Randomization & Consent Scenarios. Deneil Harney MPH, MSW HSP Coordinator University of Michigan. Randomization Scenarios.
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Deneil Harney MPH, MSWHSP CoordinatorUniversity of Michigan
Scenario 1:TBI patient arrives @ 3 AM. A Study team member is paged about a possible ProTECT subject late and doesn’t arrive to the hospital until 4:15 AM. Social work informs the study team member that the patient’s mother is present and arrived shortly after 4 AM. She is talking with the treating team now. Do you:
Scenario 2: Patient arrives @ 10 AM. Two research team members are present at time of patient arrival. Attempts are being made to locate the patient’s family to no avail. It’s now 11 AM and the study team is not ready to randomize under EFIC because the lab work needed to determine the patient’s eligibility is not back yet. At 11:05 the study team is notified that family has arrived. The study team is still not ready to randomize. Do you:
Scenario 3:A family member has been notified by telephone about patient’s emergency and is in route to the hospital. The treating team has briefly discussed with them the patient’s condition. Do you:
Scenario 4: Patient arrives at 3:45 PM. The study team learns at 4:15 PM, 30 minutes after patient arrival, that an LAR is in route to the hospital and based on their location will definitely not make it to the hospital by 4:45 PM (within 1 hr. of patient arrival). Do you:
Scenario 1 Part 1: Subject is enrolled under EFIC. When family arrives a few hours later they are told about the study and decide they would like the study drug stopped but agree to ongoing follow up and long term blood storage. They sign the continuation without study drug letter. Is this recorded in WebDCU as:
Scenario 1 Part 2: Subject is enrolled under EFIC. When family arrives a few hours later they are told about the study and decide they would like the study drug stopped but agree to ongoing follow up and long term blood storage. They sign the continuation without study drug letter. Which documents are they given to keep?
Scenario 2: Subject is enrolled under EFIC. When family arrives a few hours later they are told about the study and decide they would like the drug stopped but agree to be contacted for ongoing follow up and long term blood storage. Where is their decision about long term blood storage captured?
Scenario 3: Subject is enrolled under EFIC. The ICL-CRF is started and saved while ongoing attempts are made to locate an LAR to get a consent decision. Meanwhile the ICL-CRF asks the question: Was long-term storage of blood samples declined?Do you:
Scenario 4: Subject arrives at 12:00 and ongoing attempts are made between the research team and the persons/department at your institution responsible for trying to ID the patient and locate family members. How often should you consult the persons/department trying to locate and determine family status in that first hour after the patient arrives?