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Analyze this scenario from the perspective of an Institutional Review Board (IRB) reviewer. Diagnose the ethical shortcomings of the proposed research protocol based on the core criteria the IRB is responsible for ensuring. How should the board decide on this protocol, and what specific modifications should they require the researcher to make before granting approval?
Case context: A developmental psychologist at a state university submits a research protocol to study the effects of parental separation on toddler emotional regulation. The proposed study involves observing toddlers in a lab playroom while their parents briefly exit, simulating separation. The researcher's protocol includes an informed consent form for parents but does not outline any procedures for monitoring or mitigating the toddlers' distress during the separation. The study has potential long-term benefits for understanding childhood anxiety, but the immediate distress caused to the children is significant.
Question: Analyze this scenario from the perspective of an Institutional Review Board (IRB) reviewer. Diagnose the ethical shortcomings of the proposed research protocol based on the core criteria the IRB is responsible for ensuring. How should the board decide on this protocol, and what specific modifications should they require the researcher to make before granting approval?
Sample answer: The protocol has significant ethical shortcomings regarding risk minimization and participant safety. While the study has potential benefits, the researcher has failed to minimize risks (distress) or provide adequate protocols for handling child distress during the separation. The IRB should not approve the protocol in its current form. Instead, the board should require the researcher to: 1) implement clear risk-mitigation strategies (e.g., immediate separation termination if a toddler becomes excessively distressed), 2) ensure the benefits clearly outweigh these minimized risks, and 3) ensure the informed consent procedure clearly informs parents of the potential distress their children might experience and how it will be managed.
Key points:
- Diagnose that the protocol fails to minimize psychological risks (distress) to the toddlers.
- State that the IRB must ensure risks are minimized and that benefits outweigh the risks.
- Recommend specific protocol modifications, such as setting a distress threshold for stopping the separation.
- Analyze the need to ensure the informed consent procedures adequately address these specific risks for parents.
Rubric: The response must diagnose the protocol's failure to minimize risk and manage participant distress. It must specify that the IRB should reject or require modifications to the protocol. It must recommend concrete modifications, such as establishing safety/distress thresholds and updating the informed consent process to reflect these risks.
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Research Methods in Psychology - 4th American Edition @ KPU
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Ethical Review of a Research Proposal
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Addressing IRB Concerns
Informed Consent Form
Minimal Risk
Institutional Approval
Expedited Research
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