Policy Experiments, Informed Consent, and Democratic Accountability

Abstract: In a randomized clinical trial, consenting individuals are randomly assigned to treatment and control arms. But not all randomized experiments are like this. In a cluster randomized trial (CRT), the unit of randomization is not an individual but a social entity, e.g., a hospital, school, village, or neighborhood. CRTs are frequently used in development economics and policy evaluation in both low- and middle-income countries (LMICs) and high-income countries (HICs). An ethical issue with CRTs is that they make it impracticable to obtain informed consent from research subjects. In this article, I assess the ethical permissibility of policy experimentation without consent. I argue that policy experimentation without consent shows respect for persons when conducted or authorized by democratically accountable actors.

The central argument in this article proceeds in two steps. First, I argue that informed consent matters because it is an ethical mechanism that (a) protects research subjects' autonomy and (b) protects and promotes research subjects' welfare interests. I use this analysis to support the following premise: (P1) if an ethical mechanism achieves (a) and (b), then it shows respect for persons. I then argue that (P2) democratic accountability is an ethical mechanism that achieves (a) and (b). I draw on democratic theory to support P2. From these two premises I conclude that democratic accountability shows respect for persons in the policy experimentation context. The use of CRTs in policy research is not an obstacle to permissible experimentation.