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Informed consent in an emergency care settingbased on OHRP frequently asked questionsDeveloped by:U-MICUniversity of Michigan IRB Collaborative

Informed consent in emergency care settings

Legally effective informed consent

Urgent careEmergency care

Consenting emergency care patients may not be appropriate if the emergency interferes with their ability to make an objective and informed decision.3Developed by:U-MICInformed consent in emergency care settings

Appropriateness depends on

medical conditionnature of researchsufficient time to consider participationminimizing coercion and undue influence4Developed by:U-MICInformed 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 populations likely ability toprocess informationask questionsconsider riskWhat is the timing of consent?Distinction between clinical care and research

5Developed by:U-MICInformed consent in emergency care settings

Coercion and undue influenceadditional protections

Ensure that consentis truly voluntaryis not subject to coercion/undue influence

Legally authorized representative (LAR)decisional incapacity6Developed by:U-MICInformed 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.pdf7Developed by:U-MICInformed consent in emergency care settings

8Developed by:U-MICInformed Consent in an Emergency Care Setting

Based on OHRP Frequently Asked Questions:http://answers.hhs.gov/ohrp/questions/7246

thank you.Brian SeaboltIRBMED

OHRP frequently asked questionshttp://www.hhs.gov/ohrp/policy/faq/index.html

9Developed by:U-MIC