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Additional Protections for Children Involved as Subjects in Research
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INFORMED CONSENT IN AN EMERGENCY CARE SETTING based on OHRP frequently asked questions Developed by: U-MIC University of Michigan IRB Collaborative

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. 3 Developed by: U-MIC

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

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 5 Developed by: U-MIC

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 6 Developed by: U-MIC

Informed consent in emergency care settings Exception from informed consent for emergency care research FDA guidance: University of Michigan Medical School position statement: /res_irbmed_EFIC.pdf 7 Developed by: U-MIC

Informed consent in emergency care settings 8 Developed by: U-MIC Informed Consent in an Emergency Care Setting Based on OHRP Frequently Asked Questions:

THANK YOU. Brian Seabolt IRBMED OHRP frequently asked questions 9 Developed by: U-MIC