Perspectives on the New ISSCR Guidelines for Stem Cell Research and Clinical Translation
Purpose of Review
This review seeks to highlight key elements of the ISSCR 2016 Guidelines for Stem Cell Research and Clinical Translation, describe apparent influences on the Guidelines, provide an analysis of the utility and the potential impact of the Guidelines on the field of stem cell research, and propose considerations for the future versions of the Guidelines.
Part ethical code of conduct, part “how-to” instructions, and part policy declaration, this version of the Guidelines forms ISSCR’s most up-to-date recommendations and guidance on the topic of stem cell clinical translation.
In the revised set of Guidelines, ISSCR has asserted the imperative of maintaining the highest ethical standards for clinical translation of stem cell research. The Guidelines set a sound foundation for self-regulation, not only communicating the Society’s position on what is legitimate stem cell research/treatment and what is not, but also fulfilling ISSCR’s mission of providing professional (and public) education regarding the specific steps that should be taken to translate basic research findings to the clinic. Future versions would benefit from more extensive references, including hyperlinks to regulatory authority guidance documents; and improved clarity of the writing style, including avoidance of vague descriptions and the addition of flow charts and/or tables.
KeywordsClinical translation Code of ethics Stem cell research Scientific society Guidelines
Compliance with Ethical Standards
Conflict of Interest
Erica C. Jonlin declares that he has no conflict of interest.
Human and Animal Rights and Informed Consent
This article does not contain any studies with human or animal subjects performed by any of the authors.
Papers of particular interest, published recently, have been highlighted as: • Of importance •• Of major importance
- 1.•• International Society for Stem Cell Research. Guidelines for stem cell research and clinical translation. 2016. http://www.isscr.org/membership/policy/2016-guidelines/guidelines-for-stem-cell-research-and-clinical-translation. These are the Guidelines that this paper is about.
- 2.•• Daley GQ, Hyun I, Apperley JF, Barker RA, Benvenisty N, Bredenoord AL, et al. Setting global standards for stem cell research and clinical translation: the 2016 ISCCR guidelines. Stem Cell Rep. 2016a;6:787–97. This paper summarizes the Guidelines and describes the process involved to compose, receive comments on, edit, and finalize the Guidelines. CrossRefGoogle Scholar
- 5.Frati P, Scopetti M, Santurro A, Gatto V, Fineschi V. Stem cell research and clinical translation: a roadmap about good clinical practice and patient care. Hindawi Stem Cells Int. 2017;2017: Article ID 5080259, 8 pages. https://doi.org/10.1155/2017/5080259.
- 6.The Role of Professional Societies. In: Facilitating Interdisciplinary Research. National Academy of Sciences, National Academy of Engineering, and Institute of Medicine; 2005.Google Scholar
- 8.Perlis C, Shannon N. Role of professional organizations in setting and enforcing ethical norms. Clin Dermatol. 2012;30:156–9. https://doi.org/10.1016/j.clindermatol.2011.06.002.CrossRefPubMedGoogle Scholar
- 12.National Academies’ Guidelines for human embryonic stem cell research 2005, amended 2007, 2008, 2010.Google Scholar
- 16.Cyranoski D. Stem-cell pioneer blamed media ‘bashing’ in suicide note: lawyer for Yoshiki Sasai’s family reveals motive of Japanese researcher’s act following STAP controversy. Nature. 13 August 2014b, Clarified: 15 August 2014 https://www.nature.com/news/stem-cell-pioneer-blamed-media-bashing-in-suicide-note-1.15715#/correction1. https://doi.org/10.1038/nature.2014.15715.
- 17.Zhang J, Liu H, Luo S, Chavez-Badiola A, Liu Z, Yang M, et al. First live birth using human oocytes reconstituted by spindle nuclear transfer for mitochondrial DNA mutation causing Leigh syndrome. Fertil Steril. 2016;106(3 Suppl):3375–e376.Google Scholar
- 19.International Summit on Genome Editing: A Global Discussion. http://nationalacademies.org/gene-editing/Gene-Edit-Summit/. Accessed April 30, 2018
- 23.EDITORIAL. May 2, 2018 Announcement: stem-cell policy—nature journals formalize ethics standards for human-embryo and stem-cell papers. Nature. 2018;557:6. https://doi.org/10.1038/d41586-018-05030-2. https://www.nature.com/articles/d41586-018-05030-2.
- 25.https://www.clinicaltrials.gov/ct2/about-site/disclaimer. Accessed April 30, 2018.
- 27.http://www.isscr.org/about-isscr. Accessed May 10, 2018.
- 28.Dunbar CE, High KA, Joung JK, Kohn DB, Ozawa K, Sadelain M. Science. 2018;359(6372):eaan4672. https://doi.org/10.1126/science.aan4672.
- 29.https://en.wiktionary.org/wiki. Accessed May 10, 2018.