Serious or Continuing Noncompliance      June 2006

Serious or Continuing Noncompliance (SCNC) events are defined as:

1. investigator noncompliance with
   
   
   1. the requirements or determinations of the CHR, and/or
   
   
   
   2. university policies, and/or
   
   
   
   3. state or federal regulations for protection of the rights and welfare of study participants



2. and that indicate
   
   
   1. a potential for significant risk to participants or others, or
   
   
   
   2. a compromise the integrity of the HRPP and/or the University.

Examples: Conducting human research without CHR review and approval or repeated failure to correct significant research-related problems or to comply with HRPP guidelines or directives.