Abstract
BackgroundGenomics research is becoming increasingly globally connected and collaborative, contesting traditional ethical and legal boundaries between global and local research practice. As well, global data-driven genomics research holds great promise for health discoveries. Yet, paradoxically, current research ethics review systems around the world challenge potential improvements in human health from such research and thus undermine respect for research participants. Case reports illustrate that the current system is costly, fragmented, inefficient, inadequate, and inconsistent. There is an urgent need to improve the governance system of ethics review to enable secure and seamless genomic and clinical data sharing across jurisdictions.DiscussionBuilding on the international privacy 'safe harbor’ model that was developed following the adoption of the European Privacy Directive, we propose an international infrastructure. The goal is to create a streamlined and harmonized ethics governance system for international, data-driven genomics research projects. The proposed 'Safe Harbor Framework for International Ethics Equivalency’ would consist in part of an agency supporting an International Federation for Ethics Review (IFER), formed by a voluntary agreement among countries, granting agencies, philanthropies, institutions, and healthcare, patient advocacy, and research organizations. IFER would be both a central ethics review body and also a forum for review and follow-up of policies concerning ethics norms for international genomics research projects. It would be built on five principle elements: (1) registration; (2) compliance review; (3) recognition; (4) monitoring and enforcement; and (5) public participation.SummaryA Safe Harbor Framework for International Ethics Equivalency would create many benefits for researchers, countries, and the general public, and may eventually have application beyond genomics to other areas of biomedical research that increasingly engage in secondary use of data and present only negligible risks. Among the benefits, research participants and patients would have uniform adequate protection, while researchers would be ensured expert ethics review with a reduction in cost, time, administrative hassle, and redundant regulatory hurdles. Most importantly, society would enjoy the maximization of the potential benefits of genomics research.
Highlights
Genomics research is becoming increasingly globally connected and collaborative, contesting traditional ethical and legal boundaries between global and local research practice
Summary: A Safe Harbor Framework for International Ethics Equivalency would create many benefits for researchers, countries, and the general public, and may eventually have application beyond genomics to other areas of biomedical research that increasingly engage in secondary use of data and present only negligible risks
We propose a federated ‘Safe Harbor Framework for International Ethics Equivalency’ (Safe Harbor) that facilitates the harmonization of ethics review of data-driven international genomics research projects while respecting globally transposable research ethics norms and principles
Summary
The safe harbor framework We define a safe harbor as a process, system, or framework that allows a bona fide entity to perform certain actions in compliance with defined standards or conditions in exchange for protection from ordinary regulatory burdens. An international Code of Conduct that requires NCOs or designated agencies with statutory authority to dole out strict sanctions for violations of the Safe Harbor principles and standards ensures research participants and citizens that a streamlined ethics review process does not mean a reduction in oversight or enforcement. To the contrary, it means more efficient review and increased monitoring and sanctioning for ethical or legal transgressions. Authors’ contributions All authors (Dove, Knoppers, Zawati) contributed to the preparation of this article and have read and approved the final manuscript for publication
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