The Ethics of Incidental Findings in Population-Based MRI Research

Abstract

The occurrence of incidental findings in epidemiologic studies is a well-recognized problem in medical research. The more incidental findings being encountered in MRI research, the more it is apparent that dealing with them raises fundamental ethical issues. As the core of these ethical problems posed by incidental findings in MRI research we identify a fundamental conflict between the duty of care toward the individual research subject and the need to ensure the validity of the study. Although this appears prima facie to be a collision of an ethical norm with a methodological standard, the conflict turns out to be a genuine ethical dilemma. There is, after all, a moral duty to assure a rigorous methodology when engaging in human subjects research that should guide any investigator engaging in human subjects research: studies aimed at generating knowledge that can help improve the care of future patients must be conducted with adherence to the most rigorous methodological standards in order to preclude degradation of results which may be potentially harmful to future patients. The complex issues involved boil down to the following question: Should the researcher disclose incidental findings, if this is in the interest of the research subject, or is this duty overruled by his or her responsibility to safeguard the external validity of the study results by not disclosing such findings? We evaluate two proposals to answer this question but we do not exclude the possibility that this ethical dilemma can lead to a situation where it may become impossible or at least difficult to conduct population-based research at all.