Work

Practical templates for digital health ethics applications in Sweden: lessons from a sensor-based monitoring study

Year: 2026

Type: article

Abstract: Obtaining ethical approval for digital health research involving vulnerable populations presents significant challenges for researchers, particularly when navigating complex regulatory frameworks like Sweden's ethical review system. Despite official guidelines, researchers often struggle to translate general principles into concrete application documents that satisfy review authorities. This paper presents practical, reusable templates developed through the successful preparation of an ethics application for a radar-based monitoring study of older adults in Sweden. The application, involving cross-border data handling and vulnerable populations, received first-submission approval from the Swedish Ethical Review Authority (Etikprövningsmyndigheten) without reviewer comments. We provide structured templates for key application sections, identify common pitfalls, and offer evidence-based guidance for researchers preparing similar applications. These resources are practice-grounded (one approved applications plus practice-based reflections) and are intended to reduce administrative burden and improve application quality; they should be adapted to local institutional requirements.

Source: Frontiers in Digital Health

DOI: 10.3389/fdgth.2026.1745662

Authors: Samaneh Zolfaghari, Rose-Marie Johansson-Pajala, Lena Marmstål Hammar, Masoud Daneshtalab

Institution: Mälardalen University

Language: English

Topic: Ethics in Clinical Research

Subfield: Public Health, Environmental and Occupational Health

Field: Medicine

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: gold

Estimated APC paid: $3,077