What is primarily assessed during an IRB continuation review?

During an IRB continuation review, the primary focus is on the extent to which the study meets ethical standards. The Institutional Review Board (IRB) is tasked with ensuring that all research involving human subjects complies with ethical guidelines and regulations. This includes evaluating whether the risks to participants are minimized, whether the potential benefits justify the risks, and whether the informed consent process is being followed properly.

In the context of an ongoing study, the IRB assesses whether there have been any changes to the study protocol that might impact the ethical considerations. This could involve any new risks identified since the last review or changes in the participant demographics that could affect their rights and welfare.

The other options, while potentially relevant to a research study, are not the primary focus during a continuation review. The success rate of the study, participant satisfaction, and funding level may be relevant for overall research administration, but they do not directly pertain to the ethical oversight that is the core responsibility of the IRB. The IRB’s mission is to protect the rights and welfare of research participants, which emphasizes the importance of adhering to ethical standards over other aspects of research management.