Institutional Review Board Unanticipated Problem Report PI Name: IRB #: Title of Protocol: Definitions Unanticipated problem - Any event or information that (1) was unforeseen and (2) indicates that the research procedures may have caused harm to participants or others or indicates that participants or others are at increased risk of harm. The harm does not have to be a direct harm to be reportable. The harm, as assessed by the PI or monitoring agent, has presented increased risk (e.g., losing a laptop with subject data.) Additionally, the harm doesn't have to be the harm to subjects it could involve risk to others (researchers, technicians, bystanders, the public, etc.) Note: non-medical events (e.g., breach of confidentiality, emotional breakdown, loss of insurance, etc.) if unanticipated or not specified in the approved protocol or consent – is also reportable to the IRB. Unanticipated/Unexpected- An event is unanticipated or unexpected when its specificity or severity is not consistent with the current investigator brochure, protocol, consent form, package insert or label; or unanticipated in its frequency, severity, or specificity.* Harm is anything that has negative effect on the welfare of subjects; the nature of the harm may be social, behavioral, psychological, physical, economical, legal, and reputational. Related – An event is related to a research procedures if in the opinion of the principal investigator, it was more likely than not to be caused by the research procedures or if it is more likely that not that the event affects the rights and welfare of current participants. Adverse Event – Is any physical, psychological or social harm to subjects during the course of research. *Note: If an anticipated event has changed in specificity or severity and is no longer consistent with the current protocol or consent form it is now an UNANTICIPATED EVENT. 1. Study Status Indicate where this study is taking place This is a follow-up report This study is open to enrollment Protocol Involves: Multi-Site; But event occurred here Event occurred off-site Princeton only Yes; original report date was: No; Date Event occurred: Yes No Interview procedures Investigator Initiated Investigational Drug Investigational Device IND# IDE# Unanticipated Event Report 5-2013 Page 1 of 3 2. Type of Event Any of the following must report to the IRB as soon as possible, but in all cases within 5 working days: Adverse event which in the opinion of the principal investigator is both unexpected and related An unanticipated event related to the research that exposes individuals other than the research participants (e.g., investigators, research assistants, students, the public, etc.) to potential risk Information that indicates a change to the risks or potential benefits of the research. For example: • an interim analysis or safety monitoring report indicates that frequency or magnitude of harms or benefits may be different than initially presented to the IRB • a paper is published from another study that shows that the risks or potential benefits of your A breach of confidentiality Incarceration of a participant in a protocol not approved to enroll prisoners Change to the protocol taken without prior IRB review to eliminate an apparent immediate hazard to a research participant Complaint of a participant when the complaint indicates unexpected risks or cannot be resolved by the research team Protocol violation (meaning an accidental or unintentional change to the IRB approved protocol) that harmed participants or others or that indicates participants or others may be at increased risk of harm Event that requires prompt reporting to the sponsor Sponsor imposed suspension for risk 3. Event Information Briefly describe the circumstances of this event State whether the event was anticipated and describe Yes No Other; describe: Date of the Event Intensity mild Severe Unknown Was event study-related? How long did the event last Currently enrolled volunteers will be notified of this event Yes; describe method of notification: No Previously enrolled volunteers will be notified of this event Yes; describe method of notification: No P.I.’s statement of this Event in relation to the study Event Information (Complete this section only if you are reporting an Anticipated (Expected) Event that has changed and requires updating see Definition section above) The risk of this event is currently outlined in the study’s consent form Yes No Unanticipated Problem Report 2013 Page 2 of 3 Yes No The risk of this event is currently outlined in the study’s approved protocol If you answered “yes” to either question above, explain why you are reporting this event to the IRB Explain any changes you will be making to the protocol, consent or IRB application Note: Any Changes MUST be submitted to the IRB on a Request for Amendment Form 4. Research Participant Information For purposes of this form, the term “subjects” should be read to refer to all participants, patients, etc. Yes No This event involved a healthy volunteer Participant age ( if age is > 88, do not list age just state ‘89 or above’) Participant gender Male Female Participant Status Pre-screened Enrolled Yes No: This event involved a healthy participant 5. Attachments This event has prompted a change to the Informed Consent(s)/Assent(s): This event has prompted a change to the Protocol This event has prompted an update in the IRB application Yes Attached version date is: No Yes Attached version date is: No Yes Attached version date is: No If you answered “no” to any of the question above, explain why you are reporting this event to the IRB Note: Any Changes MUST be submitted to the IRB on a Request for Modification Request form PI’s Signature Date Print Name Signature I ATTEST THAT THE INFORMATION CONTAINED HEREIN IS A TRUE AND ACCURATE REPRESENTATION OF MY ONGOING STUDY AND THE EVENTS THAT OCCURRED. (IRB Use Only) Status Acknowledged Full Board Reviewer Review Date Unanticipated Problem Report 2013 Page 3 of 3