HSC Researcher File Keeping Requirements

Researcher File Keeping Requirements (updated 11/21/14)

  • 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.

  • Research protocols that have undergone full committee review or expedited review are approved for a maximum of one year.

    1. If  those studies continue for more than one calendar year and there are any changes involving human subjects, a new approval will need to be obtained by completing a new Requirements for a Study Protocol form.  

    2. If  the study continues for more than one calendar year and there are NO changes involving human subjects, the researcher needs to send an email request to hsc@ucar.edu requesting a one-year extension, and reference the original HSC approval memo number.   

  • If the HSC has given Pending  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.

  • The researcher is required to notify the HSC annually, as to the status of the research, as well as send email notification when the study is completed.