The rector is the maximum responsible for biosafety and exercises this responsibility by means of delegation in the established line of authority and, more specifically, in the positions of vice-rector of research, in the directors of departments and research teams, in the principal investigators and those responsible for the facilities and, in the first instance, in each of the employees and students of our university.
The functions and responsibilities in the area of occupational risk prevention (ORP) are defined in the UB’s Occupational Risk Prevention Plan, which was approved by the UB’s Board of Governors on 19 December 2007.
The following functions are highlighted:
- The scientific head of the activity or principal investigator (PI) of each project or line of research is responsible for the safety and health of all personnel involved in the project.
- Facility manager, as the person primarily responsible for the facility, has the necessary authority and support to assess risks, establish safety policies and procedures, ensure adequate training of research staff and proper maintenance of the facility and equipment.
- Responsible for biosafety of the installation and/or activity. It is responsible for assessing the handling of biological agents and for carrying out the general management of biosafety within its area of responsibility (facility and/or activity).
- Teaching and research staff and technical staff of each project or line of research will be responsible for following the procedures and good practices established by the UB, the facility manager, the biosafety manager and the principal investigator (PI).
Index:
- Functions and responsibilities of the scientific head of the activity or principal investigator (PI)
- Functions and responsibilities of the person in charge of the facility
- Functions and responsibilities of the biosafety officer of the facility and/or activity
- Functions and responsibilities of research teaching staff and technical staff
- Student roles and responsibilities
Functions and responsibilities of the scientific head of the activity or principal investigator (PI)
The specific responsibilities of the scientific head of the activity or principal investigator are as follows:
- Comply with the requirements and obligations established in the applicable legal and internal regulations, and ensure that they are complied with within their area of responsibility (research project or experimental activity).
- Prior to the start of the activity, evaluate the biological risks derived from the research project or experimental activity that it leads in order to apply the appropriate preventive measures.
- Supervise the functions and responsibilities of all personnel associated with the research project or experimental activity in the field of biosafety, and ensure that they are completed.
- Ensure adequate information and training of all personnel associated with the experimental project or activity, and ensure good daily practices.
- Participate in the preparation, dissemination and supervision of all procedures and working instructions, and any subsequent modifications that may arise in the line of continuous improvement.
- Investigate and inform the CBSUB of any accident, incident and/or significant problem affecting the operation and implementation of daily practices and biosafety procedures.
- Submit notification of research activities involving the use of genetically modified organisms.
- To store and keep at the disposal of the authorities all legally required and technically necessary documentation associated with the research project or experimental activity it is leading.
- Coordinate with the Medical Service in order to carry out adequate medical surveillance of the staff for whom he/she is responsible.
- Collaborate and coordinate with the prevention service(s) and/or those responsible for biosafety whenever personnel from companies or institutions outside the UB are involved in the activity for which they are responsible.
- Attend and participate in any activity and/or instruction promoted by CBSUB.
Functions and responsibilities of the person in charge of the facility
The specific responsibilities of the person in charge of the installation are as follows
- Comply with the requirements and obligations established in the applicable legal and internal regulations, and ensure that they are complied with within their area of responsibility (installation).
- To draw up and implement the manual and general biosafety procedures for the facility for which he/she is responsible.
- Define the conditions of entry and exit of the installation.
- Communicate to the CBSUB the requests for authorisation/communication for the use of the facility with genetically modified organisms and/or pathogenic biological agents.
- Verify that all the activities that are to be carried out at the facility for which he/she is responsible have the necessary notification and/or the corresponding authorisation.
- Ensure the integrity of the physical containment of the facility (structural elements, safety equipment, laboratory practices and techniques, etc.).
- Verify before the start of the activities that the biosafety and biocontainment conditions of the facility, for which it is responsible, are adequate to the level of risk of the research projects or experimental activities presented.
- Assume the functions of management of the facility’s specific self-protection plan.
- Investigate and inform the CBSUB of any accident, incident and/or significant problem affecting the operation and implementation of daily practices and biosafety procedures.
- To keep and keep at the disposal of the authorities all the documentation that is legally required and technically necessary for the installation to function correctly.
- Coordinate with the Medical Service in order to carry out adequate medical surveillance of the staff for whom he/she is responsible.
- Collaborate and coordinate with the prevention service(s) and/or those responsible for biosafety whenever personnel from companies or institutions other than the UB work in the facility and/or the activity for which they are responsible.
- Attend and participate in any activity and/or instruction promoted by CBSUB.
Functions and responsibilities of the biosafety officer of the facility and/or activity
The specific responsibilities of the biosafety officer of the facility and/or activity are as follows:
- Comply with the requirements and obligations established in the applicable legal and internal regulations, and ensure that they are complied with within their area of responsibility (installation and/or activity).
- To provide the Biosafety Committee (CBSUB) with the documentation and technical information necessary for it to correctly develop the competences assigned to it.
- To act as an interlocutor between the teaching and research staff, the CBSUB and the competent administrations in the field.
- Carry out an initial assessment and review of the biological risk with the information available on the facility and/or activity.
- Collect, process and distribute all the CBSUB’s own documentation.
- Provide advice and training on biosafety (e.g. disinfection and/or sterilisation, handling of biological agents, disposal of biological waste, personal protective equipment, biosafety cabinets, biological emergencies, etc.) within the scope of their facility and/or activity.
- Collaborate in the design of biocontainment facilities, in the case of initiating new projects, as well as in the supervision of their maintenance and use.
- Elaborate manuals, guides and general procedures for working with biological agents and biohazardous waste.
- Defining and supervising the qualification programme for biosafety cabinets and other biosafety equipment.
- Elaborate procedures of action in case of emergency for biological and/or personal contamination.
- Investigate any accidents/incidents that may occur and make the appropriate recommendations regarding preventive measures.
- Verify before the start of the activity that the biosafety conditions of the installation and/or the activity for which he/she is responsible are appropriate to the level of risk.
- Assess teaching and research staff in the notifications required by the competent authority in terms of facilities and use of pathogenic and/or genetically modified organisms.
- Coordinate with the Medical Service in order to carry out adequate medical surveillance of the staff for whom he/she is responsible.
- Collaborate and coordinate with the prevention service(s) and/or those responsible for biosafety whenever personnel from companies or institutions besides the UB work in the facility and/or the activity for which they are responsible.
- Attend and participate in any activity and/or instruction promoted by CBSUB.
Functions and responsibilities of research teaching staff and technical staff
The specific responsibilities of research teaching staff and technical staff are as follows:
- Follow the procedures and good practices established by the UB, the head of the facility, the scientific head of the activity and/or the principal investigator.
- To know the operating procedures of the laboratory and its equipment, the potential dangers of the biological agent or material being handled and the preventive measures to be applied.
- To complete the required training and demonstrate the necessary skills to work with standard microbiological techniques and those required in the workplace.
- Use collective protection measures, such as biological safety cabinets, and appropriate personal protective equipment (PPE) to prevent exposure to biological agents and contamination of personnel and the facility.
- Communicate any dangerous condition, accident or incident to the person in charge of the facility, scientific manager and/or principal investigator.
- Carry out the assigned operational tasks in accordance with established procedures (for example: equipment maintenance, cleaning and disinfection, safe packaging, transport of biological samples, waste management and treatment, etc.).
- To carry out medical health surveillance.
Student roles and responsibilities
The specific responsibilities of university students are as follows:
- Comply with the directives issued by the personnel responsible for the laboratory practice.
- To use the installations, equipment and material, in addition to the protection equipment, according to the instructions received.
- Be prepared and responsive to emergencies that affect him/her:
- To know and follow the operative of action in case of emergency at the center.
- Participate in periodic emergency drills.
- To report any situation that, in their opinion, entails, for reasonable reasons, a risk to safety and health.
- Collaborate with the personnel responsible for risk assessments.