TY - JOUR
T1 - From Experimental Technique to Clinical Practice
T2 - Which Pathway in Transplant Surgery?
AU - Petrini, C
AU - Floridia, G
AU - Riva, L
AU - Gainotti, S
N1 - Copyright © 2018 Elsevier Inc. All rights reserved.
PY - 2019/1/19
Y1 - 2019/1/19
N2 - The question of whether a medical procedure is to be considered experimental or routine practice has enormous practical implications. In transplant surgery, as compared with pharmacologic clinical trials, the transition from experimental procedure to normal care is far from clear cut. Clinical trials comprise 4 well-established phases of evaluation going from phase I, aimed at assessing safety and identifying side effects in a few healthy volunteers, to phase IV, which involves entire populations and is aimed at long-term postmarketing surveillance. In transplant surgery, technical progress and experimentation follow more atypical and individual routes. As compared with pharmacologic research, the decision about "routine practice readiness" of a surgical procedure does not rely on a standardized formal act but rather on experts' capacity to find a consensus based on best practices and on ad-hoc criteria as well. Independent assessment by a panel of experts and oversight by an institutional review board are key to facilitating meaningful protection of transplant recipients and allowing the research to go forward. The framework of the human subjects protection regulations should also consider the transplant of organs that have previously been part of a research project.
AB - The question of whether a medical procedure is to be considered experimental or routine practice has enormous practical implications. In transplant surgery, as compared with pharmacologic clinical trials, the transition from experimental procedure to normal care is far from clear cut. Clinical trials comprise 4 well-established phases of evaluation going from phase I, aimed at assessing safety and identifying side effects in a few healthy volunteers, to phase IV, which involves entire populations and is aimed at long-term postmarketing surveillance. In transplant surgery, technical progress and experimentation follow more atypical and individual routes. As compared with pharmacologic research, the decision about "routine practice readiness" of a surgical procedure does not rely on a standardized formal act but rather on experts' capacity to find a consensus based on best practices and on ad-hoc criteria as well. Independent assessment by a panel of experts and oversight by an institutional review board are key to facilitating meaningful protection of transplant recipients and allowing the research to go forward. The framework of the human subjects protection regulations should also consider the transplant of organs that have previously been part of a research project.
KW - Ethics Committees, Research/standards
KW - Humans
KW - Research Design
KW - Transplantation/ethics
U2 - 10.1016/j.transproceed.2017.11.082
DO - 10.1016/j.transproceed.2017.11.082
M3 - Article
C2 - 30655156
VL - 51
SP - 96
EP - 99
JO - Transplantation Proceedings
JF - Transplantation Proceedings
SN - 0041-1345
IS - 1
ER -