REPORT: Ethical Issues Related to the Creation of Synthetic Human Embryos image

Harvard University Embryonic Stem Cell Research Oversight (“ESCRO”) Committee, April 2018

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Report Summary Authored by Robert D. Truog, MD (Center for Bioethics, Harvard Medical School) and Melissa J. Lopes, JD (Harvard University Office of the Vice Provost for Research)

The Harvard Embryonic Stem Cell Research Oversight (the “ESCRO”) Committee, an ethics oversight committee charged with reviewing research protocols involving human embryos, human embryonic stem cells, and certain activities with non-embryonic human pluripotent stem cells, recently issued a report exploring the ethical issues related to the creation of synthetic human embryos. 

Ethical committees such as the Harvard ESCRO occasionally receive inquiries to deliberate upon the ethical implications of emerging research technologies where there is no existing or established guidance to rely upon. Deliberating in these gray areas is not a simple task, but the Harvard ESCRO has developed a general framework for navigating this ethical terrain in real time. In these instances, the Harvard ESCRO generally consults with its peer oversight bodies, reviews data from the scientific and bioethical literature and from other scientists and ethicists in the field and, from time to time, convenes symposia to broaden the discussion around such emerging technologies.

At its December 2015 meeting, the Harvard ESCRO received such a request, prompting it to reflect on research regarding the creation of certain types of seemingly organized cellular structures that neither arise from embryogenesis nor derive from human embryos. In particular, the inquiry centered on whether the appearance of formations that resemble the primitive streak in non-embryo structures are subject to ESCRO review and oversight. In the case before the Harvard ESCRO, the formation arose, not from normal embryogenesis, but from the use of micro-patterning techniques to control the size and geometry of human pluripotent stem cell colonies. The discrete question did not require ESCRO review and approval, but it dovetailed with emerging questions surrounding the 14 day rule (i.e., pursuant to the Harvard ESCRO Policy and the NAS Stem Cell Guidelines on which it is based, the in vitro culture of any intact embryo for longer than 14 days or until formation of the primitive streak is prohibited) and raised broader questions, about the limitations of existing ethical guidelines and the developmental potential of synthetic human embryos.

After internal deliberation, and some initial outreach to leaders in this field, the Harvard ESCRO, along with the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, the Edmond J. Safra Center for Ethics, the Center for Bioethics at Harvard Medical School, the International Society for Stem Cell Research, the Harvard Stem Cell Institute, and the Harvard University Office of the Vice Provost for Research, convened a symposium on November 7th and 8th of 2016 to explore issues related to the responsible conduct of research with synthetic human embryos. The Harvard ESCRO sought to be as broad as possible, convening scientific, ethical and legal experts, as well as experts from other disciplines, such as Science, Technology and Society (“STS”), philosophy, etc. from the US and the UK, as well as members of the public. The symposium featured wide-ranging discussions into the nature of these entities, the scope and rationales for research involving such entities, the ethical implications of such research, the role of ethics oversight committees such as the Harvard ESCRO, and the limitations of existing guidance for emerging technologies such as this.

The report presents the Harvard ESCRO’s views and findings reflecting insights gleaned from the deliberations of this convened group of scholars and members of the public, with recommendations for academic institutions and ESCRO Committees about how research involving synthetic human embryos could responsibly move forward, and what principles should guide ESCRO oversight and review, as well as potential restrictions on such research.

This type of deliberative process reflects how the Harvard ESCRO has historically approached emerging technologies for which there exists no established guidelines. The Harvard ESCRO requests that labs share their findings with the Committee in a step-wise process as it explores the broader issues of how to address gray areas such as this under the NAS and ISSCR Guidelines. Further, the Harvard ESCRO engages external researchers, and peer ethics oversight committees who have straddled this gray area, as well as thought leaders in the area of bioethics and other disciplines, such as law, philosophy and STS who have professional knowledge of the evolution and implementation of norms in these areas. This is largely what prompted the Harvard ESCRO, along with its co-sponsors, to convene the November 2016 symposium which broadened the discussion to include scientific, bioethics, and other thought leaders from across the US and abroad.

bioethics biotechnology genetics human tissue international regulation research stem cells