Adapting and Adaptive Research

Abstract

AbstractResearch conducted during epidemics may warrant adaptations or adaptive designs owing to practical constraints, time pressures, uncertainty, the importance of flexibility, and the potential for research to detract from epidemic response. Adapting research entails choosing different research designs or methods if research goals, contexts or constraints justify or require a different approach. Adaptive research, by contrast, is a type of research that prospectively plans for modifications after research has been initiated, while maintaining the validity and integrity of the research. While adaptation and adaptive designs introduce an important degree of flexibility to research conducted during epidemics and help to address research objectives and constraints, adaptation and adaptive designs require close ethical scrutiny and are no different from other research in that they are expected to align with universally accepted ethical standards. Important ethical questions exist regarding the conditions that justify adaptations to research, the kinds of adaptive research designs that can be ethically justified, and how ethics review bodies ought to evaluate such novel approaches to research in epidemic contexts. The five cases included in this chapter prompt reflection on the ethical considerations and implications of adapting research in response to epidemic-related risks and the public health measures deployed in response to those risks, as well as the ethical implications of not adapting research in such contexts. These cases also highlight ethical questions and issues arising during the conduct of adaptive trials, including when treatments under study, treatment doses, sample size, and other study features are reviewed in response to evolving evidence. This chapter invites reflection on these key ethical dimensions when considering adaptive designs and adaptations to standard research procedures during epidemics. What these cases make clear is that adaptive designs and adaptations to research do not reduce the need for rigorous scientific evaluation and adherence to universal ethical standards, and must be explicitly ethically justified and reviewed through transparent and inclusive processes.