Dove Leads Ethics Review for International Data-intensive Research

An article led by Edinburgh Law School and Liminal Spaces PhD candidate Edward Dove has been published in the world-renowned journal Science.

The article, which is a ‘Policy Forum’ covering a science-relevant topic from a policy perspective, discusses key lessons learned from five data-intensive multi-jurisdictional research projects, of which several of the co-authors were personally involved.

The analysis revealed three general ethics review models—reciprocity, delegation, and federation—that clarify and add to what currently exists in some jurisdictions, integrating existing ethics review approaches in innovative ways.  It found that prior and ongoing engagement with research ethics committees (RECs), institutions, or governmental bodies to achieve REC alignment (e.g. memorandum of understanding) can be effective. A well-resourced process for developing tools (e.g. customized agreements, face-to-face meetings) for improved REC review is critical, as is (if possible) an opportunity to pilot test them before full implementation.

Research also found that ethics review for data-intensive international research should be founded on at least two principles. First, projects imposing similar risks on research participants should be subjected to similar levels of scrutiny by all RECs. Second, assuming procedural and regulatory alignment is in place, once an ethics review opinion has been provided, each jurisdiction should not require further de novo review. This does not foreclose local accommodations for issues pertinent to local context (e.g. data storage, recruitment methods).

The article suggests that although no one model will fully suit all data-intensive international research, and multiple variations can be devised, the models identified in the article can improve on the status quo of replicate REC review. It recommends that until the emergence of a competent and legitimate system for reviewing and steering data-intensive international research, a bottom-up, ad hoc solutions, ideally coupled with official recognition and support by governments and regulators, sponsors, funders, institutions, and data access committees.

The article was co-authored with members of the Ethics Review Equivalency (ERE) Task Team, which is part of the Regulatory and Ethics Working Group of the Global Alliance for Genomics and Health.

The article can be read online at http://science.sciencemag.org/content/351/6280/1399 (subscription service only). Vol 351, Issue 6280 (25 March 2016) http://dx.doi.org/10.1126/science.aad5269

Further information

The Global Alliance for Genomics and Health, an international non-profit organisation of more than 1000 individual and organisational members seeking to promote the international sharing of genomic and clinical data to advance human health.

The ERE Task Team of the Global Alliance for Genomics and Health, is coordinated by Edward Dove. It has been developing models of ‘ethics review mutual recognition’ over the course of the past year, which aim to enable mutual recognition of ethics review across jurisdictions. The purpose of such mutual recognition is to improve and streamline the process of ethics review for data-intensive international research projects (e.g. genomics research), eliminating the duplication and inconsistency that challenges multi-jurisdictional research ethics committee (REC) review, and has long been a source of concern for researchers and regulators alike. The Task Team’s work focuses on data-intensive science and internationally collaborative research projects. The Task Team aims to further develop the concept of ethics review mutual recognition and its various models through discussion of comparative analysis of different equivalence regimes; and how such models and tools can be validated and tested in international institutions and international projects carried out in multiple countries.

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