What should investigators do regarding unanticipated problems in research?

Investigators are required to obtain Institutional Review Board (IRB) approval before making any changes related to unanticipated problems in research. This is essential because unanticipated problems can pose risks to participants that were not anticipated at the time the research was approved. By seeking IRB approval, investigators ensure that these changes are reviewed in relation to ethical considerations and the overall safety of participants.

The IRB's role includes assessing whether the risks associated with the changes are justified and ensuring that appropriate measures are in place to mitigate those risks. This process protects the participants and upholds the integrity of the research study by ensuring that it continues to align with ethical guidelines and regulatory requirements.

Reporting unanticipated problems solely at the end of the study or only during annual reviews would compromise participant safety and the ethical oversight provided by the IRB. Additionally, notifying the IRB only when investigators feel it is critical could lead to significant delays in addressing potential risks, which could endanger participants involved in the study. Thus, timely communication and approval from the IRB for any changes arising from unforeseen issues is mandatory for responsible research conduct.