Certification for IRB Professionals (CIP) Practice Exam

What must an IRB do if it becomes aware of new risks associated with a study?

1. Adjust the research design

2. Notify the investigator and participants

3. Conduct an additional review

4. Terminate the study immediately

The correct answer is: Conduct an additional review

When an IRB becomes aware of new risks associated with a study, conducting an additional review is essential to ensure that the research continues to meet ethical standards and safeguards are in place for participants. The IRB's primary responsibility is to protect the rights and welfare of human subjects. An additional review allows the IRB to evaluate the implications of the newly identified risks and determine whether the study's benefits still outweigh those risks. It provides an opportunity to reassess the study protocols, informed consent documents, and any existing risk mitigation strategies. Adjusting the research design or terminating the study may be recommendations that arise from this additional review, but these actions are not automatic. Furthermore, notifying the investigator and participants is also important, but it typically occurs after the IRB has conducted its review and made appropriate decisions based on the new information. Thus, conducting an additional review in response to new risks ensures an informed and systematic approach to maintaining participant safety and ethical compliance in the study.