This section focuses on the ethical, legal, social, and policy questions arising from research involving human and animal subjects.

Concurrent with the rise of digital health and personal health tracking technologies, a market has also emerged of products targeted specifically at women: ‘femtech’. This article is motivated by the concern that insufficient regulatory attention has been devoted to this growing market, and that extant ambiguity in the regulation of femtech leaves its users at risk of relying on technologies of as-yet unproven worth. It is posited that femtech profoundly disrupts well-established regulatory mechanisms of protection in ways that mean that these silos of protection will not be adequate. This is because regulation, as it is currently constructed, is insufficiently sensitive to feminist perspectives regarding what these technologies mean for women. As a result, the regulatory sphere in which femtech operates fundamentally fails to ensure that the health and safety of femtech users are protected as this market continues to expand. To counteract this, the argument is made that an appropriate regulatory response to femtech must respond to the distinctive unmet need in the regulation of this technological realm and the acute risk that femtech poses. This must include a multidimensional whole-system approach grounded in feminist perspectives on health, fertility, and technology.

Biomedicine and the life sciences continuously rearrange the relationship between culture and biology. In consequence, we increasingly look for a suitable regulatory response to reduce perceived uncertainty and instability. This article examines the full implications of this 'regulatory turn' by drawing on the anthropological concept of liminality. We offer the term 'regulatory compression' to characterise the effects of extant regulatory approaches on health research practices. With its focus on transformation and the 'in-between', liminality allows us to see how regulatory frameworks rely on a silo-based approach to classifying and regulating research objects such that they: (1) limit the flexibility necessary in clinical and laboratory research; (2) result in the emergence of unregulated spaces that lie between the bounded regulatory spheres; and (3) curtail modes of public participation in the health research enterprise. We suggest there is a need to develop the notion of 'processual regulation', a novel framework that requires a temporal-spatial examination of regulatory spaces and practices as these are experienced by all actors, including the relationship of actors with the objects of regulation.

European and international regulation of human health research is typified by a morass of interconnecting laws, diverse and divergent ethical frameworks, and national and transnational standards. There is also a tendency for legislators to regulate in silos-that is, in discrete fields of scientific activity without due regard to the need to make new knowledge as generalisable as possible. There are myriad challenges for the stakeholders-researchers and regulators alike-who attempt to navigate these landscapes. This Delphi study was undertaken in order to provide the first interdisciplinary and crosscutting analysis of health research regulation, as it is experienced by such stakeholders in the UK context. As well as reinforcing existing understandings of the regulatory environment, Delphi participants called for greater collaboration, and even co-production, of processes involved in health research regulation. On the basis of this research, we offer insights about how health research regulation can become a matter with which a wider range of stakeholders-including researchers, regulators, publics and research sponsors-can engage. The evidence supports the normative claim that health research regulation should continue to move away from strict, prescriptive rules-based approaches, and towards flexible principle-based regimes that allow researchers, regulators and publics to coproduce regulatory systems serving core principles. By unpacking thorny concepts and practices at the heart of health research regulation-including the public interest and public engagement-our results have the potential to situate and breathe life into them. The results also demonstrate that while proportionality is well-recognised as a crucial element of flexible regulatory systems, more must be done to operationalise this as an ethical assessment of the values and risks at stake at multiple junctures in the research trajectory. This is required if we are to move beyond proportionality as a mere risk-management tool. Compliance culture no longer accurately reflects the needs and expectations of researchers or regulators, nor does it necessarily produce the best research. Embracing uncertainty-both as a human practice and a regulatory objective-may represent the brighter future for health research.

Contraceptives are vital healthcare for women and people with wombs. Recently, there has been a rise in the use of ‘digital contraceptives’, a type of ‘femtech’ software available for download on app stores which require data input in order to make predictions about users’ fertility. Digital contraceptives, when marketed as such, fall within the definition of a ‘medical device’ and under the authority of the Medical Devices Regulations 2002 are a ‘medium-risk’ device. However, not all femtech which may be used as contraception are captured by this framework. In this article, it is argued that the regulatory category into which digital contraceptives have been placed by the medical devices regime is (a) unduly limited in scope, (b) insufficiently stringent to protect users considering the grave and life-changing effects this technology can have if things go wrong, and (c) ill-conceived as a regulatory response to a technology that affects large sections of the population. It is suggested here that the broader context in which software as a contraceptive sits (i.e. within the general contraceptive market) is key to understanding the regulatory blindness that is occurring when it comes to digital contraceptives and some other forms of fertility-related femtech. As such, software which can be used as a contraceptive are in fact ‘high risk’ and should be reclassified as such.