Abstract: In order to protect those who lack the capacity to consent, regulations around the world hold that such individuals should be enrolled in clinical research only if (1) the risks of participation are minimal, or (2) the study offers them the "prospect of direct benefit" (PDB). Clinicians and bioethicists disagree widely about the nature of PDB, proposing variously that PDB involves a possibility of benefit, a high probability of benefit, or a reasonable person standard. In this paper, I show that each of these proposals is unsatisfactory, since there is no single probability threshold for PDB. I subsequently provide a novel account of PDB, which is able to explain the diversity of studies that are ethically justifiable in terms of PDB.
I argue that PDB should be understood in terms of three factors: (1) the probability of direct benefit, (2) the quality of evidence for this probability estimate, and (3) individuals' alternatives to participation. This account explains why studies with low chances of benefits and/or low-quality evidence concerning benefits can be ethically acceptable when an individual's alternatives are poor. Similarly, it explains why, when an individual's alternatives are more favorable, a study must have a higher chance of benefits and higher-quality evidence concerning benefits in order to be ethically justifiable in terms of PDB.
This account has two primary upshots. First, it shows why PDB cannot be understood in terms of a probability threshold. Second, it provides IRB members with more concrete guidance in assessing PDB.
Learning Objectives:
After participating in this conference, attendees should be able to:
Evaluate a variety of accounts of the prospect of direct benefit in clinical research.
Understand the factors that determine whether a study offers the prospect of direct benefit.
