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Informed consent in an emergency care setting based on OHRP frequently asked questions

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Informed consent in an emergency care setting based on OHRP frequently asked questions

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  1. To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the screen changes and you press enter. Developed by: U-MIC

  2. Informed consent in an emergency care settingbased on OHRP frequently asked questions Developed by: U-MIC University of Michigan IRB Collaborative

  3. Informed consent in emergency care settings Legally effective informed consent • Urgent care • Emergency care Consenting emergency care patients may not be appropriate if the emergency interferes with their ability to make an objective and informed decision. Developed by: U-MIC

  4. Informed consent in emergency care settings Appropriateness depends on • medical condition • nature of research • sufficient time to consider participation • minimizing coercion and undue influence Developed by: U-MIC

  5. Informed consent in emergency care settings Appropriateness of consent in emergency care settings • What is the likely health and emotional condition of potential subjects? • Conscious but receiving care? • Undergoing preparation for surgery? • What is subject population’s likely ability to • process information • ask questions • consider risk • What is the timing of consent? • Distinction between clinical care and research Developed by: U-MIC

  6. Informed consent in emergency care settings Coercion and undue influence additional protections Ensure that consent • is truly voluntary • is not subject to coercion/undue influence Legally authorized representative (LAR) • decisional incapacity Developed by: U-MIC

  7. Informed consent in emergency care settings Exception from informed consent for emergency care research FDA guidance: http://www.fda.gov/downloads/regulatoryinformation/guidances/ucm249673.pdf University of Michigan Medical School position statement: http://medicine.umich.edu/medschool/sites/medicine.umich.edu.medschool/files/res_irbmed_EFIC.pdf Developed by: U-MIC

  8. Informed Consent in an Emergency Care Setting Based on OHRP Frequently Asked Questions: http://answers.hhs.gov/ohrp/questions/7246 Informed consent in emergency care settings Developed by: U-MIC

  9. Brian Seabolt IRBMED OHRP frequently asked questions http://www.hhs.gov/ohrp/policy/faq/index.html thank you. Developed by: U-MIC

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