Match!

Designing Ethical Trials of Germline Gene Editing

Published on Nov 16, 2017in The New England Journal of Medicine70.67
· DOI :10.1056/NEJMp1711000
Bryan Cwik3
Estimated H-index: 3
(PSU: Portland State University)
Sources
Abstract
With gene-editing technology advancing rapidly, it is important to consider the ethical issues it raises for research, including those related to intergenerational monitoring — long-term follow-up monitoring of not just trial participants, but also their descendants.
  • References (3)
  • Citations (12)
📖 Papers frequently viewed together
201743.07Nature
31 Authors (Hong Ma, ..., Shoukhrat Mitalipov)
328 Citations
26 Citations
14 Citations
78% of Scinapse members use related papers. After signing in, all features are FREE.
References3
Newest
#1Hong Ma (Oregon National Primate Research Center)H-Index: 27
#2Nuria Marti-Gutierrez (OHSU: Oregon Health & Science University)H-Index: 1
Last. Shoukhrat MitalipovH-Index: 36
view all 31 authors...
328 CitationsSource
#1Theodore Friedmann (UCSD: University of California, San Diego)H-Index: 53
#2Erica C. Jonlin (UW: University of Washington)H-Index: 6
Last. Michel Sadelain (MSK: Memorial Sloan Kettering Cancer Center)H-Index: 76
view all 7 authors...
26 CitationsSource
Before arriving at its conclusions the working party considered a number of ethical issues including: the implications for identity; risks and safety issues; the impact upon social relationships (parentage and the status of mtDNA donors); germline modification; and implications for the wider society and future generations. As might be expected, given the credentials of the working group members, the discussion of these issues is thorough and thoughtful, and although I may not agree with their fi...
46 CitationsSource
Cited By12
Newest
Source
#1Debin Zhang (HAU: Huazhong Agricultural University)
#2Amjad Hussain (HAU: Huazhong Agricultural University)H-Index: 1
Last. Fang Ding (HAU: Huazhong Agricultural University)
view all 10 authors...
Over the last three decades, the development of new genome editing techniques, such as ODM, TALENs, ZFNs and the CRISPR-Cas system has led to significant progress in the field of plant and animal breeding. The CRISPR-Cas system is the most versatile genome editing tool discovered in the history of molecular biology because it can be used to alter diverse genomes (e.g., genomes from both plants and animals) including human genomes with unprecedented ease, accuracy and high efficiency. The recent ...
Source
#1Erica C. Jonlin (UW: University of Washington)H-Index: 6
In the event that human embryo genome editing is considered safe enough for the clinic, researchers will need to consider how to administer consent so that would-be recipients of edited embryos can make an informed decision. Informed consent will require truthfulness, sensitivity, regulatory compliance, and attention to the highest ethical standards.
Source
#1Erika Kleiderman (McGill University)H-Index: 6
#2Ian Stedman (York University)H-Index: 1
Human germline genome editing may prove to be especially poignant for members of the rare disease community, many of whom are diagnosed with monogenic diseases. This community lacks broad representation in the literature surrounding genome editing, notably in Canada, yet is likely to be directly affected by eventual clinical applications of this technology. Although not generalizable, the literature does offer some commonalities regarding the experiences of rare disease patients. This manuscript...
3 CitationsSource
#1Bryan Cwik (PSU: Portland State University)H-Index: 3
Design of clinical trials for germline gene editing stretches current accepted standards for human subjects research. Among the challenges involved is a set of issues concerning intergenerational monitoring—long-term follow-up study of subjects and their descendants. Because changes made at the germline would be heritable, germline gene editing could have adverse effects on individuals’ health that can be passed on to future generations. Determining whether germline gene editing is safe and effe...
2 CitationsSource
#1David Lorenzo (Grupo México)
#2Montse Esquerda (Grupo México)H-Index: 2
Last. Helena RoigH-Index: 1
view all 9 authors...
Source
#1Tetsuya Ishii (Hokkaido University)H-Index: 13
UK law permits parents to use mitochondrial replacement (MR) to have genetically-related children without serious mitochondrial disease. However, long-term follow-up is required for each case. Whet...
Source
#1Andrea BoggioH-Index: 6
#2Cesare P.R. RomanoH-Index: 10
Last. Jessica AlmqvistH-Index: 4
view all 3 authors...
This is an excerpt from Andrea Boggio, Cesare P.R. Romano, Jessica Almqvist (eds.), Human Germline Genome Modification and the Right to Science: A Comparative Study of National Laws and Policies, Cambridge University Press, 2019. It is the version sent to the publisher, before editing. Please, cite to the published book. This chapter is the conclusions of the book. It gives the reader a summary of the current national regulatory standards in the 18 States discussed in the book, and asks to what ...
#1Erika Kleiderman (McGill University)H-Index: 6
#2Vardit Ravitsky (UdeM: Université de Montréal)H-Index: 15
Last. Bartha Maria Knoppers (McGill University)H-Index: 49
view all 3 authors...
Current advances in assisted reproductive technologies aim to promote the health and well-being of future children. They offer the possibility to select embryos with the greatest potential of being born healthy (eg, preimplantation genetic testing) and may someday correct faulty genes responsible for heritable diseases in the embryo (eg, human germline genome modification (HGGM)). Most laws and policy statements surrounding HGGM refer to the notion of ‘serious’ as a core criterion in determining...
5 CitationsSource
#1Kirsten A. Riggan (Mayo Clinic)H-Index: 2
#2Richard R. Sharp (Mayo Clinic)H-Index: 37
Last. Megan Allyse (Mayo Clinic)H-Index: 7
view all 3 authors...
The application of gene editing technologies to prevent or mitigate genetic disease in humans is considered one of its most promising applications. However, as the technology advances, it is impera...
2 CitationsSource