A RE-STATEMENT OF THE PRINCIPLES GOVERNING
A REVIEW OF ETHICAL MERITS DECISIONS REGARDING
ANIMAL RESEARCH SUBJECTS
1.Animals for Research Act, R.S.O. 1990, Chapter A.22 and its Regulations (the Act)
The Act, section 17, defines the authority of the Animal Care Committee. The University’s legal interpretation of the Act, affirmed by the Director of the Legal Services Branch, Ministry of Agriculture and Food and the Ministry of the Attorney-General of Ontario is as follows:
“...the University’s Animal Care Committee may review all or part of its own decision or order and may confirm, vary, suspend or cancel the decision or order. However, our interpretation of the Act is that it does not provide for an appeal of a decision or order of an animal care committee to a separate body, to a separate committee within the University or to a senior administrator or even to the person at the University who is deemed to be the ‘operator’ from the purposes of the ‘Act’. If a researcher disagrees with the University’s Animal Care Committee decision or order, then he or she cannot use a separate appeal process where ultimately a senior administrator of the University or the person who is deemed to be the ‘operator’ becomes the final decision-maker or arbiter.”
As per Article IV, 3(iii) of the Animal Care Committee Terms of Reference regarding the conduct of Committee business:
Back to top“All deliberations, discussions and decisions of the Committee are subject to the Collective Agreement of the Association of Professors of the University of Ottawa and the Agreement’s regulations governing confidentiality, conflict of interest and disclosure.”
2.Process for Review of an Ethical Merits Decision
(see Animal Care Committee Terms of Reference, Article VI)
2.1A subset of the membership of the Animal Care Committee will serve on the Protocol Review Group (PRG), the Committee’s Steering Committee.
2.2The PRG’s mandate is to review all submitted protocols on behalf of the Animal Care Committee. It is empowered by the Committee to grant the approval of newly submitted protocols (with and without conditions), amendments or renewals of previously submitted protocols and to receive notice of protocol termination.
The approvals granted by the Protocol Review Group are subject to ratification or revocation by the Animal Care Committee upon reasonable grounds at any time and with notice to the researcher.
The jurisdiction to refuse to approve a protocol or to suspend or revoke a protocol is that of the Animal Care Committee and not of the Protocol Review Group.
2.3Where the Protocol Review Group is of the opinion that a protocol approval should be refused, suspended or revoked due to an actual or contemplated breach of ethical principles (Article II), by act or omission, the Protocol Review Group will recommend such action to the Committee.
Interim action may be taken by the Protocol Review Group or the University Veterinarian to protect the interests of the animals and of the institution and may include ordering that an experimental procedure be suspended pending the Committee’s decision.
The Protocol Review Group will submit in writing to the Committee, an outline of the facts as it understands them to be, its recommendations and reasons for any interim measures which may have been taken.
2.4 The Committee will consider:
2.4.1 the Protocol Review Group’s submission;
2.4.2 the submission of the researcher, and
2.4.3 any other information
which will assist it in rendering a fair and timely decision.
2.5 Where the Committee affirms the decision(s) of the Protocol Review Group, it will submit a report in writing to:
2.5.1 the Associate Vice-Rector, Research and
2.5.2 the appropriate Academic Administrator, and to
2.5.3 the researcher or his/her agent(s).
This is in keeping with the Act since the Associate Vice-Rector, Research and Faculty and Affiliated Institute Deans or Directors are ex-officio members of the Animal Care Committee.
2.6 Where the Protocol Review Group recommends that a protocol be modified so as to better balance science and ethics, this is not to be construed as a decision to refuse to approve or amend a protocol.
Only when this iterative process is exhausted and the researcher is unable or unwilling to agree to the balance proposed by his/her peers on the Protocol Review Group will the matter be referred to the Animal Care Committee for a final determination.
In such an eventuality, which is judged to be a rare occurrence, the researcher will be invited to submit to the Animal Care Committee in writing material evidence and argument in support of his or her protocol submission..
A determination by the Animal Care Committee is final as per the Act.
Back to top3. Review of a Final Determination by the Animal Care Committee
A request to review a final decisional outcome of the Animal Care Committee is anticipated to be an even rarer occurrence.
The Animal Care Committee will review a ‘final’ ethical merit determination if there has been:
3.1 procedural unfairness. In this eventuality, the Committee will correct the procedural unfairness and review the protocol submission de novo.
Where the Committee affirms the decision of the Protocol Review Group to refuse to approve a protocol submission, or the Committee itself has refused to approve the protocol submission, the Committee will review the decision:
3.2 if new and relevant information becomes available which, if available at the time the protocol was originally deliberated, may have affected the outcome of those deliberations.
As appropriate, the Committee may:
3.3 seek an opinion on the matter being reviewed from the Canadian Council on Animal Care, the Ontario Ministry of Agriculture and Food or other such competent authority and take such opinion into consideration in its deliberations.
Decisions will not be reviewed for frivolous or vexatious reasons.
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