Research led by participants: a new social contract for a new kind of research.

In recent years, there have been prominent calls for a new social contract that accords a more central role to citizens in health research. Typically, this has been understood as citizens and patients having a greater voice and role within the standard research enterprise. Beyond this, however, it is important that the renegotiated contract specifically addresses the oversight of a new, path-breaking approach to health research: participant-led research. In light of the momentum behind participant-led research and its potential to advance health knowledge by challenging and complementing traditional research, it is vital for all stakeholders to work together in securing the conditions that will enable it to flourish.

Between Rocks and Hard Places: Good Governance in Ethically Divided Communities.

This article, prompted by Heidi Crowter's campaign to eliminate the discriminatory aspects of current abortion law, outlines the challenges to good governance in a context of bioethical plurality. First, the nature of the plurality is sketched. Secondly, some reflections are presented on how those who have governance responsibilities might ease the tensions engendered by the plurality; and, at the same time, how the discontented governed might reasonably press their views. Thirdly, a model of good governance (demanding integrity by those who govern and respect for the global commons) is introduced. The conclusion is that good faith governance merits our respect, but it does not guarantee particular outcomes or positions that will meet with the approval of all bioethical constituencies or individuals. Accordingly, we have to learn not only to live with rocks and hard places but also to find civilized ways of debating our differences.

The ethics of screening for abdominal aortic aneurysm in men.

Approximately 6000 men die every year from ruptured abdominal aortic aneurysm in England and Wales. Randomised clinical trials and a large pilot study have shown that ultrasound screening of men aged 65 years can prevent about half of these deaths. However, there is a significant perioperative morbidity and mortality from interventions to repair the detected aneurysm. This paper explores the ethical issues of screening men for abdominal aortic aneurysm. It is concluded that a population screening programme for abdominal aortic aneurysm offers a clear balance of good over harm. It is therefore ethically justified, as long as men are given adequate information at every stage of the process. Each man has the right to be properly informed, regardless of whether he accepts the invitation to be screened and, if an aneurysm is detected, whether or not he accepts treatment.

Human dignity, biolaw, and the basis of moral community.

This paper argues that the concept of human dignity, as currently contested, offers no clear guidance to lawmakers. Within the "bioethical triangle", human dignity has a quite different significance depending upon whether one is a utilitarian, a human rights theorist, or a dignitarian. Having rejected the possibility of an easy accommodation between these views, it is suggested that we should conceive of human dignity as a precondition for (any form of) moral community--specifically, a setting in which humans try to do the right thing and accept responsibility for their freely chosen actions. If lawmakers re-focus on human dignity in this way, they will have some important guidance in the face of a raft of emerging technologies.

Correction to: The Right to Know and the Right Not to Know Revisited.

[This corrects the article DOI: 10.1007/s41649-017-0012-1.].

The ancillary-care responsibilities of researchers: reasonable but not great expectations.

This paper argues that, in a community of rights, the prima facie responsibilities of researchers to attend to the ancillary-care needs of their participants would be determined by a four-stage test (relating to placement, capacity, reasonable imposition, and fair demand). This test, it is suggested, sets a standard (and an example) for common law courts that are invited to recognize the ancillary-care responsibilities of researchers, whether as a matter of contract or tort law.

The Right to Know and the Right Not to Know Revisited: Part One.

Prompted by developments in human genetics, a recurrent bioethical question concerns a person's 'right to know' and 'right not to know' about genetic information held that is intrinsically related to or linked to them. In this paper, we will revisit the claimed rights in relation to two particular test cases. One concerns the rights of the 500,000 participants in UK Biobank (UKB) whose biosamples, already having been genotyped, will now be exome sequenced, and the other concerns the rights of pregnant women (and their children) who undergo non-invasive prenatal testing (NIPT)-a simple blood test that can reveal genetic information about both a foetus and its mother. This two-part paper is in four principal sections. First, we sketch the relevant features of our two test cases. Secondly, we consider the significance of recent legal jurisprudence in the UK and Singapore. Thirdly, we consider how, the jurisprudence apart, the claimed rights might be grounded. Fourthly, we consider the limits on the rights. We conclude with some short remarks about the kind of genetically aware society that we might want to be and how far there is still an opportunity meaningfully to debate the claimed rights.

Impact of detecting potentially serious incidental findings during multi-modal imaging.

Background: There are limited data on the impact of feedback of incidental findings (IFs) from research imaging.  We evaluated the impact of UK Biobank's protocol for handling potentially serious IFs in a multi-modal imaging study of 100,000 participants (radiographer 'flagging' with radiologist confirmation of potentially serious IFs) compared with systematic radiologist review of all images. Methods: Brain, cardiac and body magnetic resonance, and dual-energy x-ray absorptiometry scans from the first 1000 imaged UK Biobank participants were independently assessed for potentially serious IFs using both protocols. We surveyed participants with potentially serious IFs and their GPs up to six months after imaging to determine subsequent clinical assessments, final diagnoses, emotional, financial and work or activity impacts. Results: Compared to systematic radiologist review, radiographer flagging resulted in substantially fewer participants with potentially serious IFs (179/1000 [17.9%] versus 18/1000 [1.8%]) and a higher proportion with serious final diagnoses (21/179 [11.7%] versus 5/18 [27.8%]). Radiographer flagging missed 16/21 serious final diagnoses (i.e., false negatives), while systematic radiologist review generated large numbers of non-serious final diagnoses (158/179) (i.e., false positives). Almost all (90%) participants had further clinical assessment (including invasive procedures in similar numbers with serious and non-serious final diagnoses [11 and 12 respectively]), with additional impact on emotional wellbeing (16.9%), finances (8.9%), and work or activities (5.6%). Conclusions: Compared with systematic radiologist review, radiographer flagging missed some serious diagnoses, but avoided adverse impacts for many participants with non-serious diagnoses. While systematic radiologist review may benefit some participants, UK Biobank's responsibility to avoid both unnecessary harm to larger numbers of participants and burdening of publicly-funded health services suggests that radiographer flagging is a justifiable approach in the UK Biobank imaging study. The potential scale of non-serious final diagnoses raises questions relating to handling IFs in other settings, such as commercial and public health screening.

Human dignity: a guide to policy making in the biotechnology era?

This article explores the ways in which human dignity is used in debates about controversial biotechnologies, including biobanks, human gene patents, stem cell research and human cloning. Increasingly, human dignity is used as a form of general condemnation and as blanket justification for regulatory restraint. However, this use of human dignity marks a significant departure from the traditional, human-rights informed view of human dignity that has dominated bioethics debates for decades. In addition, on its own, it stands as dubious justification for policies that are aimed at constraining controversial biotechnologies.