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1. Governing with public engagement: an anticipatory approach to human genome editing.

Author

Barlevy, Dorit, Juengst, Eric, Kahn, Jeffrey, Moreno, Jonathan, Lambert, Lauren, Charo, Alta, Chneiweiss, Hervé, Farooque, Mahmud, Guston, David, Hyun, Insoo, Knoepfler, Paul, Selin, Cynthia, Wilbanks, Rebecca, Zaghlula, Manar, and Scott, Christopher

Subjects
anticipatory governance, human genome editing, public engagement
Abstract

In response to calls for public engagement on human genome editing (HGE), which intensified after the 2018 He Jiankui scandal that resulted in the implantation of genetically modified embryos, we detail an anticipatory approach to the governance of HGE. By soliciting multidisciplinary experts input on the drivers and uncertainties of HGE development, we developed a set of plausible future scenarios to ascertain publics values-specifically, their hopes and concerns regarding the novel technology and its applications. In turn, we gathered a subset of multidisciplinary experts to propose governance recommendations for HGE that incorporate identified publics values. These recommendations include: (1) continued participatory public engagement; (2) international harmonization and transparency of multiple governance levers such as professional and scientific societies, funders, and regulators; and (3) development of a formal whistleblower framework.

Published
2024

7. ISSCR Guidelines for Stem Cell Research and Clinical Translation: The 2021 update.

Author

Lovell-Badge, Robin, Anthony, Eric, Barker, Roger A, Bubela, Tania, Brivanlou, Ali H, Carpenter, Melissa, Charo, R Alta, Clark, Amander, Clayton, Ellen, Cong, Yali, Daley, George Q, Fu, Jianping, Fujita, Misao, Greenfield, Andy, Goldman, Steve A, Hill, Lori, Hyun, Insoo, Isasi, Rosario, Kahn, Jeffrey, Kato, Kazuto, Kim, Jin-Soo, Kimmelman, Jonathan, Knoblich, Jürgen A, Mathews, Debra, Montserrat, Nuria, Mosher, Jack, Munsie, Megan, Nakauchi, Hiromitsu, Naldini, Luigi, Naughton, Gail, Niakan, Kathy, Ogbogu, Ubaka, Pedersen, Roger, Rivron, Nicolas, Rooke, Heather, Rossant, Janet, Round, Jeff, Saitou, Mitinori, Sipp, Douglas, Steffann, Julie, Sugarman, Jeremy, Surani, Azim, Takahashi, Jun, Tang, Fuchou, Turner, Leigh, Zettler, Patricia J, and Zhai, Xiaomei

Subjects
Biochemistry and Cell Biology, Clinical Sciences
Abstract

The International Society for Stem Cell Research has updated its Guidelines for Stem Cell Research and Clinical Translation in order to address advances in stem cell science and other relevant fields, together with the associated ethical, social, and policy issues that have arisen since the last update in 2016. While growing to encompass the evolving science, clinical applications of stem cells, and the increasingly complex implications of stem cell research for society, the basic principles underlying the Guidelines remain unchanged, and they will continue to serve as the standard for the field and as a resource for scientists, regulators, funders, physicians, and members of the public, including patients. A summary of the key updates and issues is presented here.

Published
2021

9. Setting Global Standards for Stem Cell Research and Clinical Translation: The 2016 ISSCR Guidelines.

Author

Daley, George Q, Hyun, Insoo, Apperley, Jane F, Barker, Roger A, Benvenisty, Nissim, Bredenoord, Annelien L, Breuer, Christopher K, Caulfield, Timothy, Cedars, Marcelle I, Frey-Vasconcells, Joyce, Heslop, Helen E, Jin, Ying, Lee, Richard T, McCabe, Christopher, Munsie, Megan, Murry, Charles E, Piantadosi, Steven, Rao, Mahendra, Rooke, Heather M, Sipp, Douglas, Studer, Lorenz, Sugarman, Jeremy, Takahashi, Masayo, Zimmerman, Mark, and Kimmelman, Jonathan

Subjects
Stem Cells, Humans, Informed Consent, Societies, Scientific, Clinical Trials as Topic, Stem Cell Research, Translational Medical Research, EMRO, clinical translation, clinical trials, communication, embryo research, guidelines, stem cells
Abstract

The International Society for Stem Cell Research (ISSCR) presents its 2016 Guidelines for Stem Cell Research and Clinical Translation (ISSCR, 2016). The 2016 guidelines reflect the revision and extension of two past sets of guidelines (ISSCR, 2006; ISSCR, 2008) to address new and emerging areas of stem cell discovery and application and evolving ethical, social, and policy challenges. These guidelines provide an integrated set of principles and best practices to drive progress in basic, translational, and clinical research. The guidelines demand rigor, oversight, and transparency in all aspects of practice, providing confidence to practitioners and public alike that stem cell science can proceed efficiently and remain responsive to public and patient interests. Here, we highlight key elements and recommendations in the guidelines and summarize the recommendations and deliberations behind them.

Published
2016

15. Debate ethics of embryo models from stem cells

Author

Rivron, Nicolas, Pera, Martin, Rossant, Janet, Martinez Arias, Alfonso, Zernicka-Goetz, Magdalena, Fu, Jianping, van den Brink, Susanne, Bredenoord, Annelien, Dondorp, Wybo, de Wert, Guido, Hyun, Insoo, Munsie, Megan, and Isasi, Rosario

Published
2018
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18. Clarifying the Ethics and Oversight of Chimeric Research

Author

Johnston, Josephine, Hyun, Insoo, Neuhaus, Carolyn P., Maschke, Karen J., Marshall, Patricia, Craig, Kaitlynn P., Matthews, Margaret M., Drolet, Kara, Greely, Henry T., Hill, Lori R., Hinterberger, Amy, Hurley, Elisa A., Kesterson, Robert, Kimmelman, Jonathan, King, Nancy M. P., Lopes, Melissa J., O’Rourke, P. Pearl, Parent, Brendan, Peckman, Steven, Piotrowska, Monika, Schwarz, May, Sebo, Jeff, Stodgell, Chris, Streiffer, Robert, and Wilkerson, Amy

Subjects
Philosophy, Issues, ethics and legal aspects, Health (social science), Health Policy, Humans, Animals, General Medicine, Animal Welfare, Social Group, Stem Cell Research, Article
Abstract

This article is the lead piece in a special report that presents the results of a bioethical investigation into chimeric research, which involves the insertion of human cells into nonhuman animals and nonhuman animal embryos, including into their brains. Rapid scientific developments in this field may advance knowledge and could lead to new therapies for humans. They also reveal the conceptual, ethical, and procedural limitations of existing ethics guidance for human-nonhuman chimeric research. Led by bioethics researchers working closely with an interdisciplinary work group, the investigation focused on generating conceptual clarity and identifying improvements to governance approaches, with the goal of helping scholars, funders, scientists, institutional leaders, and oversight bodies (embryonic stem cell research oversight [ESCRO] committees and institutional animal care and use committees [IACUCs]) deliver principled and trustworthy oversight of this area of science. The article, which focuses on human-nonhuman animal chimeric research that is stem cell based, identifies key ethical issues in and offers ten recommendations regarding the ethics and oversight of this research. Turning from bioethics' previous focus on human-centered questions about the ethics of "humanization" and this research's potential impact on concepts like human dignity, this article emphasizes the importance of nonhuman animal welfare concerns in chimeric research and argues for less-siloed governance and oversight and more-comprehensive public communication.

Published
2022

20. Minibrains: What's in a Name? The Reality of Organoids

Author

Lopes, Melissa, Kohman, Richie E., Lunshof, Jeantine E., Paulsen, Bruna, Pigoni, Martina, White, Sasha, Aach, John, and Hyun, Insoo

Subjects
Brain -- Models -- Physiological aspects, Tissue culture -- Methods, Science and technology
Abstract

Brain organoids have emerged in recent years as a powerful new tool for neuroscience research. Unfortunately, the promise of this tool has been muddied by misplaced fear and hype, born [...]

Published
2021

21. Cell-based therapeutic strategies for multiple sclerosis

Author

Scolding, Neil J, Pasquini, Marcelo, Reingold, Stephen C, Cohen, Jeffrey A, Atkins, Harold, Banwell, Brenda, Bar-Or, Amit, Bebo, Bruce, Bowen, James, Burt, Richard, Calabresi, Peter, Cohen, Jeffrey, Comi, Giancarlo, Connick, Peter, Cross, Anne, Cutter, Gary, Derfuss, Tobias, Ffrench-Constant, Charles, Freedman, Mark, Galipeau, Jacques, Goldman, Myla, Goldman, Steven, Goodman, Andrew, Green, Ari, Griffith, Linda, Hartung, Hans-Peter, Hemmer, Bernhard, Hyun, Insoo, Iacobaeus, Ellen, Inglese, Matilde, Jubelt, Burk, Karussis, Dimitrios, Küry, Patrick, Landsman, Douglas, Laule, Cornelia, Liblau, Roland, Mancardi, Giovanni, Ann Marrie, Ruth, Miller, Aaron, Miller, Robert, Miller, David, Mowry, Ellen, Muraro, Paolo, Nash, Richard, Ontaneda, Daniel, Pasquini, Marcelo, Pelletier, Daniel, Peruzzotti-Jametti, Luca, Pluchino, Stefano, Racke, Michael, Reingold, Stephen, Rice, Claire, Ringdén, Olle, Rovira, Alex, Saccardi, Riccardo, Sadiq, Saud, Sarantopoulos, Stefanie, Savitz, Sean, Scolding, Neil, Soelberg Sorensen, Per, Pia Sormani, Maria, Stuve, Olaf, Tesar, Paul, Thompson, Alan, Trojano, Maria, Uccelli, Antonio, Uitdehaag, Bernard, Utz, Ursula, Vukusic, Sandra, Waubant, Emmanuelle, and Wilkins, Alastair

Published
2017
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22. The need for a standard for informed consent for collection of human fetal material

Author

Barker, Roger A., primary, Boer, Gerard J., additional, Cattaneo, Elena, additional, Charo, R. Alta, additional, Chuva de Sousa Lopes, Susana M., additional, Cong, Yali, additional, Fujita, Misao, additional, Goldman, Steven, additional, Hermerén, Göran, additional, Hyun, Insoo, additional, Lisgo, Steven, additional, Rosser, Anne E., additional, Anthony, Eric, additional, and Lindvall, Olle, additional

Published
2022
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25. The ISSCR Guidelines for Human Embryonic Stem Cell Research

Author

Daley, George O., Ahrlund-Richter, Lars, Auerbach, Jonathan M., Benvenisty, Nissim, Charo, R. Alta, Chen, Grace, Deng, Hong-kui, Goldstein, Lawrence S., Hudson, Kathy L., Hyun, Insoo, Junn, Sung Chull, Love, Jane, Lee, Eng Hin, McLaren, Anne, Mummery, Christine L., Nakatsuji, Norio, Racowsky, Catherine, Rooke, Heather, Rossant, Janet, Schöler, Hans R., Solbakk, Jan Helge, Taylor, Patrick, Trounson, Alan O., Weissman, Irving L., Wilmut, Ian, Yu, John, and Zoloth, Laurie

Published
2007
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28. ISSCR guidelines for the transfer of human pluripotent stem cells and their direct derivatives into animal hosts

Author

Hyun, Insoo, primary, Clayton, Ellen Wright, additional, Cong, Yali, additional, Fujita, Misao, additional, Goldman, Steven A., additional, Hill, Lori R., additional, Monserrat, Nuria, additional, Nakauchi, Hiromitsu, additional, Pedersen, Roger A., additional, Rooke, Heather M., additional, Takahashi, Jun, additional, and Knoblich, Jürgen A., additional

Published
2021
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29. The bioethics of stem cell research and therapy

Author

Hyun, Insoo

Subjects
Medical ethics -- Research -- Methods -- Forecasts and trends, Stem cell research -- Forecasts and trends -- Ethical aspects -- Research -- Methods, Stem cells -- Transplantation, Market trend/market analysis, Health care industry
Abstract

Discussion of the bioethics of human stem cell research has transitioned from controversies over the source of human embryonic stem cells to concerns about the ethical use of stem cells in basic and clinical research. Key areas in this evolving ethical discourse include the derivation and use of other human embryonic stem cell-like stem cells that have the capacity to differentiate into all types of human tissue and the use of all types of stem cells in clinical research. Each of these issues is discussed as I summarize the past, present, and future bioethical issues in stem cell research., The main bioethical issues associated with human stem cells involve their derivation and use for research. Although there are interesting ethical issues surrounding the collection and use of somatic (adult) [...]

Published
2010
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31. Stem Cell Research Ethics: Consensus Statement on Emerging Issues

Author

Caulfield, Timothy, Ogbogu, Ubaka, Nelson, Erin, Einsiedel, Edna, Knoppers, Bartha, McDonald, Michael, Brunger, Fern, Downey, Robin, Fernando, Kanchana, Galipeau, Jacques, Geransar, Rose, Grenier, Glenn, Hyun, Insoo, Isasi, Rosario, Kardel, Melanie, Knowles, Lori, Kucic, Terrence, Lotjonen, Salla, Lyall, Drew, Magnus, David, Mathews, Debra J.H., Nisbet, Matthew, Nisker, Jeffrey, Pare, Guillaume, Pattinson, Shaun, Pullman, Daryl, Rudnicki, Michael, Williams-Jones, Bryn, and Zimmerman, Susan

Published
2007
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35. Illusory fears must not stifle chimaera research

Author

Hyun, Insoo

Subjects
Chimeras (Organisms) -- Research, Stem cell research, Environmental issues, Science and technology, Zoology and wildlife conservation
Abstract

Author(s): Insoo Hyun (corresponding author) [1] After more than a decade of controversy, the United States is nudging towards approving research on human-animal embryos. Last week, the National Institutes of [...]

Published
2016
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37. Bioethics: Democracy in vitro

Author

Hyun, Insoo

Subjects
Experiments in Democracy: Human Embryo Research and the Politics of Bioethics (Nonfiction work) -- Hurlbut, J. Benjamin -- Book reviews, Environmental issues, Science and technology, Zoology and wildlife conservation
Abstract

Author(s): Insoo Hyun (corresponding author) [1] Experiments in Democracy: Human Embryo Research and the Politics of Bioethics J. Benjamin Hurlbut Columbia University Press: 2017. One of the most celebrated paintings [...]

Published
2017
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39. The ethics of experimenting with human brain tissue

Author

Farahany, Nita A., primary, Greely, Henry T., additional, Hyman, Steven, additional, Koch, Christof, additional, Grady, Christine, additional, Pașca, Sergiu P., additional, Sestan, Nenad, additional, Arlotta, Paola, additional, Bernat, James L., additional, Ting, Jonathan, additional, Lunshof, Jeantine E., additional, Iyer, Eswar P. R., additional, Hyun, Insoo, additional, Capestany, Beatrice H., additional, Church, George M., additional, Huang, Hao, additional, and Song, Hongjun, additional

Published
2018
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40. Research on Human Embryos and Reproductive Materials: Revisiting Canadian Law and Policy

Author

Ogbogu, Ubaka, primary, Zarzeczny, Amy, additional, Baltz, Jay, additional, Bedford, Patrick, additional, Du, Jenny, additional, Hyun, Insoo, additional, Jaafar, Yasmeen, additional, Jurisicova, Andrea, additional, Kleiderman, Erika, additional, Koukio, Yonida, additional, Knoppers, Bartha, additional, Leader, Arthur, additional, Master, Zubin, additional, Nguyen, Minh, additional, Noohi, Forough, additional, Ravitsky, Vardit, additional, and Toews, Maeghan, additional

Published
2018
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41. Erratum: Revisiting the Warnock rule

Author

Hurlbut, J Benjamin, primary, Hyun, Insoo, additional, Levine, Aaron D, additional, Lovell-Badge, Robin, additional, Lunshof, Jeantine E, additional, Matthews, Kirstin R W, additional, Mills, Peter, additional, Murdoch, Alison, additional, Pera, Martin F, additional, Scott, Christopher Thomas, additional, Tizzard, Juliet, additional, Warnock, Mary, additional, Zernicka-Goetz, Magdalena, additional, Zhou, Qi, additional, and Zoloth, Laurie, additional

Published
2017
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43. Revisiting the Warnock rule

Author

Hurlbut, J Benjamin, primary, Hyun, Insoo, additional, Levine, Aaron D, additional, Lovell-Badge, Robin, additional, Lunshof, Jeantine E, additional, Matthews, Kirstin R W, additional, Mills, Peter, additional, Murdoch, Alison, additional, Pera, Martin F, additional, Scott, Christopher Thomas, additional, Tizzard, Juliet, additional, Warnock, Mary, additional, Zernicka-Goetz, Magdalena, additional, Zhou, Qi, additional, and Zoloth, Laurie, additional

Published
2017
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46. Regulate embryos made for research: as technical barriers fall, the united states should adapt existing measures to govern the generation of human embryos for research

Author

Hyun, Insoo

Subjects
Embryonic development -- Laws, regulations and rules, Genetic research -- Ethical aspects, Government regulation, Environmental issues, Science and technology, Zoology and wildlife conservation
Abstract

Three independent research teams have now used cloning technology to make human embryonic stem cells carrying the genomes of existing people. The first announcement, using genomes from fetal and infant [...]

Published
2014

49. ANT vs. SCNT

Author

Hyun, Insoo, Won Jung, Kyu, Hurlbut, William B., George, Robert P., and Grompe, Markus

Subjects
Biological sciences, Health
Abstract

To the Editor: William Hurlbut and colleagues have offered what they take to be a definitive account of altered nuclear transfer (ANT) ('Seeking Consensus: A Clarification and Defense of Altered [...]

Published
2006

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