If granted a waiver by the IRB, can investigators collect any information they think is relevant in a medical record review?
No. The Privacy Rule and common sense dictate that only the minimum information necessary be collected. Investigators will need to supply the IRB with a detailed listing of all data elements to be collected. Where appropriate, the IRB may ask for a rationale for the collection of specific information that may not appear to be in keeping with the protocol.
Related Questions
- I am conducting a study using medical records under an IRB approved waiver of consent obtained prior to April 14, 2003. Do I need to do anything with respect to the Privacy Rule?
- If granted a waiver by the IRB, can investigators collect any information they think is relevant in a medical record review?
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