2. 1 Developed by: U-MIC 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.

3. INFORMED CONSENT IN AN EMERGENCY CARE SETTING based on OHRP frequently asked questions Developed by: U-MIC University of Michigan IRB Collaborative

4. 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

5. 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

6. 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

7. 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

8. 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 7 Developed by: U-MIC

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

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