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.

Ethical Approval

• 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.

Animal Welfare and Care

• 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.

Humane Endpoint and Euthanasia

• 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).

Transparency and Reporting

• Complete reporting of animal numbers, methods, results, and any adverse events is required.
• This enhances reproducibility and reduces redundant experimentation.

Researcher Training

• 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.

Informed Consent

• 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.

Participant Safety and Well-being

• Continuous monitoring of participants’ health and welfare is required.
• Preventive and corrective measures must be in place to minimize physical, psychological, and social risks.

Privacy and Data Protection

• 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.

Vulnerable Populations

• Research involving children, elderly, cognitively impaired individuals, or other vulnerable groups requires special approval and additional protective measures.

Right to Withdraw

• Participants may withdraw from the study at any time without any penalties or consequences.

Conflict of Interest

• All potential conflicts of interest must be disclosed.
• Mechanisms should be in place to mitigate their impact and ensure independent evaluation of results.

Transparency and Follow-up

• 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.

Researcher Training

• 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