What are the researchers responsibilities if a serious or unexpected adverse event occurs?
All adverse events that occur during the conduct of a research protocol involving human subjects must be addressed in accordance with sound professional judgment, and (as applicable) requirements of the sponsor, federal regulations, and institutional policy. Adverse events that also meet the criteria to be considered unanticipated problems (see section D.11) must also be reported to the IRB in RASCAL, via the Unanticipated Problems function of the IRB module. Review the Columbia policy for more details: Unanticipated Problems Reporting Policy. • When is a Certificate of Confidentiality required? A Certificate of Confidentiality is issued by a federal agency when protection against compelled disclosure of identifying information about subjects of biomedical, behavioral, clinical, and other research is necessary. For additional information, review the information posted by the US Department of Health & Human Services on the Office for Human Research Protections (OHRP) web site at: http:/
