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. Risks should be considered and disclosed with respect to their probability of occurring and their estimated magnitude. The potential benefits of epidemiologic research include providing scientific data that policy makers can use to formulate sound public health policy. Investigators should disclose any potential material conflicts of interest to their study collaborators, sponsors, research participants, journal editors, and their employer. 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. Scope of ethical guidelines for epidemiological studies is concerned with epidemiological research. 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. If privacy or confidentiality must be breached, the epidemiologist should first attempt to inform participants of such required infringements. It is asserted here that epidemiologists are members of a profession. Therefore, it should be standard practice to aggregate data in such a way that individuals cannot be deduced without additional information. This letter to the Council for International Organizations of Medical Sciences identifies some elements missing from the draft document of the document Special Ethical Considerations for Epidemiological Research and then offers some comments on particular guidelines. 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. Therefore, any system of ethical guidelines on research needs to be cognizant of, and informed by, a sensitive balance of the risks and benefits. 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 The focus is on both the obligation of researchers to disclose information about risks and potential harms and the quality of the consent of the research participant. Epidemiologists should put the strengths and limitations of their research methods into proper perspective. Examples of virtuous conduct in interacting with colleagues include avoiding personal attacks and appropriately citing the work of others. 2.6.2 Avoidance of manipulation or coercion. 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. 1996;184. For example, the release of information about a physician in a small town could "identify" an individual patient in that community even though no name or social security number was given. International guidelines for ethical review of epidemiological studies. 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. Hence, this set of ethics guidelines is intended for epidemiologists rather for "epidemiology" per se. Duties, or obligations, can be distinguished from virtues. These guidelines were prepared by the Ethics and Standards of Practice (ESOP) Committee on behalf of the American College of Epidemiology (ACE). Collectively, individuals who practice epidemiology constitute the professional group of epidemiologists. Fair subject selection. Epidemiology is the study of the distribution and determinants of health and disease in human populations. Due to further rapid developments in science and technology in India after Core values, including the above-described basic scientific and ethical values within epidemiology, can be distinguished from duties (obligations). Transplantation research, including Fetal tissue transplantation 5. Technical terms. Thus, the epidemiologist must ensure that the risks are reasonable in relation to the anticipated benefits before initiating the study. Epidemiologists should take appropriate measures to prevent their data from publication or release in a form that would allow individuals to be personally identified. The latter are motivational factors grounded in professional character (for instance, the need to treat colleagues and other parties with respect and courtesy). Among other things, it disposes us to provide benefits to socioeconomically disadvantaged persons in society. This section draws on several papers that are all available online and referenced below. J Epidemiol Community Health 2002; 56:739-741. Furthermore, JEA also announced the Ethical Guidelines for Conducting of Epidemiologic Research in October 2002. Here we are concerned with core values that are internal to the profession of epidemiology. The optimal time to disseminate the findings of epidemiologic studies is not always easy to discern. avoid causing harm to research participants and to society. The experiences of public health practitioners around the ethical problems that underlie professional practice, such as advocacy, conflicts of interest, and scientific misconduct. 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. Understanding - the individual should have the ability to understand what he or she is told and to make a reasoned choice based on that information (. To minimize risks, epidemiologists should protect individuals' privacy by storing personally identifying information securely. 06480440], 1c - Health Care Evaluation and Health Needs Assessment, 2b - Epidemiology of Diseases of Public Health Significance, 2h - Principles and Practice of Health Promotion, 2i - Disease Prevention, Models of Behaviour Change, 4a - Concepts of Health and Illness and Aetiology of Illness, 5a - Understanding Individuals,Teams and their Development, 5b - Understanding Organisations, their Functions and Structure, 5d - Understanding the Theory and Process of Strategy Development, 5f Finance, Management Accounting and Relevant Theoretical Approaches, Past Papers (available on the FPH website), Applications of health information for practitioners, Applications of health information for specialists, Population health information for practitioners, Population health information for specialists, Sickness and Health Information for specialists, 1. Indeed, epidemiologists who advocate should be open to the possibility of changing their views as new evidence or other relevant information becomes available. It is for this professional group of epidemiologists that these guidelines are particularly intended. 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. In identifying public health problems to be studied, and their priority for study, epidemiologists should take into account the perceived importance of the problem to the people living in a community after information about the problem has been provided. ), BMJ Publishing Group 2003, Good Epidemiological Practice: IEA Guidelines for Proper Conduct in Epidemiologic Research, Weed D, McKeown R. Ethics in epidemiology and public health I. Both premature and unnecessarily delayed release of research findings can be more beneficial than harmful to individuals and to society. 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). Avoiding Conflicts of Interest and Partiality, 2.10. by region, ethnicity, soci-economic position or gender) and in access to health care, including their causes, The impact of political, economic, socio-cultural, environmental and other external influences, Introduction to study designs - intervention studies and randomised controlled trials, Parametric and Non-parametric tests for comparing two or more groups, 1d - The Principles of Qualitative Methods, 1c - Approaches to the assessment of health care needs, utilisation and outcomes, and the evaluation of health and health care, Copyright © Public Health Action Support Team (PHAST) 20, Bioethics - a field of inquiry that originally explored problems faced in the practice of medicine and biomedical research, and now also covers clinical practice, regulatory policy, research practice, and cultural and social concerns, Philosophical ethics – theories and concepts drawn from the writings of Aristotle, Kant, Mill, Rawls, etc. Therefore, in 2003 CIOMS constituted a core group to consider 84 how the existing ethical guidance for epidemiological studies should be updated. 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. Ethics and epidemiology: international guidelines: proceedings of the XXVth CIOMS Conference, Geneva, Switzerland, 7-9 November 1990. Providing community service (for example, providing scientific expertise to community-based organizations) is an epidemiologic virtue. 2.8.1 Adhering to the highest scientific standards. The ethics of epidemiology and public health have emerged from several sources, including:3. Ethics and Epidemiology. Other measures that epidemiologists should take to maintain public trust are discussed in Sections 2.9 and 3.9 (avoiding conflicts of interest), Sections 2.10 and 3.10 (confronting unacceptable conduct), and Sections 2.11.1 and 3.11 (reporting results). Addressing and, if necessary, reporting or confronting unethical or unacceptable conduct such as scientific misconduct are essential actions for safeguarding the integrity and reputation of the profession. Informed consent should be given freely, without external pressure and without unreasonable inducements. Ann Epidemiol 1999;9:277-280. 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. I):151S-169S. Ethics, Values, and Mission Statements ... Chapter 11 New Ethics Guidelines for Epidemiology: Background and Rationale with ... a Scorecard Research survey may pop-up. In addressing such issues, epidemiologists should give due consideration to the complexity of many ethical issues and attempt, where possible and appropriate, to educate rather than to confront. Scientific excellence, validity, and creativity can be considered epidemiologic virtues that should be nurtured. Epidemiologists should respect the right to privacy and aggressively protect confidentiality. In the United States, researchers can further address confidentiality concerns by requesting certificates of confidentiality from the Department of Health and Human Services agency that funded the research (or, if the research is not federally funded, from the National Institutes of Health). For some epidemiological studies, particularly case-control studies and historical cohort studies, non-disclosure of the full aims of the study may be permissible, because full disclosure of the study hypothesis could bias the investigation.3. Other documents in this section also include information about the ethics of individual study designs. The quality of research should also be optimised; poor research may lead to wrong decisions which may have a profound negative impact on patient health.3 Equally it is unethical to undertake research that would involve withholding a treatment that has been previously proven to be clinically effective. Disclosure of known and potential risks should occur prior to requesting study participants' participation. Improvements in practice activities (for example, enhanced surveillance systems) also provide benefits to society. Epidemiologists should communicate to their colleagues (including those who are in other disciplines) the ethical requirements of epidemiologic research and its application. An impartial advocate should keep in mind that the core value of improving the public's health through the application of scientific knowledge relies upon the ideas that the acquisition of knowledge is dynamic and that knowledge itself can improve. Other individuals including several current and previous members of the ESOP Committee, ACE Board and Executive Committee and several other ACE members provided helpful comments on an earlier draft of this document. 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. Issues surrounding the scientific review of research protocols are discussed in Section 3.3 (providing benefits). Virtues are complementary moral considerations to duties. Research has to be funded, carried out and ultimately published, whilst researchers seek to promote their reputations and careers. For example, the appropriate attribution of scientific ideas in publications is consistent both with the virtuous conduct of epidemiology and with an ethical rule or professional obligation. Care must be taken to ensure that such advocacy does not impair scientific impartiality in designing and interpreting new research and implementation efforts pertinent to the public health problem in question. This section provides a concise set of ethics guidelines for epidemiologists. Initial comments were kindly provided by Gina Etheredge, Kenneth Goodman, and John Last. Epidemiologists should submit research protocols for review by an independent ethics committee. Thus, for example, the duties that epidemiologists have to rigorously protect the confidentiality of private and personally identifiable information are more general than the specific confidentiality safeguards (ethical rules) that epidemiologists ought to employ. Advocacy should not impair scientific objectivity. 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. Investigators are obligated to disclose information that patients or other individuals usually consider important in deciding whether to participate in research. Communicating Ethical Requirements to Colleagues, Employers, and Sponsors, 2.10.1. Generally, a committee known as ethical committee (ethical panel) is set up or appointed to look into ethical issues arising from any anticipated medical research. If an epidemiologist must infringe upon the commitment to maintain privacy, those involved should be informed of the reasons and of their rights in the circumstances. 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. 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. Conditions under which informed consent requirements may be waived, 2.7. Weed DL, Coughlin SS. The group recognized 89 how widely the latter document has been disseminated, so that it is now the basic 90 conceptual and practical guide when research undergoes ethical review in institutions The fourth part provides a summary, outlines some remaining issues, and draws some conclusions. Within the scope of main … Potential participants in epidemiologic research should be told the extent to which confidentiality can be protected and the intended and potential uses of data which contain personally identifying information. Confidentiality can be violated even without the release of personal identifiers such as names or social security numbers. Ethical constraints must be balanced against opportunities to expand knowledge and improve care for patients. Due to further rapid developments in science and technology in India after True. American Public Health Association. 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. A decision to violate privacy should be made only after consultation with administrative superiors, ethics committee chairs, and/or other persons qualified by nature of expertise and responsibilities. Towards ethics guidelines for environmental epidemiologists. Maintaining honesty and impartiality in the design, conduct, interpretation, and reporting of research findings is essential. Protecting Confidentiality and Privacy, 3.6. Assisted Reproductive Technologies Epidemiologists have an obligation to communicate with communities directly or through community representatives to explain what they are doing and why, to transmit the results of their studies, to explain their significance, and to suggest appropriate action, such as the provision of health care. 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. 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. Nevertheless, it may be difficult to strike the right balance between the need to cautiously communicate findings to other scientists with appropriate peer review and validation of findings, and the need to expeditiously communicate results to other interested parties without undue delay. Over the last 50 years, there have been a number of guidelines published, which aim to improve the ethical standards of epidemiological research. Communicating Ethical Requirements to Colleagues, Employers, and Sponsors and Confronting Unacceptable Conduct. 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. Virtues are character traits that dispose us to act in ways that achieve good things, whereas duties and obligations help define how and for whom we should act. I). No potentially identifying information should be given to third parties without the express written permission of the participant unless required by law. Although epidemiologists do not need a license to practice, individual members of this profession should be accountable for the work that they perform. Confidentiality is concerned with preventing disclosure of information in ways that are inconsistent with the understanding under which the information was obtained. Most of the remainder of this document (Parts II and III) relates to the ethical duties and professional responsibilities of epidemiologists. Ann Epidemiol 1998;8:482-489. Upholding individuals' rights to confidentiality and privacy is a … For highly sensitive information or where there is danger of retribution for having some characteristic, data from research studies should be presented in such a manner that no identifiable person is placed at such risk. Epidemiologists often use personal data, so privacy must be respected. The background to and rationale for this effort, including the purpose and nature of ethics guidelines in epidemiology, have been discussed elsewhere. Epidemiologists, as professionals, should communicate to their students, peers, employers, and sponsors the ethical requirements of scientific research and its application in professional practice. The The importance of adhering to the highest scientific standards (for example, by choosing an appropriate study design; writing a clear and complete protocol; using proper procedures for the collection, transmission, storage, and analysis of data; and properly interpreting and reporting results) is highlighted in standards of practice that have been developed in the field. Thefirst moral principle is informed consent, including communityagreement, individual consent, undue influence, selective informationdisclosure and inducement to participate. Obtaining the Informed Consent of Participants, 2.6.2. Other obligations that epidemiologists have to communities are discussed in Section 3.8 (maintaining public trust). The first version was adopted in 1964 and has been amended seven times since, most recently in 2013. There should always be an assessment of what incentives, if any, may be offered to potential respondents for participating in the study. 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. Research ethics govern the standards of conduct for scientific researchers. (2008). International Epidemiological Association. To do this effectively, epidemiologists should be well-informed about the history, circumstances, and perspectives of groups within the community. Peer review plays an important role in improving research protocols and scientific reports. Later in this document, in Part III, we describe and clarify these duties of epidemiologists. For example, clinical trials may pose greater risks (and benefits) for individuals in the treatment or intervention arm of the trial in comparison to those in the control or placebo arm (or vice versa). The non-publication of research with “negative” findings (results which fail to reject a study’s null hypothesis) is also seen as unethical. 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. 2.10.1 Communicating ethical requirements. All sponsorship of research should also be publicly acknowledged. Involving community members beyond just recruiting them as research participants might promote trust and provide other benefits. It is important to adhere to ethical principles in order to protect the dignity, rights and welfare of research participants. This effort led to the creation of the Ethical Guidelines for Epidemiologic Research in June 2002, which was revised in 2004. Informed consent requirements may be loosened or waived when epidemiologists investigate disease outbreaks or evaluate programs as part of public health practice activities. 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. Avoiding Conflicts of Interest and Partiality, 3.10. In the ethical guidelines for epidemiological research we have analyzed, the most important functions of IRBs/RECs were protection of subjects’ well-being and safety along with assuring a proper balance between risk and benefits for subjects and the public (Piasecki et al., 2016). The risks of non-research public health practice activities also should be minimized. The potential benefits of epidemiology extend to all groups of persons in society including those who are socioeconomically disadvantaged. Information - there should be adequate disclosure of information regarding risks, burdens and benefits, enabling the patient or subject to make an informed choice. A distinction should be made between societal virtues and professional virtues. 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. To promote and preserve public trust, epidemiologists should adhere to the highest ethical and scientific standards and follow relevant laws and regulations concerning the conduct of these activities, including the protection of human research participants and confidentiality protections. Epidemiologists should restrict access to personal information and store this information in secure environments (e.g., locked file cabinets) including offsite locations for any back-up documents. 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. The Science of the Total Environment. Recent developments in genetics also have heightened concern about the confidentiality of, and the inappropriate use of, genetic information, e.g., using confidential genetic information to refuse someone employment or deny health insurance. In addition, epidemiologists increasingly have a role as expert witnesses in courts of law and in the discovery process. The proponents of this argument have held that epidemiology is therefore not a distinct profession. 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. Research participants have the right to refuse to take part in a study. The risks associated with epidemiologic research and practice may be subtle. Epidemiologists may not always be able to prevent all risks for study participants. The Professional Role of Epidemiologists, 3.2. Overall Introduction to Critical Appraisal, Chapter 2 – Reasons for engaging stakeholders, Chapter 3 – Identifying appropriate stakeholders, Chapter 4 – Understanding engagement methods, Chapter 9 - Understanding the lessons learned, Programme Budgeting and Marginal Analysis, Chapter 8 - Programme Budgeting Spreadsheet, Chapter 4 - Measuring what screening does, Chapter 7 - Commissioning quality screening, Chapter 3 - Changing the Energy of the NHS, Chapter 4 - Distributed Health and Service and How to Reduce Travel, Chapter 6 - Sustainable Clinical Practice, Prioritisation and Performance Management, http://ieaweb.org/good-epidemiological-practice-gep/, https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/, Appropriate use of statistical methods in the analysis and interpretation of epidemiological studies, including life-table analysis ›, Use of routine vital and health statistics to describe the distribution of disease in time and place and by person, Numerators, denominators and populations at risk, Incidence and prevalence including direct and indirect standardisation, Measures of disease burden (event-based and time-based) and population attributable risks including identification of comparison groups appropriate to Public Health, Sources of variation, its measurement and control, Common errors in epidemiological measurements, their effects on numerator and denominator data and their avoidance, Effect measures including odds ratios, rate ratios and risk ratios (relative risk), Interactions, methods for assessment of effect modification, Strategies to allow/adjust for confounding in design and analysis, The design, applications, strengths and weaknesses of descriptive studies and ecological studies, Design, applications, strengths and weaknesses of cross-sectional, analytical studies (including cohort, case-control and nested case-control studies), and intervention studies (including randomised controlled trials), Analysis of health and disease in small areas, Validity, reliability and generalisability, Clustered data - effects on sample size and approaches to analysis, Numbers needed to treat (NNTs) - calculation, interpretation, advantages and disadvantages, Methods of allocation in intervention studies, The design of documentation for recording survey data, construction of valid questionnaires and methods for validating observational techniques, Methods for validating observational techniques, The ethics and etiquette of epidemiological research, Appropriate use of statistical methods in the analysis and interpretation of epidemiological studies, including life-table analysis, Epidemic theory (effective & basic reproduction numbers, epidemic thresholds) & techniques for analysis of infectious disease data (construction & use of epidemic curves, generation numbers, exceptional reporting & identification of significant clusters), Systematic reviews, methods for combining data from several studies, and meta-analysis, Electronic bibliographical databases and their limitations, The hierarchy of research evidence - from well conducted meta-analysis down to small case series, Understanding of basic issues and terminology in the design, conduct, analysis and interpretation of population-based genetic association studies, including twin studies, linkage and association studies, Identifying and managing internal and external stakeholder interests, Management models and theories associated with motivation, leadership and change management, and their application to practical situations and problems, Dietary Reference Values (DRVs), current dietary goals, recommendations, guidelines and the evidence for them, Section 1: The theoretical perspectives and methods of enquiry of the sciences concerned with human behaviour, Inequalities in health (e.g. Are discussed in section 3.8 ) held that epidemiology is the study 's committee... 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