Navigating ethical challenges in the development and translation of biomaterials research

Abstract

Biomaterials--from implanted iron teeth in the second century to intraocular lenses, artificial joints, and stents today--have long been used clinically. Today, biomaterials researchers and biomedical engineers are pushing beyond these inert synthetic alternatives and incorporating complex multifunctional materials to control biological interactions and direct physiological processes. These advances are leading to novel strategies for targeted drug delivery, drug screening, diagnostics and imaging, gene therapy, tissue regeneration, and cell transplantation. While the field has survived ethical transgressions in the past, the rapidly expanding scope of biomaterials science, combined with the accelerating clinical translation of this diverse field calls for urgent attention to the complex and challenging ethical dilemmas these advances pose. This perspective responds to this call, examining the intersection of research ethics -- the sets of rules, principles and norms guiding responsible scientific inquiry -- and ongoing advances in biomaterials. While acknowledging the inherent tensions between certain ethical norms and the pressures of the modern scientific and engineering enterprise, we argue that the biomaterials community needs to proactively address ethical issues in the field by, for example, updating or adding specificity to codes of ethics, modifying training programs to highlight the importance of ethical research practices, and partnering with funding agencies and journals to adopt policies prioritizing the ethical conduct of biomaterials research. Together these actions can strengthen and support biomaterials as its advances are increasingly commercialized and impacting the health care system.

Decellularized Bovine Skeletal Muscle Scaffolds: Structural Characterization and Preliminary Cytocompatibility Evaluation

“…Although several studies have already described and standardized the decellularization for muscle tissue, most of them used samples from small lab animals such as rats, mice, and rabbits, which, considering translational science, have limited application [18]. Ideally, scaffolds derived from human muscle tissue would be the best option to use in clinical practice due to allogenic compatibility; however, this scenario is not realistic, as human sample acquisition is restricted by several bioethical drawbacks, becoming an enviable source for large-scale purposes [38]. In addition, studies have already attested that xenogeneic acellular matrices, when implanted in vivo when well produced, generate little or no immunological response in the host, overcoming immune limitations for their application [39,40].…”

How Smart are Smart Materials? A Conceptual and Ethical Analysis of Smart Lifelike Materials for the Design of Regenerative Valve Implants

“…In the literature, this approach to tissue regeneration is referred as in situ tissue engineering (Abdulghani & Mitchell, 2019 ; Bouten et al, 2018 ). This differs from ‘conventional’ tissue engineering approaches that rely largely on the presence of (stem) cells on the implant construct prior to implantation (Hoerstrup et al, 2006 ). In addition to heart valve regeneration, in situ tissue engineering is also being explored for regeneration of vessels (Li et al, 2014 ), bone (Cao et al, 2020 ; Vermeulen et al, 2022 ; Wei et al, 2022 ), and cartilage in joints (Wang et al, 2022 ).…”

Plasma-Activated Polydimethylsiloxane Microstructured Pattern with Collagen for Improved Myoblast Cell Guidance

“…However, it is important to note that, for risk assessment, only a limited number of in vitro tests have been validated, primarily for individual chemical substances but not for biomaterials or medical devices [ 3 ]. This standard also introduced new guidelines aimed at enhancing in vivo biocompatibility assessment, thereby promoting a reduction in the burden on animals and economic resources [ 4 ]. Tissue engineering (TE) represents an interdisciplinary field of biomedicine that owes its rapid advancement primarily to scientific progress in developmental biology and biomaterial sciences [ 5 , 6 , 7 , 8 , 9 , 10 , 11 , 12 ].…”