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https://www.selleckchem.com/products/sovleplenib-hmpl-523.html The implementation of pragmatic clinical trials (PCTs) can be accompanied by unique regulatory challenges. In this paper, we describe the experience and management of regulatory noncompliance during a 25-site acute care PCT. During the trial, the study team conducted a comprehensive audit of all enrollment forms (informed consent and Health Insurance Portability and Accountability Act authorization forms) and related study documentation. A review of 997 participants' enrollment forms identified 138 (13.8%) that required reporting to the institutional review board due to noncompliance. To prevent subsequent noncompliance, the study team developed and introduced a revised participant tracking system, reviewed all enrollment documentation, and retrained sites regarding study procedures. Based on these experiences, we developed a set of recommendations for future PCTs to ensure both operational success and regulatory compliance.Research ethics scholarship often attends to vulnerability. People with autism may be vulnerable in research, but are also vulnerable to unjust exclusion from participation. Addressing the needs of participants with autism can facilitate inclusion and honor the bioethics principle of respect for persons while accounting for risk and vulnerability. Drawing from a review of the literature and informed by a moral deliberation process involving a task force of stakeholders (including autistic people and parents of autistic people), we use the model of person-oriented research ethics to identify several practical strategies researchers can use to address these needs and foster inclusion. Strategies include using multiple means of communication, addressing the sensory environment, preparing participants in advance, and accounting for social context. These practical strategies are not just methodological or design choices; they are inherently related to ethical issues. Method and design choi

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