ITS FRIDAY!!! YAA!!! I know I sound like a broken record (for those of you who dont know what a record is, Google it) but dont forget that registration for the fall exam is August 1st. Here are questions for today: (one Case - two questions) CASE: A Full IRB Committee meeting is convened on October 18, 2013. The IRB Committee roster consists of 15 members. However, 9 members are in attendnace for todays meeting. One agenda item is a new research proposal to evaluate how mothers interact with their learning disabled child. The inclusion criteria requires the children to be a minimum of five years of age. The protocol requires the mother of the child to look at the child without any expression and not to talk to the child for three minutes. One of the IRB members, Susan, is the PI for the study and receives a portion of her salary from the supporting grant. Question #1 - There were a number of problems with the protocol, but the IRB eventually approved the protocol at a duly constituted Full IRB Committee meeting on February 15, 2014. Accrual and treatment are planned to continue through 2015. Which of the following best describes IRB continuation review requirements for this study? A. The research must be re-reviewed by the Full IRB Committe on or before February 14, 2015. B. The research must be re-reviewed by the Full IRB Committee on or before October 17, 2014. C. The research is risky and involves a vulnerable population, the Full IRB Committee should re-review the study within 6 months of the February 14, 2015 meeting. D. The continuation review can be conducted by the IRB Chair through the expedited review process. Question #2 - The Committee determined that the mothers required task may upset the child. Which of the following actions best describes the most appropriate steps for the committee to take? A. Recommend a therapist evaluate the child after the activity is completed. B. Deny the study because it is way too risky to the child. C. Evaluate the study risks and benefits to determine appropriate procedures are in place to minimize risks. D. Assign a Committee member to observe the study procedures and submit a report to the Committee regarding the experience.
Posted on: Fri, 25 Jul 2014 12:46:39 +0000
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