Reporting an unanticipated problem or noncompliance

If you have an unexpected event that is probably related to the research and potentially increases the risk profile of the study, there is a complaint from a participant that suggests there may be an increased risk to the study, or there is a breach of confidentiality, then you must report this to the IRB. Unanticipated problems that are serious UPIRSOs (Unanticipated Problems Involving Risk to Subjects or Others) should be reported within 7 days of learning of the event, unless the UPIRSO is potentially lethal, then it should be reported within 2 days. Other unanticipated problems should be reported within 14 days of learning of the event. UPIRSOs may require an amendment to the protocol to reduce risk, notification to current and/or past participants of the new risk, and/or, in some serious cases, inactivation of the protocol. Please include these materials with your report, as applicable.

In addition, any deviation from the approved protocol, no matter how small, must be reported to the IRB using the same timeline as above, with the exception that minor deviations that do not affect safety, increase risk, or violate rights and welfare of participants may be reported on the continuing review. If the reported deviation is a permanent change, it must be accompanied by an amendment request form.

If you need to report an unanticipated problem or an event of noncompliance, please complete the forms below and any other requested items and submit to orsp@acu.edu per the submission instructions.

Forms

 

Also attach, if applicable

 

Any persons with concerns regarding human research may bring these concerns in writing or in person to the IRB Chair. Concerns may be reported anonymously, and there will be no repercussions for personnel reporting policy violations. Whistleblower protections are posted in the Employee Handbook (421).

If you need to report a human research concern, please complete the form below. You may email this form to orsp@acu.edu or to the IRB Chair directly at megan.roth@acu.edu. You may also hand deliver this form to the ORSP Office in 320 Hardin Administration Bldg. You may send the form anonymously through campus mail to ACU Box 29103 c/o Megan Roth. Finally, you may place an anonymous phone call to the ORSP Office at 674-2885.

Reporting Welfare Concern - Human