Access to medical records for research purposes:Varying perceptions across research ethics boards

Introduction: Variation across research ethics boards (REBs) in conditions placed on access to medical records for research purposes raises concerns around negative impacts on research quality and on human subject protection, including privacy. Aim: To study variation in REB consent requirements for retrospective chart review and who may have access to the medical record for data abstraction. Methods: Thirty 90-min face-to-face interviews were conducted with REB chairs and administrators affiliated with faculties of medicine in Canadian universities, using structured questions around a case study with open-ended responses. Interviews were recorded, transcribed and coded manually. Results: Fourteen sites (47%) required individual patient consent for the study to proceed as proposed. Three (10%) indicated that their response would depend on how potentially identifying variables would be managed. Eleven sites (38%) did not require consent. Two (7%) suggested a notification and opt-out process. Most stated that consent would be required if identifiable information was being abstracted from the record. Among those not requiring consent, there was substantial variation in recognising that the abstracted information could potentially indirectly re-identify individuals. Concern over access to medical records by an outside individual was also associated with requirement for consent. Eighteen sites (60%) required full committee review. Sixteen (53%) allowed an external research assistant to abstract information from the health record. Conclusions: Large variation was found across sites in the requirement for consent for research involving access to medical records. REBs need training in best practices for protecting privacy and confidentiality in health research. A forum for REB chairs to confidentially share concerns and decisions about specific studies could also reduce variation in decisions.

Informed consent and the requirement to ensure understanding

It is generally held that doctors and researchers have an obligation to obtain informed consent. Over time there has been a move in relation to this obligation from a requirement to disclose information to a requirement to ensure that that information is understood.Whilst this change has been resisted, in this article I argue that both sides on this matter are mistaken.When investigating what information is needed for consent to be informed we might be trying to determine what information a person would need in order to consent at all, or we might be trying to determine what information a person needs in order to make an informed choice about whether or not to consent. I argue that the obligation to ensure understanding only applies to information generated by the ?rst type of enquiry; but that much of the information generally thought necessary in order for consent to be informed is only required if our concern is with the second type of enquiry. For this reason it is neither the case that doctors and researchers should ensure all the information they provide is understood, nor is it the case that their only obligation is to disclose it.

Properties of SEPT9 Isoforms and the requirement for GTP binding

Members of the evolutionarily conserved septin family of genes are emerging as key components of several cellular processes including membrane trafficking, cytokinesis, and cell-cycle control events. SEPT9 has been shown to have a complex genomic architecture, such that up to 15 different isoforms are possible by the shuffling of five alternate amino termini and three alternate carboxy termini. Genomic and transcriptional alterations of SEPT9 have been associated with neoplasia. The present study has used a Sept9-specific antibody to determine the pattern of isoform expression in a range of tumour cell lines. Western blot analysis indicated considerable variation in the relative amounts and isoform content of Sept9. Immunofluorescence studies showed a range of patterns of cytoplasmic localization ranging from mainly particulate to mainly filamentous. Expression constructs were also generated for each amino terminal isoform to investigate the patterns of localization of individual isoforms and the effects on cells of ectopic expression. The present study shows that the epsilon isoform appears filamentous in this overexpression system while the remaining isoforms are particulate and cytoplasmic. Transient transfection of individual constructs into tumour cell lines results in cell-cycle perturbation with a G2/M arrest and dramatic growth suppression, which was greatest in cell lines with the lowest amounts of endogenous Sept9. Similar phenotypic observations were made with GTP-binding mutants of all five N-terminal variants of Sept9. However, dramatic differences were observed in the kinetics of accumulation of wild-type versus mutant septin protein in transfected cells. In conclusion, the present study shows that the expression patterns of Sept9 protein are very varied in a panel of tumour cell lines and the functional studies are consistent with a model of septin function as a component of a molecular scaffold that contributes to diverse cellular functions. Alterations in the levels of Sept9 protein by overexpression of individual isoforms can clearly perturb cellular behaviour and may thus provide a mechanistic explanation for observations of deranged septin expression in neoplasia. Copyright © 2004 Pathological Society of Great Britain and Ireland. Published by John Wiley & Sons, Ltd.

Network formation under mutual consent and costly communication

We consider two different approaches to describe the formation of social networks under mutual consent and costly communication. First, we consider a network-based approach; in particular Jackson–Wolinsky’s concept of pairwise stability. Next, we discuss a non-cooperative game-theoretic approach, through a refinement of the Nash equilibria of Myerson’s consent game. This refinement, denoted as monadic stability, describes myopically forward looking behavior of the players. We show through an equivalence that the class of monadically stable networks is a strict subset of the class of pairwise stable networks that can be characterized fully by modifications of the properties defining pairwise stability.

The Right to Self-Defence in National and International Law: The Role of the Imminence Requirement

This article explores the doctrine of self-defence within the context of the challenges directed at the imminence requirement, from the perspective of both national and international law. The article will attempt to illustrate that the requirement of imminence underlines the political character of the self-defence doctrine wherein private force may only be resorted to in the absence of institutional protection. This study will argue that the imminence rule can not merely be regarded as a "proxy" for establishing necessity; rather, the elements of imminence, necessity, and proportionality are inextricably connected to ensure that defensive force is only resorted to when national or international authorities are not in a position to prevent an illegal aggression, and that the defensive lethal force is not abused.