A proposed regulatory and ethical framework for the application of single-case experimental design methodology in rehabilitation research and clinical practice

Abstract

The use of single-case experimental design (SCED) methodology is growing across all domains of rehabilitation. SCED methodology may be used for several different purposes, which creates confusion about its ethical, legal and regulatory status. We will argue that aspects of SCED methodology can be helpful in clinical practice to determine the optimal treatment for a given person. Given the use of SCED methods in research, clinicians may assume that ethics committee approval is required, though this is not necessarily the case given that SCED methods may, under certain circumstances, be considered as evidence-based clinical practice, rather than generalizable research. In this paper, we aim to raise awareness of the principles and legal/ethical framework of SCEDs, and we propose a series of position points that could help researchers/ethics review boards to determine whether a SCED is "research" or "evidence-based person-specific clinical practice", based on its design and purpose. We aim to clarify how the features of SCED methodology - baseline length and content, repeated measurement, randomization, and blinding - impact SCED categorization. A secondary objective is to provide recommendations for universities and training institutes to help trainees undertaking SCED studies to use appropriate methodologies that comply with the proposed regulatory framework.

Keywords: Ethics; Multiple baseline; N of 1 trial; Research regulatory framework; Single case.