Animals and Plants Complete GM Risk Assessment Form

Slides:



Advertisements
Similar presentations
Ethics – where to start! October 2013 Lois Neal FMS Research & Innovation Office.
Advertisements

Biological Laboratory Safety Additional Information.
Guidance on Significant Changes to Animal Activities
Office of Sponsored Projects & Industry PartnershipsHuman and Animal Regulatory Committee Office Protocols vs. Proposals (research involving humans and/or.
IRB SUBMISSION PROCESS FOR SHB STUDIES Version 9/18/2013.
Submission to Approval What happens to my protocol once I submit it to the HIC office.
Single Use Expanded Access IND/IDE: FDA and IRB Requirements Before and After Use IRB Webinar October 9,2014.
Institutional Review Board Guidance.  Independent Ethics Committee  Ethical Review Board  Research Ethics Committee 2.
Safety Service 5A Lennoxvale Working Safely with Genetically Modified Organisms.
17/05/20151 Chemical and Biological Hazards Department of Cell Physiology And Pharmacology Tim Walton Departmental Safety Officer.
Exception for Informed Consent for Emergency Research and the IRB: Operationalizing It Ronald F. Maio DO, MS Director, Office of Human Research Compliance.
Columbia University IRB IRB 101 September 21, 2005 George Gasparis, Executive Director, CU IRB Asst. V.P. and Sr. Asst. Dean for Research Ethics.
Single Subject Protocol Modification Yale Human Research Protection Program * To play the presentation, click on this icon on the status bar below.
Integrated Online Research Compliance System (iORC)
Research Ethics A guide to principles and procedures
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES NATIONAL INSTITUTES OF HEALTH Working with FDA: Biological Products and Clinical Development IND Case Studies.
Foundation Training in Biological Safety. Module 4 Genetically modified organisms.
Use and Care of Vertebrate Animals: What Researchers Need to Know Brian Greene IACUC Chair and Associate Professor of Biology Missouri State University.
Continuing Review VA Requirements Kevin L. Nellis, M.S., M.T. (A.S.C.P.) Program Analyst Program for Research Integrity Development and Education (PRIDE)
Nonclinical Studies Subcommittee Advisory Committee for Pharmaceutical Science CMC Issues for Screening INDs Eric B. Sheinin, Ph.D. Acting Deputy Director.
© Imperial College London 1 Risk Assessments & Standard Operating Procedures Dr Ann Maconnachie CMIOSH Departmental Safety Officer.
Clinical Trial Review and Approval: New Regulations and their implications Siddika Mithani, Ph.D Clinical Trials & Special Access Programme Therapeutic.
RESCUE: ACRIN 4701 Protocol Development & Regulatory Compliance (PDRC) Josephine Schloesser, ACRIN Monitor Chris Steward, ACRIN QC Auditor.
Michelle Groy Johnson Quality Improvement Officer Research Integrity Office Tough Love: Understanding the Purpose and Processes of Quality Assurance.
February 12, 2014 Non-CISO Non-CTU Studies: How They Differ.
 The IRB application  The Review Process  Summary of Protocol  Appendixes  Informed Consent  Recruiting materials  Research Instruments  Other.
SUNY Oswego Human Subjects Committee Last Revised 10/28/2011.
VA Central IRB Annette R. Anderson, MS, RHIA, CIP VA Central IRB Administrator HRPP 101, September 2010.
HOW TO SUBMIT AN AMENDMENT TO A PROJECT THAT HAS ALREADY RECEIVED IRB APPROVAL Submitting an Amendment.
SUNY Oswego Human Subjects Committee Last Revised 10/28/2011.
Paula Peyrani, MD Division of Infectious Diseases University of Louisville The IRB Process What do I need to know? The IRB Process.
Animals in Research: Navigating the Animal Protocol Approval Process Summer Seminar Series Susan Warren IACUC Chair.
RHEUMATOID ARTHRITIS PROJECT: ETHICAL REQUIREMENTS May 30, 2012.
Continuing Review Presented by: Karen Jeans, PhD, CCRN, CIP Program Analyst, COACH.
ROAD MAP: Getting a Cancer Study Done at Jefferson Sylvia O’Neill, MD Associate Director of Regulatory Affairs and Quality Assurance Clinical Trials Office.
AfRE Standard Operating Procedures for University Research Ethics Committees Overview Prof Margaret Rees AfRE Chair 8 September 2015 Association for Research.
Amendments A HOW-TO. Objectives 1.What is an amendment? 2.What projects are required to submit an amendment? 3.How do I find the form? 4.How do I fill.
Office for Research Subjects (ORS) & Research Administration (ORA) In-Sync to Help Make your Research Happen Stephanie Gaudreau, Sr.Research Subjects Specialist,
INTERNATIONAL SCIENCE AND ENGINEERING FAIR Rules and Guidelines 2016.
Laboratory Closeout Procedure Procedure Overview.
CU-IBC Institutional Biosafety Committee formerly the Recombinant DNA Committee Frank Cantone, Interim IBC Chair Cornell University Biological Safety Officer.
 What is an IRB and why do we need one at Western?  Who needs to submit proposals to the IRB?  If approved, how long is your proposal good for?  Is.
ROAD MAP: Getting a Cancer Study Done at Jefferson Sylvia O’Neill, MD Associate Director of Regulatory Affairs and Quality Assurance Clinical Trials Office.
Benefit-sharing of the Biomedicine Research Results Based on Genetic Resources Benefit-sharing of the Biomedicine Research Results Based on Genetic Resources.
THE INSTITUTIONAL REVIEW BOARD. WHAT IS AN IRB? An IRB is committee set up by an institution to review, approve, and regulate research conducted under.
Lifespan 1 Submission Process to the IRB part 2 Revisions to Protocol.
Audit on herbal study protocols reviewed by an Ethics Review Committee of a Western Medical Institution Wanigatunge CA, Warnacula G, Prathapan S Ethics.
CayuseIRB A Quick Start Guide for IRB, IACUC, and IBC Researchers
Introduction Review and proper registration of Human Gene Transfer protocols is very complex. A protocol goes through rigorous review by multiple Committees.
Conditional IRB Approval
COCE Institutional Review Board Academic Spotlight
Instructions for New Revision & Deviation/Exception Forms
Procedures for seeking YSJU Research Ethics Approval
Presented by Insert Name
Procedures for Taught Degree students seeking YSJU Research Ethics Approval Does the research involve living human participants, their tissue or their.
IRB reporting updates.
TCP LIMS – Animal Use Protocol Management
Amendments A how-to Prepared by: Christine Melton-Lopez, IRB Associate.
Reportable Events & Other IRB Updates February 2017
REGULATORY PROBLEMS IN CARING OUT PRE- AND POST- AUTHORISATION CLINICAL TRIALS Dr Penka Decheva GCP Inspector, BDA.
IBC Review Pathway Approximate Timeline Online status Online“Sub”State
Animal Utilization Protocol (AUP) Approval Process
Single Subject Protocol Modification
General Grants Program Process
Review & maintenance of IAEG Glossary
AS Risk Mitigation Plan
AS Risk Mitigation Plan
Human Gene Therapy Institutional Review Procedures
REB Review Process Initial Review
Animal Utilization Protocol (AUP) Approval Process
Presentation transcript:

Procedure for submission and approval of activities involving Genetically Modified Animals and Plants Complete GM Risk Assessment Form Submit to Administrator for GM and Biological Safety Considered by Local GM Safety Committee Project Approved Local Safety Representative Email form to CBS Manager Amendments required Revisions Required Issued by Administrator for GM and Biological Safety Project Approved by CBS Manager Email form to GM Chair Project Approved with green form issued by GM Chair Email form to the Administrator Revisions verified by College GMSO Email form to Local Safety Representative Principal Investigator addresses amendments Email form to College GMSO Approval issued to PrincipaI Investigator by Administrator for GM and Biological Safety Notifiable Non-notifiable CU2 form completed by Principal Investigator Submitted to GMSO with cheque payable to HSE (Current costs are given in Guidance Note 050) HSE notified by College GMSO HSE provides written consent (usually within 45 days) Work can start Work can start All GM protocols should be submitted to the Administrator for GM and Biological Safety