PPT-IRB’s Top Ten* Investigator Responsibilities

What Every Investigator and hisher research staff Should Know about Conducting Human Research Activities Based on David Lettermens Top Ten PI Responsibility 1 In designing the study the investigator should take into consideration the three underlying ethical principles for conducting research with human subjects as delineated in the. Christopher B. Block, Esquire. 425 Eagle Rock Avenue. Suite 302. Roseland, NJ 07068. P:973.618.4176. • . F:973.618.4100 . • . E:cbblock@mdwcg.com. Jennifer Edmonds, Esquire. Great American Insurance Company. Shannon Simmons, BA, CIP. March 14, 2014. Process Improvement Team. Vanderbilt Human Research Protections Program. Agenda. Review Investigator Responsibilities. Discuss FDA Warning letters . Q & A.  . THE BEGINNING. I am happy to answer any questions you may have now or after you get home. Please don’t hesitate to contact me anytime.. Dustin E. Grate, . Lic. #632. Spencer Investigations. 1325 . Jan Zolkower, MSHL, CIP, CCRP. January 13, 2012. Review Investigator Responsibilities. Discuss recent FDA Warning letters and OHRP Determination letters. Review of Advanced Notice of Proposed Rulemaking (ANPRM). 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. & 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?. VA Central IRB Administrator. . Updated: . March 27, 2017. Purpose of VA Central IRB. Primary Purpose. Improve human research protections in VA multi-site studies by ensuring:. Consistent expert ethical and scientific review. VA Central IRB Administrator. . Updated: . March 27, 2017. Purpose of VA Central IRB. Primary Purpose. Improve human research protections in VA multi-site studies by ensuring:. Consistent expert ethical and scientific review. Stephen Workman, MPH. September 2016. Thomas Jefferson University. Investigator responsibilities. Sponsor assessment of PI performance . What TJU does well. How PIs can be more impressive to sponsors. How to Change the Principal Investigator (PI) in IRBNet and the Part I cover sheet 1 of 5 The process to change the PI is similar whether you are preparing a new submission or an amendment request to change the PI. 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?. IRB Application and Review Process. The primary responsibility of the Institutional Review Board is to protect the rights, welfare, and privacy of all individuals participating in research sponsored by Cal Lutheran.  The IRB reviews all research studies involving human subjects for safety and compliance with regulations and ethical standards.. Derita: . dbran@uthsc.edu. Margaret: . mlynn@uthsc.edu. https://tnctsi.uthsc.edu/training-and-education/seminars-and-workshops/tn-ctsi-certification-exam-preparation-course/. Handout/. Reference sheets:. Office of Grants and Contracts. Presenter: Stephanie Chandler-Thompson. Roles and Responsibilities . The Office of Grants and Contracts is responsible for ensuring proper review of sponsored project proposal submissions and stewardship of awarded...