PDF-(BOOS)-Evaluating the Science and Ethics of Research on Humans: A Guide for IRB Members

Biomedical research on humans is an important part of medical progress But when health and lives are at risk safety and ethical practices need to be the top priority The need for the committees that regulate and oversee such researchinstitutional review boards or IRBsis growing Evaluating the Science and Ethics of Research on Humans is a guide for new and veteran members of IRBs that will help them better understand the issues involved and the tasks they will be required to performThe most important purpose of an IRB is to protect the human participants in research For three major research areasdrugs medical devices and genetic informationDennis J Mazur shares the methods he has found useful in protecting human participants through the systematic review of scientific protocols and informed consent forms and through adherence to the federal regulations that apply New members will gain understanding of how proposed research projects are to be reviewed from both scientific and ethical dimensions how and when to ask key questions of principal investigators how to work with principal investigators and research teams to ensure the best protection of human participants and why to schedule regularly spaced reviews of a project that may have adverse outcomesContaining helpful summaries and checklists throughout and based on Mazurs thirty years of research experience this accessible and informative guide will give all IRB members the tools they need to protect human lives and facilitate the research process. Find us online. Information available online. IRB procedures and bylaws. IRB FAQs. Definition of research. Link to the CITI ethics training. Application form. Instructions to fill out the application form. Show the data.. Jeffery W. Rodamar. Workshop on Revisions to the Common Rule. In Relation to Behavioral and Social Sciences . National Research Council. March 21-22, 2013. . 1. Disclaimer . This presentation is intended to promote the exchange of ideas among researchers and policy makers. The views expressed in it are those of the author as part of ongoing research and analysis and do not necessarily reflect the position of the US Department of Education or any other Common Rule department or agency. . Micheal A. Kuhn, MD. Vice Chair, Loma Linda University. Institutional Review Board. What type of . research needs. IRB review?. Anything and everything . that involves human subjects. Navigating the IRB process. Susan Loess-Perez, MS, CIP, CCRC. Director of Research Compliance. Office of Research Services. Graduate Thesis and Dissertation Conference. February 6, 2016. Purpose of IRB. What Requires Review. Levels of Review. COMPLIANCE PROGRAM:. Repository Protocols . and FAQs. Compliance Deadline: August 31, 2011. Kathryn Schuff, MD, MCR Andrea Johnson, JD. IRB Co-Chair Regulatory Specialist, ORIO. Agenda. What’s a repository?. A How-To Guide. http://www.uthsc.edu/research/research_compliance/IRB. /. (901) 448-4824. irb@uthsc.edu. UTHSC Institutional Review . Board (IRB). Charged with protecting human research subjects. Ensures compliance with the federal regulations (DHHS, FDA, & HIPAA) with regards to research applications, consent forms and other research materials to be used; and with regards to the conduct of the research itself. Objectives. Define research and human subjects research.. Show the "gray area" between research and practice.. Describe the distinction between a medical education initiative and a medical education research initiative.. & Where. Kevin L. Nellis, MS, CIP. Executive Director, Human Research Protections and Quality Assurance. Objectives. 2. WHY. is IRB approval required? . WHEN. do activities require IRB approval?. & Where. Kevin L. Nellis, MS, CIP. Executive Director, Human Research Protections and Quality . Assurance. Updated: . 03/13/2017. Objectives. 2. WHY. is IRB approval required? . WHEN. do activities require IRB approval?. New Opportunities :: new challenges. Michael Zimmer, PhD. Assistant Professor, School of Information Studies. Director, Center for Information Policy Research. University of Wisconsin-Milwaukee. zimmerm@uwm.edu. Presented by. Sonu Jose. https://www.uwec.edu/orsp/faculty-academic-staff/research-using-human-subjects/. Outline. What is IRB?. Types of IRB Review. IRB Application Procedure . Obtaining . protocol approval . Melanie Locher, B.S., CIP. Assistant Director of Monitoring and Education, . UVM Research Protections Office. Aims of today’s presentation. Detail the steps for a PI to obtain IRB approval. Let’s Play Jeopardy!. Go to the Bank. Time for Your Review. Fast Lane. I’ve Got Friends. 200. 200. 200. 200. 400. 400. 400. 400. 600. 600. 600. 600. Go to the Bank for 200. You have a population of interest (e.g., women who have been diagnosed with breast cancer) that you would like to contact for future studies.. Review and Approval of Research . Molly Klote, MD, CIP. C. Karen Jeans, . PhD, CCRN, CIP. VHA Office of Research and Development (ORD). 2023 IRB and R&D Committee Chair Workshop. February 7, 2023.