Recent developments in bioengineering promise the possibility of new diagnostic and treatment strategies, novel industrial processes, and innovative approaches to thorny problems in fields such as nutrition, agriculture, and biomanufacturing. As modern genetics has matured and developed technologies of increasing power, debates over risk assessments and proper applications of the technology, and over who should have decision-making power over such issues, have become more prominent. Recently, some scientists have advocated that ethicists “step out of the way,” whereas others have called for greater ethical scrutiny, or even for moratoria on some lines of research1,2. As a community, however, we must together determine the proper application of these powerful biological tools. This paper, a consensus statement of a group of interdisciplinary delegates drawn from the top biotech-producing countries of the world, offers a set of ethical principles to contribute to the ethical conversation about human cellular biotechnological research moving forward.
Subscribe to Journal
Get full journal access for 1 year
only $8.25 per issue
All prices are NET prices.
VAT will be added later in the checkout.
Tax calculation will be finalised during checkout.
Rent or Buy article
Get time limited or full article access on ReadCube.
All prices are NET prices.
US Department of Energy, Office of Science. Synthetic Biology and the U.S. Biotechnology Regulatory System: Challenges and Options (US Department of Energy, Office of Science, 2014).
Daley, G.Q. et al. Setting global standards for stem cell research and clinical translation: the 2016 ISSCR Guidelines. Stem Cell Rep. 6, 787–797.
Committee on Science, Technology, and Law; Policy and Global Affairs; National Academies of Sciences, Engineering, and Medicine. International Summit on Human Gene Editing: A Global Discussion (National Academies Press, Washington, DC, USA, 2015).
Baltimore, D. et al. A prudent path forward for genomic engineering and germline gene modification. Science 348, 36–37 (2015).
Chan, S. et al. Genome editing technologies and human germline genetic modification: the hinxton group consensus statement. Am. J. Bioeth. 15, 42–47 (2015).
Caplan, A. & Plunkett, C. Get out of the way of human genetic engineering? Unwise and uncalled for. Pharma Healthcare (2016).
Miller, H.I. We desperately need bioethicists... to get out of the way of gene therapy. Forbes (1 June 2016).
Anonymous. Japan panel greenlights gene editing of human eggs for basic study. The Japan Times (22 April 2016).
Collins, F.S. Statement on NIH funding of research using gene-editing technologies in human embryo (The NIH Director, US National Institutes of Health, 28 April 2015).
Hyun, I., Wilkerson, A. & Johnston, J. Embryology policy: revisit the 14-day rule. Nature 533, 169–171 (2016).
Charo, R.A. & Greely, H.T. CRISPR critters and CRISPR cracks. Am. J. Bioeth. 15, 11–17 (2015).
Becker, R. US government approves transgenic chicken. Nature (9 December 2015).
Kuzma, J. Policy: reboot the debate on genetic engineering. Nature 531, 165–167 (2016).
Akbari, O.S. et al. BIOSAFETY. Safeguarding gene drive experiments in the laboratory. Science 349, 927–929 (2015).
Pinker, S. The Better Angels of Our Nature: Why Violence Has Declined (Penguin, 2011).
Gauchat, G. Politicization of science in the public sphere a study of public trust in the United States, 1974 to 2010. Am. Sociol. Rev. 77, 167–187 (2012).
Garland-Thomson, R. The case for conserving disability. J. Bioeth. Inq. 9, 339–355 (2012).
Haraway, D. Situated knowledges: the science question in feminism and the privilege of partial perspective. Fem. Stud. 14, 575–599 (1988).
Kuhn, T.S. The Structure of Scientific Revolutions (University of Chicago Press, Chicago, USA, 1962).
Wolpe, P.R. Reasons scientists avoid thinking about ethics. Cell 125, 1023–1025 (2006).
UNESCO International Bioethics Committee. Report of the IBC on Updating Its Reflection on the Human Genome and Human Rights (UNESCO, 2015).
Hamzelou, J. Let people most affected by gene editing write CRISPR rules. New Sci. (29 April 2016).
Council of Europe. Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine (Council of Europe, Oviedo, Spain, 1997).
van Bubnoff, A. The 1918 flu virus is resurrected. Nature 437, 794–795 (2005).
Grady, C. et al. Broad consent for research with biological samples: workshop conclusions. Am. J. Bioeth. 15, 34–42 (2015).
Drabiak-Syed, K. Lessons from Havasupai Tribe v. Arizona State University Board of Regents: recognizing group, cultural, and dignity harms as legitimate risks warranting integration into research practice. J. Health Biomed. L. 6, 175–225 (2010).
Kowal, E. Orphan DNA: indigenous samples, ethical biovalue and postcolonial science. Soc. Stud. Sci. 43, 577–597 (2013).
United Nations General Assembly. Declaration on the rights of Indigenous peoples, Resolution 61.295, 13 (2007).
Truog, R.D., Kesselheim, A.S. & Joffe, S. Research ethics. Paying patients for their tissue: the legacy of Henrietta Lacks. Science 337, 37–38 (2012).
Ray, S., Moiyadi, A. & Srivastava, S. Epidemiology: Biorepositories for cancer research in developing countries. Nat. Rev. Clin. Oncol. 10, 434–436 (2013).
Saini, K.S., Saini, M.L. & Marbaix, E. Biobanking in the era of precision oncology. Indian J. Med. Paediatr. Oncol. 36, 1–2 (2015).
Sgaier, S.K. et al. Public health. Biobanks in developing countries: needs and feasibility. Science 318, 1074–1075 (2007).
Singer, P.A. & Daar, A.S. Harnessing genomics and biotechnology to improve global health equity. Science 294, 87–89 (2001).
Fischhoff, B. The realities of risk-cost-benefit analysis. Science 350, aaa6516 (2015).
BEINGS was made possible by grants from the Coca-Cola Foundation, Emory University, The Marcus Foundation, Georgia Research Alliance, Wipro Limited, King & Spalding Law Firm, the Metro Atlanta Chamber of Commerce, Southwest Airlines, Sanofi, Air France, The Embassy of the Republic of France, the Atlanta Clinical and Translational Science Institute, Central Atlanta Progress, and Biofaction. Academic partners included the Georgia Institute of Technology, the University of Georgia, Kennesaw State University, Brenau University, Mercer University, Agnes Scott College, Columbia Theological Seminary, Georgia College, Georgia Gwinnett College, Georgia State University, Morehouse School of Medicine, University of Northern Georgia, Oglethorpe University Savannah College of Art and Design, and the University of West Georgia.
One author, Karol Estrada, reports receiving salary and stocks from Biogen.
About this article
Cite this article
Wolpe, P., Rommelfanger, K. & the Drafting and Reviewing Delegates of the BEINGS Working Groups. Ethical principles for the use of human cellular biotechnologies. Nat Biotechnol 35, 1050–1058 (2017). https://doi.org/10.1038/nbt.4007
Nano Research (2020)