1. True-False Question
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False
This is false. The fact that you could not find any safety information is not evidence that a procedure or intervention is safe – in some instances, it could mean that no one has ever tested its safety.
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False
This is false. Sometimes it may be important not to tell subjects about your research objectives in order to protect them from serious harm or distress. However, it is always wrong if you intentionally hide any research objectives from the knowledge of the ethics committee when applying for ethics approval.
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True
This is true. Researchers can reduce harm to research subjects by halting an intervention that is found to be clearly ineffective from interim analyses. Interim analyses can also make a beneficial intervention available to all research subjects and their wider community more quickly.
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True
This is true. Risk is a function of (magnitude x probability of harm). When assessing the overall risk level of your study, the ethics committee will consider the magnitude and likelihood of all potential harms.
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True
This is true. Control groups should at least receive standard treatment unless using placebo / no treatment control can be both scientifically and ethically justified.