To Whom it May Concern

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					To Whom It May Concern: RE: IUPUI/Clarian Policy on Adverse Events That Require Prompt Reporting to the IRB Federal regulations (45 CFR 46 and 21 CFR 56) require that institutions establish written procedures for ensuring prompt reporting to the IRB, appropriate institutional officials, and the federal department or agency head of any unanticipated problems involving risks to subjects or others. FDA has additional regulations that require reporting of adverse events from the investigators to the sponsor and from the sponsor to the FDA, as well as to other clinical investigators using the test article. Uniquely, in device studies, FDA requires reporting of unanticipated adverse device effects directly to the IRB overseeing the research. Indiana University-Purdue University, Indianapolis (IUPUI)/Clarian Health Partners (CHP) has adapted its policy to be consistent with the OHRP’s “Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events” dated January 15, 2007 and available online at: http://www.hh.sgov/ohrp/policy/AdvEvntGuid.htm. The IUPUI/Clarian policy on prompt reporting of unanticipated problems involving risks to subjects or others is contained within the following Standard Operating Procedure (SOP): IUPUI/Clarian SOP for Unanticipated Problems and Noncompliance, which can be accessed at: Although the policy describes the reporting requirements for a number of events that require prompt reporting to the IRB (adverse events being one of them), this letter only addresses the specific adverse events that must be promptly reported to the IRB. IUPUI/Clarian policy requires the prompt reporting to the IUPUI/Clarian IRBs any unanticipated problems involving risks to subjects or others. IUPUI/Clarian considers unanticipated problems, in general, to include any incident, experience, or outcome that meets all of the following criteria: 1. Suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized; AND 2. Is unexpected (in terms of the nature, frequency or severity of the event) and inconsistent with either (a) the known or foreseeable risk of adverse events associated with the procedures involved in the research that are described in (1) the protocol-related documents, and (2) other relevant sources of information; and (b) the expected natural progression of any underlying disease, disorder, or condition of the subjects experiencing the adverse event and the subject’s predisposing risk factor profile for the adverse event; AND 3. Is related or possibly related (there is a reasonably possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research) to participation in the research; AND 4. Requires revision to the informed consent process/document or changes to the research protocol. Any adverse event meeting all of the above-listed criteria must be reported to the IRB within 5 working days using the IUPUI/Clarian Prompt Reporting Form. Only a small subset of adverse events occurring in human subjects participating in research will meet these criteria for an unanticipated problem. The IUPUI/Clarian IRBs will not accept any prompt report of an adverse event that does not meet the prompt reporting requirements listed above. Instead, the adverse event shall be reported to the IRB in the adverse event summary provided at the time of continuing review. Adverse events that are submitted to the IRB on the prompt reporting form that are found not
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to meet the IRB’s prompt reporting requirements will not be promptly reviewed by the IRB and will be returned to the investigator. Adverse events that occur or become known after the study has been permanently closed with the IRB need not be reported unless they are profound. If the adverse event results in a revision to the informed consent document or the protocol, the principal investigator must also submit a study amendment for IRB review and approval. In some cases, newly discovered information and/or unanticipated risks may require the IRB to review the protocol more frequently than once a year. Sincerely, Shelley D. Bizila, MS, CIP Research Integrity Officer Director, Research Compliance Administration For additional information, please see the:  IUPUI/Clarian SOP for Unanticipated Problems and Noncompliance at:; and  Prompt Reporting Form at:



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