Related Experiment Video
Updated: Dec 8, 2025

Biobank for Translational Medicine: Standard Operating Procedures for Optimal Sample Management
Published on: November 30, 2022
Big Data, Biomedical Research, and Ethics Review: New Challenges for IRBs
Agata Ferretti1, Marcello Ienca2, Samia Hurst3
1PhD candidate in Bioethics at the Health Ethics and Policy Lab, Swiss Federal Institute of Technology in Zurich.
Abstract:
The increased use of big data in the medical field has shifted the way in which biomedical research is designed and carried out. The novelty of techniques and methods brought by big data research brings new challenges to institutional review boards (IRBs). Yet it is unclear if IRBs should be the responsible oversight bodies for big data research and, if so, which criteria they should use. A large but heterogenous set of ethics guidelines and normative responses have emerged to address these issues. In this study, we conducted a scoping review of soft-law documents and guidelines with the aim of assessing ongoing normative efforts that are proliferating in this domain. We also synthesize a set of recurrent guidelines that could work as a baseline to create a harmonized process for big data research ethics.
Related Concept Videos
Ethics in Research
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
Bioequivalence studies: Biowaivers
Ethics and Bioethics
Bioavailability Study Design: Healthy Subjects Versus Patients
Overview of Biostatistics in Health Sciences

