigration status. Kamel et al. (2001) used community collaboration (working with the Farmworker Association of Florida and relying on the members’ expertise) to identify and recruit a valid sample of farmworkers for an epidemiologic study.
The new research paradigms and exposure-monitoring technologies described in the preceding chapters will magnify current debates about exposure science and pose additional challenges in maintaining public trust. The potential for increasing private-sector involvement in this field of research may raise additional concerns about personal privacy. Future studies may seek to relate environmental exposure data to other large databases, including data on cellular-telephone use, global positioning system location, food consumption, and consumer shopping patterns. Although it may not be possible to anticipate the full array of challenges that lie ahead, several important issues can be identified now.
Returning Research Results
A difficult challenge in exposure studies concerns whether, when, and how to return exposure information to study participants (Schulte and Singal 1996). That issue can be raised at both at an individual level and a community level and can be especially difficult in contexts in which exposure studies take a long time, there may not be a direct relationship between researchers and subjects, or if the exposure data do not provide clear insights regarding the potential health effects, sources, or pathways of exposure. Questions about the return of personal exposure information will become more common as new collection methods obtain “personalized” forms of exposure data. Such data might be collected with ubiquitous monitoring devices, such as personal cellular telephones (see discussion in Chapter 5). As the volume of data collected continues to expand, exposure scientists need to consider the most appropriate approaches for reporting information on a multitude of exposure sources, some of which might be ambiguous with regard to importance, might be sensitive, or might pose personal risks to individual participants (for example, in legal proceedings) (Deck and Kosatsky 1999; Morello-Frosch et al. 2009). In addition to returning exposure data to participants, consideration will need to be given to how to place the data into context with respect to whether there are potential health implications or a need for people to take action to reduce exposures.
At the present time there is little guidance for scientists and academic-community researchers on reporting back individual and community-level expo-
sure data to study participants (NRC 2006). For example, few precedents exist for reporting biomonitoring data back to individuals when little information is available for interpreting health implications (Morello-Frosch et al. 2009). Morello-Frosch et al. identified distinct frameworks used by scientists for reporting back biomonitoring results. For example in the clinical approach, that is biomedically driven, reporting individual biomonitoring results is based on whether the risk relationship between exposure and health effects is understood. With CBPR, sharing of individual and community-level exposure data are encouraged between researchers and participants because it is believed that these data can have an impact beyond individual health, including in allowing communities to understand sources and potentially reduce exposures.
There appears to be movement in favor of addressing the issue of reporting-back exposure data in the recruitment and consent process of research studies. The ethical issues of reporting back exposure data will become more complex as data are increasingly integrated, reinforcing the need to address the rights of study participants before, during, and after studies are conducted. This is particularly true if exposure samples are to be stored for use after a study is completed (Morello-Frosch et al. 2009).
Engaging Affected Communities
As noted above, there are numerous challenges related to how scientists engage differentially burdened and exposed populations to address health disparities. With increasing recognition of the importance of social and ecologic stressors in human health, how we engage these populations in multiple aspects of exposure science—before, during, and after exposure studies—takes on even greater importance.
To be effective, community engagement must be multidirectional, with sources and receivers of information in constant communication with each other. Because scientists and the public may have different perceptions of risks (see, for example, Slovic et al. 2000), those responsible for communicating risks identified through exposure science need to understand stakeholders’ values, concerns, and perceptions. Failure to recognize the differences and address them appropriately can cause failures in communication. In addition, the social context in which communication occurs and the extent to which sources of information are trusted play a critical role in how information is understood (Slovic et al. 2000; Miller and Solomon 2003).
Studying Susceptible and Vulnerable Populations
Ethical issues associated with exposure studies that involve susceptible and vulnerable populations—such as children, economically disadvantaged populations, the infirm, and workers—will continue to present challenges for the field of exposure science and the rest of environmental health. With the increas-
ing reliance on chemicals in products and improvements in our knowledge about mixtures, cumulative exposures, and exposures at different life stages, the field of exposure science will be challenged to perform ethical studies that involve and will ultimately protect susceptible and vulnerable populations. There will be a greater demand for this type of research to advance the state of knowledge while balancing the needs of those populations and to perform exposure research that is beneficial and produces high-quality data that can be used to reduce and eliminate human exposures.
Protecting the Natural Environment
Protecting and maintaining the integrity and health of ecosystems is critical because human society depends on natural processes and goods provided by natural ecosystems. As discussed in Chapter 1, ecologic systems support human health and well-being. Thus, even from an anthropocentric perspective, alterations of natural ecosystems that reduce their capacity to provide ecologic services may harm current populations or future generations. This perspective is distinct from the continuing discussion within environmental ethics regarding the need to extend the traditional boundary of societal concerns, which center on human concerns, to include nonhuman elements of our world (Des Jardins 2012).
To the extent that human health and ecologic health are inextricably linked, agencies that fund exposure-assessment studies will need to consider the long-term value of funding studies that focus on ecologic and environmental consequences of exposure even when direct effects on human health may be unclear. This approach reflects growing awareness that our global ethical responsibilities extend beyond humans and include the nonhuman elements of ecosystems. In addition, environmental stewardship is essential for supporting the full array of ecosystem services on which human health and well-being depend. Although budgetary pressures may make it difficult to advocate for studies of environmental exposure, advancing exposure science requires recognition of the interconnectedness of human health and ecologic health.
In developing practical approaches to societal challenges that will increase public support for exposure science, researchers conducting exposure studies should be mindful of the guiding values that shape their research. The investigation of environmental problems is an inherently ethical undertaking entwined with competing societal and political values. A researcher’s choice to investigate a particular toxicant or geographic location, for example, validates a set of societal concerns about specific risks, irrespective of the eventual outcomes of the research. In addition, the limitations of public resources for research require federal agencies and the researchers that they support to be good stewards of the
resources and to choose to pursue problems that have the potential to improve public health. Studies of human exposures can create new legal and ethical obligations, both for those who have created an environmental hazard and for those who are exposed.
Human and environmental exposure-science research can seem distant to the public. Those who are familiar with exposure science have tended to view the field as driven largely by regulatory and political agendas. In addition, however, there is a need to convey to the public the rich array of information generated by human and environmental exposure science. With the development of smart phones and ubiquitous sensing, providing such information through monitoring of exposures is becoming more feasible. We elaborate on the need for transparency and engagement below, following the general theme of moving from source to dose.
1. Sources—We believe that people have a right to learn about sources of environmental exposures that potentially affect their health and well-being or the health of the ecosystems on which they depend. As with all research for public good, the exposure science community needs to make sure that ways are found to educate people about sources of exposures that may affect their health and well-being.
2. Ambient and indoor concentrations—People also have a right to know about exposure concentrations in all the microenvironments that they inhabit, and there is a reciprocal duty for researchers and others involved in the translation of scientific data to educate people about ambient concentrations that may affect their health.
3. Personal actions and exposures—People have a right to know how their own personal actions affect the environmental exposures that they encounter and how behavioral changes can reduce these exposures. To the extent that exposure assessment has traditionally been driven largely by regulatory purposes, there is a need to reorient the focus of exposure assessment to engage a more diverse set of stakeholders in decisions about the direction of human and environmental exposure science. Needs for translation of exposure science to educate citizens extends from informing people about how they can change their behaviors to improve personal health to informing those responsible for sources of harmful exposures how they can reduce harmful emissions and thereby contribute to improving environmental and public health.
4. Body burdens of exposure—With the advent of “-omics” technologies, we anticipate a wealth of information on body burdens of exposures. People who supply such information have a right to know about the body burdens of exposure that they carry, and it is incumbent on those collecting exposure data to educate people who have donated the data about their potential consequences.
Those values are consistent with another major theme in our report, namely, that exposure science needs to move beyond the assessment of ambient exposures to the characterization of dose. Emerging surveillance technologies will soon allow ubiquitous, large-scale monitoring of body burdens from multiple exposures. Although individual citizens will have different levels of interest and resources for learning about their environmental exposures, embracing the above values will help to ensure that exposure science engages a broad and diverse group of stakeholders who are interested in learning more about their personal exposures.
To be deserving of the public trust entails a commitment to maintaining the highest standards of integrity in exposure-science research. Scientists engaged in exposure assessment need to structure their studies in a way that is respectful of research volunteers and minimizes the potential for harm to people who make their research possible by voluntarily participating in exposure studies. When conducting participatory research, scientists should engage affected communities and populations in order to generate useful exposure information that stakeholders can use to reduce and eliminate their exposures and improve community health.
As we prepare for a time when new exposure-monitoring technologies and research paradigms expand the traditional scope of exposure-assessment studies, it is critical to anticipate ethical challenges that will present themselves. Several of the challenges stem from the collection of increasingly individualized data, which can present greater risk for research volunteers or create an expectation that results of potential importance will be returned to individual participants. The expanding scope of exposure-assessment studies may also create opportunities to provide citizen-volunteers with exposure data that they would find useful in reducing their personal exposure to environmental stressors. Scientists conducting exposure-assessment studies and the agencies that support their work should consider how to anticipate and respond to these challenges so as to maximize the global impact of human and environmental exposure science and sustain public confidence in the integrity of this evolving field of research.
• Federal agencies that support human and environmental exposure science need to develop educational programs to improve understanding of exposure-assessment research. The programs need to engage members of the general public, specialists in research oversight (such as members of IRBs), and specific communities that are differentially burdened by environmental toxicants.
• Federal agencies and professional societies should develop programs to assist exposure scientists in navigating the complex terrain of human-subjects research. Changing regulatory requirements demand that exposure scientists stay current with IRB expectations. Better communication between exposure scien-
tists and regulatory specialists can help to ensure that the expectations are transparent to those engaged in exposure-science studies.
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