Apples and oranges in animal research the challenges of harm-benefit analysis and its operationalization in transplantation studies

Harm-benefit analysis (HBA) is a crucial step in the evaluation process for projects using animals for scientific purposes, aiming to justify the harm inflicted on animals in relation to the project’s anticipated benefits. As such, HBA is a legally mandated component of project evaluation in countries under the Directive’s purview and is carried out by review committees. Various HBA concepts are currently proposed, risking inconsistent operationalization during the evaluation process. These discrepancies have been documented in this thesis, along with a newly introduced approach to conducting HBA using the compound model. Implementing a reliable HBA methodology is vital, especially considering that certain research projects may inflict severe pain and/or distress on animals, particularly in translational research areas such as transplantation immunology. Consequently, the creation of large animal models for the purpose of transplantation research is included in the thesis as an example of how HBA and the newly developed compound model can be utilized. Ultimately, the thesis showcases inconsistent HBA implementation, establishes a practical HBA tool, and demonstrates its feasibility through an applied case study.