Archived in January 2013 Schedule 13: Research Involving Biohazards
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1. Policy and Legislation
The Agencies require that all research they fund that involves biohazards be reviewed and approved by the Institutional Biosafety Officer (BSO) or Institutional Biosafety Committee (IBC) in accordance with the Public Health Agency of Canada’s Laboratory Biosafety Guidelines before funding is released and before the work begins. In this manner, Institutions are subject to relevant federal, provincial and territorial guidelines, laws and regulations, including but not limited to Containment Standards for Veterinary Facilities (Canadian Food Inspection Agency), Transportation of Dangerous Goods Act (Transport Canada), the Health of Animals Act (Agriculture and Agri-Food Canada) and the guidelines of the Canadian Council on Animal Care.
Technical guidance for working with biohazardous materials in laboratories is provided by the Public Health Agency of Canada publication, Laboratory Biosafety Guidelines and the CFIA Containment Standards for Veterinary Facilities.
2.1 Responsibilities of the Institution
The Institution agrees to have in place procedures to monitor ongoing research involving biohazards that is carried out under its auspices, and to:
- adhere to the Public Health Agency of Canada’s Laboratory Biosafety Guidelines and the CFIA Containment Standards for Veterinary Facilities, as they are amended from time to time, including but not limited to complying with their requirements to:
- establish an Institutional Biosafety Committee (IBC), as prescribed, or, at the Institution’s discretion when it considers that the level of research activity with biohazards warrants it, appoint a Biosafety Officer (BSO) whose duties include ensuring that all work is carried out in accordance with the safety practices described in the Public Health Agency of Canada guidelines;
- provide appropriate training, as prescribed, prior to beginning the work, for all persons whose research may involve biohazards; and
- maintain a safe working environment by regularly inspecting and maintaining all equipment and facilities used specifically for research, storage or disposal of biological hazards, in accordance with the prescribed requirements of the Public Health Agency of Canada Laboratory Safety Guidelines, and the CFIA Containment Standards for Veterinary Facilities.
- comply with all other relevant federal, provincial and territorial laws and regulations;
- release funds to researchers only if the Institutional Biosafety Committee or Biosafety Officer:
- has approved the project procedures in accordance with the different levels of risk identified in the Public Health Agency of Canada’s Laboratory Biosafety Guidelines (which includes requirements for verification of compliance with other relevant federal, provincial and territorial laws and regulations); and
- has provided a certificate to the laboratory or facility where the project will take place.
- where the research involving biohazards will not be undertaken immediately, there can be a two-stage approval process for multi-year and multi-stage projects, first, official notification of “in principle” approval, after which funds may be released on a pro-rated basis up to the projected date of the work involving biohazards and, second, a final certification before the remaining funds are released and before the proposed research involving biohazards begins;
- have a process in place to ensure that the IBC or BSO is notified promptly by the researchers if, during the course of a grant, the research changes to involve the use of biohazards or a different level of risk and consequently, thereby requiring new or updated certification;
- determine if funding for any research project already under way should be immediately suspended because the Institution reasonably believes, after consultation with the relevant IBC or BSO, that such a suspension is warranted due to a serious contravention of one or more of the following:
- the Public Health Agency of Canada’s Laboratory Biosafety Guidelines, as they are amended from time to time;
- an applicable federal, provincial or territorial law; and
- any condition of approval imposed by the IBC or BSO.
- rescind the suspension described in paragraph 2.1.(f) if, in the opinion of the Institution after consultation with the IBC or BSO, the contravention is rectified; and
- advise the Agencies in writing of any situation that results in a suspension of funds to a research project under clause 2.1.(f).
2.2 Responsibilities of Agencies
Each Agency agrees to:
- require, as a condition for release of research funds by the Institution holding the funds, that the IBC or BSO has issued certificates or notices of approval to Agency-funded investigators who are carrying out research involving biohazards;
- transmit to, or have transmitted to, the Institution, without delay and in accordance with Agency policy and the federal Privacy Act, any written allegation of an infraction of biosafety requirements that it receives; and
- work with the Public Health Agency of Canada to ensure that the research community is consulted about the development of the periodic amendments to the Laboratory Biosafety Guidelines, and collaborate with the Public Health Agency of Canada and Institutions that receive funds from the Agency to inform researchers of these amendments as they are made.
3. Resolution of Issues of Non-Compliance
In the event circumstances arise in which an Institution appears to be or are found to be in non-compliance with the Agency policy under this Schedule, the Agency will follow the procedures described in Schedule 8 at the entry level appropriate to the situation.
4. Transfer of Funds
When a Primary Institution transfers grant or award funds to a Secondary Institution for the purpose of research involving biohazards, Schedule 9 applies.