PPT-Unanticipated Problems Potentially Involving Risks to Subjects or Others

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 56108 b1 amp DHHS 45 CFR 46103b5. 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 Assessing . Risks and Benefits. Rebecca M. Thomas. IRB Program Manager. Research Integrity Office. INTRODUCTION. Risks to research subjects posed by participation in research should be justified by the anticipated benefits to the subjects or society. . Social Implications of Computers. Risks Digest (Peter Neumann). # 1.1 Recent yet-to-be-merged items. # 1.2 11 Sep 2001 and Homeland Security. # 1.3 Space. # 1.4 Defense. # 1.5 Military Aviation. # 1.6 Commercial Aviation. CS 195 Social Implications of Computers. Risks Digest (Peter Neumann). # 1.1 Recent yet-to-be-merged items. # 1.2 11 Sep 2001 and Homeland Security. # 1.3 Space. # 1.4 Defense. # 1.5 Military Aviation. 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 . 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 . NIH . Regional Seminar. Misti Ault Anderson, MS. , . MA. Senior Advisor for Public Health Education. Division . of Education and . Development. Office . for Human Research Protections (OHRP. ), HHS. Petrice Brown-Longenecker, PhD. NIH . Regional Seminar. Yvonne Lau, . MBBS, MBHL, . PhD. Director, Division . of Education and . Development (DED). Office for Human Research Protections (OHRP). Department of Health and Human Services (HHS). 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 . 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. Human Research Protection Program (HRPP). HRPP COMPLIANCE AND QUALITY TEAM . Yale University. . Federal regulations (45 CFR 46 & 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..