PPT-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 . VHA Handbook 1058.05 - . VHA OPERATIONS ACTIVITIES THAT MAY CONSTITUTE RESEARCH. Establishes procedures for determining whether a. VHA operations activity constitutes research. . Issue Date: October 28, . Thomas F. Byrd M.D.. HRRC Chair . Subcommitees. 2 and 4. December 3, 2013. US Department of Health and Human Services (HHS) definition of research. Research. means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities. VHA Handbook 1058.05 - . VHA OPERATIONS ACTIVITIES THAT MAY CONSTITUTE RESEARCH. . Establishes standards and procedures . for determining whether a. VHA operations activity constitutes . research. October 22, 2015. - through the lens of the IRB -. P. Pearl O’Rourke, MD. Partners HealthCare. Boston, MA. Context:. Institutional Review Board (IRB). Charged with the oversight of . human subjects . research. Common Rule, definition of human subject : . Research Misconduct Allegations. Yvonne Lau, MD, . PhD, MBHL. NIH Extramural Research Integrity Officer. OD/OER/OEP. National Institutes of Health. OER Regional, June 2013. NIH Mission & Goal. . By Lungile Penxa, Local government researcher, PSAM. E-mail: . L.Penxa@ru.ac.za. /call:0466038829. What does oversight in government mean?. OVERSIGHT. is the act of overseeing or monitoring the performance of government implementing departments. . . National Land Exchange Reviews. Who. What . Why. When. Where. How. . . . . . Land Exchanges are a common sense tool that enables the BLM and FS to:. FTA NATIONAL CONFERENCE - SACRAMENTO 2016. presenters. Lori Jones - King County Metro - . Seattle, WA. George Gilpatrick – Cahill Swift - . Boston, MA. OVERSIGHT FUNDAMENTALS. COMPLIANCE REQUIREMENTS. VHA Handbook 1058.05 - . VHA OPERATIONS ACTIVITIES THAT MAY CONSTITUTE RESEARCH. . Establishes standards and procedures . for determining whether a. VHA operations activity constitutes . research. October 22, 2015. Other Party (OP) Assessor Workshop. Palm Beach Gardens, Florida. January 16, . 2014. Melvin L. Jeppson. ATK Propulsion Systems. January 16, 2014. Objectives. Other Party (OP) Assessor. OP Assessor Qualifications & Training. 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. Office of Research Assurances. 205 . Albrook. , Pullman. http://www.ora.wsu.edu. Updated January . 2015. Recording date of this workshop is . January 16, 2015. Some of the rules and procedures discussed in this workshop are subject to change.. July 23, 2015. Agenda. Introduction. Approval of last meeting minutes. Internet Point-of-Presence- Status Update. SIP Cost Analysis. Analog Gateways on Capital Mall. . Disaster Recovery (DR) Plan. TEM RFP . CRC Grant Writing Workshop. 15 May 2013. W. Ross Ellington, Associate VP for Research & Greenberg Professor of Biological Science. 2. Encourage and facilitate our faculty’s efforts to obtain sponsored research funding .