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Critical Care Research危重医学研究1109
Critical Care Research危重医学研究1109
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participants life is being supported by an investigational device and the participant requests to be withdrawn from the study
Additional elements of informed consent A statement that the particular
treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable
Although an additional element, the unforeseeable risk statement is usually included in the consent form when investigational drugs and devices are being studied
Anticipated circumstances under which the subject?s participation may be terminated by the investigator without regard to the subject?s consent
This statement should provide the likely reasons that a participant would be removed from the study, such as failure to adhere to study procedures; inability to take a medication, or failure to meet certain screening criteria
Any additional costs to the subject that may result from participation in the research 。 Many IRBs have refi ned this to address more specifi cally the costs that will be covered as part of the research and those that will be billed to the participant (or their insurer) as part of routine clinical care
The consequences of a subject?s decision to with draw from the research and procedures for orderly termination of participation by the subject
Many times participants can withdra
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