1 Unanticipated problems Melody Lin, Ph.D. December,

Unanticipated problems involving risk to participants or others Is unexpected Is related or possibly related to participation in the research, and Indicates that subjects or others are at a greater risk of harm (physical, psychological, economic, or social harm) than was previously known or recognized.

Unexpected The incident, experience or outcome is not expected (in terms of nature, severity, or frequency) i.e. the IRB-approved protocol and informed consent documents; and the characteristics of the subject population being studied;

Related There is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research.

Or others UAE expose individual other than subject. i.e. PI, research assistant, student or pubic.

Examples of unanticipated problems involving risk to subjects or others A researcher – survey questions trigger an intensely negative psychological reaction in some subjects. The response is unforeseen and the possibility of such a reaction was not included in the research plan. – loses a laptop with individual identifiable subject information – accidentally injures an child during a child development assessment A research assistant is physically threatened while doing an interview in the home of a subject Sexually explicit material part of an internet survey for adults is inadvertently released on a publically available website

Reporting Unanticipated Problems to the IRB Each institution – will have policies on what constitutes “prompt” reporting. Researchers should check with their local IRB to determine reporting standards. – should determine which individual(s) or office(s) is responsible for determining whether an event is in fact an unanticipated problem involving risk to subjects or others. Researchers should develop a clear process for promptly detecting possible unanticipated problems involving risk to subjects or others promptly, and reporting them to their IRB.

Other reporting requirements Researchers should be prepared to report any of the following to their IRB: Any information that indicates a change to the risks or potential benefits of the research. Changes to the research plan made without prior IRB review to eliminate an apparent immediate hazard to a subject. Complaints from subjects that cannot be resolved by the research team. Incarceration of a subject in a study not approved to enroll prisoners. Protocol deviations that affect risk to a subject. Unexpected breaches of confidentiality. Unexpected and related adverse events.

When providing a report to the IRB, researchers should provide A description of the problem in lay language understandable to the non-scientific members of the IRB. Suggested changes to the research, if any. Suggested changes to the information disclosed in the consent process, if any