The Kenya Medical Research Institute (KEMRI) has established a Health Safety and Environment Advisory Committee (HSEAC). Within HSEAC are four sub committees on Biosafety and Biosecurity, Environment and Waste management, Chemical and Radiation safety and Quality Management (See KEMRI HSE POLICY ref. HSE/001/2007). The Biosafety and Biosecurity sub committee consults on all matters concerning biological safety (including work with recombinant DNA /Genetically Modified Organisms), formulates policies and reports their recommendations to the HSEAC. This subcommittee is also responsible for approving proposals involving rDNA/Genetically Modified Organisms (GMOs) as the Institutional Biosafety Committee for the Institute (KEMRI-IBC).

The KEMRI-IBC is established:

• To meet the requirement in "Guidelines on handling requests involving genetically modified organisms (GMOs) in Kenya"
• To meet the requirements of agencies that re quire that all research involving biohazards is reviewed and approved by the Institutional Biosafety Committ ee (IBC) before funding is released and before the work begins. Such agencies include National Institutes of Health (NIH), Public Health Agency of Canada among others (See appendix 1 for a list of funding agencies and their Guidelines/requirements). 

PURPOSE

To satisfy th

 e requirements listed in Section 1.0. (a) and (b) the KEMRI-IBC is created to approve any teaching or research project that involves:

• Use of recombinant DNA, including trans genic anima ls or plant s,   
• Use of human, animal or plant pathogens (not indigenous to Kenya) (for example, bacteria, viruses, prions, parasites), 
• Use of biological toxins, 
• Administration of experimental biological products to animals
• • Field releases of plant pests (not indigenous to Kenya) or genetically modified organisms
• Human gene transfer/therapy products, selected vaccine trials involving Investigational New Drugs (IND), and immunotherapies as defined in the KEMRI Biosafety Manual.

SCOPE

These procedures are prepared for use by all KEMRI Centres, Collaborators, and Off-KEMRI facilities (e.g. field sites, contractual facilities and Institutions) for appropriate containment of biohazardous materials as defined in the KEMRI Biosafety manual.

ABBREVIATIONS

ACUC - Animal Care and Use Committee

BSL - Biosafety level

BSO - Biosafety Officer

CVR - Centre for Virus Research

DNA - Deoxy ribose nucleic acid

ERC - Ethical Review Committee

GMO - Genetically modified organism

HSE - Health Safety and Environment

HSEAC - Health, Safety and Environment Advisory Committee

IBC - Institutional Biosafety Committee

IND - Investigational New Drugs

KEMRI - Kenya Medical Research Institute

NBC - National Biosafety Committee

NCST - National Council for Science and Technology

NIH - National Institute for Health

OSHA - Occupational Safety and Health Act, 2007

PI - Principal investigator

SOP - Standard Operating Procedures

SSC - Scientific Steering Committee

DEFINITIONS

5.1. Biohazardous materials

Biohazardous materials and organisms include all infectious agents or biologically derived infectious materials that present either a risk or a potential risk to the health of humans or animals, either directly through infection or indirectly through damage to the environment.

The following is a list of the potentially hazardous biological materials and agents. A Protocol Application Form must be submitted to the KEMRI-IBC prior to initiation of any project involving use of these materials or agents.

5.2. Human, Animal, and Plant Pathogens

These include viruses, including oncogenic and defective viruses (includes viral vectors); Rikettsiae; Chlamydiae; Bacteria, including those with drug resistance plasmids*; Fungi; Parasites; Undefined or other infectious agents, such as prions; and toxins (bacterial, fungal, plant). *Lab K-12 strains of E. coli are not included.

All human blood, blood components and products, tissues and body fluids

Cultured cells (all human and non-human primates) and potentially infectious agents these cells may contain infected animals or animal tissues

Non-human primates and any tissues derived there from(can transmit Herpes B virus)

Sheep and any tissues derived there from (can transmit Coxiella burnetii, the causative agent of Q-fever).

After examining the list, if you are not sure whether your materials are biohazardous or not, please contact the Biosafety Officer at +254-020-2716068 or by E-mail This e-mail address is being protected from spambots. You need JavaScript enabled to view it

5.3. Biosafety Level (BSL) :

A description of the degree of physical containment being employed to confine organisms containing recombinant DNA molecules and biohazardous materials and to reduce the potential for exposure to laboratory workers, persons outside of the laboratory, and the environment.

5.4. Biological Safety Officer (BSO):

An individual appointed by an institution to oversee management of biosafety risks.

5.5. Institutional Biosafety Committee (IBC):

An institutional committee created to review research involving recombinant DNA and/or biohazardous materials.

5.6. Recombinant DNA molecules:

Under the KEMRI Biosafety manual, recombinant DNA molecules are defined as (i) molecules that are constructed outside the living cells by joining natural or synthetic DNA segments to DNA molecules that can replicate in a living cell, or (ii) molecules that result from the replication of those described in (i) above.

RESPONSIBILITY

The Director KEMRI is ultimately responsible for all Institute Health, Safety & Environment (HSE) issues. This responsibility is exercised through the Health, Safety and Environment Advisory Committee (HSEAC) which is charged with ensuring that safe work practices and adherence to established policies and guidelines are followed. Appointment to HSEAC and the terms of office is outlined in the KEMRI HSE Policy (HSE/001/2007).

6.1. Role of Health Safety and Environment (HSE) Office

The HSE Office will have the following responsibilities:

1. Ensure that all recombinant DNA research conducted at or sponsored by KEMRI is conducted in compliance with the National Biosafety Committee/National Council for Science and Technology (NBC/NCST) Guidelines and/or applicable requirements by funding agencies.
2. File an annual report that includes an updated KEMRI-IBC roster. If interim changes in the membership of the committee occur, The KEMRI-IBC Chair will inform the relevant stakeholders.
3. Provide administrative support to the KEMRI-IBC
4. Provide adequate training for IBC members.
5. Keeping records, recording minutes, and scheduling meetings for the IBC. This will include review of submitted protocols for completeness of information required for IBC review.
6. Receives protocol applications and prepares them for KEMRI-IBC review and/or approval
7. Ensures that all laboratories submitting IBC registrations for approval have been audited for compliance with the proper safety levels, and conducts annual laboratory audits to ensure compliance with the KEMRI Biosafety manual, NBC/NCST or applicable funding agency guidelines
8. Keeps records of IBC registrations, viral vector registrations, any correspondence with PIs and the IBC members, and minutes of both IBC and HSEAC meetings.
9. Annually records the renewals of continuing projects, or discontinues completed ones.
10. Schedules meetings with the IBC.