A full IRB committee meeting is convened and one agenda item is a new research proposal to evaluate how mothers interact with their learning-disabled child. The inclusion criteria require 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. The committee determined that the mother's required task may upset the child. The IRB approved the study with appropriate language in the parental permission form regarding the possibility that children might become upset. After the start of the study, the Principal Investigator reports to the IRB that, as expected, one of the children became upset. The incident was handled according to the protocol and the child is fine. What should the IRB do with regard to this report?

When an Institutional Review Board (IRB) receives a report from a Principal Investigator indicating that an event occurred which was anticipated and addressed in the protocol, the IRB would typically follow these steps:

1. Review the Report: The IRB will first examine the details of the incident report from the Principal Investigator to understand the nature of the event and how it aligns with the anticipated issues mentioned in the study protocol.

2. Confirm Protocol Adherence: They would confirm that the incident was handled according to the outlined procedures in the protocol. This would involve ensuring that the appropriate steps were followed to mitigate any distress experienced by the child.

3. Assess the Impact: Evaluate if the event has broader implications on the overall risk assessment for the study participants. An isolated incident may not require changes, but if there is a pattern or increased frequency, this might indicate a need for protocol revision.

4. Determine Next Steps: If the event is consistent with what was expected and the protocol was followed correctly without causing harm, then the IRB may decide that no further action is necessary. However, if there is a need for concern or if the risk to participants is found to be greater than previously anticipated, the IRB may ask for modifications to the study or take other actions to ensure participant safety.

5. Documentation: All deliberations and decisions should be well documented for accountability and for future reference in case of similar incidents or studies.

6. Monitor the Study: The IRB may request more frequent reports from the Principal Investigator or consider additional monitoring measures if they believe that is warranted given the nature of the incident.

7. Ongoing Review: If more incidents of concern are reported, the IRB should continually reassess the risk/benefit ratio of the study and take appropriate measures which could include suspending or terminating the study if the risks outweigh the potential benefits.

Extra: The role of an IRB is to protect the rights and welfare of human research subjects recruited to participate in research activities. This protection is grounded in ethical principles outlined in the Belmont Report which include respect for persons, beneficence, and justice. The IRB reviews research protocols to ensure compliance with these principles, as well as federal, state, and institutional policies.

In this particular case, the study involves vulnerable participants - children with learning disabilities. Vulnerable populations are given special consideration under IRB policies and ethical guidelines, and protocols involving them require a careful balance of potential benefits and risks, with a strong emphasis on informed consent (or assent when appropriate) and minimizing potential harm.

The IRB's approach to reports of anticipated adverse events, like the one described, reflects its ongoing responsibility to monitor approved studies to ensure continuous protection of the participants. It is essential that the IRB be informed about all aspects of a study's conduct, so it can effectively safeguard the wellbeing of the participants while also allowing valuable research to move forward.