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The U.S. Food and Drug Administration has proposed a rule change to mandate that most multisite clinical trials adopt a single institutional review board review instead of having separate reviews for each site. The authors of this commentary examine the expected consequences of implementing this change and make 3 recommendations to minimize unwanted outcomes. [ABSTRACT FROM AUTHOR]

In this article, we develop a non-rights-based argument based on beneficence (i.e. the welfare of individuals and communities) and justice as the disposition to act justly to promote equity in health care resource allocation. To this end, we structured our analysis according to the following main sections. The first section examines the work of Amartya Sen and his equality of capabilities approach and outlines a framework of health care as a fundamental human need. In the subsequent section, we provide a definition of health equity based on the moral imperative to guarantee that every individual ought to have the freedom to pursue health goals and well-being. In the later part of the article, we outline a non-right approach to health care based on three pillars: (1) human flourishing, (2) justice as a disposition not a process, and (3) solidarity. [ABSTRACT FROM AUTHOR]

The article titled "IRB stipulations and protocol complexity: An opportunity for collaboration to reduce turnaround times" by Vazirani et al. discusses the importance of Institutional Review Board (IRB) turnaround times in the context of research. The authors explore the relationship between the complexity of a study, the number of stipulations or modification requests from an IRB, and the time it takes for a study to be approved. They found that more complex studies with more stipulations tend to have longer turnaround times. The authors provide suggestions for improving protocols and decreasing turnaround time, such as simplifying consent forms and clarifying standard of care procedures. They emphasize the need for collaboration between IRBs and study teams to facilitate ethical research. [Extracted from the article]

Standards in pupil dilation practices regarding the safety of human subjects are not present in vision research despite the potential for significant adverse effects. We developed two surveys to examine current practices around pupil dilation among vision researchers and individuals associated with oversight of human subjects research. While both groups note an absence of adverse events associated with pupil dilation, vision researcher practices differed with informed consent use and measures taken to minimize complications. For Institutional Review Boards, general risk assumption associated with dilation was not unanimous and there was a lack of specific guidance available to researchers for minimizing risk. These results uncover the need for standardized practices regarding pupil dilation in human subjects research. [ABSTRACT FROM AUTHOR]