“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.” So write Shira Kramer, Colin Soskolne, B. Adetune Mustapha, and Wael K. Al-Delaimy, in the August issue of Environmental Health Perspectives in introducing new revised ethics guidelines for the International Society for Environemental Epidemiology.

Asked about how relevant these guidelines might be for non-environmental epidemiologists, Kramer told the Epi Monitor, “I believe that the Ethics Guidelines are applicable to all epidemiologists, but we have attempted to highlight issues that are particularly relevant to environmental epidemiologists.

Challenging Topics

According to the article, the ethics committee of the ISEE was one of the earliest groups to create such guidelines and it felt that the time was ripe to revise earlier guidelines because of the evolving political and social context. The new issues that have emerged or intensified in the years between the first and the current guidelines, according to Kramer, include the following:

1.  Embracing the Precautionary Principle

2.  Obligation to protect the most vulnerable and underserved (including fetuses, children, minorities, socially or economically disadvantaged)

3.  Protection of individuals' rights regarding future use of biospecimens

4.  Rights and participation of human subjects in the research process

5.  Data access issues, e.g. balancing the need for data with confidentiality requirements

6.  Ownership of data on human subjects

7.  Conflicts of Interest (this is emphasized in the new Guidelines, as this issue has grown more prominent over time)

8.  Abuses of power and authority, especially as they relate to conflicts of interest, financial influence, political pressure, etc.  These abuses may occur at many levels, including journal editorial/review;  IRB;  institutional promotion;  rights of students;  grants; and many others.

9.  Intellectual property rights, and fair attribution of research ideas and effort

10.  Fair allocation of research resources, especially to the poorest and most vulnerable populations and areas of the world

11.  Obligation to design studies that utilize appropriate methodology to address research questions.

12.  Obligation to fairly represent research findings

13.  Obligation to address abuses within our profession

The guidelines are organized to address four major categories of responsibility which epidemiologists have to 1) individuals, 2) society, 3) funders and employers, and to 4) colleagues.

Core Values

Among the core values described in the guidelines which the authors relied upon to formulate them are objectivity, and advancing overall public health as well as that of disadvantaged and vulnerable population subgroups. On the topic of objectivity, the guidelines discuss “unconscious partiality” stating that this is a human tendency and that sociological evidence shows that one’s ethical and political worldview influences the many phases of the scientific process. According to the guidelines, researchers have “a moral duty to the profession and an ethical duty to society to seek a range of advice including from those who often disagree with us.” According to the authors, this second edition makes even more clear the obligation to include communities in our research.

The authors note that “there is no consensus among ISEE members as to whether environmental epidemiologists have a duty to go beyond objectively communicating facts or to become policy advocates.” Also, there was no consensus among environmental epidemiologists about what funding sources are acceptable when a particular environmental factor has been implicated or exonerated.

Process

As for the process of revision, it took nearly 3 years from start to finish, according to Kramer.  It included the ISEE’s Ethics and Philosophy subcommittee on the Ethics Guidelines.  Once a working draft was developed, it was released to the full Ethics & Philosophy Committee for comment and revision, and then finally to the Governing Council of the ISEE.  There were many revisions to be accommodated during this process, and the four primary authors of the article in Environmental Health Perspectives were the most involved. The Guidelines were ultimately formally accepted by the Governing Council of the ISEE on April 25, 2012.

According to Soskolne, “the second edition is far more user-friendly than what the first edition from 1996 ever was/could have been, given the advent of electronic hot- and cross-

links through a well-organized table of contents. We thus are hopeful that fellow environmental epidemiologists seeking guidance on normative approaches to choices that face us at every step in the research and/or practice mode of our day-to-day work can be successfully aided through the current revision.”

He added, “The next steps that the Ethics and Philosophy Committee is striving for are to populate the guidelines with links to case studies that will serve as examples of the many issues that face us in our day-to-day work. We hope to achieve this by the time of the next ISEE conference in Basel, Switzerland in 2013.” According to Kramer, “We hope that the addition of case studies, based upon actual experiences of the contributors, will help illuminate the Guidelines and facilitate their usefulness as a teaching tool in schools of public health.”