This article outlines procedures for the feedback of individual research data to participants. This feedback framework was developed in the context of a personalized medicine research project in Canada. Researchers in this domain have an ethical obligation to return individual research results and/or material incidental findings that are clinically significant, valid and actionable to participants. Communication of individual research data must proceed in an ethical and efficient manner. Feedback involves three procedural steps: assessing the health relevance of a finding, re-identifying (...) the affected participant, and communicating the finding. Re-identification requires researchers to break the code in place to protect participant identities. Coding systems replace personal identifiers with a numerical code. Double coding systems provide added privacy protection by separating research data from personal identifying data with a third "linkage" database. A trusted and independent intermediary, the "keyholder", controls access to this linkage database. (shrink)

Physicians are increasingly confronted with the consequences of allocation policies. In several countries, physicians have been assigned a gatekeeper role for secondary health care. Many ethicists oppose this assignment for several reasons, concentrating on the harm the intrusion of societal arguments would inflict on doctor-patient relations. It is argued that these arguments rest on a distinction of spheres of values and of rationality, without taking into account the mixing of values and rationalities that takes place in everyday medical practice. If (...) medical practice, then, does not follow a single, pure rationality, can it also incorporate the societal rationality of the gatekeeper role?Using a case from general practice, I try to show how physicians may integrate societal arguments into their practice in a morally acceptable way. A version of the model of reflective equilibrium and especially Beauchamp and Childress's safeguards, may be helpful both to analyse and teach such balancing of values and rationalities. (shrink)