Couples research is crucial to intervention development and raises unique ethical dilemmas that are not specifically addressed by regulations, laws, and ethical standards [2-4,21-23]. The members of the writing group were (alphabetically) Germaine Buck, Steven S. Coughlin (Chair), Rosanne B. McTyre, Dixie E. Snider, Jr., Colin L. Soskolne, and Douglas L. Weed. Additional issues that might be addressed in future guidelines, in policy statements, or in standards of practice include ethical rules and standards of practice for the long-term retention of data in data archives, data audit, and data sharing; ethical issues in placebo-controlled trials; ethical issues arising in genetic research; consideration of the broader social and environmental consequences of epidemiologic research; and human rights considerations relevant to epidemiology. Epidemiologists should not enter into contractual obligations that are contingent upon reaching particular conclusions from a proposed study. Newton, MA: Epidemiology Resources Inc., 1995). The identification of disparities in health or the maldistribution of health services across groups defined by race, ethnicity, class, and many other characteristics as diverse as age, gender, sexual orientation, homelessness, and rural residence can serve as a basis for health planning and policy making and, thereby, contribute to improving the health of those who are less well-off in society. J Epidemiol Community Health 2002; 56:739-741. Rather, they describe the core values, duties (obligations), and virtues that should serve as the basis for the thoughtful reflection and sound judgment that such decisions call for. 2.10.1 Communicating ethical requirements. The rights of the accused to due process should also be respected. Ensuring an Equitable Distribution of Risks and Benefits, 2.5. Ann Epidemiol 1999;9:277-280. Adhering to the highest scientific standards includes choosing an appropriate study design for the scientific hypothesis or question to be answered; writing a clear and complete protocol for the study; using proper procedures for the collection, transmission, storage, and analysis of data; making appropriate interpretations from the data analyses; and writing up and disseminating the results of the study in a manner consistent with accepted procedures for scientific publication. Ethical constraints must be balanced against opportunities to expand knowledge and improve care for patients. Weed DL, Coughlin SS. These measures help to build and maintain public trust (Section 3.8). Geneva: CIOMS; 1991. Informed consent should be given freely, without external pressure and without unreasonable inducements. Such indirect benefits of epidemiologic studies may be particularly important to consider in planning and carrying out studies in socioeconomically disadvantaged populations. They should demonstrate appropriate ethical conduct to colleagues and students by example. scientific review and epidemiological research •In externally sponsored collaborative studies, sponsors and investigators have an ethical obligation to ensure that the research projects for which they are responsible in such countries contribute effectively to national or local capacity to design and conduct epidemiological research, Epidemiologists may not always be able to prevent all risks for study participants. The Professional Role of Epidemiologists The profession of epidemiology has as its primary roles the design and conduct of scientific research and the public health application of scientific knowledge. The first part provides an overview of widely held core values, duties, and virtues in epidemiology and provides concise definitions of these concepts. Persons and groups ought to be treated equally, although the equal distribution of benefits and burdens may be modified by considerations of special need or merit. Steps should also be taken to maximize the potential benefits of public health practice activities. 6 INTERNATIONAL ETHICAL GUIDELINES FOR EPIDEMIOLOGICAL STUDIES The Council for International Organizations of Medical Sciences (CIOMS) acknowledges the fi nancial contributions of UNAIDS, the WHO Department of Reproductive Health and Research, the Swiss avoid causing harm to research participants and to society. Five main categories that are relevant to the review of epidemiological research by Institutional Review Boards/Research Ethics Committees were distinguished. There may be occasions when it becomes necessary to terminate a study early and release its findings in order to protect the public's health. Research ethics govern the standards of conduct for scientific researchers. Study findings should be interpreted and made available to the public in accordance with the current scientific thinking about the utility and validity of the information. J Epidemiol Community Health 2001; 55:855–857, Full text of the Declaration of Helsinki: (, Weed D, McKeown R. Ethics in epidemiology and public health II. To do this effectively, epidemiologists should be well-informed about the history, circumstances, and perspectives of groups within the community. The publication of both positive and negative research findings is important, since it helps to prevent publication bias and allows for additional benefits to be gleaned through meta-analyses. Although epidemiologists cannot always prevent the media or other parties from sensationalizing research results, epidemiologists should strive to ensure that, at a minimum, research findings are interpreted and reported on accurately and appropriately. Ethical duties are more general than ethical rules. A distinction should be made between societal virtues and professional virtues. The professional duties and obligations are clarified along with key epidemiologic virtues. 3.10. Other documents in this section also include information about the ethics of individual study designs. Informed consent requirements may be loosened or waived when epidemiologists investigate disease outbreaks or evaluate programs as part of public health practice activities. (2008). FOR ETHICAL REVIEW OF EPIDEMIOLOGICAL STUDIES INTRODUCTION These Guidelines are intended for investigators, health policy-makers, members of ethical review committees, and others who have to deal with ethical issues that arise in epidemiology. Nonetheless, the present revised Guidelines are intended at least to draw the attention of investigators, sponsors and ethical review committees to the need to consider … To this end, epidemiologists can be employed in government positions engaged directly in either research or practice, in university research and teaching roles, in private consulting practice, or elsewhere in the private sector. (1) Ensuring the scientific rationale and ethical propriety of epidemiological research (i) A researcher, etc. All research findings and other information important to public health should be communicated in a timely, understandable, and responsible manner so that the widest possible community stands to benefit. 1 of 2007), originally in 2002 and later amended entirely in 2007, and the Like other scientists, epidemiologists uphold values of free inquiry and the pursuit of knowledge. Informed consent requirements may also be waived when epidemiologists investigate disease outbreaks, evaluate programs, and conduct routine disease surveillance as part of public health practice activities. Confidentiality is concerned with preventing disclosure of information in ways that are inconsistent with the understanding under which the information was obtained. Although these ethics guidelines focus both on epidemiologic research and on public health practice activities such as outbreak investigations, surveillance systems, and program evaluations, we acknowledge that there are many professional duties and ethical concerns in public health practice that are not directly addressed by these guidelines. This document, which is indebted to past efforts to develop ethics guidelines for epidemiologists and to the commentary that has accompanied such efforts, provides the first set of ethics guidelines for the American College of Epidemiology. Ethical guidelines for epidemiologists. Epidemiologists should meet their obligations to communities by undertaking public health research and practice activities that address health problems including questions concerning the utilization of health care resources, and by reporting results in an appropriate fashion. Among other things, it disposes us to provide benefits to socioeconomically disadvantaged persons in society. Coughlin SS, Soskolne CL, Goodman KW. The law sometimes requires invasions of privacy, especially under conditions of a threat to public health and safety. anonymous, when the information cannot be linked to the person to whom it refers except by a code or other means known only to that person, and the investigator cannot know the identity of the person; non-nominal, when the information can be linked to the person by a code (not including personal identification) known to the person and the investigator; or. Although research participants sometimes receive compensation for their participation in studies (for example, reimbursement for transportation costs or lost earnings), they must voluntarily consent to the planned intervention without coercion, manipulation, or undue incentives for participation. Soskolne CL, Light A. Geneva: CIOMS. Epidemiologists have ethical and professional obligations to minimize risks and to. Ethics in epidemiological studies is multidimensional covering clinical medicine, public … Although epidemiologists do not need a license to practice, individual members of this profession should be accountable for the work that they perform. (Reprinted in: Coughlin SS, ed. The latter are motivational factors grounded in professional character (for instance, the need to treat colleagues and other parties with respect and courtesy). Other professional roles in epidemiology include teaching, consulting, and administration. Findings from the American College of Epidemiology Ethics Survey on the need for ethics guidelines for epidemiologists. Beauchamp TL, Cook RR, Fayerweather WE, et al. Epidemiologists should provide training and education in ethics to students of the discipline as well as to practicing scientists. New York: Oxford University Press, 1996. To the extent possible and whenever appropriate, epidemiologists should also involve community representatives in the planning and conduct of the research such as through community advisory boards. Confidential medical and other vital records that identify individuals are essential to epidemiologic research and practice, and identification of persons whose records have been obtained may be needed to prevent those individuals (or others who have contact with them) from developing disease or to identify the disease at an early stage. The reader is encouraged to read them in full for more information3,5. In such circumstances, research participants generally need protection in other ways, such as through confidentiality safeguards and appropriate review by an independent research ethics committee (often referred to as institutional review boards in the United States or as ethics review boards in Canada). Voluntariness - there should be a voluntary decision or agreement on the part of a capable person. If personal identifiers must remain linked to study records, a clear and compelling justification should be given to the ethics review committee (institutional review board or ethics review board) along with a description of how confidentiality will be adequately protected. Truth-telling and objectivity are professional duties and they can also be thought of as virtues. Data should only be stored with personal identifiers if absolutely necessary, and identifiable information should never be stored on computers outside research establishments. Epidemiologists should submit their methods and findings to peer review (for example, review for publication). Communicating ethical requirements, PART III - DISCUSSION AND CLARIFICATION OF GUIDELINES, 3.1. I):151S-169S. Disclosure of known and potential risks should occur prior to requesting study participants' participation. International Epidemiological Association. Institutions view informed consent as providing legally valid authorization to proceed with the research. Geneva: CIOMS. Initial comments were kindly provided by Gina Etheredge, Kenneth Goodman, and John Last. They should maintain honesty and impartiality in the design, conduct, interpretation, and reporting of research. The significance of the findings should neither be understated nor overstated. Protecting Confidentiality and Privacy, 3.6. Identification, usually the person 's name this professional group of epidemiologists at foundation... 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