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on-maleficence is ensuring that an individual’s freedom to choose and act is respected. True False Guidelines and regulations have been developed throughout the last several decades in order to ensure that: Studies will be allowed to include everyone they invite to participate in the research Everyone is treated as equal and no special considerations are given when consenting to research Individual’s needs come before the needs of science The consent taker assesses the individuals understanding of the information provided during the consent process so as to: Find out how likely they are to agree to participate To decide which arm of the study they will be placed in Establish if they truly understand what they are being asked to do It is important to give the potential participate adequate time to think about and ask questions on the study before they decided to consent because if they agree they cannot later change their mind. True False Informed consent is: An on-going process for the duration of the study Only necessary for certain types of studies like clinical trials Simply a procedure of getting someone to sign a form before they are enrolled in a study Which of the following should not be done? Obtaining a community leader’s agreement before approaching individuals Complying with the country’s regulations and guidelines Enrolling someone to the study on the consent of the head of the household The key facts that an individual should receive when being asked to consent includes which of the following study information: Duration Sample size Procedures Benefits, costs & risks Study related injury procedures The right to withdraw at any time All of the abov

 
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