The Animal Research Act and Regulation (including the Code of Practice for the Care and Use of Animals for Scientific Purposes) place ultimate responsibility for the care and well-being of experimental animals on the investigator.
They also set out the responsibilities of accredited research establishments and animal care and ethics committees, whose activities also have direct implications for individual animal welfare.
However, the legislation does not spell out how these responsibilities are devolved:
- if a single project is carried out at more than one institution
- if there are collaborating investigators from more than one institution
- if the animals are moved from one institution to another during the project
- or if two similar projects are being conducted simultaneously at two institutions by collaborators
This has led to confusion in some cases, with investigators, ethics committees and research establishments all being unsure of the extent of their responsibilities. The potential for the needs of the animals involved to be overlooked as a result of this confusion is very real.
It should be borne in mind that where an employee of one institution proposes to carry out animal research at another institution, the ACEC of the "host" institution would have a supervisory role over the research, but the employing institution would continue to have authority over the employee's actions and would be responsible, in terms of vicarious liability, for any acts of its employee which contravene the Animal Research Act.
These guidelines will provide a framework on which collaborating research groups can base a formal agreement. This will ensure that the animals that are used receive the care and attention to which they are entitled. These guidelines should be read in conjunction with the Act, the Regulation and the Code of Practice.
Situations which do not appear to be resolved despite use of these guidelines should be referred to veterinary officers of the Animal Welfare Unit for advice.
These guidelines apply to the following situations:
2.1 Animal research projects where the individuals participating in the project are employed by, or in a formal relationship with, different accredited research establishments. Formal relationships include those of students in the University at which they are enrolled and those of medical specialists employed by the hospital associated with the University at which they hold their academic appointments.
2.2 Animal research projects where the animals are housed in the facilities and cared for by animal care or research staff of more than one accredited research establishment, either simultaneously or at different times during the project.
2.3 Animal research projects carried out by a formally constituted collaborative research group, from different organisations/institutions, such as a cooperative research centre.
2.4 Animal research projects carried out under informal collaborative arrangements at more than one institution.
3.0 General statement of policy
3.1 When submitting a project proposal to an animal care and ethics committee for approval, the principal investigator has a duty to disclose all interactions with other institutions relevant to that proposal.
3.2 The principal investigator has a responsibility to ensure that the animal care and ethics committees of all institutions involved in the project are kept informed of all relevant correspondence and all significant aspects of the project.
The principal investigator is responsible for ensuring that monitoring of animals is appropriate at each site and of a standard considered satisfactory to the relevant ACEC (s).
3.4 The principal investigator may delegate the implementation of actions to fulfil these responsibilities to another individual but retains primary responsibility at all times. This delegation should be approved by the relevant ACEC(s).
3.5 Animal Care and Ethics Committees and Accredited Research Establishments have a responsibility to maintain lines of communication with their collaborating counterparts to facilitate exchange of information about a collaborative project and enhance their monitoring activities.
Wherever possible, they should try to streamline procedures so as to avoid duplication of effort by investigators.
4.0 Specific guidelines
4.1 These guidelines were developed primarily for formally constituted collaborative research groups, such as Cooperative Research Centres set up under the auspices of the Commonwealth Government, however they can be usefully applied to any collaborative research group.
4.2 Before any animal research commences, the collaborative research group should approach each relevant Accredited Research Establishment (ARE) and should participate in a formal written agreement that collaborative research group research will be supervised by the relevant Animal Care and Ethics Committee (ACEC) and that collaborative research group researchers will agree to abide by the decisions of the ACEC. Each ARE should be notified of the other AREs which will also be involved in the project and which will also be subject to a similar written agreement.
4.3 For each individual project, a protocol should be submitted to each relevant ACEC.
4.4 By mutual agreement, the Chairpersons of the ACECs should assign one ACEC as the primary ACEC. Comments on the protocol from the secondary ACECs should be submitted to the primary ACEC and a representative of each secondary ACEC should attend the meeting of the primary ACEC at which the protocol will be considered, if there are concerns about the protocol.
4.5 The primary ACEC should delegate responsibility for monitoring, emergency procedures etc. to secondary ACECs where appropriate. This delegation should be recorded in writing.
4.6 Any subsequent decisions with respect to the project by any of the ACECs should be conveyed to the other ACECs as soon as possible, as should any problems with the project.
4.7 Wherever possible, the formal agreement (4.2) should include acceptance by all relevant ACECs of a single protocol application form to facilitate compliance with 4.3. Where ACECs cannot agree to accept a single form, a collaborating ACEC may request additional information not requested on a particular ACEC's form.
4.8 Responsibility for the implementation of the above is as follows:
4.2 - the head of the collaborative research group;
4.3 and 4.6 - the principal investigator;
4.4 and 4.5 - the relevant ACECs.
The contribution of the following people is gratefully acknowledged: A/Professor Kevin Broady, Chair, Royal North Shore Hospital & University of Technology ACEC, Professor Don Chisholm, Chair, Garvan & St Vincents ACEC, Dr Julie Ferguson, Executive Officer, Garvan & St Vincents ACEC and member, University of New South Wales ACEC, A/Professor Robert Osborne, Acting Chair, Western Sydney Area Health Service ACEC, Professor Michael Perry, Deputy Chair, University of New South Wales ACEC and member, Garvan & St Vincents ACEC.
Animal Research Review Panel Guideline 3