PPT-An Overview of Reporting Unanticipated Problems Involving Risks to Subjects or Others

Human Research Protection Program HRPP HRPP COMPLIANCE AND QUALITY TEAM Yale University Federal regulations 45 CFR 46 amp 21 CFR 56 require institutions to establish written procedures for ensuring prompt reporting of any unanticipated problems involving risks to subjects or others UPIRSOs to the IRB appropriate institutional officials and the federal department or agency head. This guidance represents OHRP's current thinking on this topic and should be viewed as recommendations unless specific regulatory requirements are cited. The use of the word should in OHRP guidance Objectives This presentation will address the following issues: •What events must be promptly reported to the Quorum Review institutional review board •When and how such events must be repor Annual public school report to the State Education Department summarizing all . material incidents. of discrimination and/or harassment which occur on school property (. including a school bus. ) and/or at a school function. Reporting: . Who, What, When, and Why. February, 2012. CASE #1- A Serious Adverse Event. The Background:. A PI became aware of a local unanticipated serious adverse event on January 1, 2012. It was not reported to the IRB by the PI until January 25, 2012, as part of a continuing review submission. . Melody Lin, Ph.D.. December,12. 2012. Unanticipated problems involving risk to participants or others. Is . unexpected . Is . related or possibly related . to participation in the research, and. Indicates that subjects or others are at a . , Unanticipated . Problems, and Protocol Deviations. Kathleen O’Malley RN, BSN, CCRP. Manager of Education and Training. Jefferson Clinical Research Institute. Kathleen.omalley@jefferson.edu. 1. Learning Objectives: Adverse Events. An IRB . infoshort. for . IRB Members. October 2013. Unanticipated . Problems Involving Risks to Subjects or . Others . (UPIRSO) . versus . Serious Adverse Events (SAEs). GOALS. AAHRPP site-visit observation . 15. th. FERCAP International Conference. 24 Nov 15. Nagasaki, Japan . Bussara Sukpanichnant, CIP. USAMD-AFRIMS. 1. Why I need to know about Unanticipated Problems?. Unanticipated Problem Involving Risks . Word Problems Involving One-Step. Equations and Inequalities. 25R. 25L. Word Problems Reflection. Observe,. Question,. Comment . 10/31/11. 10/31/11. Warm-Up:. Warm-Up: Write and solve inequalities. Thirteen plus a number . 15. th. FERCAP International Conference. 24 Nov 15. Nagasaki, Japan . Bussara Sukpanichnant, CIP. USAMD-AFRIMS. 1. Why I need to know about Unanticipated Problems?. Unanticipated Problem Involving Risks . An IRB . infoshort. for . IRB Members. October 2013. Unanticipated . Problems Involving Risks to Subjects or . Others . (UPIRSO) . versus . Serious Adverse Events (SAEs). GOALS. AAHRPP site-visit observation . Office of Research Oversight Reporting: Who, What, When, and Why February, 2012 CASE #1- A Serious Adverse Event The Background: A PI became aware of a local unanticipated serious adverse event on January 1, 2012. It was not reported to the IRB by the PI until January 25, 2012, as part of a continuing review submission. Problems, and Protocol Deviations. Kathleen O’Malley RN, BSN, CCRP. Manager of Education and Training. Jefferson Clinical Research Institute. Kathleen.omalley@jefferson.edu. 1. Learning Objectives: Adverse Events. UVM Research Protections Office. Unanticipated Problems (UAPs). The IRB is responsible per federal guidelines to review any unanticipated problems involving risks to subjects or others occurring in approved research (FDA: 21 CFR 56.108 (b)(1) & DHHS: 45 CFR 46.103(b)(5)(.