The assessment of risks and burdens in the evaluation of clinical trials by research ethics committees (RECs)
Risks and burdens in the study participation as well as an adequate risk-benefit-balance are key concepts for the evaluation of clinical studies by RECs (§§ 4, 40, 41 Medicinal Products Act (AMG), Art. (16-18), Declaration of Helsinki, WMA, Fortaleza 2013). An adequate assessment, description and communication of risks and burdens in clinical trials has long been described as a central task in research ethics. However, there is currently no uniform and solid theoretical approach for describing and assessing risks through RECs. The current project will carry out preparatory conceptual work in order to subsequently develop a corresponding concept with the integration of external experts. In addition to clinical trials according to AMG, other clinical studies should also be taken into account.
For this purpose, the project seeks to address the issues of different risk definitions, risk analyses before and during clinical trials, adverse event reporting, different risk levels across different study populations (e.g. children and adolescents), and the comparability of risk levels in AMG clinical trials in contrast to other clinical trials. Furthermore, in the planned project conceptual considerations should be made as to whether an overarching risk concept for clinical trials in humans is in principle possible (AMG, MPG and other clinical studies) or whether there are fundamental objections with respect to different study types that must use different risk terms.
Project leader: Prof. Dr. Christian Lenk
Project member: Pranab Rudra, M.Sc.