BACKGROUND: Individual informed consent from all participants is required for most randomized clinical trials (RCTs). However, some exceptions-for example, emergency research-are widely accepted. METHODS: The literature on various approaches to randomization without consent (RWOC) has never been systematically reviewed. Our goal was to provide a survey and narrative synthesis of published proposals for RWOC. We focused on proposals to randomize at least some participants in a study without first obtaining consent to randomization. This definition included studies that omitted informed consent entirely, omitted informed consent for selected patients (e.g., the control group), obtained informed consent to research but not to randomization, or only obtained informed consent to randomization after random assignment had already occurred. It omitted oral and staged consent processes that still obtain consent to randomization from all participants before randomization occurs. RESULTS: We identified ten different proposals for RWOC: two variants of cluster randomization, two variants of the Zelen design, consent to postponed information, two-stage randomized consent, cohort multiple RCT, emergency research, prompted optional randomization trials, and low-risk pragmatic RCTs without consent. CONCLUSION: Of all designs discussed here, only cluster randomized designs and emergency research are routinely used, with the justification that informed consent is infeasible in those settings. Other designs have raised concerns that they do not appropriately respect patient autonomy. Recent proposals have emphasized the importance for RWOC of demonstrating such respect through systematic patient engagement, transparency, and accountability, potentially in the context of learning health care systems. INTRODUCTIONRandomized controlled trials (RCTs) are the gold standard for clinical research. 1 Informed consent, including disclosure of randomization, is an ethical requirement for most RCTs. 2 This principle, intended to protect participants' autonomy and dignity, is firmly embedded in guidelines and regulations. [3][4][5][6] But, critics have argued that modern consent processes often fail to convey information well, can confuse or distress participants, and may even hinder legitimate research endeavors to the point where patients are paradoxically harmed by the lack of research on the safety and effectiveness of commonly used therapies. 7,8 These arguments have led to calls to relax or eliminate informed consent requirements in certain circumstances. An example is the exception for emergency medicine studies in which it is deemed impossible to obtain informed consent and still test an emergent intervention. 9 More broadly, US Federal regulations allow a waiver of informed consent requirements for clinical research given that four requirements are met: (1) Bthe research involves no more than minimal risk to the subjects,^(2) Bthe waiver or alteration will not adversely affect the rights and welfare of the subjects,^(3) Bthe researc...

nd TwiCs international symposium was to share perspectives and experiences on ethical aspects of the TwiCs design, discuss how TwiCs relate to the current ethical framework, provide a forum in which to discuss and debate ethical issues and identify future directions for conceptual and empirical research. The symposium was supported by the Wellcome Trust and the NIHR CLAHRC Yorkshire and Humber and organised by members of the TwiCs network led by Clare Relton and attended by people from the UK, the Netherlands, Norway, Canada and USA. The two-day symposium enabled an international group to meet and share experiences of the TwiCs design (also known as the 'cohort multiple RCT design'), and to discuss plans for future research. Over the two days, invited plenary talks were interspersed by discussions, posters and mini presentations from bioethicists, triallists and health research regulators. Key findings of the symposium were: (1) It is possible to make a compelling case to ethics committees that TwiCs designs are appropriate and ethical; (2) The importance of wider considerations around the ethics of inefficient trial designs; and (3) some questions about the ethical requirements for content and timing of informed consent for a study using the TwiCs design need to be decided on a case-by-case basis. Main report On 7-8 th November 2016, 60 people with an interest in the 'Trials within Cohorts' (TwiCs) design met in London for the 2 nd TwiCs international symposium. The symposium was supported by the Wellcome Trust and NIHR CLAHRC Yorkshire and Humber and organised by members of the TwiCs network led by Clare Relton. As well as UK participants, people came from the Netherlands, Norway, Canada and USA. Over the two days, the invited plenary talks were interspersed by discussions, posters and mini presentations from bioethicists, triallists and health research regulators.On the first day (7 th November, 2016), Jon Nicholl (University of Sheffield, UK) opened the meeting, welcoming all to the symposium. He described how the first international symposium in 2014 brought together triallists using the design for the first time, and led to this, the 2 nd symposium which aimed to provide a forum in which to discuss and debate ethical issues including how the TwiCs approach relates to the current ethical framework. What are TwiCs? Clare Relton (University of Sheffield, UK) set the scene by outlining the Trials within Cohorts (TwiCs) approach as described in the original article (Fig. 1) in the BMJ in 2010 [1], and the 7 key features of the design: (I) Recruitment of a large observational cohort of patients/ people with the condition of interest (II) Regular measurement of outcomes for the whole cohort (III) Capacity for multiple randomised controlled trials over time. Then for each randomised controlled trial: (IV) Identification of all eligible people in the cohort (V) Random selection of some individuals from all eligible people in the cohort, who are then offered the trial intervention (VI) Comparison of the outcomes in ...

Implicit bias refers to a deeply rooted, often subconscious bias towards or against a person or group of people. This differs from explicit bias, which refers to conscious beliefs and attitudes. Implicit bias may be deeply ingrained; individuals may not be aware of the implicit biases they hold. Implicit racial bias refers to a person's automatic preference for one racial group over another. Although previously thought to be unchangeable, recent studies suggest that implicit bias can be altered through intervention (Lai et al., 2016;Vuletich & Payne, 2019).

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