If modifications are required before IRB/IEC approval, what should occur?

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Multiple Choice

If modifications are required before IRB/IEC approval, what should occur?

Any changes to the protocol or informed consent must ultimately receive ethical review before being used. If modifications are needed before IRB/IEC approval, the investigator should document the proposed changes and promptly inform the trial sponsor so the sponsor can review and submit the amendment to the IRB/IEC. Implementing changes unilaterally is not appropriate, and they aren’t filed away and forgotten. There is a safety exception: if a modification is needed to eliminate an immediate hazard, the change can be implemented promptly to protect participants, with rapid notice and subsequent IRB/IEC review.

Any changes to the protocol or informed consent must ultimately receive ethical review before being used. If modifications are needed before IRB/IEC approval, the investigator should document the proposed changes and promptly inform the trial sponsor so the sponsor can review and submit the amendment to the IRB/IEC. Implementing changes unilaterally is not appropriate, and they aren’t filed away and forgotten. There is a safety exception: if a modification is needed to eliminate an immediate hazard, the change can be implemented promptly to protect participants, with rapid notice and subsequent IRB/IEC review.

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