On January 30, 2014 Swedish researchers published a study detailing criteria for the evaluation of non-standard in vivo studies for health risk assessment in the scientific Journal of Applied Toxicology (Beronius et al. 2014). According to Beronius and colleagues, academic research is often not conducted in accordance with good laboratory practice (GLP) and study design guidelines such as those by the Organisation for Economic Cooperation and Development (OECD), because academic scientists may want to consider most sensitive endpoints for which no guidelines are available. However, non-standard studies are often considered by risk assessors to have methodological limitations or being poorly reported, in line with the Klimisch Scores (Klimisch et al. 1997). Yet, as pointed out by Anna Beronius, lead author of the study, non-standard studies can complement standard studies in a beneficiary manner and provide important information to regulatory risk assessment. The criteria developed by the researcher split the assessment of non-standard studies into two tiers; studies complying with tier 1 demands advance to a more comprehensive evaluation under tier 2. The guidelines come in form of a checklist and shall provide risk assessors with the tools to include all relevant data in chemical risk assessment. The criteria also facilitate reporting for academic scientists, as they show information needs for chemical risk assessment. The newly proposed criteria are a valuable addition to the widely used Klimisch Scores.
Beronius, A. et al. (2014). “Facilitating the use of non-standard in vivo studies in health risk assessment of chemicals: a proposal to improve evaluation criteria and reporting.” Journal of Applied Toxicology (published online January 30, 2014).
Klimisch, H. J., et al. (1997). "A Systematic Approach for Evaluating the Quality of Experimental Toxicological and Ecotoxicological Data." Regulatory Toxicology and Pharmacology 25(1): 1-5.