The first principal source is the heavy focus on presumed participant vulnerabilities. With the rise of Western individualism41 and the mounting influence of the civil rights movement in the second half of the last century,42 ethics review has adopted a more unilateral approach that is arguably disproportionally fixated on individual risks.43 Doing so undervalues the cognitive capacities of citizens,44 communal concerns, or alternative bioethical lenses such as solidarity and citizenry,45 that view community as a unit of identity and worthy of ethical concern. In fact, community plays a central role in non-interventional research that could only be fueled by trust, a shared belief in the common good and the importance of the contribution of all stakeholders involved.46 Ethics review that overlooks these new realities can only end up bogging down an efficient, equitable (and arguably ethical) accomplishment of international multi-site studies. The second principal source is the limited ethics review system in certain countries. Here, the deficiency lies not in a morass of red tape that thwarts cross-border data flows or knowledge exchanges, but rather, in a void of sufficient support structures and resources that facilitate studies of local populations and health issues, particularly those in the ‘omics' field.47 An unfortunate consequence is that countries, if not whole regions, can be neglected from engagement with the international research community. Swathes of the world with acute health problems, particularly in sub-Saharan Africa, may be under-researched because approvals cannot be obtained on the ground. At the same time, researchers in other, more developed regions may fear ethical and legal repercussions from venturing into ethically unchartered territory, or believe that the perceived risks of delay outweigh the perceived benefits. Certain countries in the developing world have fueled these perceptions by regarding genetic information as a matter of ‘genomic sovereignty' to be protected. For example, countries such as Brazil, India, and Mexico also have in place a second layer of regimes with centralized review or approvals for genomics research that make international participation (even when approved by local IRBs) impossible or impracticable.48The third source is more common: countries may have constructed a comprehensive ethics review infrastructure, but it is now ossified and overly politicized. Regarding the latter critique, IRBs are a growth industry,54 with expertise in demand and members increasingly becoming professionalized and embedded within institutional structures that value power and fiefdoms over community norm-making and transparency. Jurisdictional battles for control over specific areas of work are inherent in almost all professions once a profession has developed its core expertise,55 but for the emerging professional ‘human subjects regulator' (as opposed to amateur community volunteer, or even bioethicist), negative externalities are stark. Our proposed Safe Harbor Framework for International Ethics Equivalency (hereinafter ‘Safe Harbor') would consist of a new supranational agency built on five principle elements: (1) registration, (2) compliance review, (3) recognition, (4) monitoring and enforcement, and (5) public participation. The agency's mission would be to connect governments around the world to harmonize where possible ethics review guidelines and policies, increase ethical conduct, and ensure compliance for researchers involved in a clearly defined type of research project (Box 1). In recognition of the longstanding work occurring in related fields, clinical trials with pharmaceutical products or devices would remain excluded from the Safe Harbor and should remain subsumed within the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) framework.131Harmonizing ethics review for international data-driven research projects requires international ethics governance reform. An individual country may work towards reducing redundancies in ethics review and aim to create efficiencies for multi-site studies, but usually such reform stops at the political boundary. National reform alone does not and cannot address international concerns. Policymakers, researchers, and other stakeholders who wish to remedy the systemic problems in ethics review could support an international organization that is capable of steering globally collaborative research projects to an ethical safe harbor. The chief component of the proposed Safe Harbor, therefore, is a newly constituted organization. In line with the goals of the Global Alliance for Genomics and Health,133 which promotes the responsible sharing of genomic and clinical data and international interoperability and harmonization, we su
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