Individual privacy and observational health research: violating an individual's privacy to benefit the health of others.

The status of ethical considerations in the provision of health care has undergone a substantial evolution over the past 50 years. This development was partially a response to particular abuses of human rights that had occurred in the name of health research,* 1 but it was also a manifestation of the wider consumer rights movement that arose in a number of countries over the same time period. Through legal and political processes, a range of patient rights and health care worker responsibilities were identified and enshrined in a series of documents, among the first of which was the Helsinki Declaration of 1964.2 While concern about experimentation on human beings was the main motivation behind these developments, standards and procedures have also been developed and applied to studies and public health investigations that do not involve experimentation on subjects ( ‘observational research’). In some studies and investigations, information is collected exclusively from medical records and from tests that would normally be undertaken in the course of patient care. However, other studies may involve specially developed questionnaires or tests that are administered purely for the purposes of the research. Although observational research does not involve the same potential for direct harm as experimental research, it has become clear over the past few decades