Modification/Renewal BMUA - 1 EMUA# Modification/Renewal Etiologic Memoranda of Understanding and Agreement (EMUA) (For Research Involving Biohazardous Agents and/or Recombinant DNA) I. Please type. All questions (Sections I through IV) must be answered. Return to the Institutional Biosafety Committee (IBC) at ibc2@seattlechildrens.org or mail to: CW8-5A. For questions, email ibc2@seattlechildrens.org or call (206) 884-4894. Investigator(s) Principal Investigator (PI) Department Office Room#: Lab room#: Mail Stop: Telephone#: FAX#: Pager #: E-mail address: Co-investigator(s) (Name and Telephone#) – Attach Additional Sheet(s) if Needed Contact Person and Telephone#: II. Continuing Activity Study Number: Expiration date: CHECK THE APPLICABLE DESCRIPTION BELOW To be modified as described (Section III). To be renewed with no changes. To be renewed with modifications as described (Section III). To be closed. Version 1.0 D:\533561413.doc Modification/Renewal BMUA - 2 III. Certification Statements I certify that the information contained herein, is accurate and complete. I agree to comply with the requirements pertaining to shipment and transfer of bio-hazardous agents and/or recombinant DNA. I am familiar with, understand, and agree to abide by the provisions of the current NIH Guidelines and other specific granting agency instructions pertaining to the proposed project. I certify that all research personnel identified with this project are familiar with, understand, and agree to abide by the provisions of the current NIH Guidelines with regard to potential biohazards, proposed precautions, and appropriate emergency procedures, and that the practices and techniques required to ensure safety will be followed. I agree to accept responsibility for training and documentation of the training of all personnel involved in the project. I certify that written reports will be submitted to the Seattle Children’s Research Institutional Biosafety Committee (IBC) through the Office of Research Administration concerning: 1. Any accident that results in inoculation, ingestion, or inhalation of bio-hazardous agents or recombinant DNA. 2. Any incident causing serious exposures of personnel or danger of environmental contamination. 3. Any problems pertaining to operation and implementation of biological and physical containment safety procedures due to equipment and/or facility failure. 4. Any new information bearing on the NIH Guidelines such as technical information relating to hazards and safety procedures, or innovations. 5. Any change in personnel. 6. Any major changes in procedures. I certify that work described in this modification/renewal will be carried out only as approved by the IBC. Further changes to the original EMUA will be submitted to the IBC on a EMUA Modification/Renewal form at the time the changes take place or at the time of renewal (based on the date of IBC approval), whichever occurs first. Principal Investigator: _____________________________________________ (Signature) Date: ___________________________ (Date) Institutional Biosafety Committee Approved by Chair: _________________________________________________________ (Signature) Date: ___________________________ (Date) Version 1.0 D:\533561413.doc Modification/Renewal BMUA - 3 IV. Changes in personnel A. Individuals leaving project, date B. New personnel List newly hired personnel who will be working with biohazard agents, and/or recombinant DNA at Children’s. NAME Version 1.0 D:\533561413.doc TITLE Personnel Initial To Verify Receipt of Training by PI or Designee Modification/Renewal BMUA - 4 V. DESCRIPTION OF MODIFICATIONS Describe all changes pertaining to biohazardous agents, and/or recombinant DNA (originally approved by Children’s Institutional Biosafety Committee {IBC}) involving the agent, personnel, and/or procedures including but not restricted to procurement, handling, storage, waste management, or location. Page/Section From Original BMUA Version 1.0 D:\533561413.doc Description and Reason For Change