Ensuring respect for persons in COMPASS: a cluster randomised pragmatic clinical trial.

Cluster randomised clinical trials present unique challenges in meeting ethical obligations to those who are treated at a randomised site. Obtaining informed consent for research within the context of clinical care is one such challenge. In order to solve this problem it is important that an informed consent process be effective and efficient, and that it does not impede the research or the healthcare. The innovative approach to informed consent employed in the COMPASS study demonstrates the feasibility of upholding ethical standards without imposing undue burden on clinical workflows, staff members or patients who may participate in the research by virtue of their presence in a cluster randomised facility. The COMPASS study included 40 randomised sites and compared the effectiveness of a postacute stroke intervention with standard care. Each site provided either the comprehensive postacute stroke intervention or standard care according to the randomisation assignment. Working together, the study team, institutional review board and members of the community designed an ethically appropriate and operationally reasonable consent process which was carried out successfully at all randomised sites. This achievement is noteworthy because it demonstrates how to effectively conduct appropriate informed consent in cluster randomised trials, and because it provides a model that can easily be adapted for other pragmatic studies. With this innovative approach to informed consent, patients have access to the information they need about research occurring where they are seeking care, and medical researchers can conduct their studies without ethical concerns or unreasonable logistical impediments. NCT02588664, recruiting. This article covers the development of consent process that is currentlty being employed in the study.

Andrews JE ，Moore JB ，Weinberg RB ，Sissine M ，Gesell S ，Halladay J ，Rosamond W ，Bushnell C ，Jones S ，Means P ，King NMP ，Omoyeni D ，Duncan PW ，COMPASS investigators and stakeholders ... -  《-》

Cluster over individual randomization: are study design choices appropriately justified? Review of a random sample of trials.

Taljaard M ，Goldstein CE ，Giraudeau B ，Nicholls SG ，Carroll K ，Hey SP ，Brehaut JC ，Jairath V ，London AJ ，Eldridge SM ，Grimshaw JM ，Fergusson DA ，Weijer C ... -  《-》

American Society of Clinical Oncology policy statement: oversight of clinical research.

American Society of Clinical Oncology 《JOURNAL OF CLINICAL ONCOLOGY》

Informed consent in cluster randomised trials: new and common ethical challenges.

Cluster randomised trials are an increasingly important methodological tool in health research but they present challenges to the informed consent requirement. In the relatively limited literature on the ethics of cluster research there is not much clarity about the reasons for which seeking informed consent in cluster randomised trials may be morally challenging. In this paper, I distinguish between the cases where informed consent in cluster trials may be problematic due to the distinct features of 'population-based' interventions, which have not been adequately discussed in the research ethics literature, and the cases where informed consent may be problematic for reasons that investigators also encounter in other research designs. I claim that informed consent requirements in cluster trials should be adjusted to the level of risk involved, arguing for a more comprehensive notion of research risk than that currently found in the research ethics guidelines, and the amount of freedom to be sacrificed in relation to a particular research aim. I conclude that these two factors are the most important to consider when assessing whether a cluster study should proceed when informed consent is infeasible or difficult to obtain.

Lignou S 《-》

Inadequacy of ethical conduct and reporting of stepped wedge cluster randomized trials: Results from a systematic review.

Taljaard M ，Hemming K ，Shah L ，Giraudeau B ，Grimshaw JM ，Weijer C ... -  《-》