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This research presents the results of a study about people with failed metal-on-metal hip implants, and draws on the STS concept of the technological imperative alongside research on the value of patient knowledge in clinical settings and the legitimacy of embodied stories. Popularly understood as positive and life changing, hip replacement surgery was hailed as 'the operation of the century', until a series of widespread failures of hundreds of thousands of hip implants, known collectively as metal-on-metal (MoM) hips, drew attention to the poor regulation of medical implants. This paper argues that poor regulation intersects with narratives of patients' pain, which are obstructed by surgeons and the UK regulatory body, with the effect of denying both patients' embodied experiences of implant failure, and their restitution to good health. Patient narratives about problems with their hip implant are the wellspring from which scientific evidence emerges which can indicate widespread implant failure. By obstructing these narratives the regulatory system undermines the very evidence it needs to operate effectively. [ABSTRACT FROM AUTHOR]

ABSTRACT In this paper we argue that the consensus around normative standards for the ethics of research in clinical trials, strongly influenced by the Declaration of Helsinki, is perceived from various quarters as too conservative and potentially restrictive of research that is seen as urgent and necessary. We examine this problem from the perspective of various challengers who argue for alternative approaches to what ought or ought not to be permitted. Key themes within this analysis will examine these claims and argue they have implications for the interests of the research subject, research governance and regulation. Using our work with TREAT-NMD, the neuromuscular clinical trials network, we posit that there is a place for advancing the discourse of moral rights and moral duties in the context of research, especially from the perspective of patients and their families, and for including the politics of patient activism and empowerment. At the same time we remain vigilant to the danger that the therapeutic misconception and other serious vulnerabilities for the patient population in clinical trials, are at risk of being overlooked. [ABSTRACT FROM AUTHOR]

There is a growing international agreement on the need to provide greater access to research data and bio-specimen collections to optimize their long-term value and exploit their potential for health discovery and validation. This is especially evident for rare disease research. Currently, the rising value of data and bio-specimen collections does not correspond with an equal increase in data/sample-sharing and data/sample access. Contradictory legal and ethical frameworks across national borders are obstacles to effective sharing: more specifically, the absence of an integrated model proves to be a major logistical obstruction. The Charter intends to amend the obstacle by providing both the ethical foundations on which data sharing should be based, as well as a general Material and Data Transfer Agreement (MTA/DTA). This Charter is the result of a careful negotiation of different stakeholders' interest and is built on earlier consensus documents and position statements, which provided the general international legal framework. Further to this, the Charter provides tools that may help accelerate sharing. The Charter has been formulated to serve as an enabling tool for effective and transparent data and bio-specimen sharing and the general MTA/DTA constitutes a mechanism to ensure uniformity of access across projects and countries, and may be regarded as a consistent basic agreement for addressing data and material sharing globally. The Charter is forward looking in terms of emerging issues from the perspective of a multi-stakeholder group, and where possible, provides strategies that may address these issues. [ABSTRACT FROM AUTHOR]