Background The use of great apes (GA) in invasive biomedical research is one of the most debated topics in animal ethics. GA are, thus far, the only animal group that has frequently been banned from invasive research; yet some believe that these bans could inaugurate a broader trend towards greater restrictions on the use of primates and other animals in research. Despite ongoing academic and policy debate on this issue, there is no comprehensive overview of the reasons advanced for or against restricting invasive research with GA. To address this gap, we conducted a systematic review of the reasons reported in the academic literature on this topic. Methods Seven databases were searched for articles published in English. Two authors screened the titles, abstracts, and full texts of all articles. Two journals specialized in animal ethics, and the reference lists of included articles were subsequently also reviewed. Results We included 60 articles, most of which were published between 2006 and 2016. Twenty-five articles argued for a total ban of GA research, 21 articles defended partial restrictions, and 14 articles argued against restrictions. Overall, we identified 110 reason types, 74 for, and 36 against, restricting GA research. Reasons were grouped into nine domains: moral standing, science, welfare, public and expert attitudes, retirement and conservation, respect and rights, financial costs, law and legal status, and longer-term consequences. Conclusion Our review generated five main findings. First, there is a trend in the academic debate in favor of restricting GA research that parallels worldwide policy changes in the same direction. Second, in several domains (e.g., moral standing, and respect and rights), the reasons were rather one-sided in favor of restrictions. Third, some prominent domains (e.g., science and welfare) featured considerable engagement between opposing positions. Fourth, there is low diversity and independence among authors, including frequent potential conflicts of interests in articles defending a strong position (i.e., favoring a total ban or arguing against restrictions). Fifth, scholarly discussion was not the norm, as reflected in a high proportion of non-peer-reviewed articles and authors affiliated to non-academic institutions.

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.

Background: An increasingly large proportion of clinical trials is being conducted at non-traditional geographic regions such as Latin America. However, concerns have been raised that hosting countries may lack adequate research regulations and that clinical trials may not address local health needs. In this context, Chile has been hosting a relatively large proportion of clinical trials and has introduced new regulatory protections. Aim: To study trends and characteristics of clinical trials in Chile, including the effects of regulatory protections and whether clinical trials are aligned with the local burden of diseases. Material and Methods: Data from clinical trials on pharmaceutical products registered over the last decade in Chile's Institute of Public Health was reviewed. Clinical trials were analyzed according to sponsorship, phase, disease studied, and whether distribution of trials according to diseases was aligned with the local burden of diseases measured in disability-adjusted life years. Results: Most of the 876 clinical trials analyzed were funded by external pharmaceutical companies and corresponded to late-phase trials. The most commonly studied disease groups were neoplasms, musculoskeletal disorders, other noncommunicable diseases, chronic respiratory diseases, diabetes and kidney diseases, neurological disorders, and circulatory diseases. The distribution of clinical trials was partially aligned with the distribution of major causes of disease burden. The introduction of new regulatory protections was followed by changes in the number of trials studying certain disease groups associated with a high burden. Conclusions: Clinical trials conducted in Chile over the last decade are largely funded by external pharmaceutical companies. Their distribution is partially aligned with local disease burden. The introduction of regulatory protections was followed by changes in the distribution of diseases studied.