Human and animal rights
| Post date: 2022/05/29 |
Comprehensive Guidelines on Ethics in Animal and Human Research
Ethics in Animal Research
The Three Rs Principle
- Reduction: The number of animals used should be minimized without compromising the scientific validity of the study. Strategies include precise statistical analyses, efficient study design, and data integration from previous studies.
- Refinement: Experimental procedures should be designed to minimize pain, stress, and distress. This includes appropriate anesthesia, analgesia, staff training, and optimized housing conditions.
- Replacement: Whenever possible, non-animal models such as cell cultures, computer simulations, or ex vivo models should be employed.
- All animal studies must receive prior approval from a recognized ethical committee, such as an Institutional Animal Care and Use Committee (IACUC) or its national equivalent.
- Any amendments to the study protocol must undergo re-evaluation and approval.
- Optimal conditions including temperature, lighting, ventilation, sufficient space, and access to food and water must be provided.
- Regular monitoring by an independent team and documentation of any unforeseen events are mandatory.
- Experiments should be terminated immediately if animals experience unrelievable pain or distress.
- Euthanasia must follow internationally recognized guidelines (ARRIVE, OECD, EU Directive 2010/63/EU).
- Complete reporting of animal numbers, methods, results, and any adverse events is required.
- This enhances reproducibility and reduces redundant experimentation.
- All researchers and laboratory personnel must undergo formal training in animal research ethics.
Ethics in Human Research
Ethical Approval
- Human studies must receive prior review and approval from a recognized ethical committee.
- Any changes to the study protocol require re-evaluation and approval.
- Participants must be provided with comprehensive information about the study objectives, procedures, benefits, risks, and alternatives.
- Written consent is mandatory, and participation must be voluntary and fully informed.
- Continuous monitoring of participants’ health and welfare is required.
- Preventive and corrective measures must be in place to minimize physical, psychological, and social risks.
- Personal data must be stored securely using encryption and other safeguards.
- Access should be limited to authorized personnel, and data retention should follow predefined timelines.
- Research involving children, elderly, cognitively impaired individuals, or other vulnerable groups requires special approval and additional protective measures.
- Participants may withdraw from the study at any time without any penalties or consequences.
- All potential conflicts of interest must be disclosed.
- Mechanisms should be in place to mitigate their impact and ensure independent evaluation of results.
- Comprehensive reporting of methods, outcomes, and adverse events is required.
- Whenever possible, follow-up assessments should be conducted to evaluate long-term effects and provide feedback to participants.
- All research team members must complete formal training in human research ethics.
Recommended International References and Guidelines
- ARRIVE (Animal Research: Reporting of In Vivo Experiments)
- IACUC (Institutional Animal Care and Use Committee)
- OECD Guidelines for the Testing of Chemicals
- EU Directive 2010/63/EU on the protection of animals used for scientific purposes
- Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects
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