|*NEW* The Unanticipated Problem and Adverse Event (AE) Reporting policy & form have been replaced with a new Reportable New Information policy and form.
During the course of a research study, unanticipated problems involving risk to subjects or others, non-compliances, and other events may occur that need to be reported to the IRB in accordance with 45 CFR.46.103(b)(5) and 21 CFR 56.108(b). The list below is intended to help ensure that the reporting and review of these events occur in a timely, meaningful way so that research participants can be protected from avoidable harms.
Report the information items that fall into one or more of the following categories to the IRB within 5 business days using the Reportable New Information (HRP-214) form. For any questions or clarifications on the below, please call the IRB office at 617-636-7512:
Information that does not fall under any of the categories does not require reporting to the IRB.
Do not include subject identifiers when submitting reportable new information to the IRB, unless identifying the subject is absolutely necessary (for example, if the IRB will need to contact the subject).
In general, when submitting reportable new information, redact subject identifiers by doing the following:
When corresponding by e-mail, re-read your e-mail to double check that the e-mail and any e-mails in the chain do not include subject identifiers.
Adverse Event: Any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject’s participation in the research, whether or not considered related to the subject’s participation in the research (modified from the definition of adverse events in the 1996 International Conference on Harmonization E-6 Guidelines for Good Clinical Practice).
External Adverse Event: From the perspective of one particular institution engaged in a multicenter clinical trial, external adverse events are those adverse events experienced by subjects enrolled by investigators at other institutions engaged in the clinical trial.
Internal Adverse Event: From the perspective of one particular institution engaged in a multicenter clinical trial, internal adverse events are those adverse events experienced by subjects enrolled by the investigator(s) at that institution. In the context of a single-center clinical trial, all adverse events would be considered internal adverse events.
Possibly Related to the Research: There is a reasonable possibility that the adverse event, incident, experience or outcome may have been caused by the procedures involved in the research (modified from the definition of associated with use of the drug in FDA regulations at 21 CFR 312.32(a)).
Serious Adverse Event: Any adverse event temporally associated with the subject’s participation in research that meets any of the following criteria:
Unanticipated problem involving risks to subjects or others: Any information, including any incident, experience, or outcome that meets ALL of the following conditions:
Unexpected adverse event: Any adverse event occurring in one or more subjects in a research protocol, the nature, severity, or frequency of which is not consistent with either: