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Based on the principles of protocol modification approval, evaluate Dr. Smith's actions. What did Dr. Smith do wrong, and what should they have done instead?
Case context: Dr. Smith is conducting an ongoing study on sleep deprivation. Halfway through data collection, Dr. Smith decides to add a new cognitive stressor task to the procedure. Instead of pausing data collection, Dr. Smith immediately implements the new task with the next participant, planning to notify the ethics committee at the end of the semester.
Question: Based on the principles of protocol modification approval, evaluate Dr. Smith's actions. What did Dr. Smith do wrong, and what should they have done instead?
Sample answer: Dr. Smith's actions were incorrect because adding a cognitive stressor task is more than a minor change to the procedure. According to protocol guidelines, Dr. Smith should have sought and received additional formal approval from the Institutional Review Board (IRB) or relevant ethics committee before implementing this modification to the study.
Key points:
- Dr. Smith implemented a non-minor change without prior approval.
- Dr. Smith should have sought additional formal approval.
- The approval should have come from the IRB or relevant ethics committee.
- Approval was required before implementing the new procedure.
Rubric: A correct response must diagnose that Dr. Smith violated the protocol by implementing a significant change without prior approval, and comprehend that IRB/ethics committee approval must be secured before the change is executed.
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Research Methods in Psychology - 4th American Edition @ KPU
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