National Academies Press: OpenBook
« Previous: 8 Summary of Principles and Recommendations
Suggested Citation:"References." National Academies of Sciences, Engineering, and Medicine. 2017. Human Genome Editing: Science, Ethics, and Governance. Washington, DC: The National Academies Press. doi: 10.17226/24623.
×

References

AAP (American Academy of Pediatrics). 2014. Off-label use of drugs in children. Pediatrics 133(3):563-567.

Abbott, K. W. A., D. J. Sylvester, and G. E. Marchant. 2010. Transnational regulation: Reality or romanticism? In International handbook on regulating nanotechnologies, edited by G. Hodge, D. Bowman, and A. Maynard. Cheltenham, UK: Edward Elgar Publishing. Pp. 525-544.

Abudayyeh, O. O., J. S. Gootenberg, S. Konermann, J. Joung, I. M. Slaymaker, D. B. Cox, S. Shmakov, K. S. Makarova, E. Semenova, L. Minakhin, K. Severinov, A. Regev, E. S. Lander, E. V. Koonin, and F. Zhang. 2016. C2c2 is a single-component programmable RNA-guided RNA-targeting CRISPR effector. Science 353(6299):aaf5573.

Achenbach, J. 2016. 107 Nobel laureates sign letter blasting Greenpeace over GMOs. The Washington Post, June 29. https://www.washingtonpost.com/news/speaking-of-science/wp/2016/06/29/more-than-100-nobel-laureates-take-on-greenpeace-over-gmostance/?utm_term=.feb89580ad48 (accessed October 18, 2016).

Akin, H., K. M. Rose, D. A. Scheufele, M. Simis-Wilkinson, D. Brossard, M. A. Xenos, and E. A. Corley. 2017. Mapping the landscape of public attitudes on synthetic biology. Bioscience 67(3):290-300.

Alghrani, A., and M. Brazier. 2011. What is it? Whose it? Re-positioning the fetus in the context of research. The Cambridge Law Journal 70(1):51-82.

Allen, D. B., and L. Cuttler. 2013. Short stature in childhood—challenges and choices. New England Journal of Medicine 368(13):1220-1228

American Cancer Society. 2015. Off-label drug use: What is off-label drug use? http://www.cancer.org/treatment/treatmentsandsideeffects/treatmenttypes/chemotherapy/off-label-drug-use (accessed January 5, 2017).

AMS (Academy of Medical Sciences), British Academy, Royal Academy of Engineering, and The Royal Society. 2012. Human enhancement and the future of work. https://www.acmedsci.ac.uk/viewFile/publicationDownloads/135228646747.pdf (accessed January 5, 2017).

Suggested Citation:"References." National Academies of Sciences, Engineering, and Medicine. 2017. Human Genome Editing: Science, Ethics, and Governance. Washington, DC: The National Academies Press. doi: 10.17226/24623.
×

AMS, AMRC (Association of Medical Research Charities), BBSRC (Biotechnology and Biological Sciences Research Council), MRC (Medical Research Center), and Wellcome Trust. 2015. Genome editing in human cells—initial joint statement. https://wellcome.ac.uk/sites/default/files/wtp059707.pdf (accessed January 4, 2017).

Anderson, A. A., J. Kim, D. A. Scheufele, D. Brossard, and M. A. Xenos. 2013. What’s in a name? How we define nanotech shapes public reactions. Journal of Nanoparticle Research 15(2):1-5.

Anderson, R. C., and R. W. Kulhavy. 1972. Learning concepts from definitions. American Educational Research Journal 9(3):385-390.

Andorno, R. 2005a. The Oviedo convention: A European legal framework at the intersection of human rights and health law. Journal of International Biotechnology Law 2(4):133-143.

Andorno, R. 2005b. Human dignity and the UNESCO Declaration on the Human Genome. In Ethics, Law and Society, Vol. 1, edited by J. Gunning and S. Holm. Burlington, VT: Ashgate Publishing Company. Pp. 73-84.

Anguela, X. M., R. Sharma, Y. Doyon, J. C. Miller, H. Li, V. Haurigot, M. E. Rohde, S. Y. Wong, R. J. Davidson, and S. Zhou. 2013. Robust ZFN-mediated genome editing in adult hemophilic mice. Blood 122(19):3283-3287.

ANM (Académie Nationale de Médecine). 2016. Genome editing of human germline cells and embryos. http://www.academie-medecine.fr/wp-content/uploads/2016/05/report-genome-editing-ANM-2.pdf (accessed January 4, 2017).

Arras, J. 2016. Theory and bioethics. In The Stanford encyclopedia of philosophy, edited by E. N. Zalta. http://plato.stanford.edu/archives/sum2016/entries/theory-bioethics (accessed January 4, 2017).

Au, P., D. A. Hursh, A. Lim, M. C. Moos, S. S. Oh, B. S. Schneider, and C. M. Witten. 2012. FDA oversight of cell therapy clinical trials. Science Translational Medicine 4(149): 149fs31.

Ayyar, V. S. 2011. History of growth hormone therapy. Indian Journal of Endocrinology and Metabolism 15(Suppl. 3):S162-S165.

BAC (Bioethics Advisory Committee) Singapore. 2013. Ethical, legal and social issues in neuroscience research: A consultation paper. http://www.bioethics-singapore.org/index/publications/consultation-papers.html (accessed November 4, 2016).

Baltimore, D., P. Berg, M. Botchan, D. Carroll, R. A. Charo, G. Church, J. E. Corn, G. Q. Daley, J. A. Doudna, M. Fenner, H. T. Greely, M. Jinek, G. S. Martin, E. Penhoet, J. Puck, S. H. Sternberg, J. S. Weissman, and K. R. Yamamoto. 2015. A prudent path forward for genomic engineering and germline gene modification. Science 348(6230):36-38.

Bamford, K. B., S. Wood, and R. J. Shaw. 2005. Standards for gene therapy clinical trials based on pro-active risk assessment in a London NHS Teaching Hospital Trust. QJM: Monthly Journal of the Association of Physicians 98(2):75-86.

Barrangou, R., and E. G. Dudley. 2016. CRISPR-based typing and next-generation tracking technologies. Annual Review of Food Science and Technology 7:395-411.

BBAW (Berlin-Brandenburg Academy of Sciences and Humanities). 2015. Human genome surgery—towards a responsible evaluation of a new technology. http://www.gentechnologiebericht.de/bilder/BBAW_Human-Genome-Surgery_PDF-A1b-1.pdf (accessed January 4, 2017).

Bell, J., K. L. Parker, R. D. Swinford, A. R. Hoffman, T. Maneatis, and B. Lippe. 2010. Long-term safety of recombinant human growth hormone in children. Journal of Clinical Endocrinology & Metabolism 95(1):167-177.

Berg, P., and J. E. Mertz. 2010. Personal reflections on the origins and emergence of recombinant DNA technology. Genetics 184(1):9-17.

Suggested Citation:"References." National Academies of Sciences, Engineering, and Medicine. 2017. Human Genome Editing: Science, Ethics, and Governance. Washington, DC: The National Academies Press. doi: 10.17226/24623.
×

Berg, P., D. Baltimore, S. Brenner, R. O. Roblin, and M. F. Singer. 1975. Asilomar conference on DNA recombinant molecules. Science 188(4192):991-994.

Bertero, A., M. Pawlowski, D. Ortmann, K. Snijders, L. Yiangou, M. C. de Brito, S. Brown, W. G. Bernard, J. D. Cooper, E. Giacomelli, L. Gambardella, N. R. F. Hannan, D. Iyer, F. Sampaziotis, F. Serrano, M. C. F. Zonneveld, S. Sinha, M. Kotter, and L. Vallier. 2016. Optimized inducible shRNA and CRISPR/Cas9 platforms for in vitro studies of human development using hPSCs. Development 143:4405-4418.

Beumer, K. J., and D. Carroll. 2014. Targeted genome engineering techniques in Drosophila. Methods 68(1):29-37.

Bioethics Commission. 2015. Gray matters: Topics at the intersection of neuroscience, ethics, and society (Vol. 2). Washington, DC: Presidential Commission for the Study of Bioethical Issues.

Blakeley, P., N. M. Fogarty, I. del Valle, S. E. Wamaitha, T. X. Hu, K. Elder, P. Snell, L. Christie, P. Robson, and K. K. Niakan. 2015. Defining the three cell lineages of the human blastocyst by single-cell RNA-seq. Development 142(18):3151-3165.

Blendon, R. J., M. T. Gorski, and J. M. Benson, M.A. 2016. The public and the gene-editing revolution. New England Journal of Medicine 374(15):1406-1411.

Boggio, A. 2005. Italy enacts new law on medically assisted reproduction. Human Reproduction 20(5):1153-1157.

Booth, C., H. B. Gaspar, and A. J. Thrasher. 2016. Treating immunodeficiency through HSC gene therapy. Trends in Molecular Medicine 22(4):317-327.

Borg, J. J., G. Aislaitner, M. Pirozynski, and S. Mifsud. 2011. Strengthening and rationalizing pharmacovigilance in the EU: Where is Europe heading to? A review of the new EU legislation on pharmacovigilance. Drug Safety 34(3):187-197.

Bosley, K. S., M. Botchan, A. L. Bredenoord, D. Carroll, R. A. Charo, E. Charpentier, R. Cohen, J. Corn, J. Doudna, G. Feng, H. T. Greely, R. Isasi, W. Ji, J.-S. Kim, B. Knoppers, E. Lanphier, J. Li, R. Lovell-Badge, G. S. Martin, J. Moreno, L. Naldini, M. Pera, A. C. F. Perry, J. C. Venter, F. Zhang, and Q. Zhou. 2015. CRISPR germline engineering: The community speaks. Nature Biotechnology 33(5):478-486.

Bostrom, N. 2005. In defense of posthuman dignity. Bioethics 19(3):202-214.

Bostrom, N., and T. Ord. 2006. The reversal test: Eliminating status quo bias in applied ethics. Ethics 116(4):656-679.

Brossard, D., and B. Lewenstein. 2009. A critical appraisal of model of public understanding of science: Using practice to inform theory. In Understanding science: New agendas in science sommunication, edited by L. Kahlor and P. Stout. New York: Routledge. Pp. 11-39.

Brown, K. V. 2016. Inside the garage labs of DIY gene hackers, whose hobby may terrify you. Fusion, March 29. http://fusion.net/story/285454/diy-crispr-biohackers-garage-labs (accessed January 9, 2016).

Buchanan, A., D. W. Brock, N. Daniels, and D. Wikler. 2001. From chance to choice: Genetics and justice. New York: Cambridge University Press.

Burgess M., and D. Prentice. 2016. Let Congress know to take it slow on human gene editing. Dallas News, December 28.

Cahill, L. S. 2008. Germline genetics, human nature, and social ethics. Cambridge, MA: MIT Press.

Califf, R. M. 2017. Benefit-risk assessments at the U.S. Food and Drug Administration: Finding the balance. Journal of the American Medical Association. http://jamanetwork.com/journals/jama/fullarticle/2599251 (accessed February 3, 2017).

Califf, R. M., and R. Nalubola. 2017. FDA’s science-based approach to genome edited products. FDA Voice, January 18. http://blogs.fda.gov/fdavoice/index.php/2017/01/fdas-science-based-approach-to-genome-edited-products (accessed February 2, 2017).

Suggested Citation:"References." National Academies of Sciences, Engineering, and Medicine. 2017. Human Genome Editing: Science, Ethics, and Governance. Washington, DC: The National Academies Press. doi: 10.17226/24623.
×

Campbell, A., and K. C. Glass. 2000. Legal status of clinical and ethics policies, codes, and guidelines in medical practice and research. McGill Law Journal 46(2):473-489.

Carroll, D. 2014. Genome engineering with targetable nucleases. Annual Review of Biochemistry 83:409-439.

Center for Genetics and Society. 2015. Extreme genetic engineering and the human future: Reclaiming emerging biotechnologies for the common good. http://www.geneticsandsociety.org/downloads/Human_Future_Exec_Sum.pdf (accessed January 6, 2017).

Chan, J. L., L. N. C. Johnson, M. D. Sammel, L. DiGiovanni, C. Voong, S. M. Domchek, and C. R. Gracia. 2016. Reproductive decision-making in women with BRCA1/2 mutations. Journal of Genetic Counseling 1-10.

Chan, S., P. J. Donovan, T. Douglas, C. Gyngell, J. Harris, R. Lovell-Badge, D. J. Mathews, and A. Regenberg. 2015. Genome editing technologies and human germline genetic modification: The Hinxton Group consensus statement. The American Journal of Bioethics 15(12):42-47.

Chapman, K. M., G. A. Medrano, P. Jaichander, J. Chaudhary, A. E. Waits, M. A. Nobrega, J. M. Hotaling, C. Ober, and F. K. Hamra. 2015. Targeted germline modifications in rats using CRISPR/Cas9 and spermatogonial stem cells. Cell Reports 10(11):1828-1835.

Charo, R. A. 2016a. On the road (to a cure?)—stem-cell tourism and lessons for gene editing. New England Journal of Medicine 374(10):901-903.

Charo, R. A. 2016b. The legal and regulatory context for human gene editing. Issues in Science and Technology 32(3):39.

Charpentier, E., and J. A. Doudna. 2013. Biotechnology: Rewriting a genome. Nature 494(7439):50-51.

Chen, E. A., and J. F. Schiffman. 2000. Attitudes toward genetic counseling and prenatal diagnosis among a group of individuals with physical disabilities. Journal of Genetic Counseling 9(2):137-152.

Cho, S. W., S. Kim, J. M. Kim, and J.-S. Kim. 2013. Targeted genome engineering in human cells with the Cas9 RNA-guided endonuclease. Nature Biotechnology 31(3):230-232.

Choulika, A., A. Perrin, B. Dujon, and J.-P. Nicolas. 1995. Induction of homologous recombination in mammalian chromosomes by using the I-SceI system of Saccharomyces cerevisiae. Molecular and Cellular Biology 15(4):1968-1973.

CIOMS (Council for International Organizations of Medical Sciences). 2012. Bioethics. http://www.cioms.ch/index.php/2012-06-07-19-16-08/about-us/bioethics (accessed January 4, 2017).

CIOMS. 2017. International Ethical Guidelines for Health-Related Research Involving Humans. http://apps.who.int/bookorders/anglais/detart1.jsp?codlan=1&codcol=84&codcch=35 (accessed May 9, 2017).

CIRM (California Institute for Regenerative Medicine). 2015. Scientific and medical accountability standards. https://www.cirm.ca.gov/our-funding/chapter-2-scientific-and-medical-accountability-standards (accessed January 4, 2017).

Cockburn, K., and J. Rossant. 2010. Making the blastocyst: Lessons from the mouse. Journal of Clinical Investigation 120(4):995-1003.

COE (Council of Europe). 2016. Chart of signatures and ratifications of Treaty 164. http://www.coe.int/en/web/conventions/full-list/-/conventions/treaty/164/signatures (accessed November 3, 2016).

Coghlan, A. 2016. Exclusive: “3-parent” baby method already used for infertility. New Scientist, October 10. https://www.newscientist.com/article/2108549-exclusive-3-parent-baby-method-already-used-for-infertility (accessed November 3, 2016).

Coghlan, A. 2017. First baby born using three-parent technque to treat infertility. New Scientist, January 18. https://www.newscientist.com/article/2118334-first-baby-born-using-3-parent-technique-to-treat-infertility (accessed January 19, 2017).

Suggested Citation:"References." National Academies of Sciences, Engineering, and Medicine. 2017. Human Genome Editing: Science, Ethics, and Governance. Washington, DC: The National Academies Press. doi: 10.17226/24623.
×

Cohen, I. G. 2015. Patients and passports: Medical tourism, law, and ethics, 1st ed. New York: Oxford University Press.

Cohen, P., G. M. Bright, A. D. Rogol, A. M. Kappelgaard, and R. G. Rosenfeld. 2002. Effects of dose and gender on the growth and growth factor response to GH in GH-deficient children: Implications for efficacy and safety. Journal of Clinical Endocrinology & Metabolism 87(1):90-98.

Cole-Turner, R. 1993. The new genesis: Theology and the genetic revolution. Louisville, KY: Westminster/John Knox Press.

Collins, F.S. 2015. Statement of NIH Funding of Research Using Gene-Editing Technologies in Human Embryos. https://www.nih.gov/about-nih/who-we-are/nih-director/statements/statement-nih-funding-research-using-gene-editing-technologies-human-embryos (accessed May 9, 2017).

Cong, L., F. A. Ran, D. Cox, S. Lin, R. Barretto, N. Habib, P. D. Hsu, X. Wu, W. Jiang, and L. A. Marraffini. 2013. Multiplex genome engineering using CRISPR/Cas systems. Science 339(6121):819-823.

Cook, D. M., and S. R. Rose. 2012. A review of guidelines for use of growth hormone in pediatric and transition patients. Pituitary 15(3):301-310.

Cornwall, A. 2008. Democratising engagement: What the U.K. can learn from international experience. London, U.K.: Demos.

Corrigan-Curay, J. 2013. NIH Recombinant DNA Advisory Committee (RAC) and gene transfer research. Presentation at the First Meeting on Independent Review and Assessment of the Activities of the NIH Recombinant DNA Advisory Committee, Washington, DC, June 4. https://www.nationalacademies.org/hmd/Activities/Research/ReviewNIHRAC/2013-JUN-04.aspx (accessed November 4, 2016).

Corrigan-Curay, J., M. O’Reilly, D. B. Kohn, P. M. Cannon, G. Bao, F. D. Bushman, D. Carroll, T. Cathomen, J. K. Joung, and D. Roth. 2015. Genome editing technologies: Defining a path to clinic. Molecular Therapy 23(5):796-806.

Council of Europe. 2015. Statement on genome editing technologies. http://www.coe.int/en/web/bioethics/-/gene-editing (accessed October 21, 2016).

Couzin-Frankel, J. 2016. Ailing fetuses to be treated with stem cells. Science, April 14. http://www.sciencemag.org/news/2016/04/ailing-fetuses-be-treated-stem-cells (accessed January 5, 2017).

Cox, D. B. T., R. J. Platt, and F. Zhang. 2015. Therapeutic genome editing: Prospects and challenges. Nature Medicine 21(2):121-131.

Cronin, R. 2008. Bureaucrats vs. physicians: Have doctors been stripped of their power to determine the proper use of human growth hormone in treating adult disease. Washington University Journal of Law & Policy 27:191. http://openscholarship.wustl.edu/cgi/view-content.cgi?article=1141&context=law_journal_law_policy (accessed January 6, 2017).

Cuttler, L., and J. Silvers. 2010. Growth hormone and health policy. The Journal of Clinical Endocrinology & Metabolism 95(7):3149-3153.

Cyranoski, D. 2016. Chinese scientists to pioneer first human CRISPR trial. Nature 535:476-477.

Daniels, N. 2000. Normal functioning and the treatment-enhancement distinction. Cambridge Quarterly of Healthcare Ethics 9(3):309-322.

Danish Board of Technology. 2006. The consensus conference. http://www.tekno.dk/subpage.php3?article=468&toppic=kategori12&language=uk (accessed December 10, 2016).

Danish Board of Technology. 2010a. A clear message from world citizens to COP15 politicians. http://www.tekno.dk/article/offentliggrelse-af-policy-rapport-om-wwviews-resultater-19-november/ (accessed December 11, 2016).

Danish Board of Technology. 2010b. Profile of the Danish Board of Technology. http://www.tekno.dk/about-dbt-foundation/?lang=en (accessed December 11, 2016).

Suggested Citation:"References." National Academies of Sciences, Engineering, and Medicine. 2017. Human Genome Editing: Science, Ethics, and Governance. Washington, DC: The National Academies Press. doi: 10.17226/24623.
×

Davis, B. D. 1970. Prospects for genetic intervention in man. Science 170(3964):1279-1283.

de la Noval, B. D. 2016. Potential implications on female fertility and reproductive lifespan in BRCA germline mutation women. Archives of Gynecology and Obstetrics 294(5): 1099-1103.

De Ravin, S. S., X. Wu, S. Moir, L. Kardava, S. Anaya-O’Brien, N. Kwatemaa, P. Littel, N. Theobald, U. Choi, and L. Su. 2016. Lentiviral hematopoietic stem cell gene therapy for x-linked severe combined immunodeficiency. Science Translational Medicine 8(335):335ra357.

DEA (Drug Enforcement Administration). 2013. Human growth hormone (trade names: Genotropin®, Humatrope®, Norditropin®, Nutropin®, Saizen®, Serostim®). http://www.deadiversion.usdoj.gov/drug_chem_info/hgh.pdf (accessed January 4, 2017).

Decruyenaere, M., G. Evers-Kiebooms, A. Boogaerts, K. Philippe, K. Demyttenaere, R. Dom, W. Vandenberghe, and J. P. Fryns. 2007. The complexity of reproductive decision-making in asymptomatic carriers of the Huntington mutation. European Journal of Human Genetics: EJHG 15(4):453-462.

Deglincerti, A., G. F. Croft, L. N. Pietila, M. Zernicka-Goetz, E. D. Siggia, and A. H. Brivanlou. 2016. Self-organization of the in vitro attached human embryo. Nature 533(7602):251-254.

Dever, D. P., R. O. Bak, A. Reinisch, J. Camarena, G. Washington, C. E. Nicolas, M. Pavel-Dinu, N. Saxena, A. B. Wilkens, S. Mantri, N. Uchida, A. Hendel, A. Narla, R. Majeti, K. I. Weinberg, and M. H. Porteus. 2016. CRISPR/Cas9 β-globin gene targeting in human haematopoietic stem cells. Nature 539:384-389.

Devereaux, M., and M. Kalichman. 2013. ESCRO committees—not dead yet. The American Journal of Bioethics 13(1):59-60.

DeWitt, M. A., W. Magis, N. L. Bray, T. Wang, J. R. Berman, F. Urbinati, S.-J. Heo, T. Mitros, D. P. Muñoz, and D. Boffelli. 2016. Selection-free genome editing of the sickle mutation in human adult hematopoietic stem/progenitor cells. Science Translational Medicine 8(360):360ra134.

Dillman, D. A., J. D. Smyth, and L. M. Christian. 2014. Internet, phone, mail, and mixed-mode surveys: The tailored design method (4th Edition). Hoboken, NJ: Wiley.

Ding, Y., H. Li, L.-L. Chen, and K. Xie. 2016. Recent advances in genome editing using CRISPR/Cas9. Frontiers in Plant Science 7:703.

Doudna, J. 2015. Perspective: Embryo editing needs scrutiny. Nature 528(7580):S6-S6.

Doudna, J. A., and E. Charpentier. 2014. The new frontier of genome engineering with CRISPR-Cas9. Science 346(6213).

DRZE (Deutsche Referenzzentrum für Ethik in den Biowissenschaften). 2016. Selected national and international laws and regulations. http://www.drze.de/in-focus/stem-cell-research/laws-and-regulations (accessed October 25, 2016).

Dudding, T., B. Wilcken, B. Burgess, J. Hambly, and G. Turner. 2000. Reproductive decisions after neonatal screening identifies cystic fibrosis. ADC Fetal & Neonatal Edition 82(2):F124-F127.

East-Seletsky, A., M. R. O’Connell, S. C. Knight, D. Burstein, J. H. Cate, R. Tjian, and J. A. Doudna. 2016. Two distinct RNase activities of CRISPR-C2c2 enable guide-RNA processing and RNA detection. Nature 538(7624):270-273.

Editing humanity. 2015. The Economist, August 22.

EGE (European Group on Ethics in Science and New Technologies). 2016. Statement on gene editing. https://ec.europa.eu/research/ege/pdf/gene_editing_ege_statement.pdf (accessed January 5, 2017).

Suggested Citation:"References." National Academies of Sciences, Engineering, and Medicine. 2017. Human Genome Editing: Science, Ethics, and Governance. Washington, DC: The National Academies Press. doi: 10.17226/24623.
×

EMA (European Medicines Agency). 2006. Guideline on non-clinical testing for inadvertent germline transmission of gene transfer vectors. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500003982.pdf (accessed February 2, 2017).

Enserink, M. 2016. Swedish academy seeks to stem “crisis of confidence” in wake of Macchiarini scandal. Science Magazine, February 11. http://www.sciencemag.org/news/2016/02/swedish-academy-seeks-stem-crisis-confidence-wake-macchiarini-scandal (accessed January 5, 2017).

European Commission. 2012. Ethics in public policy making: The case of human enhancement. http://cordis.europa.eu/result/rcn/153896_en.html (accessed November 4, 2016).

European Commission. 2016a. Horizon 2020 Work Programme 2016-2017. http://ec.europa.eu/research/participants/data/ref/h2020/wp/2016_2017/main/h2020-wp1617-swfs_en.pdf (accessed January 6, 2017).

European Commission. 2016b. Public engagement in responsible research and innovation. https://ec.europa.eu/programmes/horizon2020/en/h2020-section/public-engagement-responsible-research-and-innovation (accessed January 6, 2017).

European Commission. 2016c. Voices. http://www.ecsite.eu/activities-and-services/projects/voices (accessed January 6, 2017).

Evans, J. H. 2002. Playing God?: Human genetic engineering and the rationalization of public bioethical debate. Chicago, IL: University of Chicago Press.

Evans, J. H. 2010. Contested reproduction: Genetic technologies, religion, and public debate. Chicago, IL: University of Chicago Press.

Ezkurdia, I., D. Juan, J. M. Rodriguez, A. Frankish, M. Diekhans, J. Harrow, J. Vazquez, A. Valencia, and M. L. Tress. 2014. Multiple evidence strands suggest that there may be as few as 19,000 human protein-coding genes. Human Molecular Genetics 23(22):5866-5878.

FDA (U.S. Food and Drug Administration). 1991. Points to consider in human somatic cell therapy and gene therapy. Human Gene Therapy 2(3):251-256.

FDA. 1993. Application of current statutory authorities to human somatic cell therapy products and gene therapy products; notice. Federal Register 58(197):53248-53251. http://www.fda.gov/downloads/BiologicsBloodVaccines/SafetyAvailability/UCM148113.pdf (accessed January 5, 2017).

FDA. 2000. Guidance for industry: Formal meetings with sponsors and applicants for PDUFA products. Rockville, MD: FDA. http://www.fda.gov/OHRMS/DOCKETS/98fr/990296g2.pdf (accessed November 4, 2016).

FDA. 2001. IND meetings for human drugs and biologics: Chemistry, manufacturing, and controls information. Rockville, MD: FDA. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070568.pdf (accessed September 1, 2013).

FDA. 2006. Guidance for industry: Gene therapy clinical trials—observing subjects for delayed adverse events. Rockville, MD: FDA. http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/CellularandGeneTherapy/ucm078719.pdf (accessed September 1, 2013).

FDA. 2009. Cloning. http://www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/Cloning/default.htm (accessed January 5, 2017).

FDA. 2010. Background document: Public hearing on the labeling of food made from the AquAdvantage salmon. http://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/UCM223913.pdf (accessed January 5, 2017).

Suggested Citation:"References." National Academies of Sciences, Engineering, and Medicine. 2017. Human Genome Editing: Science, Ethics, and Governance. Washington, DC: The National Academies Press. doi: 10.17226/24623.
×

FDA. 2012a. Guidance for industry: Preclinical assessment of investigational cellular and gene therapy products. http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/CellularandGeneTherapy/ucm376136.htm (accessed February 3, 2017).

FDA. 2012b. Import alert #66-71: Detention without physical examination of human growth hormone (HGH), also known as Somatropin. http://www.accessdata.fda.gov/cms_ia/importalert_204.html (accessed January 6, 2017).

FDA. 2015a. Fast track, breakthrough therapy, accelerated approval, priority review. http://www.fda.gov/forpatients/approvals/fast/ucm20041766.htm (accessed January 4, 2017).

FDA. 2015b. Guidance for industry: Considerations for the design of early-phase clinical trials of cellular and gene therapy products. Rockville, MD: FDA. http://www.fda.gov/downloads/Biologi…/UCM359073.pdf (accessed February 1, 2017).

FDA. 2015c. Modernizing the regulatory system for biotechnology products: First public meeting. http://www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/ucm463783.htm (accessed October 19, 2016).

FDA. 2016a. Manufacturer communications regarding unapproved uses of approved or cleared medical products. http://www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/ucm489499.htm (accessed October 25, 2016).

FDA. 2016b. Public hearing; request for comments—draft guidances relating to the regulation of human cells, tissues or cellular or tissue-based products. http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/ucm462125.htm (accessed October 26, 2016).

FEAM (Federation of European Academies of Medicine), UKAMS (United Kingdom Academy of Medical Sciences), and ANM (Académie Nationale de Médecine. 2017. Human genome editing in the EU: Report of a workshop held on 28th April 2016. http://www.feam-site.eu/cms/docs/humangenomeeditingworkshop2016report.pdf (accessed March 10, 2017).

Fletcher, J. 1971. Ethical aspects of genetic controls: Designed genetic changes in man. New England Journal of Medicine 285(14):776-783.

Fletcher, J. C. 1985. Ethical issues in and beyond prospective clinical trials of human gene therapy. Journal of Medicine and Philosophy 10(3):293-310.

Frankel, M. S., and A. R. Chapman. 2000. Human inheritable genetic modifications: Assessing scientific, ethical, religious, and policy issues. Washington, DC: American Association for the Advancement of Science. https://www.aaas.org/sites/default/files/migrate/uploads/germline.pdf (accessed January 6, 2017).

Franklin, S. 2013. Biological relatives: IVF, stem cells, and the future of kinship. http://www.oapen.org/download?type=document&docid=469257 (accessed January 4, 2017).

Friedmann, T. 1989. Progress toward human gene therapy. Science 244(4910):1275-1281.

Friedmann, T., P. Noguchi, and C. Mickelson. 2001. The evolution of public review and oversight mechanisms in human gene transfer research: Joint roles of the FDA and NIH. Current Opinion in Biotechnology 12(3):304-307.

Friedmann, T., E. C. Jonlin, N. M. P. King, B. E. Torbett, N. A. Wivel, Y. Kaneda, and M. Sadelain. 2015. ASGCT and JSGT joint position statement on human genomic editing. Molecular Therapy 23(8):1282.

Frum, T., and A. Ralston. 2015. Cell signaling and transcription factors regulating cell fate during formation of the mouse blastocyst. Trends in Genetics 31(7):402-410.

Fu, Q., M. Hajdinjak, O. T. Moldovan, S. Constantin, S. Mallick, P. Skoglund, N. Patterson, N. Rohland, I. Lazaridis, and B. Nickel. 2015. An early modern human from Romania with a recent Neanderthal ancestor. Nature 524(7564):216-219.

Gaj, T., S. J. Sirk, S.-L. Shui, and J. Liu. 2016. Genome-editing technologies: Principles and applications. Cold Spring Harbor Perspectives in Biology.

Suggested Citation:"References." National Academies of Sciences, Engineering, and Medicine. 2017. Human Genome Editing: Science, Ethics, and Governance. Washington, DC: The National Academies Press. doi: 10.17226/24623.
×

Gardner, R. L., and J. Rossant. 1979. Investigation of the fate of 4-5 day post-coitum mouse inner cell mass cells by blastocyst injection. Journal of Embryology & Experimental Morphology 52:141-152.

Genovese, P., G. Schiroli, G. Escobar, T. Di Tomaso, C. Firrito, A. Calabria, D. Moi, R. Mazzieri, C. Bonini, and M. C. Holmes. 2014. Targeted genome editing in human repopulating haematopoietic stem cells. Nature 510(7504):235-240.

George, B. 2011. Regulations and guidelines governing stem cell based products: Clinical considerations. Perspectives in Clinical Research 2(3):94-99.

Giurgea, C. E. 1981. Fundamentals to a pharmacology of the mind. American lecture series, publication no. 1041. Springfield, IL: Thomas.

Goffman, E. 1974. Frame analysis: An essay on the organization of experience. New York: Harper & Row.

Green, R. 1994. The ethics of embryo research. The Washington Post, October 18.

Hadden, S. G. 1995. Regulatory negotiation as citizen participation: A critique. In Fairness and competence in citizen participation, edited by O. Renn, T. Webler, and P. Wiedemann. Dordrecht, Netherlands: Springer Science. Pp. 239-252.

Halevy, T., J. C. Biancotti, O. Yanuka, T. Golan-Lev, and N. Benvenisty. 2016. Molecular characterization of down syndrome embryonic stem cells reveals a role for RUNX1 in neural differentiation. Stem Cell Reports 7(4):777-786.

Hamzelou, J. 2016. Exclusive: World’s first baby born with new “3 parent” technique. New Scientist, September 27. https://www.newscientist.com/article/2107219-exclusive-worlds-first-baby-born-with-new-3-parent-technique (accessed November 3, 2016).

Harris, J. 2007. Enhancing evolution: The ethical case for making people better. Princeton, NJ: Princeton University Press.

Hashimoto, M., Y. Yamashita, and T. Takemoto. 2016. Electroporation of Cas9 protein/sgRNA into early pronuclear zygotes generates non-mosaic mutants in the mouse. Developmental Biology 418(1):1-9.

Hayakawa, K., E. Himeno, S. Tanaka, and T. Kunath. 2014. Isolation and manipulation of mouse trophoblast stem cells. Current Protocols in Stem Cell Biology 1:1E.4.

Hayashi, K., S. Ogushi, K. Kurimoto, S. Shimamoto, H. Ohta, and M. Saitou. 2012. Offspring from oocytes derived from in vitro primordial germ cell-like cells in mice. Science 338(6109):971-975.

HDC (Halal Industry Development Corporation). 2016. How does Islam view genetic engineering? http://www.hdcglobal.com/publisher/pid/b368dc7b-039b-4335-9df3-8c015cbb33af/container/contentId/cc170e96-408d-485d-8ec3-f63644df412c (accessed November 3, 2016).

Health Canada. 2016. News release—government of Canada plans to introduce regulations to support the Assisted Human Reproduction Act. http://news.gc.ca/web/article-en.do?nid=1131339&tp=1 (accessed January 5, 2017).

Hennette-Vauchez, S. 2011. A human dignitas? Remnants of the ancient legal concept in contemporary dignity jurisprudence. International Journal of Constitutional Law 9(1):32-57.

Hermann, B. P., M. Sukhwani, F. Winkler, J. N. Pascarella, K. A. Peters, Y. Sheng, H. Valli, M. Rodriguez, M. Ezzelarab, G. Dargo, K. Peterson, K. Masterson, C. Ramsey, T. Ward, M. Lienesch, A. Volk, D. K. Cooper, A. W. Thomson, J. E. Kiss, M. C. Penedo, G. P. Schatten, S. Mitalipov, and K. E. Orwig. 2012. Spermatogonial stem cell transplantation into rhesus testes regenerates spermatogenesis producing functional sperm. Cell Stem Cell 11(5):715-726.

Hernandez, B., C. B. Keys, and F. E. Balcazar. 2004. Disability rights: Attitudes of private and public sector representatives. Journal of Rehabilitation 70(1):28-37.

Suggested Citation:"References." National Academies of Sciences, Engineering, and Medicine. 2017. Human Genome Editing: Science, Ethics, and Governance. Washington, DC: The National Academies Press. doi: 10.17226/24623.
×

HFEA (Human Fertilisation and Embryology Authority). 2014. Third scientific review of the safety and efficacy of methods to avoid mitochondrial disease through assisted conception: Update. http://www.hfea.gov.uk/docs/Third_Mitochondrial_replacement_scientific_review.pdf (accessed January 5, 2017).

HFEA. 2016a. Guidance: Mitochondrial donation. http://www.hfea.gov.uk/9931.html (accessed November 3, 2016).

HFEA. 2016b. U.K.’s independent expert panel recommends “cautious adoption” of mitochondrial donation in treatment. http://www.hfea.gov.uk/10559.html (January 4, 2017).

HHS (U.S. Department of Health and Human Services). 1979. The Belmont Report. https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report (January 5, 2017).

Hikabe, O., N. Hamazaki, G. Nagamatsu, Y. Obata, Y. Hirao, N. Hamada, S. Shimamoto, T. Imamura, K. Nakashima, and M. Saitou. 2016. Reconstitution in vitro of the entire cycle of the mouse female germ line. Nature 539:299-303.

Hinxton Group. 2015. Statement on genome editing technologies and human germline genetic modification. http://www.hinxtongroup.org/hinxton2015_statement.pdf (accessed July 21, 2016).

Hirsch, F., Y. Levy, and H. Chneiweiss. 2017. CRISPR-Cas9: A European position on genome editing. Nature 541(7635):30.

Hoban, M. D., S. H. Orkin, and D. E. Bauer. 2016. Genetic treatment of a molecular disorder: Gene therapy approaches to sickle cell disease. Blood 127(7):839-848.

Hockemeyer, D., and Jaenisch, R. 2016. Induced pluripotent stem cells meet genome editing. Cell Stem Cell 18(5):573-586.

Holdren, J. P., C. R. Sunstein, and I. A. Siddiqui. 2011. Memorandum: Principles for regulation and oversight of emerging technologies. https://www.whitehouse.gov/sites/default/files/omb/inforeg/for-agencies/Principles-for-Regulation-and-Oversight-of-Emerging-Technologies-new.pdf (accessed January 6, 2017).

Howden, S. E., B. McColl, A. Glaser, J. Vadolas, S. Petrou, M. H. Little, A. G. Elefanty, and E. G. Stanley. 2016. A Cas9 variant for efficient generation of indel-free knockin or gene-corrected human pluripotent stem cells. Stem Cell Reports 7(3):508-517.

Hsu, P. D., E. S. Lander, and F. Zhang. 2014. Development and applications of CRISPR-Cas9 for genome engineering. Cell 157(6):1262-1278.

Huang, K., T. Maruyama, and G. Fan. 2014. The naive state of human pluripotent stem cells: A synthesis of stem cell and preimplantation embryo transcriptome analyses. Cell Stem Cell 15(4):410-415.

Hubbard, N., D. Hagin, K. Sommer, Y. Song, I. Khan, C. Clough, H. D. Ochs, D. J. Rawlings, A. M. Scharenberg, and T. R. Torgerson. 2016. Targeted gene editing restores regulated CD40L function in X-linked hyper-IgM syndrome. Blood 127(21):2513-2522.

Hughes, J. 2004. Citizen cyborg: Why democratic societies must respond to the redesigned human of the future. Cambridge, MA: Westview Press.

ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use). 2006. General principles to address the risk of inadvertent germline integration of gene therapy vectors. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Consideration_documents/GTDG_Considerations_Documents/ICH_Considerations_General_Principles_Risk_of_IGI_GT_Vectors.pdf (accessed February 2, 2017).

Ichord, R. N. 2014. Adult stroke risk after growth hormone treatment in childhood. First do no harm. Neurology 83(9):776-777.

IGSR (Institute for Governmental Service and Research). 2016. About the IGSR and the 1000 Genomes Project. http://www.internationalgenome.org/about (accessed November 4, 2016).

Suggested Citation:"References." National Academies of Sciences, Engineering, and Medicine. 2017. Human Genome Editing: Science, Ethics, and Governance. Washington, DC: The National Academies Press. doi: 10.17226/24623.
×

ILAR (Institute for Animal Laboratory Research) Roundtable. 2015. Gene editing to modify animal genomes for research scientific and ethical considerations. Presented at National Academies of Sciences, Engineering, and Medicine, Washington, DC, December 7-8. http://nas-sites.org/ilar-roundtable/roundtable-activities/gene-editing-to-modify-animal-genomes-for-research (accessed October 21, 2016).

Inhorn, M. C. 2012. The new Arab man: Emergent masculinities, technologies, and Islam in the Middle East. Princeton, NJ: Princeton University Press.

IOM (Institute of Medicine). 2005. Guidelines for human embryonic stem cell research (Vol. 23). Washington, DC: The National Academies Press.

IOM. 2014. Oversight and review of clinical gene transfer protocols: Assessing the role of the Recombinant DNA Advisory Committee. Washington, DC: The National Academies Press.

Irie, N., L. Weinberger, W. W. Tang, T. Kobayashi, S. Viukov, Y. S. Manor, S. Dietmann, J. H. Hanna, and M. A. Surani. 2015. SOX17 is a critical specifier of human primordial germ cell fate. Cell 160(1-2):253-268.

Ishikura, Y., Y. Yabuta, H. Ohta, K. Hayashi, T. Nakamura, I. Okamoto, T. Yamamoto, K. Kurimoto, K. Shirane, H. Sasaki, M. Saitou. 2016. In vitro derivation and propagation of spermatogonial stem cell activity from mouse pluripotent stem cells. Cell Reports 17(10):2789-2804.

ISSCR (International Society for Stem Cell Research). 2015. Statement on human germline genome modification. http://www.isscr.org/home/about-us/news-press-releases/2015/2015/03/19/statement-on-human-germline-genome-modification (accessed June 15, 2016).

ISSCR. 2016a. Guidelines for stem cell research and clinical translation. http://www.isscr.org/docs/default-source/guidelines/isscr-guidelines-for-stem-cell-research-and-clinical-translation.pdf?sfvrsn=2 (accessed January 5, 2017).

ISSCR. 2016b. Updated guidelines for stem cell research and clinical translation. http://www.isscr.org/home/about-us/news-press-releases/2016/2016/05/12/isscr-releases-updated-guidelines-for-stem-cell-research-and-clinical-translation (accessed November 4, 2016).

Jasanoff, S., J. B. Hurlbut, and K. Saha. 2015. CRISPR democracy: Gene editing and the need for inclusive deliberation. Issues in Science and Technology 32(1):25-32.

Jasin, M. 1996. Genetic manipulation of genomes with rare-cutting endonucleases. Trends in Genetics 12(6):224-228.

Jinek, M., K. Chylinski, I. Fonfara, M. Hauer, J. A. Doudna, and E. Charpentier. 2012. A programmable dual-RNA-guided DNA endonuclease in adaptive bacterial immunity. Science 337(6096):816-821.

Jinek, M., A. East, A. Cheng, S. Lin, E. Ma, and J. Doudna. 2013. RNA-programmed genome editing in human cells. eLife 2:e00471.

Juengst, E. T. 1991. Germ-line gene therapy: Back to basics. Journal of Medicine and Philosophy 16(6):587-592.

Juengst, E. T. 1997. Can enhancement be distinguished from prevention in genetic medicine? Journal of Medicine and Philosophy 22(2):125-142.

Juma, C. 2016. Innovation and its enemies: Why people resist new technologies. New York: Oxford University Press.

Kahneman, D., and A. Tversky. 1984. Choices, values, and frames. American Psychologist 39(4):341-350.

Kajaste-Rudnitski, A., and L. Naldini. 2015. Cellular innate immunity and restriction of viral infection: Implications for lentiviral gene therapy in human hematopoietic cells. Human Gene Therapy 26(4):201-209.

Kasowski, M., F. Grubert, C. Heffelfinger, M. Hariharan, A. Asabere, S. M. Waszak, L. Habegger, J. Rozowsky, M. Shi, and A. E. Urban. 2010. Variation in transcription factor binding among humans. Science 328(5975):232-235.

Suggested Citation:"References." National Academies of Sciences, Engineering, and Medicine. 2017. Human Genome Editing: Science, Ethics, and Governance. Washington, DC: The National Academies Press. doi: 10.17226/24623.
×

Kemp, S. F., J. Kuntze, K. M. Attie, T. Maneatis, S. Butler, J. Frane, and B. Lippe. 2005. Efficacy and safety results of long-term growth hormone treatment of idiopathic short stature. Journal of Clinical Endocrinology & Metabolism 90(9):5247-5253.

Kessler, D. P. 2011. Evaluating the medical malpractice system and options for reform. The Journal of Economic Perspectives 25(2):93-110.

Kessler, D. A., J. P. Siegel, P. D. Noguchi, K. C. Zoon, K. L. Feiden, and J. Woodcock. 1993. Regulation of somatic-cell therapy and gene therapy by the Food and Drug Administration. New England Journal of Medicine 329(16):1169-1173.

Kevles, D. J. 1985. In the name of eugenics: Genetics and the uses of human heredity. Cambridge, MA: Harvard University Press.

Kitcher, P. 1997. The lives to come: The genetic revolution and human possibilities. New York: Simon & Shuster.

Kleinstiver, B.P., V. Pattanayak, M.S. Prew, S.Q. Tsai, N.T. Nguyen, Z. Zheng, and J.K. Joung. 2016. High-fidelity CRISPR–Cas9 nucleases with no detectable genome-wide off-target effects. Nature 529(7587):490-495.

Klitzman, R. 2016. Buying and selling human eggs: Infertility providers’ ethical and other concerns regarding egg donor agencies. BMC Medical Ethics 17(1):71.

KNAW (Koninklijke Nederlandse Academie van Wetenschappen). 2016. Genome Editing: Position Paper of the Royal Netherlands Academy of Arts and Science. https://www.knaw.nl/shared/resources/actueel/publicaties/pdf/genome-editing-position-paper-knaw-november-2016 (accessed May 9, 2017).

Kohn, D. B., M. H. Porteus, and A. M. Scharenberg. 2016. Ethical and regulatory aspects of genome editing. Blood 127(21):2553-2560.

Konermann, S., M. D. Brigham, A. E. Trevino, J. Joung, O. O. Abudayyeh, C. Barcena, P. D. Hsu, N. Habib, J. S. Gootenberg, H. Nishimasu, O. Nureki, and F. Zhang. 2015. Genome-scale transcriptional activation by an engineered CRISPR-Cas9 complex. Nature 517:583-588.

Krukenberg, R. C., D. L. Koller, D. D. Weaver, J. N. Dickerson, and K. A. Quaid. 2013. Two decades of Huntington disease testing: Patient’s demographics and reproductive choices. Journal of Genetic Counseling 22(5):643-653.

Kuhlmann, I., A. M. Minihane, P. Huebbe, A. Nebel, and G. Rimbach. 2010. Apolipoprotein E genotype and hepatitis C, HIV and herpes simplex disease risk: A literature review. Lipids in Health and Disease 9:8.

Lanphier, E., F. Urnov, S. E. Haecker, M. Werner, and J. Smolenski. 2015. Don’t edit the human germ line. Nature 519(7544):410-411.

Lazaraviciute, G., M. Kauser, S. Bhattacharya, P. Haggarty, and S. Bhattacharya. 2014. A systematic review and meta-analysis of DNA methylation levels and imprinting disorders in children conceived by IVF/ICSI compared with children conceived spontaneously. Human Reproduction Update 20(6):840-852.

Ledford, H. 2015. Biohackers gear up for genome editing. Nature 524(7566):398-399.

Leshner, A. I. 2003. Public engagement with science. Science 299(5609):977. http://www.sciencemag.org/content/299/5609/977.short (accessed January 6, 2017).

Lindgren, A. C., and E. M. Ritzen. 1999. Five years of growth hormone treatment in children with Prader-Willi syndrome. Swedish National Growth Hormone Advisory Group. Acta Paediatrica Supplement 88(433):109-111.

Liu, H., D. M. Bravata, I. Olkin, S. Nayak, B. Roberts, A. M. Garber, and A. R. Hoffman. 2007. Systematic review: The safety and efficacy of growth hormone in the healthy elderly. Annals of Internal Medicine 146(2):104-115.

Liu, H., D. M. Bravata, I. Olkin, A. Friedlander, V. Liu, B. Roberts, E. Bendavid, O. Saynina, S. R. Salpeter, and A. M. Garber. 2008. Systematic review: The effects of growth hormone on athletic performance. Annals of Internal Medicine 148(10):747-758.

Suggested Citation:"References." National Academies of Sciences, Engineering, and Medicine. 2017. Human Genome Editing: Science, Ethics, and Governance. Washington, DC: The National Academies Press. doi: 10.17226/24623.
×

Lomax, G. P., and A. O. Trounson. 2013. Correcting misperceptions about cryopreserved embryos and stem cell research. Nature Biotechnology 31(4):288-290.

Lombardo, P. A. 2008. Three generations, no imbeciles: Eugenics, the Supreme Court, and Buck v. Bell. Baltimore, MD: Johns Hopkins University Press.

Long, C., J. R. McAnally, J. M. Shelton, A. A. Mireault, R. Bassel-Duby, and E. N. Olson. 2014. Prevention of muscular dystrophy in mice by CRISPR/Cas9-mediated editing of germline DNA. Science 345(6201):1184-1188.

Long, C., L. Amoasii, A. A. Mireault, J. R. McAnally, H. Li, E. Sanchez-Ortiz, S. Bhattacharyya, J. M. Shelton, R. Bassel-Duby, and E. N. Olson. 2016. Postnatal genome editing partially restores dystrophin expression in a mouse model of muscular dystrophy. Science 351(6271):400-403.

Longmore, P. K. 1995. Medical decision making and people with disabilities: A clash of cultures. Journal of Law, Medicine & Ethics 23(1):82-87.

Lu, Y.-H., N. Wang, and F. Jin. 2013. Long-term follow-up of children conceived through assisted reproductive technology. Journal of Zhejiang University. Science B 14(5):359-371.

Lyon, J. 2017. Sanctioned U.K. trial of mitochondrial transfer nears. Journal of the American Medical Association. http://jamanetwork.com/journals/jama/fullarticle/2599746 (accessed February 3, 2017).

Macer, D. R., S. Akiyama, A. T. Alora, Y. Asada, J. Azariah, H. Azariah, M. V. Boost, P. Chatwachirawong, Y. Kato, V. Kaushik, F. J. Leavitt, N. Y. Macer, C. C. Ong, P. Srinives, and M. Tsuzuki. 1995. International perceptions and approval of gene therapy. Human Gene Therapy 6(6):791-803.

Machalek, A. Z. 2009. Comparing genomes to find what makes us human. https://publications.nigms.nih.gov/computinglife/compare_genome.htm (accessed November 3, 2016).

Maiorana, A., and S. Cianfarani. 2009. Impact of growth hormone therapy on adult height of children born small for gestational age. Pediatrics 124(3):e519-e531.

Mak, T. W. 2007. Gene targeting in embryonic stem cells scores a knockout in Stockholm. Cell 131(6):1027-1031.

Makas, E. 1988. Positive attitudes toward disabled people: Disabled and nondisabled persons’ perspectives. Journal of Social Issues 44(1):49-61.

Malek, J., and Daar, J. 2012. The case for a parental duty to use preimplantation genetic diagnosis for medical benefit. American Journal of Bioethics 12(4):3-11.

Mali, P., L. Yang, K. M. Esvelt, J. Aach, M. Guell, J. E. DiCarlo, J. E. Norville, and G. M. Church. 2013. RNA-guided human genome engineering via Cas9. Science 339(6121): 823-826.

Malkki, H. 2016. Huntington disease: Selective deactivation of Huntington disease mutant allele by CRISPR-Cas9 gene editing. Nature Reviews Neurology 12(11):614-615.

Maresca, M., V. G. Lin, N. Guo, and Y. Yi Yang. 2013. Obligate Ligation-Gated Recombination (ObLiGaRe): Custom-designed nuclease-mediated targeted integration through nonhomologous end joining. Genome Research 23(3):539-546.

Margottini, L. 2014. Final chapter in Italian stem cell controversy? Science, October 7.

Maxmen, A. 2015. Easy DNA editing will remake the world. Buckle up. Wired, July.

McClain, L. E., and A. W. Flake. 2016. In utero stem cell transplantation and gene therapy: Recent progress and the potential for clinical application. Best Practice & Research Clinical Obstetrics & Gynaecology 31:88-98.

Meilaender, G. 1997. Begetting and cloning. First Things (New York, NY) 74:41-43.

Meilaender, G. 2008. Human dignity: Exploring and explicating the council’s vision. https://bioethicsarchive.georgetown.edu/pcbe/reports/human_dignity/chapter11.html (accessed January 6, 2017).

Mello, M. M. 2001. Of swords and shields: The role of clinical practice guidelines in medical malpractice litigation. University of Pennsylvania Law Review 149(3):645-710.

Suggested Citation:"References." National Academies of Sciences, Engineering, and Medicine. 2017. Human Genome Editing: Science, Ethics, and Governance. Washington, DC: The National Academies Press. doi: 10.17226/24623.
×

Merkle, D. M. 1996. The polls—review—the National Issues Convention deliberative poll. Public Opinion Quarterly 60(4):588-619.

Molitch, M. E., D. R. Clemmons, S. Malozowski, G. R. Merriam, and M. L. Vance. 2011. Evaluation and treatment of adult growth hormone deficiency: An Endocrine Society clinical practice guideline. The Journal of Clinical Endocrinology & Metabolism 96(6):1587-1609.

Mullin, E. 2016. Despite the hype over gene therapy, few drugs are close to approval. MIT Technology Review, September 29. https://www.technologyreview.com/s/602467/despite-the-hype-over-gene-therapy-few-drugs-are-close-to-approval (accessed January 22, 2017).

Murray, M., and K. Luker. 2015. Cases on reproductive rights and justice. St. Paul, MN: West Academic Publishing.

Naldini L. 2015. Gene therapy returns to centre stage. Nature 526(7573):351-360.

NASEM (National Academies of Sciences, Engineering, and Medicine). 2016a. Communicating science effectively: A research agenda. Washington, DC: The National Academies Press.

NASEM. 2016b. Gene drives on the horizon: Advancing science, navigating uncertainty, and aligning research with public values. Washington, DC: The National Academies Press.

NASEM. 2016c. Genetically engineered crops: Experiences and prospects. Washington, DC: The National Academies Press.

NASEM. 2016d. International summit on human gene editing: A global discussion. Washington, DC: The National Academies Press.

NASEM. 2016e. Mitochondrial replacement techniques: Ethical, social, and policy considerations. Washington, DC: The National Academies Press.

NASEM. 2017. Future biotechnology products and opportunities to enhance capabilities of the biotechnology regulatory system. http://nas-sites.org/biotech (accessed October 21, 2016).

National Academy of Sciences Leopoldina, Deutsche Akademie der Technikwissenshaften (National Academy of Science and Engineering: “acatech”), Deutsche Forschungsgemeinschaft (German Research Foundation: DFG), and Union der deutschen Akademien der Wissenschaften (Union of German Academies of Sciences and Humanities: Academien Union). 2015. The opportunities and limits of genome editing. http://www.leopoldina.org/nc/en/publications/detailview/?publication%5bpublication%5d=699&cHash=4d49c84a36e655feacc1be6ce7f98626 (accessed January 6, 2017).

Nature. 2017. Why researchers should resolve to engage in 2017. Nature 541(5). http://www.nature.com/news/why-researchers-should-resolve-to-engage-in-2017-1.21236?WT.mc_id=FBK_NatureNews (accessed January 12, 2017).

NCECHLS (National Consultative Ethics Committee for Health and Life Sciences). 2013. Opinion no. 122: The use of biomedical techniques for “neuroenhancement” in healthy individuals: Ethical issues. http://www.ccne-ethique.fr/sites/default/files/publications/ccne.avis_ndeg122eng.pdf (accessed January 5, 2017).

NCSL (National Conference of State Legislatures). 2016. Embryonic and fetal research laws, January 1, 2016. http://www.ncsl.org/research/health/embryonic-and-fetal-research-laws.aspx (accessed October 31, 2016).

Nelson, C. E., C. H. Hakim, D. G. Ousterout, P. I. Thakore, E. A. Moreb, R. M. C. Rivera, S. Madhavan, X. Pan, F. A. Ran, and W. X. Yan. 2016. In vivo genome editing improves muscle function in a mouse model of Duchenne muscular dystrophy. Science 351(6271):403-407.

Nelson, E. 2013. Law, policy and reproductive autonomy. Portland, OR: Hart Publishing.

NIH (National Institutes of Health). 1994. Report of the Human Embryo Research Panel. https://repository.library.georgetown.edu/bitstream/handle/10822/559352/human_embryo_vol_1.pdf?sequence=1&isAllowed=y (accessed January 5, 2017).

Suggested Citation:"References." National Academies of Sciences, Engineering, and Medicine. 2017. Human Genome Editing: Science, Ethics, and Governance. Washington, DC: The National Academies Press. doi: 10.17226/24623.
×

NIH. 2004. NIH and FDA launch new human gene transfer research data system. Journal of Investigative Medicine 52(5):286. http://jim.bmj.com/content/jim/52/5/286.1.full.pdf (accessed November 4, 2016).

NIH. 2011. Charter: Recombinant DNA Advisory Committee. Bethesda, MD: NIH. http://oba.od.nih.gov/oba/RAC/Signed_RAC_Charter_2011.pdf (accessed October 1, 2013).

NIH. 2013a. Frequently asked questions about the NIH review process for human gene transfer trials. Bethesda, MD: NIH. http://oba.od.nih.gov/oba/ibc/FAQs/NIH_Review_Process_HGT.pdf (accessed September 1, 2013).

NIH. 2013b. Frequently asked questions of interest to IBCs. Bethesda, MD: NIH. http://oba.od.nih.gov/oba/ibc/FAQs/IBC_Frequently_Asked_Questions7.24.09.pdf (accessed October 1, 2013).

NIH. 2013c. NIH guidelines for research involving recombinant or synthetic nucleic acid molecules. Bethesda, MD: NIH.

NIH. 2015a. NIH research involving introduction of human pluripotent cells into non-human vertebrate animal pre-gastrulation embryos. NOT-OD-15-158. https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-158.html (accessed January 5, 2017).

NIH. 2015b. Statement on NIH funding of research using gene-editing technologies in human embryos. https://www.nih.gov/about-nih/who-we-are/nih-director/statements/statement-nih-funding-research-using-gene-editing-technologies-human-embryos (accessed January 5, 2017).

NIH. 2016a. NIH guidelines for research involving recombinant or synthetic nucleic acid molecules. Washington, DC: HHS.

NIH. 2016b. Request for public comment on the proposed changes to the NIH guidelines for human stem cell research and the proposed scope of an NIH steering committee’s consideration of certain human-animal chimera research. https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-128.html (accessed November 4, 2016).

NIH. 2016c. State initiatives for stem cell research. https://stemcells.nih.gov/research/stateresearch.htm (accessed October 25, 2016).

NRC (National Research Council). 1996. Understanding risk: Informing decisions in a democratic society. Edited by P. C. Stern and H. V. Fineberg. Washington, DC: National Academy Press.

NRC. 2002. Scientific and medical aspects of human reproductive cloning. Washington, DC: The National Academies Press.

NRC. 2008. Public participation in environmental assessment and decision making. Washington, DC: The National Academies Press.

NRC. 2010. Final report of the National Academies’ Human Embryonic Stem Cell Research Advisory Committee and 2010 amendments to the National Academies’ guidelines for human embryonic stem cell research. Washington, DC: The National Academies Press.

NRC and IOM. 2007. 2007 amendments to the National Academies’ guidelines for human embryonic stem cell research. Washington, DC: The National Academies Press.

NRC and IOM. 2008. 2008 amendments to the National Academies’ guidelines for human embryonic stem cell research. Washington, DC: The National Academies Press.

NRC and IOM. 2010. Final report of the National Academies’ Human Embryonic Stem Cell Research Advisory Committee and 2010 amendments to the National Academies’ guidelines for human embryonic stem cell research. Washington, DC: The National Academies Press.

NSF (National Science Foundation). 2010. Ethics of human enhancement: 25 questions & answers. Studies in Ethics, Law, and Technology 4(1):1-49.

Nuffield Council. 2015. Naturalness. http://nuffieldbioethics.org/project/naturalness (accessed November 3, 2016).

Suggested Citation:"References." National Academies of Sciences, Engineering, and Medicine. 2017. Human Genome Editing: Science, Ethics, and Governance. Washington, DC: The National Academies Press. doi: 10.17226/24623.
×

Nuffield Council. 2016a. Genome editing: An ethical review. http://nuffieldbioethics.org/project/genome-editing/ethical-review-published-september-2016 (accessed January 6, 2017).

Nuffield Council. 2016b. Public dialogue on genome editing: Why? When? Who? http://nuffieldbioethics.org/wp-content/uploads/Public-Dialogue-on-Genome-Editing-workshop-report.pdf (accessed January 6, 2017).

OBA (Office of Biotechnology Activities). 2013. Office of Biotechnology Activities welcome page. http://oba.od.nih.gov (accessed September 1, 2013).

O’Connor, K. 2012. Ethics of fetal surgery. In The Embryo Project Encyclopedia. Tempe: The Embryo Project at Arizona State University.

Oktay, K., V. Turan, S. Titus, R. Stobezki, and L. Liu. 2015. BRCA mutations, DNA repair deficiency, and ovarian aging. Biology of Reproduction 93(3):67.

O’Reilly, M., A. Shipp, E. Rosenthal, R. Jambou, T. Shih, M. Montgomery, L. Gargiulo, A. Patterson, and J. Corrigan-Curay. 2012. NIH oversight of human gene transfer research involving retroviral, lentiviral, and adeno-associated virus vectors and the role of the NIH Recombinant DNA Advisory Committee. In Gene Transfer Vectors for Clinical Application, Vol. 507, edited by F. Theodore. Bethesda, MD: Academic Press. Pp. 313-335.

Orr-Weaver, T. L., J. W. Szostak, and R. J. Rothstein. 1981. Yeast transformation: A model system for the study of recombination. Proceedings of the National Academy of Sciences of the United States of America 78(10):6354-6358.

Parens, E. 1995. Should we hold the (germ) line? The Journal of Law, Medicine & Ethics 23(2):173-176.

Parens, E. 1998. Enhancing human traits: Ethical and social implications. Washington, DC: Georgetown University Press.

Parens, E., and A. Asch. 2000. Prenatal testing and disability rights. Washington, DC: Georgetown University Press.

Pera, M. F. 2014. In search of naivety. Cell Stem Cell 15(5):543-545.

Perls, T., and D. J. Handelsman. 2015. Disease mongering of age-associated declines in testosterone and growth hormone levels. Journal of the American Geriatrics Society 63(4):809-811.

Persson, I., and J. Savulescu. 2012. Unfit for the future: The need for moral enhancement. Oxford, U.K.: Oxford University Press.

Petropoulos, S., D. Edsgard, B. Reinius, Q. Deng, S. P. Panula, S. Codeluppi, A. Plaza Reyes, S. Linnarsson, R. Sandberg, and F. Lanner. 2016. Single-cell RNA-seq reveals lineage and X chromosome dynamics in human preimplantation embryos. Cell 165(4):1012-1026.

Pew Research Center. 2008. Stem cell research at the crossroads of religion and politics. Pew Forum on Religion & Public Life, July 17. http://www.pewforum.org/2008/07/17/stem-cell-research-at-the-crossroads-of-religion-and-politics (accessed July 17, 2008).

Pew Research Center. 2016. U.S. public wary of biomedical technologies to enhance human abilities. http://www.pewinternet.org/2016/07/26/u-s-public-wary-of-biomedical-technologies-to-enhance-human-abilities (accessed January 5, 2015).

Pfleiderer, G., G. Brahier, and K. Lindpaintner. 2010. GenEthics and religion. Basel, Switzerland: Karger Medical and Scientific Publishers.

Plotz, D. 2006. The genius factory: The curious history of the Nobel Prize sperm bank. New York: Random House, Inc.

Poirot, L., B. Philip, C. Schiffer-Mannioui, D. Le Clerre, I. Chion-Sotinel, S. Derniame, P. Potrel, C. Bas, L. Lemaire, and R. Galetto. 2015. Multiplex genome-edited t-cell manufacturing platform for “off-the-shelf” adoptive t-cell immunotherapies. Cancer Research 75(18):3853-3864.

Suggested Citation:"References." National Academies of Sciences, Engineering, and Medicine. 2017. Human Genome Editing: Science, Ethics, and Governance. Washington, DC: The National Academies Press. doi: 10.17226/24623.
×

Pollard, K. S. 2016. Decoding human accelerated regions. The Scientist, August 1. http://www.the-scientist.com/?articles.view/articleNo/46643/title/Decoding-Human-Accelerated-Regions (accessed November 3, 2016).

Poolman, E. M., and A. P. Galvani. 2007. Evaluating candidate agents of selective pressure for cystic fibrosis. Journal of the Royal Society, Interface 4(12):91-98.

Porteus, M. 2016. Genome editing: A new approach to human therapeutics. Annual Review of Pharmacology and Toxicology 56:163-190.

Posner, S. M., E. McKenzie, and T. H. Ricketts. 2016. Policy impacts of ecosystem services knowledge. Proceedings of the National Academy of Sciences of the United States of America 113(7):1760-1765.

Powledge, T. M., and L. Dach, eds. 1977. Biomedical research and the public: Report to the Subcommittee on Health and Scientific Research, Committee on Human Resources, U.S. Senate. Washington, DC: U.S. Government Printing Office.

Präg, P., and M. C. Mills. 2015. Assisted reproductive technology in Europe. Usage and regulation in the context of cross-border reproductive care. Families and Societies 43(1-23). http://www.familiesandsocieties.eu/wp-content/uploads/2015/09/WP43PragMills2015.pdf (accessed January 6, 2017).

President’s Commission. 1982. Splicing life: A report on the social and ethical issues of genetic engineering with human beings. Washington, DC: President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. https://bioethics.georgetown.edu/documents/pcemr/splicinglife.pdf (accessed January 6, 2017).

President’s Commission. 1983. Deciding to forego life-sustaining treatment: A report on the ethical, medical and legal issues in treatment decisions. Washington, DC: U.S. Government Printing Office.

President’s Council on Bioethics. 2002. Human Genetic Enhancement. Staff background paper. https://bioethicsarchive.georgetown.edu/pcbe/background/humangenetic.html (accessed May 9, 2015).

President’s Council on Bioethics. 2003. Beyond therapy. Washington, DC: President’s Council on Bioethics.

Qasim, W., H. Zhan, S. Samarasinghe, S. Adams, P. Amrolia, S. Stafford, K. Butler, C. Rivat, G. Wright, and K. Somana. 2017. Molecular remission of infant B-ALL after infusion of universal TALEN gene-edited CAR T cells. Science Translational Medicine 9(374):eaaj2013.

Qi, L. S., M. H. Larson, L. A. Gilbert, J. A. Doudna, J. S. Weissman, A. P. Arkin, and W. A. Lim. 2013. Repurposing CRISPR as an RNA-guided platform for sequence-specific control of gene expression. Cell 152(5):1173-1183.

Qiao, J., and H. L. Feng. 2014. Assisted reproductive technology in China: Compliance and non-compliance. Translational Pediatrics 3(2):91.

Quinn, G. P., S. T. Vadaparampil, S. Tollin, C. A. Miree, D. Murphy, B. Bower, and C. Silva. 2010. BRCA carriers’ thoughts on risk management in relation to preimplantation genetic diagnosis and childbearing: When too many choices are just as difficult as none. Fertility and Sterility 94(6):2473-2475.

Rainsbury, J. 2000. Biotechnology on the RAC-FDA/NIH regulation of human gene therapy. Food and Drug Law Journal 55:575-600.

Ramsey, P. 1970. Fabricated man: The ethics of genetic control, Vol. 6. New Haven, CT: Yale University Press.

Rawls, J. 1999. A Theory of Justice, 2nd ed. Cambridge, MA: Belknap Press.

Reardon, S. 2016. First CRISPR clinical trial gets green light from U.S. panel. Nature News, June 22. http://www.nature.com/news/first-crispr-clinical-trial-gets-green-light-from-u-spanel-1.20137 (accessed June 22, 2016).

Suggested Citation:"References." National Academies of Sciences, Engineering, and Medicine. 2017. Human Genome Editing: Science, Ethics, and Governance. Washington, DC: The National Academies Press. doi: 10.17226/24623.
×

Reeves, R. 2016. Second gene therapy wins approval in Europe. BioNews, Issue 854. http://www.bionews.org.uk/page_656625.asp (accessed February 2, 2017).

Rine, J., and A. P. Fagen. 2015. The state of federal research funding in genetics as reflected by members of the Genetics Society of America. Genetics 200(4):1015-1019.

Robertson, J. A. 2004. Procreative liberty and harm to offspring in assisted reproduction. American Journal of Law & Medicine 30(1):7-40.

Robertson, J. A. 2008. Assisting reproduction, choosing genes, and the scope of reproductive freedom. George Washington Law Review 76(6):1490-1513.

Robillard, J. M., D. Roskams-Edris, B. Kuzeljevic, and J. Illes. 2014. Prevailing public perceptions of the ethics of gene therapy. Human Gene Therapy 25(8):740-746.

Rosen, L. 2014. What Mars One needs is genetically altered human colonists. h+ Magazine, April 14. http://hplusmagazine.com/2014/04/14/what-mars-one-needs-is-genetically-altered-human-colonists (accessed January 4, 2017).

Rossant, J. 2015. Mouse and human blastocyst-derived stem cells: Vive les differences. Development 142(1):9-12.

Rossetti, M., M. Cavarelli, S. Gregori, and G. Scarlatti. 2012. HIV-derived vectors for gene therapy targeting dendritic cells. In HIV interactions with dendritic cells. New York: Springer. Pp. 239-261.

Roux, P., F. Smih, and M. Jasin. 1994a. Expression of a site-specific endonuclease stimulates homologous recombination in mammalian cells. Proceedings of the National Academy of Sciences of the United States of America 91(13):6064-6068.

Roux, P., F. Smih, and M. Jasin. 1994b. Introduction of double-strand breaks into the genome of mouse cells by expression of a rare-cutting endonuclease. Molecular and Cellular Biology 14(12):8096-8106.

Rowe, G., and L. J. Frewer. 2005. A typology of public engagement mechanisms. Science Technology & Human Values 30(2):251-290.

Rulli, T. 2014. Preferring a genetically-related child. Journal of Moral Philosophy 13(6): 669-698.

Saitou, M., and H. Miyauchi. 2016. Gametogenesis from pluripotent stem cells. Cell Stem Cell 18(6):721-735.

Sandel, M. 2004. The case against perfection. The Atlantic Monthly 293(3):51-62.

Sandel, M. 2013. The case against perfection. In Society, ethics, and technology, 5th ed., edited by M. Winston and R. Edelbach. Boston, MA: Wadsworth, Cengage Learning. Pp. 343-354.

Sander, J. D., and J. K. Joung. 2014. CRISPR-Cas systems for editing, regulating and targeting genomes. Nature Biotechnology 32(4):347-350.

Sarewitz, D. 2015. Science can’t solve it. Nature 522(7557):413-414.

Sasaki, K., S. Yokobayashi, T. Nakamura, I. Okamoto, Y. Yabuta, K. Kurimoto, H. Ohta, Y. Moritoki, C. Iwatani, H. Tsuchiya, S. Nakamura, K. Sekiguchi, T. Sakuma, T. Mori, K. Woltjen, M. Nakagawa, T. Yamamoto, K. Takahashi, S. Yamanaka, and M. Saitou. 2015. Robust in vitro induction of human germ cell fate from pluripotent stem cells. Cell Stem Cell 17(2):178-194.

Saxton, M. 2000. Why members of the disability community oppose prenatal diagnosis and selective abortion. In Prenatal testing and disability rights, edited by E. Parenz and A. Ash. Washington, DC: Georgetown University Press. Pp. 147-165.

Sayres, L. C., and D. Magnus. 2012. Duty-free: The non-obligatory nature of preimplantation genetic diagnosis. American Journal of Bioethics 12(4):1-2.

Scharschmidt, T., and B. Lo. 2006. Clinical trial design issues raised during Recombinant DNA Advisory Committee review of gene transfer protocols. Human Gene Therapy 17(4):448-454.

Suggested Citation:"References." National Academies of Sciences, Engineering, and Medicine. 2017. Human Genome Editing: Science, Ethics, and Governance. Washington, DC: The National Academies Press. doi: 10.17226/24623.
×

Scheufele, D. A. 2010. Survey research. In Encyclopedia of science and technology communication, Vol. 2, edited by S. H. Priest. Thousand Oaks, CA: SAGE Publications. Pp. 853-856.

Scheufele, D. A. 2011. Modern citizenship or policy dead end? Evaluating the need for public participation in science policy making, and why public meetings may not be the answer. Joan Shorenstein Center on the Press, Politics and Public Policy Research Paper Series (#R-43). http://shorensteincenter.org/wp-content/uploads/2012/03/r34_scheufele.pdf (accessed January 6, 2017).

Scheufele, D. A. 2013. Communicating science in social settings. Proceedings of the National Academy of Sciences of the United States of America 110(Suppl. 3):14040-14047.

Schomberg, R. 2012. Prospects for technology assessment in a framework of responsible research and innovation. In Technikfolgen abschätzen lehren: Bildungspotenziale transdisziplinärer methoden, edited by M. Dusseldorp and R. Beecroft. Wiesbaden: VS Verlag für Sozialwissenschaften. Pp. 39-61.

Sciencewise. 2016. Sciencewise—the U.K.’s national centre for public dialogue in policy making involving science and technology issues. http://www.sciencewise-erc.org.uk/cms (accessed October 19, 2016).

Scully, J. L. 2009. Towards a bioethics of disability and impairment. In The handbook of genetics and society: Mapping the new genomic era, edited by P. Atkinson, P. Glasner, and M. Lock. London, U.K.: Routledge. Pp. 367-381.

Seifter, M. 2014a. States, agencies, and legitimacy. Vanderbilt Law Review 67(2):443-504.

Seifter, M. 2014b. States as interest groups in the administrative process. Virginia Law Review 100:953-1025.

Seifter, M. 2015. Second-order participation in administrative law. UCLA Law Review 1301-1363. http://www.uclalawreview.org/second-order-participation-in-administrative-law (accessed January 4, 2017).

Shahbazi, M. N., A. Jedrusik, S. Vuoristo, G. Recher, A. Hupalowska, V. Bolton, N. M. Fogarty, A. Campbell, L. G. Devito, and D. Ilic. 2016. Self-organization of the human embryo in the absence of maternal tissues. Nature Cell Biology 18(6):700-708.

Shalala, D. 2000. Protecting research aubjects—what must be done. New England Journal of Medicine 343(11):808-810.

Sharma, R., X. M. Anguela, Y. Doyon, T. Wechsler, R. C. DeKelver, S. Sproul, D. E. Paschon, J. C. Miller, R. J. Davidson, and D. Shivak. 2015. In vivo genome editing of the albumin locus as a platform for protein replacement therapy. Blood 126(15):1777-1784.

Shelton, A. M., and R. T. Roush. 1999. False reports and the ears of men. Nature Biotechnology 17(9):832.

Shetty, G., R. K. Uthamanthil, W. Zhou, S. H. Shao, C. C. Weng, R. C. Tailor, B. P. Hermann, K. E. Orwig, and M. L. Meistrich. 2013. Hormone suppression with GnRH antagonist promotes spermatogenic recovery from transplanted spermatogonial stem cells in irradiated cynomolgus monkeys. Andrology 1(6):886-898.

Sinsheimer, R. L. 1969. The prospect for designed genetic change. American Scientist 57(1):134-142.

Skerrett, P. 2015. A debate: Should we edit the human germline? STAT, November 30. https://www.statnews.com/2015/11/30/gene-editing-crispr-germline (accessed January 5, 2017).

Slaymaker, I. M., L. Gao, B. Zetsche, D. A. Scott, X. Winston, W. X. Yan, and F. Zhang. 2016. Rationally engineered Cas9 nucleases with improved specificity. Science 351(6268):84-88.

Specter, M. 2015. The gene hackers. The New Yorker, November 16.

Steinbach, R. J., M. Allyse, M. Michie, E. Y. Liu, and M. K. Cho. 2016. “This lifetime commitment”: Public conceptions of disability and noninvasive prenatal genetic screening. American Journal of Medical Genetics 170(2):363-374.

Suggested Citation:"References." National Academies of Sciences, Engineering, and Medicine. 2017. Human Genome Editing: Science, Ethics, and Governance. Washington, DC: The National Academies Press. doi: 10.17226/24623.
×

Steinberg, A. 2006. Introduction, Ch. 3. In Halakhic-Medical Encyclopedia (Hebrew), 2nd ed., Vol. 1. Pp. 158-163.

Steinbrook, R. 2002. Improving protection for research subjects. New England Journal of Medicine 346(18):1425-1430.

Steinbrook, R. 2004. Science, politics, and federal advisory committees. New England Journal of Medicine 350(14):1454-1460.

Suh, Y., G. Atzmon, M.-O. Cho, D. Hwang, B. Liu, D. J. Leahy, N. Barzilai, and P. Cohen. 2008. Functionally significant insulin-like growth factor I receptor mutations in centenarians. Proceedings of the National Academy of Sciences of the United States of America 105(9):3438-3442.

Sulmasy, D. P. 2008. Dignity and bioethics: History, theory, and selected applications. Essays commissioned by the President’s Council on Bioethics. https://bioethicsarchive.georgetown.edu/pcbe/reports/human_dignity/chapter18.html (accessed January 6, 2017).

Suzuki, K., Y. Tsunekawa, R. Hernandez-Benitez, J. Wu, J. Zhu, E. J. Kim, F. Hatanaka, M. Yamamoto, T. Araoka, Z. Li, M. Kurita, T Hishida, M. Li, E. Aizawa, S. Guo, S. Chen, A. Goebl, R. D. Soligalla, J. Qu, T. Jiang, X. Fu, M. Jafari, C. R. Esteban, W. T. Berggren, J. Lajara, E. Nuñez-Delicado, P. Guillen, J. M. Campistol, F. Matsuzaki, G. H. Liu, P. Magistretti, K. Zhang, E. M. Callaway, K. Zhang, and J. C. Belmonte. 2016. In vivo genome editing via CRISPR/Cas9 mediated homology-independent targeted integration. Nature 540:144-149.

Tabebordbar, M., K. Zhu, J. K. Cheng, W. L. Chew, J. J. Widrick, W. X. Yan, C. Maesner, E. Y. Wu, R. Xiao, and F. A. Ran. 2016. In vivo gene editing in dystrophic mouse muscle and muscle stem cells. Science 351(6271):407-411.

Takahashi, K., and S. Yamanaka. 2006. Induction of pluripotent stem cells from mouse embryonic and adult fibroblast cultures by defined factors. Cell 126(4):663-676.

Takahashi, K., K. Tanabe, M. Ohnuki, M. Narita, T. Ichisaka, K. Tomoda, and S. Yamanaka. 2007. Induction of pluripotent stem cells from adult human fibroblasts by defined factors. Cell 131(5):861-872.

Takefman, D. 2013. The FDA review process. Presentation at the first meeting on independent review and assessment of the activities of the NIH Recombinant DNA Advisory Committee, Washington, DC, June 4. https://www.nationalacademies.org/hmd/Activities/Research/ReviewNIHRAC/2013-JUN-04.aspx (accessed November 4, 2016).

Takefman, D., and W. Bryan. 2012. The state of gene therapies: The FDA perspective. Molecular Therapy 20(5):877-878.

Taylor, T. H., S. A. Gitlin, J. L. Patrick, J. L. Crain, J. M. Wilson, and D. K. Griffin. 2014. The origin, mechanisms, incidence and clinical consequences of chromosomal mosaicism in humans. Human Reproduction Update 20(4):571-581.

Tebas, P., D. Stein, W. W. Tang, I. Frank, S. Q. Wang, G. Lee, S. K. Spratt, R. T. Surosky, M. A. Giedlin, and G. Nichol. 2014. Gene editing of CCR5 in autologous CD4 T cells of persons infected with HIV. New England Journal of Medicine 370(10):901-910.

The 1000 Genomes Project Consortium. 2015. A global reference for human genetic variation. Nature 526(7571):68-74.

The Washington Post. 1994. Embryos: Drawing the line. The Washington Post, October 2.

Turner, L., and P. Knoepfler. 2016. Selling stem cells in the USA: Assessing the direct-to-consumer industry. Cell Stem Cell 19(2):154-157.

U.K. House of Lords. 2000. Select committee on science and technology—third report. http://www.publications.parliament.uk/pa/ld199900/ldselect/ldsctech/38/3801.htm (accessed December 14).

UN (United Nations). 1948. Universal Declaration of Human Rights. http://www.un.org/en/universal-declaration-human-rights/index.html (accessed January 5, 2017).

Suggested Citation:"References." National Academies of Sciences, Engineering, and Medicine. 2017. Human Genome Editing: Science, Ethics, and Governance. Washington, DC: The National Academies Press. doi: 10.17226/24623.
×

UN. 2006. Convention on the Rights of Persons with Disabilities (CRPD). https://www.un.org/development/desa/disabilities/convention-on-the-rights-of-persons-with-disabilities.html (accessed January 5, 2017).

UNESCO (UN Educational, Scientific and Cultural Organization). 2004a. International declaration on human genetic data. European Journal of Health Law 11:93-107.

UNESCO. 2004b. National legislation concerning human reproductive and therapeutic cloning. http://unesdoc.unesco.org/images/0013/001342/134277e.pdf (accessed January 5, 2017).

UNESCO. 2005. Universal declaration on bioethics and human rights. Paris, France: UNESCO. http://www.unesco.org/new/en/social-and-human-sciences/themes/bioethics/bioethics-and-human-rights (accessed January 4, 2017).

UNESCO. 2015. Report of the International Bioethics Committee on updating its reflection on the human genome and human rights. http://www.coe.int/en/web/bioethics/-/gene-editing (accessed October 21, 2016).

UNICEF (UN Children’s Fund). 1990. Convention on the Rights of the Child. https://www.unicef.org/crc (accessed January 5, 2017).

Urnov, F. D., E. J. Rebar, M. C. Holmes, H. S. Zhang, and P. D. Gregory. 2010. Genome editing with engineered zinc finger nucleases. Nature Reviews Genetics 11(9):636-646.

van Delden, J. J. M., and R. van der Graaf. 2016. Revised CIOMS international ethical guidelines for health-related research involving humans. The JAMA Network, December 6. http://jamanetwork.com/journals/jama/fullarticle/2592245 (accessed January 4, 2017).

Vatican. 2015. Encyclical letter Laudato si’ of the Holy Father Francis on care for our common home. http://w2.vatican.va/content/francesco/en/encyclicals/documents/papafrancesco_20150524_enciclica-laudato-si.html (accessed January 4, 2017).

Vernot, B., S. Tucci, J. Kelso, J. G. Schraiber, A. B. Wolf, R. M. Gittelman, M. Dannemann, S. Grote, R. C. McCoy, and H. Norton. 2016. Excavating Neanderthal and Denisovan DNA from the genomes of Melanesian individuals. Science 352(6282):235-239.

Volokh, E. 2003. The mechanisms of the slippery slope. Harvard Law Review 116(4):1026-1137.

Waddington, S. N., M. G. Kramer, R. Hernandez-Alcoceba, S. M. Buckley, M. Themis, C. Coutelle, and J. Prieto. 2005. In utero gene therapy: Current challenges and perspectives. Molecular Therapy 11(5):661-676.

Wailoo, K., A. Nelson, and C. Lee. 2012. Genetics and the unsettled past: The collision of DNA, race, and history. New Brunswick, NJ: Rutgers University Press.

Walters, L. 1991. Human gene therapy: Ethics and public policy. Human Gene Therapy 2(2):115-122.

Walters, L., and J. G. Palmer. 1997. The ethics of human gene therapy. New York: Oxford University Press.

Wasserman, D., and A. Asch. 2006. The uncertain rationale for prenatal disability screening. The Virtual Mentor: VM 8(1):53-56.

Wasserman, D., and A. Asch. 2012. A duty to discriminate? American Journal of Bioethics 12(4):22-24.

Watson, J. D., and F. H. Crick. 1953. Molecular structure of nucleic acids. Nature 171(4356):737-738.

Werner, M., and A. Plant. 2016. Collaboration between National Institute of Standards and Technology and the Standards Coordinating Body for Regenerative Medicines. Presentation of the Alliance for Regenerative Medicine, National Academy of Sciences, Engineering, and Medicine Regenerative Medicine Forum, Washington, DC, October 14.

Suggested Citation:"References." National Academies of Sciences, Engineering, and Medicine. 2017. Human Genome Editing: Science, Ethics, and Governance. Washington, DC: The National Academies Press. doi: 10.17226/24623.
×

Willemsen, R. H., M. van Dijk, Y. B. de Rijke, A. W. van Toorenenbergen, P. G. Mulder, and A. C. Hokken-Koelega. 2007. Effect of growth hormone therapy on serum adiponectin and resistin levels in short, small-for-gestational-age children and associations with cardiovascular risk parameters. Journal of Clinical Endocrinology & Metabolism 92(1):117-123.

Wilsdon, J. 2015. Let’s keep talking: Why public dialogue on science and technology matters more than ever. The Guardian, March 20. https://www.theguardian.com/science/political-science/2015/mar/27/lets-keep-talking-why-public-dialogue-on-science-and-technology-matters-more-than-ever (accessed October 19, 2016).

WMA (World Medical Association). 2013. World Medical Association Declaration of Helsinki: Ethical principles for medical research involving human subjects. Journal of the American Medical Association 310(20):2191-2194.

Wolf, S. M., R. Gupta, and P. Kohlhepp. 2009. Gene therapy oversight: Lessons for nanobiotechnology. Journal of Law, Medicine and Ethics 37(4):659-684.

Wozniak, M. A., R. F. Itzhaki, E. B. Faragher, M. W. James, S. D. Ryder, and W. L. Irving. 2002. Apolipoprotein E-epsilon 4 protects against severe liver disease caused by hepatitis C virus. Hepatology 36(2):456-463.

Wright, A. V., J. K. Nunez, and J. A. Doudna. 2016. Biology and applications of CRISPR systems: Harnessing nature’s toolbox for genome engineering. Cell 164(1-2):29-44.

Wu, Y., D. Liang, Y. Wang, M. Bai, W. Tang, S. Bao, Z. Yan, D. Li, and J. Li. 2013. Correction of a genetic disease in mouse via use of CRISPR-Cas9. Cell Stem Cell 13(6):659-662.

Wu, Y., H. Zhou, X. Fan, Y. Zhang, M. Zhang, Y. Wang, Z. Xie, M. Bai, Q. Yin, D. Liang, W. Tang, J. Liao, C. Zhou, W. Liu, P. Zhu, H. Guo, H. Pan, C. Wu, H. Shi, L. Wu, F. Tang, and J. Li. 2015. Correction of a genetic disease by CRISPR-Cas9-mediated gene editing in mouse spermatogonial stem cells. Cell Research 25(1):67-79.

Yin, H., W. Xue, S. Chen, R. L. Bogorad, E. Benedetti, M. Grompe, V. Koteliansky, P. A. Sharp, T. Jacks, and D. G. Anderson. 2014. Genome editing with Cas9 in adult mice corrects a disease mutation and phenotype. Nature Biotechnology 32(6):551-553.

Zetsche, B., J. S. Gootenberg, O. O. Abudayyeh, I. M. Slaymaker, K. S. Makarova, P. Essletzbichler, S. E. Volz, J. Joung, J. van der Oost, A. Regev, E. V. Koonin, and F. Zhang. 2015. Cpf1 is a single RNA-guided endonuclease of a class 2 CRISPR-Cas system. Cell 163(3):759-771.

Zhang, J., H. Liu, S. Luo, A. Chavez-Badiola, Z. Liu, S. Munne, M. Konstantinidis, D. Wells, and T. Huang. 2016. First live birth using human oocytes reconstituted by spindle nuclear transfer for mitochondrial DNA mutation causing leigh syndrome. Fertility and Sterility 106(3):e375-e376.

Zheng, W., H. Zhao, E. Mancera, L. M. Steinmetz, and M. Snyder. 2010. Genetic analysis of variation in transcription factor binding in yeast. Nature 464(7292):1187-1191.

Zhou, Q., M. Wang, Y. Yuan, X. Wang, R. Fu, H. Wan, M. Xie, M. Liu, X. Guo, Y. Zheng, G. Feng, Q. Shi, X. Y. Zhao, J. Sha, and Q. Zhou. 2016. Complete meiosis from embryonic stem cell-derived germ cells in vitro. Cell Stem Cell 18(3):330-340.

Zhu, Y.-Y., and R. Rees. 2012. Vaccines, blood, & biologics: Clinical review, October 2, 2012—Ducord. http://www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/ucm326333.htm (accessed September 24, 2013).

Suggested Citation:"References." National Academies of Sciences, Engineering, and Medicine. 2017. Human Genome Editing: Science, Ethics, and Governance. Washington, DC: The National Academies Press. doi: 10.17226/24623.
×
Page 195
Suggested Citation:"References." National Academies of Sciences, Engineering, and Medicine. 2017. Human Genome Editing: Science, Ethics, and Governance. Washington, DC: The National Academies Press. doi: 10.17226/24623.
×
Page 196
Suggested Citation:"References." National Academies of Sciences, Engineering, and Medicine. 2017. Human Genome Editing: Science, Ethics, and Governance. Washington, DC: The National Academies Press. doi: 10.17226/24623.
×
Page 197
Suggested Citation:"References." National Academies of Sciences, Engineering, and Medicine. 2017. Human Genome Editing: Science, Ethics, and Governance. Washington, DC: The National Academies Press. doi: 10.17226/24623.
×
Page 198
Suggested Citation:"References." National Academies of Sciences, Engineering, and Medicine. 2017. Human Genome Editing: Science, Ethics, and Governance. Washington, DC: The National Academies Press. doi: 10.17226/24623.
×
Page 199
Suggested Citation:"References." National Academies of Sciences, Engineering, and Medicine. 2017. Human Genome Editing: Science, Ethics, and Governance. Washington, DC: The National Academies Press. doi: 10.17226/24623.
×
Page 200
Suggested Citation:"References." National Academies of Sciences, Engineering, and Medicine. 2017. Human Genome Editing: Science, Ethics, and Governance. Washington, DC: The National Academies Press. doi: 10.17226/24623.
×
Page 201
Suggested Citation:"References." National Academies of Sciences, Engineering, and Medicine. 2017. Human Genome Editing: Science, Ethics, and Governance. Washington, DC: The National Academies Press. doi: 10.17226/24623.
×
Page 202
Suggested Citation:"References." National Academies of Sciences, Engineering, and Medicine. 2017. Human Genome Editing: Science, Ethics, and Governance. Washington, DC: The National Academies Press. doi: 10.17226/24623.
×
Page 203
Suggested Citation:"References." National Academies of Sciences, Engineering, and Medicine. 2017. Human Genome Editing: Science, Ethics, and Governance. Washington, DC: The National Academies Press. doi: 10.17226/24623.
×
Page 204
Suggested Citation:"References." National Academies of Sciences, Engineering, and Medicine. 2017. Human Genome Editing: Science, Ethics, and Governance. Washington, DC: The National Academies Press. doi: 10.17226/24623.
×
Page 205
Suggested Citation:"References." National Academies of Sciences, Engineering, and Medicine. 2017. Human Genome Editing: Science, Ethics, and Governance. Washington, DC: The National Academies Press. doi: 10.17226/24623.
×
Page 206
Suggested Citation:"References." National Academies of Sciences, Engineering, and Medicine. 2017. Human Genome Editing: Science, Ethics, and Governance. Washington, DC: The National Academies Press. doi: 10.17226/24623.
×
Page 207
Suggested Citation:"References." National Academies of Sciences, Engineering, and Medicine. 2017. Human Genome Editing: Science, Ethics, and Governance. Washington, DC: The National Academies Press. doi: 10.17226/24623.
×
Page 208
Suggested Citation:"References." National Academies of Sciences, Engineering, and Medicine. 2017. Human Genome Editing: Science, Ethics, and Governance. Washington, DC: The National Academies Press. doi: 10.17226/24623.
×
Page 209
Suggested Citation:"References." National Academies of Sciences, Engineering, and Medicine. 2017. Human Genome Editing: Science, Ethics, and Governance. Washington, DC: The National Academies Press. doi: 10.17226/24623.
×
Page 210
Suggested Citation:"References." National Academies of Sciences, Engineering, and Medicine. 2017. Human Genome Editing: Science, Ethics, and Governance. Washington, DC: The National Academies Press. doi: 10.17226/24623.
×
Page 211
Suggested Citation:"References." National Academies of Sciences, Engineering, and Medicine. 2017. Human Genome Editing: Science, Ethics, and Governance. Washington, DC: The National Academies Press. doi: 10.17226/24623.
×
Page 212
Suggested Citation:"References." National Academies of Sciences, Engineering, and Medicine. 2017. Human Genome Editing: Science, Ethics, and Governance. Washington, DC: The National Academies Press. doi: 10.17226/24623.
×
Page 213
Suggested Citation:"References." National Academies of Sciences, Engineering, and Medicine. 2017. Human Genome Editing: Science, Ethics, and Governance. Washington, DC: The National Academies Press. doi: 10.17226/24623.
×
Page 214
Suggested Citation:"References." National Academies of Sciences, Engineering, and Medicine. 2017. Human Genome Editing: Science, Ethics, and Governance. Washington, DC: The National Academies Press. doi: 10.17226/24623.
×
Page 215
Suggested Citation:"References." National Academies of Sciences, Engineering, and Medicine. 2017. Human Genome Editing: Science, Ethics, and Governance. Washington, DC: The National Academies Press. doi: 10.17226/24623.
×
Page 216
Next: Appendix A: The Basic Science of Genome Editing »
Human Genome Editing: Science, Ethics, and Governance Get This Book
×
Buy Paperback | $68.00 Buy Ebook | $54.99
MyNAP members save 10% online.
Login or Register to save!
Download Free PDF

Genome editing is a powerful new tool for making precise alterations to an organism's genetic material. Recent scientific advances have made genome editing more efficient, precise, and flexible than ever before. These advances have spurred an explosion of interest from around the globe in the possible ways in which genome editing can improve human health. The speed at which these technologies are being developed and applied has led many policymakers and stakeholders to express concern about whether appropriate systems are in place to govern these technologies and how and when the public should be engaged in these decisions.

Human Genome Editing considers important questions about the human application of genome editing including: balancing potential benefits with unintended risks, governing the use of genome editing, incorporating societal values into clinical applications and policy decisions, and respecting the inevitable differences across nations and cultures that will shape how and whether to use these new technologies. This report proposes criteria for heritable germline editing, provides conclusions on the crucial need for public education and engagement, and presents 7 general principles for the governance of human genome editing.

  1. ×

    Welcome to OpenBook!

    You're looking at OpenBook, NAP.edu's online reading room since 1999. Based on feedback from you, our users, we've made some improvements that make it easier than ever to read thousands of publications on our website.

    Do you want to take a quick tour of the OpenBook's features?

    No Thanks Take a Tour »
  2. ×

    Show this book's table of contents, where you can jump to any chapter by name.

    « Back Next »
  3. ×

    ...or use these buttons to go back to the previous chapter or skip to the next one.

    « Back Next »
  4. ×

    Jump up to the previous page or down to the next one. Also, you can type in a page number and press Enter to go directly to that page in the book.

    « Back Next »
  5. ×

    Switch between the Original Pages, where you can read the report as it appeared in print, and Text Pages for the web version, where you can highlight and search the text.

    « Back Next »
  6. ×

    To search the entire text of this book, type in your search term here and press Enter.

    « Back Next »
  7. ×

    Share a link to this book page on your preferred social network or via email.

    « Back Next »
  8. ×

    View our suggested citation for this chapter.

    « Back Next »
  9. ×

    Ready to take your reading offline? Click here to buy this book in print or download it as a free PDF, if available.

    « Back Next »
Stay Connected!