How mutually recognizable is mutual recognition? An international terminology index of research ethics review policies in the USA, Canada, UK and Australia.

Abstract

Could this Shakespearean adage be true of the policy terms used to describe research ethics review processes based on the principle of mutual recognition? Today, biomedical research is contingent on sharing research data [1–3] often across international borders [4]. This is because of the size of datasets necessary to make scientifically sound links between the human genome and underlying determinants of disease [5]. The degree of collaboration between researchers/research institutions typified in genomics and related ‘omics disciplines’ can therefore pose significant challenges for research ethics review where approval is sought on an institution-byinstitution basis [6]. Policy initiatives and legislation adopted to streamline research ethics review in North America, Europe and Australia are unified in their motivation and philosophy [7–9]. The motivation is that research ethics review processes must complement the collaborative and data-centric nature of biomedical research if they are to enable clinical innovation [10]. The philosophy is the principle of mutual recognition, generally understood to describe an arrangement whereby one research ethics review committee (REC) accepts the processes used to come to decisions of other institutional RECs. The plurality of terms used for policies and models of research ethics review that activate the principle of mutual recognition is the focus of this paper. An index of the terms equivalence, reciprocity, centralization and mutual acceptance from the USA, Canada, UK and Australia, respectively, will be compared. In addition to differences in nomenclature, policies that operationalize mutual recognition between RECs also vary in their degree of legislative formality. Although some policies pursuant to mutual recognition are legislated, not all can be centrally enforced. This is particularly true of countries with federated health systems such as Canada and Australia. The tediousness of the ethics approval process for principal investigators involved in multisite/jurisdictional projects was the primary motivation for reform in these countries, where memoranda of understanding and interinwstitutional agreements are still used to operationalize mutual recognition (see Figure 1).