Dissemination to research subjects: operationalizing investigator accountability.

Recent articles have argued from principles of bioethics for the right of research subjects to receive the results of the studies in which they have participated. We argue that accountability is a powerful tool of meso-level analysis appropriate to reasoning about answerability in research ethics, and that it captures the responsibility of researchers to disseminate study results to research subjects. We offer the following features of the research situation as relevant to the manner of dissemination to study subject, in addition to factors already proposed in the literature (risk and impact on health outcome): (a) features of the research subject in relation to identity, personal investment, disease, and community; (b) characteristics of the research study and field of inquiry in relation to certainty and significance; and (c) relationships among the research subjects and the healthcare workers involved in their care and in the research.