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. 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. . SOP KP-502. Research Compliance Training. 2012. KPSC . IRB Version 2-1 . Dated . 8/27/2015. Required Training. . The training takes approximately 1 hour.. All Research Team Members who contribute to the conduct of research must complete the training, including:. 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. . , 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. 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 . There are negative issues involving science and accidents do happen.. However in general the worst issues are because society makes unwise decisions on how scientific advances should be used in for instance armed conflicts.. Q & A. Misti. Ault Anderson, . OHRP . Petrice Brown-Longenecker, NIH. Meredith Temple-O’Connor, NIH. 1. Case Study 1. An application describes the following proposed research activities:. The investigator receives autopsy specimens from a pathologist. . 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). Unanticipated inflation – some people are hurt; some people gain. . For example, borrowers are helped by unanticipated inflation while lenders are hurt. . However, even anticipated inflation results in costs for the economy.. Q & A. Yvonne Lau, OHRP. Ann Hardy, NIH. Meredith Temple-O’Connor, NIH. 1. Case Study 1. An application describes the following proposed research activities:. The investigator receives autopsy specimens from a pathologist. . 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)(. NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules. https://osp.od.nih.gov/biotechnology/nih-guidelines/. Evolving, scientifically-responsive document. – Johan Krynauw, CABRI. Framing of SOEs reporting in the context of Fiscal Transparency and progress in FOA countries. 27 October 2020. 1. SOEs form one of . the largest sectors of the economy in many African countries .