Initial heritable genome editing: mapping a responsible pathway from basic research to the clinic

What Makes Clinical Research Ethical?

Emanuel, E. J. (2000) · JAMA · doi:10.1001/jama.283.20.2701 · Cited by 2,710 · see citing works

Repair of double-strand breaks induced by CRISPR–Cas9 leads to large deletions and complex rearrangements

Kosicki, M., Tomberg, K., & Bradley, A. (2018) · Nature Biotechnology · doi:10.1038/nbt.4192 · Cited by 1,883 · see citing works

CRISPR/Cas9-mediated gene editing in human tripronuclear zygotes

Liang, P., Xu, Y., Zhang, X., Ding, C., Huang, R., Zhang, Z., Lv, J., Xie, X., Chen, Y., Li, Y., et al. (2015) · Protein & Cell · doi:10.1007/s13238-015-0153-5 · Cited by 1,135 · see citing works

Correction of a pathogenic gene mutation in human embryos

Ma, H., Marti-Gutierrez, N., Park, S.-W., Wu, J., Lee, Y., Suzuki, K., Koski, A., Ji, D., Hayama, T., Ahmed, R., et al. (2017) · Nature · doi:10.1038/nature23305 · Cited by 969 · see citing works

A prudent path forward for genomic engineering and germline gene modification

Baltimore, D., Berg, P. R., Botchan, M. R., Carroll, D., Charo, R. A., Church, G. M., Corn, J. E., Daley, G. Q., Doudna, J. A., Fenner, M. W., et al. (2015) · Science · doi:10.1126/science.aab1028 · Cited by 711 · see citing works

Comparison of Overall and Comorbidity-Free Life Expectancy Between Insured Adults With and Without HIV Infection, 2000-2016

Marcus, J. L., Leyden, W. A., Alexeeff, S., Anderson, A. N., Hechter, R. C., Hu, H., Lam, J. O., Towner, W. J., Yuan, Q. H., Horberg, M. A., et al. (2020) · JAMA Network Open · doi:10.1001/jamanetworkopen.2020.7954 · Cited by 650 · see citing works

Don’t edit the human germ line

Lanphier, E., Urnov, F., Haecker, S. E., Werner, M., & Smolenski, J. (2015) · Nature · doi:10.1038/519410a · Cited by 530 · see citing works

Adopt a moratorium on heritable genome editing

Lander, E. S., Baylis, F., Zhang, F., Charpentier, E., Berg, P., Bourgain, C., Friedrich, B., Joung, J. K., Li, J., Liu, D., et al. (2019) · Nature · doi:10.1038/d41586-019-00726-5 · Cited by 512 · see citing works

CRISPR-Cas9 DNA Base-Editing and Prime-Editing

Kantor, A., McClements, M. E., & MacLaren, R. E. (2020) · International Journal of Molecular Sciences · doi:10.3390/ijms21176240 · Cited by 490 · see citing works

Misunderstanding in Clinical Research: Distinguishing Therapeutic Misconception, Therapeutic Misestimation, & Therapeutic Optimism

Horng, S. H., & Grady, C. (2003) · IRB Ethics and Human Research · doi:10.2307/3564408 · Cited by 317 · see citing works

Threats to Validity in the Design and Conduct of Preclinical Efficacy Studies: A Systematic Review of Guidelines for In Vivo Animal Experiments

Henderson, V. C., Kimmelman, J., Fergusson, D. A., Grimshaw, J., & Hackam, D. G. (2013) · PLoS Medicine · doi:10.1371/journal.pmed.1001489 · Cited by 300 · see citing works

CRISPR’d babies: human germline genome editing in the ‘He Jiankui affair’*

Greely, H. T. (2019) · Journal of Law and the Biosciences · doi:10.1093/jlb/lsz010 · Cited by 262 · see citing works

Problems of Population Theory Obligations to Future Generations . R. I. Sikora , Brian Barry

McMahan, J. (1981) · Ethics · doi:10.1086/292301 · Cited by 255 · see citing works

Human Germline Genome Editing

Ormond, K. E., Mortlock, D. P., Scholes, D. T., Bombard, Y., Brody, L. C., Faucett, W. A., Garrison, N. A., Hercher, L., Isasi, R., Middleton, A., et al. (2017) · The American Journal of Human Genetics · doi:10.1016/j.ajhg.2017.06.012 · Cited by 252 · see citing works

A New Class of Medicines through DNA Editing

Porteus, M. H. (2019) · New England Journal of Medicine · doi:10.1056/nejmra1800729 · Cited by 229 · see citing works

Obstetrics-Gynecology

(2001) · JAMA · doi:10.1001/jama.286.17.2167-jbk1107-3-1 · Cited by 229 · see citing works

Are imprinting disorders more prevalent after human in vitro fertilization or intracytoplasmic sperm injection?

Vermeiden, J. P. W., & Bernardus, R. E. (2013) · Fertility and Sterility · doi:10.1016/j.fertnstert.2013.01.125 · Cited by 190 · see citing works

The Ethics of Germline Gene Editing

Gyngell, C., Douglas, T., & Savulescu, J. (2017) · Journal of Applied Philosophy · doi:10.1111/japp.12249 · Cited by 174 · cited 2× · see citing works

When and how should new technology be introduced into the IVF laboratory?

Harper, J. C., Magli, M. C., Lundin, K., Barratt, C. L. R., & Brison, D. R. (2011) · Human Reproduction · doi:10.1093/humrep/der414 · Cited by 174 · see citing works

Human Genome Editing: Science, Ethics, and Governance

Committee on Human Gene Editing: Scientific, M., National Academy of Sciences, National Academy of Medicine, & National Academies of Sciences, E. (2017) · doi:10.17226/24623 · Cited by 144 · see citing works

Do CRISPR Germline Ethics Statements Cut It?

Brokowski, C. (2018) · The CRISPR Journal · doi:10.1089/crispr.2017.0024 · Cited by 137 · see citing works

Single-cell analysis of human embryos reveals diverse patterns of aneuploidy and mosaicismPreprint

Starostik, M. R., Sosina, O., & McCoy, R. (2020) · bioRxiv · doi:10.1101/gr.262774.120 · Cited by 119 · see citing works

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

Baylis, F. E., & McLeod, M. (2017) · Current Gene Therapy · doi:10.2174/1566523217666171121165935 · Cited by 95 · see citing works

Altered Inheritance

Baylis, F. E. (2019) · Harvard University Press eBooks · doi:10.4159/9780674241954 · Cited by 92 · see citing works

Preferring a Genetically-Related Child

Rulli, T. (2015) · Journal of Moral Philosophy · doi:10.1163/17455243-4681062 · Cited by 91 · see citing works

Geneva Statement on Heritable Human Genome Editing: The Need for Course Correction

Andorno, R., Baylis, F. E., Darnovsky, M., et al. (2020) · Trends in biotechnology · doi:10.1016/j.tibtech.2019.12.022 · Cited by 91 · see citing works

Mitochondrial Replacement: Ethics and Identity

Wrigley, A., Wilkinson, S., & Appleby, J. (2015) · Bioethics · doi:10.1111/bioe.12187 · Cited by 82 · see citing works

Beyond safety: mapping the ethical debate on heritable genome editing interventions

Almeida, M., & Ranisch, R. (2022) · Humanities and Social Sciences Communications · doi:10.1057/s41599-022-01147-y · Cited by 80 · see citing works

Innovative reproductive technologies: risks and responsibilities

Dondorp, W., & de Wert, G. M. W. R. (2011) · Human Reproduction · doi:10.1093/humrep/der112 · Cited by 76 · see citing works

Genome editing and assisted reproduction: curing embryos, society or prospective parents?

Cavaliere, G. (2017) · Medicine Health Care and Philosophy · doi:10.1007/s11019-017-9793-y · Cited by 75 · see citing works

After the Storm — A Responsible Path for Genome Editing

Daley, G. Q., Lovell-Badge, R. H., & Steffann, J. (2019) · New England Journal of Medicine · doi:10.1056/nejmp1900504 · Cited by 74 · see citing works

Principles of and strategies for germline gene therapy

Wolf, D. P., Mitalipov, P. A., & Mitalipov, S. M. (2019) · Nature Medicine · doi:10.1038/s41591-019-0473-8 · Cited by 73 · see citing works

Human Germline CRISPR-Cas Modification: Toward a Regulatory Framework

Evitt, N. H., Mascharak, S., & Altman, R. B. (2015) · The American Journal of Bioethics · doi:10.1080/15265161.2015.1104160 · Cited by 72 · see citing works

Preclinical efficacy studies in investigator brochures: do they enable risk–benefit assessment?

Wieschowski, S., Chin, W. W. L., Federico, C., Sievers, S., Kimmelman, J., & Strech, D. (2018) · PLOS Biology · doi:10.1371/journal.pbio.2004879 · Cited by 70 · see citing works

Gene Transfer and the Ethics of First-in-Human Research: Lost in Translation

Kimmelman, J. (2009) · Cited by 70 · see citing works

Moral reasons to edit the human genome: picking up from the Nuffield report

Gyngell, C., Bowman‐Smart, H., & Savulescu, J. (2019) · Journal of Medical Ethics · doi:10.1136/medethics-2018-105084 · Cited by 70 · see citing works

Heritable Human Genome Editing

International Commission on the Clinical Use of Human Germline Genome Editing, National Academy of Medicine, National Academy of Sciences, & The Royal Society (2020) · National Academies Press eBooks · doi:10.17226/25665 · Cited by 69 · cited 3× · see citing works

Human Germline Genome Editing: On the Nature of Our Reasons to Genome Edit

Sparrow, R. (2021) · The American Journal of Bioethics · doi:10.1080/15265161.2021.1907480 · Cited by 69 · see citing works

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

de Wert, G. M. W. R., Heindryckx, B., Pennings, G., Clarke, A. J., Eichenlaub-Ritter, U., van El, C. G., Forzano, F., Goddijn, M., Howard, H. C., Radojkovic, D. P., et al. (2018) · European Journal of Human Genetics · doi:10.1038/s41431-017-0077-z · Cited by 68 · see citing works

Human germline genome editing

Lea, R. A., & Niakan, K. K. (2019) · Nature Cell Biology · doi:10.1038/s41556-019-0424-0 · Cited by 62 · see citing works

Germline genome editing versus preimplantation genetic diagnosis: Is there a case in favour of germline interventions?

Ranisch, R. (2019) · Bioethics · doi:10.1111/bioe.12635 · Cited by 59 · see citing works

Human germline editing in the era of CRISPR-Cas: risk and uncertainty, inter-generational responsibility, therapeutic legitimacy

Schleidgen, S., Dederer, H., Sgodda, S., et al. (2020) · BMC Medical Ethics · doi:10.1186/s12910-020-00487-1 · Cited by 58 · see citing works

Long-term health implications for children conceived by IVF/ICSI

Steel, A., & Sutcliffe, A. G. (2009) · Human Fertility · doi:10.1080/14647270802499201 · Cited by 57 · see citing works

Toward the ethical evaluation and use of maternal-fetal surgery

Lyerly, A. D. (2001) · Obstetrics and Gynecology · doi:10.1016/s0029-7844(01)01513-7 · Cited by 56 · see citing works

Human germline genome editing and broad societal consensus

Baylis, F. E. (2017) · Nature Human Behaviour · doi:10.1038/s41562-017-0103 · Cited by 56 · see citing works

Risks and benefits of human germline genome editing: An ethical analysis

Rubeis, G., & Steger, F. (2018) · Asian Bioethics Review · doi:10.1007/s41649-018-0056-x · Cited by 56 · see citing works

Germline Modification and the Burden of Human Existence

Harris, J. (2015) · Cambridge Quarterly of Healthcare Ethics · doi:10.1017/s0963180115000237 · Cited by 53 · see citing works

Mutation rates and the evolution of germline structure

Scally, A. (2016) · Philosophical Transactions of the Royal Society B Biological Sciences · doi:10.1098/rstb.2015.0137 · Cited by 49 · see citing works

Reproductive CRISPR does not cure disease

Rulli, T. (2019) · Bioethics · doi:10.1111/bioe.12663 · Cited by 48 · see citing works

Altered Inheritance: CRISPR and the Ethics of Human Genome Editing

Dickenson, D. L. (2020) · The New Bioethics · doi:10.1080/20502877.2020.1729578 · Cited by 48 · see citing works

Could Failure in Preimplantation Genetic Diagnosis Justify Editing the Human Embryo Genome?

Steffann, J., Jouannet, P., Bonnefont, J.-P., Chneiweiss, H., & Frydman, N. (2018) · Cell Stem Cell · doi:10.1016/j.stem.2018.01.004 · Cited by 47 · see citing works

Unexpected CRISPR on-target effects

Lee, H., & Kim, J.-S. (2018) · Nature Biotechnology · doi:10.1038/nbt.4207 · Cited by 46 · see citing works

The ethics of clinical applications of germline genome modification: a systematic review of reasons

van Dijke, I., Bosch, L., Bredenoord, A. L., Cornel, M. C., Repping, S., & Hendriks, S. (2018) · Human Reproduction · doi:10.1093/humrep/dey257 · Cited by 44 · see citing works

An ethical pathway for gene editing

Savulescu, J., & Singer, P. (2019) · Bioethics · doi:10.1111/bioe.12570 · Cited by 43 · see citing works

Designing Ethical Trials of Germline Gene Editing

Cwik, B. (2017) · New England Journal of Medicine · doi:10.1056/nejmp1711000 · Cited by 37 · see citing works

The Oldham Notebooks: an analysis of the development of IVF 1969–1978. IV. Ethical aspects

Johnson, M. H., & Elder, K. T. (2015) · Reproductive Biomedicine & Society Online · doi:10.1016/j.rbms.2015.04.002 · Cited by 33 · see citing works

Getting what you desire: the normative significance of genetic relatedness in parent–child relationships

Segers, S., Pennings, G., & Mertes, H. (2019) · Medicine Health Care and Philosophy · doi:10.1007/s11019-019-09889-4 · Cited by 33 · see citing works

The ‘serious’ factor in germline modification

Kleiderman, E., Ravitsky, V., & Knoppers, B. M. (2019) · Journal of Medical Ethics · doi:10.1136/medethics-2019-105436 · Cited by 33 · see citing works

Second International Summit on Human Genome Editing: Continuing the Global Discussion

Affairs, P. A. G., & National Academies of Sciences, E. (2019) · National Academies Press eBooks · doi:10.17226/25343 · Cited by 31 · see citing works

The fetal patient -- ethical aspects of fetal therapy.

Deprest, J. A., Toelen, J., Debyser, Z., Rodrigues, C., Devlieger, R., Catte, L. D., Lewi, L., Van Mieghem, T., Naulaers, G., Vandevelde, M., et al. (2011) · Europe PMC (PubMed Central) · Cited by 30 · see citing works

CRISPR/Cas9 and Germline Modification: New Difficulties in Obtaining Informed Consent

Smolenski, J. (2015) · The American Journal of Bioethics · doi:10.1080/15265161.2015.1103816 · Cited by 26 · see citing works

Informed Consent for Human Embryo Genome Editing

Jonlin, E. C. (2020) · Stem Cell Reports · doi:10.1016/j.stemcr.2020.03.010 · Cited by 24 · see citing works

Mitochondrial/Nuclear Transfer: A Literature Review of the Ethical, Legal and Social Issues

Dupras-Leduc, R., Birko, S., & Ravitsky, V. (2019) · Canadian Journal of Bioethics · doi:10.7202/1058264ar · Cited by 21 · see citing works

Gene Editing, Enhancing and Women’s Role

Simonstein, F. (2017) · Science and Engineering Ethics · doi:10.1007/s11948-017-9875-5 · Cited by 20 · see citing works

Intergenerational monitoring in clinical trials of germline gene editing

Cwik, B. (2019) · Journal of Medical Ethics · doi:10.1136/medethics-2019-105620 · Cited by 20 · see citing works

Human Germline Genome Editing: An Assessment

Greely, H. T. (2019) · The CRISPR Journal · doi:10.1089/crispr.2019.0038 · Cited by 18 · see citing works

Nuclear transfer to prevent maternal transmission of mitochondrial DNA disease

Poulton, J., & Oakeshott, P. (2012) · BMJ · doi:10.1136/bmj.e6651 · Cited by 17 · see citing works

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

de Wert, G. M. W. R., Heindryckx, B., Pennings, G., Clarke, A. J., Eichenlaub-Ritter, U., van El, C. G., Forzano, F., Goddijn, M., Howard, H. C., Radojkovic, D. P., et al. (2018) · Human Reproduction Open · doi:10.1093/hropen/hox024 · Cited by 14 · see citing works

‘I feel an obligation to be balanced.’ Noted biologist comes to defense of gene editing babies

Cohen, J. (2018) · Science · doi:10.1126/science.aaw2120 · Cited by 12 · see citing works

Safety of Germline Genome Editing for Genetically Related “Future” Children as Perceived by Parents

Ishii, T., & Beriaín, Í. D. M. (2019) · The CRISPR Journal · doi:10.1089/crispr.2019.0010 · Cited by 12 · see citing works

Can reproductive genetic manipulation save lives?

Schaefer, G. O. (2020) · Medicine Health Care and Philosophy · doi:10.1007/s11019-020-09947-2 · Cited by 12 · see citing works

Responsible Translational Pathways for Germline Gene Editing?

Cwik, B. (2020) · Current Stem Cell Reports · doi:10.1007/s40778-020-00179-x · Cited by 12 · see citing works

Regulating Clinical Innovation: Trachea Transplants and Tissue Engineering

Árnason, G. (2019) · The American Journal of Bioethics · doi:10.1080/15265161.2019.1602179 · Cited by 11 · see citing works

Designing Preclinical Studies in Germline Gene Editing: Scientific and Ethical Aspects

Nordgren, A. (2019) · Journal of Bioethical Inquiry · doi:10.1007/s11673-019-09947-9 · Cited by 11 · see citing works

Fading red lines? Bioethics of germline genome editing

Ranisch, R., & Ehni, H. (2019) · Bioethics · doi:10.1111/bioe.12709 · Cited by 11 · see citing works

Who Goes First? Deaf People and CRISPR Germline Editing

Padden, C. A., & Humphries, J. (2020) · Perspectives in biology and medicine · doi:10.1353/pbm.2020.0004 · Cited by 11 · see citing works

Should Long-Term Follow-up Post-Mitochondrial Replacement be Left up to Physicians, Parents, or Offspring?

Ishii, T. (2019) · The New Bioethics · doi:10.1080/20502877.2019.1654672 · Cited by 10 · see citing works

The Nuffield Council’s green light for genome editing human embryos defies fundamental human rights law

Drabiak, K. (2020) · Bioethics · doi:10.1111/bioe.12713 · Cited by 10 · see citing works

Liberale Eugenik?

Ranisch, R. (2021) · J.B. Metzler eBooks · doi:10.1007/978-3-476-04739-7 · Cited by 10 · see citing works

Ethical Considerations in Therapeutic Clinical Trials Involving Novel Human Germline-Editing Technology

Brokowski, C., & Adli, M. (2020) · The CRISPR Journal · doi:10.1089/crispr.2019.0051 · Cited by 9 · see citing works

Prioritizing Women's Health in Germline Editing Research

Farrell, R. M., Michie, M., Scott, C. T., et al. (2019) · The AMA Journal of Ethic · doi:10.1001/amajethics.2019.1071 · Cited by 7 · see citing works

Germline Genome Editing and the Functions of Consent

Ranisch, R. (2017) · The American Journal of Bioethics · doi:10.1080/15265161.2017.1388875 · Cited by 5 · see citing works

How Should “CRISPRed” Babies Be Monitored Over Their Life Course to Promote Health Equity?

Thompson, C. (2019) · The AMA Journal of Ethic · doi:10.1001/amajethics.2019.1036 · Cited by 5 · see citing works

‘Serious’ factor—a relevant starting point for further debate: a response

Kleiderman, E., Ravitsky, V., & Knoppers, B. M. (2019) · Journal of Medical Ethics · doi:10.1136/medethics-2019-105832 · Cited by 5 · see citing works

Clinical trials of germline gene editing: The exploitation problem

Malmqvist, E. (2021) · Bioethics · doi:10.1111/bioe.12903 · Cited by 5 · see citing works

‘Serious’ science: a response to Kleiderman, Ravitsky and Knoppers

Kalsi, S. (2019) · Journal of Medical Ethics · doi:10.1136/medethics-2019-105764 · Cited by 3 · see citing works

Review of Altered inheritance: CRISPR and the ethics of human genome editing by Françoise Baylis

Sun, B. Z. (2020) · Bioethics News · doi:10.1007/s40592-020-00106-0 · Cited by 3 · see citing works

Medical-ethical recommendations: preimplantation genetic testing PGT

Weekly, S. M. (2020) · Swiss Medical Weekly · doi:10.4414/smw.2020.20298 · Cited by 3 · see citing works

Is the ‘serious’ factor in germline modification really relevant? A response to Kleiderman, Ravitsky and Knoppers

Beriaín, Í. D. M. (2019) · Journal of Medical Ethics · doi:10.1136/medethics-2019-105744 · Cited by 2 · see citing works

Beyond babies: Implications of human genome editing for women, children, and families

Farrell, R. M., Malek, J., & Scott, C. T. (2021) · Accountability in Research · doi:10.1080/08989621.2021.1899824 · Cited by 1 · see citing works

Germline Genome Editing and the Functions of Consent

Ranisch, R. (2017) · The American Journal of Bioethics · doi:10.1080/15265161.2017.1388875 · Cited by 5 · see citing works

Responsible Translational Pathways for Germline Gene Editing?

Cwik, B. (2020) · Current Stem Cell Reports · doi:10.1007/s40778-020-00179-x · Cited by 12 · see citing works

Moral Boundaries of Germline Gene Editing: A Reappraisal After CRISPR-Based Clinical Trials

Radcliffe, W., Greco, M., & Silva, K. (2022) · Zenodo (CERN European Organization for Nuclear Research) · doi:10.5281/zenodo.22681129

Human germline gene editing. Recommendations of the European Society of Human Genetics and the European Society of Human Reproduction and Embryology.*

de Wert, G. M. W. R. (2019) · Reproductive BioMedicine Online · doi:10.1016/j.rbmo.2019.03.097 · Cited by 3 · see citing works

Heritable human genome editing: Research progress, ethical considerations, and hurdles to clinical practice

Turocy, J. M., Adashi, E. Y., & Egli, D. M. (2021) · Cell · doi:10.1016/j.cell.2021.02.036 · Cited by 53 · see citing works