Waiver of informed consent in clinical research: a summary of contemporary guidelines and a resource for researchers

Abstract

Objective: Low-risk pragmatic clinical research such as learning health system research, quality assurance activities and comparative effectiveness studies are approaches to embedding clinical research within routine practice to generate generalisable evidence. Individual written informed consent may present a barrier to the feasibility and inclusiveness of such low-risk clinical research. Within an overarching moral and ethical framework, the form and requirements of consent vary in both clinical practice and research settings according to the context and level of risk. Within some low-risk research settings, waiver of consent may be appropriate.

Analysis: We sought to describe contemporary national and international English-language guidelines pertaining to the use and oversight of waiver of consent in clinical research. We identify 14 guidelines including 1 international, 1 regional and 12 national statements, and summarise the principles in each for circumstances in which a waiver of consent is appropriate.

Conclusion: While complete international harmonisation of policy may be neither realistic nor necessary, there are numerous unifying concordances suggesting a broad consensus on the approach to waiver of consent research.

Keywords: Clinical Trial; MEDICAL ETHICS; Research Design; STATISTICS & RESEARCH METHODS.

Figure 1. Countries with regional or national guidelines for ‘waiver of consent’ in non-emergency clinical research. Figure sourced from MapChart and modified with permission.