TY - JOUR
T1 - Between innovation and precaution
T2 - how did offspring safety considerations play a role in strategies of introducing new reproductive techniques?
AU - Jans, Verna
AU - Dondorp, Wybo
AU - Mastenbroek, Sebastiaan
AU - Mertes, Heidi
AU - Pennings, Guido
AU - Smeets, Hubert
AU - de Wert, Guido
N1 - © The Author(s) 2020. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology.
PY - 2020
Y1 - 2020
N2 - The field of reproductive medicine has been criticized for introducing ARTs without systematic research on possible safety risks and for failing to meet the standards of evidence-based innovation held elsewhere in medicine. In this paper, firstly, we ask whether 'responsible innovation' has been a concern for the field, and if so, how it has understood the practical implications of this idea for the development and introduction of potentially risky new ARTs. Secondly, we consider whether the field has indeed fallen short of its responsibilities in this respect, and if so, how things can be improved. To answer these questions, we present three case studies involving the introduction of a new reproductive technology: ICSI, preimplantation genetic testing and mitochondrial replacement therapy. As a framework for analyzing these cases, we used Per Sandin's account of the four dimensions of dealing with risks (threat, uncertainty, action, command) that are central to debates about the possible role of the so-called precautionary principle. We conclude that, although offspring safety concerns have been on the agenda of the debate about bringing the relevant technologies to the clinic, systematic safety and effectiveness studies were not always conducted. As professionals in assisted reproduction have a responsibility to take account of the welfare of the children they are creating, we suggest a policy of proceeding with systematic caution. Legal measures may be needed to ensure that professional guidance is followed in practice. Finally, an open question concerns the threshold for acceptable risk in the context of introducing new ARTs. Multiple stakeholders, including professional societies and patient organizations, should have a role in the urgent debate about this.
AB - The field of reproductive medicine has been criticized for introducing ARTs without systematic research on possible safety risks and for failing to meet the standards of evidence-based innovation held elsewhere in medicine. In this paper, firstly, we ask whether 'responsible innovation' has been a concern for the field, and if so, how it has understood the practical implications of this idea for the development and introduction of potentially risky new ARTs. Secondly, we consider whether the field has indeed fallen short of its responsibilities in this respect, and if so, how things can be improved. To answer these questions, we present three case studies involving the introduction of a new reproductive technology: ICSI, preimplantation genetic testing and mitochondrial replacement therapy. As a framework for analyzing these cases, we used Per Sandin's account of the four dimensions of dealing with risks (threat, uncertainty, action, command) that are central to debates about the possible role of the so-called precautionary principle. We conclude that, although offspring safety concerns have been on the agenda of the debate about bringing the relevant technologies to the clinic, systematic safety and effectiveness studies were not always conducted. As professionals in assisted reproduction have a responsibility to take account of the welfare of the children they are creating, we suggest a policy of proceeding with systematic caution. Legal measures may be needed to ensure that professional guidance is followed in practice. Finally, an open question concerns the threshold for acceptable risk in the context of introducing new ARTs. Multiple stakeholders, including professional societies and patient organizations, should have a role in the urgent debate about this.
KW - reproductive medicine
KW - responsible innovation
KW - precaution principle
KW - ICSI
KW - preimplantation genetic testing
KW - mitochondrial replacement therapy
KW - ART
KW - INTRACYTOPLASMIC SPERM INJECTION
KW - PREIMPLANTATION GENETIC DIAGNOSIS
KW - IN-VITRO FERTILIZATION
KW - 2-YEAR-OLD CHILDREN BORN
KW - FOLLOW-UP
KW - PRONUCLEAR TRANSFER
KW - EMBRYO BIOPSY
KW - MALE-INFERTILITY
KW - BIRTH-WEIGHT
U2 - 10.1093/hropen/hoaa003
DO - 10.1093/hropen/hoaa003
M3 - Article
C2 - 32201741
SN - 2399-3529
VL - 2020
SP - 1
EP - 9
JO - Human reproduction open
JF - Human reproduction open
IS - 2
ER -