CRISPR: Pursuit of profit poisons collaboration

Sherkow, Jacob S.

doi:10.1038/532172a

Cited by 23 publications

(17 citation statements)

References 3 publications

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“…Furthermore, there is an ongoing debate on the ethical (i.e., the 'slippery slope' argument) and social implications of GGE, and eventually current restrictions on GGE may require a renewed debate [ 220 – 223 ]. Finally, a transparent and broad collaboration is necessary in order to move the field of GGE responsibly forward [ 224 , 225 ]. The panel concluded that although research in the field of GGE is rapidly developing, its potential medical applications within the context of ART and genetic medicine require further basic and translational research.…”

Section: Introductionmentioning

confidence: 99%

Recent developments in genetics and medically assisted reproduction: from research to clinical applications

et al. 2017

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Two leading European professional societies, the European Society of Human Genetics and the European Society for Human Reproduction and Embryology, have worked together since 2004 to evaluate the impact of fast research advances at the interface of assisted reproduction and genetics, including their application into clinical practice. In September 2016, the expert panel met for the third time. The topics discussed highlighted important issues covering the impacts of expanded carrier screening, direct-to-consumer genetic testing, voiding of the presumed anonymity of gamete donors by advanced genetic testing, advances in the research of genetic causes underlying male and female infertility, utilisation of massively parallel sequencing in preimplantation genetic testing and non-invasive prenatal screening, mitochondrial replacement in human oocytes, and additionally, issues related to cross-generational epigenetic inheritance following IVF and germline genome editing. The resulting paper represents a consensus of both professional societies involved.

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Section: Introductionmentioning

confidence: 99%

Recent developments in genetics and medically assisted reproduction: from research to clinical applications

et al. 2017

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“…Biomedical research conducted in academic institutions is now commonly intertwined with pharmaceutical and biotechnology industries as part of an innovation ecosystem [ 49 ]. In this way, academic institutions and investigators have embraced a new kind of entrepreneurship in which financial conflicts of interest may arise [ 50 ]. In an effort to manage such conflicts of interest, academic institutions and professional organizations have developed policies governing academic-industrial collaborations.…”

Section: Credibilitymentioning

confidence: 99%

First-in-human Phase 1 CRISPR Gene Editing Cancer Trials: Are We Ready?

Βaylis

McLeod

2018

CGT

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A prospective first-in-human Phase 1 CRISPR gene editing trial in the United States for pa-tients with melanoma, synovial sarcoma, and multiple myeloma offers hope that gene editing tools may usefully treat human disease. An overarching ethical challenge with first-in-human Phase 1 clinical trials, however, is knowing when it is ethically acceptable to initiate such trials on the basis of safety and effi-cacy data obtained from pre-clinical studies. If the pre-clinical studies that inform trial design are them-selves poorly designed – as a result of which the quality of pre-clinical evidence is deficient – then the ethical requirement of scientific validity for clinical research may not be satisfied. In turn, this could mean that the Phase 1 clinical trial will be unsafe and that trial participants will be exposed to risk for no potential benefit. To assist sponsors, researchers, clinical investigators and reviewers in deciding when it is ethically acceptable to initiate first-in-human Phase 1 CRISPR gene editing clinical trials, structured processes have been developed to assess and minimize translational distance between pre-clinical and clinical research. These processes draw attention to various features of internal validity, construct validi-ty, and external validity. As well, the credibility of supporting evidence is to be critically assessed with particular attention to optimism bias, financial conflicts of interest and publication bias. We critically ex-amine the pre-clinical evidence used to justify the first-in-human Phase 1 CRISPR gene editing cancer trial in the United States using these tools.We conclude that the proposed trial cannot satisfy the ethical requirement of scientific validity because the supporting pre-clinical evidence used to inform trial design is deficient.

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“…Any resulting patents could then be cross-licensed to other research institutions either freely or on very favorable conditions. 48 Such guidelines could also stipulate that patents should be used to fund academic consortia dedicated to studying the relevant technologies, or they could be applied to ignite robust and beneficial competition for commercial applications of the technology by licensing the patents on non-exclusive terms to a variety of industry competitors, with the licensing fees then being invested into further academic research. 49 As exemplified by current developments in gene editing technologies, such licensing regimes could also be used as interim tools to address currently unsolved ethical dilemmas posed by emerging technologies that are not being sufficiently regulated by existing regulations and state law.…”

Section: Property Rightsmentioning

confidence: 99%

Challenges for the Sustainability of University-Run Biobanks

Kongsholm

Christensen²,

Herrmann

et al. 2018

Biopreservation and Biobanking

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Most university biobanks begin like other university research projects, that is, with an idea conceived by an individual researcher in pursuit of his/her own research interests, publications, funding, and career. Some biobanks, however, come to have scientific value that goes beyond the projects that were initially responsible for the collection of the samples and data they contain. Such value may derive from among other things the uniqueness of the samples in terms of their sheer volume, the quality of the samples, the ability to link the samples with information retrieved in disease registries, or the fact that the samples represent very rare diseases. This article focuses on biobanks of this kind, and the special obligations that publicly funded universities have to ensure the sustainability of biobanks with continued scientific value. We argue that universities should adopt policies to deal with the various, diverse issues which may arise during the lifecycle of a biobank. The policies should be flexible, accommodate the freedoms of individual researchers, and reflect the multifaceted nature of biobanks. Yet they should be specific enough to provide guidance and robust enough to safeguard legal norms and ethical values. The article sets out concrete recommendations which universities should consider and act upon.

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CRISPR: Pursuit of profit poisons collaboration

Cited by 23 publications

References 3 publications

Recent developments in genetics and medically assisted reproduction: from research to clinical applications

Recent developments in genetics and medically assisted reproduction: from research to clinical applications

First-in-human Phase 1 CRISPR Gene Editing Cancer Trials: Are We Ready?

Challenges for the Sustainability of University-Run Biobanks

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