Which entity must researchers report potential unanticipated problems involving risks to others?

Researchers must report potential unanticipated problems involving risks to others to the Institutional Review Board (IRB). The IRB is responsible for the ethical oversight of research involving human subjects. It has the mandate to ensure the safety and welfare of participants, which includes monitoring for any unexpected issues that could arise during the research process.

When researchers encounter unanticipated problems that might pose risks not previously considered, it is their obligation to report these findings to the IRB so that the board can assess the situation and determine whether modifications to the research protocol, additional protections for participants, or even suspension of the study are necessary. This process is crucial to uphold ethical standards and participant safety within the research environment.

In contrast, while a Data Safety Monitoring Board may monitor ongoing research for safety, its role is different and usually pertains to the day-to-day monitoring of clinical trials rather than receiving reports of unanticipated problems. The Federal Trade Commission focuses on consumer protection and does not have a role in research oversight. A Research Ethics Committee may have similar functions to an IRB in some contexts, but in most cases, the IRB is the primary body that addresses these specific reporting requirements in accordance with regulations governing human subjects research.