amendments involving changes to irb-approved protocols do not need prior irb approval if:

Hi, I have a question and I hope anyone could answer it:

Amendments involving changes to IRB approved protocols do NOT need prior IRB approval if:

1 Answer

  1. Answer:

    If the approved procedures to be conducted at that visit can be done remotely without compromising the safety of the research participant or the scientific validity of the study, this would be considered a minor deviation and would not require prior approval by the IRB, and no additional consent is required.

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