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The ethics of clinical applications of germline genome modification: a systematic review of reasons.
Hum Reprod 2018; 33(9):1777-1796HR

Abstract

STUDY QUESTION

What are the reasons for or against the future clinical application of germline genome modification (GGM)?

SUMMARY ANSWER

A total of 169 reasons were identified, including 90 reasons for and 79 reasons against future clinical application of GGM.

WHAT IS KNOWN ALREADY

GGM is still unsafe and insufficiently effective for clinical purposes. However, the progress made using Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR)- CRISPR-associated system (Cas) has led scientists to expect to overcome the technical hurdles in the foreseeable future. This has invited a debate on the socio-ethical and legal implications and acceptability of clinical applications of GGM. However, an overview of the reasons presented in this debate is missing.

STUDY DESIGN, SIZE, DURATION

MEDLINE was systematically searched for articles published between January 2011 and June 2016. Articles covering reasons for or against clinical application of intentional modification of the nuclear DNA of the germline were included.

PARTICIPANTS/MATERIALS, SETTING, METHODS

Two researchers independently extracted the reported reasons from the articles and grouped them into categories through content analysis.

MAIN RESULTS AND THE ROLE OF CHANCE

The systematic search yielded 1179 articles and 180 articles were included. Most papers were written by professionals in ethics, (science) journalism and biomedical sciences. Overall, 169 reasons were identified, including 90 reasons for, and 79 reasons against future clinical application of GGM. None of the included articles mentioned more than 60/169 reasons. The reasons could be categorized into: (i) quality of life of affected individuals; (ii) safety; (iii) effectiveness; (iv) existence of a clinical need or alternative; (v) costs; (vi) homo sapiens as a species (i.e. relating to effects on our species); (vii) social justice; (viii) potential for misuse; (ix) special interests exercising influence; (x) parental rights and duties; (xi) comparability to acceptable processes; (xii) rights of the unborn child; and (xiii) human life and dignity. Considerations relating to the implementation processes and regulation were reported.

LIMITATIONS, REASONS FOR CAUTION

We cannot ensure completeness as reasons may have been omitted in the reviewed literature and our search was limited to MEDLINE and a 5-year time period.

WIDER IMPLICATIONS OF THE FINDINGS

Besides needing (pre)clinical studies on safety and effectiveness, authors call for a sound pre-implementation process. This overview of reasons may assist a thorough evaluation of the responsible introduction of GGM.

STUDY FUNDING/COMPETING INTEREST(S)

University of Amsterdam, Alliance Grant of the Amsterdam Reproduction and Development Research Institute (I.D.), and Clinical Center, Department of Bioethics, National Institutes of Health Intramural Research Program (S.H.). There are no competing interests.

Authors+Show Affiliations

Amsterdam UMC, University of Amsterdam, Center for Reproductive Medicine, Women's and Children's Hospital, Meibergdreef 9, AZ Amsterdam, The Netherlands. Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Clinical Genetics, Amsterdam Public Health Research Institute, van der Boechorsstraat 7, BT Amsterdam, The Netherlands.Amsterdam UMC, University of Amsterdam, Center for Reproductive Medicine, Women's and Children's Hospital, Meibergdreef 9, AZ Amsterdam, The Netherlands.Julius Center, Medical Humanities, University Medical Center Utrecht, Universiteitsweg 100, CG Utrecht, The Netherlands.Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Clinical Genetics, Amsterdam Public Health Research Institute, van der Boechorsstraat 7, BT Amsterdam, The Netherlands.Amsterdam UMC, University of Amsterdam, Center for Reproductive Medicine, Women's and Children's Hospital, Meibergdreef 9, AZ Amsterdam, The Netherlands.Amsterdam UMC, University of Amsterdam, Center for Reproductive Medicine, Women's and Children's Hospital, Meibergdreef 9, AZ Amsterdam, The Netherlands. Department of Bioethics, Clinical Center, National Institutes of Health, 10 Center Dr, Bethesda, MD, USA.

Pub Type(s)

Journal Article
Research Support, N.I.H., Intramural
Research Support, Non-U.S. Gov't
Systematic Review

Language

eng

PubMed ID

30085071

Citation

van Dijke, Ivy, et al. "The Ethics of Clinical Applications of Germline Genome Modification: a Systematic Review of Reasons." Human Reproduction (Oxford, England), vol. 33, no. 9, 2018, pp. 1777-1796.
van Dijke I, Bosch L, Bredenoord AL, et al. The ethics of clinical applications of germline genome modification: a systematic review of reasons. Hum Reprod. 2018;33(9):1777-1796.
van Dijke, I., Bosch, L., Bredenoord, A. L., Cornel, M., Repping, S., & Hendriks, S. (2018). The ethics of clinical applications of germline genome modification: a systematic review of reasons. Human Reproduction (Oxford, England), 33(9), pp. 1777-1796. doi:10.1093/humrep/dey257.
van Dijke I, et al. The Ethics of Clinical Applications of Germline Genome Modification: a Systematic Review of Reasons. Hum Reprod. 2018 09 1;33(9):1777-1796. PubMed PMID: 30085071.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The ethics of clinical applications of germline genome modification: a systematic review of reasons. AU - van Dijke,Ivy, AU - Bosch,Lance, AU - Bredenoord,Annelien L, AU - Cornel,Martina, AU - Repping,Sjoerd, AU - Hendriks,Saskia, PY - 2018/01/22/received PY - 2018/07/20/accepted PY - 2018/8/8/pubmed PY - 2019/5/3/medline PY - 2018/8/8/entrez SP - 1777 EP - 1796 JF - Human reproduction (Oxford, England) JO - Hum. Reprod. VL - 33 IS - 9 N2 - STUDY QUESTION: What are the reasons for or against the future clinical application of germline genome modification (GGM)? SUMMARY ANSWER: A total of 169 reasons were identified, including 90 reasons for and 79 reasons against future clinical application of GGM. WHAT IS KNOWN ALREADY: GGM is still unsafe and insufficiently effective for clinical purposes. However, the progress made using Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR)- CRISPR-associated system (Cas) has led scientists to expect to overcome the technical hurdles in the foreseeable future. This has invited a debate on the socio-ethical and legal implications and acceptability of clinical applications of GGM. However, an overview of the reasons presented in this debate is missing. STUDY DESIGN, SIZE, DURATION: MEDLINE was systematically searched for articles published between January 2011 and June 2016. Articles covering reasons for or against clinical application of intentional modification of the nuclear DNA of the germline were included. PARTICIPANTS/MATERIALS, SETTING, METHODS: Two researchers independently extracted the reported reasons from the articles and grouped them into categories through content analysis. MAIN RESULTS AND THE ROLE OF CHANCE: The systematic search yielded 1179 articles and 180 articles were included. Most papers were written by professionals in ethics, (science) journalism and biomedical sciences. Overall, 169 reasons were identified, including 90 reasons for, and 79 reasons against future clinical application of GGM. None of the included articles mentioned more than 60/169 reasons. The reasons could be categorized into: (i) quality of life of affected individuals; (ii) safety; (iii) effectiveness; (iv) existence of a clinical need or alternative; (v) costs; (vi) homo sapiens as a species (i.e. relating to effects on our species); (vii) social justice; (viii) potential for misuse; (ix) special interests exercising influence; (x) parental rights and duties; (xi) comparability to acceptable processes; (xii) rights of the unborn child; and (xiii) human life and dignity. Considerations relating to the implementation processes and regulation were reported. LIMITATIONS, REASONS FOR CAUTION: We cannot ensure completeness as reasons may have been omitted in the reviewed literature and our search was limited to MEDLINE and a 5-year time period. WIDER IMPLICATIONS OF THE FINDINGS: Besides needing (pre)clinical studies on safety and effectiveness, authors call for a sound pre-implementation process. This overview of reasons may assist a thorough evaluation of the responsible introduction of GGM. STUDY FUNDING/COMPETING INTEREST(S): University of Amsterdam, Alliance Grant of the Amsterdam Reproduction and Development Research Institute (I.D.), and Clinical Center, Department of Bioethics, National Institutes of Health Intramural Research Program (S.H.). There are no competing interests. SN - 1460-2350 UR - https://www.unboundmedicine.com/medline/citation/30085071/The_ethics_of_clinical_applications_of_germline_genome_modification:_a_systematic_review_of_reasons_ L2 - https://academic.oup.com/humrep/article-lookup/doi/10.1093/humrep/dey257 DB - PRIME DP - Unbound Medicine ER -