A Comparative Analysis of the Legal and Bioethical Frameworks Governing the Secondary Use of Data for Research Purposes.

The secondary use of research and health data for purposes that differ from the original purpose of the collection is becoming a major trend in research, since it allows for the optimal use of already available resources, and reduces the costs of research activities. However, the consent provided at the time of the initial data collection might not have foreseen these new uses of the data. This is especially true for biobanks having collected data under a restricted or a disease-specific consent, and for data linkage, which allows researchers to combine research data with information from the medical record of participants. To protect the participants' privacy, confidentiality, and autonomy, the use of identifiable research and clinical data for secondary research purposes is governed by a rather complex legal and ethical framework. This article aims to: (1) provide a comprehensive analysis of the legal and bioethical framework governing the secondary use of data at the international level, and; (2) identify points of convergence and divergence with regard to the secondary use of data for research purposes, in five countries (Australia, Canada, France, United Kingdom, and United States). While the secondary use of already collected data carries benefits and drawbacks, the international and national legal framework provide guidance to promote a wider (although limited) secondary use of data, while protecting research participants' rights and interests. Despite some differences, the similarities between international and national regulations and norms reveal the emergence of a common set of criteria for the secondary use of data in international research.