What measure should an IRB take if they have concerns about the emotional safety of participants?

Requesting changes to the study protocol is an appropriate measure for an Institutional Review Board (IRB) to take when there are concerns about participants' emotional safety. The study protocol outlines the methodology, procedures, and ethical considerations involved in the research. If there are potential emotional risks to participants, the IRB can mandate modifications to the protocol to enhance safety.

These modifications could involve changes to how participants are recruited, adjustments in the informed consent process, or the implementation of additional support services during or after participation. Such proactive measures ensure that the study design aligns with ethical research practices and prioritizes participant welfare, including their emotional well-being.

The other options may not directly address the immediate concerns about emotional safety with the same level of responsiveness. Postponing the study or changing participant inclusion criteria may mitigate some risks, but they do not actively enhance the protocols to ensure ongoing participant safety during the study itself. Conducting an additional emotional assessment could be useful, but it may only serve as a supplementary step rather than addressing potential protocol weaknesses that could lead to participant distress. Thus, requesting changes to the study protocol directly addresses the core of the issue, prioritizing participant protection.