23 - Informed consent and human genetic database research

Summary

Introduction

Since the Second World War, leading documents have espoused voluntary consent as essential to the morality of research involving human subjects. The Nuremberg Code thus begins by declaring that ‘the voluntary consent of the human subject is absolutely essential’. The Declaration of Helsinki similarly states, as one of the ‘basic principles of all medical research’, that ‘the subjects must be volunteers and informed participants in the research project’. Over the past fifty years, the principle of informed consent has become a cornerstone of institutionalized research ethics, and many nations have committed themselves to it through their laws and regulations.

In recent years, the practice of informed consent has been challenged as researchers have gained the power to accumulate and process ever larger amounts of data, including genetic data. Is it necessary to obtain informed consent for research on data that has irreversibly been rendered anonymous? Is it conceptually possible to give informed consent to participation in unspecified, future research projects? Is it possible for researchers to provide the necessary information and assurances of privacy to participants in research using data-mining technology?

Any answer to such questions depends on assumptions about what informed consent is and why it is morally important. In order to tell what counts as a departure from the rule of obtaining informed consent, one must have a conception of what informed consent is, and in order to tell which departures are justified, one must have a considered view of what makes informed consent morally important.