Regulating international clinical research: an ethical framework for policy-makers

The global distribution of clinical trials is shifting to low-income and middle-income countries (LMICs), and adequate regulations are essential for protecting the rights and interests of research participants in these countries. However, policy-makers in LMICs can face an ethical trade-off: stringent regulatory protections for participants can lead researchers or sponsors to conduct their research elsewhere, potentially depriving the local population of the opportunity to benefit from international clinical research. In this paper, we propose a three-step ethical framework that helps policy-makers to navigate this trade-off. We use a recent set of regulatory protections in Chile to illustrate the practical value of our proposed framework, providing original ethical analysis and previously unpublished data from Chile obtained through freedom of information requests.

2475 The leveling of clinical research competencies

OBJECTIVES/SPECIFIC AIMS: Objectives/goals: Describe the process used to develop leveled competencies and associated examples. Discuss the final leveled competencies and their potential use in clinical research professional workforce initiatives. METHODS/STUDY POPULATION: The revised JTFCTC Framework 2.0 has 51 competency statements, representing 8 domains. Each competency statement has now been refined to delineate fundamental, skilled or advanced levels of knowledge and capability. Typically, the fundamental level describes the competency for a professional that requires some coaching and oversight, but is able to understand and identify basic concepts. The skilled level of the competency reflects the professional’s solid understanding of the competency and use of the information to take action independently in most situations. The advanced level embodies high level thinking, problem solving, and the ability to guide others in the competency. The process for developing both the three levels and examples involved 5 workgroups, each chaired by a content expert and comprising of national/international clinical research experts, including representatives from research sites, professional associations, government, and industry and academic sponsors. RESULTS/ANTICIPATED RESULTS: The committee developed 51 specific competencies arrayed across 3 levels and examples of each to demonstrate an appropriate application of the competency. The competencies and examples, and potential utilization, will be described. DISCUSSION/SIGNIFICANCE OF IMPACT: The use of competencies in the context of workforce development and training initiatives is helping to create standards for the clinical research profession. These leveled competencies allow for an important refinement to the standards that can be used to enhance the quality and safety of the clinical research enterprise and guide workforce development.

Control Groups on Trial: The Ethics of Testing Experimental Ebola Treatments

Although randomized controlled trials (RCTs) are generally considered the “gold standard” for testing experimental treatments, their use for Ebola has been subject to strong criticism by prominent ethicists and international aid organizations, and only one of the ongoing Ebola treatment trials has been designed in this manner. This is not the first time that RCTs in developing countries have provoked ethical controversy, but the objections to the Ebola clinical trials are fundamentally different from the concerns that have been raised in the past. After briefing reviewing the ongoing research on experimental Ebola treatments, this Article examines the current controversies in the context of previous debates over the ethics of international clinical research. It concludes that RCTs provide the most reliable method for developing effective Ebola treatments, and that their methodological rigor is itself a persuasive ethical argument in favor of using them. However, limited departures from the methodologically ideal approach may be necessary to accommodate the expectations of participants and to promote community trust.