Ethics approval for animal related research projects
All research projects involving animals must have ethics approval prior to starting. Many journals require ethics approval as part of the submission process of research papers and it is important to seek this well in advance of starting any project that may result in publication. Our Ethics and Welfare Committee will consider applications for prospective studies and retrospective analyses/clinical audit concerning all animal species, including questionnaire studies concerning owners of animal subjects (where the information collected relates primarily to the animal). The college of MVLS ethics committee will consider research projects involving questionnaires which ask personal questions of the owner/human subject (not just demographics such as their sex/age bracket/income bracket etc). Projects that cause pain distress, suffering or lasting harm to an animal for research purposes only fall under the Animal (Scientific Procedures) Act 1986 (ASPA), and ethics approval is obtained from a separate university committee, the Animal Welfare and Ethics Research Body. Guidelines on what procedures fall under ASPA can be found in the RCVS flow chart and examples. Contact one of the Named Vets about such projects in the first instance.
Applying for Ethics Approval
Approval may take up to 4 weeks, so please allow sufficient time for your application. Retrospective approval for studies that have already been completed will not be granted.
Once the project outline is agreed and numbers of samples/animals have been estimated from a power calculation, complete the appropriate sections of the form, ensure all applicants have signed it and obtain Head of Division’s signature BEFORE submitting an electronic version to gillian.ironside@glasgow.ac.uk. Consent forms, owner information sheets and draft questionnaires (if relevant) should be submitted along with the form.
For retrospective studies involving clinical records, archived images etc., only sections 1, 2, 4 and 8 of the form need to be completed.
Guidelines for Form Completion
The committee needs to be content that the project has been well designed and that the use of animals is justified and does not subject them to unacceptable procedures. They will consider whether any samples being taken are collected non-invasively or are ethically justified e.g. are required for clinical purposes and only ‘left-over’ amounts will be used in research. Taking blood samples purely for research purposes and which are not for the clinical benefit of the patient (often a problem for control groups) is not permitted. Such sampling would fall under ASPA and would require authorisation via project and personal licences. There is no need to give exhaustive detail of the assays /analysis which will be used but it is important to see that the applicant is familiar with the literature and can justify the reason for the study, the number of cases for statistical power has been considered, that control groups have been selected appropriately and that the project is likely to provide valid results if it goes ahead. The applicant must consider how the animal subjects and or their owners are affected by the research project and what measures are in place to protect their interests.
Extra Considerations
Consent Forms
Although there is a generic consent form for clinical procedures at the Small Animal Hospital, Weipers Centre and Farm Animal unit, which obtains consent for spare samples to be retained, any collection of non-invasive samples that are in addition to those needed for planned clinical purposes, would require a separate consent form eg. clipped hair, free catch urine. A client information sheet briefly detailing the project and explaining the need for sample collection should accompany or be part of the consent form. The committee can provide examples of these if necessary.
Multi-Centre Studies
For collaborative projects with other centres where the other centre is the lead PI group, a copy of the ethics approval should be submitted to the Chair (Prof Joanna Morris) to ensure that samples provided from Glasgow are collected appropriately. Approval from the main centre will suffice in most cases. For collaborations where Glasgow is the main PI group, additional ethics approval may need to be sought at the other institutions involved, as well as at Glasgow, depending on the local ethics committee.
Animal Test Certificates (ATC)
Projects that are using veterinary medicinal products in a clinical/field setting to client owned animals require an ATC-type S. This may be unlicensed drugs or licensed drugs being used in a different way (off licence). Applications are submitted to the Veterinary Medicines Directorate at www.vmd.defra.gov.uk.
Project Licences
For projects that are likely to come under ASPA both project and personal licences will be required as well as appropriate training. Advice should be sought from the named vets at biologicalservices-aspa-enquiries@lists.cent.gla.ac.uk.
Ethics or funding first?
To reduce workload we would not expect to review applications prior to funding unless the funder specifically requests this. However, ethical aspects of the work should be discussed with a committee member so that any issues may be identified. If necessary, a letter of comfort can be issued to accompany an application.
Biobank samples
Clinical samples being stored in the SBOHVM -80C Biobank freezer should be part of a specific project with ethics approval obtained in advance.