Abstract
Clinical trials are important instruments for achieving scientific progress within the life sciences. However, while they are of the utmost importance to our translational efforts, they are also highly expensive. To save costs, they are often relocated into developing countries where the protection of study participants is minimal. Such relocation is not necessarily amoral, as those in charge might nevertheless adhere to high ethical standards. However, relocation is problematic if it entails the exploitation of vulnerable participants. How can such exploitation and violation of ethical standards within the life sciences be prevented? Adopting a pragmatic approach to research ethics, this paper suggests using the incentivising mechanisms of our patenting process to tackle the challenge of the prevailing unethical treatment of human subjects in life science research. By linking the granting of economic benefits via patents to the fulfilment of ethical requirements, the paper makes an important contribution to the question of how “ethical excellence” can be achieved in one of the most lucrative areas of global research.
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Notes
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For an overview of research with vulnerable participants and compelling arguments for a sound regulation of such endeavours, see Siep (2014).
- 2.
For an overview of different dimensions of property rights systems and their variations over time with regard to the transformation of intellectual property rights, see Carruthers and Ariovich (2004).
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Such an hypothesis could be formulated by proponents of a meta-ethical position of moral realism, which—by doing so—could suggest that specific ideas of patenting came closer to the “truth” of what is actually owed each to the other.
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This declaration asks, for example, for the informed consent (§ 26) of every trial participant, requiring adequate information about all relevant aspects of the study, including aims; methods; sources of funding; possible conflicts of interest; institutional affiliations of the researcher; anticipated benefits and potential risks of the study; the discomfort it may entail; post-study provisions; and the right to refuse to participate in the study or to withdraw consent to participate at any time without reprisal.
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The argument of this paper—to introduce an additional requirement of “ethical excellence” into our patenting processes—has greatly benefited from discussions with many people. I would like to thank those who provided invaluable feedback on different occasions, in particular the members of the BMBF research group Research Ethics—Current Challenges in Preclinical, Clinical and Public Health Research as well as Sarah Chan, John Harris, David Hunter, Marcel Mertz, Thomas Pogge, Heiner Raspe, Catherine Rhodes, Annette Rid, Sarah Ruth Sippel and Daniel Strech.
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Reichardt, JO. (2016). Using Patent Law to Enforce Ethical Standards: Proposal of a New Patent Requirement. In: Strech, D., Mertz, M. (eds) Ethics and Governance of Biomedical Research. Research Ethics Forum, vol 4. Springer, Cham. https://doi.org/10.1007/978-3-319-28731-7_16
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