“Proof of concept” is a phrase frequently used in descriptions of research sought in program announcements, in experimental studies, and in the marketing of new technologies. It is often coupled with either a short definition or none at all, its meaning assumed to be fully understood. This is problematic. As a phrase with potential implications for research and technology, its assumed meaning requires some analysis to avoid it becoming a descriptive category that refers to all things scientifically exciting. I provide a short analysis of proof of concept research and offer an example of it within synthetic biology. I suggest that not only are there activities that circumscribe new epistemological categories but there are also associated normative ethical categories or principles linked to the research. I examine these and provide an outline for an alternative ethical account to describe these activities that I refer to as “extended agency ethics”. This view is used to explain how the type of research described as proof of concept also provides an attendant proof of principle that is the result of decision-making that extends across practitioners, their tools, techniques, and the problem solving activities of other research groups.
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Despite its prominent use and description within synthetic biology and biological engineering, the notion of proof of concept research is not restricted to these and has been used in other fields of research as well.
One of the more lengthy definitions can be found in the National Science Foundation’s Program Solicitation: Accelerating Innovation Research-Technology Translation from the Directorate for Engineering, Industrial Innovation and Partnerships: “A proof-of-concept is the realization of a certain method or idea to ascertain its scientific or technological parameters. A proof-of-concept should be understood sufficiently so that potential application areas can be identified and a follow-on working prototype designed.” (National Science Foundation 2014, 14-569).
In 2014, the U.S. Patent and Trademark Office provided the Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena and Natural Products (Hirshfeld 2014). In this, a balancing test was suggested to decide whether a claim is “significantly different” from that which is made to be a judicial exception to patentability. That is, whether that which is to be patented has been changed sufficiently to make it different from the naturally occurring phenomena or product. But, of course, the decidability of “significantly different” is decidable only with regard to knowledge of what it is different-from, or different-in-what-way to. Like the 2013 decision, this assumes products of nature and products of humans are ontological distinct and arbitrable.
It should be noted that this concern is premised on a misunderstanding of the nature of being in two ways. Novelty is endemic in both reproduction and development. That an organism never existed cannot on its own be a source for concern as each new organism that comes into being (through either sexual or asexual reproduction) never existed before and so is in some sense the first of its kind. Further, organisms constantly change their cellular, epigenetic, and physiological makeup throughout their lifetime (cf. Kendig 2014b).
It should be recognized that this aesthetic response is not one that is universally shared. There is a wide variability of responses to these entities that goes largely unanalyzed in the discussion of the “yuck” factor. The diversity of responses can be the result of one’s training, scientific discipline, or culture. The upshot? Those moral intuitions perceived to follow from the aesthetic response of liminality-avoidance are also not universally shared.
Of course the subverting of natural categories has had a long history in selective breeding in agriculture, horticulture, and among pet breeders as well.
This is not to discount the role of thought experiments or the use of literary narratives (such as those played out in science fiction). The later discussion of extended agency ethics would suggest that these could play a role but their role would be shared with articulated network of agents involved within the system.
Doing so would be to assume a false dichotomy that suggests one must either be wholly for or wholly against technology of all types.
This is usually discussed in the context of the inadmissibility of claiming an ought from an is (the naturalistic fallacy).
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Research for this project was funded by the National Science Foundation Division of Molecular and Cellular Biosciences (MCB), BIOMAPS: Modular Programmed Evolution of Bacteria for Optimization of Metabolic Pathways, Grant No. MCB-1329350, Research Opportunity Award: "How synthetic biology reconfigures biological and bioethical categories", Amendment No. 001, Proposal No. MCB-1417799.
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Kendig, C.E. What is Proof of Concept Research and how does it Generate Epistemic and Ethical Categories for Future Scientific Practice?. Sci Eng Ethics 22, 735–753 (2016). https://doi.org/10.1007/s11948-015-9654-0
- Epistemic categories
- Extended agency
- Normative ethics
- Proof of principle
- Synthetic biology