Problems Involving Risk/Noncompliance

Guidelines for Defining Problems to be Reported:

Unanticipated problems involving risks to participants or others and adverse effects need to be reported to the IRB.  Adverse effects may be directly or indirectly related to the research and may be expected or unexpected. 

The following examples illustrate what needs to be reported:

Unanticipated problem involving risk to participants:  The laptop computer which has identifying information about research participants is stolen.

Unanticipated problem involving risk to others:  The research assistant involved in the project is inadvertently exposed to a low level of radiation.

Expected adverse effect: Subject A becomes upset when asked about feelings regarding prior sexual abuse. The subject is referred for counseling.

Unexpected adverse effect: Subject B becomes agitated and angry when asked general non-invasive questions about the appropriateness of corporal punishment of children. The subject is referred for counseling.

Reports of adverse events must be reported immediately via phone, email, or in person to the IRB Chair and to the Office of Sponsored & Academic Programs Support.  A written report of the adverse event must then be submitted to the IRB Chair and OSRP, within 5 working days after first awareness of the problem