Policy recommendations for addressing privacy challenges associated with cell-based research and interventions.

BACKGROUND: The increased use of human biological material for cell-based research and clinical interventions poses risks to the privacy of patients and donors, including the possibility of re-identification of individuals from anonymized cell lines and associated genetic data. These risks will increase as technologies and databases used for re-identification become affordable and more sophisticated. Policies that require ongoing linkage of cell lines to donors' clinical information for research and regulatory purposes, and existing practices that limit research participants' ability to control what is done with their genetic data, amplify the privacy concerns. DISCUSSION: To date, the privacy issues associated with cell-based research and interventions have not received much attention in the academic and policymaking contexts. This paper, arising out of a multi-disciplinary workshop, aims to rectify this by outlining the issues, proposing novel governance strategies and policy recommendations, and identifying areas where further evidence is required to make sound policy decisions. The authors of this paper take the position that existing rules and norms can be reasonably extended to address privacy risks in this context without compromising emerging developments in the research environment, and that exceptions from such rules should be justified using a case-by-case approach. In developing new policies, the broader framework of regulations governing cell-based research and related areas must be taken into account, as well as the views of impacted groups, including scientists, research participants and the general public. SUMMARY: This paper outlines deliberations at a policy development workshop focusing on privacy challenges associated with cell-based research and interventions. The paper provides an overview of these challenges, followed by a discussion of key themes and recommendations that emerged from discussions at the workshop. The paper concludes that privacy risks associated with cell-based research and interventions should be addressed through evidence-based policy reforms that account for both well-established legal and ethical norms and current knowledge about actual or anticipated harms. The authors also call for research studies that identify and address gaps in understanding of privacy risks.

Impulse control and criminal responsibility: lessons from neuroscience.

Almost all of the world's legal systems recognize the "M'Naghten" exception to criminal responsibility: the inability to appreciate the wrongfulness of action. This exception rests on the assumption that punishment is morally justified only if the defendant was able to choose whether to do wrong. Jurists and jurisdictions differ, however, on whether to extend M'Naghten's logic to cases where the defendant understood the wrongfulness of an act but was incapable of resisting an impulse to commit it. In this article I ask whether contemporary neuroscience can help lawmakers to decide whether to adopt or retain this defense, known variously as the "irresistible impulse" defense or the "control" or "volitional" test for insanity. More specifically, I ask firstly, whether it is empirically true that a person can understand the wrongfulness of an act yet be powerless to refrain from committing it; and second (assuming an affirmative answer to the first), whether the law of criminal responsibility can practically accommodate this phenomenon? After canvassing the relevant neuroscientific literature, I conclude that the answer to the first question is "yes." After examining the varied treatment of the defense in the United States and other nations, I also give an affirmative answer to the second question, but only in limited circumstances. In short, the defense of irresistible impulse should be recognized, but only when it can be shown that the defendant experienced a total incapacity to control his or her conduct in the circumstances.