Volume 20, Issue 2, February 2020, Page 20-22.

Volume 20, Issue 2, February 2020, Page 35-38.

Our aims are to set forth a multiprinciple system for selecting among clinical trials competing for limited space in an immunotherapy production facility that supplies products under investigation by scientific investigators; defend this system by appealing to justice principles; and illustrate our proposal by showing how it might be implemented. Our overarching aim is to assist manufacturers of immunotherapeutic products and other potentially breakthrough experimental therapies with the ethical task of prioritizing requests from scientific investigators when production capacity is limited.

Volume 20, Issue 2, February 2020, Page 38-41.

The purpose of a first-in-human (FIH) clinical trial is to gather information about how the drug or device affects and interacts with the human body: its safety, side effects, and (potential) dosage. As such, the primary goal of a FIH trial is not participant benefit but to gain knowledge of drug or device efficacy, i.e., baseline human safety knowledge. Some FIH clinical trials carry _significant_ foreseeable risk to participants with little to no foreseeable participant benefit. Participation in such trials would (...) be a bad deal for participants, and the research is considered justifiable because of the promise of significant potential social benefit. I argue that there is an ethical tension inherent in risky FIH research and that researchers should fairly compensate risky FIH trial participants. This does not make the risk–benefit outcome more favorable for participants; rather, it amounts to a collective reckoning with the ethical tension inherent in the research. (shrink)