How should an investigator communicate with the Institutional Review Board (IRB) or Independent Ethics Committee (IEC)?

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Multiple Choice

How should an investigator communicate with the Institutional Review Board (IRB) or Independent Ethics Committee (IEC)?

Ongoing, clear communication with the IRB/IEC is essential to protect participants and maintain trial integrity. Investigators must keep the IRB/IEC informed about how the study is progressing and promptly report any issues that could affect safety or the reliability of the data. This includes not only adverse events but also other important updates: protocol deviations or violations, amendments to the protocol, changes in the consent form, new safety information, and any actions that could influence risk-benefit judgments. It also covers administrative changes like new or departing investigators, recruitment challenges, and when continuing review is due. Communications should follow the IRB/IEC’s specified formats and timelines, with some information requiring expedited reporting and others requiring formal submissions at scheduled intervals. Choosing to communicate only at the end of the trial, or to treat communication as optional, would undermine subject protection and oversight. Likewise, limiting communication to adverse events misses the broader set of factors that can impact participant safety and study integrity.

Ongoing, clear communication with the IRB/IEC is essential to protect participants and maintain trial integrity. Investigators must keep the IRB/IEC informed about how the study is progressing and promptly report any issues that could affect safety or the reliability of the data.

This includes not only adverse events but also other important updates: protocol deviations or violations, amendments to the protocol, changes in the consent form, new safety information, and any actions that could influence risk-benefit judgments. It also covers administrative changes like new or departing investigators, recruitment challenges, and when continuing review is due. Communications should follow the IRB/IEC’s specified formats and timelines, with some information requiring expedited reporting and others requiring formal submissions at scheduled intervals.

Choosing to communicate only at the end of the trial, or to treat communication as optional, would undermine subject protection and oversight. Likewise, limiting communication to adverse events misses the broader set of factors that can impact participant safety and study integrity.

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