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The rapid development of human genome editing (HGE) techniques evokes an urgent need for forward-looking deliberation regarding the aims, processes, and governance of research. The framework of anticipatory governance (AG) may serve this need. This article reviews scholarly discourse about HGE through an AG lens, aiming to identify gaps in discussion and practice and suggest how AG efforts may fill them. Discourse on HGE has insufficiently reckoned with the institutional and systemic contexts, inputs, and implications of HGE work, to the detriment of its ability to prepare for a variety of possible futures and pursue socially desirable ones. More broadly framed and inclusive efforts in foresight and public engagement, focused not only upon the in-principle permissibility of HGE activities but upon the contexts of such work, may permit improved identification of public values relevant to HGE and of actions by which researchers, funders, policymakers, and publics may promote them.

Scholarship on human germline editing has centered on the risks to the genetically-modified child. However, far less emphasis is focused on women who will become pregnant with a genetically modified embryo as part of human subject research or the families that raise children whose genomes were modified as an embryo. The lack of attention on women and families places these key stakeholders in genomic technologies at significant medical, ethical, and personal harm as research rapidly moves forward to advance the science of genomic modification. Now is the time to address how the interests of women and families should be represented in the ethical and scientific frameworks of human genomic modification, with specific considerations for Institutional Review Boards who review protocols for rigorous human subject protections and scientists who develop scientific methodologies that dictate the potential risks conferred to research participants. In this paper, we examine the implications of genomic modification of human embryo for women, children, and families to explore how to review a first-in-human clinical protocol of human genomic officiation responsibly.

Hank Greely’s (2021) target article, “Human Brain Surrogates Research: The Onrushing Ethical Dilemma” reviews the manifold scientific and ethical questions surrounding models of human brains used i...

Background: Looking through the lens of the media reveals much about how new biotechnologies are portrayed and how these reports influence public policy and opinion. The roles of patients, scientists, and the government loom large in this equation. These stakeholders tell us what is important to them and why. But little research exists comparing representations of new clinical technologies in the mainstream media across time. What has changed in newspaper accounts of new biotechnologies since the 1970s? How are the stakeholders portrayed, and what do these individuals have to say? Here, we seek to answer these questions by examining media reporting of Laetrile and stem cell transplants during the time of their clinical advent. Methods : Using a qualitative coding framework, we obtained frequencies of relevant excerpts and analyzed the data using the Mann–Whitney U test. Results: We saw significant differences in how stakeholders talk about their support and criticism of unproven treatments between the two...

Electronic registries for clinical trials present an opportunity for miscommunication of benefits and risks to potential subjects. We explored early phase clinical trials registered on the National Library of Medicine's ClinicalTrials.gov for inappropriate language patterns (terms and statements) that could convey therapeutic intent. We sampled early-phase heart disease clinical trial records involving stem cells registered on Clincaltrials.gov between April 24, 2004, and September 18, 2008, and randomly selected heart disease drug trials from the same period for comparison. Trial sponsorship and location were coded. Textual data were extracted from titles, purpose, outcome measures, and detailed description statements and coded for readability and the presence of therapeutic language. Content and multiple correspondence analyses were employed to explore language patterns suggestive of therapeutic intent. We found statistically significant differences in therapeutic language use between stem cell (n = 72,...

This paper explores the notions of hope and how individual patient autonomy can trump carefully reasoned ethical concerns and policies intended to regulate stem cell transplants. We argue that the same limits of knowledge that inform arguments to restrain and regulate unproven treatments might also undermine our ability to comprehensively dismiss or condemn them. Incautiously or indiscriminately reasoned policies and attitudes may drive critical information and data underground, impel patients away from working with clinical researchers, and tread needlessly on hope, the essential motivator of patients, advocates and researchers alike. We offer recommendations to clinicians and health care providers to help balance the discourse with individuals seeking treatment while guarding against fraud, misconception, and patient harm.

In April 2015 a team of Chinese scientists reported in a little known journal, Protein & Cell, the use of CRISPR/Cas9 to cleave and then repair the HBB gene in nonviable human embryos (Liang et al....