More good than harm?

Background: Clinical research involving human subjects must be ethically legitimatised by being scientifically valid, satisfying legal norms, and adhering to basic ethical requirements such as informed consent and appropriate risk-benefit ratios. Autonomous institutional review boards (IRB) support researchers in meeting these demands. Methods: We propose and test a systematic approach to the ethical analysis of risks and potential benefits in clinical research involving human subjects. The scheme was applied on all study protocols from the year 2006 presented to the IRB of our medical faculty. Results: 46 % of the 206 analyzed protocols promise some potential direct benefit to study participants. 12 % of the planned research projects offer the chance of benefit for future patients with the same demographic and clinical characteristics as the study participants ("group-benefit"). The reminder of the protocols (42 %) reveal potential benefit only for medicine and science through gaining knowledge of clinical, social, or scientific value. More than minimal risks for research participants were identified in about 53 % of the studies. Our ethical analysis and evaluation resulted in 33 out of 206 protocols (16 %) with an unfavourable and hardly justifiable risk-benefit ratio. Conclusion: The developed taxonomy together with our conceptual framework for comparing and balancing potential research benefit and harm can increase the transparency and facilitate the communication between researchers and IRB members. Clear guidance for the IRBs supports the standardisation and harmonisation of ethical review, advice, and approval procedures.