Objective

To establish a procedure whereby Principal Investigators will be introduced to regulatory requirements and Office of Research practices related to employee health, safety, and environmental compliance.

Scope

This procedure shall apply to all Principal Investigators new to Memphis campus of University of Tennessee Health Science Center and existing Principal Investigators who are moving research operations into new laboratory space.

Roles

1. Principal Investigators or Laboratory Supervisors shall:
   • Ensure that personnel within their lab comply with UTHSC procedures for safety and regulatory compliance. This includes complying requirements of the IACUC, IBC and RSC as well as meeting all requirements pertaining to the completion of training requirements, the use of PPE, hazardous materials handling, and waste disposal.
   • Complete the Research Laboratory Move-In Checklist or delegate the completion of the checklist to the Laboratory Safety Manager.
   • Delegate the responsibilities of the Laboratory Safety Manager to a researcher within their lab. If no employees are available to act as Laboratory Safety Manager, the Principal Investigator or Laboratory Supervisor shall personally assume the role to ensure completion of those responsibilities.
   • A. Review the performance of the Laboratory Safety Manager and research personnel as part of the annual employee performance review process.
2. The Laboratory Safety Manager (if appointed) shall:
   • Ensure that laboratory activities are conducted at the appropriate chemical safety level or biosafety level and ensure that work practices comply with the institutional requirements expressed in the Chemical Hygiene Plan, Exposure Control Plan, IBC and IACUC protocol requirements and other UTHSC procedures.
   • Ensure that all laboratory personnel complete the required safety training.
   • Complete the UTHSC Research Laboratory PPE Procedure Template to articulate the laboratory procedure for PPE use and the consequences for non-compliance with PPE requirements.
   • Enforce PPE requirements and waste disposal practices within the laboratory on behalf of the Principal Investigator.
   • Maintain an accurate hazardous chemical inventory for the hazardous chemicals in the lab using the EHS Assistant web application.
   • Perform and document the weekly flush of emergency eyewash stations in the work area.
   • If applicable, use EHS Assistant to maintain accurate use and disposal records for radioactive materials.
3. Office of Research Safety Affairs shall:
   • Meet with Principal Investigators to introduce Office of Research requirements for the preparation and filing of research protocols, employee safety training, PPE requirements and other Office of Research Safety Affairs policies.
   • Inspect research laboratories prior to the initiation of research, including research on IACUC, IBC or RSC protocols. This inspection is to ensure completion of the Research Laboratory Move- In Checklist, safety training requirements, the availability of PPE, that equipment has been properly set up and certified, and that standard operating procedures (SOPs) have been established for activities involving highly hazardous materials including highly reactive compounds (e.g. pyrophoric materials) or acutely toxic compounds.
   • Confirm that a Laboratory Safety Manager has been delegated to monitor or perform routine safety responsibilities.
   • Assist with risk assessments and provide guidance for the preparation of IACUC, IBC and RSC protocol preparation.

Definitions

Biological Safety Level (BSL) – A combination of laboratory practices, techniques, safety equipment and laboratory facility features employed to mitigate risk of work with biohazardous agents.

Chemical Safety Level (CSL) – A combination of laboratory practices, techniques and safety equipment employed to mitigate the risk of working with hazardous chemicals.

EHS Assistant – Web-based software application maintained by the Office of Research Safety Affairs and accessible to researchers. EHS Assistant is used to maintain hazardous chemical and radioactive material inventories, document training, and track other regulatory requirements.

Hazardous Chemical – Any substance that capable of causing an acute or chronic health condition in humans or adversely impacting the environment. Substances that are considered physical hazards (flammable substances, explosives, shock sensitive, etc.) are included in the definition of a hazardous substance. The OSHA Hazard Communication Standard, 29 CFR 1910.1200 and the OSHA Chemical Hygiene Plan 29 CFR 1910.1450 are the two main standards that define a hazardous substance.

Institutional Animal Care and Use Committee (IACUC) – UTHSC committee responsible for oversight of the animal care and use program and its components as described in the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (Policy) and the Guide for the Care and Use of Laboratory Animals (Guide).

Institutional Biosafety Committee (IBC) – The UTHSC committee is responsible for reviewing research activities utilizing recombinant or synthetic DNA (rDNA), infectious agents, biological toxins, and other biohazardous materials to ensure that UTHSC principal investigators and lab personnel utilize appropriate best practices when performing this type of work. All research by UTHSC investigators that utilizes rDNA, as defined in the NIH Guidelines, and other biohazardous materials must be registered with the UTHSC IBC according to policies established in the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules.

Laboratory Animal Care Unit (LACU) – The Laboratory Animal Care Unit (LACU) functions as a full-service core supported by the Office of Research, serving all animal related research on the UTHSC campus. The core operates several animal facilities throughout the campus, to best serve the individual research departments and to maintain health status of the colonies.

Laboratory Safety Manager – Individual with safety and compliance responsibilities assigned to them by their supervisor or Principal Investigator.

Principal Investigator (PI) – The holder of an independent grant administered by a university and the lead researcher for the grant project, usually in the sciences, such as a laboratory study or a clinical trial. The phrase is also often used as a synonym for “head of the laboratory” or “research group leader.”

Radiation Safety Committee (RSC) – The UTHSC committee responsible for reviewing research activities using ionizing and non-ionizing radiation. The RSC will serve as the general procedure forming body for the activities which involve the use of radioactive materials and/or other sources of ionizing and non-ionizing radiations.

Procedure

1. Upon opening a research laboratory at UTHSC new Principal Investigators shall arrange an orientation meeting with the Office of Research Safety Affairs. This meeting is intended to provide the new Principal Investigator with an introduction to UTHSC policies, procedures, training requirements and filing requirements for research protocols subject to the oversight of the IACUC, IBC, IRB, and RSC.
2. Complete the safety training requirements assigned by the Office of Research Safety Affairs. Training requirements are determined based on the hazardous materials to be handled and procedures to be performed in the lab. The IACUC also maintains training requirements that must be completed by research personnel prior to entering LACU facilities.
3. New Principal Investigators and Principal Investigators moving into new laboratory space must complete the Research Laboratory Move-In Checklist included as an attachment to this procedure. Upon completion and prior to initiating research activities this checklist must be emailed to labsafety@uthsc.edu.
4. Job responsibilities often prevent Principal Investigators from providing a routine presence in their labs. To adequately maintain the laboratory environment and ensure compliance with regulatory requirements the Principal Investigator must delegate a Laboratory Safety Manager. The responsibilities that the Laboratory Safety Manager must meet in the effort to support the Principal Investigator are articulated in the Responsibilities section of this procedure.
5. Obtain PPE for personnel and visitors entering the lab. PPE requirements are identified in the UTHSC Chemical Hygiene Plan. At a minimum this includes gloves, a lab coat and eye protection for each researcher or visitor. A hazard risk assessment must be conducted to determine if additional PPE is required for activities performed in the lab. The PPE must be appropriate for the work to be performed and the materials being handled. Each individual is responsible for maintaining their PPE in clean and useable condition.
6. Establish a laboratory procedure for the use of PPE. Minimal requirements for PPE use are detailed in the UTHSC Chemical Hygiene Plan. Principal Investigators may opt for more protective and more easily enforceable PPE requirements for their lab. Examples of such alternate policies would be to require the wearing of gloves, a lab coat and eye protection whenever working at the bench or whenever in the lab. The laboratory procedure for PPE use must include an escalation procedure for staff members not properly wearing PPE in accordance with laboratory procedure. It must also articulate the procedure for when lab coats must be changed out and how this protective equipment is to be laundered. All laboratory personnel must be familiar with this procedure and the consequences for non-compliance.
7. Contact the Office of Research Safety Affairs to schedule a work area inspection prior to the initiation of research activities in new laboratory space. The intent of this inspection is to verify completion of the UTHSC Laboratory Move-In Checklist, to identify the name of the Laboratory Safety Manager and ensure that the lab is compliant and ready for research activities.

Contact Information

IBC Chairperson: Dr. Mark Miller ibc@uthsc.edu

IACUC Chairperson: Jeff Steketee, PhD. jstekete@uthsc.edu

IRB Reporting/IRB Director Cameron Barclay, barclay@uthsc.edu

Occupational Health: Evelyn Wright-Lewis, eohs@uthsc.edu

Office of Research Safety Affairs: (901) 448-6114

labsafety@uthsc.edu

Responsible Official & Additional Contacts

Appendices

UT Health Science Center Laboratory Move-In Checklist