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)

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.

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)