ethics in epidemiological studies

The goal should be to communicate the core values and obligations of a professional epidemiologist (i.e., ethics guidelines) and to provide an ethical foundation so that students can deal appropriately with ethical challenges that they will face in their future practice. Epidemiological research is subject to an ethics review. Check your inbox or spam folder to confirm your subscription. ECOLOGICAL, ECONOMICAL & CLIMATE CHANGE IMPLICATIONS OF EUTROPHICATION, GOOD MANUFACTURING PRACTICE (GMP): PRINCIPLES & APPLICATIONS. Epidemiologists should submit research protocols for review by an independent ethics committee. Please select Ok if you would like to proceed with this request anyway. No consideration of the potential harms and risks of epidemiologic research and practice would be complete without a consideration of the measures that epidemiologists ought to employ to protect personal privacy and safeguard the confidentiality of information (e.g., income and history of disease) collected as part of studies and practice activities. Carrying out studies and practice activities that provide benefits to socioeconomically disadvantaged and underserved persons in society is a part of the virtuous conduct of epidemiology. Nelson K.E and Williams C (2013). Another source of scholarship is philosophical ethics. The proponents of this argument have held that epidemiology is therefore not a distinct profession. Soskolne CL, Bertollini R, eds. Trust is an expression of faith and confidence that epidemiologists will be fair, reliable, ethical, competent, and nonthreatening. Cien Saude Colet. This document is divided into four parts. The appropriate peer review, replication and validation of study findings, and other safeguards to assure scientific validity are important, but they require time. Privacy is concerned with the right of individuals to be left alone and not be forced to provide information about themselves except when, how, and to those to whom they choose to reveal this information. Other obligations that epidemiologists have to communities are discussed in Section 3.8 (maintaining public trust). Epidemiologists should confront unacceptable conduct such as scientific misconduct, even though confronting it can be difficult in practice. American Public Health Association. It has been suggested that epidemiology is a set of methods employed in a variety of professions and disciplines (for example, medicine, health services administration, clinical trials, and environmental health). BUMC Proceedings, 17:400-406. Ethical guidelines for epidemiologists. Weed DL, Coughlin SS. Care should be taken to ensure that community participation in studies does not adversely affect scientific objectivity. Jones and Bartleh Learning. Similar issues arise in efforts to provide societal benefits by maximizing the potential benefits of epidemiologic research (Sections 2.3 and 3.3). Written consent from voluntary subjects or sick patients in the study must not be obtained under duress. Newton, MA: Epidemiology Resources Inc., 1995). Ethics are the principles of right and wrong that are acceptable to a group of people or an individual. For instance, in good epidemiological … Individuals' privacy and confidentiality of information need to be ensured unless there is an overriding moral concern (e.g., health or safety) justifying the release of such information or if such release is required by law. Among other things, it disposes us to provide benefits to socioeconomically disadvantaged persons in society. Other professional roles in epidemiology include teaching, consulting, and administration. Modern Epidemiology. Also discussed are specific ethical rules that protect the welfare and rights of research participants and help to ensure that the potential benefits of epidemiologic research and practice are maximized and distributed in an equitable fashion. Epidemiologists should respect cultural diversity in carrying out research and practice activities and in communicating with community members. Institutions view informed consent as providing legally valid authorization to proceed with the research. Third edition. Partiality can arise through a scientist's own biases and preconceived notions about a problem being investigated. Prior to the starting of any epidemiological research, written or informed consent is usually obtained (when the study has to do with human subjects), and in the case of medical research involving animal subjects, ethical issues arising in the study must be properly reviewed and ethical clearance approved for the study by the ethical panel. These guidelines were prepared by the Ethics and Standards of Practice (ESOP) Committee on behalf of the American College of Epidemiology (ACE). It is a system of standards that governs the morality and acceptability of any medical research involving human or animal subjects. The mere formulation of ethical guidelines for epidemiological research involving human subjects will hardly resolve all the moral doubts that can arise in association with such research. Epidemiologists have organized themselves into various national, international, and subspecialty organizations and in North America have established the American College of Epidemiology to further their professional interests in this region. The research proposal must be duly submitted to an ethical committee for consideration, comments, guidance and approval before the research study begins. 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. © Copyright 2018 American College of Epidemiology. Third edition. Agencies, institutions, and research sponsors should accept responsibility for adjudicating situations of alleged unethical and/or unacceptable conduct fairly, objectively, and in a manner that maintains or restores the integrity of the research process, while preserving the rights of the accused and protecting an accuser acting in good faith from retribution and other adverse treatment. Morever, epidemiological studies can either be therapeutics or non-therapeutics, and this has implication on ethical issues involved which vary de- pending on the type of the research. Core values and ethical rules about which it is possible to build a consensus are reflected in this document. As detailed in the Council for International Organizations of Medical Sciences (CIOMS) International Guidelines for Ethical Review of Epidemiological Studies (Appendix), information about research participants is generally divisible into: Unlinked information, which cannot be linked, associated or connected (even by deduction) with the person to whom it refers. The rights of the accused to due process should also be respected. The guidelines are designed to enable countries to define national policy on the ethics of epidemiological research and practice, adopt ethical standards for their specific national needs, and establish adequate mechanisms for ethical review of epidemiological studies. Ethical principles ensure that researchers protect their subject’s confidentiality, their human rights and that the truthfulness of the study is not influenced for any personal reasons. In carrying out their research, epidemiologists should abstain from conduct that may injure or jeopardize the welfare of study participants either through intentional or unintentional behaviors or actions (e.g., negligence or unjustified departure from study protocols or standards of practice) or omissions. Gordis L (2013). The wellbeing of human subjects in any medical research must take superiority over all other interests in the study. American College of Epidemiology Ethics Guidelines, 1/24/2000, html 2/21/2000Annals of Epidemiology, November 2000. Epidemiologists should take care to distinguish the perceived conflicts of interests of others from actual conflicting interests. Ethics and Study Design - Introductory ... Epidemiological studies of populations with or without an intervention. Rather, an account of professional ethics in epidemiology is more complete if virtuous traits of character are identified such as humility, fidelity, justice, patience, industry, and veracity. Additional disclosures may be necessary depending on the circumstances. Ethics in epidemiological research. Research participants must voluntarily consent to the research without coercion, manipulation, or undue incentives for participation. Beauchamp TL, Cook RR, Fayerweather WE, et al. This includes the reporting of results to the scientific community, to research participants, and to society; and the maintenance, en… 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 carefully the ethical implications of … I):151S-169S. The welfare of animals used for scientific research must be respected. Epidemiologists provide societal benefits and advance the profession by carrying out studies and improving research methods. Such measures contribute directly to the potential benefits of epidemiologic studies to the scientific community and to society. The background to and rationale for this effort, including the purpose and nature of ethics guidelines in epidemiology, have been discussed elsewhere. International guidelines for ethical review of epidemiological studies. Thus, all information important to public health should be communicated in a timely, understandable, and responsible manner. PART I - CORE VALUES, DUTIES, AND VIRTUES IN EPIDEMIOLOGY, 1.1 Definition and discussion of core values, 1.2 Definition and discussion of duties and obligations, 2.1. needs of society. The certificate relieves the holder (for example, investigators carrying out genetic testing as part of a research protocol) from the obligation to comply with some categories of compulsory legal demands for disclosure such as court subpoenas for individual research records. 2.10.1 Communicating ethical requirements. Epidemiologists should not enter into contractual obligations that are contingent upon reaching particular conclusions from a proposed study. Third edition. We also relate core values to the mission of epidemiology: the pursuit of knowledge through scientific research and the improvement of public health through the application of that knowledge. Your email address will not be published. Ann Epidemiol 1998;8:482-489. Researchers must protect the life, dignity, health, integrity, right to self-determination, privacy and confidentiality of personal information of research subjects. Epidemiology. Epidemiologists should ensure that the potential benefits of studies to research participants and to society are maximized by, for example, communicating results in a timely fashion. EPIDEMIOLOGICAL STUDIES: ETHICAL MATTERS. The study of Epidemiology. In this section we define and discuss core values, scientific and ethical precepts widely held within the profession, as well as duties and virtues in epidemiology. The professional duties and obligations are clarified along with key epidemiologic virtues. Epidemiology is the study of the distribution and determinants of health and disease in human populations. Maintaining public trust is especially important in planning and carrying out community studies. by MicroDok. 2.6.3 Conditions under which informed consent requirements may be waived. Epidemiologists should obtain the prior informed consent of research participants (with exceptions noted below in Section 2.6.3), in part by disclosing those facts and any information that patients or other individuals usually consider important in deciding whether or not to participate in the research. Reports of epidemiologic findings should include sufficient data (in aggregate form) and sufficient information about the study methods to ensure that interpretations and conclusions made from the findings can be independently corroborated by others. Epidemiology -- ethics. In order to assure confidentiality, epidemiologists should use all appropriate physical safeguards (e.g., locked file cabinets, locked rooms) and security measures (e.g., password access, encryption) to protect records from unauthorized access. Although worldwide epidemiological studies examined the association between tea consumption and risk of GC, tea consumption has only been shown to be protective in Chinese populations with a VLJQLٽFDQW risk reduction of 39% (summary RR=0.61, 95% CI=0.47-0.81) [16]. If an untoward event occurs during the course of a study, such as an adverse drug reaction in a clinical trial or an adverse psychological response during an observational study, the event should be promptly reported to the research ethics committee so that they may help to determine if and how the study should proceed. Partiality can arise when pressure is brought to bear on the researcher by any parties that have an interest in seeing the research results favor their particular interests. 2.8.1 Adhering to the highest scientific standards. Adhering to the highest scientific standards, 2.8.2. Such actions have potentially severe consequences and should be undertaken and carried out with great discretion and appropriate consultation. Ensuring an Equitable Distribution of Risks and Benefits, 3.5. Jones and Bartlett Publishers, Sudbury, Massachusetts, USA. Initial comments were kindly provided by Gina Etheredge, Kenneth Goodman, and John Last. They should demonstrate appropriate ethical conduct to colleagues and students by example. Ethics guidelines are not static documents. Confirm this request. Epidemiologists should submit their methods and findings to peer review (for example, review for publication). Steven S. Coughlin. Towards ethics guidelines for environmental epidemiologists. A rich and growing body of literature has emerged on ethics in epidemiologic research and public health practice [1–11].Recent articles have included conceptual frameworks of public health ethics and overviews of historical developments in the field [7, 8, 11].Several important topics in public health ethics have also been highlighted [7, 11, 12]. Scientific misconduct itself can also have potentially severe consequences for public health, for health professions, and for individual researchers. Barata RB(1). Epidemiologic Case Studies. Requirements to obtain the informed consent of research participants may be waived in certain circumstances, such as when it is not feasible to obtain the informed consent of research participants, in some studies involving the linkage of large databases routinely collected for other purposes, and in studies involving only minimal risks. 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. However, these guidelines do not provide an exhaustive account of professional duties and ethical concerns in epidemiology. J Clin Epidemiology 1991;44: (Suppl. To promote public trust, especially in unempowered communities, epidemiologists should consider adopting a "participatory" approach to a research project. Industrial Epidemiology Forum's Conference on Ethics in Epidemiology. Information should be provided about the purposes of the study, the sponsors, the investigators, the scientific methods and procedures, any anticipated risks and benefits, any anticipated inconveniences or discomfort, and the individual's right to refuse participation or to withdraw from the research at any time without repercussions. Ethical Matters in Epidemiological Studies. Proceedings for a WHO/ISEE International Workshop, 16-18 September, 1994, Research Triangle Park, North Carolina, USA. Steps should also be taken to maximize the potential benefits of public health practice activities. Professional virtues are those traits of character that dispose us to act in ways that contribute to achieving the good that is internal to the practice of epidemiology. It is also necessary, however, to ensure that studies involving human research participants be submitted for review by a research ethics committee. As such, they are more restricted in scope than general ethical principles such as beneficence (which relates to the balancing of risks and benefits and the promotion of the common welfare). 14INTERNATIONAL ETHICAL GUIDELINES FOR EPIDEMIOLOGICAL STUDIES “Epidemiology is the study of the distribution and determinants of health-related states or events in specifi ed populations, and the applica- tion of this study to control of health problems.” (John Last, Dictionary of … Epidemiologists, as professionals, should communicate to their students, peers, employers, and sponsors the ethical requirements of scientific research and its application in professional practice. 2.10. 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. Providing community service (for example, providing scientific expertise to community-based organizations) is an epidemiologic virtue. Obtaining the Informed Consent of Participants, 2.6.2. Epidemiologists meet their obligations to communities by undertaking public health research and practice activities that address causes of morbidity and mortality or utilization of health care resources, and by reporting results in a timely fashion so that the widest possible community stands to benefit. They should form relationships with formal or informal leaders in the community and consider the relevance of the epidemiologic research agenda to perceived community needs. 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. Communicating Ethical Requirements to Colleagues, Employers, and Sponsors and Confronting Unacceptable Conduct. The potential benefits of epidemiology extend to all groups of persons in society including those who are socioeconomically disadvantaged. Confidentiality can be violated even without the release of personal identifiers such as names or social security numbers. 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. Other examples include honesty, prudence, excellence, and integrity, which can be cultivated by actions and experience. 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. Saunders Publishers, USA. Epidemiologists should demonstrate appropriate ethical conduct to colleagues by example. Where group confidentiality cannot be maintained or is violated, the investigators should take steps to avoid contributing to the stigmatization of the group or discrimination against its members. Therefore, it should be standard practice to aggregate data in such a way that individuals cannot be deduced without additional information. The profession of epidemiology has at its foundation the maintenance, enhancement and promotion of public health by better understanding the determinants of disease. She has an impressive dataset that includes information on demographics, environmental exposures, diet, genetics, and various disease outcomes such as cancer, Parkinson’s disease (PD), and ALS. Protection of confidentiality is required not only to follow the ethical principle of respecting persons, but also because the disclosure of certain information to third parties may cause harm to an individual, e.g., discrimination in employment, housing, and health insurance coverage. Protecting Confidentiality and Privacy, 2.6. 125 epidemiological studies to be designed and reviewed under the 2002 document, and to 126 restrict the current guidelines to the unique features of observational epidemiological 127 studies. Both premature and unnecessarily delayed release of research findings can be more beneficial than harmful to individuals and to society. Ethics and Epidemiology. Subsection 301(d) of the Public Health Service Act, added in 1988, provides authority for the issuance of certificates of confidentiality for health research projects. The goal should be to communicate research findings in ways that allow full use of the information for the public good. Coughlin SS, Soskolne CL, Goodman KW. It is for this professional group of epidemiologists that these guidelines are particularly intended. Measures for the secure storage and transmittal of confidential information (Sections 2.5 and 3.5), including the development and retention of coding manuals, are also addressed in standards of practice for epidemiologists. Schneider M.J (2011). This duty also applies to personal information about individuals in public health practice activities. Riedel S (2004). Examples of virtuous conduct in interacting with colleagues include avoiding personal attacks and appropriately citing the work of others. epidemiology. Descriptive studies that examine populations, or groups, as the unit of observation, are known as ecological studies. The implementation of any epidemiological study is usually governed by some ethical standards in order to ensure compliance to their proper implementation, and to reduce any untoward effect of the study to the environment and the general population. It is a system of standards that governs the morality and acceptability of any medical research involving human or animal subjects. Epidemiologists have obligations to maximize the potential benefits of research studies to participants and to society. These committees may be created under the aegis of national or local health administrations, national medical research councils, or other nationally representative health-care bodies. The goal of these guidelines is to provide a useful account of the ethical and professional obligations of members of the American College of Epidemiology as they engage in professional activities and the application and dissemination of information to colleagues and the public. 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. Professional organizations such as the American College of Epidemiology have a role in the maintenance and encouragement of professional standards through continuing education and through the development of policy statements and guidelines. 2 Comments. When under a legal obligation to make disclosures that invade privacy, the epidemiologist should carefully weigh an obligation to the law against the moral importance of preserving the privacy of research participants. Council for International Organizations of Medical Sciences. Avoiding Conflicts of Interest and Partiality, 3.10. Introduction to Public Health. This includes the reporting of results to the scientific community, to research participants, and to society; and the maintenance, enhancement, and promotion of health in communities. The profession of epidemiology has as its primary roles the design and conduct of scientific research and the public health application of scientific knowledge. Recent advances in computer technology, the development of large data sets and the ability to link different data sets which contain personal identifiers have created great concern about our ability to maintain confidentiality of information about an individual's health. 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. Ethics in Epidemiology and Clinical Research: Annotated Readings. Epidemiologists should ensure that the potential benefits and burdens of epidemiologic research and public health practice activities are distributed in an equitable fashion. Epidemiologists should employ the means available to them to contribute to scientific findings and techniques so as to provide benefits to society and advance the profession. Coughlin SS, Beauchamp TL, eds. Epidemiologists can bene­. Given that sexual transmission is one of the main modes of HIV infection, these questions of “who” are inextricably linked to knowledge about sex, gender, sexuality, sexual populations and HIV epidemiology. 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