Public health ethics, like the field of public health it addresses, traditionally has focused more on practice and particular cases than on theory, with the result that some concepts, methods, and boundaries remain largely undefined. This paper attempts to provide a rough conceptual map of the terrain of public health ethics. We begin by briefly defining public health and identifying general features of the field that are particularly relevant for a discussion of public health ethics.Public health is primarily concerned with (...) the health of the entire population, rather than the health of individuals. Its features include an emphasis on the promotion of health and the prevention of disease and disability; the collection and use of epidemiological data, population surveillance, and other forms of empirical quantitative assessment; a recognition of the multidimensional nature of the determinants of health; and a focus on the complex interactions of many factors—biological, behavioral, social, and environmental—in developing effective interventions. (shrink)

Introduction Understanding the views of the public is essential if generally acceptable policies are to be devised that balance research access to general practice patient records with protection of patients' privacy. However, few large studies have been conducted about public attitudes to research access to personal health information. Methods A mixed methods study was performed. Informed by focus groups and literature review, a questionnaire was designed which assessed attitudes to research access to personal health information and factors that influence these. (...) A postal survey was conducted of an electoral roll-based sample of the adult population of Ireland. Results Completed questionnaires were returned by 1575 (40.6%). Among the respondents, 67.5% were unwilling to allow GPs to decide when researchers could access identifiable personal health information. However, 89.5% said they would agree to ongoing consent arrangements, allowing the sharing by GPs of anonymous personal health information with researchers without the need for consent on a study-by-study basis. Increasing age (by each 10-year increment), being retired and primary level education only were significantly associated with an increased likelihood of agreeing that any personal health information could be shared on an ongoing basis: OR 1.39 (95% CI 1.18 to 1.63), 2.00 (95% CI 1.22 to 3.29) and 3.91 (95% CI 1.95 to 7.85), respectively. Conclusions Although survey data can be prone to response biases, this study suggests that prior consent agreements allowing the supply by GPs of anonymous personal health information to researchers may be widely supported, and that populations willing to opt in to such arrangements may be sufficiently representative to facilitate valid and robust consent-dependent observational research. (shrink)

Background The purpose of this study is to explore laypersons' attitudes toward the use of archived (existing) materials such as medical records and biological samples and to compare them with the attitudes of physicians who are involved in medical research. Methods Three focus group interviews were conducted, in which seven Japanese male members of the general public, seven female members of the general public and seven physicians participated. Results It was revealed that the lay public expressed diverse attitudes towards the (...) use of archived information and samples without informed consent. Protecting a subject's privacy, maintaining confidentiality, and communicating the outcomes of studies to research subjects were regarded as essential preconditions if researchers were to have access to archived information and samples used for research without the specific informed consent of the subjects who provided the material. Although participating physicians thought that some kind of prior permission from subjects was desirable, they pointed out the difficulties involved in obtaining individual informed consent in each case. Conclusions The present preliminary study indicates that the lay public and medical professionals may have different attitudes towards the use of archived information and samples without specific informed consent. This hypothesis, however, is derived from our focus groups interviews, and requires validation through research using a larger sample. (shrink)

Objectives: Recent legislative changes within the United Kingdom have stimulated professional debate about access to patient data within research. However, there is currently little awareness of public views about such research. The authors sought to explore attitudes of the public, and their lay representatives, towards the use of primary care medical record data for research when patient consent was not being sought.Methods: 49 members of the public and four non-medical members of local community health councils in South Wales, UK gave (...) their views on the value and acceptability of three current research scenarios, each describing access to data without patient consent.Results: Among focus group participants, awareness of research in primary care was low, and the appropriateness of general practitioners as researchers was questioned. There was general support for research but also concerns expressed about data collection without consent. These included lack of respect and patient control over the process. Unauthorised access to data by external agencies was a common fear. Current data collection practices, including population based disease registers elicited much anxiety. The key informants were equally critical of the scenarios and generally less accepting.Conclusions: This exploratory study has highlighted a number of areas of public concern when medical records are accessed for research without patient consent. Public acceptability regarding the use of medical records in research cannot simply be assumed. Further work is required to determine how widespread such views are and to inform those advising on confidentiality issues. (shrink)

Observational research involving access to personally identifiable data in medical records has often been conducted without informed consent, owing to practical barriers to soliciting consent and concerns about selection bias. Nevertheless, medical records research without informed consent appears to conflict with basic ethical norms relating to clinical research and personal privacy. This article analyzes the scope of these norms and provides an ethical justification for research using personally identifiable medical information without consent.

Research drawn from data contained in medical records is a common and immensely important means of scientific investigation in epidemiology and health services research. It provides valuable knowledge regarding risk factors for disease, the safety of pharmaceuticals and medical procedures, and the quality of medical care. Electronic information technology has greatly enhanced the capability of conducting research using medical records, but it has also generated increasing concern about invasions of privacy. Both practical and scientific considerations militate against soliciting consent for (...) population-based observational research. Retrospective review of existing medical records, especially with large samples, poses insuperable barriers to locating human subjects in order to obtain their informed consent. When efforts are made to obtain informed consent for prospective research drawn from disease and treatment registries, mounting evidence has accumulated that substantial selection biases are introduced into the data, as those who consent are not necessarily representative of the population of relevant patients. (shrink)

The success of the health care system depends on the accuracy, correctness and trustworthiness of the information, and the privacy rights of individuals to control the disclosure of personal information. A national policy on health informational privacy should be guided by ethical principles that respect individual autonomy while recognizing the important collective interests in the use of health information. At present there are no adequate laws or constitutional principles to help guide a rational privacy policy. The laws are scattered and (...) fragmented across the states. Constitutional law is highly general, without important specific safeguards. Finally, a case study is provided showing the important trade-offs that exist between public health and privacy. For a model public health law, see www.critpath.org/msphpa/privacy. (shrink)

A communitarian approach to bioethics adds a core value to a field that is often more concerned with considerations of individual autonomy. Some interpretations of liberalism put the needs of the patient over those of the community; authoritarian communitarianism privileges the needs of society over those of the patient. Responsive communitarianism’s main starting point is that we face two conflicting core values, autonomy and the common good, and that neither should be a priori privileged, and that we have principles and (...) procedures that can be used to work out this conflict but not to eliminate it. This discussion uses the debate in the US over funding for entitlements as a case study to apply the values of communitarian bioethics. (shrink)

Book reviewed in this article: Principles of Biomedical Ethics. By Tom L. Beauchamp and James F. Childress.

The European Union Data Protection Regulation will have profound implications for public health, health services research and statistics in Europe. The EU Commission's Proposal was a breakthrough in balancing privacy rights and rights to health and healthcare. The European Parliament, however, has proposed extensive amendments. This paper reviews the amendments proposed by the European Parliament Committee on Civil Liberties, Justice and Home Affairs and their implications for health research and statistics. The amendments eliminate most innovations brought by the Proposal. Notably, (...) derogation to the general prohibition of processing sensitive data shall be allowed for public interests such as the management of healthcare services, but not health research, monitoring, surveillance and governance. The processing of personal health data for historical, statistical or scientific purposes shall be allowed only with the consent of the data subject or if the processing serves an exceptionally high public interest, cannot be performed otherwise and is legally authorised. Research, be it academic, government, corporate or market research, falls under the same rule. The proposed amendments will make difficult or render impossible research and statistics involving the linkage and analysis of the wealth of data from clinical, administrative, insurance and survey sources, which have contributed to improving health outcomes and health systems performance and governance; and may illegitimise efforts that have been made in some European countries to enable privacy-respectful data use for research and statistical purposes. If the amendments stand as written, the right to privacy is likely to override the right to health and healthcare in Europe. (shrink)

Written by epidemiologists, ethicists and legal scholars, this book provides an in-depth account of the moral problems that often confront epidemiologists, including both theoretical and practical issues. The first edition has sold almost three thousand copies since it was published in 1996. This edition is fully revised and includes three new chapters:Ethical Issues in Public Health Practice, Ethical Issues in Genetic Epidemiology, and Ethical Issues in International Health Research and Epidemiology. These chapters collectively address important developments of the past decade. (...) Three chapters from the first edition have also been reorganized: Ethicall Optimized Study Deisgns in Epidemiology, Ethical Issues in Epidemiologic Research with Children, and The Ethics of Epidemiologic Research with Older Populations. Instead of standing alone, these chapters have been integrated into chapters on informed consent, confidentiality and privacy protection, and community-based intervention studies. (shrink)

Machine generated contents note: Preface; Introduction Angus Dawson; Part I. Concepts: 1. Resetting the parameters: public health as the foundation for public health ethics Angus Dawson; 2. Health, disease and the goal of public health Bengt Brülde; 3. Selective reproduction, eugenics and public health Stephen Wilkinson; 4. Risk and precaution Stephen John; Part II. Issues: 5. Smoking, health and ethics Richard Ashcroft; 6. Infectious disease control Marcel Verweij; 7. Population screening Ainsley Newson; 8. Vaccination ethics Angus Dawson; 9. Environment, ethics (...) and public health: the climate change dilemma Anthony Kessel and Carolyn Stephens; 10. Public health research ethics: is non-exploitation the new principle for population-based research ethics? John McMillan; 11. Equity and population health: toward a broader bioethics agenda Norman Daniels; 12. Health inequities James Wilson; Index. (shrink)