Chapter 10: Research Environment Safety: Trainings and Procedures

Duke University strives to maintain a research environment that protects the health and safety of investigators, research personnel, staff and trainees, and to prevent property damage. According to the Duke University Safety Manual, an optimum safe environment can be achieved most effectively by early identification and understanding of safety issues; close interaction among managers, employees, students, Employee Occupational Health and Wellness, and the Occupational & Environmental Safety Office (OESO); and adherence to Duke University safety policies.

The OESO publishes the Duke University Safety Manual, the Duke University Laboratory Safety Manual, the Radiation Safety Manual, and the Laser Safety Manual. These manuals, along with the policies maintained on the OESO website, provide members of the research enterprise with general safety requirements for conducting fieldwork and working in laboratories with hazardous substances and equipment such as recombinant and synthetic nucleic acids, infectious agents, chemicals, radioactive materials, radiation-producing machines, and lasers.

The following information highlights and supplements those safety policies most applicable to the research environment; however, it is the responsibility of all Principal Investigators and research personnel to prepare, consult and adhere to safety procedures appropriate for their work environment.

10.1 Laboratory Safety

Research personnel who operate in laboratory-based environments are encouraged to review the materials, resources, and procedures published on the Laboratory Safety section of the OESO website.

10.2 Fieldwork Safety

Fieldwork activities such as those involving isolated or remote locations, extreme weather, hazardous terrain, harmful wildlife, or lack of ready access to emergency services can expose participants to significant risks to their health and/or safety. Investigators conducting fieldwork activities must follow the Fieldwork Safety Policy. This includes developing and adhering to a Safety Plan. More information, including the Safety Guidelines for Fieldwork, is located on the Fieldwork Safety section of the OESO website.

10.3 Safety Training Requirements

Research personnel are assigned safety training and other requirements based on a risk assessment, performed by the OESO in collaboration with the individual’s supervisor. Personnel should complete all identified requirements within the timeframe specified in the Training & Reports section of the OESO website.

The OESO has developed training materials for individuals new to research at Duke; individuals should complete the training relevant to their work area and responsibilities.

The general training provided by OESO does not cover project- or lab-specific hazards. Principal Investigators are encouraged to contact the OESO to conduct a risk assessment and provide guidance on mitigation measures. Principal Investigators are responsible for assuring that research personnel and trainees are trained on specific hazards that they may encounter in the course of their work. In addition, PIs are responsible for ensuring research personnel and trainees have an understanding and working knowledge of appropriate control measures, emergency procedures, and other safety protocols.

The following statements provide examples of specific hazards and the University expectations for usage.

10.4 Laser Safety

Lasers are a potential safety hazard in the laboratory. To address the most serious risks, which are posed by Class 3b and Class 4 lasers, Duke has designed the Laser Safety Program.

An investigator responsible for operating a Class 3b or Class 4 laser is identified as a Principal Laser User (PLU) in the Duke University Laser Safety Policy. The PLU is directly responsible for the safe use of the lasers under their control, and must complete the online Laser Registration Form for each Class 3b or Class 4 laser.

10.5 Radiation Safety

To obtain an authorization for possession and use of radioactive materials and radiation-producing machines, including X-ray units and clinical/research accelerators, an investigator must a) be a full-time member of the faculty, b) have training and experience commensurate with the types and amounts of radioactive materials to be used, and c) submit an application for review and approval by the appropriate Institutional Radiation Safety Committee.

Investigators may not use radioactive materials and radiation-producing machines in research environments without first receiving the appropriate authorizations.

10.6 Use of Hazardous Materials

All research activities involving the use of hazardous materials must comply with federal, state, and local regulations regarding the shipment, handling, and disposal of such materials, which include infectious, radioactive, carcinogenic, teratogenic, mutagenic, toxic, reactive, corrosive, and flammable materials. Use of any such materials may require the review and approval of the Institutional Biosafety Committee (IBC), the Medical Center Radiation Safety Committee (RSC), the University RSC, or other institutional authority.

A PI who uses hazardous materials and generates chemical and/or radioactive wastes must register as a waste generator with the OESO to assure proper management of regulated wastes. Policies and procedures related to managing Medical, Chemical and Radioactive waste are available on the Hazardous Waste section of the OESO website. Principal Investigators are responsible for complying with the published policies and federal and North Carolina regulations.

All PIs using chemicals will need to prepare a lab-specific chemical hygiene plan. PIs should provide a list of all chemicals used in research to OESO to assure compliance with the Toxic Substances Control Act (TSCA) and the notification requirements of the Emergency Preparedness and Community Right-to-Know Act.

Certain chemicals are considered “Particularly Hazardous Substances” (PHSs), which include materials that are reactive, highly toxic, carcinogenic, or that affect human reproduction. Resources to help labs identify chemical hazards can be found on the Particularly Hazardous Substances page of the OESO website. Investigators are responsible for identifying particularly hazardous or high-risk chemicals on their lab’s inventory. Labs must prepare and implement customized standard operating procedures (to include methods of use and required protective measures) for any identified materials.

10.7 Use of Recombinant and synthetic nucleic acids in Research

Regardless of funding source, all research involving recombinant and synthetic nucleic acids must comply with federal regulations and guidelines. All non-exempt research with recombinant and synthetic nucleic acid materials must be registered with the IBC before it is initiated. Registration forms, found on the OESO website, must be completed and submitted to the Biological Safety Division of OESO for review and approval by the IBC. Meeting dates and deadlines are available on the website.

Work with viral vectors, human derived materials (including cell lines), or pathogens (Risk Group 2 or above) requires a written standard operating procedure (SOP), templates for which can be found on the Recombinant DNA/Viral Vectors webpage.
Experiments involving the deliberate transfer of certain recombinant and synthetic nucleic acid material into human subjects must also be reviewed and approved by the IBC and the IRB. The Clinical Research Pharmacy and Duke University Hospital Infection Control must also approve the clinical procedures when a biological vector is used in a clinical trial.

10.8 Use of Federally-regulated Biological Select Agents and Toxins

The Duke University policy on the use of biological select agents and toxins provide requirements for ensuring that “select agents or toxins” on Duke University campuses are handled safely, secured properly, and properly registered with the Department of Health and Human Services, Centers for Disease Control and Prevention (CDC) and/or the United States Department of Agriculture, Animal Plant Health Inspection Service (USDA). The CDC and the USDA maintain a list of all regulated “Select Agents or Toxins” for investigator review and reference. Individuals planning to transport to, or store or work with these agents and toxins at Duke, should contact the Duke Select Agent Program Responsible Official at 919-684-8822.

Small quantities of some Select Toxins are exempted from the federal regulations; however, certain Duke University biosafety and biosecurity policies and procedures must be followed by the laboratory.

Each PI is responsible for ensuring the registration of all possession, transfer, and receipt of Select Agents and Toxins with the CDC or USDA. The PI is also responsible for assuring that the laboratory fully complies with all required safety policies and procedures. All PIs must work closely with the Director of the Biological Safety Division of the Occupational and Environmental Safety Office (who serves as Duke’s Responsible Official, or “RO”) to assure compliance with this standard.