How Risky Can Biomedical Research Be?: On Setting an Upper Limit of Risk in Non-beneficial Research Involving Volunteers

One of the unmet challenges for risk–benefit assessment in biomedical research is whether there should be an upper limit of risk in non-beneficial studies involving competent and consenting participants, and if yes, how it should be defined. This chapter focuses on this second question. It examines the four dominant regulatory and conceptual approaches to setting a maximal risk threshold in research: no catastrophic harm/risk approach, pure procedural approach, numerical approach, and comparative approach. It then considers the pure procedural approach, which leaves the judgment of risk acceptability to RECs discretion. The approach has significant advantages, but it is not free from certain shortcomings, such as unwarranted diversity and arbitrariness of RECs judgments. The chapter concludes by sketching the outlines of what is referred to as the “ELS procedural approach” that provides RECs with procedural recommendations for identifying an ethically, legally and socially acceptable upper limit of risk in non-beneficial research on volunteers. The ELS procedural approach is an improvement over the pure procedural approach. It is more standardized and accountable, but still context-sensitive and flexible.