What do institutional animal ethics boards do?
In the previous post of this series, I spoke about the role of regulatory bodies governing animal research. It’s now time to talk about what institutional ethics boards do when it comes to vetting animal research proposals. I’ll also share tips on the things to remember when you submit your proposal for your study involving animals.
What does an animal ethics review committee do?
Studies involving animals undergo an animal ethics review process as part of the research proposal approval process. An animal ethics committee typically evaluates the quality and consistency of a proposal. It reviews the proposed use of animals in research by evaluating the scientific design and conduct of the study and assesses if there are any modifications required in the protocols prior to approval. The committee ensures that the protocols in the proposal adhere to the standard guidelines and the personnel involved in animal care and use are appropriately qualified to perform their duties and conduct the proposed activities. The committee also looks into any legitimate concerns involving the care and use of animals during research. The review board inspects the housing and other facilities in the animal facility in the institution to make sure that the experiments are conducted under hygienic conditions. The ethics committee assesses predictable risks/harms to the animals to weigh them against advantage of research outcomes with every study protocol. The final decision of approval/rejection of a research proposal and the final number of animals to be allotted is made after all committee members arrive at a consensus.
A protocol review by an institutional animal ethics committee typically covers the following points:
1. The basis for approving animal research proposals: Approvals are based on the potential contribution the research can make towards the understanding of biological or environmental principles, or issues that benefit humans, animals, and the environment. The focus is also on research that can yield reproducible results.
2. The three Rs: Adherence to the code of the three “R”s of animal research is a pre-requisite. What are the three “R”s?
- Replacement – techniques that replace the use of animals must be sought and used where possible
- Reduction – each project must use no more than the minimum number of animals necessary
- Refinement – Projects should be designed to avoid pain and distress in animals)
3. Plain-language summary: Since the animal research ethics committee is supposed to include a non-scientist, a plain language summary of the project – including the primary aims, proposed use of animals, description of procedures designed to assure that animal suffering will be prevented or at least minimized – is first reviewed.
4. Relationship between the experiment and study objectives: The review also includes an examination of the following
- The relationship between the proposed experiment and the overall objective
- Identification of the species/strain of animals (justified by the structural, behavioural, physiological, biochemical or other features/considerations based on previous studies)
- Approximate number of animals to be used for the experiment and appropriateness of this number [based on experimental design along with the statistical rationale which supports the size of the control and test group(s)]
- Rationale for using the animals
- Complete description of the experimental protocols to be used on animals The procedures designed to limit physical injury/psychological distress caused to animals
- Setting of humane endpoints to the experiment
- Expertise of personnel conducting the experiments
- Use of anaesthetics, modes of surgery, analgesics, antibiotics, and euthanasia methods
- Living conditions of the animals – housing, feeding, medical and non-medical care of the animals
5. Risk analysis: If hazardous physical, chemical, and biological agents (such as radioactive materials, recombinant DNA/RNA, human/plant/animal pathogens, acute toxins, chemical carcinogens, ethers, etc.) are used, the potential health risks to humans or animals, special animal care required, precautions for personnel, special containment requirements, specific storage, waste and animal disposal requirements, and emergency procedures are reviewed extensively.
6. Necessity: The use of animals for teaching protocols is approved only if alternative methods such as models, videos, computer simulations and emulations, etc., do not exist.
7. Animal treatment: Experimental procedures involving the capture, handling, and release of wild animals are given utmost importance. When protocols involve aspects such as population sampling by sacrificing, a strong justification is needed for the method used. These approvals are granted to researchers who have adequate experience and expertise in wildlife studies.
Thus, the goal of having protocols for animal experiments is to balance the ever-increasing demand of animals for medical, scientific, and economic progress, while simultaneously ensuring the ethical treatment of animals by reducing their usage and suffering. The guidelines stipulated by the government and the protocols reviewed by the institutional animal ethics committee try to reconcile these aspects and aim to achieve a cost/benefit assessment involving ethical, scientific, and social issues. The protocols for animal usage and the committee justifies the need for animal use, thereby assuring that the expected outcome of the experiments will outweigh the cost involved and contribute positively towards scientific advancement.
Related reading:
- US Government Publishing Office Food and Drug Regulations
- Guidelines on Good Clinical Laboratory Practice
- A young researcher's guide to a clinical trial
- Can a veterinary medicine paper be published without informed consent of animal owner?
Other parts in the series:
Part 1: The role of regulatory bodies governing animal research
Published on: Mar 27, 2018
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