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I waive any possibility of compensation for injuries that I may receive as a result of participation in this research.
Which of the following is a requirement of an informed consent form quizlet?A general requirement for the informed consent form is that it may not include any exculpatory language. Exculpatory language is that which waives or appears to waive any of the subject's legal rights or releases or appears to release those conducting the research from liability for negligence.
Who is responsible for making the initial risk determination for a device being used in a study?7. Who decides whether a device study is SR or NSR? Sponsors are responsible for making the initial risk determination and presenting it to the IRB.
Which purpose is served by obtaining informed consent?The main purpose of the informed consent process is to protect the patient. A consent form is a legal document that ensures an ongoing communication process between you and your health care provider.
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