The need to set explicit goals for human germline gene editing public dialogues.

Given the potentially large ethical and societal implications of human germline gene editing (HGGE) the urgent need for public and stakeholder engagement (PSE) has been repeatedly expressed. However, the explicit goals of such PSE efforts often remain poorly defined. In this program report, we outline the goals of our Dutch project called De DNA dialogen (The DNA dialogues). We believe that setting explicit goals in advance is essential to enable meaningful PSE efforts. Moreover, it enables the evaluation of our engagement efforts. The following four goals, which result from intensive consultations among the transdisciplinary projects' consortium members and based on the literature, form the foundation for how we will engage the public and stakeholders in deliberation about HGGE: 1) Enable publics and stakeholders to deliberate on "what if" questions, before considering "whether" and "how" questions regarding HGGE, 2) Investigate agreement and disagreement in values and beliefs regarding HGGE in order to agree and disagree more precisely, 3) Involve diverse publics with various perspectives, with a focus on those that are typically underrepresented in PSE, 4) Enable societally aligned policy making by providing policymakers, health care professionals and legal experts insight into how values are weighed and ascribed meaning in the context of HGGE by various publics, and how these values relate to the principles of democratic rule of law and fundamental rights. The effort to describe our goals in detail may serve as an example and can inform future initiatives striving for open science and open governance in the context of PSE.

Commercial DNA tests and police investigations: a broad bioethical perspective.

Over 30 million people worldwide have taken a commercial at-home DNA test, because they were interested in their genetic ancestry, disease predisposition or inherited traits. Yet, these consumer DNA data are also increasingly used for a very different purpose: to identify suspects in criminal investigations. By matching a suspect's DNA with DNA from a suspect's distant relatives who have taken a commercial at-home DNA test, law enforcement can zero in on a perpetrator. Such forensic use of consumer DNA data has been performed in over 200 criminal investigations. However, this practice of so-called investigative genetic genealogy (IGG) raises ethical concerns. In this paper, we aim to broaden the bioethical analysis on IGG by showing the limitations of an individual-based model. We discuss two concerns central in the debate: privacy and informed consent. However, we argue that IGG raises pressing ethical concerns that extend beyond these individual-focused issues. The very nature of the genetic information entails that relatives may also be affected by the individual customer's choices. In this respect, we explore to what extent the ethical approach in the biomedical genetic context on consent and consequences for relatives can be helpful for the debate on IGG. We argue that an individual-based model has significant limitations in an IGG context. The ethical debate is further complicated by the international, transgenerational and commercial nature of IGG. We conclude that IGG should not only be approached as an individual but also-and perhaps primarily-as a collective issue.

A Revolution by Stealth: A Legal-Ethical Analysis of the Rise of Pre-Conception Authorization of Surrogacy Agreements.

This article offers a legal-ethical analysis of recent UK and Dutch proposals to regulate surrogacy proactively through a national system of pre-conception authorization of surrogacy agreements. Within such a system, authorities are already before conception called upon to examine and assess contractual arrangements between the intending parents and the prospective surrogate mother. This regulatory approach is presented by its advocates as a win-win for all parties involved; as bringing family law in line with the changed social reality of creating families; and as maintaining a non-permissive approach toward commercial surrogacy. In this article, we critically examine these claims. Our analysis suggests that the proposed systems may result in the facilitation of surrogacy practices with commercial, commodifying and exploitative dimensions. Moreover, although these frameworks are presented as merely regulating something that is already taking place, they silently introduce a radically new and, as we shall argue, highly problematic legal-ethical approach to surrogacy.

Accessing medical biobanks to solve crimes: ethical considerations.

Millions of human biological samples are stored worldwide for medical research or treatment purposes. These biospecimens are of enormous potential value to law enforcement as DNA profiles can be obtained from these samples. However, forensic use of such biospecimens raises a number of ethical questions. This article aims to explore ethical issues of using human bodily material in medical biobanks for crime investigation and prosecution purposes. Concerns about confidentiality, trust, autonomy and justice will be discussed. We explore how to balance these concerns against the importance of crime solving. Relevant case examples of forensic use of medical biobanks show that requests by law enforcement to access biobanks are handled in disparate ways. We identify some core ethical issues and conclude that further research on these issues is needed to provide ethical guidance.

Rewriting the human genome, rewriting human rights law? Human rights, human dignity, and human germline modification in the CRISPR era.

In most legal orders, human germline modification is either prohibited or severely restricted. A recurring thought in these legal frameworks is that heritable genome editing would result in practices that are at odds with principles of human rights, such as dignity, justice, and equality. However, now that CRISPR is bringing heritable genome editing within human reach, the question has risen as to whether these human rights bans still make sense. The call is growing louder to lift the ban on heritable genome editing for therapeutic purposes as soon as the technology is safe for introduction in the clinic. This article critically examines these recent proposals from a human rights perspective. First, it examines the question as to how realistic the proposed distinction between the therapeutic and the nontherapeutic uses of human germline modification is in the CRISPR era. Second, it argues that these proposals rely on a one-dimensional understanding of the meaning of human rights for this issue. Finally, it suggests that this one-dimensional understanding paves the way for a regime of self-regulation by the scientific community that leaves little room for public debate on the question as to whether or how human germline modification fits in the long-term aspirations of society.

Is Europe 'giving in to baby markets?' Reproductive tourism in Europe and the gradual erosion of existing legal limits to reproductive markets.

The main question in this article is how national legal orders in Europe, given their often restrictive laws on reproductive markets and assisted reproductive technologies (ARTs), are currently responding and should respond to reproductive tourism, in light of the fact that access to foreign reproductive markets seems to be making these national laws 'merely symbolic'. Although many national governments have finally managed after many years of political and legal struggles to establish a carefully balanced legal framework for the regulation of these often ethically and religiously sensitive matters, ironically reproductive travel seems to be turning national reproductive laws into a dead letter. Currently, as a reaction to these developments, new legal strategies are being proposed and explored. Within the European context, the view is gaining ground that laws that curb international reproductive markets and their accompanying streams of fertility tourism have become ineffective, meaningless, and even harmful. As a result, a certain tendency towards tolerance of reproductive markets and reproductive travel can be detected in both politics and academia. According to this line of reasoning, restrictive and prohibitive legislation should be replaced by more pragmatic policies that take the realities of reproductive markets as a starting point. From this perspective, the legal restrictions within the country of origin, rather than the lack of regulation in the country of destination, should be regarded as the core of the problem. As a result, an increasing number of scholars and policy makers are arguing for more lenient national policies towards ARTs, hoping to thereby remove the main incentive for aspiring parents to resort to foreign reproductive services. This emerging pragmatic strategy of tolerance towards reproductive tourism and international reproductive markets rests on three arguments, which are each critically examined in this article. Although these arguments offer valuable insights, several disadvantages and weaknesses tend to be overlooked. The critical examination of these pragmatic arguments is followed by a plea for a more positive understanding and recognition of the symbolic dimensions of reproductive legislation. It is argued that ART laws also have an important communicative, expressive and anthropological meaning and function, which surpass these laws' practical effectiveness. Alternatively, policies based on the pragmatic tolerance of reproductive markets show significant shortcomings, which also need to be taken into consideration by national governments when evaluating existing ART laws.