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The research and development of any “new” agricultural crop created using genetic modification technologies, even if undertaken with the best of intentions, is accompanied by novel human health, environmental, social, economic and other risks. To date, much of the research that has accompanied the release of genetically modified (GM) crops has focused on the environmental and health impacts. Evidence has been inconclusive, however, with debates remaining highly divided and contested, and each “camp” presenting evidence to support its position.

Mobile cellular subscriptions had reached 87% of the world’s population by 2011 (ITU ). Notably, Africa has “the fastest mobile phone growth rate in the world and … a proliferation of social media users” (Mutula in Information ethics in Africa: cross-cutting themes. African Centre of Excellence for Information Ethics, Pretoria, pp 29–42, :31). Mobile phones that can run software applications (apps) are increasingly used in health settings, for example, to improve diagnosis and personalize health care (Mosa et al. in BMC Medical Informatics and Decision Making 12(1):67, ). This fast-paced development saw the number of “mHealth” apps reach 97,000 as of March 2013 (He et al. in AMIA Annual Symposium Proceedings, pp 645–654, ).

This case study looks into recent developments with regard to the CRISPR/Cas9 and other novel genome editing technologies that are becoming widely available thanks to their low costs and modest technological requirements.

The increase in the volume of health-related research in Africa has not everywhere been accompanied by improvements in research oversight systems related to biomedical and health services research, including the strengthening of institutional review boards (IRBs) and national regulatory oversight institutions. Critical to such oversight are not only competencies in ethics for the review of clinical trials, but also competencies in diverse research methods, statistical analyses and project implementation. In Liberia, there are recognized weaknesses in the existing infrastructure and capacity to regulate and monitor clinical research based on ethical institutional regulations and guidance for the protection of human research participants. During the height of the Ebola virus disease (EVD) surge in Liberia in 2014, there was a fragile national regulatory framework to oversee research. Some researchers took undue advantage of this gap to conduct unethical research.

A 78-year-old Chinese woman joined a clinical trial sponsored by a pharmaceutical company. Unfortunately a serious adverse event (SAE) occurred. The sponsor paid for the cost of the medical care arising from the SAE, but refused the family’s request for compensation. The family then sued the company and the hospital in Beijing. Although the SAE was related to a complication of lower extremity angiography and not the drug itself, it was a direct consequence of participating in the trial. According to Good Clinical Practice, a set of regulations promulgated under Chinese law, “the sponsor should provide insurance to those human subjects who participate in clinical trials, cover the cost of treatment and the corresponding economic compensation for the occurrence of the harm or death associated with the trial” (SFDA in Good clinical practice. State Food and Drug Administration,: art. 43). The court ordered the trial sponsor to provide a translation of the company’s insurance policy, so that the court could understand the amount of compensation available to the patient under the policy, but the sponsor never surrendered either the documentation or a translation. Consensus was never reached about the amount of compensation due to the patient through negotiation with the hospital, the company and the family. The litigation ended after nine hearings and five long years. This chapter provides an ethical analysis of the case relative to at least three areas of risk of exploitation when a major, international pharmaceutical company sponsors clinical research in a country with an immature legal system and where research participants have limited resources.