ࡱ> _ Jbjbj @l9b9b G@ VVVjjj8ljJ>.X$=======$x@.C@=QVb"=>R8V==:$,>!%p "fR$ y=>0J>$RnDnD!%!%nDV5%D==J>nD B :   REPORT OF AN ADVERSE EVENT OR UNANTICIPATED PROBLEM for Human Subject Research Adverse events and unanticipated problems must be reported to the IRB as soon as they are identified. Adverse event or unanticipated problem defined: Adverse event: Adverse events encompass both physical and psychological harm. They occur most commonly in the context of biomedical research, although on occasion, they can occur in the context of social and behavioral research. Unanticipated problem: Any incident, experience or outcome that meets all of the following criteria: Unexpected (in terms of nature, severity, or frequency) given the research procedures that are described in the protocol-related documents (such as the IRB-approved research protocol and informed consent document), and the characteristics of the subject population being studied; Related or possibly related to participation in the research (possibly related means there is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research); and Suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized. 1. ProtocolTitle: FORMTEXT      IRB Number:  FORMTEXT      Today s Date:  FORMTEXT      Principal Investigator:  FORMTEXT      E-mail:  FORMTEXT      Other person to correspond with regarding this report:  FORMTEXT      E-mail:  FORMTEXT       FORMCHECKBOX  I am a student. If a student, please provide information about your faculty sponsor below.Name:  FORMTEXT      E-mail:  FORMTEXT      2. Event/Problem ReportingDate event/problem occurred:  FORMTEXT      Date event/problem was identified:  FORMTEXT      Location of event/problem:  FORMTEXT      Please describe event/problem: FORMTEXT      Has this happened previously?  FORMCHECKBOX  Yes  FORMCHECKBOX  No If  yes, please describe: FORMTEXT      Does this involve a breach of confidentiality?  FORMCHECKBOX  Yes  FORMCHECKBOX  No3. Analysis/Plan of ActionDo you think this changes the risk benefit ratio of the study?  FORMCHECKBOX  Yes  FORMCHECKBOX  No9:;<UVW # | ŵҨwgWHWH8Hh\2h<5CJOJQJaJh\2h<CJOJQJaJh\2h<6CJOJQJaJh\2h<>*CJOJQJaJh6 KOJQJh<OJQJh">OJQJhR^5OJQJh9lXhR^5CJOJQJaJhR^5CJOJQJaJhR^hR^5CJOJQJaJh">5CJOJQJaJhj(5CJOJQJaJ-jhj(5CJOJQJUaJmHnHuh*YE5OJQJV ? 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FORMCHECKBOX  Yes  FORMCHECKBOX  No Please explain: FORMTEXT       What actions have you taken in response to this event/problem? FORMTEXT      What actions, if any, do you think are appropriate to prevent this from occurring again? FORMTEXT       FORMTEXT       FORMTEXT      Principal Investigator Name and SignatureDate NOTE: If this form is e-mailed from the Principal Investigator s Davidson e-mail account, a hand written signature is not needed. Please type in name and date and e-mail to HYPERLINK "mailto:hsirb@davidson.edu?subject=Adverse%20Event"hsirb@davidson.edu as an attachment.       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