Transcription of Informed Consent in Research
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Informed Consent in Research
Informed Consent in ResearchMonthly IRB Investigator MeetingFebruary 21, 2019 Objectives Informed Consent Basics Definition Basic Elements Review of the Process Documentation of Informed Consent Waivers e- Consent and Remote Consent Special Situations Informed Consent Review Observations Q&A2 Informed Consent BasicsDefinition3 What is Informed Consent ?The communication and information exchange between a prospective subject and an investigator. Begins with the initial approach of an investigator to the prospective subject, and continues with new information as the clinical investigation progresses until the completion of the Research study Provides adequate informationabout the study Gives sufficient opportunityfor the subject to understand and consider whether or not to participate in the study Is documented by the Investigator4 Why is It Important?
Feb 21, 2019 · Obtaining Consent The PI or designee should … • Obtain consent prior to any study procedures and assessments being performed • Demonstrate that all elements of informed consent are explained, and that the subject understands all of such elements of informed consent. • Give the subject opportunity to consider all information related to
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