Reflections on the Ethics of Biomaterials Science

Abstract

The subject of biomaterials science concerns artificial materials used in medical devices to repair or reconstruct natural human tissue damaged by disease or trauma. It embraces the emerging field of tissue engineering, where artificial materials are used as scaffolds to provide the architecture for replacement organs. As such, the field raises numerous ethical issues, which are reviewed in this paper. These include the use of animal models, the testing materials and devices in patients, and what may be viewed as potential abuses, where augmentation and repair are carried out for cosmetic as opposed to clinical reasons. The paper gives detailed consideration of the recent problems of metal-on-metal hip replacements as an exemplar of some of the key ethical issues that arise in this field.

The Ethical Implications of Tissue Engineering for Regenerative Purposes: A Systematic Review

“… 74 , 75 Some suggest that consent should be specific to the intended use 17 while others argue that broad consent suffices. 20 , 76 As a prerequisite for consent, donors should be provided relevant information, including information on present and foreseeable use of the collected tissues, 7 , 77–81 on the need to forego financial rights over the tissue, 82 and on policies outlining the return of findings 83 , 84 and the possibility to withdraw. 85 , 86 …”

“… 22 , 120 Fourth, possible positive bias and conflicting financial or professional interest of the physician-researcher involved in an experimental TE treatment might affect the neutrality of the information provided. 119 , 121–123 And last, uncertainty about possible complications due to the novel, 81 complex, 22 , 119 , 124 invasive, 20 , 118 and irreversible 125 nature of TE makes it difficult to provide accurate information about the risk-benefit ratio of the intervention. 23 , 71 , 88 , 104 , 112 …”

“…Finally, TE should not merely be aimed at treating disease, but also at improving overall quality of life 20 and promoting human flourishing. 153 …”

“… 212 Moreover, TE could be used for cosmetic purposes or potentially to enhance physical or cognitive abilities. While the pursuit of enhancement is deeply embedded in human culture 23 , 75 , 112 and could help to pursue the good life, 88 it raises concerns about potential harm, 108 increasing inequalities, 70 , 158 fair resource distribution, 20 , 110 and the legitimate goals of medicine. 180 , 190 , 213 , 214 …”

“…However, industry involvement and commercial pressure might steer the research agenda, 106 incentivize selection of trial sites in areas with permissive regulations, 177 , 180 , 237 and lead to premature clinical testing and commercialization of TE products. 20 , 115 , 118 , 174 , 178 , 194 To deal with potential conflicts of interest and to maintain trust from physicians and the public, independent oversight mechanisms are needed, 80 , 89 , 168 full disclosure of interests should be provided by those involved in clinical trials 67 , 131 and trials sponsored by governments rather than industry might be preferred. 17 , 162 …”