3-Ethical issues, harm-benefit assessment and humane endpoints

Each research project has its own set of ethical challenges, but the following general questions should be raised for all projects:

1. Have national or local research ethics committees already produced statements relevant to the research being planned?
2. Have the Three Rs (Replacement, Reduction, Refinement) been addressed, and will any advances in this area be mentioned in publications of the study (remembering that many databases only index the title and abstract of papers)? Which non-animal alternatives have been considered but rejected?
3. Have the Three S's (Good Science, Good Sense and Good Sensibilities) been addressed?
4. Does the proposed study have a clear rationale and scientific relevance, and what will be the next step if the hypothesis is supported or rejected?
5. Have the experiments been carried out before, and is any repetition justifiable?
6. What approaches to reduce distress have been considered?

‘Choosing the right animal for the right reason’ (Harry Rowsell).
The large increase in use of genetically altered lines has created increasing concern about the suitability of these animals as models of human conditions. This, and the high level of attrition in animal research, is discussed in a paper by Joseph Garner (2014): The Significance of Meaning: Why Do Over 90% of Behavioral Neuroscience Results Fail to Translate to Humans, and What Can We Do to Fix It?

Ethics are also discussed in a separate section of this website. 

Will the project undergo pre-registration, and will negative results be published, to avoid publication bias?

Preregistration promotes transparency by sharing study designs a priori and making them accessible to others. This process participates in the reduction of reporting biases (e.g. selective outcomes reporting and HARKing), prevents the involuntary duplication of animal studies, and can be used by researchers as proof of good planning and management.

Resources

• preclinicaltrials.eu: an international register of preclinical trial protocols
• Registered Reports at Nature
• Registered Reports at COS (Center for Open Science)
• Registered Reports: what are they and why are they important? (Royal Society, 2016)
• Dirnagl (2020): Preregistration of exploratory research: Learning from the golden age of discovery

This page was updated on 11 April 2022