ABSTRACT
Research practices and regulation aimed at addressing environmental contamination have shifted dramatically in academic and policy arenas, due to challenges from social movements and innovative scientists who have collaborated directly with affected communities to conduct research linked to regulatory change. This shift has also catalyzed new initiatives from some federal and state agencies as well as foundations to support community-engaged science (Balazs and Frosch 2012). As science and technocratic decision-making increasingly shape policy and environmental regulation in the United States, some affected communities have marshaled their own scientific resources, often by engaging in research collaborations with academic partners. These community-academic collaborations entail direct public engagement in the scientific enterprise (including development of research questions, study protocol design, data collection, interpretation and dissemination of results) with an eye toward leveraging data to improve policy-making and protect public health.This form of community-engaged research pointedly resists forms of “scientization” in which decision-making is dominated by experts who work to ensure that debates over policy remain “objective” and divorced from their socioeconomic and political contexts (Morello-Frosch et al. 2011). Instead, community-engaged research elucidates the potential and limitations of medical science in solving persistent health problems that are socially and economically mediated. The experience of the environmental health movement, which is concerned with environmental causation of disease, demonstrates that lay pressure is critical to advancing environmental and occupational health. In an environment of uncertainty and consequent contestation, the scientific data and analy-
sis on which policy and regulation is based inevitably integrates “large doses of social and political judgment” (Jasanoff 1990, 229).Where judgment is a central part of data development and the data collected can affect communities, it makes ethical sense for communities to have a voice at the table. However, this not only creates institutional challenges to the scientific enterprise and the regulatory process, but also raises significant bioethical questions as
Institutional Review Boards (IRB) – the entities that oversee human subjects research in university and related settings – grapple with the governance of research projects that entail extensive engagement between study participants and researchers, the sharing of research results despite scientific uncertainties, and meeting the sometimes competing demands of communitylevel and individual-level research protections. We call these emerging tensions in human subjects’ protection “post-Belmont research ethics.” In 1979, the Belmont Report established ethical principles for the use of human subjects in
scientific research. Developed partly in response to theTuskegee syphilis study1, Belmont identified three basic principles, which are interpreted and applied by IRBs that oversee human subjects research.The first of these principles,“respect for persons,” stresses that an individual’s decision to become a research participant must be voluntary and calls for special protection for those who lack the capacity to make such a decision themselves (such as children).The second principle,“beneficence,” calls on researchers to “do no harm” or barring that, to maximize the benefits of their research while reducing, as much as possible, risks to study participants. Finally, the principle of “justice” requires careful attention to the fair distribution of risks and benefits, calling on researchers to select study participants only “for reasons directly related to the problem being studied” and to vigilantly avoid the selection of subjects for “their easy availability, their compromised position, or their manipulability.” Justice also requires that those who bear the risks of research should, whenever possible, be among the first to benefit from its insights (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research 1979). Thus, IRBs’ Belmont-driven approach to human subjects protection represents an institu-
tionalized practice of research oversight.The highly bureaucratized nature of IRBs, which Stark (Chapter 25 of this volume) analyzes, has become a barrier to some of the protections that IRBs were intended to provide.While suitable for many biomedical applications, IRBs often strictly apply Belmont principles in ways that impede legitimate social science and communitybased participatory research (CBPR). Indeed, formalized ethical protocols provide structured guidelines for research, but they do not fully address the uncertainties faced by researchers as they navigate new ethical terrains of community engaged science and the dynamic relationships between multiple parties within a research project (for example, individual study participants and their communities as well as researchers). Our notion of post-Belmont ethics acknowledges the importance of formal ethical stan-
dards used by IRBs, while also recognizing that ethical research requires continued reflexivity, communication, and attention to community rights, not solely individual rights. In this approach, community harm and benefit is consistently taken into account, as is individual harm and benefit. Sharing information is emphasized, even in light of scientific uncertainties, which contrasts with the tendency of IRBs to withhold uncertain information for fear of unduly alarming study participants. In short, post-Belmont ethics disrupt the passive and paternalistic formulation of human subjects in favor of directly engaging study participants in the implementation and oversight of environmental health research. As the icon of environmental contamination changes from drums of toxic waste to test tubes
of human blood or breast milk, so too does the measurement of chemical contamination change from exposures outside the body to those inside it. Concerned citizens are just as likely to ask “is it in us?” as to ask what a nearby refinery emits from its smokestacks. Personal exposure research methods, including household air and dust sampling and biomonitoring of human tissues (such as blood, breast milk, or hair) have become important ways to examine the impact of chemical and other contaminants on humans.This expansion in how human exposures to environmental chemicals is measured, coupled with increased institutional support for
community-engaged environmental health science more broadly, has opened the way for communities, scientists, and some regulatory officials to challenge established institutional norms in the realms of scientific methods and study protocol design; development of relevant research questions; the intersection of science, decision-making and policy advocacy; institutional review board (IRB) governance; and public participation in the scientific enterprise and the regulatory process. Citizen, scientist and regulator challenges to established research norms and practices can all
be seen through the lens of the right-to-know and right-to-act (and the inherent tensions between the two) approaches.The research right-to-know asserts the rights of study participants to know their results from exposure research on their homes and bodies, even if the implications for health effects and strategies for exposure reduction are uncertain.This orientation challenges established norms concerning IRB tendencies toward withholding data from study participants when health effects are not well understood. In all, the various confrontations with the established guiding framework of IRBs are part of a broad constellation of organizing and advocacy activities that provide communities with knowledge of contamination in their homes and bodies, while seeking to empower them to act in order to reduce or prevent future exposures. Community-based participatory research (CBPR) in environmental health science is one
mechanism through which citizens directly act on their right to know. CBPR has promoted changes in theories of disease causation and new lines of scientific inquiry that have helped to (re)shape scientific fact-making, particularly in regulatory science (Morello-Frosch et al. 2006; Morello-Frosch et al. 2011).This is exemplified in the cumulative impacts arena. Here, environmental justice advocates have long asserted that chemical-by-chemical and source-specific assessments of the health risks of environmental hazards are scientifically problematic because they do not reflect the cumulative impacts of multiple environmental and social stressors that are disproportionately faced by marginalized and vulnerable communities, and which may act additively or synergistically to harm health (Cal-EPA 2003; Sadd et al. 2011; Morello-Frosch and Shenassa 2006).This can involve chemical exposures from ubiquitous consumer products (for example, flame retardants or phthalates) and multiple chemical exposure that are placebased due to multiple emission sources in a geographic area. CBPR has helped advance the science of “cumulative impacts” by elevating the role of structural determinants and their associated social stressors in creating vulnerabilities to the adverse health effects of environmental hazards among people of color and the poor. Ultimately, this focus on cumulative impacts or the “double jeopardy” of environmental and social stressors is transforming how scientists study environmental health problems (Clougherty and Kubzansky 2009; NRC 2009; DeFur et al. 2007) and how regulators address them.We can think of CBPR as a reflection of a postBelmont environment in which the rights of communities, not just individuals are taken seriously. This chapter covers three elements of the research right-to-know and its transformative
potential in the realms of environmental health science and regulation: contestations over cumulative impacts in regulatory science; CBPR strategies in personal exposure assessment science; and post-Belmont research ethics.We begin by discussing the role of communities in transforming regulatory science through its efforts to compel agencies to address cumulative impacts of environmental and social stressors, particularly in marginalized communities. We then examine ways in which CBPR is transforming scientific knowledge production with a focus on personal exposure assessment science and biomonitoring research. Next, we proceed with an examination of the ethical challenges of these collaborations, specifically whether and how exposure results are shared with study participants who want them.This issue in particular has raised ethical tensions between CBPR research collaborations and the IRBs that oversee
the human subjects’ protection of this work.We conclude with an exploration of reflexive research ethics – an approach to addressing some of the post-Belmont ethics questions emerging from CBPR personal exposure research. Reflexive research ethics provides a way for researchers to grapple with the institutional disruption of traditional research ethics, question their own ethical standpoints, and move toward a more integrated, and community-engaged perspective.
