Typical Informed Consent Mistakes and How to Address Them (Part II Activity)

2. Typical Informed Consent Mistakes and How to Address Them (Part II Activity) Training for Investigators and Research Staff

3. Scenario #9: You have recently been hired as the Research Compliance Officer for an academic medical center that conducts several different types of clinical research studies. Recently, the IRB administrator has notified you that they have seen some weird deviations come from a specific department for a specific study. It seems that the IRB chair would like for you to conduct a directed (for-cause) audit on this study as soon as possible. After notifying the principal investigator and their team that you will be conducting a directed audit next Monday, you go to work and start looking into the study’s documents on iRIS. This study appears to be enrolling minors as well as regular subjects and requires access to the subject’s medical records. 1

4. Your Mission: Your mission, should you choose to accept it (you don’t really have a choice), will be to review the signature pages of each consent, assent and HIPAA. During the review, you will be working with your teammates to find as many possible errors as you can on each form. Keep in mind that some forms may be filled with mistakes while others may not have a single one. For this activity, you may circle or highlight the mistakes since you will be allowed to keep these forms. You and your team will have 10-15 minutes to identify all the errors. At the end of the 15 minutes we will review each form to determine what the errors were and to see if you were able to identify each one. As you work, keep in mind what corrective action you would recommend for each mistake. 1

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36. Questions? 1