21 These evidence-based data provoke questions: how to deal with incidental findings in banked data and how to interpret individual findings that fall outside a normative range yielded by group-averaged functional images, and particularly how to deal with such findings towards “study participants, patients and consumers to enable them to navigate through the labyrinth Inhibitors,research,lifescience,medical of information about incidental findings in research, clinical care, and the rapidly

evolving industry of personalized medicine.“ ”Information available online to the self-guided user is noisy and unreliable.“ Therefore, ”the professional community has the duty to ensure that rational decisions can Inhibitors,research,lifescience,medical be made,“ especially because such findings ”might become a part of a person’s life. Questions about anticipating and managing such finding must be explicitly and systematically encouraged.“20 Until now neither the law nor governmental Inhibitors,research,lifescience,medical regulations as well as ECs offer clear guidance to researchers on handling unexpected findings22,23 and a frame for participants to contextualize their expectations.24 However, there seems to be agreement that before screening procedures for research studies the potential research subject should be informed about the Inhibitors,research,lifescience,medical possibility

of an incidental finding and how to deal with it. We preferred to obtain the consent of the research participant that we might inform his/her practitioner about unexpected and perhaps clinically relevant findings, because the practitioner – knowing the patient and his/her context – is better equipped to judge the clinical significance of the finding and how to convey the

information to the subject.25 This is particularly valid if the researcher is not a clinician or has no specific competence, eg, in evaluating functional MRI images. Bay 11-7085 If the potential research Inhibitors,research,lifescience,medical subject refuses to have such information transmitted to his/her practitioner or if he/she has no physician at all, the information about the possibility of an unexpected finding and its potential and perhaps severe consequences for the individual’s life (Kerr 1995, cited in refs 26,27) must be given explicitly and in detail, in order to enable the subject to make a rational decision. If an incidental finding of potential clinical relevance is discovered, the subject should be advised to NVP-BGJ398 consult a physician as soon as possible. A comprehensive analysis of handling incidental findings in brain imaging has resulted in a range of options, examples of key points, and practical guidelines.