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Reporting individual results for biomonitoring and environmental exposures: lessons learned from environmental communication case studies.

ABSTRACT: Measurement methods for chemicals in biological and personal environmental samples have expanded rapidly and become a cornerstone of health studies and public health surveillance. These measurements raise questions about whether and how to report individual results to study participants, particularly when health effects and exposure reduction strategies are uncertain. In an era of greater public participation and open disclosure in science, researchers and institutional review boards (IRBs) need new guidance on changing norms and best practices. Drawing on the experiences of researchers, IRBs, and study participants, we discuss ethical frameworks, effective methods, and outcomes in studies that have reported personal results for a wide range of environmental chemicals. Belmont Report principles and community-based participatory research ethics imply responsibilities to report individual results, and several recent biomonitoring guidance documents call for individual reports. Meaningful report-back includes contextual information about health implications and exposure reduction strategies. Both narrative and graphs are helpful. Graphs comparing an individual's results with other participants in the study and benchmarks, such as the National Exposure Report, are helpful, but must be used carefully to avoid incorrect inferences that higher results are necessarily harmful or lower results are safe. Methods can be tailored for specific settings by involving participants and community members in planning. Participants and researchers who have participated in report-back identified benefits: increasing trust in science, retention in cohort studies, environmental health literacy, individual and community empowerment, and motivation to reduce exposures. Researchers as well as participants gained unexpected insights into the characteristics and sources of environmental contamination. Participants are almost universally eager to receive their results and do not regret getting them. Ethical considerations and empirical experience both support study participants' right to know their own results if they choose, so report-back should become the norm in studies that measure personal exposures. Recent studies provide models that are compiled in a handbook to help research partnerships that are planning report-back. Thoughtful report-back can strengthen research experiences for investigators and participants and expand the translation of environmental health research in communities.

SUBMITTER: Brody JG

PROVIDER: S-EPMC4098947 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:As the number of personal exposure studies expands and trends favor greater openness and transparency in the health sciences, ethical issues arise around reporting back individual results for contaminants without clear health guidelines. Past research demonstrates that research participants want their results even when the health implications are not known. The experiences of researchers and institutional review boards (IRBs) in studies that have reported personal chemical exposures can provide insights about ethical and practical approaches while also revealing areas of continued uncertainty. We conducted semi-structured interviews with 17 researchers and nine IRB members from seven personal exposure studies across the United States to investigate their experiences and attitudes about the report-back process. Researchers reported multiple benefits of report-back, including increasing retention and recruitment, advancing environmental health literacy, empowering study participants to take actions to reduce exposures, encouraging shifts in government and industry practices, and helping researchers discover sources of exposure through participant consultation. Researchers also reported challenges, including maintaining ongoing contact with participants, adopting protocols for notification of high exposures to chemicals without health guidelines, developing meaningful report-back materials, and resource limitations. IRB members reported concern for potential harm to participants, such as anxiety about personal results and counterproductive behavior changes. In contrast, researchers who have conducted personal report-back in their studies said that participants did not appear overly alarmed and noted that worry can be a positive outcome to motivate action to reduce harmful exposures. While key concerns raised during the early days of report-back have been substantially resolved for scientists with report-back experience, areas of uncertainty remain. These include ethical tensions surrounding the responsibility of researchers to leverage study results and resources to assist participants in policy or community-level actions to reduce chemical exposures, and how to navigate report-back to vulnerable populations.

Project description:BackgroundThere is a long tradition in environmental health of using frameworks for evidence synthesis, such as those of the U.S. Environmental Protection Agency for its Integrated Science Assessments and the International Agency for Research on Cancer Monographs. The framework, Grading of Recommendations Assessment, Development, and Evaluation (GRADE), was developed for evidence synthesis in clinical medicine. The U.S. Office of Health Assessment and Translation (OHAT) elaborated an approach for evidence synthesis in environmental health building on GRADE.MethodsWe applied a modified OHAT approach and a broader "narrative" assessment to assess the level of confidence in a large systematic review on traffic-related air pollution and health outcomes.DiscussionWe discuss several challenges with the OHAT approach and its implementation and suggest improvements for synthesizing evidence from observational studies in environmental health. We consider the determination of confidence using a formal rating scheme of up- and downgrading of certain factors, the treatment of every factor as equally important, and the lower initial confidence rating of observational studies to be fundamental issues in the OHAT approach. We argue that some observational studies can offer high-confidence evidence in environmental health. We note that heterogeneity in magnitude of effect estimates should generally not weaken the confidence in the evidence, and consistency of associations across study designs, populations, and exposure assessment methods may strengthen confidence in the evidence. We mention that publication bias should be explored beyond statistical methods and is likely limited when large and collaborative studies comprise most of the evidence and when accrued over several decades. We propose to identify possible key biases, their most likely direction, and their potential impacts on the results. We think that the OHAT approach and other GRADE-type frameworks require substantial modification to align better with features of environmental health questions and the studies that address them. We emphasize that a broader, "narrative" evidence assessment based on the systematic review may complement a formal GRADE-type evaluation. https://doi.org/10.1289/EHP11532.

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Reporting individual results for biomonitoring and environmental exposures: lessons learned from environmental communication case studies.

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