Protection of human subjects; prisoners used as subjects in research; stay of effective date--Food and Drug Administration. Final rule; stay of effective date

The Food and Drug Administration (FDA) is staying the effective date of its regulations establishing conditions under which biomedical research o prisoners will be accepted in satisfaction of FDA's regulatory requirements. All provisions of Subpart C of Part 50 of the final regulations are stayed pending reproposal of the subpart, including 50.44 (21 CFR 50.44). The stay will remain in effect until final action taken on the reproposal in effective.     

Protection of human subjects; informed consent--FDA. Final rule

The Food and Drug Administration (FDA) is amending its current informed consent regulations to permit harmonization of the Department of Health and Human Services' (DHHS) policies on emergency research and to reduce confusion on when such research can proceed without obtaining an individual subject's informed consent. This regulation provides a narrow exception to the requirement for obtaining and documenting informed consent from each human subject, or his or her legally authorized representative, prior to initiation of an experimental intervention. The exception would apply to a limited class of research activities involving human subjects who are in need of emergency medical intervention but who cannot give informed consent because of their life-threatening medical condition, and who do not have a legally authorized person to represent them. FDA is taking this action in response to growing concerns that current rules are making high quality acute care research activities difficult or impossible to carry out at a time when the need for such research is increasingly recognized.     

Protection of human subjects; informed consent; standards for institutional review boards for clinical investigations--FDA. Final rule

The Food and Drug Administration (FDA) is amending its regulations on institutional review boards (IRB's) and on informed consent to conform them to the "Federal Policy for the Protection of Human Research Subjects" (Federal Policy) published elsewhere in this issue of the Federal Register. Existing FDA regulations governing the protection of human subjects share a common core with the Federal Policy and implement the fundamental principles embodied in that policy.     

Vulnerable data subjects

Discussion about vulnerable individuals and communities spread from research ethics to consumer law and human rights. According to many theoreticians and practitioners, the framework of vulnerability allows formulating an alternative language to articulate problems of inequality, power imbalances and social injustice. Building on this conceptualisation, we try to understand the role and potentiality of the notion of vulnerable data subjects. The starting point for this reflection is wide-ranging development, deployment and use of data-driven technologies that may pose substantial risks to human rights, the rule of law and social justice. Implementation of such technologies can lead to discrimination systematic marginalisation of different communities and the exploitation of people in particularly sensitive life situations. Considering those problems, we recognise the special role of personal data protection and call for its vulnerability-aware interpretation. This article makes three contributions. First, we examine how the notion of vulnerability is conceptualised and used in the philosophy, human rights and European law. We then confront those findings with the presence and interpretation of vulnerability in data protection law and discourse. Second, we identify two problematic dichotomies that emerge from the theoretical and practical application of this concept in data protection. Those dichotomies reflect the tensions within the definition and manifestation of vulnerability. To overcome limitations that arose from those two dichotomies we support the idea of layered vulnerability, which seems compatible with the GDPR and the risk-based approach. Finally, we outline how the notion of vulnerability can influence the interpretation of particular provisions in the GDPR. In this process, we focus on issues of consent, Data Protection Impact Assessment, the role of Data Protection Authorities, and the participation of data subjects in the decision making about data processing.     

Intensive teaching in law subjects

The use of intensive teaching is increasing in Australian law schools. For some Australian law schools, most of their masters subjects are now taught on an intensive basis. This article reviews the literature on intensive teaching. The observation is made that there has been little discussion in the literature of the merits of such teaching in law schools. The article also reports the results of a statistical analysis comparing the student evaluations of a subject in the masters program of an Australian law school that was taught on an intensive basis with the student evaluations of the same subject taught by the same teacher across a full semester. Finally, the article reports the results of interviews with teachers at one Australian law school that makes extensive use of intensive teaching in its masters program. The teachers identify successful teaching techniques and they also identify some challenges with intensive teaching.