Randomization & Consent Scenarios

1. Randomization & Consent Scenarios Deneil Harney MPH, MSWHSP CoordinatorUniversity of Michigan

2. Randomization Scenarios

3. 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: • Enroll under EFIC and talk to the mother as soon as possible after the study drug is hung. • Approach the mother first to learn if she has any objection and if not enroll under EFIC. • Get consent from the family first and then randomize under consent.

4. 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: • Proceed with getting consent from the family after they speak with the treating team and then randomize under consent. • Approach the family after they speak with the treating team to learn if they have any objection to the patient being enrolled and proceed under EFIC if they do not. • Proceed with EFIC as soon as possible and talk to the family after study drug is hung. • Both B & C are correct.

5. 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: • Call the family member back and discuss the ProTECT study with them over the telephone too. • Wait for the family member to arrive to talk to them about ProTECT.

6. 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: • Proceed with randomization under EFIC at 4:20 PM, 40 minutes after patient arrival. The LAR is clearly not going to make it to the hospital in the next 20 minutes so why wait. • Wait the full hour from time of subject arrival and proceed with EFIC as soon as possible after 4:45 PM, if there is indeed no family present.

7. Consent Scenarios

8. 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: • Consent obtained. • Consent declined.

9. 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? • A copy of the continuation without study drug letter only. • A copy of the consent form only. • Both A & B.

10. 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? • On the consent form with or without their signature. • On the continuation without study drug letter along with their signature. • Either A or B are correct.

11. 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: • Answer No, a written decision has not yet been obtained. • Answer Yes, a written decision has not yet been obtained. • Leave it blank, a written decision has not yet been obtained.

12. 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? • As soon as you are notified a patient has arrived that may be eligible for ProTECT. • Just before the hour is up to learn if you need to get consent or else enroll the patient under EFIC. • Every 15 minutes. • All the above.