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BRIAN REED: The last time Georgia Wise saw her daughter in law was a Thursday in April. Arlene Fields was visiting her kids, who live with Wise because she was staying in a shelter, working through a drug addiction. They were excited to see their mom.
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The CONSORT (Consolidated Standards of Reporting Trials) Statement, updated in 2010,http://www.cheapjerseys11.com presents systematic evidence based guidance for organising final study reports based on a checklist, and this can be used to inform protocol writing.3 CONSORT’s checklist highlights 3 of the 11 elements contained in our Ethics Tool Kit, specifically the importance of proper study design, the choice of study population and the criticality of addressing potential harms. Similarly, the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 Statement, generated by an international group of stakeholders, recommends minimum standards for inclusion in clinical trial protocols.1 SPIRIT includes two topics that might particularly require ethical consideration: the importance of informed consent and trial design, which are both included and broadened in our Ethics Tool Kit. Neither CONSORT nor SPIRIT comprehensively and directly addressed ethical issues in clinical trial protocols.
