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Responsible innovation in human germline gene editing: Background document to the recommendations of ESHG and ESHRE.

ABSTRACT: Technological developments in gene editing raise high expectations for clinical applications, including editing of the germline. The European Society of Human Reproduction and Embryology (ESHRE) and the European Society of Human Genetics (ESHG) together developed a Background document and Recommendations to inform and stimulate ongoing societal debates. This document provides the background to the Recommendations. Germline gene editing is currently not allowed in many countries. This makes clinical applications in these countries impossible now, even if germline gene editing would become safe and effective. What were the arguments behind this legislation, and are they still convincing? If a technique could help to avoid serious genetic disorders, in a safe and effective way, would this be a reason to reconsider earlier standpoints? This Background document summarizes the scientific developments and expectations regarding germline gene editing, legal regulations at the European level, and ethics for three different settings (basic research, preclinical research and clinical applications). In ethical terms, we argue that the deontological objections (e.g., gene editing goes against nature) do not seem convincing while consequentialist objections (e.g., safety for the children thus conceived and following generations) require research, not all of which is allowed in the current legal situation in European countries. Development of this Background document and Recommendations reflects the responsibility to help society understand and debate the full range of possible implications of the new technologies, and to contribute to regulations that are adapted to the dynamics of the field while taking account of ethical considerations and societal concerns.

SUBMITTER: De Wert G

PROVIDER: S-EPMC5891502 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature

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Responsible innovation in human germline gene editing: Background document to the recommendations of ESHG and ESHRE.

De Wert Guido G Heindryckx Björn B Pennings Guido G Clarke Angus A Eichenlaub-Ritter Ursula U van El Carla G CG Forzano Francesca F Goddijn Mariëtte M Howard Heidi C HC Radojkovic Dragica D Rial-Sebbag Emmanuelle E Dondorp Wybo W Tarlatzis Basil C BC Cornel Martina C MC

European journal of human genetics : EJHG 20180112 4

Technological developments in gene editing raise high expectations for clinical applications, including editing of the germline. The European Society of Human Reproduction and Embryology (ESHRE) and the European Society of Human Genetics (ESHG) together developed a Background document and Recommendations to inform and stimulate ongoing societal debates. This document provides the background to the Recommendations. Germline gene editing is currently not allowed in many countries. This makes clini ...[more]

PMID: 29326429

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Project description:BackgroundResponsible innovation in health (RIH) emphasizes the importance of developing technologies that are responsive to system-level challenges and support equitable and sustainable healthcare. To help decision-makers identify whether an innovation fulfills RIH requirements, we developed and validated an evidence-informed assessment tool comprised of 4 inclusion and exclusion criteria, 9 assessment attributes and a scoring system.MethodsWe conducted an inter-rater reliability assessment to establish the extent to which 2 raters agree when applying the RIH Tool to a diversified sample of health innovations (n=25). Following the Tool's 3-step process, sources of information were collected and cross-checked to ensure their clarity and relevance. Ratings were reported independently in a spreadsheet to generate the study's database. To measure inter-rater reliability, we used: a non-adjusted index (percent agreement), a chance-adjusted index (Gwet's AC) and the Pearson's correlation coefficient. Results of the Tool's application to the whole sample of innovations are summarized through descriptive statistics.ResultsOur findings show complete agreement for the screening criteria, "almost perfect" agreement for 7 assessment attributes, "substantial" agreement for 2 attributes and "almost perfect" agreement for the RIH overall score. A large portion of the sample obtained high scores for 6 attributes (health relevance, health inequalities, responsiveness, level and intensity of care and frugality) and low scores for 3 attributes (ethical, legal, and social issues [ELSIs], inclusiveness and eco-responsibility). At the rating step, 88% of the innovations had a sufficient number of attributes documented (≥ 7/9), but the assessment was based on sources of moderate to high quality (mean score ≥ 2 points) for 36% of the sample. While "Almost all RIH features" were present for 24% of the innovations (RIH mean score between 4.1-5.0 points), "Many RIH features" were present for 52% of the sample (3.1-4.0 points) and "Few RIH features" were present for 24% of the innovations (2.1-3.0 points).ConclusionBy confirming key aspects of the RIH Tool's reliability and applicability, our study brings its development to completion. It can be jointly put into action by innovation stakeholders who want to foster innovations with greater social, economic and environmental value.

Project description:Study questionWhat recommendations can be provided to improve terminology for normal and ectopic pregnancy description on ultrasound?Summary answerThe present ESHRE document provides 17 consensus recommendations on how to describe normally sited and different types of ectopic pregnancies on ultrasound.What is known alreadyCurrent diagnostic criteria stipulate that each type of ectopic pregnancy can be defined by clear anatomical landmarks which facilitates reaching a correct diagnosis. However, a clear definition of normally sited pregnancies and a comprehensive classification of ectopic pregnancies are still lacking.Study design size durationA working group of members of the ESHRE Special Interest Group in Implantation and Early Pregnancy (SIG-IEP) and selected experts in ultrasound was formed in order to write recommendations on the classification of ectopic pregnancies.Participants/materials setting methodsThe working group included nine members of different nationalities with internationally recognised experience in ultrasound and diagnosis of ectopic pregnancies on ultrasound. This document is developed according to the manual for development of ESHRE recommendations for good practice. The recommendations were discussed until consensus by the working group, supported by a survey among the members of the ESHRE SIG-IEP.Main results and the role of chanceA clear definition of normally sited pregnancy on ultrasound scan is important to avoid misdiagnosis of uterine ectopic pregnancies. A comprehensive classification of ectopic pregnancy must include definitions and descriptions of each type of ectopic pregnancy. Only a classification which provides descriptions and diagnostic criteria for all possible locations of ectopic pregnancy would be fit for use in routine clinical practice. The working group formulated 17 recommendations on the diagnosis of the different types of ectopic pregnancies on ultrasound. In addition, for each of the types of ectopic pregnancy, a schematic representation and examples on 2D and 3D ultrasound are provided.Limitations reasons for cautionOwing to the limited evidence available, recommendations are mostly based on clinical and technical expertise.Wider implications of the findingsThis document is expected to have a significant impact on clinical practice in ultrasound for early pregnancy. The development of this terminology will help to reduce the risk of misdiagnosis and inappropriate treatment.Study funding/competing interestsThe meetings of the working group were funded by ESHRE. T.T. declares speakers' fees from GE Healthcare. The other authors declare that they have no conflict of interest.Trial registration numberN/A.DisclaimerThis Good Practice Recommendations (GPR) document represents the views of ESHRE, which are the result of consensus between the relevant ESHRE stakeholders and where relevant based on the scientific evidence available at the time of preparation. ESHRE's GPRs should be used for informational and educational purposes. They should not be interpreted as setting a standard of care or be deemed inclusive of all proper methods of care nor exclusive of other methods of care reasonably directed to obtaining the same results. They do not replace the need for application of clinical judgement to each individual presentation, nor variations based on locality and facility type. Furthermore, ESHRE's GPRs do not constitute or imply the endorsement, recommendation or favouring of any of the included technologies by ESHRE.

Dataset Information

Responsible innovation in human germline gene editing: Background document to the recommendations of ESHG and ESHRE.

Publications

Responsible innovation in human germline gene editing: Background document to the recommendations of ESHG and ESHRE.

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