PPT-Considerations for IRB Review of Cell-Based Therapies

D Craig Hooper PhD FNAI Professor of Cancer Biology SKCC TJU DouglasCHooperJeffersonedu Therapeutic Modalities Cancer immunotherapy Hematologic disorders nonmalignant Regenerative medicine. 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. . Mechanics: Looking under the hood. IRB Administrators 2012. PRIDE. Lucindia Shouse, MS, CIP. May 31, 2012. Road Map. Question-and-Answer Session. Traveling to and fro (basic, beyond and in between). 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. . Agenda. GRU IRB Development and Changes. WIRB-Copernicus Group. Process for transfer of Chesapeake IRB protocols. Process for the new WIRB submissions. GRU IRB Development and Changes. WIRB and IRBNet. in International Research. IRB 2 Continuing Education. March 10, 2015. Outcomes. Consider utility of cultural competence frameworks in the assessment of graduate . s. tudent’s . i. nternational research. 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. May 19, 2017. Topics. Drivers for Centralized IRB Review. Regulatory changes . Trial Innovation Network. How JHM IRB will address the Single IRB requirements . Key Decisions. When JHM is serving as the IRB of Record. A Brief Overview of the Types of Projects Which Need IRB Oversight. Back to Basics…. Anyone engaged in human subjects research at Emory is bound to comply with regulations and policies for protecting participants. . Where do I start?. IRB Process Basic Overview. https://research.uga.edu/hso/resources. History:. H. uman Subjects Research Protection. 4. 1974. Congress established National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Amy Krenzer, CIP, IRB Coordinator. Hila Berger, MPH, CIP, Research compliance Officer. 1. Objectives . What is the Institutional Review Board (IRB) responsible for? And why?. What is Human subjects research?. Institutional Review Board. What is an IRB?. What is its job?. What are its guiding Principles?. Belmont Report (i.e., Respect for Persons, Beneficence, Justice). Code of Federal Regulations, Title 45 – Public Welfare, Part 46 Protection of Human Participants (aka . June 2014. Working Definition . A central IRB is one that serves as IRB of record for all of the sites engaged in a research study . All institutions involved in the study have developed an agreement ceding IRB review responsibility to the central IRB. Mary Eckart, BS, CIP, VA Central IRB Manager . Mikaela Myers, MA , VA Central IRB Manager. Jessica Kroll, MA, CIP, VA Central IRB Administrator . Webinar Housekeeping. Recording. - This session is recorded, and the associated handouts will be available on ORPP&E’s Education and Training website within a week after the webinar.. Summary deck. 2. With over 7,000 medicines in development, the exciting new wave of medical innovation will play a key role in . addressing the challenges faced by patients and healthcare systems . Source: Health Advances analysis; Adis R&D Insight Database. March 2015, compiled by PhRMA.