Federal regulations require the reporting of unanticipated problems and adverse events that occur while a research study is underway. These problems and events need to be reported using the Unanticipated Problems and Adverse Events Report Form regardless of whether they are directly related to participation in a research study. The guidelines and procedures below are consistent with federal regulations and are meant to provide guidance to Clayton State University personnel involved in research studies. Detailed information and guidance provided by the federal Office for Human Research Protections (OHRP) as part of the Department of Health and Human Services can be found at (all files are pdf):
All unanticipated problems should be reported to the appropriate institutional officials, the supporting agency head (or designee), and OHRP within 1 month of the CSU IRB's receipt of a report from an investigator. Further actions that might need to be taken in response to an unanticipated problem or adverse event include:
*Source: Office of Human Research Protections (2007). Guidance on reviewing and reporting unanticipated problems involving risks to subjects or others and adverse events. Washington, DC: Department of Health and Human Services.