ࡱ>  ȑbjbj Bee3, , 8H0\ ( _!:%<' .......,1z4/(_!_!((/) /)))(  .)(.))-.p>?)../00.8<5)<5(.).8(((//)(((0<5(((((((((, :   NEIU ADVERSE EVENT/UNANTICIPATED PROBLEM REVIEW/REPORTING POLICY An Adverse Effect or Event (AE) is defined as An unfavorable or unintended physical or psychological event, injury or other unanticipated problem that occurs to a human subject associated with a research study or Any unfavorable and unintended diagnosis symptom, sign, syndrome or disease which either occurs during the study, having been absent at baseline, or, if present at baseline, appears to worsen. An adverse event is considered to be a serious adverse event (SAE) if the event results in or requires medical or surgical intervention to prevent any of the following outcomes: death, a life-threatening situation, hospitalization or prolongation of existing hospitalization, a persistent or significant disability or incapacity, a congenital anomaly or birth defect. A serious adverse event may be related or unrelated to the research and is usually unanticipated. Unanticipated risks are sometimes discovered during the course of research. Information that may impact on the risk/benefit ratio of the research should be promptly reported to, and reviewed by the IRB to ensure adequate protection of the welfare of the subjects. Based upon such information, the IRB may reconsider its approval of the study, require modifications to the protocol and/or consent process, or revise the continuing review timetable. Unanticipated problems (such as a breach of confidentiality, subject complaint, or protocol deviations) can occur in all types of human subject research both behavioral and biomedical. Federal Regulations require that all serious adverse events and/or unanticipated problems be promptly reported to the IRB. OSP requires that all serious adverse events and/or unanticipated problems be reported within five (5) working days of discovery of the incident. Non-serious, research-related, adverse events that do not impact the risk/benefit ratio of the research should be reported to the IRB on the Continuing Review Report at the time of protocol renewal. 45 CFR 46.103(b)(5) states that an IRB must have written procedures for ensuring prompt reporting to the IRB, appropriate institutional officials, and the Department or Agency head of (i) any unanticipated problems involving risks to subjects or others or any serious or continuing noncompliance with this policy or the requirements or determinations of the IRB; and (ii) any suspension or termination of IRB approval. The following policy describes the procedures for the reporting and review of all reportable events (adverse events, safety reports, subject complaints and unanticipated problems) to OSP. The Human Subjects Committee will be reviewing these reports. Please contact them through the Office of Sponsored Programs (L-Illian@neiu.edu or 773/442-4672) if you have any questions regarding this policy or how to handle a specific event. EVENT REPORTING PROCESS Reporting Events to the NEIU IRB All serious adverse events and unanticipated problems or adverse events that represent an increase in severity or frequency of the known risks should be reported within five (5) working days of discovery of the incident. Any death of a NEIU subject enrolled in a research project must be reported as soon as possible, but no later than within 48 hours of discovery of the event by calling the OSP. A written summary of this event must be submitted to OSP within five (5) working days following the telephone call. You must use the NEIU Adverse Event/Unanticipated Problem Report Form to submit your written summary of this event. Non-serious adverse events not affecting the risk/benefit ratio of the research, but related to research participation in the research should be reported to the IRB on the Continuing Review Report at the time of protocol renewal. Protocol Deviations, Unanticipated Problems, and Subject Complaints should be individually reported using the Adverse Event/Unanticipated Problem Report form. In the report of these events, please particularly describe how the event was resolved and if changes are required in the protocol procedures and/or the consent process. Event Submission Process The process for submitting a reportable event is as follows: Complete the NEIU Adverse Event/Unanticipated Problem Report Form. One report form must be completed for each reportable event. You must answer the questions in both Sections A and B. Incomplete forms may be returned without review. Attach one (1) copy of any supporting documentation (i.e., case report form, death certificates). Attach copies of any amendments, revised informed consent documents, assent documents, research protocol, and/or protocol application, if applicable. See below for more information regarding amendments/revisions. Submit the completed report form and supporting documentation to the OSP office. The Principal Investigator will be notified only if any missing documentation or additional information is required, or if the AE requires review by the convened IRB. 3) Additional Reporting Requirements and Considerations: Changes to the Consent Process/Documents, Protocol Application, and/or Research Protocol If the reportable event warrants change to the informed consent process/document(s) (consent, parent/guardian permission or assent documents), the research protocol application, and/or research protocol, the document NEIU IRB Amendments to Previously Approved Research must also be completed and submitted for review by the IRB. See the amendment submission instructions for the appropriate submission procedures and number of copies. 4) Reportable Event Review Process The HSC Chair will conduct a pre-review of the reportable event. Based upon this pre-review, if it is noted that any documentation/information is missing that may assist in the review, the HSC Chair will request the missing documentation/information from the PI prior to the IRB review. Incomplete submissions may be returned to the PI without review. Events that need no further action will be documented and reported to the IRB. You will receive an e-mail notification acknowledging the submission of the report from OSP. Events that require IRB review (changes to the protocol or consent, apparent increase in the risks, or other actions) will be reviewed through either expedited or convened IRB review procedures as deemed appropriate and the PI will be notified. If convened IRB review is required, additional copies and/or information may be requested as required. A letter informing the PI of the outcome of the IRBs determination will be provided. If changes are required to the consent documents, consent process, and/or research protocol, appropriate revisions will need to be submitted to the IRB for further review.  ADVERSE EVENT / UNANTICIPATED PROBLEM REPORT INSTITUTIONAL REVIEW BOARD/HUMAN SUBJECTS COMMITTEE Office of Sponsored Programs 5500 N. St. Louis Ave, CLS 2108 Phone:773/442-4672 Fax:773/442-4673  HYPERLINK "http://www.neiu.edu/~sprogram" http://www.neiu.edu/~sprogram Date Report Completed:  FORMTEXT       Research Protocol Number  FORMTEXT      Project Title  FORMTEXT      Principal Investigator Name (Last, First) Degree Campus Phone Campus Fax E-mail Address  FORMTEXT        FORMTEXT        FORMTEXT        FORMTEXT        FORMTEXT       A. DESCRIPTION OF EVENT 1. Type of Event  FORMCHECKBOX  Adverse Event  FORMCHECKBOX  Unanticipated Problem  FORMCHECKBOX  Subject Complaint2. Report Type  FORMCHECKBOX  Initial  FORMCHECKBOX  Follow-up Follow-up #  FORMTEXT      Amendment Attached?  FORMCHECKBOX  Yes  FORMCHECKBOX  No  FORMCHECKBOX  Pending4. Location of Event  FORMCHECKBOX  NEIU Performance Site:  FORMCHECKBOX  Off-campus:  FORMTEXT       FORMTEXT        FORMCHECKBOX  Non-NEIU Site:  FORMTEXT       FORMTEXT        FORMCHECKBOX  Reportable event occurred outside of this research protocol, i.e. Safety Report5. Subject Study ID#  FORMTEXT      6. Date and Time of Event  FORMTEXT      7. Number of Subjects Currently Enrolled at NEIU Sites  FORMTEXT      8. Provide a brief narrative of the event, injury, problem, or complaint including steps or actions taken to resolve the issue attach additional pages as necessary.  FORMTEXT      9. Did the reportable event involve: Check ALL that apply.  FORMCHECKBOX  Life threatening experience  FORMCHECKBOX  Psychological harm or injury  FORMCHECKBOX  Required in-patient hospitalization  FORMCHECKBOX  Social harm or injury  FORMCHECKBOX  Prolonged current hospitalization  FORMCHECKBOX  Economic harm  FORMCHECKBOX  Congenital anomaly/birth defect  FORMCHECKBOX  Breach of confidentiality  FORMCHECKBOX  Persistent or significant disability/incapacity  FORMCHECKBOX  Drug:  FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT        FORMCHECKBOX  New disease or problem  FORMCHECKBOX  Device:  FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT        FORMCHECKBOX  Death - underlying/progressive disease  FORMCHECKBOX  Biological:  FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT        FORMCHECKBOX  Death - research related  FORMCHECKBOX  Other:  FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       10. What was subject s participation level after the event?  FORMCHECKBOX  Stopped research intervention  FORMCHECKBOX  Continued research intervention / interaction  FORMCHECKBOX  Continued research - follow-up only  FORMCHECKBOX  Already completed research  FORMCHECKBOX  Subject withdrew from further participation  FORMCHECKBOX  Investigator withdrew subject from further participation 11. Has this incident occurred previously in this research at NEIU or another site? If so, please describe.  FORMTEXT      B. INVESTIGATOR S ASSESSMENT 1. In the Principal Investigator s judgment, what was the event? Choose one of each.A. FORMCHECKBOX  Expected  FORMCHECKBOX  UnexpectedB. FORMCHECKBOX  Serious  FORMCHECKBOX  Non-serious 2. 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FORMCHECKBOX  Definite - clearly related to the research  FORMCHECKBOX  Unlikely - doubtfully related to the research  FORMCHECKBOX  Probable likely related to the research  FORMCHECKBOX  Unrelated clearly not related to the research  FORMCHECKBOX  Possible - may be related to the research 3. In the Principal Investigators judgment, are the probability, magnitude, and reversibility of this event consistent with the risk information in the research protocol, protocol application and the informed consent document previously reviewed and approved by the IRB?  FORMCHECKBOX  Yesif yes, attach a copy of the relevant page in these documents concerning risk information, highlight the applicable information, and go to question #6.  FORMCHECKBOX  No if no, complete all the remaining questions. 4. In the Principal Investigators judgment, should the research protocol and/or application be revised?  FORMCHECKBOX  Yesif yes, you must submit a revised research protocol and/or application to OPRS following the directions on the NEIU Amendment application.  FORMCHECKBOX  No 5. In the Principal Investigators judgment, which of the following subject groups, legally authorized representatives, and/or parents/guardians should be notified of the event?  FORMCHECKBOX  New subjects  FORMCHECKBOX  Currently enrolled subjects  FORMCHECKBOX  Subjects that have completed the research  FORMCHECKBOX  None If any subject groups are checked, you must submit a revised informed consent document, consent addendum, and/or proposed subject notification to OSP following the directions on the NEIU Amendment application. 6. In the Principal Investigators judgment, should the research?  FORMCHECKBOX  Continue as planned; no changes needed to the research protocol and/or consent process  FORMCHECKBOX  Continue with amendment/changes to the research protocol and/or consent process as noted above  FORMCHECKBOX  Be suspended (stop new subject enrollment) until event is further assessed  FORMCHECKBOX  Be terminated (stopped completely) and all subjects removed from research 7. To whom has the event been reported?  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