9 Questions
What does AEC stand for and what role does it play in research activities?
Animal Ethics Committee; review, approve, and monitor research activities involving animals
Who is responsible for the wellbeing of animals throughout their lifespan in a research project?
Principal Investigator
Animal care should be supervised by an adequate number of competent people at all times.
True
Animal monitoring should be conducted at least once daily, all throughout the ____.
365 days/year
Match the following Acts/Laws with their respective areas of regulation:
Animals Protection Act = Protection of animals Veterinary Act = Veterinary practices Medicines Act = Medications Animal Diseases / Animal Health Act = Disease control Stock Remedies = Medications for livestock
What details should be provided to the owner regarding their responsibilities?
document, details & duration of owner responsibilities, owner to accept in writing
What information should be included in the Records & Reporting by Investigators?
All of the above
____ should be addressed rapidly when adverse impacts occur.
Adverse impacts
Match the following terms with their meanings:
Welfare Monitoring & Assessment = Monitoring the wellbeing of animals Unscheduled Adverse Events = Unexpected negative events during the study Incidents & Deviations = Occurrences not following approved protocols Other Reports as Required by AEC = Additional reports needed by the Animal Ethics Committee
Study Notes
Investigators, Researchers, Teachers, and Students
- All activities involving animals are subject to Animal Ethics Committee (AEC) policies and legislation.
- Researchers, teachers, undergraduate and postgraduate students, and people involved in product testing, environmental testing, producing biological products, wildlife surveys, and scientific purposes must comply with AEC policies and national laws.
- Activities and projects must comply with SANS 10386 and are subject to review, approval, and monitoring by AEC.
- Commencement of projects is only allowed after AEC approval is granted, and changes can only be made after AEC approval for amendments.
Investigators
- Have personal responsibility for animal wellbeing throughout the lifetime of the animal, from issuance to the study or activity to the end of use.
- Must ensure animal monitoring at least once daily (365 days/year).
- Must report to AEC, maintain records, and declare all hazards.
- Must receive education and training, complete continuing education, and undergo competency assessments.
Principal Investigator
- Has ultimate responsibility for animal care and use.
- Must be competent and experienced with respect to animal wellbeing.
- Must ensure that all people involved in the project understand and accept their roles and responsibilities.
- Must ensure that procedures and resources are in place to meet responsibilities, including education, training, supervision, and competence.
- Must familiarize themselves with SANS 10386:2021 and ensure relevant experts are consulted.
Scientific Integrity
- Ethical principles govern animal use, with benefits outweighing harms.
- Projects must have significant scientific or educational merit.
- No replacements are available, and animal use is essential.
- The 4Rs principle (Replacement, Reduction, Refinement, and Responsibility) must be applied.
- Projects must be scientifically valid, well-designed, and have a reasonable expectation of achieving aims.
Design of Projects
- Investigators must apply the 4Rs principle at all stages of the project.
- Species and nature of animals must be suited to the project.
- Living conditions and management must be species-suitable.
- Numbers of animals must satisfy good statistical design.
- Current best practices must be applied to minimize pain, suffering, distress, and lasting harm.
- Pilot studies and staged assessments must be conducted.
Conduct of Projects
- Investigators must minimize known or potential causes of pain, suffering, distress, and lasting harm.
- Animal care must be provided by competent people.
- Monitoring and assessment of animal wellbeing must be conducted at least once daily.
- Refinement and competent procedures must be implemented and reviewed.
- Unanticipated adverse events must be notified to AEC, and prompt action must be taken.
New Animal Lines
- Creation and breeding of new animal lines require AEC approval.
- AEC approval is only granted if animal or in vitro models are not available.
- Procedures for creating and breeding must be regarded as a protocol application to AEC.
- Persons responsible are considered investigators until the impact on animal wellbeing is known and AEC has approved the final report on the line's generation.
Privately-Owned Animals
- Informed consent forms must be completed, including project title, researcher, institution, and funder.
- Owner and animal details must be provided, along with a brief project description and statement of ethical approval.
- Potential benefits, risks, and implications must be explained to the owner.
Records and Reporting by Investigators
- Records of animal care and use must be maintained, including welfare monitoring and assessment.
- Annual reports must be submitted, including protocol outcome, retrospective review, and final report.
- Unscheduled adverse events and incidents must be reported, along with deviations from the approved AEC protocol.
- Records must be available to the institution, AEC, and independent reviewers.
This quiz covers the responsibilities of investigators, researchers, teachers, and students in research ethics and governance, including private and independent records management.
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