Reporting to IRB
Unanticipated Problems (any incident, experience, or outcomes that meets all of the following criteria:
- unexpected(in terms of nature, severity, or frequency) given (a) the research procedures that are described in the protocol-related documents, such as the IRB-approved research protocol and informed consent document; (b) the characteristics of the subject population being studied; and
- is related or possibly relatedto the research (this means that it is more likely than not, the incident, experience, or outcome was 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.
Unanticipated Problem that are serious adverse events should be reported to the IRB within one (1) week of the investigator becoming aware of the event. Any other Unanticipated Problem should be reported to the IRB within two (2) weeks of the investigator becoming aware of the problem.
Please see TAMUT SOP Section 19 for more information.
If you come across any concerns, please contact TAMUT IRB as irb@tamut.edu.