Ethics Guidelines in Environmental Epidemiology: Their Development and Challenges We Face
Purpose of Review
This review integrates historical developments and key events in bringing ethics into epidemiology in general and into environmental epidemiology in particular. The goal is to provide context for and discern among the various approaches and motivations that drive the need for ethical conduct in support of the public interest.
The need for ethics guidelines in epidemiology is different from developments in other biomedical-related fields by virtue of its focus on populations rather than on individuals. The need for ethics guidelines in environmental epidemiology as a subspecialty of epidemiology stems from the larger scale of its mission than that of epidemiology per se.
Ethics guidelines in the field of environmental epidemiology have been established. They articulate not only the profession’s core values and mission, but more specifically, they address the environmental epidemiologist’s obligations to the participants in research, to colleagues, and to employers. They are the product of consensus, scholarship, and diligent stewardship over several decades. The next challenge is ensuring their value and impact. The forces that support professional and institutional success, and the power of special interests, are the major threats to achieving the goals of ethical conduct and research for the public good. In environmental epidemiology, these threats have global implications.
KeywordsConflicting interests Code of ethics Normative practices Standards of practice Regulatory controls and implementation Funding and research sponsorship
The authors acknowledge Stephanie M. Hikel for assistance in formatting and editing.
Compliance with Ethical Standards
Conflict of Interest
Shira Kramer is the President and an owner of Epidemiology International, Inc. (EI). She has served as an expert witness on behalf of Plaintiffs in toxic, environmental, and pharmaceutical tort litigation. EI has performed research under contract for the US CDC, pharmaceutical companies, and private corporations.
Colin L. Soskolne is retired and unfunded since 2013. He served for a few years until 2012 as an expert witness in litigation on behalf of plaintiffs, the monies from which generally went into a University-managed research account. As a professional legacy, he has been bankrolling the International Joint Policy Committee of the Societies of Epidemiology (IJPC-SE) (2011–2016) as a voluntary professional society in the hope that it will become self-sustaining in the pursuit of science in the public interest.
Human and Animal Rights and Informed Consent
This article does not contain any studies with human or animal subjects performed by any of the authors.
Papers of particular interest, published recently, have been highlighted as: •Of importance ••Of major importance
- 1.American Association for the Advancement of Science (AAAS). Scientific Responsibility, Human Rights & Law Program: Part of the Center of Science, Policy, and Society Programs. 2016. https://www.aaas.org/program/scientific-responsibility-human-rights-law. Accessed 18 Oct 2016.
- 2.Chalk R, Frankel MS, Chafter SB. AAAS Professional Ethics Project: professional ethics activities in the scientific and engineering societies (AAAS Publication No. 80-R-4). AAAS Committee on Scientific Freedom and Responsibility: Washington; 1980.Google Scholar
- 3.Council for International Organizations of Medical Sciences (CIOMS). International ethical guidelines for biomedical research involving human subjects. Geneva: CIOMS/WHO; 2002.Google Scholar
- 7.Centers for Disease Control and Prevention (CDC). U.S. Public Health Service Syphilis study at Tuskegee: the Tuskegee Timeline. 2013. http://www.cdc.gov/tuskegee/timeline.htm. Accessed 18 Oct 2016.
- 8.International Military Tribunal. Trials of war criminals before the Nuernberg Military Tribunals under Control Council Law No. 10. Vol. II: “The Medical Case”, “The Milch Case”. Washington: U.S: Government Printing Office; 1949. p. 181–2.Google Scholar
- 9.Dunn CM, Chadwick G. Protecting study volunteers in research: a manual for investigative sites. University of Rochester Medical Center: CenterWatch, Inc.; 1999.Google Scholar
- 10.World Medical Association (WMA). Declaration of Geneva. 1948. https://www.wma.net/policies-post/wma-declaration-of-geneva/. Accessed 11 Oct 2016.
- 11.United Nations (UN). The Universal Declaration of Human Rights. 1948. http://www.un.org/en/universal-declaration-human-rights/. Accessed 11 Oct 2016.
- 12.World Medical Association (WMA). Declaration of Helsinki—ethical principles for medical research involving human subjects. 1964. https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/. Accessed 9 Oct 2016.
- 14.U.S. Department of Health and Human Services (HHS). Office for Human Research Protections. 2016. http://www.hhs.gov/ohrp/. Accessed 18 Oct 2016.
- 15.•• International Society for Environmental Epidemiology (ISEE), Kramer S, Soskolne CL, Al-Delaimy WK, Mustapha BA. “Ethics guidelines for environmental epidemiologists” adopted on April 25, 2012. 2012. http://www.iseepi.org/About/Docs/ethics_guidelines_adopted_april_25_2012.pdf. Accessed 9 Oct 2016. The complete ISEE Guidelines for Environmental Epidemiology are available on the ISEE website.
- 17.Metcalf J. Ethics codes: history, context, and challenges. Council for Big Data, Ethics, and Society. 2014. http://bdes.datasociety.net/council-output/ethics-codes-history-context-and-challenges/. Accessed 12 Oct 2016.
- 18.The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: ethical principles and guidelines for the protection of human subjects of research. 1979. http://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html. Accessed 11 Oct 2016.
- 19.Beauchamp TL, Childress JF. Principles of biomedical. Ethics. 7th ed. New York: Oxford University Press; 2012.Google Scholar
- 20.U.S. Department of Health and Human Services (HHS) Office for Human Research Protections. Code of Federal Regulations. Title 45: Public Welfare, Part 46: Protection of Human Subjects (45 CFR 46). 2009. http://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html. Accessed 11 Oct 2016.
- 22.U.S. Department of Health and Human Services (HHS) Office for Human Research Protections. International compilation of human research standards: 2016 Edition. 2016. http://www.hhs.gov/ohrp/sites/default/files/internationalcomp2016.pdf. Accessed 11 Oct 2016.
- 27.Soskolne CL, Zeighami EA. Research, interest groups, and the review process (Abstract #016). Paper presented at the 10th Scientific Meeting of the International Epidemiological Association, Vancouver, British Columbia, Canada. 1984.Google Scholar
- 28.Soskolne CL. Should epidemiologists subscribe to a code of ethical conduct? (Abstract #68). Paper presented at the 11th Scientific Meeting of the International Epidemiological Association, Helsinki, Finland. 1987.Google Scholar
- 29.Industrial Epidemiology Forum’s Conference on Ethics in Epidemiology. J Clin Epidemiol. 1991; 44(Suppl 1):1S–169S.Google Scholar
- 30.International Epidemiological Association (IEA). IEA Guidelines for proper conduct in epidemiologic research. 2007. http://ieaweb.org/good-epidemiological-practice-gep/. Accessed 9 Oct 2016.
- 31.American College of Epidemiology (ACE). Ethics guidelines. 2003. http://acepidemiology.org/sites/default/files/EthicsGuide.pdf Accessed 9 Oct 2016.
- 35.Council for International Organizations of Medical Sciences (CIOMS), in collaboration with the World Health Organization. International guidelines for ethical review of epidemiological studies. J Law Med Ethics. 1991;19(3–4):247–58.Google Scholar
- 37.Soskolne CL. (ed.). Proceedings of the symposium on ethics and law in environmental epidemiology. J Expos Anal Environ Epidemiol Part II. 1993;3(Suppl 1):243–319.Google Scholar
- 41.International Society for Environmental Epidemiology (ISEE). Ethics guidelines for environmental epidemiologists. 1999. http://www.iseepi.org/About/Docs/ethicsguidelinesforenvironmentalepidemiologists.pdf. Accessed 10 Oct 2016.
- 42.Council for International Organizations of Medical Sciences (CIOMS). International ethical guidelines for epidemiological studies. Geneva: CIOMS/WHO; 2009.Google Scholar
- 44.International Statistical Institute (ISI). Declaration on professional ethics. 2010. https://www.isi-web.org/images/about/Declaration-EN2010.pdf. Accessed 9 Oct 2016.
- 49.Michaels D. Doubt is their product: how industry’s assault on science threatens your health. New York: Oxford University Press; 2008.Google Scholar
- 50.• Friedman L, Friedman M. Financial conflicts of interest and study results in environmental and occupational health research. J Occup Environ Med. 2016;58(3):238–47. This study provides evidence of the tendency to report negative results in environmental epidemiological studies depending on the source of funding or sponsorship CrossRefPubMedGoogle Scholar
- 52.Wells EM. Evidence regarding the impact of conflicts of interest on environmental and occupational health research. Curr Environ Health Rep. 2017; in press Google Scholar
- 53.Smith R. What is research misconduct? A background paper prepared for the Joint Consensus Conference on Misconduct in Biomedical Research. J R Coll Surg Edinb. 2000;30:4–8.Google Scholar
- 54.• Nichols-Casebolt A, Macrina FL. Current perspectives regarding institutional conflict of interest : commentary on “Institutional conflicts of interest in academic research”. Sci Eng Ethics. 2015; doi: 10.1007/s11948-015-9703-8. This Commentary addresses the risks to research integrity of iCOI, and the processes that may be implemented to manage them PubMedGoogle Scholar