Research Ethics and Governance
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Questions and Answers

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 (correct)
  • Teachers
  • Investigators
  • Students
  • 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 ____.

    <p>365 days/year</p> Signup and view all the answers

    Match the following Acts/Laws with their respective areas of regulation:

    <p>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</p> Signup and view all the answers

    What details should be provided to the owner regarding their responsibilities?

    <p>document, details &amp; duration of owner responsibilities, owner to accept in writing</p> Signup and view all the answers

    What information should be included in the Records & Reporting by Investigators?

    <p>All of the above</p> Signup and view all the answers

    ____ should be addressed rapidly when adverse impacts occur.

    <p>Adverse impacts</p> Signup and view all the answers

    Match the following terms with their meanings:

    <p>Welfare Monitoring &amp; Assessment = Monitoring the wellbeing of animals Unscheduled Adverse Events = Unexpected negative events during the study Incidents &amp; Deviations = Occurrences not following approved protocols Other Reports as Required by AEC = Additional reports needed by the Animal Ethics Committee</p> Signup and view all the answers

    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.

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    Description

    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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