Revised Ethics Guidelines for Environmental Epidemiologists

Abstract

Environmental epidemiology, a well-established subspecialty of epidemiology, is of vital importance in the identification and prevention of environmentally linked morbidity and premature mortality. Perhaps more than most other applied sciences, the discipline of environmental epidemiology faces significant ethical challenges because of the involvement of powerful stakeholders whose influence may affect all levels of research and policy formulation. Although findings of environmental epidemiologic studies play a critical role in arguing for evidenced-based policies aimed at protecting the public from harms, they can also have direct effects on industry profits, political careers, academic funding, and professional advancement. Conflicting interests among various stakeholders create ethically challenging situations that may threaten the core tenets of the discipline, which focus on maintaining, enhancing, and promoting health in communities worldwide. The International Society for Environmental Epidemiology (ISEE) Ethics and Philosophy (E & P) Committee is one of the earliest, active, and enduring ethics committees in the field of epidemiology. Since its inception in 1991, the committee has taken an active role in supporting ethical conduct and formulating ethics guidelines for the profession of environmental epidemiology, publishing its first set of Ethics Guidelines in 1996 (Soskolne and Light 1996) and formally adopting the guidelines in 1999. These guidelines addressed the four major categories of ethical conduct: obligations to subjects of research, obligations to society, obligations regarding funders/sponsors and employers, and obligations to colleagues. Our profession functions within a social and political context in which laws, technology, economic pressures, and social norms are evolving. Thus, it behooves the custodians of guidelines to revisit their guidelines from time to time to reflect on new ethical challenges and on the current context in which they are to be applied. We recognize that guidelines cannot be enforced; they serve rather as a reference and pathway for ethically conscious professionals in our field who are seeking to improve the integrity of their research or to resolve ethical challenges that they face in their work. At the 2009 ISEE annual meeting in Dublin, Ireland—10 years after the Ethics Guidelines were adopted—a subcommittee of the ISEE E & P committee was formed to review and update the guidelines. Certain trends and growing research challenges served as an impetus for the project, including A sharp increase in reports of conflicting interests (> 7,000 references in a 2011 PubMed search) An increase in industry-funded research at academic institutions (and a concomitant increase in the proportion of academic faculty supported by or funded by industry) Research with an a priori agenda and expected results Industry and economic stakeholder influence on government policies Environmental (in)justice Imbalances in allocation of research funding and priorities Purposes of environmental epidemiologic research Public input into public health research processes and policies Data access and ownership of public health information Nature of informed consent Control and use of biospecimens Maintenance of confidentiality Fair attribution for research contributions and protection of intellectual property Influence of ghost-written scientific articles on law making and on international bodies whose mission is to protect the public interest Challenging unacceptable behavior and protecting whistleblowers Major expansion of the field of environmental epidemiology The globalization of public health issues that require collaborative professional efforts to address them. The goals of the subcommittee focused on including current and evolving ethical and philosophical challenges, re-crafting recommendations and providing guidance for professional conduct, and providing case studies to enhance the relevance of the guidelines and to stimulate discussion about solutions (still pending). A core writing group (S.K., C.L.S., B.A.M., and W.K.A.D.) took primary responsibility for conducting the review and developing revisions, with input invited from members of the E & P committee at large. Over a 2-year period, and through an iterative process, suggested revisions and updates were evaluated and incorporated by consensus of the core writing group and the E & P committee. Once the draft guidelines were accepted by majority vote of the E & P committee, they were submitted to the Governing Council of the ISEE for comment and review. Members of the Governing Council submitted additional comments and suggested changes, leading to further refinement by the core writing group. The finalized version of the Ethics Guidelines for Environmental Epidemiologists was accepted and adopted by the Governing Council of the ISEE on 25 April 2012 [ISEE 2012; see also Supplemental Material (http://dx.doi.org/10.1289/ehp.1205562)]. This is the first time that the guidelines (first published in 1996) have been revised.