What might happen if an IRB detects new risks during a continuing review?

When an Institutional Review Board (IRB) conducts a continuing review and identifies new risks, the primary concern is the safety and welfare of the research participants. In such cases, study parameters may need to be modified to mitigate these newfound risks. This may involve altering the study protocol, adjusting eligibility criteria, implementing additional monitoring procedures, or providing more robust informed consent processes to ensure that participants are aware of any potential harm associated with the study.

The IRB's role revolves around safeguarding participants, and detecting new risks typically leads to a reassessment of how the study is being conducted. Modifications could enhance the protections in place and help ensure that the research complies with ethical standards and regulatory requirements.

In contrast, options addressing the cessation of the investigation, increased funding, or withholding notifications to participants either overlook the ethical responsibilities of the IRB or misrepresent the typical responses to new risks identified during ongoing research. The IRB's focus is to ensure participant safety while allowing valuable research to continue under appropriate modifications.