Researcher File Keeping Requirements
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- Researcher must keep copies of signed consent forms under lock and key, available for HSC inspection.
- Researcher should keep own file of all correspondence with HSC.
- Researcher must notify HSC of unexpected events that change the research procedure or raise risks or other concerns that UCAR should know about. Researcher’s file should document such events.
- For research protocols that have undergone full committee review (vs. expedited review), when those studies continue for more than one calendar year the researcher will provide a yearly status to the HSC via email to hsc@ucar.edu. Status should include: 1) whether the research is still ongoing, and 2) if its scope involving human subjects research as presented to the HSC remains the same.
- If the HSC has given preliminary approval of a protocol, it is up to the researcher to update the HSC and resubmit the protocol once the grant is awarded or the study scope is more complete.
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