Ethical considerations in tissue engineering research: Case studies in translation.
Tissue engineering research is a complex process that requires investigators to focus on the relationship between their research and anticipated gains in both knowledge and treatment improvements. The ethical considerations arising from tissue engineering research are similarly complex when addressing the translational progression from bench to bedside, and investigators in the field of tissue engineering act as moral agents at each step of their research along the translational pathway, from early benchwork and preclinical studies to clinical research. This review highlights the ethical considerations and challenges at each stage of research, by comparing issues surrounding two translational tissue engineering technologies: the bioartificial pancreas and a tissue engineered skeletal muscle construct. We present relevant ethical issues and questions to consider at each step along the translational pathway, from the basic science bench to preclinical research to first-in-human clinical trials. Topics at the bench level include maintaining data integrity, appropriate reporting and dissemination of results, and ensuring that studies are designed to yield results suitable for advancing research. Topics in preclinical research include the principle of "modest translational distance" and appropriate animal models. Topics in clinical research include key issues that arise in early-stage clinical trials, including selection of patient-subjects, disclosure of uncertainty, and defining success. The comparison of these two technologies and their ethical issues brings to light many challenges for translational tissue engineering research and provides guidance for investigators engaged in development of any tissue engineering technology.
Department of Biomedical Engineering, Virginia Tech-Wake Forest School of Biomedical Engineering and Sciences, Wake Forest Institute for Regenerative Medicine, 391 Technology Way, Winston-Salem, NC 27103, United States.
Hannah B
HB
Baker
Department of Biomedical Engineering, Virginia Tech-Wake Forest School of Biomedical Engineering and Sciences, Wake Forest Institute for Regenerative Medicine, 391 Technology Way, Winston-Salem, NC 27103, United States.
John P
JP
McQuilling
Department of Social Sciences and Health Policy and Wake Forest Institute for Regenerative Medicine, Wake Forest School of Medicine, Center for Bioethics, Health, and Society and Graduate Program in Bioethics, Wake Forest University, Medical Center Blvd, Winston-Salem, NC 27157, United States. Electronic address: nmpking@wakehealth.edu.
Nancy M P
NM
King
D000818:Animals; D035843:Biomedical Research / Q000941:ethics; D002986:Clinical Trials as Topic; D006801:Humans; D007258:Informed Consent; D016377:Organ Transplantation / Q000941:ethics; D018579:Patient Selection; D023822:Tissue Engineering / Q000941:ethics*; D057170:Translational Research, Biomedical / Q000941:ethics
Animal research ethics; Bioartificial pancreas; Human research ethics; Tissue-engineered skeletal muscle; Translational research ethics