Mapping Benefits and Harms in Direct-to-Consumer Genetic Testing: A Scoping Review Protocol

Direct-to-consumer genetic testing (DTC-GT) enables individuals to access genetic and genomic information without the involvement of healthcare professionals and has expanded rapidly. While DTC-GT is often associated with increased access to information, convenience, and consumer empowerment, concerns persist regarding test validity, result interpretation, psychological effects, impacts on healthcare systems, data governance, equity, and ethical oversight. The existing evidence on DTC-GT is fragmented. Previous reviews have focused on consumer-level outcomes, with limited attention to practitioner-level impacts, public and health system consequences, or environmental sustainability. As a result, there is currently no comprehensive synthesis that maps both benefits and harms of DTC-GT across multiple levels of impact. The purpose of this project is to conduct a scoping review that systematically maps reported benefits and harms of DTC-GT across four levels: consumers, practitioners, the public, and the planet. The review will follow JBI methodology and be reported in accordance with PRISMA-ScR guidelines. Empirical studies and reviews published from January 2015 onwards will be included to reflect the contemporary phase of DTC-GT, while gray literature will be excluded. This scoping review will produce an evidence map of the benefits and harms associated with DTC-GT, identify research gaps, and highlight cross-level tensions where benefits at one level may coincide with harms at another. The findings are intended to inform responsible innovation, policy development, and future research on DTC-GT.