Incidental findings in human subjects research: Is ignorance really bliss?

Human subjects research has the potential to produce information beyond the aims of the research study. This information may, nevertheless, have health or reproductive significance for the research participant. With the development of sophisticated technologies, these occurrences, known as incidental findings (IFs), are becoming increasingly common. As yet, however, there is no consensus on how IFs in human subjects research should be managed. This paper examines the current law and guidelines relating to human subjects research, and in doing so determines that research participants are inadequately informed about IFs. Consequently, their ability to make an informed choice about and provide informed consent to research procedures is compromised. After addressing the ethical and practical issues most salient to IFs, a framework for their management is developed. The framework sets out the information that should be discussed with research participants during the informed consent process. Recommendations for how this framework should be implemented are then made. The paper concludes that guidelines establishing minimum standards for communicating the possibility and presence of IFs are urgently required so that the rights of research participants are sufficiently protected.