PI: IRB# Title: Funding source: #: Brief Description of Problem: Yes No NA FUNDING SOURCE: Is this study federally funded? Is this study FDA regulated? DETERMINATION: Represents Serious Non-Compliance, defined as: Noncompliance that, in the judgment of the University IRB, significantly adversely affects the rights or welfare of participants, or significantly compromises the quality of the research data. Examples of serious non-compliance include, but are not limited to: performing non-exempt human subject research without obtaining University IRB approval implementing substantial modifications to a research study without obtaining formal University IRB approval failing to systematically obtain research subjects’ informed consent as required by the IRB approved protocol failing to comply with federal regulations governing human subject protections (this includes activities of the University IRB and/or University IRB Office staff) Represents Continuing Non-Compliance, defined as: Noncompliance that has been previously reported or a pattern of ongoing noncompliance that, in the judgment of the University IRB, significantly adversely affects the rights and welfare of participants or significantly compromises the quality of the research data. defined as: places subjects or others at a Represents Risk to Subjects or Others, greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized CORRECTIVE ACTION PLAN Was a Corrective Action Plan provided by the investigator? Is Corrective Action Plan acceptable? Are changes required to the Corrective Action Plan? POSSIBLE COMMITTEE ACTIONS: Request additional records or information the event and its outcome Interview the involved investigators, research and/or research subjects Interview other individuals who may have knowledge of the event Request an independent of the event/protocol or of other related protocols. IMPLEMENT ADMINISTRATIVE ACTIONS: Request the IRB (or Vice Chair) to meet with the involved investigator and/or research staff, and the appropriate department chair and/or dean to discuss the event/problem Request corrective plan of action and/or written standard operating procedures from the involved investigator and/or his/her department chair or dean Require members of the research team to participate in pertinent training and education programs
PI: IRB# Title: Funding source: #: Brief Description of Problem: Yes No NA FUNDING SOURCE: Is this study federally funded? Is this study FDA regulated? DETERMINATION: Represents Serious Non-Compliance, defined as: Noncompliance that, in the judgment of the University IRB, significantly adversely affects the rights or welfare of participants, or significantly compromises the quality of the research data. Examples of serious non-compliance include, but are not limited to: performing non-exempt human subject research without obtaining University IRB approval implementing substantial modifications to a research study without obtaining formal University IRB approval failing to systematically obtain research subjects’ informed consent as required by the IRB approved protocol failing to comply with federal regulations governing human subject protections (this includes activities of the University IRB and/or University IRB Office staff) Represents Continuing Non-Compliance, defined as: Noncompliance that has been previously reported or a pattern of ongoing noncompliance that, in the judgment of the University IRB, significantly adversely affects the rights and welfare of participants or significantly compromises the quality of the research data. Represents Risk to Subjects or Others, defined as: places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized CORRECTIVE ACTION PLAN Was a Corrective Action Plan provided by the investigator? Is Corrective Action Plan acceptable? Are changes required to the Corrective Action Plan? POSSIBLE COMMITTEE ACTIONS: Request additional records or information the event and its outcome Interview the involved investigators, research and/or research subjects Interview other individuals who may have knowledge of the event Request an independent of the event/protocol or of other related protocols. IMPLEMENT ADMINISTRATIVE ACTIONS: Request the IRB (or Vice Chair) to meet with the involved investigator and/or research staff, and the appropriate department chair and/or dean to discuss the event/problem Request corrective plan of action and/or written standard operating procedures from the involved investigator and/or his/her department chair or dean Require members of the research team to participate in pertinent training and education programs
Reportable%20Event%20Checklist.docx