Sarah Chan

Marketing of unproven stem cell–based interventions: A call to action

Commercial promotion of unsupported therapeutic uses of stem cells is a global problem that should be addressed by coordinated approaches at the national and international levels. Commercial promotion of unsupported therapeutic uses of stem cells is a global problem that has proven resistant to regulatory efforts. Here, we suggest a coordinated approach at the national and international levels focused on engagement, harmonization, and enforcement to reduce the risks associated with direct-to-consumer marketing of unproven stem cell treatments.

Montgomery and informed consent: where are we now?

The Montgomery case in 2015 was a landmark for informed consent in the UK. Two years on, Sarah Chan and colleagues discuss the consequences for practising doctors

How to Rethink the Fourteen-Day Rule

Recently, attention has been drawn to the basic principles governing the use of human embryos in research: specifically, the so-called fourteen-day rule. This rule stipulates that human embryos should not be allowed to grow in vitro past fourteen days of development. For years, the fourteen-day limit was largely theoretical, since culture techniques were not sufficient to maintain embryos up to this point. Yet in the past year, research has suggested that growing embryos beyond fourteen days might be feasible and scientifically valuable. At the same time, work with pluripotent stem cells, including human PSCs, has shown that under certain conditions, they can form structures that recapitulate developmental features of the postimplantation embryo. This raises the possibility that PSCs could generate embryo-like structures in vitro, even synthetic embryos, that might provoke moral concern but would not fall under most current embryo research policies. In countries that permit embryo research, the fourteen-day rule has long been the linchpin of an effective policy compromise between what remain deeply divided moral positions on the human embryos status. It has also, particularly in the United Kingdom, been influential in establishing a bioethics public-policy process. Any moves to change the rule must consider not just the implications for the use of embryos but also the potential impact of this model of bioethical governance of science.

Mitochondrial Replacement Techniques, Scientific Tourism, and the Global Politics of Science

Abstract The United Kingdom is the first and so far only country to pass explicit legislation allowing for the licensed use of the new reproductive technology known as mitochondrial replacement therapy. The techniques used in this technology may prevent the transmission of mitochondrial DNA diseases, but they are controversial because they involve the manipulation of oocytes or embryos and the transfer of genetic material. Some commentators have even suggested that MRT constitutes germline genome modification. All eyes were on the United Kingdom as the most likely location for the first MRT birth, so it was a shock when, on September 27, 2016, an announcement went out that the first baby to result from use of the intervention had already been born. In New York City, United States‐based scientist John Zhang used maternal spindle transfer (one of the recognized MRT methods) to generate five embryos for a woman carrying oocytes with deleterious mutations of the mitochondrial DNA. Zhang then shipped the only euploid embryo to Mexico, where it was transferred to the mothers uterus. Zhangs teams travel across international borders to carry out experimental procedures represents a form of scientific tourism that has not been properly ethically explored; it can, however, have seriously detrimental effects for developing countries.

What's in a Name? The Politics of ‘Precision Medicine’

While both types of trust may be required for including (underrepresented) populations in biomedical research, it is important to distinguish the role of these types of trust: Vertical trust can help in allowing researchers to use the participants’ data in biomedical research; horizontal trust is important to recruit participants in the first place. Whether the need for both types of trust is only required for doing research with underrepresented populations is, however, questionable. For overrepresented groups, these two types of trust may have been better established. The historical discrimination, the maltreatment of underrepresented populations, all kinds of implicit biases, and the lack of suitable communication indicate that ways to incorporate both types of trust have not been successfully developed yet. The inclusion of a wide variety of participants including underrepresented groups becomes even more important in the light of precision medicine. Precision medicine aims to understand the role of genetics, the environment, and lifestyle for tailoring approaches to prevent or treat diseases. Precision medicine starts from the idea of diversity, that there are differences between different groups of people and individuals, between different living environments, and between different lifestyles that matter for deciding which treatment works best for individuals or subgroups. Rightly, research for precision medicine therefore needs to be inclusive and also to include genetic data, biological samples, and other health information of groups that are currently still underrepresented in biomedical research. In order to include diverse populations in such research, both types of trust need to be fostered. This means that the trust-corroding factors, identified by the authors of the target article (Kraft et al. 2018), need to be dealt with, too. These trust-corroding factors will not solely be tackled by procedural mechanisms such as institutional oversight and informed consent. The nature of precision medicine, which starts from the idea of diversity and individual variability, and which may require open data sharing, means that the research enterprise will have to incorporate ways to build horizontal trust, too. Horizontal trust can be build by open, transparent, and accustomed communication, by taking experiences and expectations of participants seriously, and by including their values and wishes in the research practice. A possible way forward for attaining such horizontal trust from underrepresented groups is by adjusting to the needs, goals, and values of these groups, by, for example, participatory research. In participatory research these groups are not simple research subjects, but are actively involved, communicated with, or even actively shape and co-create research procedures and goals of research and have influence on the governance of these trials.

Current and emerging global themes in the bioethics of regenerative medicine: the tangled web of stem cell translation

Probably the most serious problem facing the field of regenerative medicine today is the challenge of effective translation and development of viable stem cell-based therapies. Particular concerns have been raised over the growing market in unproven cell therapies. In this article, I explore recent developments in the stem cell therapy landscape and argue that while the sale of unproven therapies undoubtedly poses ethical concerns, it must be understood as part of a larger problem at the interface between biomedicine, healthcare, publics, policy and the market. Addressing this will require a broader perspective incorporating the shifting relationships between different stakeholder groups, the global politics of research and innovation, and the evolving role of publics and patients with respect to science.

Key challenges in bringing CRISPR-mediated somatic cell therapy into the clinic

Editorial summaryGenome editing using clustered regularly interspersed short palindromic repeats (CRISPR) and CRISPR-associated proteins offers the potential to facilitate safe and effective treatment of genetic diseases refractory to other types of intervention. Here, we identify some of the major challenges for clinicians, regulators, and human research ethics committees in the clinical translation of CRISPR-mediated somatic cell therapy.