BackgroundTo date there is no established consensus of assessment criteria for evaluating research ethics review.MethodsWe conducted a scoping review of empirical research assessing ethics review processes in order to identify common elements assessed, research foci, and research gaps to aid in the development of assessment criteria. Electronic searches of Ovid Medline, PsychInfo, and the Cochrane DSR, ACP Journal Club, DARE, CCTR, CMR, HTA, and NHSEED, were conducted. After de-duplication, 4234 titles and abstracts were reviewed. Altogether 4036 articles were excluded following screening of titles, abstracts and full text. A total of 198 articles included for final data extraction.ResultsFew studies originated from outside North America and Europe. No study reported using an underlying theory or framework of quality/effectiveness to guide study design or analyses. We did not identify any studies that had involved a controlled trial - randomised or otherwise – of ethics review procedures or processes. Studies varied substantially with respect to outcomes assessed, although tended to focus on structure and timeliness of ethics review.DiscussionOur findings indicate a lack of consensus on appropriate assessment criteria, exemplified by the varied study outcomes identified, but also a fragmented body of research. To date research has been largely quantitative, with little attention given to stakeholder experiences, and is largely cross sectional. A lack of longitudinal research to date precludes analyses of change or assessment of quality improvement in ethics review.

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Critical care studies often do not provide the information recommended for those providing consent for research. These clear recommendations provide testable hypotheses about how to improve the consent process for patients and family members considering trial participation in the critical care setting.

BackgroundThere remains a disproportionally high tobacco smoking rate in low-income populations. Multicomponent tobacco dependence interventions in theory are effective. However, which intervention components are necessary to include for low socioeconomic status (SES) populations is still unknown.ObjectiveTo assess the effectiveness of multicomponent tobacco dependence interventions for low SES and create a checklist tool examining multicomponent interventions.MethodsEMBASE and MEDLINE databases were searched to identify randomised controlled trials (RCTs) published with the primary outcome of tobacco smoking cessation measured at 6 months or post intervention. RCTs that evaluated tobacco dependence management interventions (for reduction or cessation) in low SES (experience of housing insecurity, poverty, low income, unemployment, mental health challenges, illicit substance use and/or food insecurity) were included. Two authors independently abstracted data. Random effects meta-analysis and post hoc sensitivity analysis were performed.ResultsOf the 33 included studies, the number of intervention components ranged from 1 to 6, with smoking quit rates varying between 1% and 36.6%. Meta-analysis revealed that both the 6-month and 12-month outcome timepoints, multicomponent interventions were successful in achieving higher smoking quit rates than the control (OR 1.64, 95% Cl 1.41 to 1.91; OR 1.74, 95% Cl 1.30 to 2.33). Evidence of low heterogeneity in the effect size was observed at 6-month (I2=26%) and moderate heterogeneity at 12-month (I2=56%) outcomes.ConclusionMulticomponent tobacco dependence interventions should focus on inclusion of social support, frequency and duration of components. Employing community-based participatory-action research approach is essential to addressing underlying psychosocioeconomic-structural factors, in addition to the proven combination pharmacotherapies.PROSPERO registration numberCRD42017076650.