Ethical review process

The inadequate quality of reporting of animal studies also raises the question how effective the ethical review proces has been. Pound (Pound & Nicol, 2018) reanalysed data from a landmark paper to conduct a retrospective harm-benefit analysis of animal research. In 2007 Perel et al published a landmark study in the BMJ which explored the clinical relevance of animal research by comparing systematic reviews of animal studies with systematic reviews of human studies for the same 6 interventions (antifibrinolytics for haemorrhage, bisphosphonates for osteoporosis, corticosteroids for brain injury, Tirilazad for stroke, antenatal corticosteroids for neonatal respiratory distress and thrombolytics for stroke)(Perel et al., 2007).

A reanalysis of the same animal studies originally reviewed by Perel et al. was done by Bristol researchers, who extracted data on harms to animals from the animal studies (covering the period 1967 to 2005) and an expert panel scored the severity of those harms. In addition to Perel et al’s findings on the clinical relevance of the animal studies, the latter was also explored in terms of current clinical practice, while the impact of the research was investigated using citation scores. These new data enabled the researchers to conduct a systematic retrospective harm-benefit analysis (HBA), the first of its kind, for each of the 6 interventions. Bateson’s Cube was used to guide the HBA.

The most common assessment of animal harms by the expert panel was ‘severe’. All the studies were poor quality. Having weighed the actual harms to animals against the actual clinical benefits accruing from these studies, and taking into account the quality of the research and its impact, less than 7% of the studies were judged permissible according to Bateson’s Cube: only the ‘moderate’ bisphosphonate studies appeared to minimise harms to animals whilst being associated with benefits for humans.

Under current EU regulations and elsewhere, harms to animals have to be minimised and the benefits of the research are supposed to justify the harms to the animals involved. Pandora Pound, who led the research, said, ‘The regulatory systems in place when these studies were conducted failed to safeguard animals from severe suffering or  to ensure that only beneficial, scientifically rigorous research was conducted.’